FDA Approves AMTAGVI for Melanoma Treatment

Melanoma Research Alliance Applauds FDA Approval of First Cellular Therapy in Melanoma

The Melanoma Research Alliance (MRA), the largest non-profit funder of melanoma research worldwide, welcomes the U.S. Food and Drug Administration (FDA) decision to approve Iovance Biotherapeutics’ AMTAGVI™ (lifileucel) for the treatment of patients with advanced melanoma in the second line treatment setting. AMTAGVI is the first individualized Tumor Infiltrating Lymphocyte (TIL) therapy to earn FDA approval for […]

Dragonfly Therapeutics Clinical Collaboration Announcement
Drug Updates

Dragonfly Announces Clinical Collaboration Exploring Combinations Between Dragonfly’s DF1001 HER-2 TriNKET® and Gilead’s Trodelvy® in Two Cancer Indications

Dragonfly Therapeutics, Inc., a clinical-stage biotechnology company developing novel immunotherapies, today announced a new clinical collaboration designed to evaluate and combine DF1001, a HER-2 immune activating device developed using Dragonfly’s TriNKET technology platform and Dragonfly’s lead clinical asset, with Trodelvy, Gilead’s Trop-2-directed antibody-drug conjugate in metastatic breast cancer and non-small cell lung cancer (NSCLC). “DF1001, […]

"Pancreatic Cancer Treatment"
Hospital Updates

AIM ImmunoTech Announces First Subject Dosed in the Netherlands for Phase 1b/2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca’s Imfinzi (durvalumab) for the Treatment of Pancreatic Cancer

AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the first subject has been dosed at Erasmus Medical Center (“Erasmus MC”) in a Phase 1b/2 clinical trial combining AIM’s Ampligen® (rintatolimod) with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of late-stage pancreatic cancer (the “DURIPANC Study”). The DURIPANC Study is an […]

"BioXcel Therapeutics Fast Track Designation"
Digital Health News

BioXcel Therapeutics Receives FDA Fast Track Designation for BXCL701 for Treatment of Small Cell Neuroendocrine Prostate Cancer (SCNC)

BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of BXCL701 in combination with a CPI for the treatment of patients with metastatic small cell […]

"23andMe '1473 Cancer Treatment Image"
Digital Health News

23andMe Announces FDA Clearance of IND Application for its Dual Mechanism Antibody, 23ME-01473, Targeting ULBP6

23andMe Holding Co. (Nasdaq: ME) (23andMe), a leading human genetics and biopharmaceutical company, announced the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug application for 23ME-01473 (‘1473), a natural killer (NK) cell activator intended to treat cancer. 23andMe plans to evaluate ‘1473 in participants with advanced solid tumors in a Phase […]

FK-PC101 Clinical Trial Image
Hospital Updates

CellVax Therapeutics Announces FDA Clearance of IND Application for FK-PC101, a Novel Personalized Cancer Immunotherapy

Theragent Inc., a comprehensive CDMO focused on advancing next-generation cell-based therapies, has announced that its sponsor client, CellVax Therapeutics Inc., received clearance of its Investigational New Drug application (IND) by the U.S. Food and Drug Administration (FDA) for FK-PC101. Patient recruitment for the randomized Phase II trial will begin in March of 2024, with first […]

Digital Health News

March Biosciences and Cancer Focus Fund Announce $4.8 Million Investment to Support a Phase 2 Clinical Trial of Novel CAR-T Therapy for T-Cell Lymphoma

March Biosciences (March Bio), a clinical stage biotechnology company committed to combating challenging cancers unresponsive to existing immunotherapies, and Cancer Focus Fund, LP, a unique investment fund established in collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) to provide funding and clinical expertise to advance promising cancer therapies, today announced that Cancer Focus Fund […]

KangaBio KGX101: Revolutionizing Cancer Therapy
Drug Updates

Sanyou Bio Congratulates KangaBio on their IND Approval for Next-Generation IL-12 Prodrug Cancer Immunotherapy

On October 26, 2023, KangaBio announced that the U.S. FDA has granted official approval for their independent R&D clinical trial application (IND) for KGX101. KGX101 is a recombinant IL-12 Fc fusion protein designed for intravenous injection. The KGX101 clinical trials will be carried out simultaneously in both United States and Australia. These trials will primarily focus on late-stage solid […]

Drug Updates

Triumvira Immunologics Announces First Patient Dosed in Phase II of TACTIC-2 Cell Therapy Trial for the Treatment of HER2+ Gastric and GEJ Cancers

 Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, today announced that the first patient has been dosed in Phase II of its Phase I/II study TACTIC-2 (NCT04727151) investigating the safety and efficacy of autologous TAC-T […]

Pancreatic Cancer Research Advances 2023
Hospital Updates

Biotech Companies Make Further Progress in Promising Pancreatic Cancer Treatment Research

According to the American Cancer Society in its Cancer Facts & Figures 2023 report, the five-year survival rate for pancreatic cancer increased by 1% from the previous year to 12%. The increase has generated more optimism from the Pancreatic Cancer Action Network (PanCAN), whose President and CEO Julie Fleshman, JD, MBA, stated, “It’s an important milestone that shows we’re headed in the right […]