Gamida Cell Announces FDA Clearance of IND and Removal of Clinical Hold for NK Cell Therapy Candidate GDA-201
Gamida Cell Ltd. (NASDAQ: GMDA) announced that the FDA cleared its IND application for GDA-201, a cryopreserved cell therapy candidate targeting follicular and diffuse large B-cell lymphomas. This milestone allows Gamida Cell to commence a Phase 1/2 clinical study in 2022. Previous studies have shown promising results with GDA-201, including a 74% overall response rate among lymphoma patients. The therapy employs Gamida Cell's NAM technology platform to enhance natural killer cell functionality, aiming to meet the urgent need for effective treatments in this patient population.
- FDA clearance of IND application for GDA-201 allows initiation of Phase 1/2 study.
- Previous studies indicate a 74% overall response rate and 68% complete response rate in treated patients.
- GDA-201 shows potential to address unmet medical needs in lymphoma treatment.
- None.
Company advancing plans to begin Phase 1/2 study in patients with follicular and diffuse large B-cell lymphomas
“FDA clearance of our IND for the cryopreserved formulation of GDA-201 represents a significant milestone for the company and reflects our team’s expertise in the development of NAM-enabled cell therapies,” said
GDA-201 leverages Gamida Cell’s proprietary NAM technology platform to expand the number and functionality of NK cells to direct tumor cell killing properties and antibody-dependent cellular cytotoxicity (ADCC). In an investigator-sponsored Phase 1/2 study in patients with relapsed or refractory lymphoma, treatment with the fresh formulation of GDA-201 with rituximab demonstrated significant clinical activity. Of the 19 patients with non-Hodgkin lymphoma (NHL) , 13 complete responses and one partial response were observed, with an overall response rate of
About GDA-201
For more information about GDA-201, please visit https://www.gamida-cell.com. For more information on the Phase 1/2 clinical trial of GDA-201, please visit www.clinicaltrials.gov.
GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
About NAM Technology
Our NAM-enabling technology, supported by positive Phase 3 data, 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
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 Cell’s product candidates (including GDA-201), anticipated regulatory filings and the potentially life-saving or curative therapeutic and commercial potential of Gamida Cell’s product candidates (including 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 the impact that the COVID-19 pandemic could have on our business, and including the scope, progress and expansion of Gamida Cell’s 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 Cell’s Annual Report on Form 10-K, filed with the
View source version on businesswire.com: https://www.businesswire.com/news/home/20220426005545/en/
For investors:
Stern Investor Relations, Inc.
Courtney.Turiano@sternir.com
1-212-362-1200
For media:
Ten
rhiannon@tenbridgecommunications.com
1-978-417-1946
Source:
FAQ
What is the significance of the FDA's approval for GDA-201 on GMDA stock?
When will the Phase 1/2 clinical study for GDA-201 start?
What is the clinical efficacy of GDA-201 based on initial studies?