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HOUSTON, July 29, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Charles M. Balch, MD, FACS, FASCO is acknowledged as a Pinnacle Lifetime Member for his contributions to Surgical Oncology and Medical Education. Dr. Charles M. Balch stands as a beacon of excellence in the fields of surgical oncology and medical education, with a global impact that spans continents. With a diverse background and unparalleled expertise, Dr. Balch has dedicated his career to advancing the treatment of cancer and shaping the future of medical professionals worldwide. Continue Reading Charles M Balch, MD, FACS, FASCO Dr. Balch's journey began with a Bachelor of Science degree in biology, with a minor in chemistry, from the University of Toledo in Ohio. He furthered his education with a prestigious MD from Columbia College of Physicians and Surgeons, followed by extensive training in general surgical residency at renowned institutions such as Duke University Medical Center and the University of Alabama at Birmingham. Dr. Balch honed his skills through specialized fellowships in immunology at the Scripps Clinic and Research Foundation, as well as clinical administrative research with the National Institutes of Health. As a board-certified surgeon with more than 49 years in the medical field, Dr. Balch's impact extends far beyond the operating room. He is a Fellow of the American College of Surgeons and has held leadership positions in numerous prestigious organizations, including serving as Past President of the Society of Surgical Oncology and Chair of the executive committee for the Commission on Cancer. His contributions to melanoma staging as Chair of the melanoma staging committee for the American Joint Committee on Cancer have been instrumental in advancing cancer care worldwide. A leading authority in both melanoma and breast cancer, as well as immunotherapy, Dr. Balch has made significant contributions to laboratory research in tumor immunology and human T lymphocyte differentiation. He is the author of more than 840 publications which have been cited more than 35,000 times in the biomedical literature (an average of 75 citations per article, h-index of 89). In addition to his clinical work, Dr. Balch has been deeply involved in medical education and research throughout his career. He has served as Executive Vice President and CEO for the American Society of Clinical Oncology and played pivotal roles in organizations such as the National Comprehensive Cancer Network and the Association for Academic Surgeons. Dr. Balch's commitment to education is further evidenced by his involvement with the founding boards of the NASA Space Center in Houston and the NASA Astronaut Medical Standards Committee. A renowned and exceptional leader in multiple arenas, Dr. Balch is the Founding Editor-in-Chief Emeritus of the Annals of Surgical Oncology, which is recognized as the leading journal in the world in its field, with more than 11,000 surgical and library subscribers in 110 countries; Co-Editor-in-Chief of Chinese Clinical Oncology; Founding Editor-in-Chief of Patient Resource Cancer Guides now in its 15th year, which distributes nearly one million cancer guides (with 51 different titles) to cancer patients each year; President of Cancer Expert Now International; President of International Sentinel Node Society; Professor and Past-Chair of Surgery of the Department of Surgical Oncology at the University of Texas MD Anderson Cancer Center in Houston, Texas. He is the former Executive Vice-President and Chief Executive Officer of the American Society of Clinical Oncology in Alexandria, Virginia; President and CEO, City of Hope National Medical Center in Duarte, California; Professor of Surgery, Oncology and Dermatology; Deputy Director for Clinical Trials and Outcomes Research; Director of Johns Hopkins Clinical Research Network Institute for Clinical and Translational Research, Johns Hopkins Medical Institutions in Baltimore, Maryland. Further, Dr. Balch has served on The American Board of Surgery (Board of Directors); the Association of Academic Surgeons (President); The International Sentinel Node Society (as President); the Commission on Cancer (Chair, Board of Directors); the National Comprehensive Cancer Network (Founding Board of Directors); and the American Joint Committee on Cancer (Executive Committee). He holds honorary memberships in 12 national surgical organizations (including the Royal Australasian College of Surgeons; the Japan Surgical Society; the National Academy of Medicine of Mexico; and the European Society of Surgical Oncology); a Ph.D degree (honora causa) from the University of Crete; a Lifetime Achievement Award from the British Association of Surgical Oncology; National Academy of Medicine of Mexico Honorary Member; Professor Emeritus from John Hopkins University; and the Highest Alumni Award from his alma mater, The University of Toledo. The doctor has lectured in more than 42 different countries in the world and most of the major academic centers in the United States. As one of the leading melanoma experts in the world, Dr. Balch is the editor of Cutaneous Melanoma, regarded as the authoritative textbook on melanoma, now in its 6th edition through Spring Publications. His contributions to the melanoma literature include over 147 published articles, 6 books, and 154 book chapters or invited educational articles regarding his clinical investigations involving the natural history of melanoma, prognostic factors predicting clinical outcome, and standards of surgical treatment. He has published extensively on the conduct and methodology of clinical research. Dr Balch, Dr Seng-jaw Soong and colleagues performed one of the first prognostic factors analysis for melanoma in a landmark paper which was the first to use the Cox multifactorial regression analysis. They were the first to identify the major prognostic factors for Stage I, II and III melanoma that were the independent predictor of survival, including melanoma ulceration as a key predictor of metastases and interferon sensitivity. Their research on the natural history and predictive factors of melanoma clinical outcome essentially redefined the criteria now used worldwide for stratification criteria and end results reporting of clinical trials as well as TNM staging for melanoma. Dr. Balch is an acclaimed expert in the area of breast cancer and was one of the co-co-principal investigators of the only randomized surgical trial that compared Halsted radical mastectomy with modified radical mastectomy and was one of the pioneers of skin-sparing mastectomies followed by immediate breast reconstruction. As a distinguished professional in immunology research, he was the first to demonstrate that T lymphocytes were bone marrow derived and then processed in the thymus, and first described T lymphocyte distribution in various animal species including rats, guinea pigs, rabbits and monkeys. He was also the first to describe human NK and T Cell differentiation antigens, including the widely studied CD57 lymphocyte antigen. He has numerous articles about tumor and transplantation immunology, with more than 100 scientific publications and book chapters. Dr. Balch attributes much of his success to the guidance and mentorship of esteemed figures in medicine, including the late Dr. Donald Morton, Dr. John R. Durant, and Dr. R. Lee Clark, Jr. Their influence has shaped his approach to patient care, research, and leadership. Beyond his professional accomplishments, Dr. Balch is deeply involved in his communities, serving as an Elder and member of multiple churches. He also contributes to humanitarian efforts as Chair of the Board of Directors for Undying Hope International. As Dr. Balch continues to leave an indelible mark on the field of surgical oncology and medical education, his legacy of excellence and compassion serves as an inspiration to all who have the privilege of working alongside him. Contact: Katherine Green, 516-825-5634, [email protected] SOURCE The Inner Circle

Data further characterize the mechanism for Gamida Cell’s proprietary nicotinamide (NAM) technology’s expansion and enhancement of cellsBOSTON, Nov. 04, 2023 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today shared new data on the impact of the company’s proprietary nicotinamide (NAM) technology on its allogeneic stem cell therapy omidubicel and investigational natural killer (NK) cell therapy candidate GDA-201 at the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting in San Diego, CA. Both omidubicel and GDA-201 are powered by Gamida Cell’s proprietary NAM technology, which enhances and expands cells to create potentially curative cell therapies for patients with cancer. Omidubicel was approved under the brand name Omisirge™ (omidubicel-onlv) by the U.S. FDA in April 2023 for allogeneic stem cell transplant; GDA-201 is in Phase 1 study for the treatment of non-Hodgkin lymphoma (NCT05296525). Data on the first three cohorts of the Phase 1 study of GDA-201 were recently reported. “The data presented at SITC further our understanding of the effect of NAM in enhancing and expanding cells,” said Ronit Simantov, MD, Chief Medical and Scientific Officer of Gamida Cell. “Our data characterize the unique cellular composition of omidubicel, which is enriched in myeloid populations and dendritic cells, providing a potential mechanism for rapid engraftment and immune reconstitution, and is associated with lower infection rates observed in patients transplanted with omidubicel. Similarly, our data on GDA-201 demonstrate the unique, active phenotype of our NK cells expanded in the presence of NAM.” Additional details are as follows: Title: Significant myeloid and dendritic cellular enrichment of omidubicel graft suggests fast homeostatic proliferation of lymphoid populations Abstract number: 336 Presenting author: Dima Yackoubov Time: Saturday, November 4, 2023, 9:00 a.m. – 8:30 p.m. PDT Location: Exhibit Halls A and B1 Highlights: In this study, immunophenotyping was used to evaluate and characterize the cellular populations in the cultured fraction (CF) and non-cultured fraction (NF) of omidubicel (manufactured with Gamida Cell’s proprietary NAM technology) compared to standard umbilical cord blood (UCB). Manufacturing significantly increased the total nucleated cells (1.2-1.6-fold) and myeloid cells (2.2-3.6-fold) in the omidubicel CF compared to UCB. In addition, high resolution analysis of the CF showed a 25-62-fold increase in myeloid populations and dendritic cells and an absence of mature lymphoid cell populations. The NF was found to contain 50-70% fewer total with a comparable percentage of T cells, B cells, NK cells and NK-T cells to UCB. The results of this phenotypic characterization of omidubicel provide a potential mechanism for the rapid engraftment and immune reconstitution observed in transplanted patients. Title: GDA-201, nicotinamide (NAM) expanded NK cells derived from peripheral apheresis, show unique culture kinetics and increased expansion Abstract number: 401 Presenting author: Avner Yeffet, Ph.D. Time: Friday, November 3, 2023, 9:00 a.m. – 7:00 p.m. PDT Location: Exhibit Halls A and B1 Highlights: This study evaluated the impact of Gamida Cell’s NAM technology on NK cell kinetics. During the first days of expansion, NAM increased the survival of the feeder cells (45% on day 2-3 vs 13% on day 2-3) and prolonged their support in NK cell expansion, resulting in higher fold expansion persisting up to 21 days. In addition, NK cells expanded using NAM showed significantly higher cytotoxicity against leukemia cells (from a killing cytotoxicity function of 62.54% without NAM to 81.84% with NAM), and preservation of the NK cells in a partially mature state with low expression of CD57. These data provide further evidence for the unique cell culture kinetics of NAM-NK cells, GDA-201, which is currently being evaluated in a Phase 1 clinical trial in patients with non-Hodgkin lymphoma. About GDA-201GDA-201 is an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. A multicenter Phase 1 study of GDA-201 for the treatment of non-Hodgkin lymphoma is ongoing (NCT05296525). Results are expected in Q1 2024. GDA-201 is an investigational cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. Omisirge™ (omidubicel-onlv) Indication Omisirge is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. Important Safety Information for Omisirge BOXED WARNING: INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE, ENGRAFTMENT SYNDROME, AND GRAFT FAILURE Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material.Graft-versus-Host Disease may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD.Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids.Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery. Contraindications OMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products. Warnings and Precautions Hypersensitivity ReactionsAllergic reactions may occur with the infusion of OMISIRGE. Reactions include bronchospasm, wheezing, angioedema, pruritis and hives. Serious hypersensitivity reactions, including anaphylaxis, may be due to DMSO, residual gentamicin, Dextran 40, human serum albumin (HSA) and bovine material in OMISIRGE. OMISIRGE may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following OMISIRGE administration. Infusion ReactionsInfusion reactions occurred following OMISIRGE infusion, including hypertension, mucosal inflammation, dysphagia, dyspnea, vomiting, and gastrointestinal toxicity. Premedication with antipyretics, histamine antagonists, and corticosteroids may reduce the incidence and intensity of infusion reactions. In patients transplanted with OMISIRGE in clinical trials, 47% (55/117) patients had an infusion reaction of any severity. Grade 3-4 infusion reactions were reported in 15% (18/117) patients. Infusion reactions may begin within minutes of the start of infusion of OMISIRGE, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion. Monitor patients for signs and symptoms of infusion reactions during and after OMISIRGE administration. When a reaction occurs, pause the infusion and institute supportive care as needed. Graft-versus-Host DiseaseAcute and chronic GvHD, including life-threatening and fatal cases, occurred following treatment with OMISIRGE. In patients transplanted with OMISIRGE Grade II-IV acute GvHD was reported in 58% (68/117). Grade III- IV acute GvHD was reported in 17% (20/117). Chronic GvHD occurred in 35% (41/117) of patients. Acute GvHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Patients treated with OMISIRGE should receive immunosuppressive drugs to decrease the risk of GvHD, be monitored for signs and symptoms of GvHD, and treated if GvHD develops. Engraftment SyndromeEngraftment syndrome may occur because OMISIRGE is derived from umbilical cord blood. Monitor patients for unexplained fever, rash, hypoxemia, weight gain, and pulmonary infiltrates in the peri-engraftment period. Treat with corticosteroids as soon as engraftment syndrome is recognized to ameliorate symptoms. If untreated, engraftment syndrome may progress to multiorgan failure and death. Graft FailurePrimary graft failure occurred in 3% (4/117) of patients in OMISIRGE clinical trials. Primary graft failure, which may be fatal, is defined as failure to achieve an absolute neutrophil count greater than 500 per microliter blood by Day 42 after transplantation. Immunologic rejection is the primary cause of graft failure. Monitor patients for laboratory evidence of hematopoietic recovery. Malignancies of Donor OriginTwo patients treated with OMISIRGE developed post-transplant lymphoproliferative disorder (PTLD) in the second-year post-transplant. PTLD manifests as a lymphoma-like disease favoring non-nodal sites. PTLD is usually fatal if not treated. The etiology is thought to be donor lymphoid cells transformed by Epstein-Barr virus (EBV). Serial monitoring of blood for EBV DNA may be warranted in patients with persistent cytopenias. One patient treated with OMISIRGE developed a donor-cell derived myelodysplastic syndrome (MDS) during the fourth-year post-transplant. The natural history is presumed to be the same as that for de novo MDS. Monitor life-long for secondary malignancies. If a secondary malignancy occurs, contact Gamida Cell at (844) 477-7478. Transmission of Serious InfectionsTransmission of infectious disease may occur because OMISIRGE is derived from umbilical cord blood. Disease may be caused by known or unknown infectious agents. Donors are screened for increased risk of infection, clinical evidence of sepsis, and communicable disease risks associated with xenotransplantation. Maternal and infant donor blood is tested for evidence of donor infection. See full Prescribing Information, Warnings and Precautions, Transmission of Serious Infections for list of testing performed. OMISIRGE is tested for sterility, endotoxin, and mycoplasma. There may be an effect on the reliability of the sterility test results if the cord blood donor was exposed to antibiotics in utero. Product manufacturing includes bovine-derived reagents. All animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use. These measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Test results may be found on the container label and/or in accompanying records. If final sterility results are not available at the time of use, Quality Assurance will communicate any positive results from sterility testing to the physician. Report the occurrence of transmitted infection to Gamida Cell at (844) 477-7478. Transmission of Rare Genetic DiseasesOMISIRGE may transmit rare genetic diseases involving the hematopoietic system because it is derived from umbilical cord blood. Cord blood donors have been screened to exclude donors with sickle cell anemia, and anemias due to abnormalities in hemoglobins C, D, and E. Because of the age of the donor at the time cord blood collection takes place, the ability to exclude rare genetic diseases is severely limited. ADVERSE REACTIONS The most common adverse reactions (incidence > 20%) are infections, GvHD, and infusion reaction. Please see full , including Boxed Warning. About Gamida Cell Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge™ (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram. 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 the potentially life-saving or curative therapeutic and commercial potential of Omisirge™ (omidubicel-onlv), and the Company’s cell therapy candidate, GDA-201. Any statement describing Gamida Cell’s 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 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. 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 Cell’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 14, 2023, and other filings that Gamida Cell makes with the SEC from time to time (which are available at www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cell’s actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cell’s 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. OMISIRGE™ is a trademark of Gamida Cell Inc. © 2023 Gamida Cell Inc. All Rights Reserved Media Contact: Dan Boyle Orangefiery media@orangefiery.com 1-818-209-1692 Investor Contact: Chuck Padala LifeSci Advisors Chuck@lifesciadvisors.com 1-646-627-8390

BOSTON--( BUSINESS WIRE )-- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that an oral presentation highlighting Gamida Cell’s investigational natural killer (NK) cell therapy candidate GDA-201 will be shared at the International Society for Cell and Gene Therapy (ISCT) 2023 Annual Meeting. The meeting takes place May 31-June 3 in Paris, France. Additionally, a poster will be presented with data from Gamida Cell’s pre-clinical NK cell therapy candidate GDA-501, an engineered intrinsic NK cell with a CAR modification targeting the HER2 protein. “ The data being presented at ISCT add to the body of evidence demonstrating the power of our nicotinamide (NAM) technology to enhance and expand cells,” said Ronit Simantov, M.D., Chief Medical and Scientific Officer of Gamida Cell. “ The unique, active phenotype of NAM-NK cells and the high levels of potency and cytotoxicity observed support the strong potential of GDA-201 as a cell therapy for cancer.” Additional details about the presentations are as follows: Title: GDA-201: Phenotypic and Functional Characterization of Cryopreserved Nicotinamide-Expanded Allogeneic Natural Killer Cells Demonstrate an Activated and Non-exhausted Phenotype Abstract Number: 36 Presentation Date: June 2, 9:15-10:15 am CET Presenting Author: Yona Geffen, Ph.D.; Vice President of R&D at Gamida Cell Highlights: This study investigated the phenotype and function of GDA-201, NK cells expanded using Gamida Cell’s proprietary NAM technology. NAM-NK demonstrated increased expression of lymphoid homing marker CD62L and decreased levels of lineage exhaustion markers CD57 and CD161 compared with NK cells expanded in the absence of NAM. Batch-to-batch variability of 18 batches of cryopreserved formulation of GDA-201 from 18 donors demonstrated an overall variability of ≤25% in critical parameters including viability, phenotyping and cytotoxicity. Title: GDA-501 HER2 Chimeric Antigen Receptor Natural Killer Cells: Dual Cytotoxicity in Solid Tumors Mediated via HER2 and TRAIL Abstract Number: 1225 Presentation Date: June 1, 6-7:30 pm CET Presenting Author: Julia Rifman, Ph.D.; Senior Project Manager at Gamida Cell Highlights: GDA-501, an expanded, enhanced and engineered NAM HER2-CAR NK cell, showed high levels of TNF-related apoptosis-inducing ligand (TRAIL) expression, suggesting possible meditation of target cell apoptosis. Compared with non-engineered NK cells cultured with NAM, GDA-501 cells displayed increased cytotoxicity against HER2+ tumor cells. When TRAIL was neutralized on GDA-501, a decrease in cytotoxicity was observed. These data suggest that the cytotoxic effect of GDA-501 may be mediated by dual mechanisms: HER2 binding by the HER2-CAR and apoptosis mediated by TRAIL. Note: Gamida Cell announced it would discontinue the development of GDA-501 in March 2023. About GDA-201 GDA-201 is an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. Preclinical studies have shown that GDA-201 may address key limitations of cultured NK cells by increasing cytotoxicity and in vivo retention as well as proliferation in the bone marrow and lymphoid organs. Furthermore, these data suggest GDA-201 may improve antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. A multicenter Phase 1/2 study of GDA-201 for the treatment of non-Hodgkin lymphoma is ongoing (NCT05296525). GDA-201 is an investigational cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. About Gamida Cell Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge®, an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn , Facebook , Twitter and Instagram. Omisirge ® is a registered trademark of Gamida Cell Inc. © 2023 Gamida Cell Inc. All Rights Reserved. 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 the potentially life-saving or curative therapeutic and commercial potential of GDA-201. Any statement describing Gamida Cell’s 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 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. 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 Cell’s Quarterly Report on Form 10-Q filed with the SEC on May 15, 2023, the accompanying prospectus and other filings that Gamida Cell makes with the SEC from time to time (which are available at www.sec.gov ), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cell’s actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cell’s 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.