On October 17, 2022 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported the publication of promising new pre-clinical data from the Company’s next-generation radioligand therapy (RLT) program for prostate cancer, PNT2001 (Press release, Point Biopharma, OCT 17, 2022, View Source [SID1234622073]).
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"We are entering an exciting stage in POINT’s prostate cancer franchise," said Joe McCann, Ph.D., Chief Executive Officer of POINT Biopharma. "Our PNT2001 actinium-225 program exemplifies our team’s deep expertise in the rapid development of new and innovative radioligands. And while we are advancing the next generation of PSMA-targeted radioligand therapy, we are simultaneously continuing our pre-commercial planning for our lead asset, PNT2002, by evaluating the most capital efficient approaches to commercialization including resourcing of internal commercial capabilities and exploring strategic commercial partnership options."
PNT2001 builds on POINT’s first-generation, lutetium-based program with a next-generation ligand optimized for use with the alpha-emitting radioisotope actinium-225.
The new PNT2001 data were shared in E-poster #039, "Development and characterization of a next-generation 225Ac-PMSA radioligand", at the 35th Annual Congress of the European Association of Nuclear Medicine, currently taking place in Barcelona, Spain.
In pre-clinical models, 225Ac-PNT2001 demonstrated:
Increased internalization by tumor cells in vitro, compared to that of a first-generation ligand
More precise tumor targeting in vivo (due to decreased kidney uptake, high tumor retention, and rapid renal clearance), leading to a promising safety profile in murine models
Compelling therapeutic activity, including suppression of tumor growth and metastases, along with improved survival, following the administration of a single dose in mice
These pre-clinical findings support the advancement of 225Ac-PNT2001 to clinical evaluation.
Having secured access to actinium-225 from the US Department of Energy, as well as agreements with Ionetix, TerraPower, and Northstar, POINT aims to accelerate radiochemistry and formulation optimization, as well as cGMP process and method development and validation, to facilitate progression to an IND/CTA submission in H1 2023.
About the SPLASH Trial
The phase 3 SPLASH trial is a multi-center, randomized, open label assessment of PNT2002 in participants with PSMA-expressing mCRPC who have progressed on androgen receptor pathway inhibitor (ARPI) therapy and refuse, or are not eligible for, chemotherapy. The randomization phase of the study is expected to enroll approximately 400 participants across North America, Europe, and the United Kingdom. Participants will be randomized 2:1 with participants in arm A receiving PNT2002 and participants in arm B receiving either abiraterone or enzalutamide. Participants in arm B who experience centrally assessed radiographic progression and meet protocol eligibility will have the option to crossover and receive PNT2002. Patients will be subject to follow-up for up to 5 years from their first PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival. Key secondary endpoints include overall response rate, overall survival, and pharmacokinetics.