BioAtla Announces Regulatory Update on Clinical Development Plan for Ozuriftamab Vedotin in Oropharyngeal Squamous Cell Carcinoma (OPSCC) Following Productive Type B (End of Phase 2) Meeting with FDA
BioAtla (NASDAQ:BCAB) has received FDA alignment on the Phase 3 trial design for ozuriftamab vedotin (Oz-V) in treating Oropharyngeal Squamous Cell Carcinoma (OPSCC). The trial will involve approximately 300 patients randomized between Oz-V and investigator's choice of standard treatments.
The company's Phase 2 trial demonstrated promising results with an overall response rate of 45% and median overall survival of 11.6 months, significantly outperforming current treatments which show only 0-3.4% response rates and 4.4 months median survival. The Phase 3 study design includes potential for accelerated approval based on response rate improvements, with full approval contingent on overall survival benefits.
BioAtla plans to initiate the Phase 3 study with a strategic partner in early 2026 and maintains guidance for completing a strategic partnership for one of its advanced clinical assets this year.
BioAtla (NASDAQ:BCAB) ha ottenuto l'allineamento della FDA sul disegno dello studio di Fase 3 per ozuriftamab vedotin (Oz‑V) nel trattamento del carcinoma squamoso dell'orofaringe (OPSCC). Lo studio coinvolgerà circa 300 pazienti randomizzati tra Oz‑V e la scelta dell'investigatore tra i trattamenti standard.
La Fase 2 dell'azienda ha mostrato risultati promettenti con un tasso di risposta globale del 45% e una sopravvivenza globale mediana di 11,6 mesi, nettamente superiori ai trattamenti attuali che riportano solo 0–3,4% di risposta e 4,4 mesi di sopravvivenza mediana. Il disegno della Fase 3 prevede la possibilità di approvazione accelerata basata sul miglioramento del tasso di risposta, mentre l'approvazione completa dipenderà dai benefici sulla sopravvivenza globale.
BioAtla prevede di avviare lo studio di Fase 3 con un partner strategico all'inizio del 2026 e conferma la previsione di completare quest'anno una partnership strategica per uno dei suoi asset clinici avanzati.
BioAtla (NASDAQ:BCAB) ha obtenido el alineamiento de la FDA sobre el diseño del ensayo de Fase 3 para ozuriftamab vedotina (Oz‑V) en el tratamiento del carcinoma escamoso orofaríngeo (OPSCC). El ensayo incluirá a aproximadamente 300 pacientes aleatorizados entre Oz‑V y la opción de tratamiento estándar a elección del investigador.
El ensayo de Fase 2 de la compañía mostró resultados prometedores con una tasa de respuesta global del 45% y una supervivencia global mediana de 11,6 meses, superando ampliamente a los tratamientos actuales, que presentan solo un 0–3,4% de respuesta y 4,4 meses de supervivencia mediana. El diseño de Fase 3 contempla la posibilidad de aprobación acelerada basada en la mejora de la tasa de respuesta, mientras que la aprobación completa dependerá de beneficios en la supervivencia global.
BioAtla planea iniciar el estudio de Fase 3 con un socio estratégico a principios de 2026 y mantiene la guía de completar este año una asociación estratégica para uno de sus activos clínicos avanzados.
BioAtla (NASDAQ:BCAB)는 구강인두 편평세포암(OPSSC) 치료를 위한 오주리프타맙 베도틴(Oz‑V)의 임상 3상 설계에 대해 FDA와 일치된 의견을 받았습니다. 해당 시험은 약 300명의 환자를 Oz‑V군과 연구자 선택 표준치료군으로 무작위 배정하여 진행됩니다.
회사의 2상에서 총반응률 45%와 중위 전체생존기간 11.6개월이라는 유망한 결과를 보였으며, 이는 현재 치료법의 0–3.4% 반응률과 4.4개월 중위 생존기간을 크게 상회합니다. 3상 설계는 반응률 개선을 근거로 한 가속 승인 가능성을 포함하며, 완전 승인 여부는 전체생존 개선에 달려 있습니다.
BioAtla는 2026년 초 전략적 파트너와 함께 3상 연구를 개시할 계획이며, 올해 자사의 선도 임상 자산 중 하나에 대한 전략적 파트너십 체결을 완료하겠다는 가이던스를 유지하고 있습니다.
BioAtla (NASDAQ:BCAB) a obtenu l'alignement de la FDA sur le plan de l'essai de Phase 3 pour ozuriftamab vedotina (Oz‑V) dans le traitement du carcinome épidermoïde de l'oropharynx (OPSCC). L'étude impliquera environ 300 patients randomisés entre Oz‑V et le traitement standard choisi par l'investigateur.
La Phase 2 de la société a montré des résultats prometteurs avec un taux de réponse global de 45% et une survie globale médiane de 11,6 mois, surpassant nettement les traitements actuels, qui n'obtiennent que 0–3,4% de réponses et 4,4 mois de survie médiane. Le design de la Phase 3 prévoit la possibilité d'une autorisation accélérée basée sur l'amélioration du taux de réponse, tandis que l'autorisation complète dépendra des bénéfices sur la survie globale.
BioAtla prévoit de lancer l'étude de Phase 3 avec un partenaire stratégique début 2026 et maintient sa guidance de conclure cette année un partenariat stratégique pour l'un de ses actifs cliniques avancés.
BioAtla (NASDAQ:BCAB) hat die FDA‑Zustimmung bzw. Übereinstimmung zum Phase‑3‑Prüfungsdesign für ozuriftamab vedotin (Oz‑V) zur Behandlung von Oropharynx‑Plattenepithelkarzinom (OPSCC) erhalten. Die Studie wird etwa 300 Patienten umfassen, die randomisiert zwischen Oz‑V und der vom Prüfarzt gewählten Standardtherapie zugeteilt werden.
Die Phase‑2‑Studie des Unternehmens zeigte vielversprechende Ergebnisse mit einer Gesamtansprechrate von 45% und einem medianen Gesamtüberleben von 11,6 Monaten, deutlich besser als die derzeitigen Behandlungen mit nur 0–3,4% Ansprechrate und 4,4 Monaten medianem Überleben. Das Phase‑3‑Design sieht die Möglichkeit einer beschleunigten Zulassung bei Verbesserung der Ansprechrate vor; eine vollständige Zulassung hängt von Vorteilen beim Gesamtüberleben ab.
BioAtla plant, die Phase‑3‑Studie Anfang 2026 mit einem strategischen Partner zu starten und bestätigt die Erwartung, in diesem Jahr eine strategische Partnerschaft für einen seiner fortgeschrittenen klinischen Wirkstoffkandidaten abzuschließen.
- Phase 2 trial showed strong efficacy with 45% overall response rate vs 0-3.4% for standard treatments
- FDA alignment obtained for Phase 3 trial design with potential accelerated approval pathway
- Median overall survival of 11.6 months vs 4.4 months for current treatments
- Strategic partnership expected to be completed this year
- Phase 3 trial requires large patient enrollment of approximately 300 subjects
- Study initiation dependent on securing strategic partnership
Insights
BioAtla secures FDA alignment on Phase 3 design for Oz-V in HPV+ throat cancer with potential accelerated approval pathway.
This regulatory update represents a significant milestone for BioAtla's lead antibody-drug conjugate (ADC) program. The FDA has aligned with the company on the pivotal Phase 3 trial design for ozuriftamab vedotin (Oz-V) in oropharyngeal squamous cell carcinoma (OPSCC), including crucial elements like dosing regimen and endpoints that could support accelerated approval.
The clinical rationale for advancing Oz-V is compelling. In Phase 2, the drug demonstrated a
The Phase 3 design includes ~300 patients randomized 1:1 between Oz-V (1.8 mg/kg every other week) and investigator's choice of monotherapy. For accelerated approval, Oz-V must show statistically significant improvement in confirmed objective response rate by independent review with adequate duration of response without overall survival detriment. Full approval requires statistically significant overall survival benefit.
BioAtla's Conditionally Active Biologic (CAB) platform is particularly relevant for this indication. Oz-V targets ROR2, which is overexpressed in HPV-driven cancers and associated with poor prognosis and treatment resistance. The conditional activation mechanism potentially offers improved safety and efficacy over traditional ADCs.
This regulatory clarity enhances BioAtla's strategic partnering position, as the company aims to advance the Phase 3 study with a partner while maintaining guidance for completing a strategic partnership for one of their advanced clinical assets this year.
- FDA alignment on Phase 3 ozuriftamab vedotin (Oz-V) trial design, including dosing regimen and endpoints to support potential accelerated approval
- Company continues preparations for enabling initiation of the Phase 3 study with the goal of advancing the study with a strategic partner early next year
- Company maintains previous guidance for completion of a strategic partnership with one of our advanced clinical assets this year
SAN DIEGO, Sept. 08, 2025 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics using its proprietary CAB platform for the treatment of solid tumors, today announced outcomes from its Type B meeting with the United States Food and Drug Administration (FDA).
Ozuriftamab vedotin (Oz-V), CAB-ROR2-ADC, is a conditionally and reversibly active antibody drug conjugate directed against ROR2 which is expressed across many different solid tumors including head and neck cancer. Overexpression of ROR2 is driven by E6 / E7 oncoproteins associated with human papillomavirus (HPV) infection and is associated with poor prognosis and resistance to chemo- and immunotherapies. OPSCC is recognized as a distinct anatomical entity within head and neck cancers with up to
As previously reported, Oz-V has demonstrated compelling clinical data in HPV+ OPSCC in a Phase 2 trial with an overall response rate (ORR) of
Key Outcomes from the FDA Type B Meeting
Pivotal Trial Design: For full approval, approximately 300 OPSCC patients prospectively randomized and stratified, one to one between two open label treatment arms.
Oz-V Dose and Regimen: Patients randomized to the investigational arm will receive 1.8 mg/kg every other week.
Investigator’s Choice (IC) control arm: Patients randomized to the control arm will receive either cetuximab, docetaxel, or methotrexate monotherapy.
Accelerated Approval Endpoint: Based on interim analysis of enrolled patients, statistically significant improvement of confirmed ORR by Blinded Independent Central Review (BICR) supported by an adequately characterized Duration of Response (DOR) without detriment in OS.
Full Approval Endpoint: Statistically significant improvement of OS.
“The actionable regulatory alignment represents an important milestone for BioAtla as it enables initiation of the first Phase 3 study of a CAB ADC in an indication that represents a sizable and steadily growing population that is poorly served by current standard of care agents, including EGFR inhibitors,” said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc. “Having a clear registrational path with the potential for accelerated approval is very positive for our near-term strategic partnering objectives and enabling initiation of the Oz-V Phase 3 study with a partner. This underscores the potential of the CAB platform technology, which includes clinical readouts on our dual CAB EpCAM T-cell engager (BA3182) later this year.”
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. 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.
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
About CAB-EpCAM x CAB-CD3 Bispecific T-cell Engager Antibody
BioAtla is developing BA3182 as a potential anticancer therapy for patients with advanced adenocarcinoma. BA3182 is a (CAB) EpCAM x (CAB) CD3 bispecific T cell engager antibody that contains two binding sites for EpCAM and two binding sites for CD3ε. The binding sites for EpCAM and CD3ε have been designed to bind their respective targets specifically and reversibly under the conditions found in the TME and to have reduced binding outside of the TME. The CAB selective binding to both the CAB EpCAM and CAB CD3ε arms are required to activate the T cell engagement against the tumor, thus
enabling the combined selectivity of each CAB binding arm in the bispecific antibody. BioAtla continues to advance the ongoing Phase 1 study to evaluate the safety, pharmacokinetics, and efficacy of BA3182 in advanced adenocarcinoma patients.
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 plans and expectations regarding future data updates. 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; 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; 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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