Category Archives: Cell Therapy

According to hematologists/oncologists, the current referral processes at tertiary sites have made it challenging to refer patients for chimeric antigen receptor (CAR) T-cell therapy. Other challenges identified with the referral process may also limit future outpatient CAR T-cell administration, according to the physicians surveyed.

The community physicians were a part of a cross-sectional survey conducted by Cardinal Health Specialty Solutions with the overarching goal of understanding how physicians perceive barriers to in-office CAR T-cell infusion and the factors that physicians consider when deciding to refer patients to undergo CAR T-cell therapy at a tertiary site.

CAR T-cell therapy is a new and innovative treatment approach that has been FDA approved in multiple hematologic malignancies, and because of its importance in treatment for hematologic malignancies, the surveyors though it important to gather data from the physician population. Further, there is a known disparity around the availability of CAR T-cell therapy in rural vs suburban settings that has not been well described in prior research.

This is observational research, which Cardinal has had more than a decade experience conducting. Some of that research actually does require physicians abstracting charts of patients. In some cases, it's combining that charge abstraction with understanding physician perceptions and physicians experiences. And so, we're able to not only know and look at the sequence of events, but we're also able to address the why behind those choices and those sequence of events. So, the work that we do is often trying to get physicians to give us that firsthand account. What was the patient experience? What led you to make this choice in treatment? What were the potential barriers to exercising that choice of treatment? What were the patient outcomes from that choice? explained Bruce Feinberg, DO, vice president, chief medical officer Cardinal Health Specialty Solutions, in an interview with Targeted Oncology. Often, we don't get that full story because when we're looking at only the clinical trials, we really see just that episode of care around the treatment itself, we see what happened at that institution when the CAR T cells were administered, not the story that led up to it or the story that follows when those patients returned to the community.

Characteristics of the physician population showed that 22.1% were from large, privately owned community practices, 13.2% were from small, privately owned community practices a, 5.9% were from medium, privately owned, community practices, and 1.5% were from solo, privately owned, community practices.The population also included physicians from academic centers or affiliated teaching hospitals (32.4%), community-based hospitals (7.4%), and medical centers or cancer centers (2.9%).

In terms of primary medical specialty, the majority of the physicians who responded to the survey were hematologists (64.7%), with the rest being either medical oncologists (33.8%), or other (1.5%). The mean years in practice among the survey responders was 9.7 years (range 2-43).

According to the survey results, most physicians (39%) referred 2 to 5 patients to a certified CAR T-cell treatment center to receive commercially available and FDA-approved CAR T cells in the past 3 years. Notably, 27% of physicians did not refer any patients to received CAR T-cell therapy, 20% referred 1 patient, 4% referred 6 to 10 patients, another 4% referred 11 to 15 patients, and 6% referred greater than 15 patients.

Physicians have 9 options for which type of CAR T-cell treatment center they are most likely to refer patients to and why. The top 4 responses showed that center reputation and location were the key factors.

Other factors, such as quick responses from the referral center, a CAR T-cell therapy supported by more published research, recommendations from colleagues, knowledge of CAR T-cell therapy, and patient eligibility, were less impactful on the physicians decision making.

In terms of the second survey goal, physicians have 5 options of CAR T-cell administration setting they utilize. Forty-seven percent of responders said their practice does not administer CAR T-cell therapy, 25% administer them at the hospital and have no intention on performing in-office infusions, 20% administer in the hospital but are considered in-office infusion, 6% perform in-office CAR T-cell therapy infusions, and 2% do both hospital and in-office infusions.

The top barriers to performing in-office CAR T-cell therapy administration were the ability to manage acute/immediate complications of treatment (78%), concerns around in-patient hospitalization within 2 hours after CAR T-cell infusion (66%), as well as lack of knowledge of the infusion process or CAR T cells, challenges with billing and reimbursement, and prior authorization/payer approval (38% each).

The barriers that we have witnessed are those barriers we've seen before. [The barriers are] having an educated community workforce of healthcare providers who are knowledgeable about these treatments, an academic, tertiary care environment, where they remove all the barriers to those patient referrals, and hopefully patients who understand to some degree that complexity of the program, so that they will be willing to undergo consent for those procedures. Each of those barriers exist, but each of those barriers has been seen before, and we can really rely on past experiences to help guide us forward, said Feinberg.

Because few practices are performing in-office CAR T-cell administration and there is a growing interest in doing so, Feinberg et al recommend stakeholder alignment to address the concerns of the oncology population.

REFERENCE:

Pink S, Deune-Smith Y, Klink AJ, et al. Community hematologist/oncologist (CH/O) barriers to CAR T referral and concerns with possible in-office car-t administration. Presented at: 2022 International Society for Pharmacoeconomics and Outcomes Research; May 15-18, 2022. Washington, DC. Abstract HSD44.

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Community Providers Face Hurdles With CAR T-Cell Therapy Referrals and In-Office Infusion - Targeted Oncology

-- Largest Analysis Examining Use of CAR T-cell Therapy Across Race and Ethnicity --

-- Black or African American Patients Experienced Longer Time from Diagnosis to Infusion Compared to White Patients, Possibly Impacting Overall and Complete Response Rates; More Study Warranted --

-- Clinical Trials of Yescarta in the U.S. and Real-World Use from CIBMTR Registry Show Consistent Participation of Approximately 5% Black or African American Patients --

SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite, a Gilead Company (Nasdaq: GILD), today announced findings from a safety and efficacy retrospective analysis by race and ethnicity from the ongoing post-authorization study of Yescarta (axicabtagene ciloleucel) in adult patients with relapsed or refractory large B-cell lymphoma (LBCL). In the largest real-world analysis of its kind evaluating data from the CIBMTR (Center for International Blood and Marrow Transplant Research), overall outcomes including overall survival (OS) and progression-free survival (PFS) rates were consistent with Yescarta in the real-world setting, regardless of race and ethnicity. The findings were presented today in an oral session during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #7571).

The incidence of diffuse LBCL in the U.S. is 4.8 per 100,000 per year in non-Hispanic Black or African Americans and 7.1 per 100,000 per year in non-Hispanic Whites. Clinical trials of Yescarta in the U.S. have enrolled an average of 6% Black or African American patients, consistent with the roughly 5% of patients in the real-world CIBMTR registry.* Further research is ongoing to investigate whether or not there is under-representation by race and ethnicity in both clinical trials and the real-world usage of CAR T-cell therapy.

The investigation of CAR T-cell therapy outcomes by race and ethnicity is important to the continued understanding of the impact of these innovative therapies, and an area in which there is a significant deficit in clinical trials and real-world studies published to date, said Frederick L. Locke, MD, lead author and Co-Leader of the Immuno-Oncology Program at Moffitt Cancer Center, Tampa, Florida. The results of this analysis are encouraging in that axi-cel was safe and effective regardless of race or ethnicity, and also warrant further investigation to understand the lower rate of response among Black or African American patients and the potential role of factors such as higher disease burden, disease biology and, importantly, differential access to care.

A total of 1,389 adult patients with LBCL treated with Yescarta in the commercial setting in the U.S. from October 2017 to August 2020 were included in the analysis. Race and ethnicity (Hispanic or Latino vs. not Hispanic or Latino) were self-reported and included: White (81%); Black or African American (5%); Asian (6%); American Indian or Alaska Native <1%; Native Hawaiian or other Pacific Islander <1%; More than one race <1%; Race not reported (7%). Eleven percent of patients evaluated self-identified as Hispanic or Latino.

At a median follow-up of 12.7 months, outcomes for objective response rate (ORR), complete response (CR), duration of response (DOR) at 6 months, PFS at 12 months, and OS were as follows:

Black orAfrican American

Asian

White

Hispanicor Latino

Objective response rate (ORR)

57%

67%

74%

73%

Complete response (CR)

45%

53%

57%

55%

Duration of response (DOR; 6-month)

66%

81%

70%

71%

PFS at 12 months

36%

55%

48%

50%

OS at 12 months

62%

65%

63%

65%

Multivariable analyses found no statistical differences in OS and PFS across races. Efficacy outcomes across patients who were Hispanic or Latino and not Hispanic or Latino were also consistent. Among Black or African American patients, ORR and CR were lower compared to White patients [(Odds Ratio (OR) 0.40; 95% Confidence Interval [CI], 0.240.69) and (OR 0.55; 95% CI 0.320.93), respectively]. Black or African American patients, compared to White patients, were more likely to have moderate to severe pulmonary impairment (41% vs. 28%) and tended to have a longer time from diagnosis to infusion of Yescarta (12 months: 71% vs. 59%). DOR rates among Asian patients were more favorable compared to both White patients (Hazard Ratio (HR) 0.46; 95% CI 0.240.87) and Black or African American patients (HR 0.39; 95% CI 0.170.88). No differences in cytokine release syndrome (CRS; any grade) and Grade 3 CRS by race and ethnicity were observed. Asian patients (OR 0.52; 95% CI 0.290.96 vs. White) and Hispanic or Latino patients (OR 0.51; 95% CI 0.310.85 vs. not Hispanic or Latino) experienced a lower risk of Grade 3 ICANS (ASTCT consensus grade).

As the global leader in CAR T-cell therapy, it is important to Kite that we support research to help better understand outcomes of CAR T-cell therapy across different races and ethnicities, said Frank Neumann, MD, PhD, SVP & Global Head of Clinical Development, Kite. Through ongoing data generation, increasing diversity in Kites clinical trials, and partnerships with patient advocacy organizations and community partners to reduce barriers to care, we are actively working to increase our understanding of CAR T-cell therapy in diverse populations and treatment settings.

Yescarta was the first CAR T-cell therapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy. Yescarta was also approved by the FDA in April 2022 as the first CAR T-cell therapy for adult patients with LBCL that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. The Yescarta U.S. Prescribing Information has a BOXED WARNING for the risks of CRS and neurologic toxicities, and Yescarta is approved with a Risk Evaluation and Mitigation Strategy (REMS) due to these risks; see below for Important Safety Information.

*Average is based on combined enrollment in ZUMA-1 and ZUMA-7 trials. Terminology for self-reporting of race has changed during the time period of these trials.

About LBCL

Globally, LBCL is the most common type of non-Hodgkin lymphoma (NHL). In the United States, more than 18,000 people are diagnosed with LBCL each year. The incidence of diffuse LBCL per 100,000 people per year in the U.S. is 4.8 in non-Hispanic Black or African American, 7.1 in non-Hispanic White, 6.8 in Hispanic or Latino, and 5.9 in Asian/Pacific Islander populations, respectively.

About Yescarta

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

CYTOKINE RELEASE SYNDROME (CRS)

CRS, including fatal or life-threatening reactions, occurred. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL), including Grade 3 in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including Grade 3 in 9%. Among patients with LBCL who died after receiving YESCARTA, 4 had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1-12 days) and the median duration was 7 days (range: 2-58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1-10 days) and the median duration was 7 days (range: 2-43 days). CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including Grade 3 in 8%. Among patients with iNHL who died after receiving YESCARTA, 1 patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1-20 days) and the median duration was 6 days (range: 1-27 days) for patients with iNHL.

Key manifestations of CRS ( 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1-8 days) and the median duration of CRS was 7 days (range: 2-16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS and were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing Grade 3 CRS. The median time to onset of CRS was 5 days (range: 1-15 days) and the median duration of CRS was 4 days (range: 1-10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities.

Ensure that 2 doses of tocilizumab are available prior to YESCARTA infusion. Monitor patients for signs and symptoms of CRS at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

NEUROLOGIC TOXICITIES

Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life-threatening occurred. Neurologic toxicities occurred in 78% (330/422) of all patients with NHL receiving YESCARTA, including Grade 3 in 25%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including Grade 3 in 31% and in 74% (124/168) of patients in ZUMA-7 including Grade 3 in 25%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range: 1-133 days) and the median duration was 15 days in patients with LBCL in ZUMA-7. Neurologic toxicities occurred in 77% (112/146) of patients with iNHL, including Grade 3 in 21%. The median time to onset was 6 days (range: 1-79 days) and the median duration was 16 days. Ninety-eight percent of all neurologic toxicities in patients with LBCL and 99% of all neurologic toxicities in patients with iNHL occurred within the first 8 weeks of YESCARTA infusion. Neurologic toxicities occurred within the first 7 days of infusion for 87% of affected patients with LBCL and 74% of affected patients with iNHL.

The most common neurologic toxicities ( 10%) in all patients combined included encephalopathy (50%), headache (43%), tremor (29%), dizziness (21%), aphasia (17%), delirium (15%), and insomnia (10%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including aphasia, leukoencephalopathy, dysarthria, lethargy, and seizures occurred. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41), and 20% (8/41) had Grade 3 neurologic toxicities; no patients experienced a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those patients, 85% (33/39) developed neurologic toxicities, 8% (3/39) developed Grade 3, and 5% (2/39) developed Grade 4 neurologic toxicities. The median time to onset of neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 days). Prophylactic corticosteroids for management of CRS and neurologic toxicities may result in a higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay the onset of and decrease the duration of CRS.

Monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly.

REMS

Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that: Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA are trained in the management of CRS and neurologic toxicities. Further information is available at http://www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).

HYPERSENSITIVITY REACTIONS

Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of YESCARTA.

SERIOUS INFECTIONS

Severe or life-threatening infections occurred. Infections (all grades) occurred in 45% of patients with NHL; Grade 3 infections occurred in 17% of patients, including Grade 3 infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 36% of all patients with NHL and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS

Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. Grade 3 cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA

B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment.

SECONDARY MALIGNANCIES

Secondary malignancies may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

ADVERSE REACTIONS

The most common non-laboratory adverse reactions (incidence 20%) in patients with LBCL in ZUMA-7 included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with an unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting.

The most common adverse reactions (incidence 20%) in patients with LBCL in ZUMA-1 included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections with an unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

The most common non-laboratory adverse reactions (incidence 20%) in patients with iNHL in ZUMA-5 included fever, CRS, hypotension, encephalopathy, fatigue, headache, infections with an unspecified, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with manufacturing operations in North America and Europe. Kites singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit http://www.kitepharma.com.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Kite and Gilead to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Yescarta; the risk that physicians and patients may not see the potential benefits of Yescarta; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gileads Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Kite and Gilead, and Kite and Gilead assume no obligation and disclaim any intent to update any such forward-looking statements.

U.S. Prescribing Information for Yescarta including BOXED WARNING, is available at http://www.kitepharma.com and http://www.gilead.com.

Kite, the Kite logo, Yescarta, Tecartus, XLP and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.

For more information on Kite, please visit the companys website at http://www.kitepharma.com. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220603005447/en/

Jacquie Ross, Investorsinvestor_relations@gilead.com

Anna Padula, Mediaapadula@kitepharma.com

Source: Gilead Sciences, Inc.

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Yescarta CAR T-cell Therapy Demonstrates Consistent Survival Outcomes and Safety in Real-World Setting Regardless of Race and Ethnicity - Gilead...

For certain side effects of complex and lifesaving medical procedures, care teams can be left with limited and risky treatment options, but a program at UW Health is changing that using patients own cells as living therapeutics.

In 2017, the UW Program for Advanced Cell Therapy (PACT), in partnership with the UW Carbone Cancer Center, began examining this possibility and recently treated its first patients in a first-of-its-kind clinical trial to treat dry mouth technically termed xerostomia which is a serious side effect that can arise after radiation therapy in head and neck cancer patients.

Emily Kumlien(608) 516-9154ekumlien@uwhealth.org

What seems like a minor annoyance on a hot day is a common and major hindrance to quality of life for patients following radiation treatment, according to Dr. Jacques Galipeau, director, PACT.

Patients who have dry mouth struggle to eat, sleep and speak, on top of the pain, fatigue and tooth decay it can cause, he said. Now we have something that has the potential to treat this without any serious side effects.

The new therapy uses a special kind of cell from the bodys bone marrow called interferon-gamma activated marrow stromal cells. Once the cells are collected with a needle from the liquid part of bone marrow (the spongy material inside bones that generates red blood cells), they are processed and a crop of cells are grown at PACTs pharmaceutical-grade cell manufacturing facility at University Hospital. Then, the cells are injected into saliva-producing glands to replenish the tissue and restore function.

The PACT dry mouth trial is led by Dr. Randy Kimple, associate professor of human oncology, UW School of Medicine and Public Health. Kimple and his team will enroll about 20 people in the trial.

Currently, the only options to help these patients is to ask them to consume specifically prepared food, suck on sugar-free candy and drink water frequently, Kimple said.

We can do better than this for these patients, he said. We are at the starting line, and if this proves safe, we will start testing efficacy and soon we hope to have the best possible alternative to make their lives as comfortable as we can.

Philanthropy can help expand the scope of this studys future phases, and other novel clinical trials conducted by PACT researchers. Other studies include research investigating the use of mesenchymal stromal cells to prevent cytomegalovirus reinfection in kidney transplant and bone marrow transplant patients, for example. The impact of such research is tremendous but it takes resources to make it a reality, Galipeau said.

The help of outside funding is critical to our work, he said. We have the ideas and the technology, but to help the largest number of people the fastest, its going to take investment.

Philanthropy helps expand research of this type, and highlights the vital importance of the recently announced Wisconsin Medicine philanthropic campaign designed to invest in the future of health and enable researchers and providers to revolutionize cell therapy and other medical science and health care.

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The future of cell therapy: Novel study tests treatment for radiation-induced dry mouth - University of Wisconsin School of Medicine and Public Health

Latest analysis from the Cancer Research Institute of the global landscape of cellular immunotherapies, including R&D trends and real-world usage, highlights key challenges including effective solid tumor targeting, manufacturing complexities, and commercial access to approved therapies

Newswise NEW YORK, June 1, 2022 The Cancer Research Institute (CRI), a nonprofit organization dedicated to the discovery and development of powerful immunotherapies for all types of cancer, announced today the publication of its newest analysis of the global landscape of cellular immunotherapies, including R&D trends and real-world usage data. The report, published today in Nature Reviews Drug Discovery, highlights trends in cellular immunotherapy for cancer including top modalities, targets, clinical development, and data from patients receiving CAR-T therapies in clinical practice. This report is an update to CRIs prior cellular immunotherapy landscape analysis published in July 2021.

In this analysis, author Samik Upadhaya, Ph.D., assistant director of scientific affairs and member of the Anna-Maria Kellen Clinical Accelerator team at CRI, and colleagues provide an update on the overall status of the cellular cancer immunotherapy landscape as well as observations on key changes within the field including clinical practice. Findings include:

This latest report from the Cancer Research Institute, titled, Landscape of cancer cell therapies: trends and real-world data, was generated in collaboration with IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, which provided the authors with access to IQVIAs proprietary clinical trials database. The report is part of a suite of CRI-owned immuno-oncology landscape analyses that includes reports on cell therapy drug development and the broader IO landscape including clinical development of checkpoint inhibitors, cancer vaccines, and oncolytic viruses in addition to bispecific antibodies and other immunomodulators.

To access an interactive dashboard of the Cancer Research Institutes cancer cell immunotherapy report, visit the CRI website at cancerresearch.org/cell-therapy.

Reference: Saez-Ibaez AR et al. Landscape of cancer cell therapies: trends and real-world data. Nat. Rev. Drug Discov. https://www.nature.com/articles/d41573-022-00095-1

About the Cancer Research Institute The Cancer Research Institute (CRI), established in 1953, is a highly rated U.S. nonprofit organization dedicated exclusively to saving more lives by fueling the discovery and development of powerful immunotherapies for all cancers. Guided by a world-renowned Scientific Advisory Council that includes four Nobel laureates and 27 members of the National Academy of Sciences, CRI has invested $474 million in support of research conducted by immunologists and tumor immunologists at the worlds leading medical centers and universities and has contributed to many of the key scientific advances that demonstrate the potential for immunotherapy to change the face of cancer treatment. To learn more, go to cancerresearch.org.

About the Anna-Maria Kellen Clinical Accelerator CRIs clinical program, the Anna-Maria Kellen Clinical Accelerator is a unique academic-nonprofit-industry collaboration model that serves an as incubator that delivers multicenter clinical trials of promising new immunotherapy combinations. CRIs venture philanthropy fund supports clinical trials within the program, which fosters a collaborative environment that enables scientists to advance their most ambitious research ideas by accelerating studies that one group or company could not do alone. To learn more, go to cancerresearch.org/clinical-accelerator.

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Cellular Cancer Immunotherapy Clinical Development Continues to Evolve and Expand with Novel Technologies and Targets, New Report From Cancer Research...

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Yescarta Car T-Cell Therapy Demonstrates Consistent Survival Outcomes And Safety In Real-World Setting Re - Benzinga

- Omidubicel is a first-in-class, advanced NAM-enabled stem cell therapy candidate being evaluated as the first potential allogeneic advanced cell therapy donor source for patients with blood cancers in need of a transplant

- Omidubicel has Orphan Drug Designation and Breakthrough Therapy Designation -

BOSTON, June 02, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, today announced completion of the rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for omidubicel for the treatment of patients with blood cancers in need of an allogenic hematopoietic stem cell transplant.

"The BLA submission marks an important milestone for both Gamida and the transplant community, as omidubicel has the potential to be the first approved advanced cell therapy product for allogeneic stem cell transplantation," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. "Completion of this BLA submission is a key inflection point in our mission to deliver a new treatment option for patients with blood cancers. We look forward to working closely with the FDA to bring this potentially important therapy to patients."

The FDA has 60 days to determine whether the BLA for omidubicel is acceptable for filing. The omidubicel BLA is supported by the statistically significant results from Gamida Cells pivotal Phase 3 study, the results of which were published in Blood, the official journal of the American Society of Hematology. For the studys primary endpoint, the median time to neutrophil engraftment in patients with hematologic malignancies undergoing allogeneic bone marrow transplant receiving omidubicel compared to standard umbilical cord blood (UCB), the median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p < 0.001).

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In key secondary endpoints of this Phase 3 study: platelet engraftment was significantly accelerated [55 percent of patients randomized to omidubicel achieving platelet engraftment by day 42, compared to 35 percent for the comparator (p = 0.028)]; the rate of infection was significantly reduced [cumulative incidence of first grade 2 or grade 3 bacterial or invasive fungal infection for patients randomized to omidubicel of 37 percent, compared to 57 percent for the comparator (p = 0.03)]; and hospitalization in the first 100 days after transplant was significantly reduced [median number of days alive and out of hospital for patients randomized to omidubicel of 61 days, compared to 48 days for the comparator (p = 0.005)]. Omidubicel was generally well tolerated in the Phase 3 study.

The full Blood manuscript is available here: https://ashpublications.org/blood/article/doi/10.1182/blood.2021011719/476235/Omidubicel-Versus-Standard-Myeloablative-Umbilical.

About Omidubicel

Omidubicel is an advanced cell therapy candidate developed as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multi-center, randomized Phase 3 study (NCT0273029) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit https://www.gamida-cell.com.

Market Opportunity

In 2019, approximately 8,000 patients who were 12 years old and up with hematologic malignancies underwent an allogeneic stem cell transplant.1 Unfortunately, it is estimated that another 1,200 patients were eligible for transplant but could not find a donor source.2 Omidubicel, if approved, has the potential to improve outcomes for patients based on transplanter feedback and to potentially increase access for patients to get to transplant. Omidubicel, if approved, has the potential to treat approximately 2,000 2,500 patients each year in the U.S.

About NAM Technology

Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types including stem cells and natural killer cells with appropriate growth factors to maintain the cells active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.

About Gamida Cell

Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapy candidates for patients with solid tumor and blood cancers and other serious blood diseases. We apply a proprietary expansion platform leveraging the properties of NAM to allogeneic cell sources including umbilical cord blood-derived cells and NK cells to create therapy candidates with potential to redefine standards of care. These include omidubicel, an investigational product with potential as a life-saving alternative for patients in need of bone marrow transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at solid tumor and hematological malignancies. For additional information, please visit http://www.gamida-cell.com or follow Gamida Cell on LinkedIn, Twitter, Facebook or Instagram at @GamidaCellTx.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to timing of initiation and progress of, and data reported from, the clinical trials of Gamida Cells product candidates (including omidubicel), anticipated regulatory filings (including the timing of submission of the BLA for omidubicel to the FDA), commercialization planning efforts, and the potentially life-saving or curative therapeutic and commercial potential of Gamida Cells product candidates (including omidubicel), and Gamida Cells expectations for the expected clinical development milestones set forth herein. Any statement describing Gamida Cells goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions, including those related to the impact that the COVID-19 pandemic could have on our business, and including the scope, progress and expansion of Gamida Cells clinical trials and ramifications for the cost thereof; clinical, scientific, regulatory and technical developments; and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such product candidates. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cells Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 24, 2022, as amended, and other filings that Gamida Cell makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cells actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cells forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements.

1CIBMTR 2019 allogeneic transplants in patients 12+ years with hematological malignancies.2Gamida Cell market research

View source version on businesswire.com: https://www.businesswire.com/news/home/20220602005395/en/

Contacts

Courtney TurianoStern Investor Relations, Inc.Courtney.Turiano@sternir.com 1-212-362-1200

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Gamida Cell Completes Rolling Biologics License Application Submission to the FDA for Omidubicel - Yahoo Finance

A recent Phase 1 clinical trial has administered a dose of an experimental anticancer drug called CF33-hNIS, or Vaxinia, to the studys first participant. This novel therapy involves using an oncolytic virus, a type of virus that can infect and kill cancer cells without harming healthy tissue.

Vaxinia, a genetically modified smallpox virus, has been previously shown to be effective against a broad range of cancers in laboratory and animal models. This clinical trial conducted by City of Hope, a cancer research and treatment institute in the United States, in collaboration with Imugene, a biotech company in Australia, will test the novel oncolytic virus in cancer patients with advanced solid tumors.

Laboratory studies suggest that Vaxinia may be more effective than the previous generation of oncolytic viruses in reducing the size of tumors, making this therapy especially promising.

Dr. Yuman Fong, the chair of the Department of Surgery at City of Hope, told Medical News Today, The particular importance of CF33/ Vaxinia is that this virus is designed to target all types of cancers. It is one of the first of a new generation of therapeutic viruses that would be much more potent than prior viruses, and it is potentially more selective for cancer while able to spare normal tissues.

Leslie Chong, the CEO of Imugene, told MNT, We are keen to revolutionize cancer therapy, and no longer are we satisfied with incremental improvements in survival, we want to cure patients. By making cancer into one disease and having a targeted agent to obliterate it, thats the holy grail of cancer therapeutics!

Oncolytic viruses include viruses found in nature or are genetically engineered to selectively infect and replicate in tumor cells.

As oncolytic viruses replicate, they can disintegrate and kill infected tumor cells. When tumor cells burst, they release tumor proteins or antigens, which the immune system recognizes as foreign. The immune response then elicits against these antigens resulting in further death of tumor cells.

Additionally, the immune systems ability to recognize the tumor cells creates a memory against the tumor antigens, which can help prevent cancer recurrence. Besides providing durable protection, a small dose of oncolytic viruses can be effective against the tumor due to the ability of the virus to replicate and spread in the tumor cells.

Cancer cells express proteins and receptors on their surface distinct from healthy cells that help them evade the immune system, metastasize, and prevent cell death. Oncolytic viruses use these cancer cell-specific proteins and receptors to target them.

Dr. Fong notes, Interestingly, the same characteristics that eventually make cancer cells resistant to chemotherapy or radiation treatment actually enhance the success of oncolytic viruses, such as CF33-hNIS.

Moreover, the proteins targeted by oncolytic viruses are often common to a broad range of cancers, making these viruses a versatile tool.

CF33-hNIS or Vaxinia, developed by the researchers at City of Hope is a genetically modified version of the vaccinia or smallpox virus. The researchers have designed CF33-hNIS to enhance its ability to replicate in tumor cells, facilitating a large immune response against the tumor cells.

In addition, the modified vaccinia virus also expresses a protein called human sodium iodide symporter (hNIS), which transports iodide ions into the cells. Thus, tumor cells infected by the virus express hNIS, allowing radioactive iodine uptake.

Imaging techniques such as position emission technology (PET) scans can then be used along with radiolabeled iodine as a dye to help track the distribution of the virus in the body and its effectiveness.

Moreover, hNIS can also help selectively target tumor cells that accumulate radioactive iodine using radiotherapy.

Previous studies have shown that CF33-hNIS is effective against cell culture and animal models of breast, colorectal, pancreatic, ovarian, and lung cancers. During the Phase 1 clinical trial, researchers will test the safety and tolerability of CF33-hNIS in cancer patients by injecting the virus directly into the blood or the tumor.

Specifically, the trial will include about 100 cancer patients with metastatic or advanced solid tumors who have previously received at least two standard cancer treatments.

Upon successful demonstration of Vaxinias safety, the researchers also intend to test treating tumor cells using a combination of this oncolytic virus and another type of cancer therapy called pembrolizumab, an immune checkpoint inhibitor.

Cancer cells tend to express certain checkpoint proteins that prevent their elimination by T cells, a part of the immune system. Immune checkpoint inhibitors are drugs that block such proteins action to enhance the immune cells ability to kill tumor cells.

Previous data suggest that CF33-hNIS increases the expression of a checkpoint protein, which can improve the efficacy of immune checkpoint inhibitors, such as pembrolizumab.

Oncolytic viruses have already been shown in animal models to be as effective as combination therapy with many other immunotherapies, including checkpoint inhibitors and CAR T therapies. We are hoping the CF33/ Vaxinia platform will move rapidly to clinical testing in combinations with these and become effective combination immunotherapies in the treatment of human cancer, said Dr. Fong.

The researchers also intend to examine the efficacy of this therapy as a secondary outcome throughout this phase 1 trial.

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Cancer-killing virus injected into human for the first time in new clinical trial - Medical News Today

SHANGHAI, NANJING, China, and SAN JOSE , Calif., June 2, 2022 /PRNewswire/ --IASO Biotherapeutics ("IASO Bio"), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, and Innovent Biologics, Inc. ("Innovent," HKEX: 01801), today jointly announced that the China National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for Equecabtagene Autoleucel (IASO Bio R&D code: CT103A, Innovent R&D code: IBI326), a fully human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy for the treatment of relapsed and/or refractory multiple myeloma (R/R MM).

(PRNewsfoto/IASO Biotherapeutics)

Equecabtagene Autoleucel is the first CAR-T therapy in China that is self-developed with proprietary whole-process product development and the first BCMA-targeting CAR T-cell therapy in China with its NDA formally accepted by the NMPA.It is an innovative therapy co-developed by IASO Bio and Innovent. In February 2021, Equecabtagene Autoleucel was granted "Breakthrough Therapy DesignationBTD" by the NMPA.

The acceptance of NDA is based on data from a single-arm, open-label, multi-center phase 1/2 study being conducted in China. Study results showed that Equecabtagene Autoleucel has excellent safety and efficacy profiles, low immunogenicity given a fully-human scFv, robust expansion and prolonged persistence in vivo. It will potentially offer a breakthrough treatment option for patients with R/R MM. The data from the phase 1/2 clinical study of Equecabtagene Autoleucel was presented in an oral presentation at the 63rd American Society of Hematology (ASH) Annual Meeting (Abstract #547) and the updated data was accepted as an oral presentation at the 27th Annual Congress of the European Hematology AssociationEHAVirtual Meeting (Abstract #S187), held on June 9-12, 2022.

"Multiple Myeloma (MM) is the second-most-common hematologic malignancy. Although the survival in MM patients has been dramatically extended to 7-10 years on average with recent drug development, the disease is still incurable and relapse or refractory after standard therapies is common for most MM patients. The later lines of treatment the patients are receiving, the shorter of survival time for those patients. Usually, the median progression-free survival of MM patients who had received at least third-line of prior therapy is only 3-6 months, and the overall survival time is less than 1 year. In recent years, there have been some encouraging breakthroughs in drugs and therapeutic interventions for the treatment of MM. The most exciting progress is BCMA CAR-T cell immunotherapy." said the two principal investigators at the primary study sites - Prof. Lugui Qiu, MD, from the Chinese Academy of Medical Science Hematology Hospital and Prof. Chunrui Li, MD, PhD, from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology. "At the 63rd Annual Meeting of the American Society of Hematology (ASH) in 2021, we reported the results of the clinical study on Equecabtagene Autoleucel injection. The study was conducted in 14 clinical centers and enrolled 79 patients with MM who had received at least third-line of prior therapy. Of the 79 patients, the overall response rate(ORR) was 94.9% and the complete response/stringent complete response (CR/sCR) rate was 58.2%. These study results showed that Equecabtagene Autoleucel has excellent safety and efficacy profiles.In addition,Equecabtagene Autoleucel also demonstrated favorable efficacy in patients with extramedullary multiple myeloma and patients who had received prior CAR-T therapy. These results suggest that Equecabtagene Autoleucel is potentially a new and effective immunotherapy treatment option for patients with MM. We hope that Equecabtagene Autoleucel can be launched in China soon, bringing long-term benefits to patients."

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"IASO Bio currently has more than 10 innovative pipeline products under development. Equecabtagene Autoleucel is China's first domestically developed CAR T-cell therapy with global intellectual property rights and the first BCMA-targeting CAR T-cell therapy with its NDA formally accepted by the NMPA. This is a significant milestone for IASO Bio. IASO Bio's over 100,000 ft manufacturing facility in Nanjing, which has end-to-end manufacturing capability that covers the entire CAR-T production process, received its drug manufacturing license earlier this year, will be the future commercial production site for Equecabtagene Autoleucel." said Wen (Maxwell) Wang, M.D., Ph.D., Chief Executive Officer and Chief Medical Officer of IASO Bio.

"In 2018, Professor Jianfeng Zhou of Tongji Hospital, Tongji Medical College led a team of clinicians and biologists to initiate clinical study of the world's first fully-human BCMA CAR T-Cell therapy (Equecabtagene Autoleucel) for the treatment of multiple myeloma. The first patient of the study has maintained strict complete remission (sCR) for over 40 months. "Maxwell added, "Many thanks to Professor Jianfeng Zhou for his unremitting efforts to promote the development of novel cell therapies and provide the impetus for the continuous innovation of CAR-T therapy. We look forward to the commercialization of Equecabtagene Autoleucel to bring hope to more multiple myeloma patients."

Dr. Yongjun Liu, President of Innovent, said,"We are glad about the NDA acceptance of Equecabtagene Autoleucel, a product candidate co-developed by Innovent and IASO Bio, and it will potentially to be the domestic first approved and launch-to-market BMCA CAR-T therapy for multiple myeloma. In the clinical studies, Equecabtagene Autoleucel demonstrated impressive efficacy and favorable safety profiles. We hope that this breakthrough therapy could be approved in the near future and we will actively coordinate with all parties including the government authorities, hospitals, commercial insurance and charity funds to bring benefit to more multiple myeloma patients.

IASO Bio and Innovent are actively advancing the clinical development of Equecabtagene Autoleucel. In February 2022, it was granted"Orphan Drug Designation (ODD)" by the Office of Orphan Products Development (OOPD) of the U.S. Food and Drug Administration (FDA). In January 2022, IASO Bio and Innovent have jointly granted non-exclusive commercial rights of the fully-human BCMA CAR construct used in Equecabtagene Autoleucel to Sana Biotechnology (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, for use in its in vivo gene therapy and ex vivo hypoimmune cell therapy applications. Sana's clinical and commercial development could further enhance the potential value of CT103A, benefitting a broader patient population. In addition to multiple myeloma, the NMPA has accepted IND application of Equecabtagene Autoleucel for the new expanded indication of Neuromyelitis Optica Spectrum Disorder (NMOSD).

About Multiple Myeloma (MM)

In the United States, MM accounts for nearly 2% of new cancer cases, and more than 2% of all cancer-related deaths. According to Frost & Sullivan, the number of new MM cases in the United States rose from 30,300 in 2016 to 32,300 in 2020 and is expected to increase to 37,800 by 2025. Additionally, the total number of patients diagnosed with MM increased from 132,200 in 2016 to 144,900 in 2020 and is expected to rise to 162,300 by 2025. In China, the number of new MM cases rose from 18,900 in 2016 to 21,100 in 2020 and is expected to increase to 24,500 by 2025. The total number of patients diagnosed with MM in China increased from 69,800 in 2016 to 113,800 in 2020 and is expected to rise to 182,200 by 2025.

About IASO Biotherapeutics

IASO Bio is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and autoimmune diseases. Leveraging its proprietary fully-human antibody discovery platform (IMARS), high-throughput CAR T drug priority platform, and proprietary manufacturing processes, IASO Bio is developing a rich clinical-stage pipeline of multiple autologous and allogeneic CAR-T and biologics product candidates. This includes a diversified portfolio of 10 novel pipeline products, including IASO's leading asset, Equecabtagene Autoleucel, an innovative anti-BCMA CAR-T cell therapy under pivotal study for relapsed/refractory multiple myeloma (R/R MM). In February 2021, Equecabtagene Autoleucel was granted "Breakthrough Therapy Designation" by the NMPA. In February 2022 it was granted "Orphan Drug Designation (ODD) "by the Office of Orphan Products Development (OOPD) of the U.S. Food and Drug Administration (FDA).In addition to multiple myeloma, China's National Medical Products Administration (NMPA) has accepted its investigational new drug (IND) application for the new extended indication of Neuromyelitis Optica Spectrum Disorder (NMOSD). In addition, the company's in-house developed fully-human CD19/CD22 dual-targeted chimeric antigen receptor (CAR) T cell therapy has entered phase I/II registrational clinical trial for the treatment of CD19/CD22-positive relapsed/refractory B-cell non-Hodgkin's lymphoma (r/r B-NHL). It was also granted Orphan Drug Designation by the U.S. Food and Drug Administration in October 2021. For more information on IASO Bio, please visit http://www.iasobio.com and http://www.linkedin.com/company/iasobiotherapeutics/.

About Innovent Biologics

Inspired by the spirit of "Start with Integrity, Succeed through Action", Innovent's mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of cancer, metabolic, autoimmune and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 32 valuable assets in the fields of cancer, autoimmune, metabolic, ophthalmology and other major therapeutic areas, with 7 products approved for marketing in China TYVYT (sintilimab injection), BYVASDA (bevacizumab biosimilar injection), SULINNO (adalimumab biosimilar injection), HALPRYZA (rituximab biosimilar injection) , Pemazyre (pemigatinib oral inhibitor) and olverembatinib (BCR-ABL TKI) and Cyramza (ramucirumab) , 2 asset under NMPA NDA review, 4 assets in Phase 3 or pivotal clinical trials, and an additional 19 molecules in clinical studies.

Innovent has built an international team with expertise in cutting-edge biological drug development and commercialization. The company has also entered into strategic collaborations with Eli Lilly and Company, Roche, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. For more information, please visit: http://www.innoventbio.com and http://www.linkedin.com/company/innovent-biologics/.

Note:

TYVYT (sintilimab injection) is not an approved product in the United States.

BYVASDA (bevacizumab biosimilar injection), SULINNO, and HALPRYZA (rituximab biosimilar injection) are not approved products in the United States.

TYVYT (sintilimab injection, Innovent)

BYVASDA (bevacizumab biosimilar injection, Innovent)

HALPRYZA (rituximab biosimilar injection, Innovent)

SULINNO (adalimumab biosimilar injection, Innovent)

Pemazyre (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.

CYRAMZA (ramucirumab, Eli Lilly). Cyramza was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Innovent's Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate toInnovent Biologics, Inc. ("Innovent" or "Company"), are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

Related News

IASO Biotherapeutics' Equecabtagene Autoleucel, the World's First CAR-T for Treatment of NMOSD, Receives IND Application Acceptance by NMPA U.S. FDA Grants Orphan Drug Designation to BCMA CAR-T Cell Therapy Co-Developed by IASO Bio and Innovent Sana Biotechnology, IASO Biotherapeutics, and Innovent Biologics Announce Non-Exclusive License Agreement for Clinically Validated BCMA CAR Construct IASO Biotherapeutics and Innovent Biologics Announced Updated Clinical Data of BCMA CAR-T Therapy in Oral Presentation at 2021 ASH Annual Meeting IASO Bio's Nanjing Manufacturing Facility Granted the Drug Manufacturing License for CAR-T Cell Therapy Products

SOURCE IASO Biotherapeutics

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IASO Bio and Innovent Jointly Announce the NMPA Acceptance of the New Drug Application for Equecabtagene Autoleucel for the Treatment of Relapsed...

John Theurer Cancer Center investigators report their latest research findings at American Society of Clinical Oncology (ASCO) 2022 Annual Meeting

Researchers from Hackensack Meridian John Theurer Cancer Center are presenting data from 29 studies at the Annual Meeting of the American Society of Clinical Oncology (ASCO), the largest world cancer professionals meeting, being held in person in Chicago June 3-7, 2022. Abstracts of the studies can be viewed at abstracts.asco.org.

Hackensack Meridian John Theurer Cancer Center is the largest and premier cancer program in NJ, and #1 cancer program in New Jersey according to U.S. News & World Report. It is part of the Georgetown Lombardi Comprehensive Cancer Center, an NCI-designated Comprehensive Cancer Center. John Theurer is known for being one of the leading blood cancer programs in the nation and was the first center in New Jersey to offer CAR T-cell therapy, a revolutionary immunotherapy for patients with select leukemias and lymphomas.

I am proud that our team is taking part in these amazing times in oncology, bringing our patients the next options when needed, noted Andre Goy, M.D., M.S., chairman and executive director of John Theurer Cancer Center. As the leading cancer program in our state, we are embracing innovation, which is at the core of our mission.

Here are some of the key presentations:

In acute myeloid leukemia (AML): A great trial building up on the success of Vyxeos (dual-drug liposomal encapsulation of daunorubicin and cytarabine) adding in the V-FAST multicenter trial a number of established targeted agents (midostaurin, venetoclax, enasidenib). Though preliminary, this is a great approach to refine the induction of AML and will be presented by Dr James McCloskey. (https://meetings.asco.org/abstracts-presentations/208210).

CAR T cell update: With the three year follow up of ZUMA-2, the 1st CAR T approved in mantle cell showing that brexucabtagene autoleucel (KTE-X19) which led to an ORR of 91%, with a 68% CR rate in heavily pretreated MCL pts and at 3 years 37% of pts still in ongoing response (all CR) and results were even better in patients who tested MRD-ve with medians for DOR, PFS, and OS not reached at 3y. (https://meetings.asco.org/abstracts-presentations/207240).

An update on ZUMA-7, which confirmed the benefit of Axi-cel (over standard of care) and its approval in April 2022 as a 2nd line therapy in relapsed/refractory diffuse large cell lymphoma, including in the population over 65 years old with significantly superior CR rate, EFS as well as meaningful improvement in QoL over SOC, measured by multiple validated PRO instruments.(https://meetings.asco.org/abstracts-presentations/209923).

Other data on CAR T include CAR T combinations to improve outcome in diffuse large cell lymphoma such as the ZUMA-14 trial. (https://meetings.asco.org/abstracts-presentations/210280)

Other forms of T cell engaging therapies focused on building on checkpoint blockade in solid tumors with the use of MK-0482, a novel humanized IgG4 mAb targeting immunoglobulin-like transcript 3 (ILT3) - an inhibitory receptor associated with immune tolerance and T-cell suppression within the tumor microenvironment in combination with pembrolizumab (pembro) in advanced solid tumors which will be featured as an oral presentation by Dr Gutierrez, who leads the phase I program at the John Theurer Cancer Center. (https://meetings.asco.org/abstracts-presentations/207289).

A multicenter vaccine trial to induce PD1 antibodies through PD1-VAxx in combination with other checkpoint inhibitors in advanced lung cancers, also presented by Dr Gutierrez. (https://meetings.asco.org/abstracts-presentations/212919).

Natural Killer (NK) cells therapy in glioblastomas: CYNK-001 is a CD56+CD3- enriched, off-the-shelf, allogeneic NK cell product expanded from placental CD34 cells with preclinical activity and evidence on intracranial route administration showing activity and now used IV in postresection setting to prevent recurrence. Study is ongoing and will be presented in this highly unmet need situation and will be presented by Dr. Andrew Pecora. (https://meetings.asco.org/abstracts-presentations/213107).

NGs in practice. Several abstracts illustrate the growing importance of NGS in practice from liquid biopsies full DNA and RNA profiling which show that using cfRNA and cfTNA provides complementary comprehensive information for evaluating mutations, fusion genes, and structural abnormalities (https://meetings.asco.org/abstracts-presentations/210584) and help refine treatment decisions. Such technology will also help monitor MRD and predict risk of relapse for example in colon cancer (https://meetings.asco.org/abstracts-presentations/208568).

LBA: A new paradigm in the frontline setting in mantle cell lymphoma will be presented as a late breaking abstract during ASCO integrating ibrutinib to bendamustine-rituximab combination (https://meetings.asco.org/abstracts-presentations/207242).

Additional abstracts in which JTCC took part in the development of novel emerging agents in lymphoma, CLL, myeloma and solid tumors can be found here.

Meet Us at ASCO

Stop by Booth #28125 in the exhibition hall to meet team members from Hackensack Meridian John Theurer Cancer Center and learn about our research, education, and patient care.

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Pioneering Studies Provide New Options for Patients with Advanced Cancers, Particularly Through Immunotherapy, New Targeted Therapies and Genomics...

BOSTON & SEATTLE, June 02, 2022--(BUSINESS WIRE)--Affini-T Therapeutics, Inc., a biotechnology company unlocking the power of T cells against oncogenic driver mutations, today announced that the clinical strategy for enhancing the efficacy of its Merkel cell polyomavirus (MCPyV)-specific T cell receptor (TCR) program for the treatment of PD-1 refractory Merkel cell carcinoma (MCC), from its strategic collaboration with Fred Hutchinson Cancer Center, will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2022. The poster presentation will be delivered by Joshua Veatch, M.D., Ph.D., from Fred Hutch.

"We recognize that MCC patients are in desperate need of new treatments, in particular due to having no curative therapeutic options and a five-year survival rate of less than ten percent in those who have developed widespread disease," said Loc Vincent, Ph.D., Chief Scientific Officer of Affini-T. "The clinical strategy to be presented at ASCO is the result of tumor biopsy analyses generated from treating MCC patients and reflects the recent addition of an MHC-I boosting molecule to the MCPyV-specific T cell Phase I/II study protocol. By enhancing MHC-I expression on MCC tumors, we hope to minimize immune system evasion and maximize the clinical efficacy of MCPyV-specific T cells to treat MCC patients."

Poster presentation details are as follows:

Title: ATTAC-MCC: Phase I/II study of Autologous CD8+ and CD4+ Transgenic T cells expressing a high-affinity MCPyV-specific TCR combined with checkpoint inhibitors and Class I MHC-upregulation in patients with metastatic MCC refractory to PD-1 axis blockadePresenting Author: Joshua Veatch, M.D., Ph.D., Fred Hutchinson Cancer CenterAbstract Number: TPS9596Poster Number: 186bPoster Session Title: Melanoma/Skin CancersDate & Time: June 6, 2022, 2:15 PM EDT

About Merkel Cell Carcinoma and Merkel Cell PolyomavirusMerkel cell carcinoma (MCC) is a highly aggressive skin cancer, with an incidence that has doubled in the last 20 years to approximately 3,000 cases per year in the U.S. Over one-third of patients will develop widespread disease and outcomes for these patients have been historically poor with a five-year survival rate of less than ten percent. Cancer-causing Merkel cell polyomavirus (MCPyV) is expressed in most MCC tumors and can be leveraged to target these tumors. Although immune checkpoint inhibitors (ICIs) targeting relevant biochemical pathways show promise, most MCC patients will eventually relapse. There is no standard of care for patients whose cancer has become resistant to ICIs. We believe that cellular immune therapies targeting MCPyV may provide additional clinical benefit to these patients.

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About Affini-T TherapeuticsAffini-T is unlocking the power of T cells and targeting core oncogenic drivers to develop potentially curative therapies for solid tumor cancers. Our differentiated cell therapy platform harnesses state-of-the-art engineering and synthetic biology capabilities to target even the most devastating cancer-driving mutations, beginning with KRAS. We leverage these tools to optimize T cell functions and rewrite the rules of the solid tumor microenvironment, enabling the potential for sustained clinical outcomes in patients. Building on the world-class innovation inherent in our leadership team, founders and technologies, we are powered to develop transformational medicines that last. Follow us on LinkedIn and Twitter.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220602005386/en/

Contacts

Media Contacts Danielle CanteyCanale CommunicationsDanielle.Cantey@canalecomm.com 619-826-4657

Ian StoneCanale Communications Ian.stone@canalecomm.com 619-849-5388

Investor ContactIR@affinittx.com

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Clinical Strategy for Enhancing Affini-T Therapeutics Merkel Polyoma Virus TCR Therapy to be Presented at ASCO 2022 - Yahoo Finance