BioAtla Highlights Promising Clinical Data and Financial Results in Q3 2024
核心洞察
BioAtla's ozuriftamab vedotin Phase 2 trial shows a 9-month median overall survival in heavily pretreated head and neck cancer (搜索) patients, indicating potential efficacy.
Evalstotug combined with PD-1 demonstrates tumor reduction in all first-line melanoma (搜索) patients, including one complete response, with favorable tolerability.
The company's cash position of $56.5 million, along with recent licensing revenue, is projected to fund operations into early 2026, ensuring continued development.
BioAtla, Inc. (Nasdaq: BCAB) announced its third quarter 2024 financial results and highlighted recent clinical progress, showcasing promising data from its lead clinical programs. The company's advancements in conditionally active biologic (CAB) antibody therapeutics for solid tumors are paving the way for potential registrational trials in 2025.
Clinical Program Highlights
Ozuriftamab vedotin (CAB-ROR2 (搜索)-ADC), in a Phase 2 trial for squamous cell carcinoma of the head and neck (SCCHN), continues to demonstrate durable clinical responses. Updated data as of September 10, 2024, showed a median overall survival (OS) of approximately 9 months in a heavily pretreated population. The study also reported a 38% response rate in heavily pre-treated patients, with a median duration of response (DOR) for all confirmed responders now at 4.4 months. The U.S. Food and Drug Administration (FDA) provided actionable guidance on a pivotal trial in second-line (2L) plus SCCHN, supporting a limited randomized evaluation of the Q2W and 2Q3W dosing schedules at the current dose of 1.8 mg/kg. The FDA also granted Fast Track Designation to ozuriftamab vedotin for the treatment of patients with recurrent or metastatic SCCHN.
Evalstotug (CAB-CTLA-4 (搜索)), in combination with PD-1, demonstrated tumor reduction in all eight first-line unresectable or metastatic melanoma (搜索) patients, with 4 responses including a complete response (CR), ongoing, with relatively low incidence and severity of immune-related adverse events. The FDA provided guidance on ongoing dose optimization and control arm anticipated to enable a Phase 3 trial in first line patients with unresectable or metastatic melanoma anticipated to enable study initiation in 2025.
Mecbotamab vedotin (CAB-AXL (搜索)-ADC) Phase 2 trial in non-small cell lung cancer (NSCLC (搜索)) shows tumor reduction across nine different mutant KRAS (搜索) (mKRAS) variants; an improved median OS of 12.6 months, ongoing, among treated patients with tumors expressing mKRAS variants compared to KRAS wildtype (median OS = 8.7 months).
BA3182 (CAB-EpCAM (搜索) x CAB-CD3 (搜索) TCE) observed multiple patients with tumor reduction, including one colorectal cancer (搜索) patient with stable disease for one year (ongoing).
Financial Performance
For the third quarter ended September 30, 2024, BioAtla reported a net loss of $10.6 million, including $11.0 million in collaboration revenue. Research and development expenses were $16.4 million, compared to $28.4 million for the same quarter in 2023. The company's cash and cash equivalents totaled $56.5 million as of September 30, 2024, which is expected to fund planned operations into early 2026.
Strategic Outlook
"BioAtla remains focused on execution of key business drivers, as evident by the recent successful out-licensing of our CAB-nectin-4 bispecific T-cell engager and extending operating runway into 2026, while also advancing our lead clinical programs," said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc. "We are seeing clinical data with encouraging overall survival in both of our ADC programs and promising antitumor activity and tolerability with our CAB-CTLA4 antibody, evalstotug. Following recent, positive interactions with the FDA regarding ozuriftamab vedotin and evalstotug, we believe the company is well-positioned for two potentially registrational trials in 2025. Given our ongoing discussions with potential strategic partners, we remain confident in establishing a near-term collaboration for one of our Phase 2 clinical assets."