mecbotamab vedotin (BA3011) / BioAtla - LARVOL DELTA

BioAtla’s Mecbotamab Vedotin (Mec-V), an AXL-targeting ADC, Demonstrates a Median Overall Survival (OS) of 21.5 months in Subtypes of Refractory Soft Tissue Sarcomas (GlobeNewswire) - "Patients (n=44) with leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma were heavily pretreated, having received a median of 2 prior lines of therapy (range 0–10). Mec-V was administered every two weeks either as monotherapy (n=33) or in combination with anti–PD-1 antibody (n=11); data reflect a March 25, 2025 cutoff. Median overall survival was 21.5 months across all patients, with 22.9 months observed in the combination arm and 18.4 months in the monotherapy arm. In addition, the 12-month OS rate was 73%, compared to approximately 50% historically reported for approved agents in similar populations."

P2 data • Leiomyosarcoma • Liposarcoma • Undifferentiated Pleomorphic Sarcoma

Median OS of 21.5 months among 44 patients with treatment-refractory leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma treated with mecbotamab vedotin, an AXL-targeting ADC. (SITC 2025) - "Background Despite advances in therapy, sarcomas remain a significant unmet need.1 2 Median OS among patients with treatment-refractory soft tissue sarcomas (STS) treated with either trabectedin, pazopanib, or eribulin has been reported to range from 12.5 to 13.6 months.3 4 AXL, a cell-surface receptor tyrosine kinase, is highly expressed in several STS subtypes and has been shown to drive increased metastasis, resistance to chemotherapy, and poor outcomes.5 Mecbotamab vedotin (Mec-V, BA3011, Conditionally Active Biologic CAB-AXL-ADC) is designed to reduce off-tumor toxicity and improve pharmacokinetics by conditionally binding to AXL under low-pH conditions (pH<6.7) of the tumor microenvironment.6 7Methods A phase 2 open-label study evaluated Mec-V among adult and adolescent patients with AXL-expressing locally advanced, unresectable, or metastatic STS with measurable disease by RECIST v1.1. The manageable safety profile remained consistent with previous reports...."

Clinical • Leiomyosarcoma • Liposarcoma • Oncology • Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma • AXL

CRI-CCTG-0003/IND.240: Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Canadian Cancer Trials Group | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Platinum resistant • Trial completion date • Trial primary completion date • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

BioAtla to Present Clinical Data for Mecbotamab Vedotin (BA3011) in Soft Tissue Sarcoma at SITC 2025 (GlobeNewswire) - "The presentation...will be delivered by Dr. Mihaela Druta of Moffitt Cancer Center on Friday, November 7, 2025. The abstract (#523) will be featured in the poster session, with presentation time to be announced."

Clinical data • Leiomyosarcoma • Liposarcoma • Undifferentiated Pleomorphic Sarcoma

BA3011-002: CAB-AXL-ADC Safety and Efficacy Study in Adults With NSCLC (clinicaltrials.gov) - P2 | N=85 | Completed | Sponsor: BioAtla, Inc. | Active, not recruiting ➔ Completed | N=240 ➔ 85

Enrollment change • Trial completion • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BA3011-001: CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma (clinicaltrials.gov) - P1/2 | N=245 | Completed | Sponsor: BioAtla, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Jun 2025 ➔ Jan 2025

Trial completion • Trial completion date • Oncology • Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma

BA3011-001: CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma (clinicaltrials.gov) - P1/2 | N=300 | Active, not recruiting | Sponsor: BioAtla, Inc. | Trial completion date: Jan 2025 ➔ Jun 2025

Trial completion date • Oncology • Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma

Preclinical development of mecbotamab vedotin (BA3011), a novel, AXL-specific conditional active biologic antibody-drug conjugate. (PubMed, Antib Ther) - "Furthermore, in nonhuman primates, mecbotamab vedotin demonstrated excellent tolerability at doses of up to 5 mg/kg and maintained linker-payload stability in vivo. These findings indicate that mecbotamab vedotin has the potential to be a robust and less toxic therapeutic agent, offering promise as a treatment for patients with AXL-positive cancers."

Journal • Preclinical • Hematological Disorders • Hematological Malignancies • Oncology • AXL

Phase 2 trial of mecbotamab vedotin (Mec-V), CAB-AXL-ADC (NCT04681131) in mKRAS NSCLC (median of 3 prior lines of treatment) (GlobeNewswire) - "Two-year landmark survival of 59% in mKRAS non-small cell lung cancer (NSCLC); Previous studies have reported 2-year landmark survival less than 20% among patients treated with standard of care agents; Continuing to observe a high correlation of AXL and mKRAS expression; Currently positioning asset for a future pivotal trial with Phase 2 clinical data readout in 1H26"

New P2 trial • Trial status • Non Small Cell Lung Cancer

BioAtla Reports First Quarter 2025 Financial Results and Highlights Recent Progress (GlobeNewswire) - "Research and development (R&D) expenses were $12.4 million for the quarter ended March 31, 2025 compared to $18.9 million for the same quarter in 2024. The decrease of $6.5 million was primarily due to lower clinical development expenses in 2025 for our Phase 2 trials for mecbotamab vedotin, ozuriftamab vedotin and evalstotug as we complete trials for certain indications."

Commercial • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

Exploratory analysis showed increased overall survival among non-small cell lung cancer (NSCLC) patients with mutated KRAS compared with wildtype KRAS in a phase II trial of mecbotamab vedotin (CAB-AXL-ADC) (ELCC 2025) - P2 | "Eligible pts whose NSCLC tumors expressed AXL were treated on days 1 and 8 of a 3-week cycle or every other week with 1.8 mg/kg Mec-V±nivolumab...Patients received a median of 3 prior lines of therapy, including 1 pt with a partial response who was previously treated with Sotorasib (G12C inhibitor)... Overall survival was meaningfully improved for Mec-V treated pts whose NSCLC expressed mKRAS compared to those with wtKRAS. Anti-tumor activity was seen across 9 unique mKRAS variants, indicating pan-mKRAS activity. Pts with mKRAS NSCLC may benefit from the conditionally active AXL-targeting ADC, potentially due to the elimination of cells expressing the tumor resistant AXL receptor."

Clinical • P2 data • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • AXL • KRAS

Phase 2 trial of mecbotamab vedotin (Mec-V), CAB-AXL-ADC (NCT04681131) in NSCLC (median of 3 prior lines of treatment) (GlobeNewswire) - P2 | N=240 | NCT04681131 | Sponsor: BioAtla, Inc. | "Promising anti-tumor activity among 17 patients whose tumors express mKRAS mutations with multiple confirmed responses at the 1.8 mg/kg Q2W dosing regimen. Data presented at the European Lung Cancer Congress on March 27, 2025....Q2W dosing regimen associated with exceptional OS and encouraging clinical benefit / risk profile: 66% of patients alive at a landmark of one year; 58% of patients alive at landmark of two years; Median OS not reached at 35 months from first dose, ongoing. Responses and preliminary clinical benefit demonstrated across nine different mKRAS variants: PR observed in a patient who had experienced prior failure of sotorasib; Patient treated with mec-V + anti-PD-1 antibody remains in CR for >2 years."

P2 data • Non Small Cell Lung Cancer

BioAtla Announces Two Poster Presentations at Upcoming Medical Meetings (GlobeNewswire) - "BioAtla...announced two abstracts accepted for poster presentations at the upcoming European Lung Cancer Congress (ELCC) 2025 Scientific Committee and Mayo Clinic Multidisciplinary Head and Neck Cancer Symposium 2025, to be held in Paris, France from March 26–29, 2025 and in Scottsdale, AZ from March 27–29, 2025, respectively....Venue: ELCC 2025; Title: Exploratory Analysis of Overall Survival among Non-Small Cell Lung Cancer (NSCLC) Patients with Mutated KRAS in a Phase 2 Trial of Mecbotamab Vedotin (CAB-AXL-ADC)....Venue: Mayo Clinic Multidisciplinary Head and Neck Cancer Symposium 2025; Title: Ozuriftamab Vedotin (BA3021), a Conditionally Binding ROR2-ADC; Phase 2 experience in Patients with Heavily Pretreated Squamous Cell Carcinoma of the Head and Neck."

P2 data • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

CRI-CCTG-0003/IND.240: Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Canadian Cancer Trials Group | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

BA3011-001: CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients with Sarcoma (clinicaltrials.gov) - P1/2 | N=300 | Active, not recruiting | Sponsor: BioAtla, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma

BioAtla, Inc. Announces Registered Direct Offering to Advance Two Mid-Stage Clinical Programs to Key Inflection Points (GlobeNewswire) - "The gross proceeds to the Company from the offering are expected to be approximately $9.2 million, before deducting expenses related to the offering payable by the Company. The Company intends to use the net proceeds to be received by it in the offering, along with its existing cash and cash equivalents, to fund its research and development efforts, including to reach several key inflection points for its mid-stage clinical T-Cell Engager (TCE) and Antibody Drug Conjugate (ADC) programs: BA3182 (CAB-EpCAM x CAB-CD3 TCE) Phase 1 dose escalation data (expected readout 2Q25) and Phase 2 expansion data (expected readout 1H26); and mecbotamab vedotin (CAB-AXL-ADC) Phase 2B data in mutated KRAS (mKRAS) non-small cell lung cancer (NSCLC) (expected readout 1H26), to support its partnering activities, and for working capital and other general corporate purposes."

Clinical data • Financing • Non Small Cell Lung Cancer • Solid Tumor

BioAtla Presented Data Characterizing Mutated KRAS Genotype and Clinical Outcomes in Patients with Advanced NSCLC Treated with Mecbotamab Vedotin (Mec-V), a CAB-AXL-ADC, at the IASLC 2024 Hot Topic in Basic & Translational Science Meeting (GlobeNewswire) - P2 | N=240 | NCT04681131 | Sponsor: BioAtla, Inc. | "'Based on these findings and previous discussions with the FDA, a randomized trial of Mec-V in patients with treatment-refractory mKRAS NSCLC is planned for initiation in 2025.'...Phase 2 trial of Mec-V, CAB-AXL-ADC (NCT04681131) in NSCLC: 78 patients were enrolled and received either Mec-V monotherapy (n=59) or Mec-V + nivolumab (n=19)...Overall survival analyses: Landmark OS at one year: 58% for patients with mKRAS NSCLC vs. 23% for patients with wtKRAS NSCLC; Median OS was not yet reached (6.5-Not Estimable) for patients with mKRAS NSCLC vs. 8.7 (5.8–10.2) months for patients with wtKRAS NSCLC...Among 21 efficacy-evaluable patients with mKRAS NSCLC: 6 responses (ORR=28.6%; including 1 patient previously treated with sotorasib)....Among 27 NSCLC samples harboring any KRAS mutation, AXL was highly expressed (tumor membrane expression of AXL ≥ 1% of tumor cells): 19 of 27 (70.3%)..."

New trial • P2 data • Non Small Cell Lung Cancer

BioAtla Announces Upcoming Poster Presentation at the IASLC 2024 Hot Topic in Basic & Translational Science Meeting (GlobeNewswire) - "Presentation Details: (i) Title: Characterization of Mutated KRAS Genotype and Clinical Outcomes in Patients With Advanced NSCLC Treated With Mecbotamab Vedotin, a CAB-AXL-ADC...; (ii) Poster Number: PP01.03...; (iii) Session Date and Time: Saturday, December 14, 2024 from 5:40 P.M. - 6:40 P.M. ET."

Clinical data • Non Small Cell Lung Cancer

BA3011-002: CAB-AXL-ADC Safety and Efficacy Study in Adults with NSCLC (clinicaltrials.gov) - P2 | N=240 | Active, not recruiting | Sponsor: BioAtla, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

CRI-CCTG-0003/IND240 AN IMMUNOTHERAPY PLATFORM STUDY (IPROC) IN PLATINUM-RESISTANT HIGH GRADE SEROUS OVARIAN CANCER (PLTNR-HGSC): SUBSTUDIES A/B: DURVALUMAB + BA3011 OR BA3021.(NCT04918186) (IGCS 2024) - P2 | "Pts screened/AXL+/ROR2+ were 62/19/41. 20 pts, 10/sub-study, were treated. Sub-study A: Best response was SD (N=7/10pts) median duration and range (MD/R) 3.6 mo/2.4 – 3.7."

High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • AXL • ROR2

BioAtla Highlighted Clinical Program and Pipeline Updates at Virtual R&D Day (GlobeNewswire) - P2 | N=240 | NCT04681131 | Sponsor: BioAtla, Inc. | "AXL expression ≥1% correlated with clinical benefit in heavily pretreated patients with a median three prior lines of therapy...​Initial clinical benefit with multiple confirmed responses among patients with tumors expressing mutated KRAS: Responses across multiple KRAS mutation variants to date including G12A, G12C, and G12V; Findings support overall survival benefit trend among patients expressing the KRAS mutation compared to KRAS wildtype; mKRAS variant highly correlated with AXL expression. Manageable safety continues, no new safety signals identified."

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

CRI-CCTG-0003/IND.240: Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Canadian Cancer Trials Group | Trial primary completion date: Jun 2024 ➔ Dec 2024

Trial primary completion date • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor

Antibody-Drug Conjugates in the Pipeline for Treatment of Melanoma: Target and Pharmacokinetic Considerations. (PubMed, Drugs R D) - "So far, the antibody-drug conjugates have struggled from efficacy problems, with modest effects at best, leading many to be discontinued for melanoma. At the same time, conjugates such as AMT-253, targeting melanoma cell adhesion molecule, and mecbotamab vedotin  targeting AXL receptor tyrosine kinase, are among the most exciting for melanoma treatment in the future."

Journal • PK/PD data • Review • Genetic Disorders • Melanoma • Oncology • Skin Cancer • Solid Tumor • AXL • MCAM

BioAtla Reports First Quarter 2024 Financial Results and Highlights Recent Progress (GlobeNewswire) - "Phase 2 Trials of mecbotamab vedotin, CAB-AXL-ADC: NSCLC: Dosed 33 target-agnostic patients at the 1.8 mg/kg 2Q3W regimen across squamous and non-squamous patients; Study remains on track to evaluate initial clinical benefit in the target-agnostic, non-squamous, EGFR wild-type patient population in 2Q 2024."

Trial status • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology

BioAtla Reports First Quarter 2024 Financial Results and Highlights Recent Progress (GlobeNewswire) - "Phase 2 Trials of mecbotamab vedotin, CAB-AXL-ADC: UPS...ongoing potentially registrational trial: Completed enrollment of initial 20 patients at 1.8 mg/kg 2Q3W regimen with encouraging compliance and manageable safety; Anticipate meeting with the FDA for guidance on the remaining portion of the potentially registrational trial in 2H 2024."

Enrollment status • FDA event • Oncology • Undifferentiated Pleomorphic Sarcoma