BioAtla Inc. (BCAB) has announced promising clinical trial results for its drug candidate, Tab-cel, in patients with refractory head and neck cancer. The data, presented during the company's Q3 2024 earnings call, revealed an overall response rate of 37.9% (11 out of 29 evaluable patients) in a heavily pretreated population. This outcome is particularly significant given the limited treatment options available for these patients.
The FDA has granted Fast Track designation to Tab-cel, a decision that highlights the drug's potential to address unmet medical needs in head and neck cancer. The median overall survival observed in the trial was approximately nine months, which BioAtla considers competitive compared to current standard treatments in this setting.
Clinical Trial Design and Outcomes
BioAtla is in discussions with the FDA regarding the design of a pivotal trial for Tab-cel. Feedback from the agency has been supportive, potentially paving the way for accelerated marketing authorization. The company anticipates initiating this pivotal trial in 2025.
In addition to Tab-cel, BioAtla is also advancing its CTLA-4 program. The company plans to initiate a pivotal trial for this program in 2025 as well, following the Tab-cel trial. The initial focus for the CTLA-4 program was BRAF-mutated melanoma, but the company has expanded its focus to include all first-line unresectable and metastatic melanoma patients, based on observed tumor reductions in all eight patients treated, including those with BRAF mutations.
Financial Strategy and Future Plans
BioAtla reported a net loss of $10.6 million for the quarter, despite recognizing $11 million in collaboration revenue. The company's cash and cash equivalents have decreased from $111.5 million at the end of 2023 to $56.5 million as of September 30, 2024. While the company projects that its current cash reserves will fund operations into early 2026, it is actively exploring partnerships to support the advancement of its clinical programs.
BioAtla intends to advance one of its programs independently while seeking a partner for the other. This strategy is designed to optimize resource allocation and ensure efficient progress towards potential regulatory approvals. The company is also working to finalize dose optimization for its CTLA-4 program under Project Optimist.
Trial Details and Patient Population
The pivotal trial for Tab-cel will compare the drug to investigator's choice of cetuximab, docetaxel, or methotrexate. For the Roar Two frontline study, BioAtla anticipates enrolling approximately 570 patients for the full approval endpoint of overall survival, with an earlier look for accelerated approval based on response rate. This is a smaller study than the CheckMate 067 trial, which had 945 patients across three arms.
The FDA has requested results from a limited randomized evaluation of dosing schedules, which BioAtla plans to integrate into the phase three trial. Formal agreement from the agency on the dose is contingent upon presentation of this data.
