BioAtla Presents Ozuriftamab Vedotin Clinical Data Targeting ROR2 In HPV+ Head & Neck Cancer at IPVS Conference 2025

BioAtla, Inc. (NASDAQ:BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced presentation of a poster entitled "Targeting HPV E6/E7 Upregulation of the Transmembrane Receptor Tyrosine Kinase ROR2 with the ADC Ozuriftamab Vedotin in Patients with Advanced HPV+ Oropharyngeal Squamous Cell Carcinoma" which details clinical data from its investigational antibody-drug conjugate (ADC), ozuriftamab vedotin (Oz-V), at the International Papillomavirus Society (IPVS) Conference, taking place October 23–26, 2025, in Bangkok, Thailand.

The poster will provide a deeper molecular review of Oz-V, CAB-ROR2-ADC, a more detailed mechanistic discussion regarding the relationship between ROR2 expression and HPV infection and will highlight clinical data previously presented at medical congresses. The poster will be presented on October 25th during E-Poster 02 Session taking place from 6:30 to 8:00 p.m. ICT.

About Ozuriftamab Vedotin

Ozuriftamab vedotin (Oz-V), CAB-Platform-ROR2-ADC, is a conditionally and reversibly active antibody drug conjugate directed against ROR2, a transmembrane receptor tyrosine kinase that is present across many different solid tumors including head and neck, lung, triple-negative breast cancer and melanoma. Overexpression of ROR2, a noncanonical wnt5A signaling receptor, is driven by oncoproteins associated with HPV infection and forms a cancer axis that is associated with poor prognosis and resistance to chemo- and immunotherapies. In refractory, median 4th line patients Oz-V demonstrated compelling clinical data in HPV+ OPSCC in a Phase 2 trial with an overall response rate (ORR) of 45% (confirmed and unconfirmed), disease control rate (DCR) of 100%, and a median overall survival (OS) of 11.6 months. Other studies using either cetuximab, docetaxel, or methotrexate monotherapy have reported an ORR of 0 - 3.4% and a median OS of 4.4 months in a similar patient population. OPSCC represents a sizable and rapidly growing patient population that is poorly served by EGFR inhibitors and other standard of care regimens. The FDA granted Fast Track Designation to Oz-V for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who have previously experienced progression on PD-1/L1 therapies and platinum chemotherapy. Following an end of Phase 2 (Type B) meeting in September, there is alignment with FDA on Phase 3 trial design, and the Company continues preparations for enabling initiation of the Phase 3 study with the goal of advancing the study with a strategic partner in early 2026.

About OPSCC

OPSCC is a subset of SCCHN arising from the squamous cells that line the oropharynx, the middle part of the throat. This anatomic region is located behind the oral cavity and OPSCC typically involves the tonsils, soft palate, pharyngeal walls, and/or the base of the tongue. A striking year-to-year increase in OPSCC is due to the rapidly increasing incidence of HPV infections which currently represents approximately 80% of OPSCC in the United States. HPV associated expression of E6 and/or E7 oncoproteins drives cancer progression by upregulating ROR2 expression, which is expressed at high rates in OPSCC. This direct mechanistic link combined with the antitumor activity observed to date, provides a compelling rationale to evaluate Oz-V in a pivotal study in OPSCC patients. The worldwide market opportunity for 2nd line plus OPSCC is over $1 billion and for 1st line HPV+ tumors is potentially over $7 billion. The prognosis is currently poor for patients with recurrent/metastatic OPSCC who have previously received standard treatments including surgery, radiation, platinum-based chemotherapy, and PD-1 inhibitor therapy.