Articles from Wugen, Inc.

Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological malignancies, today announced that the U.S. Food and Drug Administration (FDA) has selected Sofi-cel, an investigational allogeneic CAR-T cell therapy, to participate in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. Wugen was invited by the FDA to participate in the CDRP program, which selects up to nine development programs annually across the FDA’s two product review centers for biologics and drugs.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced that it has initiated patient dosing in the first-in-human Phase 1 clinical trial of WU-NK-101 for patients with relapsed or refractory (r/r) acute myelogenous leukemia (AML). Additionally, Wugen announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to WU-NK-101 for the treatment of AML.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, today presented data for its two lead programs, WU-CART-007 and WU-NK-101, in separate presentations at the European Hematology Association (EHA) 2023 Congress, taking place from June 8 – 11, 2023 in Frankfurt, Germany.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced an oral presentation and an onsite poster presentation highlighting data from Wugen’s WU-NK-101 and WU-CART-007 programs at the European Hematology Association (EHA) 2023 Congress, taking place from June 8 – 11, 2023 in Frankfurt, Germany.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced the appointment of industry veteran Mark Alles as Chair of the Board of Directors. Mr. Alles is the former Chairman and Chief Executive Officer of Celgene Corporation. He has over 30 years of biopharmaceutical experience, and an outstanding record of driving growth and innovation at multiple oncology-focused organizations. Mr. Alles succeeds Natalie Mount, Ph.D., who will transition to Board Director.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today presented data on WU-NK-101, the company’s lead memory natural killer (NK) cell therapy product, in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place in Orlando, Florida from April 14 – 19, 2023.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced an upcoming presentation highlighting WU-NK-101, the company’s lead memory natural killer (NK) cell therapy product. The data support the potential of WU-NK-101 to overcome resistance to immune checkpoint blockade (ICB) therapy and will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2023 taking place April 14 – 19, 2023 in Orlando, Florida.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced that Kumar Srinivasan Ph.D., M.B.A., has been appointed President and Chief Executive Officer, effective March 13, 2023. Dr. Srinivasan succeeds Dan Kemp, Ph.D., who has stepped down from his CEO role and the Board of Directors to pursue other opportunities.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, today presented preclinical data on WU-NK-101, the company’s lead memory natural killer (NK) cell therapy product, in combination with cetuximab (Ctx), at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium taking place January 19-21, 2023, in San Francisco, California.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, today presented data on WU-NK-101, the company’s lead memory natural killer (NK) cell therapy product, at the 64th Annual Meeting of the American Society of Hematology (ASH) taking place December 10 – 13, 2022 in New Orleans, Louisiana.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced that management will present at 9:45 a.m. GMT (4:45 a.m. ET) on Thursday, November 17, 2022 at the upcoming Jefferies London Healthcare Conference.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced an upcoming presentation outlining the unique molecular characteristics of WU-NK-101, the company’s lead memory natural killer (NK) cell therapy product, at the upcoming Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting taking place November 8-12, 2022 in Boston, MA.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced an upcoming presentation highlighting key features of WU-NK-101, the company’s lead memory natural killer (NK) cell therapy product, that support its application for the treatment of relapsed/refractory (R/R) acute myelogenous leukemia (AML) and elucidate predictors of therapeutic response to cytokine-induced memory-like (CIML) NK cell therapy. The data will be presented at the 64th Annual Meeting of the American Society of Hematology (ASH) taking place December 10 – 13, 2022 in New Orleans, Louisiana.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced that management will participate in a fireside chat at 1:30 p.m. ET on Friday, September 30, 2022 at the upcoming Jefferies Cell & Genetic Medicine Summit set to take place in New York City.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today presented preclinical data on WU-NK-101, the company’s lead memory natural killer (NK) cell therapy product, in a poster session at the European Society for Medical Oncology (ESMO) Congress 2022, taking place in Paris, France from September 9-13, 2022.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced it will present preclinical data on WU-NK-101, the company’s lead memory natural killer (NK) cell therapy product, at the European Society for Medical Oncology (ESMO) Congress 2022, taking place in Paris, France from September 9-13, 2022.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced the appointment of biotech executive and cell therapy veteran Natalie Mount, Ph.D., as Chair of the Board of Directors. Dr. Mount has over 25 years of biopharmaceutical experience, including more than a decade of leadership in cell and gene therapy manufacturing and early clinical development. Dr. Mount succeeds John McKearn, Ph.D., who will transition to Board Director.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation and Rare Pediatric Disease Designation (RPDD) for WU-CART-007, the company’s off-the-shelf CAR-T cell therapy. WU-CART-007 is currently being explored for the treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL).

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today presented new preclinical data demonstrating the enhanced anti-tumor properties of WU-NK-101, Wugen’s lead memory natural killer (NK) cell therapy product. The data elucidate the unique cytokine-induced memory-like (CIML) phenotype of WU-NK-101 and further support its clinical development for acute myeloid leukemia (AML) and a range of solid tumor indications. The findings will be presented during a poster session at the European Hematology Association (EHA) 2022 Hybrid Congress in Vienna.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced that management will participate in two upcoming investor conferences in June:

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced it will present new preclinical data highlighting the anti-tumor activity of Wugen’s lead memory natural killer (NK) product candidate WU-NK-101 at the European Hematology Association (EHA) 2022 Hybrid Congress being held June 9-12, 2022, virtually and in-person in Vienna, Austria.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced that management will participate in two upcoming virtual investor conferences in April:

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced that management will participate in a fireside chat and presentation at the Innate Killer Summit 2022 being held in San Diego, CA from Wednesday, March 30 – Friday, April 1, 2022.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced that the first patient has been dosed in a Phase 1/2 trial of WU-CART-007 for the treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). WU-CART-007 is an off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Additionally, Wugen announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to WU-CART-007 for the treatment of acute lymphoblastic leukemia.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today presented new preclinical data supporting the safety and efficacy profile of WU-CART-007 for T-cell malignancies. Further, today’s data highlighted Wugen’s clinical readiness and robust manufacturing process for WU-CART-007. The U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for WU-CART-007 and Wugen is preparing for enrollment of a Phase 1/2 clinical trial for relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL) (NCT#04984356).

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today presented new data from its best-in-class memory natural killer (NK) cell therapy platform at the Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting. The presentation highlighted the preclinical development and proprietary manufacturing details of Wugen’s lead product candidate WU-NK-101 for the treatment of relapsed/refractory (r/r) acute myeloid leukemia (AML). The findings presented at SITC support development of WU-NK-101 as an off-the-shelf therapy for r/r AML and solid tumor indications.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced that management will participate in the upcoming Virtual Jefferies London Healthcare Conference set to take place November 16 - 19, 2021. The presentation will be available to registered conference attendees for on-demand viewing on Thursday, November 18 at 8:00 a.m. GMT (3:00 a.m. ET).

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf memory natural killer (NK) cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced it will present new data highlighting the preclinical development of Wugen’s lead product WU-NK-101 at the Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting.

Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced it will present preclinical data on the characterization of WU-CART-007 at the 63rd Annual Meeting of the American Society of Hematology (ASH) which will be held virtually and in-person in Atlanta, Georgia from December 11-14, 2021. The results demonstrate preclinical safety and anti-tumor activity of WU-CART-007. Wugen is preparing to begin enrollment for a Phase 1/2 clinical trial for relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL) (NCT#04984356).

Wugen, Inc., a clinical stage biotechnology company developing a pipeline of off-the-shelf cell therapies, today announced the completion of an oversubscribed $172 million Series B financing led by Abingworth and Tybourne Capital Management, and joined by new investors Fidelity Management & Research Company, Intermediate Capital Group (ICG), Sands Capital, Aisling Capital Management, Alexandria Venture Investments, Velosity Capital and Falcon Edge Capital. Existing investors, including RiverVest Venture Partners, LYZZ Capital, and Lightchain Capital, also participated. In connection with the financing, Bali Muralidhar, M.D., Ph.D., Managing Partner at Abingworth, Bosun Hau, Managing Director at Tybourne Capital Management, and Peter Kiener, Ph.D., Venture Partner at ICG, will join Wugen’s Board of Directors. The proceeds of the financing will support further clinical development of Wugen’s best-in-class memory natural killer (NK) cell platform and advance ongoing trials for patients with severe acute myelogenous leukemia (AML) and other oncology indications, including solid tumors. Wugen also plans to apply these proceeds to advance its broader pipeline of next-generation products into the clinic, including its allogeneic CD7-targeted CAR-T cell therapy to treat T-cell leukemia and lymphoma.