On August 13, 2024 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production, and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and Convergent Therapeutics, Inc., a clinical stage radiopharmaceutical company, reported the signing of a strategic contract manufacturing services agreement (Press release, NorthStar Medical Radiostopes, AUG 13, 2024, View Source [SID1234645837]). Convergent’s lead asset CONV01-α is a prostate-specific membrane antigen (PSMA)-targeted monoclonal antibody linked to Ac-225 and is currently being investigated as a treatment for prostate cancer.

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Under the terms of the expanded collaboration, NorthStar will:

Provide Convergent with its environmentally preferred, high purity non-carrier-added (n.c.a) Ac-225 for use in CONV01-α,
Utilize its new, state-of-the-art contract development and manufacturing facility to manufacture CONV01-α to serve patients in Convergent’s clinical trials, and
Perform research and development activities to support continued development of CONV01-α and other Convergent assets.
In March of this year, Convergent received U.S. Food and Drug Administration ("FDA") clearance for its investigational new drug ("IND") application for CONV01-α, a key milestone that enables Convergent to advance CONV01-α into Phase 2 studies and expand the scope of clinical development of CONV01-α as a monotherapy and in combination with other cancer therapies. The manufacturing supply agreement announced today will support these trials and, if U.S. FDA approved, the manufacturing of CONV01-α for commercial purposes.

"The last several years have seen an explosion of research and clinical trials in the area of radiotherapies, especially those using Ac-225," said Frank Scholz, Chief Executive Officer of NorthStar, "and yet today there are still far too few effective therapies for patients suffering from a variety of serious diseases including many cancers. Why? Because the processes to develop, manufacture and deliver therapeutically effective radiopharmaceuticals like Convergent’s CONV01-α to market – in particular at a scale able to meet patient demand for an approved, marketed medicine — are highly specialized and complex. At NorthStar, our passion is to reduce technological and operational barriers to help companies like Convergent Therapeutics not only secure a reliable source of Ac-225, but manufacture a finished, patient-ready drug product and continue to develop new and additional therapeutic indications for the patients who need new and better medicines. We are proud to be supporting Convergent and look forward to working with them to help make new medicines like CONV01-α therapeutic reality."

"We are excited to expand our partnership with NorthStar and the opportunity to leverage NorthStar’s unique position to scale both Ac-225 generation and manufacturing capacity," said Caitlyn Harvey, Head of Manufacturing at Convergent. "Convergent will begin enrolling patients into the CONVERGE-01 Phase 2 clinical trial in the next couple of months as we continue building on extensive clinical experience which will allow us to rapidly move into our Phase 3 study."

About CONV01-α

CONV01-α, Convergent’s alpha emitting radioantibody, combines the precision and pharmacokinetics of antibodies with the tumor-killing potential of alpha emitting radionuclides. Specifically, CONV01-α uses a humanized monoclonal antibody targeted at prostate-specific membrane antigen (PSMA) which is highly overexpressed in prostate cancer cells. Since PSMA is a validated target, several therapeutics are directed at this antigen and CONV01-α is differentiated by its use of both an antibody and alpha emitter. CONV01-α is linked to a powerful radionuclide called Ac-225, which releases alpha particles which kill cancer cells through DNA double strand breaks. Unlike other radioactive sources, alpha particles deliver high-energy radiation over very short distances, thereby minimizing radiation exposure to healthy neighboring cells and tissues. Pairing highly selective antibodies with such a powerful yet precise payload offers the ideal combination to treat many types of cancers.