Granted FDA Breakthrough Therapy Designation for ficerafusp alfa in combination with pembrolizumab in 1L HPV-negative R/M HNSCC Data from a Phase 1b expansion cohort evaluating 750mg of ficerafusp alfa weekly in combination with pembrolizumab in 1L HPV-negative R/M HNSCC patients expected at ESMO Asia 2025 Strong financial position with approximately $408 million in cash, cash equivalents, and investments as of September 30, 2025 BOSTON, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: B ...

Core Insights - The U.S. FDA has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) expressing PD-L1 with CPS ≥1, specifically for HPV-negative cases [1][2][3] Company Overview - Bicara Therapeutics is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for solid tumors, with ficerafusp alfa as its lead program [10] - Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by targeting both epidermal growth factor receptor (EGFR) and human transforming growth factor beta (TGF-β) [8][10] Clinical Trial Insights - The BTD was supported by results from multiple Phase 1/1b dose cohorts, showing a median duration of response of 21.7 months and a median overall survival of 21.3 months, alongside a favorable safety profile [3] - The ongoing pivotal trial, FORTIFI-HN01, aims to enroll approximately 650 patients with R/M HNSCC, focusing on overall response rate and overall survival as primary endpoints [5][9] Industry Context - HPV-negative HNSCC is recognized as a distinct clinical indication with poor outcomes and limited treatment options, representing a significant unmet need in oncology [2][7] - HNSCC is one of the most common cancers globally, with an anticipated rise to one million new cases annually by 2030, and approximately 80% of R/M HNSCC cases are HPV-negative [6][7]

Group 1 - Bicara Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for patients with solid tumors [2] - The company's lead program, ficerafusp alfa, is a first-in-class bifunctional antibody that targets the tumor microenvironment to enhance treatment efficacy [2] - Ficerafusp alfa combines an EGFR-directed monoclonal antibody with a domain that binds to TGF-β, aiming to reverse the fibrotic and immune-excluded tumor microenvironment [2] Group 2 - Bicara Therapeutics will participate in multiple investor conferences, including the Cantor Global Healthcare Conference and the Wells Fargo Healthcare Conference [3] - The live webcasts of the investor presentations will be available on the company's Investor Relations website [1][3] - Replays of the webcasts will be archived for access after each event [1]

Core Insights - Bicara Therapeutics Inc. has presented updated data from its Phase 1/1b trial at the 2025 ASCO Annual Meeting, showing significant anti-tumor responses in patients with HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [1][2] - The company maintains a strong financial position with approximately $437 million in cash and cash equivalents, expected to fund operations into the first half of 2029 [1][11] Clinical Development - Ficerafusp alfa, a first-in-class bifunctional antibody, is being developed to enhance tumor penetration by addressing barriers in the tumor microenvironment [3][8] - The ongoing pivotal Phase 2/3 FORTIFI-HN01 trial is evaluating ficerafusp alfa in combination with pembrolizumab for first-line treatment in recurrent/metastatic HNSCC [4][8] - Updated Phase 1/1b trial data indicates a median duration of response of 21.7 months and a median overall survival of 21.3 months in the HPV-negative population [5] Efficacy Data - In the efficacy evaluable HPV-negative population (n=28), the confirmed objective response rate (ORR) was 54%, with a complete response rate of 21% [5] - The disease control rate was reported at 89%, and 80% of responders achieved a deep response (≥80% tumor shrinkage) [5] Financial Performance - For the second quarter of 2025, research and development expenses increased to $24.8 million from $15.8 million in the same quarter of 2024, primarily due to costs associated with the FORTIFI-HN01 trial [11] - General and administrative expenses rose to $7.2 million from $3.9 million year-over-year, reflecting increased personnel costs and professional fees [11] - The net loss for the second quarter of 2025 was $27.4 million, compared to $17.0 million in the same quarter of 2024 [11]

Core Insights - Bicara Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for patients with solid tumors [3] - The company will participate in the Goldman Sachs 46th Annual Global Healthcare Conference on June 10, 2025 [1] Company Overview - Bicara Therapeutics is dedicated to creating transformative bifunctional therapies, with its lead program being ficerafusp alfa, a first-in-class bifunctional antibody [3] - Ficerafusp alfa targets the tumor microenvironment by combining an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β) [3] - The therapy aims to reverse the fibrotic and immune-excluded tumor microenvironment, facilitating deeper tumor penetration and promoting durable responses [3] - Ficerafusp alfa is currently being developed for head and neck squamous cell carcinoma and other solid tumor types, addressing significant unmet medical needs [3]

Core Insights - Bicara Therapeutics presented updated data from its Phase 1/1b clinical trial of ficerafusp alfa combined with pembrolizumab for treating first-line recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), showing promising efficacy and overall survival rates [1][2][4] Efficacy Data - The median duration of response (DOR) was reported at 21.7 months, with 80% of responders achieving a deep response defined as ≥80% tumor shrinkage [1][4] - The median overall survival (OS) was 21.3 months, with a 2-year OS rate of 46% in HPV-negative patients [2][4] - The objective response rate (ORR) was 54% (15 out of 28 patients), with a complete response rate of 21% (6 out of 28 patients) [4] Clinical Significance - The results indicate a significant improvement over historical controls for HPV-negative recurrent/metastatic HNSCC, addressing a critical unmet need in this patient population [3][4] - The combination therapy demonstrated a median progression-free survival of 9.9 months and a disease control rate of 89% [4] Mechanism of Action - Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by targeting both the epidermal growth factor receptor (EGFR) and human transforming growth factor beta (TGF-β), which helps remodel the tumor microenvironment [8][10] Company Overview - Bicara Therapeutics is a clinical-stage biopharmaceutical company focused on developing transformative bifunctional therapies for solid tumors, with ficerafusp alfa being its lead program [10]

Core Insights - Bicara Therapeutics is advancing its clinical programs, particularly the pivotal Phase 2/3 trial of ficerafusp alfa in HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [2][4] - The company has a strong financial position with approximately $462 million in cash and cash equivalents, expected to fund operations into the first half of 2029 [1][11] - Updated data from ongoing clinical trials will be presented at the 2025 ASCO Annual Meeting, showcasing the potential of ficerafusp alfa to demonstrate differentiated depth and durability of response [2][7] Clinical Development - Enrollment is ongoing in the FORTIFI-HN01 trial, which is a global, randomized, double-blind, placebo-controlled study of ficerafusp alfa in combination with pembrolizumab for first-line treatment of R/M HNSCC [4] - The ongoing Phase 1/1b trial is expected to provide insights into the drug's efficacy and mechanisms of action, with preliminary findings indicating effective TGF-β signaling blockade [11][6] - Several expansion cohorts are evaluating different dosing regimens of ficerafusp alfa in combination with pembrolizumab for various patient populations, including those with HPV-negative and HPV-positive cancers [7][6] Financial Performance - For the first quarter of 2025, research and development expenses increased to $34.3 million from $12.0 million in the same period of 2024, primarily due to costs associated with the initiation of clinical trials [11][9] - General and administrative expenses rose to $7.5 million in Q1 2025 from $3.3 million in Q1 2024, reflecting increased personnel costs and professional fees [11][9] - The net loss for the first quarter of 2025 was $36.8 million, compared to a net loss of $12.5 million in the first quarter of 2024 [11][9]

Core Viewpoint - Bicara Therapeutics Inc. is advancing its lead product, ficerafusp alfa, a bifunctional antibody targeting EGFR and TGF-β, showing promising results in treating solid tumors, particularly in head and neck squamous cell carcinoma and cutaneous squamous cell carcinoma [1][2][9] Company Overview - Bicara Therapeutics is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for solid tumors, with ficerafusp alfa as its lead program [9] - The company aims to address significant unmet needs in cancer treatment, particularly in patients with advanced or metastatic diseases [4][9] Product Development - Ficerafusp alfa is a first-in-class bifunctional antibody that combines an EGFR-directed monoclonal antibody with a TGF-β binding domain, potentially enhancing anti-tumor activity by targeting both cancer cell survival and immunosuppressive signaling [7][9] - The drug is currently being evaluated in pivotal Phase 2/3 clinical trials for first-line recurrent/metastatic head and neck squamous cell carcinoma [8] Clinical Data Highlights - Recent presentations at the AACR Annual Meeting 2025 showcased data supporting ficerafusp alfa's ability to block TGF-β signaling, which may prevent resistance mechanisms in HPV-negative recurrent/metastatic head and neck squamous cell carcinoma [2][3] - In a Phase 1/1b trial for second-line metastatic cutaneous squamous cell carcinoma, ficerafusp alfa demonstrated an overall response rate of 30.4% and a clinical benefit rate of 82.6%, with a median progression-free survival of 7.0 months [3][4] - The drug also showed potential in reversing acquired resistance to KRAS G12C inhibitors in KRAS G12C-mutant lung cancer, indicating its broad therapeutic potential [5][11] Market Context - Cutaneous squamous cell carcinoma is the second most common skin cancer, with rising incidence highlighting the need for effective treatment options, especially for patients who progress on anti-PD-1 therapies [4][6] - The lack of approved second-line therapies for patients with advanced or metastatic cutaneous squamous cell carcinoma underscores the importance of ficerafusp alfa's development [4][6]

Core Insights - Bicara Therapeutics has initiated dosing in the pivotal Phase 2/3 trial, FORTIFI-HN01, for ficerafusp alfa in first-line recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [1][4] - The company reported a strong financial position with approximately $490 million in cash and cash equivalents, expected to fund operations into the first half of 2029 [1][12] - The year 2024 was significant for Bicara, marked by its transition to a public company and advancements in its lead asset, ficerafusp alfa [2] Pipeline Highlights - Ficerafusp alfa is a first-in-class bifunctional antibody targeting both epidermal growth factor receptor (EGFR) and transforming growth factor beta (TGF-β) for various solid tumors [3][10] - The ongoing Phase 1/1b trial data will be presented at the 2025 ASCO Annual Meeting, showcasing the potential of ficerafusp alfa in HNSCC [5] Clinical Trials - The FORTIFI-HN01 trial is a global, randomized, double-blind, placebo-controlled study combining ficerafusp alfa with pembrolizumab in first-line R/M HNSCC, excluding HPV-positive oropharyngeal cases [4] - Additional expansion cohorts for ficerafusp alfa are planned in various cancer types, including cutaneous squamous cell carcinoma and colorectal cancer [8] Financial Results - For the fourth quarter of 2024, research and development expenses were $19.9 million, up from $10.6 million in the same period of 2023, primarily due to costs associated with the FORTIFI-HN01 trial [12] - General and administrative expenses increased to $6.8 million for Q4 2024, compared to $3.1 million in Q4 2023, reflecting costs related to operating as a public company [12] - The net loss for the fourth quarter of 2024 was $21.0 million, compared to $12.4 million in Q4 2023 [12][15] Cash Position - As of December 31, 2024, Bicara had cash and cash equivalents of $489.7 million, significantly up from $230.4 million at the end of 2023 [12][17] - The company expects its cash resources to sustain operations through the first half of 2029, supporting ongoing clinical trials and development efforts [12][13]