Telix Licenses Lilly Drug to Develop Radiolabeled Form for Treatment of Rare Cancer

Australian biotech Telix Pharmaceuticals said it entered an agreement with Eli Lilly under which it obtained exclusive worldwide rights to develop and commercialize radiolabeled forms of Lilly’s olaratumab antibody for the diagnosis and treatment of human cancers.

Photo: Christian Behrenbruch, CEO and managing director of Telix Group

Telix’s initial development focus will be on a rare type of cancer known as soft tissue sarcoma.

Olaratumab was originally developed by Lilly as a (non-radiolabeled) monoclonal antibody targeting platelet derived growth factor receptor alpha (PDGFRα). PDGFRα is expressed in multiple tumor types including soft tissue sarcoma. It was granted accelerated approval by U.S. regulators in 2016 for a subset of patients with soft tissue sarcoma who could not be treated with radiation or surgery. A confirmatory study, however, did not show overall survival benefit and Lilly pulled it from the market after three years.

Soft tissue sarcoma is generally a radiation susceptible cancer that may be inherently amenable to systemic radionuclide therapy and olaratumab’s ability to target PDGFRα makes it a highly novel and potentially exciting candidate for use as a radionuclide targeting agent, according to Telix. The exclusive worldwide license will allow Telix to repurpose olaratumab, which has an established safety profile, as a targeting agent for radiopharmaceutical imaging and therapy of cancer.

Under the terms of the license agreement, Telix will pay Lilly an upfront payment of $5 million for an exclusive license to Lilly’s intellectual property related to the development of a radiolabeled olaratumab, as well as access to material for use by Telix in initial pre-clinical and early-phase clinical studies in application to potential uses for the diagnosis and treatment of human cancers.

Lilly may be eligible for up to $225 million in payments based upon the achievement of pre-specified development, regulatory and commercial milestones, plus royalties on net sales. The agreement also includes an option for Lilly to be granted an exclusive license to a radiolabeled companion diagnostic, which would be developed by Telix. If exercised, Lilly will pay Telix $5 million and up to $30 million in potential development milestones, as well as royalties.

“This in-license transaction with Lilly is a valuable—and rare—opportunity to acquire an asset which has demonstrated clinical safety. In our pre-transaction diligence and research, we have identified that a radiolabeled version of olaratumab could be efficacious in patients with soft tissue sarcoma, particularly as it is a highly radiation sensitive cancer,” said Christian Behrenbruch, CEO and managing director of Telix Group. “The safety data generated by Lilly in relation to the original development program significantly de-risks the program for Telix. We anticipate that early clinical translation with a radiolabeled olaratumab as an imaging agent may also provide valuable clinical information as to whether this asset has potential therapeutic efficacy, demonstrating the advantage of Telix’s “theranostic” approach.”

Author: Rare Daily Staff