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).

Start Date28 Jan 2025

Sponsor / Collaborator

Bicara Therapeutics, Inc.

NCT04429542

/ RecruitingPhase 1

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.

Start Date01 Jun 2020

Sponsor / Collaborator

Bicara Therapeutics, Inc.

[+1]

100 Clinical Results associated with Ficerafusp alfa

100 Translational Medicine associated with Ficerafusp alfa

100 Patents (Medical) associated with Ficerafusp alfa

Literatures (Medical) associated with Ficerafusp alfa

14 Nov 2025·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

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

02 Jun 2023·Cancer research

BCA101 Is a Tumor-Targeted Bifunctional Fusion Antibody That Simultaneously Inhibits EGFR and TGFβ Signaling to Durably Suppress Tumor Growth

Article

Author: Dhamne, Chaitrali ; Tan, Seng-Lai ; Shri, Meena ; Alke, Bhavna ; Nair, Pradip ; Sagar, Milind ; Marigowda, Shivakumar Bhadravathi ; Tiwari, Vinita ; Moole, Praveen Reddy ; Sreenivas, Suma ; Kuriakose, Moni Abraham ; Bughani, Usha ; Periyasamy, Sankar ; Boreddy, Srinivas Reddy ; Sharma, Pinky ; Reddy, Ram Bhupal ; Banerjee, Arindam ; Kulkarni, Hanumant ; Pandey, Prashant Kumar ; Govindappa, Nagaraja ; Suresh, Amritha ; Bhatnagar, Jaya ; MV, Prashantha Kumar ; AR, Madhukara ; Rao, Shruthi ; Kuriakose, Anshu ; Krishn, Shiv Ram ; Patel, Sonal ; Nair, Reshmi ; Dey, Chaitali

Abstract:

The EGFR and TGFβ signaling pathways are important mediators of tumorigenesis, and cross-talk between them contributes to cancer progression and drug resistance. Therapies capable of simultaneously targeting EGFR and TGFβ could help improve patient outcomes across various cancer types. Here, we developed BCA101, an anti-EGFR IgG1 mAb linked to an extracellular domain of human TGFβRII. The TGFβ “trap” fused to the light chain in BCA101 did not sterically interfere with its ability to bind EGFR, inhibit cell proliferation, or mediate antibody-dependent cellular cytotoxicity. Functional neutralization of TGFβ by BCA101 was demonstrated by several in vitro assays. BCA101 increased production of proinflammatory cytokines and key markers associated with T-cell and natural killer–cell activation, while suppressing VEGF secretion. In addition, BCA101 inhibited differentiation of naïve CD4+ T cells to inducible regulatory T cells (iTreg) more strongly than the anti-EGFR antibody cetuximab. BCA101 localized to tumor tissues in xenograft mouse models with comparable kinetics to cetuximab, both having better tumor tissue retention over TGFβ “trap.” TGFβ in tumors was neutralized by approximately 90% in animals dosed with 10 mg/kg of BCA101 compared with 54% in animals dosed with equimolar TGFβRII-Fc. In patient-derived xenograft mouse models of head and neck squamous cell carcinoma, BCA101 showed durable response after dose cessation. The combination of BCA101 and anti-PD1 antibody improved tumor inhibition in both B16-hEGFR–expressing syngeneic mouse models and in humanized HuNOG-EXL mice bearing human PC-3 xenografts. Together, these results support the clinical development of BCA101 as a monotherapy and in combination with immune checkpoint therapy.

Significance::

The bifunctional mAb fusion design of BCA101 targets it to the tumor microenvironment where it inhibits EGFR and neutralizes TGFβ to induce immune activation and to suppress tumor growth.

14 Nov 2025·CLINICAL CANCER RESEARCH

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

Article

Author: 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

News (Medical) associated with Ficerafusp alfa

12 Jan 2026

·www.biospace.com

Bicara Therapeutics Announces Phase 3 Optimal Dose and Provides 2026 Corporate Outlook

Selected 1500 mg of ficerafusp alfa as the optimal dose for the treatment of 1L HPV-negative R/M HNSCC in Phase 3 FORTIFI-HN01 pivotal study Expects to achieve substantial enrollment in FORTIFI-HN01 in 2026 to enable interim analysis in mid-2027 Anticipates multiple expansion cohort data readouts in 2026 to further characterize ficerafusp alfa’s pro HPV-negative HNSCC and support potential expansion into other solid tumor types, including colorectal cancer Claire Mazumdar, PhD, MBA, Chief Executive Officer, to present at the J.P. Morgan 2026 Healthcare Conference on Monday, January 12 at 11:15 a.m. PT (2:15 p.m. ET) BOSTON, Jan. 12, 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 provided a 2026 corporate outlook and strategy for continued growth, building upon the clinical success of ficerafusp alfa, the first and only bifunctional epidermal growth factor receptor (EGFR)-directed antibody combined with a TGF-β ligand trap designed to drive increased tumor penetration and improve survival outcomes. “Bicara is entering 2026 with strong momentum and a clear plan for growth as we advance ficerafusp alfa, designed to generate significantly improved clinical outcomes in head and neck cancer that we believe will translate to commercial success,” said Claire Mazumdar, PhD, MBA, Chief Executive Officer at Bicara Therapeutics. “We are thrilled to announce that we have selected 1500 mg of ficerafusp alfa as the optimal dose for Phase 3 of the FORTIFI-HN01 pivotal study. Our focus for 2026 is to accelerate enrollment and end the year with a clear line of sight to an interim analysis in mid-2027 to support a potential accelerated filing. Our goal is to ensure that we are best positioned to achieve ficerafusp alfa’s blockbuster commercial potential, while advancing other signal-finding efforts that are based upon clear biologic and mechanistic rationale to better characterize ficerafusp alfa’s pipeline-in-a-product potential.” Selected 1500 mg QW of ficerafusp alfa in combination with pembrolizumab as the optimal dose for Phase 3 FORTIFI-HN01 pivotal study, earlier than anticipated Bicara has aligned with the U.S. Food and Drug Administration (FDA) on a clear path to implement, by the end of the first quarter, the optimal dose for Phase 3 of FORTIFI-HN01, a global, randomized, double-blind, placebo-controlled, pivotal trial of ficerafusp alfa in combination with pembrolizumab in first-line (1L) human papillomavirus (HPV)-negative recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Executing our strategic development plan for FICERA The company anticipates that FORTIFI-HN01 will be substantially enrolled by the end of 2026 to enable an interim analysis in the middle of 2027. Preparing for a successful commercial launch in HPV-negative HNSCC, a large and growing market with significant unmet need Ficerafusp alfa has the potential to achieve blockbuster status in HPV-negative R/M HNSCC, a multi-billion-dollar market that continues to grow. HPV-negative R/M HNSCC is a biologically distinct disease, often marked by immune exclusion and a hostile tumor microenvironment that limits the depth and durability of response to currently available therapies. Moreover, the majority of patients rapidly develop therapeutic resistance, underscoring the urgent need for more effective and durable treatment options. Ficerafusp alfa has a proven clinical dataset that more than doubles median overall survival in HPV-negative patients compared to standard of care and substantially improves upon median duration of response compared to other pembrolizumab combinations, including other approved and investigational EGFR-targeting agents. With increased conviction in ficerafusp alfa’s clinical potential, and as the company accelerates enrollment in the FORTIFI-HN01 pivotal study, Bicara plans to make critical commercial hires in 2026 to establish a strong foundation for future commercial success. Following EGFR and TGF-β biology to expand ficerafusp alfa’s potential while maintaining financial discipline Ficerafusp alfa is the first and only bifunctional EGFR-directed antibody combined with a TGF-β ligand trap designed to drive increased tumor penetration and improve survival outcomes. By simultaneously targeting EGFR-expressing tumor cells and modulating TGF-β–driven tumor microenvironment signaling, ficerafusp alfa is designed to improve tumor accessibility and enable more effective immune activity within the tumor. This bifunctional approach is intended to support deeper and more durable anti-tumor responses when used in combination with immune checkpoint inhibitors. There is a compelling biological rationale to explore ficerafusp alfa’s potential in solid tumors outside of HNSCC, especially in indications where EGFR is overexpressed and TGF-β signaling contributes to tumor progression. Bicara is currently evaluating ficerafusp alfa in metastatic colorectal cancer (mCRC) and plans to expand signal-finding efforts in other solid tumors with significant unmet need to further evaluate ficerafusp alfa’s pipeline-in-a-product potential. 2026 Corporate Milestones HNSCC Present data from an exploratory Phase 1b expansion cohort evaluating 2000 mg of ficerafusp alfa every other week in combination with pembrolizumab in 1L HPV-negative R/M HNSCC patients in the first quarter of 2026 to inform alternate dosing strategy for commercialization. Present long-term follow-up data from Phase 1b study of ficerafusp alfa in combination with pembrolizumab in 1L R/M HPV-negative HNSCC in the second quarter of 2026. Achieve substantial enrollment in FORTIFI-HN01 pivotal study by the end of 2026 to enable interim analysis in the middle of 2027. Make critical commercial hires, including a Chief Commercial Officer, by the end of 2026 to advance organizational preparation for launch readiness. Other Solid Tumors, Including mCRC Present data from Phase 1b expansion cohort evaluating ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ mCRC (RAS/BRAF wild type MSS) in the second half of 2026. J.P. Morgan Healthcare Conference Presentation Information Claire Mazumdar, PhD, MBA, Chief Executive Officer, will present at the J.P. Morgan 2026 Healthcare Conference on Monday, January 12, at 11:15 a.m. PT (2:15 p.m. ET). A live webcast of the presentation will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations . A replay of the webcast will be archived and available following the event. 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 and 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 Bicara’s clinical development of ficerafusp alfa both as a monotherapy and in combination with pembrolizumab, including the anticipated data readouts in 2026 and potential expansion of ficerafusp alfa into other solid tumor types, the timing of the implementation of the optimal dose for Phase 3 of FORTIFI-HN01, the potential path with the FDA regarding such implementation and the benefits associated therewith, the planned substantial enrollment in the FORTIFI-HN01 pivotal study in 2026 and potential interim analysis in the middle of 2027, the expected therapeutic potential and clinical benefits of ficerafusp alfa and Bicara’s commercialization plans. 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 Securities and Exchange Commission (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

Phase 3Phase 1Clinical Result

09 Dec 2025

·www.globenewswire.com

Bicara Therapeutics’ Preliminary Phase 1b Expansion Cohort Data Evaluating 750mg of Ficerafusp Alfa Weekly Plus Pembrolizumab Advances Pivotal Study Dose Selection on Track for First Quarter 2026

Ficerafusp alfa 750mg QW in combination with pembrolizumab demonstrates consistent overall response rate and safety profile comparable to 1500mg QW dose, further derisking pivotal FORTIFI-HN01 study interim analysis Totality of data demonstrates that greater TGF-β inhibition, observed at 1500mg of ficerafusp alfa, drives deeper tumor responses that translate to more durable outcomes for patients Pivotal FORTIFI-HN01 optimal dose declaration expected in first quarter 2026 Company to host conference call and webcast today at 9:00 a.m. ET Dec. 06, 2025 -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today presented preliminary data from a Phase 1b expansion cohort evaluating 750 mg of ficerafusp alfa weekly (QW) in combination with pembrolizumab in first-line (1L) human papillomavirus (HPV)-negative recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). The data were highlighted in an oral presentation by Deborah Wong, MD, PhD of UCLA Medical Center at the European Society for Medical Oncology (ESMO) Asia Congress and will be discussed on a company conference call and webcast today, December 6, at 9:00 a.m. ET. “Inadequate tumor penetration remains a major barrier in treating solid tumors such as R/M HNSCC,” said Claire Mazumdar, PhD, MBA, Chief Executive Officer of Bicara Therapeutics. “Ficerafusp alfa, the first and only bifunctional EGFR-directed antibody x TGF-β ligand trap, was purposefully designed to deliver deep and durable responses with the potential to meaningfully extend overall survival for patients. The data presented today mark an important advancement in our dose-optimization strategy, reinforce our confidence in the interim overall response rate analysis as the foundation for pursuing accelerated approval in the FORTIFI-HN01 pivotal trial, and further elucidate the relative contribution of TGF- β in driving deep and durable tumor responses. We have made significant progress in the FORTIFI-HN01 trial this year and are on track to declare an optimal dose in the first quarter of 2026.” Phase 1/1b expansion cohort data presented at ESMO Asia show that 750mg ficerafusp alfa in combination with pembrolizumab was generally well-tolerated, with a safety profile consistent with the known safety profile of ficerafusp alfa plus pembrolizumab in R/M HNSCC. At a preliminary duration of follow-up, 750 mg of ficerafusp alfa demonstrated a 57% confirmed overall response rate, with 10% of patients achieving a completed response, and 29% of responders demonstrating deep responses of at least 80% tumor shrinkage. New biomarker data to be presented during Bicara’s corporate call and webcast show that 1500mg of ficerafusp alfa yielded a greater increase TGF-β inhibition within the tumor microenvironment and greater immune activation, compared to 750mg of ficerafusp alfa. The increased TGF-β inhibition in the tumor translated to greater depth of clinical responses at 24 weeks. The median depth of response was 82% at the 1500mg dose vs. 63% at the 750mg dose, and 64% of responders at 1500mg achieved a deep response, compared to 27% of responders at the 750mg dose. The totality of the data suggests that a higher dose of ficerafusp alfa with greater TGF-β inhibition and immune activation drives deeper tumor responses that translate to more durable outcomes for patients. Bicara plans to declare the optimal biologic dose for use in the pivotal FORTIFI-HN01 study in the first quarter of 2026. Bicara Therapeutics will host a conference call and webcast today December 6, 2025 at 9:00 a.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. An archived replay will also be available for 30 days following the webcast. 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. 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. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ficerafusp alfa in combination with pembrolizumab for the first line (1L) treatment of patients with metastatic or with unresectable, recurrent (R/M) head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand 1 with combined positive score (CPS) ≥1, excluding human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma. Ficerafusp alfa is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial in patients with 1L R/M HNSCC. 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. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultBreakthrough TherapyPriority Review

08 Dec 2025

·endpoints.news

Day One was one of three parties interested in Mersana; Bihua Chen and Cormorant’s third SPAC

Plus, news about Bicara Therapeutics, Boehringer Ingelheim, Gubra, AbbVie, OSE Immunotherapeutics, Encoded Therapeutics, UCB and Immix Biopharma: 🤝 Two other companies were interested in Mersana: Day One wasn’t the only company to submit offers to acquire the ADC biotech, according to a regulatory document outlining their up to $285 million deal last month. The Friday evening SEC filing details how an undisclosed “Party A” submitted multiple offers to collaborate on Mersana’s B7-H4-targeted ADC, nicknamed Emi-Le. Another unnamed company, referred to as “Party B,” revised its offer to acquire Mersana multiple times. But Day One, which had backed out of deal discussions at one point, came out over the top with a higher upfront offer of $129 million. — Kyle LaHucik 🏎️ Another SPAC from Bihua Chen and Cormorant: The Cormorant leader and her investment firm are revving up the engines on Helix Acquisition Corp. III, with plans for a $125 million IPO outlined in a Monday morning SEC filing . The special purpose acquisition company (SPAC) will focus on finding a biotech company to take public. Cormorant’s prior two blank-check companies took BridgeBio Oncology Therapeutics and MoonLake Immunotherapeutics onto the Nasdaq. SPACs are seeing a somewhat of a comeback, with cancer-testing startup Freenome inking a SPAC deal last week. — Kyle LaHucik 📊 Bicara Therapeutics’ data reassures: An expansion cohort in a Phase 1b trial studied 750 mg weekly of ficerafusp alfa in a combo approach with Keytruda in first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma. At ESMO Asia, the biotech said Saturday that its approach offered 57% confirmed overall response rate and that 10% of patients had a complete response. In a Sunday note, TD Cowen analysts wrote that the results “significantly derisks” the company’s pivotal Phase 2/3 trial studying the 750 mg and 1,500 mg doses . — Reynald Castaneda ⏩ Boehringer progresses Gubra’s obesity triple-agonist: The German pharma giant will move the candidate, called BI 3034701, into mid-stage development. The decision comes after “a favorable safety and tolerability profile” with “encouraging weight loss” in a Phase 1 in healthy volunteers. The partners did not disclose the Phase 1 data. Boehringer Ingelheim licensed the drug from the small Danish biotech. Boehringer axed a different obesity candidate in their collaboration last year. Meanwhile, Gubra’s amylin program serves as the anchor of AbbVie’s foray into obesity . — Kyle LaHucik ✍️ AbbVie adjusts OSE Immunotherapeutics deal: The Nantes, France-based biotech will now be responsible for Phase 1 development of a monoclonal antibody for chronic and severe inflammation. AbbVie can still decide to advance ABBV-230 after that Phase 1. OSE will no longer get a milestone payment for starting the Phase 1. That was part of an overall $665 million biobucks package for the $48 million upfront deal disclosed in February 2024. — Kyle LaHucik 📁 Encoded Therapeutics report data from POLARIS: The program includes three studies in the US, UK and Australia that are investigating ETX101 in patients aged 6 months to 7 years old who have Dravet syndrome because of SCN1A gene variants. The company said Friday that in 19 patients, the therapy led to “dose-dependent and sustained reduction” in a measure called monthly countable seizure frequency. — Reynald Castaneda 🏀 UCB’s Fintepla scores Phase 3 win in rare disease: The biotech’s drug produced a “statistically significant reduction” in countable motor seizure frequency in patients with a rare disease called CDKL5 deficiency disorder. It cut the frequency of seizures by about 48% from baseline, compared with 3% for placebo. UCB plans to file the data with regulators. Fintepla is already approved in the US for Dravet syndrome and Lennox-Gastaut syndrome. — Ayisha Sharma 💰 Immix Biopharma’s $100M offering: The biotech is looking to sell about 19 million shares at $5.10 apiece. This comes after Immix presented Phase 2 data for NXC-201 at ASH in relapsed/refractory AL amyloidosis. — Reynald Castaneda

Clinical ResultPhase 1Phase 2Drug ApprovalAcquisition

100 Deals associated with Ficerafusp alfa

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
PD-L1-positive head and neck squamous cell carcinoma	Phase 3	United States	Bicara Therapeutics, Inc.	28 Jan 2025
PD-L1-positive head and neck squamous cell carcinoma	Phase 3	Australia	Bicara Therapeutics, Inc.	28 Jan 2025
PD-L1-positive head and neck squamous cell carcinoma	Phase 3	Austria	Bicara Therapeutics, Inc.	28 Jan 2025
PD-L1-positive head and neck squamous cell carcinoma	Phase 3	Belgium	Bicara Therapeutics, Inc.	28 Jan 2025
PD-L1-positive head and neck squamous cell carcinoma	Phase 3	Canada	Bicara Therapeutics, Inc.	28 Jan 2025
PD-L1-positive head and neck squamous cell carcinoma	Phase 3	France	Bicara Therapeutics, Inc.	28 Jan 2025
PD-L1-positive head and neck squamous cell carcinoma	Phase 3	Germany	Bicara Therapeutics, Inc.	28 Jan 2025
PD-L1-positive head and neck squamous cell carcinoma	Phase 3	Ireland	Bicara Therapeutics, Inc.	28 Jan 2025
PD-L1-positive head and neck squamous cell carcinoma	Phase 3	Italy	Bicara Therapeutics, Inc.	28 Jan 2025
PD-L1-positive head and neck squamous cell carcinoma	Phase 3	New Zealand	Bicara Therapeutics, Inc.	28 Jan 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04429542 (ESMO_ASIA2025) Manual	Phase 1	Squamous Cell Carcinoma of Head and Neck PD-L1 Expression (CPS >= 1)	31	Ficerafusp alfa 750 mg QW + pembrolizumab 200 mg Q3W	hsdgkhhpsw(xitwuaoixc) = The most frequent TRAEs (any grade) were acneiform dermatitis (84%), pruritus (45%) and fatigue (39%). qcbyvoajar (pyqpcpliih ) View more	Positive	05 Dec 2025
				Ficerafusp alfa 1500 mg QW + pembrolizumab
NCT04429542 (GlobeNewswire) Manual	Phase 1	Squamous Cell Carcinoma of Head and Neck First line human papillomavirus (HPV)-negative	28	Ficerafusp alfa 1500mg + pembrolizumab (HPV-negative)	dcgfqmvnrt(baqlzekckt) = jhrpooawje kusalixhfm (zbjqiwmzwf ) View more	Positive	12 Aug 2025
NCT04429542 (ASCO2025 \| NEWS) Manual	Phase 1	Squamous Cell Carcinoma of Head and Neck	42	Ficerafusp alfa + Pembrolizumab	ejsejkgrty(ifbhfyvjxz) = cxdllikthz nreeafagwd (fwnrglatxm, 37 - 70) View more	Positive	30 May 2025
				Ficerafusp alfa + Pembrolizumab (HPV-negative)	ejsejkgrty(ifbhfyvjxz) = onkmnyerzy nreeafagwd (fwnrglatxm, 44 - 81) View more
phase 1/1b trial (AACR2025)	Phase 1	Advanced Skin Squamous Cell Carcinoma Second line anti-PD-1 therapy \| anti-EGFR antibodies	14	Ficerafusp alfa 1500 mg IV weekly	crgfwwqpft(fegrhamiut) = qhpolmnmjy wqbtebneny (iqfvduerao, 15.2 - 72.3) View more	Positive	28 Apr 2025
NCT04429542 (Company_Website \| NEWS) Manual	Phase 1	Anal canal squamous cell carcinoma Second line \| Third line	28	Ficerafusp alfa Ficerafusp alfa + Pembrolizumab	rzcwpsmrix(dpbhrhqbnb) = 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%). zjsqaovewj (quhmgrwynu )	Positive	27 Jan 2025
NCT04429542 (ASCO_GI2025) Manual	Phase 1	Anal canal squamous cell carcinoma Second line \| Third line	26	Ficerafusp alfa + pembrolizumab	dgudfexxph(nvmduhiegx) = xvdiwbfayo xyrqiozfmq (yzuvespdzg ) View more	Positive	23 Jan 2025
NCT04429542 (Biospace) Manual	Phase 1	Recurrent Squamous Cell Carcinoma of the Head and Neck First line	39	Ficerafusp alfa (BCA101) + Pembrolizumab	dhtencgmvi(gxamnkolco) = acneiform rash (76%, with majority being Grade 1/2 in severity), fatigue (43%), and hypophosphatemia (38%). vncpynsoip (kizeuxryot ) View more	Positive	27 Jun 2024
				Ficerafusp alfa (BCA101) + Pembrolizumab (HPV-negative)
NCT04429542 (ESMO 12023 \| ESMO 22023) Manual	Phase 1	Squamous Cell Carcinoma of Head and Neck First line PD-L1 \| HPV Negative	33	BCA101 1500 mg+pembrolizumab 200 mg	evrkdjzhfd(nagcguccvd) = mdouqsfphu eikycbabbt (lmyawjribv ) View more	Positive	22 Oct 2023
				BCA101 1500 mg+pembrolizumab 200 mg (HPV(-) pts)	zpdqwyccer(xhbfrjblzc) = psfyqvccok ztfsurhyap (xsagmbedcg )
NCT04429542 (ASCO 12023 \| ASCO 22023) Manual	Phase 1	Squamous cell carcinoma of head and neck metastatic First line	18	BCA101+pembrolizumab	lpflrbepuf(zsywdccoct) = aubmotdixk ejbwjwzcsk (nfidhktijn ) View more	Positive	26 May 2023
				BCA101+pembrolizumab (HPV-neg)	qpwdzzfcea(llxhrheqtt) = ldfvwglkid lazpdlidth (smrrdlgktr ) View more
NCT04429542 (ESMO2022) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	60	BCA101	fvslybwnud(vbqramppsm) = Most common AEs attributed to BCA101 include rash (72%), fatigue (30%), pruritis (20%), and epistaxis (17%); all G2 or less gegaecbqgw (khkrjkrakl ) View more	Positive	10 Sep 2022
				BCA101+pembrolizumab

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