-The company-sponsored Phase 1/2 study is evaluating a cryopreserved, readily available formulation of GDA-201 for the treatment of follicular and diffuse large B cell lymphomas -
BOSTON, August 10, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, announces dosing of the first patient in a company-sponsored Phase 1/2 study evaluating a cryopreserved, readily available formulation of GDA-201 for the treatment of follicular and diffuse large B cell lymphomas (NCT05296525).
"We are excited to further advance the development of GDA-201, a NAM-enabled natural killer (NK) cell therapy candidate which we believe has the potential to be a new readily available, cryopreserved treatment option for cancer patients with relapsed/refractory lymphoma," said Ronit Simantov, M.D., chief medical and scientific officer of Gamida Cell. "Our NK cells elicited an adaptive immune response in patients in the previous investigator-sponsored study with the fresh formulation of GDA-201, potentially leading to durable remissions. We are truly grateful for the contribution of all the participants and clinical collaborators who will allow us to continue studying GDA-201 in this multi-center open label trial."
The Phase 1 portion of the study is a dose escalation phase, designed to evaluate the safety of GDA-201, and will include patients with follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL)/high grade B-cell lymphoma, marginal zone lymphoma or mantle cell lymphoma. The Phase 2 expansion phase is designed to evaluate the safety and efficacy of GDA-201 in 63 patients comprised of two cohorts of patients with either FL or DLBCL. The study will include patients who have relapsed or refractory lymphoma after at least two prior treatments, which may include CAR-T or stem cell transplant.
"Interest in NK cell therapies has increased in recent years as a potential alternative to current cell therapies, as NK cells have the potential to be effective in hematological and solid tumors while avoiding common safety issues," said Veronika Bachanova, M.D., Ph.D., University of Minnesota. "We are particularly excited about Gamida’s cryopreserved formulation of GDA-201, which has potential as a new treatment option for patients."
GDA-201 leverages Gamida Cell’s proprietary NAM (nicotinamide) 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 74% and a complete response rate of 68%. Two-year data on outcomes and cytokine biomarkers associated with survival data demonstrated a median duration of response of 16 months (range 5-36 months) and an overall survival at two years of 78% (95% CI, 51%–91%). In this study, GDA-201 was well-tolerated and no dose-limiting toxicities were observed in 19 patients with NHL and 16 patients with multiple myeloma. The most common Grade 3/4 adverse events were thrombocytopenia, hypertension, neutropenia, febrile neutropenia, and anemia. There were no incidents of cytokine release syndrome, neurotoxic events, graft versus host disease or marrow aplasia.
About NAM Technology
Our NAM-enabled technology, supported by positive Phase 3 data for omidubicel, 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, we can expand and metabolically modulate multiple cell types — including stem cells and NK 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.
Spread the love. Be the first to like this post!
Recent GMDA News
- Current Report Filing (8-k) • Edgar (US Regulatory) • 03/27/2023 11:16:25 AM
- Gamida Cell Reports Full Year 2022 Financial Results and Provides Company Update • Business Wire • 03/27/2023 11:00:00 AM
- Statement of Changes in Beneficial Ownership (4) • Edgar (US Regulatory) • 03/22/2023 08:35:41 PM
- Current Report Filing (8-k) • Edgar (US Regulatory) • 03/20/2023 08:46:51 PM
- Gamida Cell Announces Changes to Board of Directors • Business Wire • 03/20/2023 08:30:00 PM
- Gamida Cell Announces the Date of Its Fourth Quarter and Full Year 2022 Financial Results and Webcast • Business Wire • 03/20/2023 12:00:00 PM
- Gamida Cell to Present Corporate Highlights at the Oppenheimer 33rd Annual Healthcare Conference • Business Wire • 03/07/2023 01:00:00 PM
- Amended Statement of Beneficial Ownership (sc 13d/a) • Edgar (US Regulatory) • 03/03/2023 09:03:47 PM
- Data Presented on Gamida Cell’s Omidubicel, GDA-201 at the 2023 Tandem Meetings of ASTCT and CIBMTR • Business Wire • 02/18/2023 05:30:00 PM
- Statement of Ownership (sc 13g) • Edgar (US Regulatory) • 02/14/2023 09:10:55 PM
- Amended Statement of Ownership (sc 13g/a) • Edgar (US Regulatory) • 02/09/2023 04:02:40 PM
- Additional Proxy Soliciting Materials (definitive) (defa14a) • Edgar (US Regulatory) • 01/30/2023 12:03:54 PM
- Current Report Filing (8-k) • Edgar (US Regulatory) • 01/30/2023 12:01:20 PM
- Notice of Effectiveness (effect) • Edgar (US Regulatory) • 01/23/2023 11:04:06 AM
- Prospectus Filed Pursuant to Rule 424(b)(3) (424b3) • Edgar (US Regulatory) • 01/20/2023 09:32:22 PM
- Current Report Filing (8-k) • Edgar (US Regulatory) • 01/19/2023 09:44:26 PM
- Proxy Statement (definitive) (def 14a) • Edgar (US Regulatory) • 01/10/2023 10:13:59 PM
- Current Report Filing (8-k) • Edgar (US Regulatory) • 01/09/2023 05:16:06 PM
- Proxy Statement - Notice of Shareholders Meeting (preliminary) (pre 14a) • Edgar (US Regulatory) • 12/30/2022 10:17:38 PM
- Analysts’ Top Healthcare Picks: Crispr Therapeutics AG (CRSP), Arcutis Biotherapeutics (ARQT) • TipRanks • 12/12/2022 06:11:45 PM
- Current Report Filing (8-k) • Edgar (US Regulatory) • 12/12/2022 12:16:53 PM
- Gamida Cell Announces Closing of $25 Million Financing With Highbridge • Business Wire • 12/12/2022 12:00:00 PM
- Gamida Cell to Present Corporate Highlights at Multiple Upcoming Investor Conferences • Business Wire • 11/23/2022 01:00:00 PM
- Statement of Changes in Beneficial Ownership (4) • Edgar (US Regulatory) • 11/22/2022 09:37:38 PM
- Statement of Changes in Beneficial Ownership (4) • Edgar (US Regulatory) • 11/22/2022 09:35:07 PM
FEATURED Fineqia's EEA Unit Receives Approval of Base Prospectus for Issuing Exchange Traded Notes (ETNs) • Mar 28, 2023 9:37 AM
FEATURED Usha Resources Enters Hard-Rock Lithium Space with Acquisition of Significant Ontario Land Package with Highly Evolved LCT-Pegmatites • Mar 28, 2023 8:26 AM
FEATURED Edison Lithium Provides Update on Spin-Out of Cobalt Assets • Mar 28, 2023 8:09 AM
FEATURED Epazz Holdings: ZenaDrone, Inc. 1000 AI Predictive Received a Letter of Support from the US Airforce for Drone Cargo Delivery and Intent to Use ZenaDrone 1000 Platform • Mar 28, 2023 7:11 AM
Metatron Releases All-in-One Artificial Intelligence Mobile Apps for iPhone and Android • MRNJ • Mar 27, 2023 9:00 AM
Memorandum of Understanding With Miranda Water Treatment Systems and Rainmaker Worldwide Inc. Extended • RAKR • Mar 27, 2023 8:50 AM