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

Rhea-AI Summary

BioAtla (Nasdaq: BCAB) has received FDA Fast Track Designation for ozuriftamab vedotin (CAB-ROR2-ADC) to treat recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). This conditionally active antibody drug conjugate has shown promising clinical activity and a manageable safety profile in treatment-refractory SCCHN patients during its Phase 2 trial. The company plans to meet with the FDA in the second half of 2024 to discuss a potential registrational trial. Fast Track Designation could expedite development and review, potentially leading to priority review if supported by clinical data at BLA submission.

Positive

• FDA granted Fast Track Designation for ozuriftamab vedotin
• Promising clinical activity in treatment-refractory SCCHN patients
• Manageable safety profile with no new safety signals
• Potential for expedited development and review process
• Possibility of priority review if supported by clinical data

Negative

• None.

Insights

Medical Research Analyst

The FDA's Fast Track Designation for ozuriftamab vedotin is a significant step forward for BioAtla, particularly in the realm of oncology. This designation highlights the potential efficacy of the drug in treating a highly challenging and life-threatening condition, squamous cell carcinoma of the head and neck (SCCHN). The fact that the drug has demonstrated promising clinical activity in patients who have already undergone multiple lines of treatment underscores its potential impact on the market. Furthermore, a manageable safety profile is crucial, as it suggests a lower barrier to patient compliance and fewer potential roadblocks during later stages of clinical trials.

This designation also opens the door for expedited development and review, which can accelerate the pathway to market. Given the competitive landscape in oncology, this is a notable advantage and may position BioAtla ahead of competitors if the Phase 2 trial results are replicated in subsequent studies.

Financial Analyst

From a financial perspective, the FDA Fast Track Designation for ozuriftamab vedotin is very promising for BioAtla. This development can potentially lead to increased investor confidence and result in a positive shift in stock prices. Fast Track Designation often serves as an indicator of a drug's potential to address unmet medical needs, reducing the risks associated with late-stage clinical trials.

Moreover, the ability to interact more frequently with the FDA can streamline the approval process, potentially leading to faster commercialization and revenue generation. This could positively impact the company's financial projections and create a compelling narrative for both existing and potential investors. However, it's essential to note that while this designation is promising, it does not guarantee approval and the company must still navigate subsequent clinical trial stages successfully.

Oncology Doctor

The FDA Fast Track Designation for ozuriftamab vedotin is a noteworthy development in the treatment landscape for SCCHN. This type of cancer is notoriously difficult to treat, particularly in patients who have not responded well to existing therapies such as platinum-based chemotherapy and anti-PD-1/L1 antibody therapy. The promising clinical activity observed in Phase 2 trials suggests that ozuriftamab vedotin could become a vital option for these patients.

Additionally, the manageable safety profile of the drug is particularly encouraging. In oncology, the balance between efficacy and safety is critical and a treatment that offers both can significantly improve patient outcomes. The Fast Track Designation also means more frequent FDA interactions, which can result in more refined clinical trial designs, ultimately benefiting patient care and potentially leading to faster access to new therapies.

Ozuriftamab vedotin, the Company’s conditionally and reversibly active antibody drug conjugate directed against ROR2, has shown promising clinical activity with a manageable safety profile in treatment-refractory patients with squamous cell carcinoma of the head and neck (SCCHN) in its Phase 2 clinical trial

The Company is on track to meet with the FDA for guidance on a potentially registrational trial in 2H 2024

SAN DIEGO, July 23, 2024 (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 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.

“The FDA’s decision is an important recognition of the potential of our CAB-ROR2-ADC, ozuriftamab vedotin. There remains a significant unmet need in refractory head and neck cancer where previous treatments have failed and current outcomes are suboptimal with low response rates,” said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc. “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 Designation applies to a drug that is intended to treat a serious or life-threatening disease or condition and where the drug has demonstrated the potential to address unmet medical need. It could lead to actions to expedite development and review of the drug, including opportunities for frequent interactions with the FDA review team and potential priority review if supported by the clinical data at the time of a BLA submission.

About Ozuriftamab Vedotin
Ozuriftamab vedotin, CAB-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, TNBC and melanoma. Overexpression of ROR2, a noncanonical wnt5A signaling receptor, forms a cancer axis that is associated with poor prognosis and resistance to chemo- and immunotherapies. This Phase 2 stage clinical asset is targeting multiple solid tumor indications, including the treatment of SCCHN patients who have previously progressed on PD-1/L1 therapies with or without platinum chemotherapy,

About BioAtla^®, Inc. 
BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through our contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary Conditionally Active Biologics (CAB) 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 technology and products with greater than 750 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. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing, mecbotamab vedotin, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). The Phase 2 stage CAB-CTLA-4 antibody is a novel CTLA-4 inhibitor designed to reduce systemic toxicity and potentially enable safer combination therapies with checkpoint inhibitors such as anti-PD-1 antibody. The company’s first bispecific T-cell engager antibody, BA3182, is currently in Phase 1 development. BA3182 targets EpCAM, which is highly and frequently expressed on many adenocarcinomas while engaging human CD3 expressing T cells. BioAtla recently received FDA IND clearance on its next-gen CAB-Nectin4-ADC, BA3361, the Company’s first glycoconjugate. 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 the timing of our research and development programs and clinical trials. 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: potential delays in clinical and pre-clinical 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 any resurgence of COVID-19 and its variants; 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 (SEC) on March 26, 2024, in our Quarterly Report on Form 10-Q filed with the SEC on May 14, 2024 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 law.

Internal Contact: 
Richard Waldron 
Chief Financial Officer 
BioAtla, Inc. 
rwaldron@bioatla.com
858.356.8945 

External Contact: 
Bruce Mackle
LifeSci Advisors, LLC 
bmackle@lifesciadvisors.com

FAQ

What is the FDA Fast Track Designation granted to BioAtla (BCAB) for?

The FDA granted Fast Track Designation to BioAtla (BCAB) for ozuriftamab vedotin (CAB-ROR2-ADC) for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who have disease progression after platinum-based chemotherapy and anti-PD-1/L1 antibody therapy.

What are the potential benefits of Fast Track Designation for BioAtla (BCAB)?

Fast Track Designation could lead to expedited development and review of ozuriftamab vedotin, including opportunities for frequent interactions with the FDA review team and potential priority review if supported by clinical data at the time of BLA submission.

When does BioAtla (BCAB) plan to meet with the FDA to discuss a potential registrational trial?

BioAtla (BCAB) plans to meet with the FDA in the second half of 2024 to discuss guidance for a potential registrational trial for ozuriftamab vedotin in SCCHN patients.

What results has ozuriftamab vedotin shown in clinical trials for BCAB?

Ozuriftamab vedotin has shown promising clinical activity and a manageable safety profile in treatment-refractory SCCHN patients who had a median of 3 prior lines of therapy during its Phase 2 clinical trial.