Latest news with #BicaraTherapeutics
Associated Press
01-06-2025
- Business
- Associated Press
Bicara Therapeutics Demonstrates Deep and Durable Responses with Ficerafusp Alfa Plus Pembrolizumab in 1L HPV-Negative R/M HNSCC at ASCO 2025
Median DOR of 21.7 months with 80% of responders achieving a deep response (≥80% tumor shrinkage) Depth and durability translating to prolonged OS with median OS of 21.3 months and 2-year OS of 46% in HPV-negative HNSCC Conference call and webcast today at 3:00 p.m. CT / 4:00 p.m. ET BOSTON, June 01, 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 presented updated data from the company's Phase 1/1b clinical trial of ficerafusp alfa in combination with pembrolizumab in patients with first line (1L) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa 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). 'Ficerafusp alfa was specifically designed to impact the tumor stroma and drive tumor penetration with the goal of leading to deeper and more durable responses. We've now begun to see this translate clinically, with responses lasting nearly two years and contributing to prolonged overall survival in HPV-negative patients, a population that typically faces poor outcomes due to resistance to available therapies,' said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. 'The strength of the totality of this updated dataset, including 80% of responders achieving a deep response of at least 80% tumor shrinkage, median duration of response of 21.7 months, median progression free survival of 9.9 months, overall survival of 21.3 months, and a 2-year overall survival rate of 46%, provides compelling support for the continued advancement of FORTIFI-HN01, our pivotal Phase 2/3 trial in the first-line recurrent/metastatic setting.' Key highlights from the presentation include: 'These latest Phase 1/1b data are impressive, particularly the duration of response, which represents a significant advance over historical controls in patients with HPV-negative recurrent/metastatic head and neck squamous cell carcinoma, including anti-PD-1 combinations with chemotherapy or EGFR inhibitors,' said Christine H. Chung, MD, Chair of the Department of Head and Neck-Endocrine Oncology and Deputy Physician-in-Chief at the Moffitt Cancer Center. 'This reflects the enhanced ability of ficerafusp alfa to remodel the tumor microenvironment allowing the tumor penetration of immune cells required for deep and durable responses in these patients. In addition, the prolonged overall survival, highlighted by a median OS of 21.3 months, reinforces the potential of ficerafusp alfa to address a critical unmet need by delivering durable anti-tumor responses and meaningful improvements in patients' quality of life.' Conference Call and Webcast Information Bicara Therapeutics will host a conference call and webcast today, June 1, 2025 at 3:00 p.m. CT / 4:00 p.m. ET. Individuals may register for the conference call by clicking the link here. Once registered, participants will receive dial-in details and a unique PIN which will allow them to access the call. An audio webcast will be accessible through the Investor Relations section of Bicara's website under Events and Presentations. Following the live webcast, an archived replay will also be available. About Head and Neck Squamous Cell Carcinoma Head and neck squamous cell carcinomas (HNSCCs) develop from the mucosal epithelium in the oral cavity, pharynx and larynx and are the most common malignancies that arise in the head and neck. HNSCC is one of the most common cancers in the United States and globally with a rising incidence anticipated to reach one million new global cases annually by 2030. Ten percent of HNSCC patients are diagnosed with metastatic disease and up to 30% develop a recurrence or metastases over time after receiving initial treatment for advanced HNSCC. Most cases of HNSCC are thought to result from accumulated mutations caused by carcinogenic exposures such as tobacco smoke or HPV infection. Approximately 80% of patients with R/M HNSCC are HPV-negative. These HPV-negative tumors often exhibit a recurrence pattern that is primarily local and are associated with severe morbidities, including fatal tumor bleeding, intense pain, difficulty swallowing, significant weight loss, and cachexia. This highlights a critical unmet need for therapies that have the potential to deliver durable anti-tumor responses, ultimately leading to meaningful improvements in patients' quality of life. About Ficerafusp Alfa Ficerafusp alfa is a first-in-class bifunctional antibody designed to drive tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa 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 targeted mechanism, ficerafusp alfa reverses the fibrotic and immune-excluded tumor microenvironment driven by TGF-β signaling to enable tumor penetration that drives deep and durable responses. Ficerafusp alfa is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial in patients with first line (1L) 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 first-in-class bifunctional antibody designed to drive tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa 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 targeted mechanism, ficerafusp alfa reverses the fibrotic and immune-excluded tumor microenvironment driven by TGF-β signaling to enable tumor penetration that drives deep and durable responses. 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 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 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 ability, profile and clinical benefits of ficerafusp alfa, including potential and anticipated efficacy, depth, durability, tolerability, and success, and the potential clinical results from the Phase 2/3 pivotal trial of ficerafusp alfa. 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. Contacts Investors Rachel Frank [email protected] Media Amanda Lazaro 1AB [email protected]
Yahoo
01-06-2025
- Business
- Yahoo
Bicara Therapeutics Demonstrates Deep and Durable Responses with Ficerafusp Alfa Plus Pembrolizumab in 1L HPV-Negative R/M HNSCC at ASCO 2025
Median DOR of 21.7 months with 80% of responders achieving a deep response (≥80% tumor shrinkage) Depth and durability translating to prolonged OS with median OS of 21.3 months and 2-year OS of 46% in HPV-negative HNSCC Conference call and webcast today at 3:00 p.m. CT / 4:00 p.m. ET BOSTON, June 01, 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 presented updated data from the company's Phase 1/1b clinical trial of ficerafusp alfa in combination with pembrolizumab in patients with first line (1L) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa 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). 'Ficerafusp alfa was specifically designed to impact the tumor stroma and drive tumor penetration with the goal of leading to deeper and more durable responses. We've now begun to see this translate clinically, with responses lasting nearly two years and contributing to prolonged overall survival in HPV-negative patients, a population that typically faces poor outcomes due to resistance to available therapies,' said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. 'The strength of the totality of this updated dataset, including 80% of responders achieving a deep response of at least 80% tumor shrinkage, median duration of response of 21.7 months, median progression free survival of 9.9 months, overall survival of 21.3 months, and a 2-year overall survival rate of 46%, provides compelling support for the continued advancement of FORTIFI-HN01, our pivotal Phase 2/3 trial in the first-line recurrent/metastatic setting.' Key highlights from the presentation include: In the Phase 1/1b trial, ficerafusp alfa in combination with pembrolizumab resulted in deep and durable anti-tumor activity with improved overall survival (OS) compared to historical benchmarks in patients with 1L R/M human papillomavirus (HPV)-negative HNSCC with a PD-L1 combined positive score (CPS) of ≥1 and with at least 24 months of follow-up. In the efficacy evaluable human papillomavirus (HPV)-negative population (n=28): Median duration of response (DOR) of 21.7 months amongst responders (n=15). Median OS of 21.3 months; 2-year OS rate of 46%. 54% (15/28) confirmed objective response rate (ORR); 64% (18/28) ORR, including an additional three unconfirmed responses. 21% (6/28) complete response rate. 80% (12/15) of responders achieved a deep response (≥80% tumor shrinkage). Disease control rate of 89% (25/28 patients). Median progression-free survival of 9.9 months. Manageable safety profile consistent with previously reported adverse events. 'These latest Phase 1/1b data are impressive, particularly the duration of response, which represents a significant advance over historical controls in patients with HPV-negative recurrent/metastatic head and neck squamous cell carcinoma, including anti-PD-1 combinations with chemotherapy or EGFR inhibitors,' said Christine H. Chung, MD, Chair of the Department of Head and Neck-Endocrine Oncology and Deputy Physician-in-Chief at the Moffitt Cancer Center. 'This reflects the enhanced ability of ficerafusp alfa to remodel the tumor microenvironment allowing the tumor penetration of immune cells required for deep and durable responses in these patients. In addition, the prolonged overall survival, highlighted by a median OS of 21.3 months, reinforces the potential of ficerafusp alfa to address a critical unmet need by delivering durable anti-tumor responses and meaningful improvements in patients' quality of life.' Conference Call and Webcast InformationBicara Therapeutics will host a conference call and webcast today, June 1, 2025 at 3:00 p.m. CT / 4:00 p.m. ET. Individuals may register for the conference call by clicking the link here. Once registered, participants will receive dial-in details and a unique PIN which will allow them to access the call. An audio webcast will be accessible through the Investor Relations section of Bicara's website under Events and Presentations. Following the live webcast, an archived replay will also be available. About Head and Neck Squamous Cell CarcinomaHead and neck squamous cell carcinomas (HNSCCs) develop from the mucosal epithelium in the oral cavity, pharynx and larynx and are the most common malignancies that arise in the head and neck. HNSCC is one of the most common cancers in the United States and globally with a rising incidence anticipated to reach one million new global cases annually by 2030. Ten percent of HNSCC patients are diagnosed with metastatic disease and up to 30% develop a recurrence or metastases over time after receiving initial treatment for advanced HNSCC. Most cases of HNSCC are thought to result from accumulated mutations caused by carcinogenic exposures such as tobacco smoke or HPV infection. Approximately 80% of patients with R/M HNSCC are HPV-negative. These HPV-negative tumors often exhibit a recurrence pattern that is primarily local and are associated with severe morbidities, including fatal tumor bleeding, intense pain, difficulty swallowing, significant weight loss, and cachexia. This highlights a critical unmet need for therapies that have the potential to deliver durable anti-tumor responses, ultimately leading to meaningful improvements in patients' quality of life. About Ficerafusp AlfaFicerafusp alfa is a first-in-class bifunctional antibody designed to drive tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa 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 targeted mechanism, ficerafusp alfa reverses the fibrotic and immune-excluded tumor microenvironment driven by TGF-β signaling to enable tumor penetration that drives deep and durable responses. Ficerafusp alfa is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial in patients with first line (1L) 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 first-in-class bifunctional antibody designed to drive tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa 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 targeted mechanism, ficerafusp alfa reverses the fibrotic and immune-excluded tumor microenvironment driven by TGF-β signaling to enable tumor penetration that drives deep and durable responses. 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 or follow us on LinkedIn or X. Forward-Looking StatementsThis 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 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 ability, profile and clinical benefits of ficerafusp alfa, including potential and anticipated efficacy, depth, durability, tolerability, and success, and the potential clinical results from the Phase 2/3 pivotal trial of ficerafusp alfa. 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. Contacts InvestorsRachel FrankIR@ MediaAmanda Lazaro1ABAmanda@ in to access your portfolio
Business Insider
23-05-2025
- Business
- Business Insider
Bicara Therapeutics publishes updated data from Phase 1/1b trial of Ficerafusp
The company states: 'Bicara Therapeutics (BCAX) announced the publication of an abstract with updated interim data from the company's Phase 1/1b clinical trial of ficerafusp alfa in combination with pembrolizumab in patients with first line recurrent/metastatic head and neck squamous cell carcinoma on the 2025 American Society of Clinical Oncology Annual Meeting website. The company will host a conference call on Sunday, June 1, 2025 at 3:00 p.m. CT / 4:00 p.m. ET to present the fulsome dataset, including overall survival and duration of response data, following an oral presentation of the data at the ASCO Annual Meeting. Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by breaking barriers within the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa combines two clinically validated targets: an epidermal growth factor receptor directed monoclonal antibody with a domain that binds to human transforming growth factor beta.' 'We are pleased to present the fulsome dataset from our Phase 1/1b trial of ficerafusp alfa in patients with recurrent/metastatic head and neck squamous cell carcinoma during our upcoming oral presentation at ASCO,' said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. 'The interim data featured in the ASCO abstract demonstrate encouraging signals that represent a meaningful improvement over historical benchmarks in patients with HPV-negative disease, a population with high unmet need and worse survival outcomes than those with HPV-positive disease. Notably, we're encouraged to see how ficerafusp alfa, specifically designed to drive tumor penetration within the tumor microenvironment, is leading to deep, and now, durable responses that appear to be translating to prolonged overall survival.'
Yahoo
22-05-2025
- Business
- Yahoo
Bicara Therapeutics Announces Publication of an Abstract with Updated Interim Data from Phase 1/1b Trial of Ficerafusp alfa in 1L R/M HNSCC at the 2025 ASCO Annual Meeting
Company to host conference call on Sunday, June 1, 2025 at 3:00 p.m. CT / 4:00 p.m. ET to discuss fulsome dataset BOSTON, May 22, 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 the publication of an abstract with updated interim data from the company's Phase 1/1b clinical trial of ficerafusp alfa in combination with pembrolizumab in patients with first line (1L) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) on the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting website. The company will host a conference call on Sunday, June 1, 2025 at 3:00 p.m. CT / 4:00 p.m. ET to present the fulsome dataset, including overall survival (OS) and duration of response (DOR) data, following an oral presentation of the data at the ASCO Annual Meeting. Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by breaking barriers within the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa 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). 'We are pleased to present the fulsome dataset from our Phase 1/1b trial of ficerafusp alfa in patients with recurrent/metastatic head and neck squamous cell carcinoma during our upcoming oral presentation at ASCO,' said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. 'The interim data featured in the ASCO abstract demonstrate encouraging signals that represent a meaningful improvement over historical benchmarks in patients with HPV-negative disease, a population with high unmet need and worse survival outcomes than those with HPV-positive disease. Notably, we're encouraged to see how ficerafusp alfa, specifically designed to drive tumor penetration within the tumor microenvironment, is leading to deep, and now, durable responses that appear to be translating to prolonged overall survival.' ASCO Presentation Details Christine Chung, MD, Chair, Department of Head and Neck-Endocrine Oncology and Program Leader of Head and Neck Oncology at Moffitt Cancer Center will present the fulsome dataset during an oral presentation at the 2025 ASCO Annual Meeting, on behalf of the patients and investigators who have contributed to this clinical trial. 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 Key highlights of the abstract include: Updated interim data (December 16, 2024 cutoff date) from the Phase 1/1b clinical trial of ficerafusp alfa in patients with 1L R/M HNSCC patients with a PD-L1 combined positive score (CPS) of ≥1. In the efficacy evaluable human papillomavirus (HPV)-negative population (n=28): 64% (18/28) objective response rate, including 21% (6/28) of patients who achieved a complete response. Median progression-free survival was 9.8 months (95% CI: 4.4–23.2) and the 12-month OS rate was 61% (95% CI: 40–76%). Median overall survival (mOS) and median DOR had not been reached yet, with mOS surpassing 20 months. Safety findings were consistent with the known safety profile of ficerafusp alfa plus pembrolizumab. Data from paired tumor biopsies demonstrated encouraging post-treatment downregulation of phospho-SMAD2, supporting targeted TGF-β inhibition. Company Conference Call DetailsBicara Therapeutics will host a conference call and webcast on Sunday, June 1, 2025 at 3:00 p.m. CT / 4:00 p.m. ET. Individuals may register for the conference call by clicking the link here. Once registered, participants will receive dial-in details and unique PIN which will allow them to access the call. An audio webcast will be accessible through the Investor Relations section of the Bicara's website under Events and Presentations. Following the live webcast, an archived replay will also be available. About Head and Neck Squamous Cell CarcinomaHead and neck squamous cell carcinomas (HNSCCs) develop from the mucosal epithelium in the oral cavity, pharynx and larynx and are the most common malignancies that arise in the head and neck. HNSCC is one of the most common cancers in the United States and globally with a rising incidence anticipated to reach one million new global cases annually by 2030. Ten percent of HNSCC patients are diagnosed with metastatic disease and up to 30% develop a recurrence or metastases over time after receiving initial treatment for advanced HNSCC. Most cases of HNSCC are thought to result from accumulated mutations caused by carcinogenic exposures such as tobacco smoke or HPV infection. Approximately 80% of patients with R/M HNSCC are HPV-negative. These HPV-negative tumors often exhibit a recurrence pattern that is primarily local and are associated with severe morbidities, including fatal tumor bleeding, intense pain, difficulty swallowing, significant weight loss, and cachexia. This highlights a critical unmet need for therapies that have the potential to deliver durable anti-tumor responses, ultimately leading to meaningful improvements in patients' quality of life. About Ficerafusp AlfaFicerafusp alfa is a first-in-class bifunctional antibody designed to drive tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa 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 targeted mechanism, ficerafusp alfa reverses the fibrotic and immune-excluded tumor microenvironment driven by TGF-β signaling to enable tumor penetration that drives deep and durable responses. Ficerafusp alfa is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial first line (1L) 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 or follow us on LinkedIn or X. Forward-Looking StatementsThis 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 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, depth, durability 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. Contacts InvestorsRachel FrankIR@ MediaAmanda Lazaro1ABamanda@ in to access your portfolio
Globe and Mail
13-05-2025
- Business
- Globe and Mail
Bicara Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update
Updated data from ongoing Phase 1/1b trial in 1L R/M HNSCC to be presented at 2025 ASCO Annual Meeting Enrollment ongoing in FORTIFI-HN01, a pivotal Phase 2/3 trial of ficerafusp alfa in 1L R/M HNSCC Strong financial position with approximately $462 million in cash and cash equivalents expected to fund operations into the first half of 2029 BOSTON, May 13, 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 financial results for the first quarter ended March 31, 2025 and provided a business update. "We continued to execute across our clinical programs in the first quarter, maintaining strong momentum as we advance FORTIFI-HN01, the pivotal Phase 2/3 trial of ficerafusp alfa in HPV-negative recurrent/metastatic head and neck squamous cell carcinoma," said Claire Mazumdar, PhD, MBA, Chief Executive Officer of Bicara Therapeutics. "Near term, we look forward to presenting updated data from our ongoing Phase 1/1b clinical trial in this patient population as part of an oral presentation at the 2025 ASCO Annual Meeting. We believe the data have the potential to demonstrate differentiated depth and durability of response driven by the TGF-β arm of ficerafusp alfa. Additionally, we recently presented several datasets at AACR highlighting the broad therapeutic potential of ficerafusp alfa, including translational data that support its potential to prevent resistance mechanisms and potentially prolong durability in HPV-negative patients." Pipeline Highlights Bicara is developing ficerafusp alfa, a first-in-class, dual-action bifunctional epidermal growth factor receptor (EGFR)/transforming growth factor beta (TGF-β) antibody for multiple different solid tumor cancer types. Enrollment is ongoing in FORTIFI-HN01, a global, randomized, double-blind, placebo-controlled, pivotal Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab in 1L (first line) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), excluding patients with oropharyngeal squamous cell carcinoma associated with human papillomavirus infection (HPV-positive). Ongoing Phase 1/1b Clinical Trial in 1L R/M HNSCC Updated data with extended follow-up from an ongoing Phase 1/1b trial 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. Additional Phase 1b expansion cohorts evaluating ficerafusp alfa in 1L R/M HNSCC remain ongoing: A cohort evaluating 750mg of ficerafusp alfa weekly in combination with pembrolizumab in HPV-negative patients has completed enrollment. A cohort evaluating 2000mg of ficerafusp alfa every other week in combination with pembrolizumab in HPV-negative patients is enrolling. A cohort evaluating 1500mg weekly of ficerafusp alfa in combination with pembrolizumab in HPV-neg patients with combined positive scores of 0 is enrolling. A cohort evaluating ficerafusp alfa in combination with pembrolizumab in HPV-positive patients with a history of heavy smoking is expected to initiate in 2025. Ongoing Phase 1/1b Expansion Cohorts and Development of Ficerafusp Alfa Across Other HNSCC Populations and Solid Tumor Types At the American Association for Cancer Research (AACR) Annual Meeting 2025, Bicara presented several datasets that underscore the broad therapeutic potential of ficerafusp alfa. These presentations included: Preliminary findings from a translational medicine biomarker dataset from Bicara's ongoing Phase 1/1b trial of ficerafusp alfa in 1L R/M HNSCC demonstrated that ficerafusp alfa effectively blocked TGF-β signaling and enabled tumor penetration to modulate key mechanisms associated with drug resistance. Updated data from an ongoing Phase 1b expansion cohort evaluating ficerafusp alfa monotherapy in patients with second line or later cutaneous squamous cell carcinoma (cSCC) that showed continued single agent activity with an overall response rate (ORR) of 30.4% (7/23 patients) and median progression-free survival of 7.0 months (95% CI, 2.7-8.9 months), demonstrating improvements over historical treatment in cSCC. New preclinical data offered insights into how TGF-β inhibition may help overcome acquired resistance to KRAS G12C inhibitors in KRAS G12C-mutant lung cancer, an important area of unmet need for patients with these types of rat sarcoma (RAS) mutations. A Phase 1b expansion cohort evaluating ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ metastatic colorectal cancer (RAS/B-Rapidly Accelerated Fibrosarcoma (BRAF) wild type) is expected to initiate in 2025. Upcoming Events and Presentations Details of Bicara's oral presentation at 2025 ASCO Annual Meeting, which will be held from May 30-June 3, 2025 in Chicago, IL, 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 First Quarter 2025 Financial Results Cash Position: As of March 31, 2025, Bicara had cash and cash equivalents of $462.1 million, compared to $489.7 million as of December 31, 2024. Based on its current operating and development plans, the Company expects that its existing cash and cash equivalents will fund operations into the first half of 2029. Research and Development Expenses: Research and development expenses were $34.3 million for the first quarter of 2025 as compared to $12.0 million for the first quarter of 2024. The increase was primarily due to additional costs associated with the initiation of FORTIFI-HN01 a pivotal Phase 2/3 clinical trial, as well as the Company's ongoing Phase 1/1b clinical trials to advance ficerafusp alfa. General and Administrative Expenses: General and administrative expenses were $7.5 million for the first quarter of 2025 as compared to $3.3 million for the first quarter of 2024. The increase was primarily due to additional personnel costs and professional fees to support the advancement of our clinical trials and operations as a public company. Net Loss: Net loss totaled $36.8 million for the first quarter of 2025 as compared to $12.5 million for the first quarter of 2024. 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 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. These statements may be identified by words such as '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 contain identifying words. Any statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, Bicara's strategy, business plans and focus; express or implied statements regarding the clinical development of ficerafusp alfa, including 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, the initiation, timing, progress and results of ongoing and planned clinical trials, including the initiation of additional cohorts; the expected therapeutic potential and clinical benefits of ficerafusp alfa, including potential efficacy, depth, durability and tolerability; Bicara's expected operating expenses and capital expenditure requirements, including its cash runway through the first half of 2029; and participation at upcoming conferences and the timing of data readouts. 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 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; 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 its Annual Report on Form 10-K for the year ended December 31, 2024, its upcoming Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 and any subsequent filings Bicara makes with the SEC. In addition, any 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. Bicara intends to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company's Investor Relations website, in addition to following the Company's press releases, SEC filings, public conference calls, presentations, and webcasts. Contacts Investors Rachel Frank IR@ Media Amanda Lazaro 1AB Amanda@
