Context Therapeutics has secured an exclusive, worldwide license to BioAtla's BA3362, a preclinical-stage Nectin-4 x CD3 T-cell engager (TCE), in a deal potentially worth up to $133 million. This strategic move allows Context to develop, manufacture, and commercialize the drug, funding all future development and commercialization activities. The acquisition underscores the growing interest in TCE therapies that redirect T cells to eliminate tumor cells expressing specific surface proteins.
Mechanism of Action and Clinical Potential
BA3362 is designed to target Nectin-4, a protein overexpressed in various cancers, and redirect T cells to these cancer cells, promoting their destruction. BioAtla's proprietary Conditionally Active Biologics (CAB) platform is central to BA3362's design, intended to minimize off-target toxicities while enhancing anti-tumor potency. According to Jay Short, Ph.D., Chairman, CEO, and Co-founder of BioAtla, this deal validates the CAB technology and BioAtla's ability to develop CAB antibodies that effectively target cancer cells while sparing normal healthy cells.
Financial Terms and Strategic Implications
Under the agreement, BioAtla is eligible to receive up to $133 million in aggregate payments. This includes $15 million in upfront and near-term milestone payments, as well as potential clinical, development, and commercial milestones totaling $118.5 million, along with tiered royalties on net sales. For BioAtla, this deal allows them to focus on their lead clinical CAB programs while ensuring the advancement of BA3362 under Context Therapeutics' leadership. Martin Lehr, CEO of Context Therapeutics, stated that the transaction aligns with their focus on building a pipeline of TCE assets through strategic in-licensing or acquisition, identifying BioAtla's therapeutic as a potentially best-in-class asset.
Development Timeline and BioAtla's Pipeline
BA3362 is one of five therapeutics in BioAtla's pipeline and is currently in the preclinical development stage. First-in-human studies are anticipated to begin in approximately 18 months. BioAtla's Q2 2024 earnings report indicated R&D expenses of $16.2 million, a decrease from $31 million in the same quarter last year, attributed to the completion of preclinical development for BA3362, which received IND clearance in May. BioAtla expects R&D expenses to continue to decrease as they advance Phase 2 clinical trials and meet with the FDA to schedule registrational trials. The company's cash and cash equivalents were reported at $61.7 million, expected to fund planned operations through Q3 of 2025.
BioAtla's Future Collaborations
BioAtla intends for this collaboration with Context Therapeutics to be the first of several, including a targeted collaboration for one of its Phase 2 drugs in the coming months. The company aims to advance next-generation cancer-fighting mechanisms through the clinic, toward approval. BioAtla has raised nearly $600 million in funding to date, with lead investors including Acorn Bioventures, Soleus Capital Management, L.P., Millennium Management LLC, Tang Capital Management and LLC, and BlackRock, Inc.
