Bicara Therapeutics to Present Updated Data from Ongoing Phase 1/1b Trial of Ficerafusp alfa in 1L R/M HNSCC at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

BOSTON, April 23, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (NASDAQ:BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced that updated data from the company's ongoing Phase 1/1b clinical trial of ficerafusp alfa in 1L (first line) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) will be highlighted in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held from May 30-June 3, 2025 in Chicago, IL. Ficerafusp alfa is a first-in-class bifunctional antibody that combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β) and is being evaluated across multiple solid tumor types.

"We're honored to have been selected for an oral presentation at ASCO, which we believe reflects the strong interest from the clinical community in our updated survival and durability data," said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. "We believe these data continue to build confidence in the potential of ficerafusp alfa to provide meaningful, durable clinical benefit to HPV-negative recurrent/metastatic head and neck squamous cell carcinoma patients, who typically have a worse prognosis and poorer outcomes as compared to those with HPV-positive disease."

Details of the oral presentation are as follows:

Title: Ficerafusp alfa with pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma: Updated results from an expansion cohort of an open-label, multicenter, phase 1/1b trial

• Abstract #: 6017
• Session Title: Rapid Oral Abstract Session
• Session Category: Rapid Oral Abstract Session
• Session Date and Time: 6/1/2025 12:12 - 12:18 p.m. CT
• Location: McCormick Place Convention Center
  
  
  
  

Following the meeting, the presentation will be available on Bicara's website at www.bicara.com.

About Ficerafusp Alfa

Ficerafusp alfa is a first-in-class bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-b signaling within the tumor microenvironment.

Ficerafusp alfa is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial 1L (first line) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

About Bicara Therapeutics

Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara's lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn or X.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Bicara's clinical development of ficerafusp alfa in combination with pembrolizumab and presentation of updated results from an expansion cohort of an open-label, multicenter, phase 1/1b trial of ficerafusp alfa with pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma, and the expected therapeutic potential and clinical benefits of ficerafusp alfa, including potential efficacy and tolerability. The words "may," "might," "will," "could," "would," "should," "plan," "anticipate," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target" and similar words or expressions, or the negative thereof, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks and uncertainties that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to uncertainties inherent in the development of product candidates, including the conduct of research activities and the conduct and enrollment of clinical trials; uncertainties as to the availability and timing of results and data from clinical trials; whether results from prior preclinical studies and clinical trials will be predictive of the results of subsequent preclinical studies and clinical trials and regulatory developments in the United States and foreign countries, whether Bicara's cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and uncertainties identified in Bicara's filings with the Securities and Exchange Commission (SEC), including in Bicara's most recent Annual Report on Form 10-K, as well as any subsequent filings that Bicara makes with the SEC. In addition, forward-looking statements represent Bicara's views only as of today and should not be relied upon as representing its views as of any subsequent date. Bicara explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

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