Category Archives: Stem Cell Therapy

In a retrospective analysis of 115 patients with relapsed/refractory multiple myeloma who progressed after therapy on a bispecific antibody, researchers found that the myeloma patients can be salvaged with sequential T-cell redirection therapy.

While the depth and duration of response to bispecific antibodies do not predict how patients with multiple myeloma will respond to CAR T-cell therapy as a second-line treatment, the T-cell therapy is effective for this patient population, according to data published in Blood Advances.1

In a retrospective analysis of 115 patients with relapsed/refractory multiple myeloma (RRMM) who progressed after therapy on a bispecific antibody, phase 1 dose escalation or phase 2 clinical trial researchers found that the myeloma patients can be salvaged with sequential T-cell redirection therapy.

This T-cell therapy led to an 84% (95% CI, 60%-97%) overall response rate (ORR), but median overall survival (OS) was not reached at a 30.5-month follow-up. Moreover, the clinical benefit rate favored patients on T-cell therapy at 84% (95% CI, 60%-97%) compared with 54% (95% CI, 37%-70%) in the non-T-cell redirection arm.

Eight patients given T-cell redirection as first salvage therapy (FST) had a complete response (CR), 4 had a stringent CR (sCR), 4 had a partial response, 1 patient had stable disease, and 2 patients had partial disease. In the non-T-cell redirection arm (n = 39), there were no sCRs, 1 CR, 4 very good partial responses, 14 partial responses, 2 had minimal responses (MR), 8 had stable disease, and 10 patients had partial disease.

Of the 115 patients that failed bispecific antibody treatment, 58 patients went on to receive their FST with either T-cell redirection or a non-T- cell redirection therapy, such as chemotherapy. Nineteen patients were given T-cell redirection as their FST with 32% of these patients needing to receive a second salvage therapy (SST) due to a relapse of non-response to therapy. In comparison, 79% of patients given a non-T-cell redirected therapy needed a SST with some of these patients moving on to T-cell redirected therapy for a total of 28 patient that ultimately received T-cell redirected therapy.

Our data suggests that after treatment with a bispecific antibody, this high-risk patient population can still exhibit favorable outcomes when exposed again to T-cell redirection therapeutics such as other bispecific antibodies and CAR T-cell therapy, the researchers wrote in their published results. While conventional salvage therapy had a relatively good ORR of around 50%, it did not lead to durable responses, which translated to significantly lower [progression-free survival (PFS)] and OS.

While the researchers noted the survival results were not durable, nor significant, they did favor the initial 19 patients given T-cell redirection therapy as FST. The median PFS1 of these patients was 28.9 months (95% CI, 18.7-NE), compared to 2.6 months (95% CI, 1.9-4.1) in the non-redirection arm. Within the 19 patients, those who received a bispecific antibody as FST had a median PFS of 18.7 months (95% CI, 2.3-18.7) vs the 9 patients who got CAR-T cell therapy who did not reach their median PFS1 (95% CI, 28.9-NE), however, this finding was not statistically significant.

PSF2 was also evaluated due to the additional patients that moved to T-cell redirection therapy with the researchers observing a median PFS2 of 30.9 months (95% CI, 21.3%-37.3%) in the 28 patients given T-cell redirection as either FST or SST, compared with 5.7 months (95% CI, 3.7-7.7) for the 30 patients the didnt receive T-cell redirection therapy as either FST or SST.

OS was not reached among patients with T-cell redirection as FST nor patients on CAR T-cell therapy, but comparisons to patients in the other arm were not statistically significant. Sixty-two percent (95% CI, 44%-88%) of patients given T-cell redirection therapy had an OS at 2 years compared with to 24% (95% CI, 11%-49%) at 2 years for the remaining 30 patients.

As the clinical use and advancement of T-cell redirection therapies continue to grow, effective strategies are needed to manage outcomes for patients who relapse or are unresponsive to this initial treatment, said senior author of the study Samir Parekh, MD, director of Translational Research in Myeloma, co-leader of the Cancer Clinical Investigation program at The Tisch Cancer Institute, and a member of the Icahn Genomics Institute at the Icahn School of Medicine at Mount Sinai.2 This study shows patients relapsing after initial bispecific antibodies therapy can benefit from a second bispecific antibody or CAR T-cell therapy.

Patients in the analysis were treated on phase 1/2 trials and were a median of 60 years old at diagnosis and 67 years old at the time of their FST. Most patients in the analysis had IgG multiple myeloma with that subtype making up 50% of the T-cell redirection group. Moreover, 78% of patients overall were considered high-risk with 88% being triple-refractory and 84% progressed after being on pomalidomide (Pomalyst). Fifty-nine percent of patients had 1 prior autologous stem cell transplant.

All patients observed in the analysis were on bispecific antibody studies conducted at the Tisch Cancer Center at Mount Sinai hospital.

Future clinical trials incorporating sequential combinations of T-cell redirection therapy will build upon these findings to further develop treatment guidelines and improve long-term outcomes for multiple myeloma patients, Parekh said.

The rest is here:
T-Cell Redirection Therapy Shows Promise As Salvage Therapy in R/R Multiple Myeloma - Targeted Oncology

This facility will support the late-stage clinical development and commercialization of Orca Bios precision cell therapies, including Orca-T, which is currently being evaluated in a Phase 3 registrational trial.

The new facility is located in Sacramento's newly developed Metro Air Park next to the Sacramento International Airport, enabling direct shipping access to transplant centers across the US. It is also in close proximity to Orca Bio's existing clinical manufacturing building.

The facility is uniquely tailored to manufacture precision cell therapies designed to replace cancerous blood and immune systems with healthy ones. It will include modular production suites, which are adjustable for future growth, quality control laboratories, warehouse space and offices.

The site will have the capacity to manufacture around 3,000 cell therapy products a year: thus allowing the company to scale to meet future demand and providing the critical infrastructure to enable Orca Bio to expand its pipeline.

Construction has already begun and is scheduled to be completed later this year, with the facility set to be fully validated and operational in the first half of 2023.

Orca Bio uses precision cell selection technology to identify the less than 1% of the 100 billion donor cells that potentially contain therapeutic benefits for patients. These cells are then manufactured into potentially curative cell therapies designed to maximize efficacy of treatment and significantly limit treatment-related risks.

Orca-T is an investigational high-precision allogeneic cellular therapy consisting of infusions containing regulatory T-cells, conventional T-cells and CD34+ stem cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and is being studied to treat multiple hematologic malignancies.

At the head of its pipeline is Orca-T: which recently entered a Phase 3 study for the treatment of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndromes (MDS).

Throughout the clinical development of our products, we have demonstrated the ability to reliably manufacture and deliver high-precision cell therapies with rapid turnaround times, regardless of donor and patient location, said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio.

This new facility will further enhance our capabilities to deliver our therapies urgently and seamlessly to patients at scale, while meeting the highest quality and regulatory standards.

Link:
Orca Bio expands manufacturing capabilities to take cell therapies through to commercialization - BioPharma-Reporter.com

FORWARD LOOKING STATEMENT

STATEMENTS IN THIS PRESENTATION, INCLUDING THE INFORMATION SET FORTH AS TO THE FUTURE FINANCIAL OR OPERATING PERFORMANCE OF BIORESTORATIVE THERAPIES, INC. (THE "COMPANY") THAT ARE NOT CURRENT OR HISTORICAL FACTUAL STATEMENTS MAY CONSTITUTE "FORWARD LOOKING" INFORMATION WITHIN THE MEANING OF THE U.S. FEDERAL AND STATE SECURITIES LAWS. WHEN USED IN THIS PRESENTATION, SUCH STATEMENTS MAY INCLUDE, AMONG OTHER TERMS, SUCH WORDS AS "MAY," "WILL," "EXPECT," "BELIEVE," "PLAN," "ANTICIPATE," "INTEND," "ESTIMATE," "PROJECT," "TARGET" AND OTHER SIMILAR TERMINOLOGY. THESE STATEMENTS REFLECT CURRENT EXPECTATIONS, ESTIMATES AND PROJECTIONS REGARDING FUTURE EVENTS AND OPERATING PERFORMANCE AND SPEAK ONLY AS TO THE DATE OF THIS PRESENTATION. READERS SHOULD NOT PLACE UNDUE IMPORTANCE ON FORWARD LOOKING STATEMENTS AND SHOULD NOT RELY UPON THIS INFORMATION AS OF ANY OTHER DATE.

FORWARD LOOKING STATEMENTS INVOLVE KNOWN AND UNKNOWN RISKS, UNCERTAINTIES AND OTHER IMPORTANT FACTORS THAT COULD CAUSE OUR ACTUAL RESULTS, PERFORMANCE OR ACHIEVEMENTS, BUSINESS PLAN OR INDUSTRY RESULTS, TO DIFFER MATERIALLY FROM OUR EXPECTATIONS OF FUTURE RESULTS, PERFORMANCE OR ACHIEVEMENTS EXPRESSED OR IMPLIED BY THESE FORWARD LOOKING STATEMENTS. THESE FORWARD LOOKING STATEMENTS MAY NOT BE REALIZED DUE TO A VARIETY OF FACTORS, INCLUDING WITHOUT LIMITATION: (I) OUR LIMITED OPERATING HISTORY, LACK OF SIGNIFICANT REVENUES, AND SUBSTANTIAL LOSSES SINCE INCEPTION;(II) OUR ABILITY TO OBTAIN SUFFICIENT FINANCING TO INITIATE AND COMPLETE OUR CLINICAL TRIALS AND FUND OUR OPERATIONS; (III) OUR ABILITY TO TIMELY AND SUCCESSFULLY DEVELOP AND COMMERCIALIZE BRTX-100, OUR LEAD PRODUCT CANDIDATE FOR THE TREATMENT OF CHRONIC LUMBAR DISC DISEASE; (IV) DELAYS IN ENROLLING PATIENTS IN OUR CLINICAL TRIALS; (V) DISRUPTION TO OUR ACCESS TO THE MEDIA (INCLUDING CELL CULTURE MEDIA) AND REAGENTS THE COMPANY IS USING IN THE CLINICAL DEVELOPMENT OF OUR CELL THERAPY PRODUCT CANDIDATES; (VI) FAILURE OF OUR CLINICAL TRIALS TO DEMONSTRATE ADEQUATELY THE SAFETY AND EFFICACY OF OUR PRODUCT CANDIDATES; (VII) OUR LACK OF MANUFACTURING CAPABILITIES TO PRODUCE OUR PRODUCT CANDIDATES AT COMMERCIAL SCALE QUANTITIES AND LACK OF AN ALTERNATIVE MANUFACTURING SUPPLY; (VIII) A LOSS OF OUR EXCLUSIVE LICENSE RIGHTS WITH REGARD TO OUR DISC/SPINE TECHNOLOGY; (IX) SAFETY PROBLEMS ENCOUNTERED BY US OR OTHERS DEVELOPING NEW STEM CELL- BASED THERAPIES; (X) ETHICAL AND OTHER CONCERNS SURROUNDING THE USE OF STEM CELL THERAPY WHICH NEGATIVELY IMPACT THE PUBLIC PERCEPTION OF OUR STEM CELL PRODUCTS AND/OR SERVICES; (XI) OUR LIMITED EXPERIENCE IN THE DEVELOPMENT AND MARKETING OF CELL THERAPIES; (XII) OUR RELIANCE ON NOVEL TECHNOLOGIES THAT ARE INHERENTLY EXPENSIVE AND RISKY; (XIII) SIGNIFICANT PRODUCT LIABILITY CLAIMS AND LITIGATION TO WHICH THE COMPANY MAY BE SUBJECT, INCLUDING POTENTIAL EXPOSURE FROM THE USE OF OUR PRODUCT CANDIDATES IN HUMAN SUBJECTS; (XIV) OUR INABILITY TO OBTAIN REIMBURSEMENT FOR OUR PRODUCTS AND SERVICES FROM PRIVATE AND GOVERNMENTAL INSURERS; (XV) OUR INABILITY TO PROTECT OUR PROPRIETARY RIGHTS; AND (XVI) COMPLIANCE WITH APPLICABLE FEDERAL, STATE, LOCAL, AND INTERNATIONAL REQUIREMENTS. SEE ALSO "MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS - FACTORS THAT MAY AFFECT FUTURE RESULTS AND FINANCIAL CONDITION" SET FORTH IN THE

COMPANY'S MOST RECENT ANNUAL REPORT FILED WITH THE SEC.

MANY OF THESE ISSUES CAN AFFECT THE COMPANY'S ACTUAL RESULTS AND COULD CAUSE THE ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE EXPRESSED OR IMPLIED IN ANY FORWARD LOOKING STATEMENTS MADE BY, OR ON BEHALF OF, THE COMPANY. YOU ARE CAUTIONED THAT FORWARD LOOKING STATEMENTS ARE NOT GUARANTEES OF FUTURE PERFORMANCE, AND YOU SHOULD NOT PLACE RELIANCE ON THEM. IN FORMULATING THE FORWARD LOOKING STATEMENTS CONTAINED IN THIS PRESENTATION, IT HAS BEEN ASSUMED THAT BUSINESS AND ECONOMIC CONDITIONS AFFECTING THE COMPANY AND THE ECONOMY GENERALLY WILL CONTINUE SUBSTANTIALLY IN THE ORDINARY COURSE. THESE ASSUMPTIONS, ALTHOUGH CONSIDERED REASONABLE AT THE TIME OF PREPARATION, MAY PROVE TO BE INCORRECT.

THE DESCRIPTION OF THE COMPANY AND ITS BUSINESS IN THIS PRESENTATION DOES NOT PURPORT TO BE COMPLETE AND IS SUBJECT TO THE MORE DETAILED DESCRIPTION OF THE

COMPANY AND ITS BUSINESS IN THE COMPANY'S ANNUAL, QUARTERLY AND CURRENT REPORTS FILED WITH THE SEC.

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LANCE ALSTODT

Chairman & CEO

Lance leads BRTX's mission to improve the lives of patients through the use of Regenerative Medicine

Lance spent over 30 years leading, advising and operating companies within the Healthcare sector. He is the founder of MedVest Capital, a Healthcare fund created in 2013 and prior to that led the Medical Technology Investment banking group at Bank of America Merrill Lynch and Leerink Partners.

ROBERT KRISTAL

Chief Financial Officer

Robert has a versatile background of over 25 years on Bay Street and Wall Street

Robert most recently was the DOR for a Healthcare focused Investment Bank. His career has spanned Trading, Sales, Investment Banking and Research.

FRANCISCO SILVA

Vice President of R&D

Francisco has over 20 years of experience in the development of cell based and off the shelf therapeutics.

Francisco has obtained a number of issued patents in cell therapy, and has manuscripts published with regard to translational stem cell research.

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Disruptive Platform Technologies in Cellular Therapy

Strong Preliminary Data Indicative of Positive Trial Outcomes

Active Phase 2 Trial in Spine

Addressing Multi-Billion Dollar Markets with Unmet Needs

Opportunity for Key Strategic Partnerships

Multiple Near-Term Value Enhancing Inflection Points

Strong Intellectual Property Protection

Experienced Management Team & Scientific Advisory Board

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Preclinical

Phase 1

Phase 2

Phase 3

Spine

Lumbar

Cervical

Thoracic

Musculoskeletal System

Hips/Knees

Extremities

Avascular Zones

Metabolic

Type 2 Diabetes

Obesity

PCOS

Brown Adipose Stem Cells

ARDS

Long Hauler Covid

Gene Modification

BRTX 200 Polymer/Crispr

Disclaimer

BioRestorative Therapies Inc. published this content on 13 September 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 14 September 2022 18:59:06 UTC.

Publicnow 2022

Income Statement Evolution

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BioRestorative Therapies : BRTX Presentation September 2022 - Marketscreener.com

NEW YORK and LOUISVILLE, Ky, Sept. 15, 2022 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company discovering and developing innovative gamma-delta T cell therapies that utilize its DeltEx platform, today announced it has selected the UofL Health - Brown Cancer Center GMP Manufacturing Facility at the University of Louisville, home of the Dunbar CAR T-Cell Program, as its manufacturing partner for INB-400. The collaboration provides IN8bio exclusive access to a state-of-the-art GMP manufacturing facility and is structured to support the Companys anticipated INB-400 Phase 2 clinical program in glioblastoma.

We are proud to be partnering with the University of Louisville (UofL), the UofL Health - Brown Cancer Center and the Dunbar CAR T-Cell Program who have been at the forefront of clinical development and patient access to novel cellular immunotherapies. One of the biggest challenges facing cell therapy companies is efficient access to high-quality manufacturing facilities with the experience and capacity required to support multicenter clinical trials and commercial manufacturing, said Kate Rochlin, Ph.D., Chief Operating Officer of IN8bio. The Dunbar CAR T-Cell Program has a superb facility designed specifically to advance the development of promising T-cell therapies. We are excited to progress our INB-400 program towards a Company sponsored investigational new drug (IND) application that will advance this program into Phase 2.

Since their inception, the UofL Health Brown Cancer Center GMP Manufacturing Facility and the Dunbar CAR T-Cell Program at the University of Louisville have been committed to bringing these lifesaving immunotherapies to adult and pediatric cancer patients throughout Kentucky and the region. This manufacturing agreement with IN8bio will allow our facility to provide these groundbreaking immunotherapies for patients throughout the United States, said James Cripps, Ph.D., manager of the Brown Cancer Center GMP Manufacturing Facility.

It is with the greatest excitement for the Evan Dunbar Foundation CAR T-cell program that we announce that IN8bio has joined us in this world-changing research, said Thomas E. Dunbar. Along with the amazing work at the University of Louisville, I believe that IN8bio can join with us in achieving the goals of the Evan Dunbar Foundation CAR T-cell program. These three organizations working together will create trials that will impact hundreds, if not thousands of patients.

I am so honored and pleased to see our vision of cancer research come closer to trial and real-time treatment of patients. This has been my lifelong dream and is the most fulfilling way to honor my son, Evan Dunbar, my wife, Dr. Stephanie Altobellis, my father, Wallace and the rest of my family.

The Dunbar CAR T-Cell Program was created in 2019 thanks to a $1-million pledge from Dunbar, a Louisville resident. It is a state-of-the-art manufacturing facility custom built to collaborate with the biotech industry to advance cutting-edge cell and gene therapies. T-cell therapies utilize immune cells that are genetically modified to fight cancer. The modified cells are infused into the patient with the goal of fighting the cancer and creating long-term immunity to delay or prevent recurrence. The facility is led by and staffed with experts in cell therapy manufacturing who will work closely with the IN8bio team to produce the DeltEx DRI cells for INB-400.

Facility team in the of the UofL Health - Brown Cancer Center GMP Manufacturing Facility at the University of Louisville.

About INB-400INB-400 is IN8bios DeltEx Allogeneic DRI. INB-400 expands the application of DRI gamma-delta T cells into other solid tumor types through the development of allogeneic or off-the-shelf DeltEx DRI therapies. INB-400 will be a genetically modified DeltEx allogeneic candidate in both newly diagnosed and relapsed refractory glioblastoma.

About IN8bioIN8bio is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing gamma-delta T cell product candidates for solid and liquid tumors. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. IN8bios DeltEx platform employs allogeneic, autologous, iPSC, and genetically modified approaches to develop cell therapies that synergize with chemotherapy to effectively identify and eradicate tumor cells.

IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation. IN8bio also has a broad portfolio of preclinical programs focused on addressing other solid tumor types. For more information about IN8bio and its programs, please visitwww.IN8bio.com.

Forward Looking StatementsThis press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as aims, anticipates, believes, could, estimates, expects, forecasts, goal, intends, may, plans, possible, potential, seeks, will and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the success of IN8bios partnership with UofL Health - Brown Cancer Center GMP Manufacturing Facility at the University of Louisville; the timing of initiation, progress and scope of clinical trials for IN8bios product candidates; the potential of IN8bios DeltEx platform to discover and develop innovative product candidates, including iPSC-derived cell therapies; and IN8bios ability to achieve planned milestones, including data readouts from its trials and plans to file an IND application. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as IN8bios ability to meet anticipated deadlines and milestones, presented by the ongoing COVID-19 pandemic; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bios product candidates; the risk that IN8bio may not realize the intended benefits of its DeltEx platform; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of IN8bios product candidates; expectations for regulatory approvals to conduct trials or to market products; IN8bios reliance on third parties, including licensors and clinical research organizations; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled Risk Factors in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 12, 2022, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

About the University of Louisville:Founded in 1798 as one of the nations first city-owned, public universities, the University of Louisville (UofL) is a vital ecosystem that creates thriving futures for students, our community and society. As one of only 79 universities in the United States to earn recognition by the Carnegie Foundation as both a Research 1 and a Community Engaged university, we impact lives in areas of student success and research and innovation, while our dynamic connection with our local and global communities provides unparalleled opportunities for students and citizens both. The university serves as an engine that powers Metro Louisville and the commonwealth and as a classroom for UofLs more than 23,000 students, who benefit from partnerships with top employers and a wide range of community service opportunities.

Get more news from UofL delivered straight to your inbox every Thursday evening by signing up for our UofL News Weekly Roundup here: uoflalumni.org/uoflnews-signup.

About UofL Health:UofL Health is a fully integrated regional academic health system with seven hospitals, four medical centers, Brown Cancer Center, Eye Institute, nearly 200 physician practice locations, and more than 800 providers in Louisville and the surrounding counties, including southern Indiana. Additional access to UofL Health is provided through a partnership with Carroll County Memorial Hospital.

With more than 12,000 team members physicians, surgeons, nurses, pharmacists and other highly-skilled health care professionals, UofL Health is focused on one mission: to transform the health of communities we serve through compassionate, innovative, patient-centered care.

Company Contact:IN8bio, Inc.Patrick McCall+ 1 646.600.6GDT (6438)info@IN8bio.com

Investors & Media Contact: Argot PartnersIN8bio@argotpartners.com

University of Louisville Contact:Jill Scoggins+1 502.650.2624Jill.scoggins@louisville.edu

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5340530f-9020-4612-aeb7-ef243b175770

Facility team in the of the UofL Health - Brown Cancer Center GMP Manufacturing Facility at the University of Louisville.

Facility team in the of the UofL Health - Brown Cancer Center GMP Manufacturing Facility at the University of Louisville.

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IN8bio Partners with the Dunbar CAR T-Cell Program at the University of Louisville as the Manufacturing Center for INB-400 - BioSpace

Cancer remains a major public health and economic burden on patients, families, and healthcare systems. But breakthrough advances in cancer biology in the last two decades have dramatically changed our understanding of its pathogenesis and, consequently, our strategies to beat it.

The progress in managing blood cancers, specifically lymphoma, has raised optimism in the medical community. Lymphomas are a diverse group of cancers that affect the lymphatic system and are one of the most common malignancies worldwide and in Saudi Arabia. They are histologically categorized into Hodgkin's lymphoma and non- Hodgkin's lymphoma (NHL), where each category has many subtypes.

Related: Pregnancy-associated breast cancer: How common is it?

Until the late 1990s, all we had in our battle against cancer were conventional treatment methods with surgery, radiation, and chemotherapy. With the more advanced medical tools at our disposal, drug development and discovery have shifted toward personalised cancer treatment with molecular and immunological targeted agents.

A good example is chimeric antigen receptor T-cell (CAR T-cell) therapy, a revolutionary approach for treating different haematologic malignancies, including NHL, acute lymphoblastic leukemia, and multiple myeloma. The currently available CAR T-cell therapies are genetically engineered autologous T lymphocytes with an enhanced immune response against a specific tumour antigen, CD19 in the case of NHL.

Related: HIPEC increases cancer survival rates but lacks regional awareness

The introduction of anti-CD19 CAR T-cell therapies to the market has given new hope to patients with refractory and relapsed aggressive B-cell lymphomas who progressed despite multiple prior treatments. This represents a paradigm shift in NHL treatment, where it induced an impressive response rate of 82 per cent in ZUMA-1 study with a five-year overall survival rate of 43 per cent and a 63.1-month median follow up. This encouraged the medical community to explore other ways to optimise the clinical impact of CAR-T cell therapy by studying how to integrate it with allogeneic hematopoietic stem cell transplantation or checkpoint blockade in the future.

More promising new innovative cellular therapeutics are on the future horizon for cancer patients, such as "off-the-shelf" or allogeneic CAR-T cell and CAR natural killer cell-based immunotherapy. This type of treatment may eventually replace conventional chemotherapy, which is the standard of care for patients with advanced stage Diffuse Large B Cell Lymphoma (DLBCL) for the past 20 years. While the addition of rituximab to CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) in 2010 has shown significant benefit over CHOP in all categories of older patients, only about two-thirds of patients are typically cured with R-CHOP in the first-line setting. Many clinical trials over the past years have evaluated different ways to improve R-CHOP outcomes with no luck.

Furthermore, there is a huge unmet need for effective treatment options in refractory and relapsed DLBCL. The prognosis of these patients is generally poor, where only 30 per cent to 40 per cent of patients will respond to chemotherapy.

Additionally, the safety of intense chemotherapy regimens for the treatment of NHL is a significant concern, especially in older, frail patients with other comorbidities. This becomes a challenge, as we know that survival of lymphoma patients is correlated with achievement of complete remission; hence, dose reductions could compromise the treatment outcomes. A recent challenge we have been facing regionally and globally is the shortage of essential conventional chemotherapy agents. This has led to treatment delays or treating urgent cases with suboptimal alternative chemotherapy regimens.

Any progress in diagnosing and treating lymphoma is welcome news in Saudi Arabia, where NHL is ranked as the second most common cancer type in Saudi men and fifth among Saudi women (Source: Saudi Cancer Registry, 2016). The median age of diagnosis is 50 years in males compared to 57 years in females, which is remarkably younger than the reported median age of diagnosis in the U.S.

Diffuse Large B Cell Lymphoma is the most common subtype of NHL, where it accounts for half of NHL cases in both genders among the Saudi population. More than 40 per cent of DLBCL cases present with an advanced-disease stage, which is associated with a lower survival rate. This delay in seeking medical attention could be explained by the lack of public awareness about the disease, especially since the clinical presentation includes unspecific symptoms, in addition to the absence of effective screening methods for early detection.

An important note to consider is that the local literature reporting lymphoma in Saudi Arabia is limited, as the reported data may not represent lymphoma epidemiology in the Kingdom. More data are needed, especially from peripheral hospitals.

Cancer management is complex, and various medical professionals play a critical role in the overall patient journey. As pharmacists, our responsibilities in CAR-T cell therapy programmes include policy development, clinical assessment of bridging and lymphodepleting chemotherapy, toxicity management, and patient and staff education. Pharmacists with an experience in cellular therapy are highly needed in clinical practice, as this treatment modality continues to evolve to effectively treat incurable haematologic malignancies and potentially even solid tumours.

See the original post here:
Advanced cellular therapy brings hope to KSA cancer patients - Omnia Health Insights

India is brimming with biotech companies and a young and skilled workforce. Heres a quick glance at the private healthcare biotechs in India that captured investors imaginations in the last couple of years.

India has historically been known for its large IT, pharmaceutical and vaccine manufacturing sectors, but is also a force to be reckoned with in the global biotechnology market. The nation boasts around 5,000 biotech companies, with more than 4,000 being startups. This startup count is expected to reach 10,000 by 2024.

With a huge population of young and skilled workers, India has many ingredients for expanding the number of its biotech companies in the coming years. Add to this a large patient pool for lifestyle-related diseases such as type 2 diabetes, and there is a large potential for generating innovations in healthcare.

Weve assembled a shortlist of the hottest private biotech companies in India by checking whos raised impressive cash in the last few years. These companies are carrying out innovative healthcare research and are primarily based in Mumbai and Bengaluru.

Founded: 2014

Headquarters: Bengaluru, India and Saratoga, U.S.

Bugworks has multiple sites in the U.S. and Australia with a research and development base in India. The firm specializes in the development of antibiotics that could address the growing crisis of antimicrobial resistance.

Bugworks lead candidate antibiotic blocks the replication machinery in invading bacteria. In addition, the drug is designed to bypass normal resistance mechanisms in bacteria, which could make it harder for strains to become resistant to the treatment.

The company is testing its antibiotic in phase 1 trials for the treatment of multi-drug resistant infections in collaboration with the nonprofit initiatives CARB-X and the Global Antibiotic Research and Development Partnership (GARDP).

Bugworks is financing its antibiotics research with a $18 million Series B1 round closed in February 2022. In addition, Bugworks will use the proceeds to fund the preclinical development of a dual-acting drug to treat cancer.

Founded: 2012

Headquarters: Mumbai

Epigeneres Biotech hit the headlines in January 2022 with a $6 million Series B funding round. The Indian biotech company is using the cash to develop a wide range of different technologies in its arsenal, including cancer tests, nanotechnology-based medicines and nutraceuticals.

Cancer detection is Epigeneres most recent pursuit. In 2021, the firm teamed up with the Singaporean company Tzar Labs to develop cancer diagnostics that screen for telltale RNA molecules from tumors at early stages of disease. Epigeneres is poised to launch a screening service in India based on the technology.

Epigeneres also has nucleic acid drugs in development for the treatment of conditions ranging from infertility to renal failure to autoimmune diseases. The firm uses a form of nanotechnology to boost the delivery of the drugs to the target cells.

In addition, Epigeneres is working on small molecule drugs that can increase the population of stem cells in the body in a regenerative medicine setting.

Founded: 2016

Headquarters: Bengaluru

In August 2022, Eyestem caught the eye of investors in a $6.4 million Series A round. The Indian biotech startup is working on cell therapies for eye disorders, with a flagship therapy in the pipeline for the treatment of dry age-related macular degeneration (dry AMD).

There is currently no treatment for dry AMD. In patients with the condition, the eye accumulates cellular debris, which causes destructive inflammation in the retina. This leads to a loss of retinal pigment epithelium, the layer of cells that support the photosensitive cells we need to see.

Eyestem is developing an off-the-shelf stem cell therapy to replace lost retinal pigment epithelium. The biotech has earmarked money from its recent Series A round for preparing its cell therapy for early-stage clinical testing.

Founded: 2019

Headquarters: Bengaluru

Immuneel Therapeutics is making waves in the field of autologous CAR-T cell therapy, where a patients immune T cells are removed, engineered in the lab to kill blood cancer cells, and reinfused into the patient. There are CAR-T therapies already available, but these complex, expensive therapies are currently limited to only the wealthiest countries.

Immuneels mission is to develop CAR-T therapies that are accessible and affordable in India. To support this push, the company raised $15 million in June 2022 in a Series A round.

The therapies in Immuneels pipeline are targeted to various types of blood cancer in children and adult patients. As the Indian biotech closed its Series A round, Immuneel kicked off a phase 2 trial of a CAR-T therapy in what it claims is the first industry-sponsored CAR-T trial in India.

Founded: 2013

Headquarters: Bengaluru and Wilmington, U.S.

MedGenome has sites around the globe, with a large part of its operations and genetic testing situated in, and targeted to, India.

The company carries out genomics-focused research and diagnostics services for biopharma clients that can help in the development of drugs tackling cancer, diabetes, eye conditions and cardiovascular diseases. To provide a rich dataset, the company works with more than 500 hospitals in India.

MedGenome raised one of the Asia-Pacific regions biggest biotech investments in August 2022 a $50 million round led by Novo Holdings. The funds will be used to increase access to genetic testing in emerging markets, which have lagged behind the wealthier parts of the world.

MedGenome also aims to collect genetic data from a wide range of populations in Asia, which could provide a treasure trove of clinical insights for genes related to disease. In keeping with this aim, the company is a founding member of the initiative GenomeAsia 100K, which will analyze the genomes of 100,000 people from a range of Asian populations to speed up the development of precision medicine in this part of the world.

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The five hottest private biotech companies in India - Labiotech.eu

The Foundation's donation and fundraising efforts will help diversify the Be The Match Registry

MINNEAPOLIS, Sept. 13, 2022 /PRNewswire/ -- In support of enhanced accessibility to life-saving stem cell transplants through the Be The Match Registry, the William G. Pomeroy Foundation has made a $500,000 grant to Be The Match that will further the organization's partnerships at historically Black colleges and universities (HBCUs).

"Patients are most likely to match a donor of their own ethnic background," said Bill Pomeroy

The $500,000 gift will enable Be The Match to grow its partnerships at HBCUs with focused recruitment efforts, education, awareness and internship opportunities for students; all in pursuit of increased stem cell transplant accessibility for Black and African American patients. Six new campus partnerships have already been established as a result of this gift.

"This generous gift from the Pomeroy Foundation is going to have a lasting impact on our ability to reach Black and African American communities and will make a difference for diverse patients in need of a donor," said Amy Ronneberg, Chief Executive Officer of Be The Match.

In addition, the Pomeroy Foundation donation sponsors a gift matching campaign that will help to diversify the donor registry. The matching opportunity coincides with this year's observance of World Marrow Donor Day on Saturday, Sept. 17. Donations to Be The Match throughout the month of September will be matched dollar for dollar, up to $500,000. Visit this link to donate and have your gift matched. The doubled donation will give patients a greater chance of finding a match and a second chance at life.

"Patients are most likely to match a donor of their own ethnic background," said Bill Pomeroy, Founder and Trustee of the Pomeroy Foundation. "Improving the ethnic diversity of the registry improves all patients' odds of finding a life-saving match."

Currently, the chance of having a matched, available donor on the registry ranges from 29-79%, with people of color less likely to find a match because fewer potential donors with diverse backgrounds are registered.

In 2004, Bill Pomeroy was diagnosed with an aggressive form of leukemia. He received a life-saving transplant from a fully matched donor found on the Be The Match Registry in 2005. Bill's transplant experience served as a catalyst for the creation of the Pomeroy Foundation, which works closely with Be The Match to expand recruitment efforts, especially for ethnically diverse donors. Bill is Trustee Emeritus for the Be The Match Foundation.

To double your donation to Be The Match during this month's matching gift campaign and to learn more about diversifying the Be The Match Registry, visit: bethematch.org.

About Be The Match:

Be The Match is the leading global partner working to save lives through cellular therapy. With more than 30 years of experience managing the most diverse registry of potential unrelated blood stem cell donors and cord blood units in the world, Be The Match is a proven partner in providing cures to patients with life-threatening blood and marrow cancers and diseases. Through their global network, they connect centers and patients to their best cell therapy options, from blood stem cell transplant to next-generation therapy, and collaborate with cell and gene therapy companies to support therapy development and delivery through Be The Match BioTherapies. Learn more at bethematch.org.

About the Pomeroy Foundation

The William G. Pomeroy Foundationis committed to supporting the celebration and preservation of community history; and working to improve the probability of finding appropriate donor matches or other life-saving treatments for blood cancer patients. Established by Trustee Bill Pomeroy in 2005 to bring together his two greatest passions, the Pomeroy Foundation is a private, philanthropic organization located in Syracuse, N.Y. As the nation's leading funder of historic roadside markers, the Pomeroy Foundation has awarded nearly 2,000 grants for markers and bronze plaques in 46 states and Washington, D.C. To learn more about the Pomeroy Foundation, visit wgpfoundation.org.

Media Contact: Erica SevillaPhone Number: 763-406-8758Email: [emailprotected]Website: bethematch.org

Media Contact: Steve BodnarCommunications ConsultantWilliam G. Pomeroy Foundation[emailprotected]315-913-4068

SOURCE Be The Match; William G. Pomeroy Foundation

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Be The Match and William G. Pomeroy Foundation Announce $500k Gift and Matching Campaign - PR Newswire

A man in southern California, dubbed the 'City of Hope patient', appears to be the latest person cured of HIV after receiving a stem cell transplant from a donor with a rare mutation, bringing the total to five, according to a presentation on Monday at the24th International AIDS Conference (AIDS 2022)in Montreal. The man remains free of HIV more than 17 months after stopping antiretroviral therapy (ART) and his leukaemia also remains in remission.

The man is older than the handful of other people previously cured after such a procedure, he has been living with HIV longer and he received a less harsh conditioning regimen prior to the transplant. This suggests that this approach may be possible for a wider subset of HIV-positive people with advanced cancer, but it is far from feasible for the vast majority of people living with HIV. Yet the case could provide clues that help researchers develop more widely applicable approaches for long-term HIV remission.

Dr Jana Dickter talks about the 'City of Hope patient' at AIDS 2022.

The City of Hope patients case, if the right donor can be identified, may open up the opportunity for more older patients living with HIV and blood cancers to receive a stem cell transplant and go into remission for both diseases, said DrJana Dickter of the City of Hope cancer centrenear Los Angeles, who described the case at the conference and at an advance media briefing last week.

The latest case involves a 66-year-old white man who was diagnosed with HIV in 1988. At one point, his CD4 count fell so low (below 100) that he was diagnosed with AIDS. He started ART when it became available in the mid-1990s. In 2018, he was diagnosed with acute myelogenous leukaemia.

Cells from which all blood cells derive. Bone marrow is rich in stem cells.

A protein on the surface of certain immune system cells, including CD4 cells. CCR5 can act as a co-receptor (a second receptor binding site) for HIV when the virus enters a host cell. A CCR5 inhibitor is an antiretroviral medication that blocks the CCR5 co-receptor and prevents HIV from entering the cell.

The disappearance of signs and symptoms of a disease, usually in response to treatment. The term is often used in relation to cancer, indicating that there is no evidence of disease, although the possibility of cancer remaining in the body cannot be ruled out. In HIV, remission is an alternative term for functional cure. A sustained ART-free remission would boost the immune system to induce long-term control of HIV, allowing a person living with HIV to maintain an undetectable viral load without daily medication.

In cell biology, a structure on the surface of a cell (or inside a cell) that selectively receives and binds to a specific substance. There are many receptors. CD4 T cells are called that way because they have a protein called CD4 on their surface. Before entering (infecting) a CD4 T cell (that will become a host cell), HIV binds to the CD4 receptor and its coreceptor.

The use of drugs to treat an illness, especially cancer.

In early 2019, at age 63, he received a stem cell transplant from an unrelated donor with a double CCR5-delta-32 mutation, which deletes the receptors most strains of HIV use to enter cells. Before the procedure, he underwent reduced-intensity conditioning chemotherapy designed for older and less fit patients, and he developed only mild graft-versus-host disease, a condition that occurs when donor immune cells attack the recipients body.

Tests showed that the man achieved 100% chimerism, meaning all his immune cells originated from the donor, Dickter reported. He continued ART (dolutegravir, tenofovir alafenamide and emtricitabine) for two years after the transplant. At that point, with a stable undetectable viral load, he and his doctors decided to try a carefully monitored treatment interruption.

More than three years after the transplant and over 17 months after stopping antiretrovirals he has no evidence of HIV RNA viral load rebound and no detectable HIV DNA in peripheral blood cells, a marker of the latent viral reservoir. Gut tissue biopsies also found no evidence of replication-competent virus.

Laboratory studies showed that his new blood cells were impervious to HIV strains that use the CCR5 receptor. However, Dickter noted that the man might remain susceptible to infection with virus that uses the alternative CXCR4 receptor, so she has counselled him about using PrEP (regular medication to prevent HIV infection).

Whats more, the man shows no detectable HIV-specific T-cell responses and his HIV antibody level has declined over time. Interestingly, he does continue to have antibodies against hepatitis B virus, even though the donor is HBV-negative.

We were thrilled to let him know that his HIV is in remission and he no longer needs to take antiretroviral therapy that he had been on for over 30 years, Dickter said in a City of Hope press release. He saw many of his friends die from AIDS in the early days of the disease and faced so much stigma when he was diagnosed with HIV in 1988. But now, he can celebrate this medical milestone.

The man, who wishes to remain anonymous, added, When I was diagnosed with HIV in 1988, like many others, I thought it was a death sentence, I never thought I would live to see the day that I no longer have HIV.

Only a small number of people have been cured of HIV after stem cell transplants. The first, Timothy Ray Brown, formerly known as the Berlin patient, received two transplants to treat leukaemia in 2006. His oncologist, DrGero Htter, came up with the idea of using stem cells with the CCR5-delta32 mutation, speculating that it might cure both cancer and HIV.

As described at the 2008 Conference on Retroviruses and Opportunistic Infections (CROI), Brown first underwent intensive chemotherapy and whole-body radiation, and he developed near-fatal graft-versus-host disease. He stopped ART at the time of his first transplant, at age 40, but his viral load did not rebound. Researchers extensively tested his blood, gut and other tissues, finding no traces of replication-competent HIV. At the time of his death in September 2020, due to a recurrence of leukaemia, Brown had been free of HIV for more than 13 years.

A second man, Adam Castillejo, dubbed the London Patient, was also cured after receiving a stem cell transplant to treat Hodgkin lymphoma. As described at CROI 2019, he too received cells from a donor with the CCR5-delta-32 mutation, but he had less aggressive conditioning chemotherapy and developed milder graft-versus-host disease. A year and a half after the transplant, with no evidence of viable HIV, he stopped ART in September 2017, and he has now been HIV-free for more than four years.

At this years CROI, New York City researchers described a middle-aged woman with leukaemia who received a transplant using a combination of umbilical cord blood cells with the CCR5-delta-32 mutation and partially matched adult stem cells from a relative. She received intensive chemotherapy and radiation prior to the transplant but did not develop graft-versus-host disease, which is less common with cord blood. She stopped ART three years after the transplant and her viral load remains undetectable a year and a half later.

Finally, a German man, dubbed the Dsseldorf Patient, has not experienced HIV rebound more than three years after stopping ART following a CCR5-delta-32 stem cell transplant. Less is known about this case, which has not receive widespread media attention, but DrBjrn Jensen told NBC News that the man is almost definitely cured.

These cures are no longer anecdotal we now have a real case series, DrSteven Deeks of the University of California at San Francisco told aidsmap. That this approach is curative is no longer really questioned.

Researchers are still working to learn why these cures after stem cell transplantation were successful while other attempts have failed. Using stem cells with a double CCR5-delta-32 mutation seems to be key. At CROI 2012, researchers described two HIV-positive men in Boston who received stem cell transplants for cancer treatment from donors without the mutation. Both experienced viral rebound after stopping ART, though this was delayed.

Some have posited that the graft-versus-host reaction might play a role in eradicating HIV, but the five patients who were cured received different pre-transplant conditioning regimens and some experienced mild or no graft-versus-host disease.

Even as each new case provides more answers, stem cell transplants remain far too risky for people who do not need them to treat life-threatening cancer. Seeing the host as foreign, the donor immune cells can attack the recipients tissues and organs, which may necessitate immunosuppressive therapy. While waiting for donor cells to engraft, patients are highly susceptible to infections. Whats more, the procedure is medically intensive and costly and would be impossible to scale up to treat the millions of people living with HIV worldwide.

Nonetheless, each case offers clues that could help researchers develop strategies that lead to more widely applicable functional cures, or long-term remission without ART. Deeks, for example, hopes emerging gene-editing technologies might be used to delete or disable CCR5 receptors and make an individuals own immune cells resistant to HIV entry.

These cases are still interesting, still inspiring and illuminate the search for a cure, International AIDS Society president-elect DrSharon Lewin of the Peter Doherty Institute for Infection and Immunity in Melbourne told reporters during an AIDS 2022 advance media briefing.

But some advocates question why these rare cures, which wont help most people living with HIV, get so much more attention than natural or post-treatment controllers, one of whom was also described at the conference.

I think theyre selling us a bill of goods, DARE-CAB member Michael Louella said during the discussion following the presentation. Im never going to get that [a stem cell transplant], but this other type of remission that doesnt get so much attention could be applicable for more people.

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California man appears to be another person cured of HIV after a stem cell transplant - aidsmap

Leveraging Poseida's novel approach to cell therapy and Roche's expertise in developing and commercializing therapies to transform cancer care, the collaboration is focused on advancing multiple existing and additional next generation allogeneic CAR-T programs directed to hematologic malignancies

Poseida will receive $110 million upfront, could receive up to $110 million in near-term milestones and other payments, and is eligible for future development and commercial milestones and tiered royalty payments

Poseida to host a brief conference call today at 8:30 a.m. ET

SAN DIEGO, Aug.3, 2022 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today announced it has entered into a broad strategic collaboration and license agreement with Roche, focused on developing allogeneic CAR-T therapies directed to hematologic malignancies. The global collaboration covers the research and development of multiple existing and novel "off-the-shelf" cell therapies against targets in multiple myeloma, B-cell lymphomas and other hematologic indications.

"We are excited to partner and collaborate with Roche, one of the world's largest biotechnology companies, which has a successful track record in the discovery, development and commercialization of innovative medicines," said Mark Gergen, Chief Executive Officer of Poseida. "Roche is an ideal strategic partner for Poseida with its industry-leading R&D capabilities in oncology, complementary technologies and expertise, and global regulatory and commercial capabilities. Working together, we look forward to advancing novel allogeneic cell therapies based upon Poseida's technologies for patients battling cancer."

Poseida Therapeutics announces strategic global collaboration with Roche focused on #allogeneic CAR-T cell therapies.

Under the agreement, Roche will receive from Poseida either exclusive rights or options to develop and commercialize a number of allogeneic CAR-T programs in Poseida's portfolio that are directed to hematologic malignancies, including P-BCMA-ALLO1, an allogeneic CAR-T for the treatment of multiple myeloma and for which a Phase 1 study is underway, and P-CD19CD20-ALLO1, an allogeneic dual CAR-T for the treatment of B-cell malignancies with an IND expected in 2023. Building on complementary expertise and capabilities, the parties will also collaborate in a research program to create and develop next-generation features and improvements for allogeneic CAR-T therapies, from which they would jointly develop additional allogeneic CAR-T product candidates directed to existing and new hematologic targets. For a subset of both the Poseida portfolio programs licensed or optioned to Roche and the parties' future collaboration programs, Poseida will conduct the Phase 1 studies and manufacture clinical materials before transitioning the programs to Roche for further development and commercialization. Roche will be solely responsible for the late-stage clinical development and global commercialization of all products that are subject to the collaboration.

"We are excited to partner with Poseida to further explore the potential of allogeneic cell therapies to transform cancer care by developing off-the-shelf products that can address high unmet medical needs for a broad patient population," said James Sabry, Global Head of Pharma Partnering at Roche. "Poseida's differentiated platform technologies complement our ongoing internal efforts and partnerships to discover and develop cell therapies as a next generation of medicines for patients."

Under the agreement, Poseida will receive $110 million upfront and could receive up to $110 million in near-term milestonesand other payments in the next several years. In addition, Poseida is eligible to receive research, development, launch, and net sales milestones and other payments potentially up to $6 billion in aggregate value, as well as tiered net sales royalties into the low double digits, across multiple programs.

"We are thrilled that Roche has embraced the opportunity to partner with us and use Poseida's unique allogeneic approach to develop CAR-T product candidates," said Devon J. Shedlock, Ph.D., Chief Scientific Officer, Cell Therapy at Poseida. "Using our proprietary technologies and manufacturing process including our booster molecule, we have the potential to develop and manufacture a product with high levels of stem cell memory T cells, which are correlated with potent antitumor efficacy in the clinic, at a scale that can potentially reach more patients and enable broad commercial use."

The effectiveness of the agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act (HSR Act).

Poseida Therapeutics Conference Call and Webcast InformationWednesday, August 3, 2022 at 8:30 a.m. ET

Poseida's management team will host a conference call and webcast today at 8:30 a.m. ET to discuss the collaboration and Poseida's novel approach to allogeneic cell therapy. The dial-in numbers for domestic and international callers are 800-267-6316 and 203-518-9814, respectively. The conference ID number for the call is PSTX0803.

Participants may access the live webcast on the Investors & Media Section of the Poseida website, http://www.poseida.com. An archived replay of the webcast will be available for approximately 30 days following the event.

About Poseida Therapeutics, Inc.

Poseida Therapeutics is a clinical-stage biopharmaceutical company dedicated to utilizing our proprietary genetic engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure. We have discovered and are developing a broad portfolio of product candidates in a variety of indications based on our core proprietary platforms, including our non-viral piggyBac DNA Delivery System, Cas-CLOVER Site-specific Gene Editing System and nanoparticle- and AAV-based gene delivery technologies. Our core platform technologies have utility, either alone or in combination, across many cell and gene therapeutic modalities and enable us to engineer our portfolio of product candidates that are designed to overcome the primary limitations of current generation cell and gene therapeutics. To learn more, visit http://www.poseida.com and connect with us on Twitter and LinkedIn.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the upfront payment and other potential fees, milestone and royalty payments and development activities under the collaboration agreement, the potential benefits of Poseida's technology platforms and product candidates, the clearance of the collaboration agreement under the HSR Act, Poseida's plans and strategy with respect to developing its technologies and product candidates, and anticipated timelines and milestones with respect to Poseida's development programs and manufacturing activities. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Poseida's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the fact that the collaboration agreement may not become effective based on HSR Act clearance, or the effectiveness may be substantially delayed, or may be terminated early, the fact that the Company will have limited control over the efforts and resources that Roche devotes to advancing development programs under the collaboration agreement and Poseida may not receive the potential fees and payments under the collaboration agreement or fully realize the benefits of the collaboration, risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry, the fact that future preclinical and clinical results could be inconsistent with results observed to date, and the other risks described in Poseida's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Poseida undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

SOURCE Poseida Therapeutics, Inc.

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Poseida Therapeutics Announces Strategic Global Collaboration with Roche Focused on Allogeneic CAR-T Cell Therapies for Hematologic Malignancies - PR...

Dublin, Aug. 01, 2022 (GLOBE NEWSWIRE) -- The "Induced Pluripotent Stem Cell (iPSC) Global Market Report 2022, By Derived Cell Type, By Application, By End-User" report has been added to ResearchAndMarkets.com's offering.

The global induced pluripotent stem cell (iPSC) market is expected to grow from $ 2431.2 million in 2021 to $ 2640.80 million in 2022 at a compound annual growth rate (CAGR) of 8.6%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $ 3571.48 million in 2026 at a CAGR of 7.8%.

Increase in the prevalence of chronic disorders is one of the major factors that is driving the growth of Induced pluripotent stem cell market. Chronic disorders like heart disease, cancer, stroke, diabetes can be treated with Induced pluripotent stem cell.

Induced Pluripotent stem cells are taken from any tissues from a child or an adult and are genetically modified to behave like embryonic stem cells. According to the report published by Partnership to Fight Chronic Disorder (PFCD), it was found that out of 133 million Americans, 45% of the population had at least one chronic disorder. Moreover, it was estimated that 7 out of 10 deaths in the USA, which is approximately 1.7 million, are due to chronic disorders and these deaths can be controlled by induced pluripotent stem cell treatment. This rise in incidences of chronic diseases is driving the demand for induced pluripotent stem cell treatment.

The potential risk of tumour is one of the major restraints on the growth of Induced pluripotent stem cell market. As per a scientific research, it was found that there might be a chance of getting cancer from the treatment and people are unwilling to take treatment through Induced pluripotent stem cell therapy.

According to the report by American Association for cancer research, in most of the cases while doing the experiment it was found that the occurrence of the tumours was prevalent after a short period of time. This risk of developing a tumour due to Induced pluripotent stem cell therapy is limiting the number of patients opting for this treatment, thereby restraining the growth of the market.

ScopeMarkets Covered:1) By Derived Cell Type: Hepatocytes; Fibroblasts; Keratinocytes; Amniotic Cells; Others2) By Application: Academic Research; Drug Development And Discovery; Toxicity Screening; Regenerative Medicine3) By End-User: Hospitals; Research Laboratories

Key Topics Covered:

1. Executive Summary

2. Induced Pluripotent Stem Cell (iPSC) Market Characteristics

3. Induced Pluripotent Stem Cell (iPSC) Market Trends And Strategies

4. Impact Of COVID-19 On Induced Pluripotent Stem Cell (iPSC)

5. Induced Pluripotent Stem Cell (iPSC) Market Size And Growth

6. Induced Pluripotent Stem Cell (iPSC) Market Segmentation

7. Induced Pluripotent Stem Cell (iPSC) Market Regional And Country Analysis

8. Asia-Pacific Induced Pluripotent Stem Cell (iPSC) Market

9. China Induced Pluripotent Stem Cell (iPSC) Market

10. India Induced Pluripotent Stem Cell (iPSC) Market

11. Japan Induced Pluripotent Stem Cell (iPSC) Market

12. Australia Induced Pluripotent Stem Cell (iPSC) Market

13. Indonesia Induced Pluripotent Stem Cell (iPSC) Market

14. South Korea Induced Pluripotent Stem Cell (iPSC) Market

15. Western Europe Induced Pluripotent Stem Cell (iPSC) Market

16. UK Induced Pluripotent Stem Cell (iPSC) Market

17. Germany Induced Pluripotent Stem Cell (iPSC) Market

18. France Induced Pluripotent Stem Cell (iPSC) Market

19. Eastern Europe Induced Pluripotent Stem Cell (iPSC) Market

20. Russia Induced Pluripotent Stem Cell (iPSC) Market

21. North America Induced Pluripotent Stem Cell (iPSC) Market

22. USA Induced Pluripotent Stem Cell (iPSC) Market

23. South America Induced Pluripotent Stem Cell (iPSC) Market

24. Brazil Induced Pluripotent Stem Cell (iPSC) Market

25. Middle East Induced Pluripotent Stem Cell (iPSC) Market

26. Africa Induced Pluripotent Stem Cell (iPSC) Market

27. Induced Pluripotent Stem Cell (iPSC) Market Competitive Landscape And Company Profiles

28. Key Mergers And Acquisitions In The Induced Pluripotent Stem Cell (iPSC) Market

29. Induced Pluripotent Stem Cell (iPSC) Market Future Outlook and Potential Analysis

30. Appendix

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/mkszf2

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Induced Pluripotent Stem Cell (iPSC) Global Market to Reach $3.57 Billion by 2026 - Benzinga