Bicara reports positive Phase 1/1b trial results for cancer therapy

BOSTON - Bicara Therapeutics Inc. (NASDAQ:BCAX), a clinical-stage biotech company with a market capitalization of $631 million currently trading near its 52-week low of $11.61, has shared promising results from a recent clinical trial involving a new cancer treatment. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet, providing runway for its development programs. The company presented data from the Phase 1/1b dose expansion cohort of ficerafusp alfa combined with pembrolizumab in patients with squamous cancer of the anal canal (SCAC). The findings were revealed at the 2025 ASCO Gastrointestinal Cancers Symposium on Saturday.

Ficerafusp alfa is a novel bifunctional antibody targeting epidermal growth factor receptor (EGFR) and human transforming growth factor beta (TGF-β). The trial evaluated its combination with pembrolizumab, an immune checkpoint inhibitor, in 28 patients with SCAC who were immune checkpoint inhibitor-naive and had advanced or metastatic disease after 1-2 prior chemotherapy lines.

The trial reported a confirmed overall response rate of 25.0%, including six partial responses and one complete response. Additionally, one patient is pending a confirmed partial response. The median progression-free survival was 2.9 months, with a 12-month progression-free survival rate of 40.7% among 27 evaluable patients.

The safety profile was tolerable, with the most common treatment-related adverse events being acneiform dermatitis, epistaxis, and pruritus. Notably, responses were observed in patients with liver metastases, a significant outcome for this patient group. The company's robust current ratio of 36.01 and minimal debt exposure support its ability to advance clinical development programs.

David Raben, MD, Chief Medical (TASE:PMCN) Officer of Bicara Therapeutics, expressed optimism about the preliminary data, noting the enhanced efficacy of the combination therapy in SCAC. He emphasized the potential for improved outcomes compared to pembrolizumab monotherapy, based on the increased overall response rate, disease control rate, and progression-free survival.

Van K. Morris, MD, from The University of Texas MD Anderson Cancer Center, also highlighted the importance of further investigation to assess the potential of this combination therapy in improving patient outcomes.

SCAC is commonly associated with HPV infection and is the most prevalent type of anal canal cancer in the United States. The current standard treatment is chemoradiation for localized disease at diagnosis.

Bicara Therapeutics is focused on developing bifunctional therapies for solid tumors and is actively pursuing further development of ficerafusp alfa in various solid tumor types, including first-line recurrent/metastatic head and neck squamous cell carcinoma.

The information reported is based on a press release statement from Bicara Therapeutics. While analysts maintain optimistic price targets ranging from $36 to $47, InvestingPro subscribers have access to additional insights, including 8 more ProTips and detailed financial metrics that could help evaluate the company's investment potential. Discover comprehensive analysis tools and real-time updates to make informed investment decisions.

In other recent news, Bicara Therapeutics has been under the spotlight following a series of positive assessments from investment firms. H.C. Wainwright analyst Robert Burns raised the price target on Bicara Therapeutics to $45 from $42, maintaining a buy rating. The revision was triggered by Bicara's presentation of clinical trial data at the ASCO GI conference. Bicara showcased Phase 1/1b results assessing the combination of ficerafusp alfa and Keytruda in patients with EGFR+ squamous cell carcinoma of the anal canal, revealing a 28.6% objective response rate.

In addition, Bicara has received a buy rating from H.C. Wainwright, emphasizing the potential of ficerafusp alfa, a bispecific antibody that targets both EGFR and TGF-β. Other firms such as Cantor Fitzgerald, TD Cowen, Morgan Stanley (NYSE:MS), and Stifel have initiated coverage with positive ratings, citing the potential of ficerafusp alfa as a treatment for head and neck squamous cell carcinoma. Cantor Fitzgerald projected that ficerafusp alfa could generate over $1 billion in peak sales.

These are among the recent developments that underline the growing recognition of Bicara's potential within the investment community. All these assessments are based on the potential of Bicara's leading drug candidate, ficerafusp alfa, and its capacity to impact the market positively, especially for patients with specific types of cancer that express EGFR.

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