Alpha Tau Medical and Tolmar partner to commercialise Alpha DaRT prostate cancer therapy in the US

Alpha Tau Medical Ltd, developer of the innovative alpha-radiation cancer therapy Alpha DaRT, and Tolmar International Ltd., one of the strongest commercial players in the U.S. urology, oncology, endocrinology and paediatric endocrinology markets, have announced a strategic collaboration agreement to develop and commercialise Alpha DaRT for the treatment of prostate cancer in the United States.

Through the collaboration, Tolmar will hold exclusive rights to commercialise Alpha DaRT in the United States for prostate cancer indications for a term that is expected to extend for 20 years from first commercial sale, subject to the terms and conditions of the Collaboration Agreement.

Tolmar also holds an option, exercisable upon achievement of specified clinical criteria, to expand commercially into bladder cancer in the United States.

Alpha Tau CEO, Uzi Sofer, said: “Our clinical exploration of prostate cancer is already well underway, having treated patients in Israel and secured an IDE from the FDA for a U.S. trial.

“Working alongside Tolmar, a top commercial leader with a keen understanding of this market, unlocks a vital channel with the potential to reach tens of thousands of patients per year in this first urological indication alone.

“Alongside our core clinical programmes to date in glioblastoma, pancreatic cancer, and squamous cell carcinoma, expanding into prostate cancer allows us to extend the reach of our platform technology exponentially and builds upon our deep commitment to advancing innovative therapies across multiple oncology settings.

“This partnership will also spur additional expansion of our U.S. manufacturing capacity, advancing our commitment to deliver this groundbreaking science to patients as quickly as possible.”

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) represents a paradigm shift in the treatment of solid tumors.

While traditional radiation therapies face limitations of efficacy and focused targeted delivery, Alpha DaRT is designed to deliver highly potent and conformal therapy directly inside the tumor, by means of recoiling radioisotopes that release alpha particles with high energy and short diffusion.

Alpha DaRT therefore has the potential to destroy cancer cells with precision and spare the surrounding healthy tissue, offering patients a new and highly localised treatment modality to maximise their quality of life.

Anil D’Souza, CEO of Tolma, said: “Alpha DaRT represents a meaningful advancement in oncology, with the potential to make a significant difference for patients facing prostate cancer.

“By combining innovative science with Tolmar’s proven capabilities and deep experience supporting providers, we are focused on expanding access to new treatment options for patients and the clinicians who care for them.

“Throughout our extensive due diligence of Alpha Tau, we were consistently impressed with Uzi and the talent of the Alpha Tau leadership team, thinking strategically through all aspects of this unique therapy, from manufacturing to supply chain, and into clinical settings, as we were increasingly convinced of the promise of the technology, the market opportunity, and the commercial prospects.

“Together, we are mobilized to work to accelerate its development and bring this therapy to patients across the United States as efficiently as possible.”