Point unveils new Indy site to shore up supply chain in fight against prostate cancer
With a new manufacturing facility and a candidate for prostate cancer in clinical trials, Point Biopharma is moving fast to bring its radioligand operations online. Now, it will get some help from the US Department of Energy.
Point will receive actinium-225 from the DOE’s Isotope Program to support its early-stage pipeline and in-house manufacturing of lutetium-177, a radioactive medicine that binds itself to tumor cells. The help will allow Point to stay on track to launch in 2023 and will supplement the company’s supply chain from TerraPower, NorthStar Medical and Ionetix. All of these partnerships will help bolster the company’s internal production, the company said.
Last June, Point began finishing touches on an 80,000-square foot center that it intends to become one of the largest radioligand facilities in the world. Tuesday, the company announced that the Indianapolis production facility has been completed, and it has begun production of PNT-2002. The candidate is a PSMA-targeted therapy for metastatic castration-resistant prostate cancer, which accounts for more than 85% of prostate cancers. About 52,000 men are diagnosed with this form of cancer.
“With our facility now operational, Point is one of the only pharmaceutical companies globally positioned to manufacture radiopharmaceuticals on a commercial scale,” CEO Joe McCann said in a statement. “Our team’s significant experience and expertise in the development of radiopharmaceuticals is highlighted by the consistency and speed of our execution of the SPLASH trial. These unique core strengths position POINT to be a leader in this burgeoning modality.”
The SPLASH trial — which began in December — added the Indianapolis site to its supply chain alongside its Investigational New Drug amendment. The site is producing no-carrier-added lutetium-177 as of last month, and enrollment of 400 patients in the US and Canada has already begun. Enrollment of participants from the UK and Europe will start later this quarter.
Right now, there are 21 sites in North America enrolled in the trial. Data are expected by the middle of 2023.
Point is expected to learn the regulatory decisions surrounding candidate PNT-2003 — which targets somatostatin receptor-positive neuroendocrine tumors — by the end of Q1 this year. The company is exploring an ANDA for GEP NETs and an NDA for non-GEP NETs.
In March, the company entered a reverse-merger agreement with Boston-based Research Alliance Corp. I, the first SPAC backed by biotech investor Peter Kolchinsky. Point received a projected $300 million in proceeds through the acquisition, which includes $165 million from RA Capital and other investors. The move helped finance the company to a point where they could complete Phase III trials for radioligands to treat prostate and neuroendocrine cancers. They also went toward strengthening internal manufacturing and logistics capabilities.