Takeda Inks Deal with Maverick Therapeutics

 

Takeda Pharmaceutical is advancing its immune-oncology portfolio with a lot of help from a Maverick – Maverick Therapeutics that is. The Japanese pharma giant announced today that it will acquire the immunotherapy pioneer it has been helping to build since its inception.                  

The potentially $525 million deal is the culmination of an exclusive, multi-year “build-to-buy” collaboration struck in January 2017 to develop conditionally active T-cell engager therapies. The agreement gave Takeda an equity stake and the exclusive right to purchase Maverick after five years.

As Takeda is exercising the option early in the fifth year, it’s clear that the private California biopharma company has impressed its partner.

“I think the fact that they’ve decided to jump in early speaks to two things. One is the validation of what we’re excited about, the progress that we’ve made as a team, as a company,” said Maverick chief executive officer, Jim Scibetta. “Also, I think for them, the hope that this can be done in an orderly way that has our team join the Takeda organization, especially during this critical period for us as we’re executing on the two big drugs.”

Takeda expressed confidence and optimism in the new additions to its pipeline.

“The COBRA platform fits seamlessly in our immuno-oncology portfolio as a complement to our growing redirected immunity pipeline,” said Chris Arendt, Ph.D., Head of the Oncology Therapeutic Area Unit at Takeda. “Pre-clinical data from Maverick showed an encouraging safety profile and demonstrated COBRA’s immense therapeutic potential within solid tumors, which deepened our confidence in the platform.”

The pair’s lead candidate, TAK-186 (formerly MVC-101), a first-in-class conditionally active T-cell engager, has recently entered the clinic in a Phase I/II study for the treatment of EGFR-expressing solid tumors such as those found in head and neck cancers. 

TAK-280 (MVC-280) is expected to join TAK-186 in the clinic during the second half of 2021 in pursuit of B7H3-expressing solid tumors such as prostate cancer.  

Maverick’s COBRA™ platform takes a highly specific and potent approach to target solid tumors, while the technology allows it to limit the toxicities levied on normal tissues. 

Bispecific T-cell engagers have had clinic success in the treatment of hematological cancers, but to date have had limited application in solid tumors– which make up 90% of diagnosed cancers – due to these toxicity challenges. COBRA, which stands for COnditional Bispecific Redirected Activation, takes advantage of the tumor’s highly proteolytic microenvironment for T-cell activation.

“The solid tumor patients, around the time they start to see a response to the tumor, they also see a dose-limiting toxicity that prevents them from receiving sufficient doses,” explained Maverick SVP of Research and Development, Chad May. “To overcome this, we developed this platform we call COBRA, and here, it’s administered as a prodrug. Upon administration, it can home in by the target on the tumor, or normal tissue, but it isn’t turned on or activated until a proteolytic event occurs, and there’s a cleavage of the molecule that changes its structuring from an active T-cell engager.” 

The manufacturing process for this type of drug is complex, and when Maverick ran into challenges with facilities, some of them related to the COVID-19 pandemic, Takeda answered the call.

“That was the period where they jumped in and provided some expertise in helping us figure out how to proceed with our lead drug. Then, with our second drug that will be in the clinic later this year, they actually jumped in as the manufacturer at a site that they were just opening in Japan when we ran up against other manufacturers who didn’t really have the ability to follow through.” 

Under the terms of the agreement, Maverick will receive a pre-negotiated upfront payment, along with potential development and regulatory milestones. The deal is expected to be finalized in Q1 of Takeda’s fiscal year 2021.

“Solid tumors remain a high area of unmet need, so by exercising our option to acquire Maverick, we hope to unlock the power of the immune system in solid tumors while also applying learnings from the COBRA platform across other I-O programs and modalities,” said Arendt. “We’re excited to welcome Maverick employees to the Takeda team and to continue our work together.”