April 12, 2024

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Gamida Cell Presents New Omidubicel Data at 63rd ASH Annual Meeting

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BOSTON–(Company WIRE)–Gamida Cell Ltd. (Nasdaq: GMDA), an sophisticated cell remedy business dedicated to cures for most cancers and other critical disorders, presented clinical updates on omidubicel in two displays on the initially working day of the 63rd American Modern society of Hematology (ASH) Once-a-year Conference getting held in Atlanta, Ga and pretty much December 11-14, 2021.

In an oral presentation titled “Hematopoietic Stem Mobile Transplantation (HSCT) with Omidubicel is Associated with Robust Immune Reconstitution and Decrease Charges of Intense Infection As opposed to Typical Umbilical Twine Blood Transplantation,” Gamida Cell shared facts from an examination of a subset of 37 patients from the Stage 3 randomized demo of omidubicel. The evaluation was aimed at investigating the diminished an infection costs noticed in the research and showed that the omidubicel-dealt with clients had far more swift recovery of a large assortment of immune cells together with CD4+ T cells, B cells, NK cells and dendritic cell subtypes. The robust restoration of the immune process provides rationale for fewer extreme bacterial, fungal and viral infections in individuals treated with omidubicel. Even more analyses are ongoing to additional characterize the immune recovery next omidubicel transplantation.

“These effects demonstrating swift and practical reconstitution of the immune cells – specifically the T mobile recovery which is recognized to lag in wire blood transplants – provides mechanistic support for the reduce premiums of intense infection observed in the omidubicel-addressed patients,” said Paul Szabolcs, M.D., Division of Blood and Marrow Transplantation and Mobile Remedy, UPMC Children’s Hospital of Pittsburgh. “These info offer encouraging aid for sufferers suffering from blood cancers who are especially vulnerable to devastating bacterial infections adhering to transplant.”

An extra poster presentation unveiled currently, “Allogeneic Stem Cell Transplantation with Omidubicel: Extensive-Expression Adhere to-up from a Solitary Center,” features outcomes of 22 people in the Period 1 and 2 studies of omidubicel at Duke College more than a 10-calendar year interval and shows long-time period sustained bone marrow functionality and immune recovery. With a median observe-up of 2.3 yrs the estimated 10-year overall survival (OS) is 48.5{73375d9cc0eb62eadf703eace8c5332f876cb0fdecf5a1aaee3be06b81bdcf82} and condition-no cost survival (DFS) is 43.6{73375d9cc0eb62eadf703eace8c5332f876cb0fdecf5a1aaee3be06b81bdcf82}, with no significant and or sudden extensive-expression difficulties. Sturdy hematopoiesis was observed at up to 10 years with just one case of secondary graft failure and no secondary malignancies.

“Following our constructive Period 3 examine effects that confirmed enhanced hematopoietic recovery with omidubicel, it is particularly encouraging to see these more information that reveal the toughness of the graft, giving long-time period recovery of the hematopoietic program,” said Ronit Simantov, M.D., Chief Professional medical Officer of Gamida Cell. “The analyses introduced at ASH construct on our being familiar with of the clinical advantages of omidubicel and present compelling proof of its probable to improve the outlook for a affected individual populace in dire require of improved cure alternatives.”

Gamida Cell will current additional scientific updates at ASH together with two-12 months survival details for GDA-201, the company’s lead NAM-enabled NK mobile therapy, and an investigation of medical center and healthcare useful resource use for clients addressed with omidubicel as opposed to wire blood transplantation. Both of those poster displays will be publicly obtainable on Monday, Dec. 13.

About Omidubicel

Omidubicel is an highly developed cell remedy underneath improvement as a likely existence-preserving allogeneic hematopoietic stem cell (bone marrow) transplant answer for clients with blood cancers. Omidubicel is the very first bone marrow transplant graft to acquire Breakthrough Remedy Designation from the U.S. Food and drug administration and has also been given Orphan Drug Designation in the U.S. and EU. For more information about omidubicel, remember to go to https://www.gamida-mobile.com.

Omidubicel is an investigational therapy, and its protection and efficacy have not been founded by the Fda or any other health and fitness authority.

About Gamida Mobile

Gamida Cell is pioneering a various immunotherapy pipeline of probably healing cell therapies for individuals with good tumor and blood cancers and other major blood diseases. We implement a proprietary enlargement platform leveraging the properties of NAM to allogeneic mobile resources which includes umbilical cord blood-derived cells and NK cells to generate therapies with likely to redefine expectations of treatment. These involve omidubicel, an investigational product with prospective as a existence-saving alternative for individuals in need of bone marrow transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at good tumor and hematological malignancies. For additional data, please pay a visit to www.gamida-cell.com or stick to Gamida Mobile on LinkedIn, Twitter, Facebook or Instagram at @GamidaCellTx.

Cautionary Take note Relating to Forward Wanting Statements

This push launch includes ahead-looking statements as that phrase is outlined in the Private Securities Litigation Reform Act of 1995, like with regard to timing of initiation and progress of, and details reported from, the clinical trials of Gamida Cell’s product or service candidates (which includes GDA-201), predicted regulatory filings (such as the timing of submission of the BLA for omidubicel to the Food and drug administration), commercialization organizing initiatives, and the perhaps lifestyle-conserving or curative therapeutic and professional opportunity of omidubicel, and Gamida Cell’s anticipations for the predicted medical development milestones set forth herein.. Any assertion describing Gamida Cell’s aims, anticipations, monetary or other projections, intentions or beliefs is a ahead-looking statement and should be regarded an at-possibility assertion. These types of statements are subject to a number of threats, uncertainties and assumptions, which include those people connected to the effects that the COVID-19 pandemic could have on our business enterprise, and which include the scope, progress and growth of Gamida Cell’s clinical trials and ramifications for the price tag thereof clinical, scientific, regulatory and specialized developments and people inherent in the course of action of acquiring and commercializing merchandise candidates that are secure and powerful for use as human therapeutics, and in the endeavor of setting up a company close to these types of solution candidates. In gentle of these threats and uncertainties, and other threats and uncertainties that are described in the Hazard Things section and other sections of Gamida Cell’s Yearly Report on Variety 20-F, submitted with the Securities and Trade Commission (SEC) on March 9, 2021, as amended, and other filings that Gamida Cell helps make with the SEC from time to time (which are readily available at http://www.sec.gov), the situations and situations discussed in such forward-hunting statements may perhaps not arise, and Gamida Cell’s precise results could vary materially and adversely from those predicted or implied thus. Whilst Gamida Cell’s forward-seeking statements reflect the fantastic faith judgment of its administration, these statements are dependent only on points and aspects at this time recognized by Gamida Cell. As a outcome, you are cautioned not to rely on these ahead-looking statements.

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