Gamida Cell Announces Results of New Health Economic and Outcome Study Reporting Improved Health Equity and Health Outcomes With Omidubicel at 2022

BOSTON–(Company WIRE)–Gamida Mobile Ltd. (Nasdaq: GMDA), the chief in the advancement of NAM-enabled mobile therapies for individuals with sound and hematological cancers and other really serious health conditions, nowadays declared the effects of a new study demonstrating the prospective influence of entry to omidubicel on health disparities in allogeneic hematopoietic stem cell transplant in a poster presentation at the 2022 Transplantation & Cellular Treatment Conferences of ASTCT and CIBMTR Tandem Conferences (TCT), getting held in Salt Lake Metropolis, UT, April 23-26, 2022.

The analyze, titled “Projected Influence of Omidubicel on Racial and Ethnic Disparities in Allogeneic Hematopoietic Mobile Transplant Access and Outcomes for People with Hematologic Malignancies in the US,” leveraged a choice-tree design to job allo-HCT obtain and clinical outcomes in a hypothetical inhabitants of 10,000 allo-HCT–eligible patients in the U.S. with hematologic malignancies with no an obtainable match-connected donor. The review concluded that wide use of omidubicel will increase access for allo-HCT-eligible people, lower time to transplant and make improvements to medical results, notably between racial and ethnic groups with worse position quo results. Projected improves in just one-yr in general survival ranged (with 20% omidubicel use between allo-HCT–eligible people) from 2.5% for whites clients to 6.3% for Black sufferers. The analyze also concluded that increased levels of modeled omidubicel uptake were involved with larger advancements in medical outcomes and better reductions in racial disparities.

Prior reports point out that non-white patients have a reduce chance of obtaining an correct match in the U.S. general public donor registries, with Black sufferers have a 16-20% chance of getting an appropriate match. Provided that an allogeneic stem mobile transplant is meant as a healing selection, if sufferers are unable to come across an ideal match they will not have access to allogeneic stem mobile transplant, a likely healing treatment. The Period 3 examine of omidubicel shown the capacity of the treatment to be utilised as a donor supply for racially and ethnically diverse people with 40% of sufferers enrolled in the analyze being non-white.

“Today, minority teams comprise only about 30% of all allogeneic hematopoietic stem mobile transplant transplants, indicating that lack of obtain to a matched donor is a substantial barrier to therapy in the present-day landscape,” said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. “This research is encouraging in that it projects that broad entry to omidubicel has the possible to open up up allo-HSCT as an successful procedure for a lot more clients and handle the boundaries that have contributed to this alarming health and fitness disparity. These knowledge are significantly encouraging as we go on to advance our rolling BLA submission to the Food and drug administration and move nearer to bringing the treatment to much more individuals in will need.”

Gamida Cell initiated a rolling Biologics License Application (BLA) submission for omidubicel in the initially quarter of 2022 and is on-observe to full submission of all modules of the BLA in the second quarter of 2022.

In addition to this poster, two oral displays and four added poster displays on omidubicel and a poster presentation on GDA-201, the company’s major NK cell remedy software, will be shared through the meeting. All poster displays will be publicly accessible at www.ASTCT.org. Details below:

• Title (Oral Presentation): Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel is Linked with Improved Circulatory Plasmacytoid Dendritic Cells (pDC), NK Cells and CD4+ T Cells with Lessen Prices of Intense Bacterial infections Compared to Regular Umbilical Twine Blood Transplantation (Portion of Ideal Summary Award Session)
  • Presenting Author: Paul Szabolcs, M.D., Division of Blood and Marrow Transplantation and Mobile Remedy, UPMC Children’s Clinic of Pittsburgh, Pittsburg, PA
  • Session Title: Tandem Meetings Very best Abstracts Session in the Scientific Keep track of
  • Session Day / Time: Monday, April 25, 2022, 6:00 PM – 6:15 PM MT, SPCC, Ballroom D
• Title (Oral Presentation): Allogeneic HSCT with Omidubicel demonstrates sustained scientific enhancement versus conventional myeloablative UCBT: Last success of a Period III randomized multicenter research
  • Presenting Writer: Mitchell Horwitz, M.D., Professor of Medication, Duke Cancer Institute
  • Session Title: Oral Abstract – Session L – Consider the Source: Stem Cell Grafts and Donors
  • Session Day / Time: Tuesday, April 26, 2022, 3:15 PM – 3:30 PM MT
• Title: (Poster): Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) With Omidubicel: Lengthy-Term Observe-Up From A One Middle (ASH Encore)
  • Guide Writer: Chenyu Lin, M.D., Section of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke College Professional medical Middle, Durham, NC
• Title (Poster): Total Expenditures of Care and Complication Fees Between People with Hematologic Malignancies Who Get Allogeneic Hematopoietic Mobile Transplants in the US
  • Lead Creator: Richard Maziarz, M.D., Professor of Medicine, Medical Director Adult Blood and Marrow Stem Cell Transplant Plan, Oregon Well being and Science University, Portland, OR
• Title (Poster): Hospitalization and Health care Useful resource Use of Omidubicel Vs Umbilical Wire Blood (UCB) for Hematological Malignancies in a World-wide Randomized Phase III Medical Trial Location
  • Direct Creator: Navneet Majhail, M.D., Taussig Cancer Institute, Section of Hematology and Oncology, Cleveland Clinic, Cleveland, OH
• Title (Poster): HRQOL subsequent transplantation with omidubicel versus UCB in patients with hematologic malignancies: Results from a Section III randomized , multicenter study
  • Lead Author: Mitchell Horwitz, M.D., Professor of Medicine, Duke Most cancers Institute
• Title (Poster): Transcriptional and Metabolic Profiling of Nicotinamide-Enhanced All-natural Killer (NAM-NK) Cells (GDA-201)
  • Lead Author: Dima Yackoubov, Scientist, Gamida Mobile

About Omidubicel

Omidubicel is an highly developed mobile therapy under development as a opportunity everyday living-saving allogeneic hematopoietic stem mobile transplant for people with hematologic malignancies (blood cancers), for which it has been granted Breakthrough Position and orphan drug designation by the Fda. Omidubicel is also staying evaluated in a Section 1/2 medical research in sufferers with severe aplastic anemia (NCT03173937). For much more data on medical trials of omidubicel, remember to pay a visit to the Gamida Cell web page.

Omidubicel is an investigational remedy, and its security and efficacy have not been founded by the Fda or any other overall health authority.

About NAM Technological innovation

Our NAM-enabling technological innovation is designed to boost the number and functionality of qualified cells, enabling us to go after a healing strategy that moves outside of what is feasible with current therapies. Leveraging the exceptional qualities of NAM (nicotinamide), we are in a position to increase, extend and metabolically modulate numerous cell styles — which include stem cells and normal killer cells — with acceptable expansion aspects to preserve the cells’ energetic phenotype and improve efficiency. This allows us to administer a therapeutic dose of cells that may possibly assist most cancers sufferers dwell for a longer time much better life.

About Gamida Mobile

Gamida Mobile is pioneering a proprietary NAM-enabled immunotherapy pipeline of assorted most likely curative cell therapies for clients with sound tumor and blood cancers and other major blood conditions. We utilize a proprietary system leveraging the homes of NAM to allogeneic cell sources like umbilical cord blood-derived cells and NK cells to develop therapies with possible to redefine expectations of treatment. These contain omidubicel, an investigational merchandise with possible as a lifetime-conserving choice for sufferers in want of transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at reliable tumor and hematological malignancies. For further info on Gamida Cell, make sure you check out www.gamida-cell.com or adhere to Gamida Cell on LinkedIn, Twitter, Fb or Instagram at @GamidaCellTx.

Cautionary Observe Relating to Forward Seeking Statements

This push release includes forward-wanting statements as that expression is defined in the Personal Securities Litigation Reform Act of 1995, which include with regard to timing of initiation and progress of, and facts reported from, the medical trials of Gamida Cell’s products candidates (including GDA-201), expected regulatory filings and the most likely life-conserving or healing therapeutic and industrial likely of omidubicel. Any assertion describing Gamida Cell’s targets, expectations, economic or other projections, intentions or beliefs is a ahead-seeking statement and should be considered an at-possibility statement. These statements are matter to a selection of threats, uncertainties and assumptions, including all those linked to the impression that the COVID-19 pandemic could have on our organization, and together with the scope, progress and enlargement of Gamida Cell’s scientific trials and ramifications for the expense thereof medical, scientific, regulatory and specialized developments and these inherent in the course of action of developing and commercializing product candidates that are safe and effective for use as human therapeutics, and in the endeavor of making a company all over these solution candidates. In mild of these challenges and uncertainties, and other risks and uncertainties that are explained in the Danger Components part and other sections of Gamida Cell’s Annual Report on Type 10-K, filed with the Securities and Trade Commission (SEC) on March 24, 2022, as amended, and other filings that Gamida Cell will make with the SEC from time to time (which are readily available at http://www.sec.gov), the occasions and instances discussed in these kinds of ahead-seeking statements may perhaps not manifest, and Gamida Cell’s precise benefits could differ materially and adversely from all those anticipated or implied thus. Despite the fact that Gamida Cell’s ahead-seeking statements reflect the good faith judgment of its administration, these statements are dependent only on facts and components currently identified by Gamida Cell. As a result, you are cautioned not to rely on these ahead-hunting statements.