ozuriftamab vedotin (BA3021) / BioAtla - LARVOL DELTA

Phase 2 trial of ozuriftamab vedotin (BA3021), a conditionally binding ROR2-ADC, in patients with heavily pretreated squamous cell carcinoma of the head and neck. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT03504488 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • P2 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ROR2

BioAtla Announces Upcoming Poster Presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - "BioAtla...announced a poster presentation at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting....Title: Phase 2 trial of ozuriftamab vedotin (BA3021), a conditionally binding ROR2-ADC, in patients with heavily pretreated squamous cell carcinoma of the head and neck; Abstract Number: 6048."

P2 data • Squamous Cell Carcinoma of Head and Neck

Preclinical development of ozuriftamab vedotin (BA3021), a novel ROR2-specific conditionally active biologic antibody-drug conjugate. (PubMed, MAbs) - "In non-human primates, BA3021 was well tolerated at doses of up to 10 mg/kg and showed excellent stability in vivo. These preclinical results indicate that CAB anti-ROR2 ADC is efficacious and well tolerated and may be a promising treatment for cancer patients with ROR2-expressing tumors."

Journal • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Gastrointestinal Stromal Tumor • Genito-urinary Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Osteosarcoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Renal Cell Carcinoma • Sarcoma • Solid Tumor • ROR2

Phase 2 Trial of ozuriftamab vedotin (Oz-V), CAB-ROR2-ADC (NCT05271604) in treatment-refractory SCCHN (median of 3 prior lines of treatment) (GlobeNewswire) - P2 | N=290 | NCT05271604 | Sponsor: BioAtla, Inc. | "Oz-V monotherapy continues to deliver responses among patients with 2L+ SCCHN at the 1.8 mg/kg Q2W dosing regimen; ORR, DOR, PFS, and OS data capture ongoing. Updated data presented at the Mayo Multidisciplinary Head and Neck Cancer Symposium on March 27, 2025....Differentiated anti-tumor activity observed particularly in treatment-refractory and metastatic HPV-positive SCCHN, which is poorly served by EGFR inhibitors (n=11). 45% ORR (confirmed and unconfirmed); 27% confirmed so far with a DOR >5.3 months with multiple patients remaining on treatment. 100% disease control. The one patient who achieved a CR continues in complete remission, now at greater than 16 months ongoing. Oz-V continues to be well-tolerated, consistent with previous reports."

P2 data • Squamous Cell Carcinoma of Head and Neck

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

BA3021-001: CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2) (clinicaltrials.gov) - P1/2 | N=132 | Completed | Sponsor: BioAtla, Inc. | Active, not recruiting ➔ Completed | N=420 ➔ 132

Enrollment change • Trial completion • Breast Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

BA3021-001: CAB-ROR2-ADC Safety and Efficacy Study in Patients with TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2) (clinicaltrials.gov) - P1/2 | N=420 | Active, not recruiting | Sponsor: BioAtla, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Dec 2024 | Trial primary completion date: Dec 2025 ➔ Dec 2024

Combination therapy • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

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

BA3021-002: A Phase 2 Open Label Study of BA3021 in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov) - P2 | N=290 | Recruiting | Sponsor: BioAtla, Inc. | N=80 ➔ 290 | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Phase II trial of ozuriftamab vedotin (BA3021), a conditionally active biologic (CAB)-ROR2-ADC, in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) (ESMO 2024) - P2 | "Treatment with BA3021 yielded promising antitumor activity with a manageable tolerability profile in heavily pretreated pts (median 3 prior regimens) with R/M SCCHN. Further evaluation of BA3021 in earlier-stage pts is planned."

Clinical • Metastases • P2 data • Head and Neck Cancer • Melanoma • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ROR2

BioAtla Presented Phase 2 Ozuriftamab Vedotin Clinical Trial Data Demonstrating Meaningful Antitumor Activity with Manageable Tolerability among Heavily Pretreated Patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting (GlobeNewswire) - P2 | N=80 | NCT05271604 | Sponsor: BioAtla, Inc. | "An ongoing complete response (CR) with an overall response rate (ORR) of 32% achieved across two dosing regimens; Underscores ozuriftamab vedotin’s activity in a high unmet need SCCHN patient population; The conditionally binding ADC targeting ROR2 was notably well tolerated; The Company intends to meet with the FDA to discuss a SCCHN potential registrational trial in 2H 2024."

New trial • P2 data • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

868P - Phase II trial of ozuriftamab vedotin (BA3021), a conditionally active biologic (CAB)-ROR2-ADC, in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) (ESMO 2024) - P2 | N=80 | NCT05271604 | Sponsor: BioAtla, Inc. | "As of March 13, 2024, 31 pts with a median of 3 prior lines of therapy received BA3021 either Q2W (n=12) or 2Q3W (n=19) for a median of 58 days. Overall, among 25 pts evaluable for efficacy, 8 responders (32%; 1 CR and 7 PR; confirmed and unconfirmed) were reported, and 10 pts had SD. In the Q2W cohort (12 evaluable pts), 1 CR, 2 PR, and 4 SD were reported. In the 2Q3W cohort (13 evaluable pts), 5 PR and 6 SD were reported. The most frequent TEAEs were fatigue (55%), nausea (29%), anemia (26%), decreased appetite (26%), and diarrhea (26%). Nineteen pts had grade 3‒4 TEAEs; the most frequent (10% each) were anemia, hyponatremia, and hypoxia. Related grade 3 peripheral neuropathy led to study drug discontinuation in 1 pt. As of the data cut, 11 pts remained on BA3021 (2 in Q2W and 9 in 2Q3W)."

P2 data • Squamous Cell Carcinoma of Head and Neck

BioAtla Announces Upcoming Poster Presentation at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting (GlobeNewswire) - "BioAtla, Inc...announced a poster presentation at the upcoming 2024 European Society for Medical Oncology (ESMO) Annual Meeting to be held in Barcelona, Spain from September 13–17, 2024."

P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

BioAtla Granted FDA Fast Track Designation for Ozuriftamab Vedotin (CAB-ROR2-ADC) for Treatment of Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (GlobeNewswire) - "BioAtla, Inc...today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ozuriftamab vedotin, the Company’s conditionally and reversibly active ROR2 antibody drug conjugate directed for the treatment of patients with recurrent or metastatic SCCHN with disease progression on or after platinum-based chemotherapy and anti-PD-1/L1 antibody therapy....'To date, ozuriftamab vedotin has shown promising clinical activity in treatment-refractory SCCHN patients who had a median of 3 prior lines of therapy. In addition, ozuriftamab vedotin continues to have a manageable safety profile with no new safety signals. We look forward to discussing with the FDA plans for a potential registrational trial in the second half of this year.'"

Fast track • New trial • 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 primary completion date: Jun 2024 ➔ Dec 2024

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

BioAtla Reports First Quarter 2024 Financial Results and Highlights Recent Progress (GlobeNewswire) - P2 | N=80 | NCT05271604 | Sponsor: BioAtla, Inc. | "Phase 2 Trials of ozuriftamab vedotin, CAB-ROR2-ADC in treatment-refractory SCCHN....To date, a total of 11 responses at the combined 2Q3W and Q2W dose regimens (5 confirmed, including 1 complete response); Among the 5 confirmed and 6 unconfirmed responders, the median number of prior treatments was 2 and 3, respectively, indicating that less heavily pretreated responders were generally more likely to receive confirmational scans; Disease Control Rate (DCR) is 86%; Anticipate FDA meeting in 2H 2024 for potential registrational trial in SCCHN."

FDA event • P2 data • Squamous Cell Carcinoma of Head and Neck

BioAtla Reports First Quarter 2024 Financial Results and Highlights Recent Progress (GlobeNewswire) - P1/2 | N=420 | NCT03504488 | Sponsor: BioAtla, Inc. | "Melanoma patients (n=29) dosed at the 1.8 mg/kg Q2W regimen (1 received 3 mg/kg Q3W in phase 1); 27 evaluable patients (median 2 prior lines of treatment); To date, a total of 5 responses (2 confirmed, including 1 complete response); DCR is 67%; Ozuriftamab vedotin continues to have a manageable safety profile with no new safety signals observed."

P1/2 data • Melanoma

BioAtla Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Progress (GlobeNewswire) - "Phase 2 Trials of Ozuriftamab Vedotin, CAB-ROR2-ADC, (BA3021) in treatment-refractory melanoma (NCT03504488) and treatment-refractory SCCHN (NCT05271604): (i) Melanoma patients (n=28) dosed at the Q2W regimen; anticipate two plus scans in April; (ii) SCCHN patients dosed at Q2W or 2Q3W regimens (n=12 and 20, respectively); anticipate two plus scans in May; (iii) Data readouts for both indications anticipated in May."

P1/2 data • P2 data • Trial status • Melanoma • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

BioAtla Reports Third Quarter 2023 Financial Results and Highlights Recent Progress (GlobeNewswire) - "Phase 2 Trials of Ozuriftamab Vedotin, BA3021: All dosing to be completed before year-end 2023...Squamous Cell Carcinoma of Head and Neck (SCCHN): On track to complete all dosing regimens enrollment by year-end 2023....Phase 1/2 dose-escalation trial of CAB-CTLA-4, BA3071 basket trial: Phase 1 data readout and path forward at upcoming R&D Day on December 13....Phase 1/2 dose-escalation for CAB-EpCAM x CAB-CD3 TCE, BA3182: Progressing Phase 1 study for the treatment of advanced adenocarcinoma; Anticipated completion of Phase 1 and data readout remains on track in 2024."

P1 data • Trial completion date • Trial status • Cervical Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatocellular Cancer • Kidney Cancer • Liver Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Phase 2 Open Label Study of BA3021 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: BioAtla, Inc. | N=40 ➔ 80 | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Enrollment change • IO biomarker • Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Phase 1/2 Dose Escalation and Dose Expansion Study of Ozuriftamab Vedotin (BA3021) Alone and in Combination with Nivolumab (IASLC-WCLC 2023) - "Introduction: Ozuriftamab vedotin (BA3021) is a conditionally active biologic (CAB) anti-receptor tyrosine kinase orphan receptor 2 (ROR2) humanized monoclonal antibody (IgG1) conjugated to monomethyl auristatin E (MMAE) using a cleavable linker (CAB ROR2 ADC). NSCLC patients must have experienced failure, defined as disease progression or discontinuation due to an adverse event, of a PD-1/L-1, epidermal growth factor receptor (EGFR) inhibitor, or anaplastic lymphoma kinase (ALK) inhibitor (either monotherapy or in combination with another therapy such as ipilimumab). Enrollment completion is anticipated in 2023."

Combination therapy • P1/2 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • PD-1 • ROR2

CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2) (clinicaltrials.gov) - P1/2 | N=420 | Recruiting | Sponsor: BioAtla, Inc. | Trial completion date: Jun 2023 ➔ Dec 2025 | Trial primary completion date: Mar 2023 ➔ Dec 2025

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

CRI-CCTG-0003/IND.240: An immunotherapy platform study in platinum-resistant high grade serous ovarian cancer (IPROC). (ASCO 2023) - P2 | "Sub study A is evaluating the combination of durvalumab and BA3011, a conditionally active anti-AXL humanized monoclonal antibody (IgG1) conjugated to monomethyl auristatin E (MMAE) in AXL overexpressing HGSC. Sub study B is evaluating durvalumab plus BA3021, a CAB anti-receptor tyrosine kinase orphan receptor 2 (ROR2) humanized monoclonal antibody (IgG1) conjugated to MMAE in ROR2 overexpressing HGSC. Further sub studies are planned (NCT04918186). Clinical trial information: NCT04918186."

IO biomarker • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • AXL • ROR2

A phase 2 open-label study of conditionally active biologic ozuriftamab vedotin (BA3021) in failed PD-1/L1 treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck. (ASCO 2023) - P2 | "Short, J.M. Nature Biotechnology 2014 Nov 8, 13(20). Clinical trial information: NCT05271604."

Clinical • IO biomarker • Metastases • P2 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ROR2