FDA Alignment on Phase Three Trial Design
BioAtla achieved FDA alignment on the phase three OSV registrational trial design for OPSCC, which includes a dual primary endpoints design for potential accelerated approval followed by full approval.
Development Milestone with Context Therapeutics
Achieved a development milestone under a license agreement with Context Therapeutics related to the dual CAB Nectin 4 TCE program, providing non-dilutive capital and further validating the CAB T cell engager platform.
Compelling Data from CAB Platform Programs
Presented compelling data for dual CAB EpCAM TCE and MACV programs, demonstrating potential for differentiated therapies for difficult-to-treat cancers.
Potential Strategic Transaction
BioAtla is in advanced stages to finalize a strategic transaction with a potential partner by year-end.
Strong Phase Two Data for OSV
Phase two data for OSV in late-line OPSCC patients showed an overall response rate of 45% and a median overall survival of 11.6 months, significantly higher than historical response rates and survival with standard therapies.
Market Opportunity for OSFI
OSFI has demonstrated clinical activity in HPV-positive OPSCC and is projected to achieve worldwide peak sales of $800 million in second-line and later OPS alone, with the total worldwide OPSCC market projected to reach $3 billion by 2032.
Progress in Dual CAB EpCAM T Cell Engager Program
Preliminary data from phase one trial in advanced adenocarcinomas indicate a manageable safety profile and encouraging signs of tumor reductions, with a confirmed partial response at 0.6 mg dose.
MEKV Program's Potential in Soft Tissue Sarcoma
Phase two trial data for MEKV showed a median overall survival of 21.5 months in soft tissue sarcoma patients, compared to 11.5 to 13.6 months for approved agents, with a manageable safety profile.