A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β).
This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

开始日期2025-01-28

申办/合作机构

Bicara Therapeutics, Inc.

NCT04429542

/ Recruiting临床1期

First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGFβ Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-Driven Advanced Solid Tumors

The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.

开始日期2020-06-01

申办/合作机构

Bicara Therapeutics, Inc.

[+1]

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100 项与 Ficerafusp alfa 相关的转化医学

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100 项与 Ficerafusp alfa 相关的专利（医药）

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项与 Ficerafusp alfa 相关的文献（医药）

2026-05-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Beyond EGFR inhibition in head and neck squamous cell carcinoma: Overcoming resistance mechanisms and novel therapeutic frontiers

Review

作者: Carosi, Francesca ; Romaniello, Donatella ; Le Tourneau, Christophe ; Filippini, Daria Maria ; Fermi, Matteo ; Mercante, Giuseppe ; Monte, Andrea ; Tarsitano, Achille ; Querzoli, Giulia ; Carlini, Andrea ; Lauriola, Mattia ; Fabbri, Laura ; Sgarzi, Michela

Head and neck squamous cell carcinoma (HNSCC) remains a significant global health challenge. The epidermal growth factor receptor (EGFR) is overexpressed in the majority of HNSCCs and represents a well-established therapeutic target. Cetuximab, a chimeric IgG1 monoclonal antibody anti-EGFR, is the only EGFR-targeted agent approved for HNSCC and has shown efficacy in both locally advanced (in platinum-unfit patients) and recurrent/metastatic (R/M) settings. However, clinical benefit is limited by intrinsic and acquired resistance mechanisms, including EGFR mutations, compensatory activation of alternative receptor tyrosine kinases (RTKs), downstream pathway alterations (e.g., PIK3CA mutations, PTEN loss), epithelial-mesenchymal transition (EMT), and immunosuppressive tumor microenvironment factors. Emerging strategies aim to overcome resistance through dual EGFR inhibition, combination with new generation targeted agents, and immunomodulation. Irreversible pan-HER tyrosine kinase inhibitors (e.g., afatinib, dacomitinib), dual-target bispecific antibodies such as duligotuzumab (EGFR/HER3), petosemtamab (EGFR/LGR5) or ficerafusp alfa (EGFR/TGF-β) have led to promising preclinical and early-phase clinical activity. Additionally, intratumoral EGFR antisense DNA (EGFR-AS) has shown synergy with cetuximab and radiotherapy in preclinical models and a phase I trial. This narrative review provides a comprehensive overview of the EGFR signaling network in HNSCC, the mechanisms underpinning resistance to EGFR-targeted therapies, and the evolving therapeutic landscape. While EGFR remains a valid therapeutic target, future efforts must focus on biomarker-driven patient selection and combination strategies to enhance efficacy and durability of response. Ongoing trials will further define the role of emerging anti-EGFR agents and their integration into HNSCC treatment algorithms.

2025-11-14·CLINICAL CANCER RESEARCH

Bridging EGFR/TGF-β Signaling to Bypass Resistance to Immune Checkpoint Blockade

Article

作者: Issaeva, Natalia ; Kothari, Aditi ; Bestvina, Christine M. ; Choudhury, Noura J.

Summary:

Although EGFR is a common target in squamous cancers, anti-EGFR monotherapies have shown modest success because of existing or acquired activation of other oncogenic pathways and tumor heterogeneity. A bifunctional fusion protein ficerafusp alfa in combination with pembrolizumab represents a potential solution to overcome resistance in early-phase clinical investigation.See related article by Hernando-Calvo et al., p. 4623

2025-11-14·CLINICAL CANCER RESEARCH

Phase I Clinical Trial of the Bifunctional EGFR/TGF-β Fusion Protein Ficerafusp Alfa (BCA101) Alone and in Combination with Pembrolizumab for Advanced Solid Tumors

Article

作者: Zandberg, Dan P. ; Carvajal, Richard D. ; Bedard, Philippe L. ; Paik, Paul K. ; Morris, Van Karlyle ; Hernando-Calvo, Alberto ; Salazar, Rachel L. ; Bohr, David N. ; Kaczmar, John M. ; Reiners, Ralf D. ; Ivanova, Elena V. ; Hanna, Glenn J. ; Lizotte, Patrick Hall ; Gharakhani, Elham

Abstract:

Purpose::

To evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of ficerafusp alfa (BCA101), a first-in-class bifunctional protein targeting EGFR and TGF-β, as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors.

Patients and Methods::

At escalating doses in a parallel 3 + 3 design, patients with EGFR-driven advanced solid tumors received weekly intravenous ficerafusp alfa as monotherapy (64–1,500 mg) or in combination (240–1,500 mg) with pembrolizumab (200 mg i.v. every 3 weeks). The primary objective was to determine safety/tolerability. Secondary objectives included assessment of pharmacokinetics, immunogenicity, and preliminary efficacy per investigator-assessed response. Exploratory analyses included pharmacodynamic biomarkers.

Results::

Among 61 patients (monotherapy, n = 46; combination, n = 15), the most common treatment-related adverse events included acneiform dermatitis (46%) and fatigue (20%) with monotherapy and acneiform dermatitis (73%), fatigue (53%), pruritus (40%), epistaxis (40%), and maculopapular rash (40%) with combination therapy. One patient had a dose-limiting toxicity with 1,250-mg monotherapy (grade 3 anemia and hematuria). The MTD was not reached in either cohort. With monotherapy, objective response was observed in one of 42 evaluable patients and 16 (38%) achieved stable disease. With combination therapy, four of 13 evaluable patients (31%) had a confirmed response, including one with head and neck squamous cell carcinoma refractory to anti–PD-1 therapy and cetuximab. Prolonged neutralization of plasma TGF-β1 was observed at doses ≥500 mg.

Conclusions::

Ficerafusp alfa exhibited a manageable safety profile and clinical activity as monotherapy and in combination with pembrolizumab, with exposure increasing proportionally at anticipated therapeutic doses.See related commentary by Choudhury et al., p. 4617

项与 Ficerafusp alfa 相关的新闻（医药）

2026-02-26

·PRNewswire

Head and Neck Cancer Therapeutics Market to Reach USD 2.6 Billion by 2032, Driven by Immunotherapy and Precision Oncology - Credence Research Inc.

LONDON, Feb. 26, 2026 /PRNewswire/ -- The "Head and Neck Cancer Therapeutics Market – Growth, Share, Opportunities & Competitive Analysis, 2024 – 2032" report has been added to the offering of Credence Research Inc. The global head and neck cancer therapeutics market is projected to grow from USD 1.58 billion in 2024 to USD 2.6 billion by 2032, reflecting a CAGR of 6.8% over 2024–2032. Growth is supported by rising incidence, expanding use of immunotherapy and targeted therapies, and broader adoption of precision medicine, subject to access and reimbursement constraints across regions. Key Attributes Historical Period: 2020–2023 Base Year: 2024 Forecast Period: 2025–2032 Head and Neck Cancer Therapeutics Market Size 2024: USD 1.58 Billion Head and Neck Cancer Therapeutics Market Size 2032: USD 2.6 Billion Head and Neck Cancer Therapeutics Market CAGR (2024–2032): 6.8% Access crucial information at unmatched prices! Request your sample report today and start making informed decisions powered by Credence Research Inc. - Rising Prevalence of Head and Neck Cancers Higher prevalence and diagnosis rates of head and neck cancers underpin demand for therapeutics. Tobacco use, alcohol consumption, and HPV infection remain key risk factors in many markets. Some public health agencies report that HPV accounts for a substantial share of throat and mouth cancers, reshaping incidence patterns by subsite and region. These factors expand the treated population and support demand across first-line, recurrent, and metastatic care settings. Population aging further increases risk in many countries, adding to the addressable patient base. However, treatment uptake still depends on stage at diagnosis, timely referral to specialist centers, and patient ability to access and afford care. Advancements in Targeted and Immunotherapy Treatments Targeted therapies and immunotherapies have broadened the available treatment toolkit, particularly in recurrent or metastatic disease and biomarker-defined subgroups. EGFR-directed approaches and monoclonal antibodies are used in certain regimens. Checkpoint inhibitors, including pembrolizumab, have shown survival benefits in selected populations. These modalities can offer different efficacy and safety profiles versus conventional chemotherapy. Clinical benefit, though, varies by tumor type, line of therapy, biomarker status, and patient health. Ongoing clinical trials and label expansions continue to adjust where and how these agents are positioned within treatment pathways. Growing Adoption of Immunotherapy Immunotherapy is becoming a key component of the head and neck cancer treatment landscape. Immune checkpoint inhibitors and other immune-based approaches are gaining traction due to their ability to boost anti-tumor immune responses and extend survival in certain settings. For instance, GeoVax's Phase 2 trial of gene therapy Gedeptin combined with pembrolizumab (Keytruda) in recurrent head and neck cancer aims for pathologic complete responses in 36 patients, reflecting growing interest in immune-based strategies. Regulatory approvals and expanding clinical experience have supported the inclusion of immunotherapy in more treatment protocols. This trend reflects a broader shift in oncology toward immune-modulating approaches, although cost and eligibility criteria still constrain uptake. Market Challenges High Treatment Costs The high cost of advanced treatment options remains a major restraint. Immunotherapies, targeted therapies, and precision diagnostics often carry substantial price tags, which can limit access for many patients, especially in low- and middle-income regions. Expenses from prolonged therapies, companion diagnostics, and supportive care add further burden to patients and health systems. This financial pressure can constrain adoption, even where clinical benefit is demonstrated. Limited Access to Advanced Healthcare Infrastructure Access to specialized oncology services remains uneven. Many patients in developing and underdeveloped regions cannot reach centers that provide advanced therapies or complex diagnostics. Rural areas face gaps in diagnostic capacity, specialist availability, and timely referrals. This imbalance contributes to late-stage diagnosis and reduces the effectiveness of available interventions. The disparity in infrastructure and trained personnel remains a significant barrier to broader adoption of advanced therapeutics. Market Opportunities The increasing adoption of precision medicine presents a key opportunity. Advances in genomic profiling and biomarker identification support development of targeted therapies and more personalized regimens. Tailored treatment strategies can improve clinical outcomes and reduce unnecessary exposure to less effective options. Growing use of immunotherapy and combination regimens offers further opportunity. Integrating checkpoint inhibitors and other immune-based therapies with established treatments can improve survival and address resistance patterns. Firms that focus on novel combinations and biomarker-guided approaches can capture new growth segments. Improving healthcare infrastructure and access in emerging markets also expands opportunity. Investments in oncology centers, diagnostics, and reimbursement schemes can unlock new demand. Strategic collaborations, local trials, and adaptive pricing models can help companies build presence in these regions. Market Segmentation By Therapy Type Chemotherapy Immunotherapy Targeted Therapy By Route of Administration Injectable Oral By Distribution Channel Hospital Pharmacies Retail and Specialty Pharmacies Online Pharmacies By Region North America: United States, Canada Europe: United Kingdom, Germany, France, and others Asia-Pacific: China, India, Japan Latin America: Brazil, Mexico Middle East and Africa: South Africa, United Arab Emirates, and others Browse Complete Report Originally Published by Credence Research - Regional Analysis North America North America is described as accounting for around 40% of global revenue. The region benefits from established oncology infrastructure, high adoption of advanced therapies, and strong clinical research activity. Some sources cite more than 65,000 new head and neck cancer cases per year, supporting consistent treatment demand. Uptake of checkpoint inhibitors such as pembrolizumab and nivolumab has influenced treatment patterns in eligible patients. Reimbursement policies play a central role in shaping access and choice of therapy. Europe Europe is described as contributing around 30% of global share. Public health coverage, oncology research funding, and awareness campaigns support early detection and treatment access. Annual incidence is cited at more than 150,000 cases, with rising HPV-linked disease reported in some subtypes. EU-level initiatives and national programs support personalized medicine and development of novel therapies. Vaccination and prevention may affect long-term incidence, but near-term demand is driven by existing diagnosed populations. Key Player Analysis AstraZeneca Bristol-Myers Squibb Company Clinigen Group plc. Coherus BioSciences Eli Lilly and Company Hoffmann-La Roche Ltd. Merck & Co. Sanofi Takeda Pharmaceutical Company Limited Teva Pharmaceutical Industries Ltd Recent Developments In February 2025, Merus N.V. reported that the U.S. FDA granted Breakthrough Therapy Designation for petosemtamab in combination with pembrolizumab for first-line treatment of adults with recurrent or metastatic PD-L1–positive head and neck squamous cell carcinoma (CPS ≥ 1). In March 2025, Aprea Therapeutics signed a Material Transfer Agreement with MD Anderson Cancer Center to evaluate its WEE1 inhibitor, APR-1051, in HPV-positive and HPV-negative head and neck cancers. The work includes preclinical studies on replication stress and evaluation of combination strategies, including with immune checkpoint inhibitors. In April 2025, Akeso, Inc. received U.S. FDA approval for penpulimab-kcqx (a PD-1 monoclonal antibody) in combination with cisplatin or carboplatin and gemcitabine for adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). In June 2025, Exelixis discontinued development of zanzalintinib for advanced head and neck cancer, citing a more competitive FGFR-inhibitor landscape. In June 2025, the U.S. FDA approved peri-operative pembrolizumab following KEYNOTE-689 results reporting event-free survival benefit. In July 2025, Rakuten Medical, Inc. expanded patient recruitment to Japan and reported plans to expand to Eastern Europe for its Phase 3 ASP-1929 photoimmunotherapy program in combination with pembrolizumab as first-line therapy for recurrent head and neck squamous cell carcinoma. In September 2025, Transgene reported positive Phase 1 results for TG4050 in operable head and neck squamous cell carcinoma. In October 2025, Bicara Therapeutics, Inc. reported that the U.S. FDA granted Breakthrough Therapy Designation for ficerafusp alfa in combination with pembrolizumab for first-line treatment of head and neck squamous cell carcinoma (HNSCC). In December 2025, Pyxis Oncology reported positive preliminary Phase 1 data for micvotabart pelidotin (MICVO) in patients with recurrent or metastatic head and neck squamous cell carcinoma. Report Coverage The research report offers an in-depth analysis by Therapy Type, Route of Administration, and Distribution Channel. It profiles leading market players, outlining their business overviews, product portfolios, investment focus, revenue streams, and key applications. The report also examines the competitive environment, SWOT positions, key market trends, and primary drivers and restraints. It reviews market dynamics, regulatory frameworks, and technological advances shaping the sector. The analysis includes assessment of macroeconomic factors and healthcare system changes affecting demand. Finally, the report provides strategic recommendations for new entrants and established companies to navigate regulatory complexity, optimize portfolios, and capture growth opportunities in both mature and emerging markets. Browse Complete Report Originally Published by Credence Research - Related Reports – Neoantigen-Based Personalized Cancer Therapeutic Vaccines Market Colorectal Cancer Therapeutics Market Head and Neck Cancer Therapeutics Market Lung Cancer Therapeutics Market Cancer Therapeutics Market Checkpoint Inhibitor Refractory Cancer Market Antisense RNAi Therapeutics Market U.K. Monoclonal Antibodies Therapeutics Market Italy Monoclonal Antibodies Therapeutics Market France Monoclonal Antibodies Therapeutics Market Europe Monoclonal Antibodies Therapeutics Market Australia Monoclonal Antibodies Therapeutics Market U.S. Monoclonal Antibodies Therapeutics Market mRNA Therapeutics Market Brain Metastasis Therapeutics Market About Us Credence Research Inc is a global market intelligence and consulting firm founded in 2015. It delivers deep market insights, quantitative analysis, and strategic guidance to business leaders, investors, governments, NGOs, and non-profit groups worldwide. The company helps organizations evaluate markets, understand trends, reduce risk, and make data-driven decisions that support growth and competitive strategy. Credence Research is known for rigorous research methods and comprehensive analytics. The firm produces detailed reports covering market size, forecasts, growth drivers, trends, and competitive landscapes across many industries. Each report often includes frameworks like PESTLE and Porter's Five Forces to give a complete view of market dynamics and future potential. Credence Research also provides tailored consulting services, due diligence support, go-to-market planning, and pre-IPO research to strengthen client strategies and investment narratives. Its insights come from both primary and secondary research, expert interviews, and advanced data modelling. The firm's client base spans Europe, the Americas, Asia-Pacific, and the Middle East/Africa. To find out more, visit or follow us on X.com, LinkedIn and Facebook Contact Us – Credence Research Inc, Tower C-1105, S 25, Akash Tower, Vishal Nagar, Pimple Nilakh, Haveli, Pune – 411027, India USA: +1-888-600-6441 Email: [email protected] Visit Our Website: Logo - SOURCE Credence Research Inc. 21% more press release views with Request a Demo

免疫疗法上市批准临床结果临床2期突破性疗法

2026-02-26

·BioSpace

Bicara Therapeutics Announces Closing of Oversubscribed Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

BOSTON, Feb. 26, 2026 (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 closing of its underwritten public offering of 8,581,250 shares of its common stock, and to certain investors that so choose, pre-funded warrants to purchase 2,200,000 shares of its common stock at an exercise price of $0.0001 per share. The shares of common stock sold include 1,406,250 shares pursuant to the option granted by Bicara to the underwriters, which option was exercised in full. The public offering price of each share of common stock was $16.00 and the public offering price of each pre-funded warrant was $15.9999. The aggregate gross proceeds to Bicara from this offering were approximately $172.5 million, before deducting underwriting discounts and commissions and other estimated offering expenses. Bicara intends to use the net proceeds of the offering to further invest in and build its medical and commercial infrastructure to support a planned regulatory filing and commercial launch for ficerafusp alfa, if approved, in the U.S.; to further accelerate the development of ficerafusp alfa in 1L R/M HPV-negative HNSCC, including a less frequent dosing schedule; to fund manufacturing costs for ficerafusp alfa for ongoing and anticipated drug development efforts; to fund early signal-finding to support future indication expansion for ficerafusp alfa; and for other general corporate purposes. Morgan Stanley, TD Cowen, BofA Securities, Cantor and Stifel acted as joint book-running managers for the offering. The securities described above were offered by Bicara pursuant to an effective “shelf” registration statement on Form S-3 (File No. 333-290707) that was filed with the Securities and Exchange Commission (the “SEC”) on October 3, 2025 and declared effective on November 26, 2025. The securities was offered only by means of a prospectus supplement and an accompanying prospectus that form a part of the registration statement. A final prospectus supplement and the accompanying prospectus relating to and describing the offering have been filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained by visiting the SEC’s website at or by contacting Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2 nd Floor, New York, NY 10014, or by email at prospectus@morganstanley.com; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at TDManualrequest@broadridge.com; BofA Securities, NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at dg.prospectus_requests@bofa.com; Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 110 E. 59 th Street, 6 th Floor, New York, NY 10022, or by email at prospectus@cantor.com; or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at syndprospectus@stifel.com . This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction. 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. 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, the anticipated use of such proceeds from the offering. 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, preliminary or interim data from earlier stage 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 SEC, including its Annual Report on Form 10-K for the year ended December 31, 2024, its Quarterly Report on Form 10-Q for the quarter ended September 30, 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. Contacts: Investors Jenna Cohen IR@bicara.com Media Amanda Lazaro 1AB Amanda@1abmedia.com

2026-02-25

·BioSpace

Bicara Therapeutics Announces Proposed Public Offering of Common Stock

BOSTON, Feb. 24, 2026 (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 it has commenced an underwritten public offering of $150 million of shares of its common stock. Bicara intends to grant the underwriters a 30-day option to purchase up to an additional $22,500,000 of shares of common stock offered in the public offering, at the public offering price, less underwriting discounts and commissions. All of the shares of common stock to be sold in the proposed offering will be sold by Bicara. Morgan Stanley, TD Cowen, BofA Securities, Cantor and Stifel are acting as joint book-running managers for the offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed or as to the actual size or terms of the proposed offering. Bicara intends to use the net proceeds of the offering to further invest in and build its medical and commercial infrastructure to support a planned regulatory filing and commercial launch for ficerafusp alfa, if approved, in the U.S.; to further accelerate the development of ficerafusp alfa in 1L R/M HPV-negative HNSCC, including a less frequent dosing schedule; to fund manufacturing costs for ficerafusp alfa for ongoing and anticipated drug development efforts; to fund early signal-finding to support future indication expansion for ficerafusp alfa; and for other general corporate purposes. The securities described above will be offered by Bicara pursuant to an effective “shelf” registration statement on Form S-3 (File No. 333-290707) that was filed with the Securities and Exchange Commission (the “SEC”) on October 3, 2025 and declared effective on November 26, 2025. The securities may be offered only by means of a prospectus supplement and an accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the proposed offering will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and, when available, copies of the final prospectus supplement, and the accompanying prospectus relating to the offering may be obtained by visiting the SEC’s website at or by contacting Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2 nd Floor, New York, NY 10014, or by email at prospectus@morganstanley.com; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at TDManualrequest@broadridge.com; BofA Securities, NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at dg.prospectus_requests@bofa.com; Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 110 E. 59th Street, 6th Floor, New York, NY 10022, or by email at prospectus@cantor.com; or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at syndprospectus@stifel.com. This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. 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. 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, the proposed underwritten public offering, including the size, timing and structure of the proposed offering, the expectation to grant the underwriters an option to purchase additional shares, the completion of the proposed offering on the anticipated terms, and the anticipated use of proceeds from the proposed offering. 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, preliminary or interim data from earlier stage 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 SEC, including its Annual Report on Form 10-K for the year ended December 31, 2024, its Quarterly Report on Form 10-Q for the quarter ended September 30, 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. Contacts: Investors Jenna Cohen IR@bicara.com Media Amanda Lazaro 1AB Amanda@1abmedia.com

临床研究

100 项与 Ficerafusp alfa 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
PD-L1阳性头颈部鳞状细胞癌	临床3期	美国	Bicara Therapeutics, Inc.	2025-01-28
PD-L1阳性头颈部鳞状细胞癌	临床3期	澳大利亚	Bicara Therapeutics, Inc.	2025-01-28
PD-L1阳性头颈部鳞状细胞癌	临床3期	奥地利	Bicara Therapeutics, Inc.	2025-01-28
PD-L1阳性头颈部鳞状细胞癌	临床3期	比利时	Bicara Therapeutics, Inc.	2025-01-28
PD-L1阳性头颈部鳞状细胞癌	临床3期	加拿大	Bicara Therapeutics, Inc.	2025-01-28
PD-L1阳性头颈部鳞状细胞癌	临床3期	法国	Bicara Therapeutics, Inc.	2025-01-28
PD-L1阳性头颈部鳞状细胞癌	临床3期	德国	Bicara Therapeutics, Inc.	2025-01-28
PD-L1阳性头颈部鳞状细胞癌	临床3期	爱尔兰	Bicara Therapeutics, Inc.	2025-01-28
PD-L1阳性头颈部鳞状细胞癌	临床3期	意大利	Bicara Therapeutics, Inc.	2025-01-28
PD-L1阳性头颈部鳞状细胞癌	临床3期	新西兰	Bicara Therapeutics, Inc.	2025-01-28

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04429542 (ESMO_ASIA2025) 人工标引	临床1期	头颈部鳞状细胞癌 PD-L1 Expression (CPS >= 1)	31	Ficerafusp alfa 750 mg QW + pembrolizumab 200 mg Q3W	鏇鹽壓膚糧範選選鹹觸(鑰簾醖網簾選鹹範範鏇) = The most frequent TRAEs (any grade) were acneiform dermatitis (84%), pruritus (45%) and fatigue (39%). 遞願夢膚艱膚簾窪膚繭 (簾齋鹹顧積網觸鑰願製 ) 更多	积极	2025-12-05
				Ficerafusp alfa 1500 mg QW + pembrolizumab
NCT04429542 (GlobeNewswire) 人工标引	临床1期	头颈部鳞状细胞癌一线 human papillomavirus (HPV)-negative	28	Ficerafusp alfa 1500mg + pembrolizumab (HPV-negative)	獵鬱餘壓製廠窪繭艱製(壓廠鬱積廠鏇顧壓鹽鏇) = 淵鏇構築選糧膚衊糧餘艱遞糧選餘襯構糧構顧 (遞衊繭築淵蓋簾蓋鹹顧 ) 更多	积极	2025-08-12
NCT04429542 (ASCO2025 \| NEWS) 人工标引	临床1期	头颈部鳞状细胞癌	42	Ficerafusp alfa + Pembrolizumab	艱鹽鏇願醖廠窪醖鬱憲(憲艱廠觸醖觸壓艱廠壓) = 鑰積製鏇壓夢窪廠齋廠糧淵範願顧鹹鹹範鹹製 (淵襯襯鏇鹽顧顧網製顧, 37 ~ 70) 更多	积极	2025-05-30
				Ficerafusp alfa + Pembrolizumab (HPV-negative)	艱鹽鏇願醖廠窪醖鬱憲(憲艱廠觸醖觸壓艱廠壓) = 顧鹹醖鹹鹹衊壓蓋鬱選糧淵範願顧鹹鹹範鹹製 (淵襯襯鏇鹽顧顧網製顧, 44 ~ 81) 更多
phase 1/1b trial (AACR2025)	临床1期	晚期皮肤鳞状细胞癌二线 anti-PD-1 therapy \| anti-EGFR antibodies	14	Ficerafusp alfa 1500 mg IV weekly	壓鏇願艱膚願齋觸淵齋(窪鬱壓網憲遞膚築構齋) = 鏇顧鹹製鹽選窪鹹襯遞廠簾築窪觸糧觸網獵觸 (餘憲艱築網構簾憲鏇遞, 15.2 ~ 72.3) 更多	积极	2025-04-28
NCT04429542 (Company_Website \| NEWS) 人工标引	临床1期	肛管鳞状细胞癌二线 \| 三线	28	Ficerafusp alfa Ficerafusp alfa + Pembrolizumab	淵網鏇鹹觸積襯觸齋醖(夢積膚糧鹽鏇遞觸窪鏇) = the most common TRAE of any grade including, acneiform dermatitis (16/28 patients; 57.1%), epistaxis (14/28 patients; 50.0%), and pruritus (13/28 patients; 46.4%). 觸壓淵鏇築網鹽憲鏇遞 (衊築鹽襯齋淵築鏇窪鬱 )	积极	2025-01-27
NCT04429542 (ASCO_GI2025) 人工标引	临床1期	肛管鳞状细胞癌二线 \| 三线	26	Ficerafusp alfa + pembrolizumab	簾繭淵範簾餘網壓壓鏇(夢獵廠網窪鹹鹽顧鑰鹹) = 艱夢艱膚範願窪糧繭鏇積壓鬱夢選襯蓋醖蓋夢 (窪醖鏇襯製遞繭鑰範餘 ) 更多	积极	2025-01-23
NCT04429542 (Biospace) 人工标引	临床1期	复发性头颈部鳞状细胞癌一线	39	Ficerafusp alfa (BCA101) + Pembrolizumab	憲遞廠鏇網壓醖遞糧簾(蓋壓憲襯糧積醖製鬱醖) = acneiform rash (76%, with majority being Grade 1/2 in severity), fatigue (43%), and hypophosphatemia (38%). 遞壓觸鏇醖範醖憲範蓋 (糧夢願範膚積艱鏇衊夢 ) 更多	积极	2024-06-27
				Ficerafusp alfa (BCA101) + Pembrolizumab (HPV-negative)
NCT04429542 (ESMO 12023 \| ESMO 22023) 人工标引	临床1期	头颈部鳞状细胞癌一线 PD-L1 \| HPV Negative	33	BCA101 1500 mg+pembrolizumab 200 mg	齋廠衊襯夢廠積選觸製(顧遞鹹積積獵夢網顧憲) = 齋鏇獵觸築鏇壓遞選鑰鏇願繭繭衊淵簾鹽膚網 (構築築壓製鬱餘鏇鹽艱 ) 更多	积极	2023-10-22
				BCA101 1500 mg+pembrolizumab 200 mg (HPV(-) pts)	糧顧簾膚鹹獵獵構襯壓(願築壓鹹構窪積繭獵選) = 簾獵壓築衊築獵蓋顧鬱簾鏇淵構鏇廠夢醖襯網 (築醖醖選衊顧鏇餘積製 )
NCT04429542 (ASCO 12023 \| ASCO 22023) 人工标引	临床1期	转移性头颈部鳞状细胞癌一线	18	BCA101+pembrolizumab	窪壓鬱遞醖壓顧餘衊鑰(鏇鏇鏇壓夢網廠夢艱製) = 築憲衊淵遞鏇鹹製鹹壓鏇壓繭鹹蓋築觸繭觸積 (壓艱鹹範衊顧網壓窪齋 ) 更多	积极	2023-05-26
				BCA101+pembrolizumab (HPV-neg)	淵餘製簾獵鏇獵積遞繭(簾選餘觸淵鹹構膚糧鬱) = 網窪廠夢廠艱餘範製構範窪鏇窪願艱顧壓壓鹹 (艱製鬱選鑰壓顧艱顧衊 ) 更多
NCT04429542 (ESMO2022) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	60	BCA101	顧糧選糧網網願醖獵製(構糧鏇製構鑰憲襯鹽齋) = Most common AEs attributed to BCA101 include rash (72%), fatigue (30%), pruritis (20%), and epistaxis (17%); all G2 or less 鑰憲餘遞願膚繭蓋簾顧 (鹽鬱鏇製蓋鬱鹽簾壓鏇 ) 更多	积极	2022-09-10
				BCA101+pembrolizumab