Verastem pens KRAS-focused drug licensing deal with Chugai

Verastem Oncology has signed a pact to license a drug targeting KRAS-mutation positive cancers from Chugai.

Under the deal, which is worth only $3 million upfront, Verastem nabs worldwide development and sales rights to RAF/MEK inhibitor CH5126766 (CKI27) from Chugai, which is in tests for KRAS mutant solid tumors. The company will host an investor call to discuss the opportunity and a development update today (details below).

The drug is already in a combo phase 1 trial with Verastem’s focal adhesion kinase inhibitor, defactinib, in KRAS-positive cancers, including ovarian, non-small cell lung and colorectal cancers.

Verastem is also testing Copiktra in relapsed and refractory blood cancers and as a first-line treatment for younger patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

Now, Verastem gets its hands on the med and will be responsible for the development and selling of CH5126766. Along with the $3 million upfront, it will also pay royalties to Chugai.

Verastem added that “given the potential of the opportunity, the company will be evaluating various partnering strategies,” but gave no further details.

“Based on the single-agent defactinib results in KRAS mutant NSCLC, we conducted an internal pre-clinical effort to identify drug classes that were synergistic with defactinib and saw the highest level of synergy in combination with MEK inhibitors and, specifically, with CH5126766,” said Dan Paterson, president and chief operating officer at Verastem.

“The exciting early clinical results led to our decision to enter into a partnership with Chugai for CH5126766 and accelerate the combination development program for patients with KRAS mutant cancers, which are highly aggressive and recurrent. We plan to initiate discussions with regulatory authorities about our development plans and to define the registration path early this year.”

This comes around six months after Verastem took on a new leader: Brian Stuglik, the Eli Lilly veteran who sat on Verastem’s board of directors. Stuglik’s appointment came a month after Robert Forrester stepped down from the CEO post. He soon took the chop to 40 positions from the company in an attempt to lower costs.

Stuglik’s predecessor, Forrester, joined Verastem as COO in 2011 and replaced Christoph Westphal as CEO in 2013. He steered the company through turbulent times marked by the foundering of its lead asset and the subsequent regrouping around the AbbVie and Infinity castoff duvelisib.

Now known as Copiktra and after a troubled path, duvelisib earned an FDA nod in 2018 as a third-line treatment for CLL, SLL and follicular lymphoma. But that approval came with a black box warning that could limit use of the drug. The company predicted Copiktra to log about $10 million in sales, but analysts expect revenues to rise beyond that. Peak sales for the drug have been forecast as high as $850 million.

Verastem is also testing Copiktra in relapsed and refractory blood cancers and as a first-line treatment for younger patients with CLL and SLL. Last year, Sanofi signed up to sell the drug in certain regions.

Verastem is now hoping to pull off a similar feat with its Chugai deal, although there is a long way to go and many hurdles to trip up on.

The biotech was up 12% premarket with a market cap of just under $100 million.