BioAtla Presents Compelling Mechanistic Rationale for Targeting ROR2 with Ozuriftamab Vedotin (Oz-V) in Oropharyngeal Squamous Cell Carcinoma (OPSCC) at the Annual Conference of the International Papillomavirus Society
SAN DIEGO, Oct. 23, 2025 (GLOBE NEWSWIRE) -- 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.
A copy of the presentation materials can be accessed on the “Publication” section of the Company’s website at www.bioatla.com once the presentation has concluded.
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.
About BioAtla®, Inc.
BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through its contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary CAB platform technology, BioAtla develops novel, reversibly active monoclonal and bispecific antibodies and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB platform technology and products with greater than 780 active patent matters, more than 500 of which are issued patents. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. To learn more about BioAtla, Inc., visit www.bioatla.com.
Forward-looking Statements
Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "expect," "believe," "will," "may," "should," "estimate," "project," "outlook," "forecast" or other similar words. Examples of forward-looking statements include, among others, statements we make regarding BioAtla’s business plans and prospects, whether our clinical trials will support registration, the potential regulatory approval path for Oz-V, the expected timing to initiate a phase 3 study; the ability of Oz-V to progress to a phase 3 study and receive accelerated or full approval, the potential for Oz-V to address the OPSCC population, the timing of and the ability to establish collaborations or other strategic partnerships, and the expected market opportunity for Oz-V. Forward-looking statements are based on BioAtla's current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: factors that raise substantial doubt about our ability to continue as a going concern and that we will need additional funding to continue development of our CAB technology platform and our CAB product candidates; the risk that preliminary or interim clinical results may not be indicative of results from later cohorts or larger populations; potential delays in clinical and preclinical trials; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, or regulatory approval dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; whether regulatory authorities will be satisfied with the design of and results from the clinical studies or take favorable regulatory actions based on results from the clinical studies; our dependence on the success of our CAB technology platform; our ability to enroll patients in our ongoing and future clinical trials; the successful selection and prioritization of assets to focus development on selected product candidates and indications; our ability to form collaborations and partnerships with third parties and the success of such collaborations and partnerships; our reliance on third parties for the manufacture and supply of our product candidates for clinical trials; our reliance on third parties to conduct our clinical trials and some aspects of our research and preclinical testing; the accuracy of our estimates regarding addressable patient populations and market opportunity; potential adverse impacts due to geopolitical or macroeconomic events outside of our control, including health epidemics or pandemics; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 27, 2025, our Quarterly Reports on Form 10-Q filed with the SEC on May 6, 2025 and August 7, 2025 and our other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and BioAtla undertakes no duty to update such information except as required under applicable laws.
Internal Contact:
Richard Waldron
Chief Financial Officer
BioAtla, Inc.
rwaldron@bioatla.com
858.356.8945
External Contact:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
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