Point Biopharma14 Feb 2022 15:48
POINT Biopharma Provides Early-Stage Program Updates
Phase 1 therapeutic trial for PNT6555, the lead of the pan-cancer PNT2004 fibroblast activation protein-alpha (FAP-alpha) inhibitor program, planned for summer 2022
Initiated IND-enabling studies for next-generation actinium-225 radiolabeled PSMA targeted program, PNT2001, to support an IND/CTA filing expected H1 2023
February 14, 2022 – INDIANAPOLIS, INDIANA – POINT Biopharma Global Inc. (NASDAQ: PNT) (the “Company” or “POINT”), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, today provided progress updates on its early-stage programs, including the pan-cancer fibroblast activation protein-alpha (FAP-alpha) inhibitor program PNT2004, and the next-generation actinium-225 PSMA targeted program PNT2001.
“One of the most exciting things about our early-stage programs is their potential to help a significantly greater number of patients.” said Dr. Joe McCann, CEO of POINT Biopharma. “Pan-cancer programs, such as PNT2004, could be the breakthrough which brings radiopharmaceuticals to a variety of high-volume indications, both as a monotherapy or in combination. The future is bright for radiopharmaceuticals, and we here at POINT are excited to lead the way in helping them reach their full potential.”
PNT2004 (FAP-alpha inhibitor): Initiation of a Phase 1 therapeutic dose-escalating clinical trial planned for summer 2022
POINT accelerated PNT2004’s therapeutic program after the compelling preclinical data for PNT2004’s lead candidate PNT6555 was first announced in Q4 2021. The Company recently completed a pre-CTA (Clinical Trial Application) meeting with Health Canada regarding the development pathway and clinical study design for the upcoming Phase 1 trial, and expects to file a CTA with Health Canada at the end of Q1 2022.
The clinical trial is expected to commence in summer 2022 in Canada and will use a gallium-68 (Ga-68)-based PNT6555 molecular imaging agent to select patients to receive a no-carrier-added (n.c.a.) lutetium-177 (Lu-177)-based PNT6555 therapeutic agent. Additional preclinical studies in syngeneic and PDX models for monotherapy and combination treatment are in development and include other therapeutic isotopes such as actinium-225 (Ac-225).
PNT2001 (Next generation PSMA): IND-enabling studies with actinium-225 planned for 2022, IND/CTA filing expected H1 2023
The PNT2001 program leverages linker technology that promotes increased tumor accumulation. Pre-clinical studies of PNT2001 have resulted in the identification of a lead candidate which, as compared to late-stage PSMA ligands, demonstrates potent anti-tumor activity using Ac-225, while also having an improved safety profile. The Company has advanced the lead candidate into IND-enabling studies which are expected to support an IND/CTA submission in H1 2023. The clinical development pathway being considered for PNT2001 is in recurrent hormone-sensitive