Tuesday September 24, 2019 0 comments
BOULDER/BERLIN -- Clovis Oncology, Inc. (NASDAQ: CLVS) announced it has entered into a global licensing and collaboration agreement with 3B Pharmaceuticals GmbH (3BP), a private German biotechnology company developing targeted radiopharmaceutical drugs and diagnostics for oncology indications with a high unmet medical need.
The initial focus is on developing a 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, the company said.
Clovis said it will conduct global clinical trials and has obtained U.S. and global rights, excluding Europe (inclusive of Russia, Turkey and Israel), where 3BP retains rights.
The parties have also agreed to collaborate on a discovery program directed at three additional targets for radionuclide therapy, to which Clovis will have global rights.
Terms of the transactions include approximately $12 million in upfront payments to 3BP. Upon achievement of certain development and regulatory milestones, additional potential milestone payments and single- to low-double-digit commercial royalties would be paid to 3BP by Clovis.
Clovis will be responsible for a limited number of 3BP full-time employees (FTEs) and external costs during the pre-clinical development. Research and development expense guidance provided by Clovis on its Aug. 1 financial results call does not change as a result of today’s announcement.
“We are extremely enthusiastic about the opportunity to develop this novel class of targeted radiopharmaceutical therapies, with an initial focus on fibroblast activation protein alpha,” said Patrick J. Mahaffy, Clovis president and CEO.
“Targeted radiopharmaceutical therapy represents a next frontier in oncology drug development, with potential application across multiple tumor types. In particular, FAP represents a very compelling target given its overexpression across numerous tumor types and limited expression in healthy tissue.
“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.
“We are delighted to work with 3BP given their leadership in the discovery and development of peptide-targeted radionuclide therapies.”
The collaboration is initially focused on development of an FAP-targeted preclinical candidate identified by 3BP’s technology platform. FAP 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 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 Investigational New Drug (IND)-enabling studies.
“We have focused for many years on developing a peptide technology platform for the discovery and development of innovative radiopharmaceuticals, which we believe represents the best means of selectively delivering potent radiation to tumors,” said Dr. Ulrich Reineke, managing director of 3BP.
“As we are approaching clinical development, we are very enthusiastic about partnering with Clovis Oncology to move our FAP-targeted product forward and to collaborate further on building a portfolio of targeted radiopharmaceutical therapeutics.
“We believe this is an ideal partnership for the rapid clinical development of our radiopharmaceuticals for the benefit of patients with many different types of cancer.”