Boston, November 23, 2022–(BUSINESS WIRE)–Gamida Cell Ltd. (Nasdaq: GMDA), a leader in developing NAM-enhanced cell therapies for patients suffering from hematological and solid cancers and other serious diseases, today announced that members of its management team will be represented at the following upcoming investor conferences:
34th Annual Piper Sandler Healthcare Conference, November 29, 2022 with Fireside Chat at 1:00 p.m. ET.
Evercore ISI Healthcare Conference, December 1, 2022 with Fireside Chat at 2:15 p.m. ET.
A webcast of the event will be available in the Investors & Media section of Gamida Cell’s website at www.gamida-cell.com and will be available for at least 14 days after the event.
Omidubicel is an advanced cell therapy candidate being developed as a potentially life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancer. Omidubicel demonstrated a statistically significant reduction in time to neutrophil transplantation compared to conventional cord blood in patients with haematological malignancies undergoing allogeneic bone marrow transplantation in an international, multicentre, randomized phase 3 study (NCT0273029). The phase 3 study also showed a shorter time to platelet accumulation, fewer infections and fewer days in hospital. One year post-transplant, the data showed sustained clinical benefits of Omidubicel, as evidenced by a significant reduction in infectious complications and reduced non-recurrence mortality and no significant increase in recurrence rates or increases in Graft-versus-Host-Disease (GVHD) rates became . Omidubicel is the first donor source for stem cell transplants to receive Breakthrough Therapy Designation from the FDA and Orphan Drug Designations in the US and EU.
The BLA for Omidubicel has been assigned May 1, 2023 as the target date for application of the Prescription Drug User Fee Act (PDUFA). If approved, Omidubicel will be the first allogeneic donor source for an advanced stem cell therapy for patients with blood cancers who require stem cell transplantation.
Omidubicel is an investigational stem cell therapy whose safety and efficacy have not been established by the FDA or any other health authority. You can find more information about omidubicel at https://www.gamida-cell.com.
About NAM technology
Our NAM-enabled technology is designed to increase the number and functionality of target cells, enabling us to take a curative approach beyond what is possible with existing therapies. By utilizing the unique properties of NAM (Nicotinamide), we are able to 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 increase potency. In addition, our NAM technology improves the cells’ metabolic fitness, allowing for continuous activity throughout the expansion process.
Gamida Cell leveraged the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy candidate for the potential treatment of hematological and solid tumors in combination with standard antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has shown promising early clinical trial data. Preclinical studies have shown that GDA-201 can address important limitations of NK cells by increasing cytotoxicity and in vivo Retention and proliferation in the bone marrow and the lymphatic organs. In addition, these data suggest that GDA-201 could enhance antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. There are approximately 40,000 patients with relapsed/refractory lymphoma in the US and EU. This is the patient population being studied in the ongoing Phase 1/2 GDA-201 clinical trial.
For more information on GDA-201, visit https://www.gamida-cell.com. For more information on the GDA-201 Phase 1/2 clinical trial, visit www.clinicaltrials.gov.
GDA-201 is an investigational cell therapy candidate and its safety and effectiveness have not been determined by the FDA or any other health authority.
About Gamida Cell
Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapy candidates for patients with solid tumors and leukemia and other serious blood disorders. We are applying a proprietary expansion platform that leverages the properties of NAM to allogeneic cell sources, including cord blood-derived cells and NK cells, to create therapy candidates that have the potential to redefine standards of care. These include Omidubicel, an investigational product with potential as a life-saving alternative for patients requiring bone marrow transplantation, and a range of modified and unmodified NAM-capable NK cells targeting solid tumors and hematologic malignancies. For more information please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, TwitterFacebook 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 the timing of the FDA’s review of the BLA for Omidubicel and the potentially life-saving or curative therapeutic and commercial potential of Gamida Cell’s product candidates. Any statement that describes Gamida Cell’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered a 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 may have on our business; 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. Given these risks and uncertainties and other risks and uncertainties 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 November 14, 2022 , and other filings that Gamida Cell files 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 Cell is actual Results may differ materially and adversely from anticipated or implied results. Although Gamida Cell’s forward-looking statements reflect management’s good faith judgment, these statements are based only on facts and factors currently known to Gamida Cell. Therefore, you are cautioned not to rely on these forward-looking statements.
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Stern Investor Relations, Inc.
Director, Investor Relations and Corporate Communications