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LONDON—The Cancer Research UK Drug Development Office (DDO) has completed an agreement with Clovis Oncology Inc., of Boulder, Colo., for the licensing of data from the Cancer Research UK Phase II clinical trial of rucaparib (AG014699) in breast and ovarian cancer patients with known mutations in their BRCA 1 or 2 genes.
As part of the agreement, Clovis will gain access to the clinical data from this study, and Cancer Research UK will receive license fees.
Research initially conducted in Cancer Research UK-funded laboratories at the Northern Institute for Cancer Research, and subsequently in collaboration with Agouron Pharmaceuticals—which later became part of Pfizer GRD—led to the development of the poly (ADP-ribose) polymerase inhibitor rucaparib. Rucaparib is a PARP inhibitor being investigated as a potential anticancer agent. It is thought to inhibit the contraction of isolated vascular smooth muscle, including that from the tumors of cancer patients.
According to the literature, it also reduces the migration of some cancer and normal cells in culture. It can be administered orally in tablet form. It had undergone Phase I clinical trials for patients with advanced solid tumors prior to initiation of Phase II clinical trials for metastatic breast and ovarian cancer with known BRCA 1 or BRCA 2 mutation. As of November 2012, four clinical trials of rucaparib were recruiting patients.
The DDO points out that the average woman in the United Kingdom has a 12.5-percent chance of developing breast cancer at some point in her life. But a female BRCA 1 carrier, such as Angelina Jolie, who recently—and bravely—went public with her decision to have a double mastectomy, has between a 60- and 90-percent chance of developing breast cancer. In other words, between 60 and 90 out of every 100 BRCA 1 carriers go on to develop breast cancer. They also have around a 40-to 60-percent chance of developing ovarian cancer.
"This exciting deal underlines the value of the data from this Cancer Research UK trial," says Dr. Nigel Blackburn, director of drug development at the DDO. "We will look forward to the ongoing clinical development of this very promising agent by Clovis Oncology with great interest."
The Cancer Research UK DDO has a number of collaborations of this type with both large pharmaceutical and smaller biotechnology companies, he notes. This particular collaborative trial came about when Pfizer Inc. was developing the compound, which was subsequently licensed and transferred to Clovis Oncology.
A DDO spokesman points out that rucaparib differs from other drugs, and that there are no currently marketed therapies specifically for patients with mutations of BRCA 1 or 2.
"Rucaparib is a highly potent and selective PARP inhibitor, and both preclinical and clinical data have suggested it has great potential in the treatment of BRCA-mutated cancers. This agent has subsequently been licensed by Pfizer to Clovis Oncology who are now actively developing it in a number of cancer indications," the spokesman tells DDNEWS.
Clovis has three product candidates in its development pipeline for which the company holds global rights. In addition to rucaparib, there is CO-1686, an orally available epidermal growth factor receptor (EGFR) covalent inhibitor currently in Phase I/II development for the treatment of non-small cell lung cancer (NSCLC), in patients with initial activating EGFR mutations, as well as the T790M dominant resistance mutation. The third product candidate, currently in the discovery phase, is a novel cKIT inhibitor targeting resistance mutations for the treatment of gastrointestinal stromal tumors.