Actinium-225 PNT6555 / Eli Lilly - LARVOL DELTA

POINT Biopharma Reports Third Quarter 2023 Financial Results and Provides Business Highlights (GlobeNewswire) - "Enrollment in PNT2002's phase 3 SPLASH trial (NCT04647526) is complete and topline data is expected in the fourth quarter of 2023....Presentation of data from the FRONTIER study is anticipated in the first half of 2024, and based on initial promising data we expect to advance at least one 2nd-generation D-ala-boroPro-based lead into the clinic next year....For the phase 1 portion of ACCEL, the first-in-human phase 1/2 clinical trial for PNT2001's actinium-225 program, we expect the first patient dosed in this trial to be in the first quarter of 2024. The trial was designed to enable the parallel exploration of PNT2001 in two populations: patients with later-stage mCRPC and patients with earlier-stage BCR or PSMA-positive oligorecurrent disease."

New P1 trial • New trial • P1 data • P3 data: top line • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

POINT Biopharma Expands Its Research with Next-Generation Isotopes, Publishing New Preclinical Data at SNMMI’s Annual Congress (GlobeNewswire) - "POINT Biopharma Global Inc...announced the publication of preclinical data from their pan-cancer, fibroblast activation protein-α (FAP)-targeted program, PNT2004, at the 2023 Annual Meeting of the Society of Nuclear Medicine & Molecular Imaging (SNMMI), taking place June 24-27, 2023, in Chicago, IL. PNT6555, the lead candidate in the PNT2004 program, led to complete and durable tumor regression and improved survival in HEK-mFAP tumor-bearing mice when chelated to any one of the three radioisotopes studied: lutetium-177 (177Lu), actinium-225 (225Ac), and terbium-161 (161Tb). Additionally, 177Lu-PNT6555 in combination with anti-PD-1 checkpoint blockade was assessed in the aggressive, immunocompetent CT26-mFAP mouse model and demonstrated a significant survival benefit compared to either treatment alone."

Preclinical • Oncology • Solid Tumor

POINT Biopharma Reports First Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "The Company filed a clinical trial application (CTA) with Health Canada at the end of the first quarter of 2022 for PNT6555, the lead of the pan-cancer PNT2004 fibroblast activation protein-alpha (FAP-alpha) targeted program. The clinical trial for PNT2004 is expected to first initiate in Canada in summer 2022....The Company remains on track to launch its in-house n.c.a. 177Lu manufacturing program in 2023."

Canadian regulatory • Commercial • Oncology • Solid Tumor

Pre-clinical characterization of the novel FAP targeting ligand PNT6555 for imaging and therapy of cancer (AACR 2022) - "PNT6555, and its radiometal chelates, are potent and specific inhibitors of FAP. 68Ga/177Lu-PNT6555 showed rapid and prolonged uptake into FAP expressing tumors with limited uptake or retention observed in normal tissues. 177Lu/225Ac-PNT6555 showed compelling efficacy in pre-clinical tumor models that expressed FAP."

Preclinical • Oncology • FAP

POINT Biopharma to Present on its Pan-Cancer FAP-Alpha Targeted Program at the AACR Annual Meeting (GlobeNewswire) - "POINT Biopharma Global...will present a poster on its FAP-Alpha targeted program PNT2004 at the American Association for Cancer Research (AACR) 2022 Annual Meeting....Efficacy studies with 177Lu-PNT6555 or 225Ac-PNT6555 demonstrate compelling and dose-responsive inhibition of HEK-mFAP tumor growth....In animal studies, PNT6555 has successfully delivered large doses of radiation to tumors with limited uptake observed in non-target tissues."

Preclinical • Oncology • Solid Tumor

POINT Biopharma Provides Early-Stage Program Updates (GlobeNewswire) - "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)."

Canadian regulatory • New P1 trial • Preclinical • Oncology

POINT Biopharma Reports Third Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - "PNT2002: Investigational 177Lu-PSMA targeted radioligand therapy...Enrollment for this phase of the SPLASH study has commenced in Canada and will continue to expand globally in the fourth quarter of 2021; POINT is progressing through IND enabling studies and clinical development plans with expectations to submit an IND/CTA for PNT2004 in the first half of 2022; PNT2001: Family of next-generation PSMA radioligands...The Company plans to advance a single compound from the family for the treatment of prostate cancer and expects to initiate IND-enabling studies for the program in 2022; Research and development expenses were $13.0 million for the quarter ended September 30, 2021, as compared to $2.5 million for the same period in 2020."

Commercial • Enrollment status • IND • New trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

POINT Biopharma and IONETIX Announce Ac-225 Supply Agreement (GlobeNewswire) - "POINT Biopharma Global Inc...and IONETIX Corporation...announced today a long-term supply agreement for actinium-225 (Ac-225) to support POINT’s validation, drug development, and clinical trials for Ac-225-based radiopharmaceuticals....POINT plans to use Ac-225 in investigational studies of PNT2001, a next-generation Prostate-Specific Membrane Antigen (PSMA) directed radioligand for non-metastatic castrate-sensitive prostate cancer (nmCSPC) and PNT2004, a Fibroblast Activation Protein-α inhibitor candidate with potential pan-cancer applications."

Clinical • Licensing / partnership • Genito-urinary Cancer • Oncology • Prostate Cancer

NorthStar Medical Radioisotopes and POINT Biopharma Announce Supply Agreement for Therapeutic Medical Radioisotope Actinium-225 (Businesswire) - "NorthStar Medical Radioisotopes, LLC...and POINT Biopharma Global Inc...announced the signing of a supply agreement for the therapeutic medical radioisotope actinium-225....Under the terms of the agreement, NorthStar will provide POINT with its electron accelerator-produced Ac-225 and POINT will use NorthStar’s Ac-225 in investigational studies of PNT2001, a next-generation Prostate-Specific Membrane Antigen (PSMA) for non-metastatic castrate-sensitive prostate cancer (nmCSPC); PNT2004, a Fibroblast Activation Protein-α candidate with potential pan-cancer applications; and to advance its novel Tumor Microenvironment (TME) tumor-targeting technology platform."

Licensing / partnership • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

POINT Biopharma Reports Second Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - “PNT2004…POINT is continuing preclinical studies and expects to initiate clinical development for this program in 2022…Research and Development Expenses: Research and development expenses were $ 6.7 million for the quarter ended June 30, 2021, as compared to $ 2.2 million for the same period in 2020, an increase of approximately 210.3%. The increase in research and development expense was primarily due to increases in (a) costs associated with our licensing agreements and related sponsored research in connection with our product candidates both pre-clinical and clinical, (b) costs incurred in clinical trials, including manufacturing and development of product candidates…”

Commercial • Trial status • Oncology • Solid Tumor