FK-PC101 / CellVax Therap, FK Biotec - LARVOL DELTA

Reduced recurrence of prostate cancer with novel autologous cancer vaccine (FK- PC101) post-prostatectomy: long-term results from a single-center phase 1/2 study. (PubMed, Future Sci OA) - "FK-PC101 demonstrated safety and potential clinical benefit in reducing prostate specific antigen (PSA) recurrence after RP in high-risk prostate cancer patients. These findings support further evaluation in a randomized phase 2 trial."

Journal • P1/2 data • Erectile Dysfunction • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Theragent and CellVax Therapeutics Announce First Patient Dosed in Phase 2 Trial of FK-PC101, a Novel Personalized Cancer Immunotherapy (PRNewswire) - "Theragent...has announced a significant milestone for both Theragent and its sponsor client, CellVax Therapeutics Inc. This past week, Theragent produced the first batch of autologous cancer vaccine to dose the first patient in CellVax Therapeutics' randomized Phase 2 clinical trial for FK-PC101....The trial, CELLVX-230, is a multicenter, adaptive, Phase 2, randomized, open-label study of irradiated autologous cellular vaccine in men with high-risk prostate cancer post-radical prostatectomy."

Trial status • Prostate Cancer

FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Cellvax Therapeutics Inc

New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

CellVax Therapeutics Announces FDA Clearance of IND Application for FK-PC101, a Novel Personalized Cancer Immunotherapy (PRNewswire) - "Theragent...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 patient treatments expected in Q2 2024....The trial, CELLVX-230, is a randomized, multicenter, open-label study of irradiated autologous cellular vaccine in men with high-risk prostate cancer post-radical prostatectomy....Patient recruitment will begin in March 2024, with a goal of up to 230 participants sourced from 21 pre-selected sites across the US."

IND • New P2 trial • Prostate Cancer

CellVax Submits IND Application for Individualized Cell-based Immunotherapy FK-PC101 with Support of Theragent (PRNewswire) - "Theragent...announced that their sponsor client, CellVax Therapeutics Inc., has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for FK-PC101. CellVax and Theragent partnered in November of 2022, with CellVax seeking clearance to proceed with their Phase II adaptive design clinical trial...."We are eager to initiate this adaptative Phase 2 trial for prostate cancer patients upon FDA clearance'....Following the IND submission, CellVax is expecting the FDA's response by February 2024. The target start date for the patient recruitment is March of 2024. Approximately 230 patients will be recruited from 20 sites across the United States."

IND • New P2 trial • Oncology • Prostate Cancer