Clinical Program Updates
- Phase 2 Trial of Mecbotamab Vedotin (BA3011, NCT03425279) in Patients with:
- AXL-positive NSCLC
- Part 1 of the trial ongoing in patients who have previously experienced failure of PD-1/L1, EGFR, or ALK inhibitor therapy (average failure 3 lines of therapy)
- 29 patients enrolled to date (as of January 2023)
- 20 efficacy-evaluable patients (18 in the non-squamous adenocarcinoma group and 2 in the squamous cell carcinoma group)
- In the non-squamous group, 10 of 18 had monotherapy and 8 of 18 had combination therapy with nivolumab
- All CR / PRs observed were in the non-squamous group
- 4 PRs were in the monotherapy group (4 of 10, ORR 40%)
- 4 PRs were in the monotherapy PD-1 failure group (4 of 9, ORR 44%)
- 1 CR in combination therapy, (1 of 8, ORR 12.5%)
- 20 efficacy-evaluable patients (18 in the non-squamous adenocarcinoma group and 2 in the squamous cell carcinoma group)
- Following BA3011 in both monotherapy and in combination with nivolumab in advanced NSCLC patients, the safety profile continues to be differentiated, with no new safety signals observed
- AXL-positive Soft Tissue and Primary Bone Sarcomas
- Following FDA feedback to the proposed Phase 2 part 2 of the potentially registrational sarcoma study, protocol for UPS study design, including primary endpoint and size of study, finalized and the study is being initiated.
- Part 1 of the Phase 2 study:
- Study is progressing with continued efficacy in UPS with 50.0% PFS at 12 weeks (n=10 patients)
- Study ongoing in patients with liposarcoma, synovial sarcoma, and osteosarcoma with continued, encouraging PFS at 12 weeks
- Liposarcoma – 66.7% PFS (n=8)
- Synovial sarcoma – 53.5% PFS (n=5)
- Osteosarcoma – 66.7% PFS (n=7)
- In refractory sarcomas, BA3011 in both monotherapy and in combination with nivolumab is generally well-tolerated with no new safety signals observed
- AXL-positive NSCLC
- Phase 1/2 Dose-Escalation Trial of CAB-CTLA-4 (BA3071) Across Multiple Solid Tumor Types responsive to CTLA-4
- Trial ongoing with two of three cohorts completed without any DLTs or SAEs reported
Expected Timing for Key 2023 Milestones
- 1H23
- Phase 2 study of mecbotamab vedotin (BA3011, NCT03425279) in patients with AXL-positive NSCLC
- Initiating preparations for discussions with the FDA regarding the potentially registrational part 2 of the study in AXL-positive NSCLC patients.
- Submission of Phase 2 part 1 interim data for presentation at ASCO
- First patient dosed in Phase 2 part 2 study in AXL-positive UPS patients
- Interim data in the Phase 2 part 1 ROR-2 positive NSCLC study
- CAB-EpCAM x CAB-CD3 TCE (BA3182) Phase 1 study initiation
- Phase 2 study of mecbotamab vedotin (BA3011, NCT03425279) in patients with AXL-positive NSCLC
- 2H23
- Phase 2 part 2 of the BA3011 study in NSCLC patients anticipated initiation
- Interim data in the Phase 2 part 1 ROR-2 positive melanoma study
- Interim data in the Phase 2 part 1 ROR-2 positive SCCHN study
- Phase 1 data and Phase 2 initiation in CAB-CTLA-4 (BA3071) study