Clovis Moves into Radiopharmaceuticals Through $12 Million Deal with 3B

Clovis Oncology plunked down $12 million in an upfront payment to Germany-based 3B Pharmaceuticals for licensing rights to peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein alpha (FAP).

FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas. Clovis plans to pursue a broad and accelerated clinical development program. With the license in hand, Clovis is already anticipating filing an Investigational New Drug application with the U.S. Food and Drug Administration for the therapy in the second half of 2020, the Boulder, Colo.-based Clovis announced this morning.

With the rights to the 3B PTRT in hand, Clovis is eying oncology territory that other companies such as Novartis and J&J-backed Fusion Pharmaceuticals are already exploring. For Clovis, the move is an attempt to provide the company with another revenue driver to bolster sales of its PARP inhibitor Rubraca, which did not hit analysts’ expectations in the most recent quarter with sales of $33 million.

Patrick J. Mahaffy, president and chief executive officer of Clovis, said the company is “extremely enthusiastic” about the licensing deal for the novel class of targeted radiopharmaceutical therapies licensed from 3B.

“Targeted radiopharmaceutical therapy represents a next frontier in oncology drug development, with potential application across multiple tumor types. In particular, FAP (fibroblast activation protein alpha) represents a very compelling target given its overexpression across numerous tumor types and limited expression in healthy tissue,” Mahaffy said in a statement. “Additionally, as a result of our discovery collaboration, Clovis intends to further expand its pipeline with additional targeted radiopharmaceutical candidates that result from the discovery program using 3BP's technology platform.”

FAP, which is the initial focus of Clovis’ plans for the peptide-targeted radionuclide therapy, is highly expressed in cancer-associated fibroblasts (CAFs) which are found in the majority of cancer types and play an intricate role in driving tumor growth. Targeting CAFs with an FAP radiopharmaceutical is believed to have multiple modes of anti-tumor action, but principally relies on the induction of DNA damage in tumor cells by ionizing radiation emitted locally from neighboring CAFs targeted by the therapy, Clovis said.

Under terms of the deal, Clovis provides 3B with $12 million. The German company will be eligible for additional milestone payments should Clovis achieve certain developmental and regulatory milestones. Clovis and 3BP also announced their intention to enter into a collaboration for the discovery and development of radiopharmaceuticals for three additional targets using 3BP's technology platform. 3BP will be responsible for discovery activities for the three targets. Once lead molecules have been identified, responsibilities will transition to Clovis for IND-enabling studies.

Ulrich Reineke, managing director of 3BP, touted the partnership with Clovis. Reineke said the relationship will help move its FAP-targeted product forward and also aid in the development of future peptide-targeted radionuclide therapies.