- 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.

Story continues

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

Here is the original post:
Clinical Strategy for Enhancing Affini-T Therapeutics Merkel Polyoma Virus TCR Therapy to be Presented at ASCO 2022 - Yahoo Finance

SAN FRANCISCO, June 03, 2022 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc.(Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs, todayannouncedthat the company will present clinical trial design details for three of its wholly-owned investigative therapies, NX-2127, DeTIL-0255 and NX-1607, each currently in Phase 1 development, at the Annual Meeting of the American Society of Clinical Oncology (ASCO). The meeting is being held from June 3-7, 2022 in Chicago, IL and virtually.

Poster and presentation details are included below:

Title: A First-in-Human Phase 1 Trial of NX-2127, a First-in-Class Oral BTK Degrader With Immunomodulatory Activity, in Patients With Relapsed and Refractory B-Cell Malignancies Authors: Anthony Mato, Alexey Danilov, Manish R. Patel, Michael Tees, Ian Flinn, Weiyun Ai, Krish Patel, Michael Wang, Susan OBrien, Srinand Nandakumar, May Tan, Erin Meredith, Melissa A. Gessner, Su Young Kim, Adrian Wiestner, William G. WierdaSession: Hematologic MalignanciesLymphoma and Chronic Lymphocytic LeukemiaAbstract: TPS7581; Poster: 232aTime: June 4, 8:00 a.m. - 11:00 a.m. CDT

Title: A Phase 1 Adoptive Cell Therapy Using Drug-Enhanced, Tumor-Infiltrating Lymphocytes, DeTIL-0255, in Adults With Advanced Malignancies Authors: Eugenia Girda, Emese Zsiros, John Nakayama, Sarah Whelan, Srinand Nandakumar, Seema Rogers, Beverly Benson, Frank G. Basile, Michael T. Lotze, Robert Brown, and Robert M. WenhamSession: Gynecologic CancerAbstract: TPS5602; Poster: 477bTime: June 4, 1:15 p.m. - 4:15 p.m. CDT

Title: A First-in-Human Phase 1 Trial of NX-1607, a First-in-Class Oral CBL-B Inhibitor, in Patients with Advanced Solid Tumor MalignanciesAuthors: Adam Sharp, Anja Williams, Sarah Blagden, Ruth Plummer, Daniel Hochhauser, Matthew G. Krebs, Simon Pacey, Jeff Evans, Sarah Whelan, Srinand Nandakumar, Seema Rogers, Katherine L. Jameson, Frank G. Basile, Johann de Bono, and Hendrik-Tobias ArkenauSession: Developmental TherapeuticsImmunotherapyAbstract: TPS2691; Poster: 333bTime: June 5, 8:00 a.m. - 11:00 a.m. CDT

Abstracts can be found on the ASCO website at: ASCO.org/abstracts.

Posters will be available for registered attendees for on-demand viewing on the ASCO website. They can also be viewed on the Events and Presentations page of the Investors section of Nurixs website at the date and time of the poster presentation.

About NX-2127NX-2127 is a novel bifunctional molecule that degrades Brutons tyrosine kinase (BTK) and cereblon neosubstrates Ikaros (IKZF1) and Aiolos (IKZF3). NX-2127 is currently being evaluated in a Phase 1a/1b clinical trial in patients with relapsed or refractory B cell malignancies. Initial data from the Phase 1a dose-escalation portion of the study demonstrated clinically meaningful degradation of BTK in all patients, including in a chronic lymphocytic leukemia patient with significant mutations in the BTK gene associated with resistance to standard of care BTK inhibitors. Nurix expects to present additional data from this study in the second half of 2022. Additional information on the clinical trial can be accessed at http://www.clinicaltrials.gov (NCT04830137).

About DeTIL-0255DeTIL-0255 is an autologous cell therapy consisting of T cells derived from a patients tumor expanded in culture with recombinant interleukin-2 and the small molecule Casitas B-lineage lymphoma proto-oncogeneB (CBL-B) inhibitor NX-0255. DeTIL-0255 is designed to be a single administration autologous TIL therapy infused following non-myeloablative chemotherapy. Given the improved phenotypes of T cells produced with CBL-B inhibition, DeTIL-0255 could allow a broader application of TIL therapy, potentially providing long term benefit to patients with multiple types of cancer. Nurix is conducting a Phase 1 trial of DeTIL-0255 in patients with advanced gynecologic tumors at multiple sites in the United States. Additional information on the clinical trial can be accessed at http://www.clinicaltrials.gov (NCT05107739).

About NX-1607 NX-1607 is an orally bioavailable inhibitor of CBL-B for immuno-oncology indications including a range of solid tumor types. NX-1607 acts on T cells, NK cells, and dendritic cells to enhance anti-tumor immunity, and has demonstrated single-agent anti-tumor activity in multiple tumor models. Nurix is evaluating NX-1607 in an ongoing, Phase 1 dose escalation and expansion trial in adults with a variety of oncology indications at multiple clinical sites in the United Kingdom. Additional information on the clinical trial can be accessed at http://www.clinicaltrials.gov (NCT05107674).

About Nurix Therapeutics, Inc. Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of small molecule and cell therapies based on the modulation of cellular protein levels as a novel treatment approach for cancer and other challenging diseases. Leveraging Nurixs extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurixs drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels. Nurixs wholly owned pipeline includes targeted protein degraders of Brutons tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogeneB, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California. For more information, please visit http://www.nurixtx.com.

Forward Looking StatementThis press release contains statements that relate to future events and expectations and as such constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When or if used in this press release, the words anticipate, believe, could, estimate, expect, intend, may, outlook, plan, predict, should, will, and similar expressions and their variants, as they relate to Nurix, may identify forward-looking statements. All statements that reflect Nurixs expectations, assumptions or projections about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements regarding our current and prospective drug candidates; the planned timing and conduct of our clinical trial programs for our drug candidates; the planned timing for the provision of clinical updates and initial findings from our clinical studies; the potential advantages of our DELigase platform and drug candidates; and the extent to which our scientific approach and DELigase platform may potentially address a broad range of diseases. Forward-looking statements reflect Nurixs current beliefs, expectations, and assumptions. Although Nurix believes the expectations and assumptions reflected in such forward-looking statements are reasonable, Nurix can give no assurance that they will prove to be correct. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and changes in circumstances that are difficult to predict, which could cause Nurixs actual activities and results to differ materially from those expressed in any forward-looking statement. Such risks and uncertainties include, but are not limited to: (i) risks and uncertainties related to Nurixs ability to advance its drug candidates, obtain regulatory approval of and ultimately commercialize its drug candidates; (ii) the timing and results of preclinical studies and clinical trials; (iii) Nurixs ability to fund development activities and achieve development goals; (iv) the impact of the COVID-19 pandemic on Nurixs business, clinical trials, financial condition, liquidity and results of operations; (v) Nurixs ability to protect intellectual property and (vi) other risks and uncertainties described under the heading Risk Factors in Nurixs Quarterly Report on Form 10-Q for the fiscal period ended February 28, 2022, and other SEC filings. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. The statements in this press release speak only as of the date of this press release, even if subsequently made available by Nurix on its website or otherwise. Nurix disclaims any intention or obligation to update publicly any forward-looking statements, whether in response to new information, future events, or otherwise, except as required by applicable law.

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Nurix Therapeutics Will Present Trial in Progress Posters for Three Clinical Programs at the Annual Meeting of the American Society of Clinical...