BeiGene is jumping on the bandwagon for PD-(L)1/CTLA-4 combos — with a twist.
Through a development and commercialization pact with San Diego-based BioAtla, BeiGene is pairing its PD-1 drug tislelizumab with BA3071, a CTLA-4 blocking “conditionally active biologic” that gets turned on or off based on whether it’s inside the tumor microenvironment.
San Diego-based BioAtla is responsible for early clinical work, while BeiGene will lead the joint efforts thereafter to develop the combo and deal with regulators around the world. The Chinese biotech, which is committing $20 million upfront and $249 million in biobucks as well as a cost-sharing scheme, is also picking up all costs in Asia (except Japan), Australia and New Zealand from here on out. It has a full license to commercialization rights.
CTLA-4 was the first checkpoint to hit the market, with Bristol-Myers snagging boasting rights with Yervoy. But while effective in unleashing a T cell response and improving survival rates, their significant toxicity has also made their use problematic and thus thwarted their prominence. In recent years, though, a crop of biotechs has risen up on the promise to target CTLA-4 with higher specificity as CTLA-4 remains the hottest add-on in PD-(L) combo studies.
CTLA-4 was the first checkpoint to hit the market, with Bristol-Myers snagging boasting rights with Yervoy. But while effective in unleashing a T cell response and improving survival rates, their significant toxicity has also made their use problematic and thus thwarted their prominence. In recent years, though, a crop of biotechs has risen up on the promise to target CTLA-4 with higher specificity as CTLA-4 remains the hottest add-on in PD-(L) combo studies.
It is this backdrop that BioAtla has entered with its platform, which designs drugs that only bind to the target when they sense the the unique physiology and metabolism of a tumor. In addition to antibodies like BA3071, the platform can also give birth to antibody drug conjugates, bispecifics and CAR-Ts.
BioAtla president Scott Smith (yes, the former Celgene COO) says the deal fits with its strategy for advancing CABs beyond clinical proof-of-concept, as BeiGene is “a recognized leader in China-inclusive global clinical development.”
The company is prepping an imminent first IND filing for both the BA3071 monotherapy and the combo with tislelizumab, with a Phase I/II expected to start in the second half of 2019.
For BeiGene, the deal marks another addition to the broad pipeline around tislelizumab, which spans a dozen solo indications as well as early combo studies with its own PARP and BTK inhibitors.
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