POINT Biopharma Global Inc. (NASDAQ: PNT) (the “Company” or “POINT”), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, today released new preclinical data from the Company’s pan-cancer fibroblast activation protein-α (FAP-α) targeted program, PNT2004.
The preclinical study focused on assessing the potential of the lead candidate in the PNT2004 clinical program, 177Lu-PNT6555, in combination with anti-PD-1 immunotherapy. The CT26-mFAP tumor model used expresses low levels of FAP, grows aggressively, and is insensitive to anti-PD-1 immunotherapy. The study found that combination treatment with 177Lu-PNT6555 and anti-PD-1 resulted in a significant survival benefit, as compared to either treatment independently. The new preclinical data from the study can be found in an updated investor presentation available on the investors section of the Company’s website.
“While the initial clinical development of 177Lu-PNT6555 has focused on its application as a monotherapy, we have always held optimism for its broad potential in combination therapies.” said Joe McCann, Ph.D., Chief Executive Officer of POINT Biopharma. “Radioligand therapy could offer a synergistic mechanism of action with multiple existing therapeutic classes, expanding their applicability or effectiveness. For example, RLT combined with checkpoint blockade could unleash an immune attack against tumors that are otherwise insensitive to immunotherapy, or RLT combined with DNA repair/cell cycle inhibitors could amplify DNA damage to increase cell death. As a pan-cancer program, the 177Lu-PNT6555 lead presents significant opportunities for both monotherapy and combination trials in a variety of indications of high unmet need. We look forward to providing more data in the coming months on both our FAP program as well as our other exciting next generation radioligand programs.”
177Lu-PNT6555, the lead of the PNT2004 program, is currently in the phase 1 FRONTIER trial with cohort 1 underway and three clinical sites open. Cohort 2 in FRONTIER is expected to commence in Q1 2023. Preclinical activities are currently underway, including additional studies in syngeneic and PDX models, and will be used to inform phase 2 opportunities. CMC and clinical teams are actively expanding access to gallium-68 imaging agent, technology transfers of imaging agent to multiple sites to expand phase 1 recruitment, and plans for phase 2 are underway.
More information about 177Lu-PNT6555, including the new preclinical data from the study, can be found in an updated investor presentation available on the investors section of the Company’s website at https://www.pointbiopharma.com/investors.
About the FRONTIER Trial
The FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability, and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients with Select Solid Tumors (FRONTIER) trial is an open-label, phase 1 trial to evaluate safety, tolerability, and dosimetry of 177Lu-PNT6555 and 68Ga-PNT6555, the lead assets of the PNT2004 program. The phase 1 clinical trial commenced in summer 2022 in Canada and uses a 68Ga-based PNT6555 molecular imaging agent to select patients to receive a no-carrier-added (n.c.a.) 177Lu-based PNT6555 therapeutic agent. The phase 1 clinical protocol will evaluate PNT6555 in approximately 30 patients in five FAP-avid cancer indications: colorectal, pancreatic, esophageal, melanoma, and soft tissue sarcoma.
About POINT Biopharma Global Inc.
POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT aims to transform precision medicine by combining a portfolio of radiopharmaceutical assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for rare medical isotopes like actinium-225 (225Ac) and lutetium-177 (177Lu). POINT’s active clinical trials include FRONTIER, the phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein-α (FAP-α), and SPLASH, the phase 3 trial for PNT2002 for people with metastatic castration resistant prostate cancer (mCRPC) after second-line hormonal treatment.
