Bicara Therapeutics Highlights Broad Potential of Ficerafusp Alfa at AACR Annual Meeting 2025
Bicara Therapeutics presented multiple datasets for their lead drug ficerafusp alfa at the AACR Annual Meeting 2025. The drug is a first-in-class bifunctional antibody targeting EGFR and TGF-β across various solid tumors.
Key highlights:
- In head and neck cancer trials, the drug showed effectiveness in blocking TGF-β signaling and preventing drug resistance
- For skin cancer patients, the drug achieved a 30.4% overall response rate and 82.6% clinical benefit rate in previously treated patients
- Median progression-free survival reached 7.0 months in skin cancer patients
- Common side effects included skin-related issues and fatigue
The company also presented promising preclinical data showing ficerafusp alfa's potential to overcome resistance to KRAS-G12C inhibitors in lung cancer treatment. These results support the drug's broad therapeutic potential across multiple solid tumor types, particularly in combination with other cancer therapies.
Bicara Therapeutics ha presentato diversi set di dati per il loro farmaco principale ficerafusp alfa durante l'AACR Annual Meeting 2025. Il farmaco è un anticorpo bifunzionale di prima classe che mira a EGFR e TGF-β in vari tumori solidi.
Punti salienti:
- Nei trial sul cancro della testa e del collo, il farmaco ha dimostrato efficacia nel bloccare la segnalazione di TGF-β e nel prevenire la resistenza al trattamento
- Nei pazienti con cancro della pelle, il farmaco ha raggiunto un tasso di risposta globale del 30,4% e un tasso di beneficio clinico dell'82,6% in pazienti già trattati
- La sopravvivenza libera da progressione mediana è stata di 7,0 mesi nei pazienti con cancro della pelle
- Gli effetti collaterali comuni includevano problemi cutanei e affaticamento
L'azienda ha inoltre presentato dati preclinici promettenti che mostrano il potenziale di ficerafusp alfa nel superare la resistenza agli inibitori KRAS-G12C nel trattamento del cancro polmonare. Questi risultati supportano il vasto potenziale terapeutico del farmaco in diversi tipi di tumori solidi, specialmente in combinazione con altre terapie oncologiche.
Bicara Therapeutics presentó múltiples conjuntos de datos sobre su fármaco principal ficerafusp alfa en la Reunión Anual AACR 2025. El medicamento es un anticuerpo bifuncional de primera clase que apunta a EGFR y TGF-β en varios tumores sólidos.
Puntos clave:
- En ensayos de cáncer de cabeza y cuello, el fármaco demostró eficacia bloqueando la señalización de TGF-β y previniendo la resistencia al medicamento
- En pacientes con cáncer de piel, el medicamento alcanzó una tasa de respuesta global del 30.4% y una tasa de beneficio clínico del 82.6% en pacientes previamente tratados
- La mediana de supervivencia libre de progresión fue de 7.0 meses en pacientes con cáncer de piel
- Los efectos secundarios comunes incluyeron problemas cutáneos y fatiga
La compañía también presentó datos preclínicos prometedores que muestran el potencial de ficerafusp alfa para superar la resistencia a los inhibidores KRAS-G12C en el tratamiento del cáncer de pulmón. Estos resultados respaldan el amplio potencial terapéutico del fármaco en múltiples tipos de tumores sólidos, especialmente en combinación con otras terapias contra el cáncer.
Bicara Therapeutics는 AACR 연례 회의 2025에서 주요 약물 피세라푸스 알파에 대한 여러 데이터 세트를 발표했습니다. 이 약물은 다양한 고형암에서 EGFR과 TGF-β를 표적으로 하는 최초의 이중기능 항체입니다.
주요 내용:
- 두경부암 임상시험에서 약물은 TGF-β 신호 전달 차단과 약물 내성 예방에 효과를 보였습니다
- 피부암 환자에서는 이전 치료를 받은 환자에서 전체 반응률 30.4%, 임상적 이익률 82.6%를 달성했습니다
- 피부암 환자의 무진행 생존 중앙값은 7.0개월에 달했습니다
- 일반적인 부작용으로는 피부 관련 문제와 피로가 있었습니다
회사는 또한 폐암 치료에서 KRAS-G12C 억제제에 대한 내성을 극복할 수 있는 피세라푸스 알파의 잠재력을 보여주는 유망한 전임상 데이터를 발표했습니다. 이러한 결과는 특히 다른 암 치료제와의 병용 시 여러 고형암 유형에 걸친 약물의 광범위한 치료 가능성을 뒷받침합니다.
Bicara Therapeutics a présenté plusieurs ensembles de données concernant leur médicament principal ficerafusp alfa lors de la réunion annuelle AACR 2025. Ce médicament est un anticorps bifonctionnel de première classe ciblant EGFR et TGF-β dans divers tumeurs solides.
Points clés :
- Dans les essais sur le cancer de la tête et du cou, le médicament a démontré son efficacité en bloquant la signalisation de TGF-β et en empêchant la résistance au traitement
- Chez les patients atteints de cancer de la peau, le médicament a obtenu un taux de réponse globale de 30,4 % et un taux de bénéfice clinique de 82,6 % chez les patients préalablement traités
- La survie sans progression médiane a atteint 7,0 mois chez les patients atteints de cancer de la peau
- Les effets secondaires fréquents comprenaient des problèmes cutanés et de la fatigue
L'entreprise a également présenté des données précliniques prometteuses montrant le potentiel de ficerafusp alfa à surmonter la résistance aux inhibiteurs KRAS-G12C dans le traitement du cancer du poumon. Ces résultats soutiennent le large potentiel thérapeutique du médicament dans plusieurs types de tumeurs solides, notamment en association avec d'autres thérapies anticancéreuses.
Bicara Therapeutics stellte auf dem AACR Annual Meeting 2025 mehrere Datensätze zu ihrem führenden Medikament ficerafusp alfa vor. Das Medikament ist ein neuartiger bifunktionaler Antikörper, der EGFR und TGF-β bei verschiedenen soliden Tumoren angreift.
Wichtige Highlights:
- In Studien zum Kopf-Hals-Karzinom zeigte das Medikament Wirksamkeit bei der Blockade der TGF-β-Signalgebung und der Verhinderung von Medikamentenresistenzen
- Bei Hautkrebspatienten erreichte das Medikament eine Gesamtansprechrate von 30,4 % und eine klinische Nutzenrate von 82,6 % bei zuvor behandelten Patienten
- Das mediane progressionsfreie Überleben betrug bei Hautkrebspatienten 7,0 Monate
- Häufige Nebenwirkungen waren Hautprobleme und Müdigkeit
Das Unternehmen präsentierte außerdem vielversprechende präklinische Daten, die das Potenzial von ficerafusp alfa zeigen, Resistenzen gegen KRAS-G12C-Inhibitoren in der Lungenkrebsbehandlung zu überwinden. Diese Ergebnisse untermauern das breite therapeutische Potenzial des Medikaments bei verschiedenen soliden Tumorarten, insbesondere in Kombination mit anderen Krebstherapien.
- 30.4% overall response rate (7/23 patients) in Phase 1/1b trial for cutaneous squamous cell carcinoma
- 82.6% clinical benefit rate (19/23 patients) showing strong efficacy in cSCC treatment
- 7.0 months median progression-free survival in cSCC, improving upon historical treatments
- Promising preclinical data showing effectiveness against KRAS G12C inhibitor resistance in lung cancer
- Positive biomarker data showing effective TGF-β signaling blockade in head and neck cancer trial
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Insights
Bicara's ficerafusp alfa shows promising efficacy in treatment-resistant cancers with 30.4% response rate and mechanistic validation of its dual-targeting approach.
Bicara's data for ficerafusp alfa demonstrates meaningful clinical activity in challenging cancer populations. In cutaneous squamous cell carcinoma patients who previously failed anti-PD-1 therapy, the drug achieved an overall response rate of 30.4% (7/23 patients) and an impressive clinical benefit rate of 82.6% (19/23 patients). The median progression-free survival of 7.0 months with a 25.4% PFS rate at 12 months indicates durable responses in a subset of patients where no approved second-line options exist.
The mechanistic data is particularly compelling. By simultaneously targeting both EGFR (tumor growth) and TGF-β (immunosuppression), ficerafusp alfa addresses multiple cancer-promoting pathways. The translational medicine findings confirm effective TGF-β signaling blockade and downregulation of epithelial-mesenchymal transition pathways in HPV-negative tumors, explaining how the drug potentially overcomes resistance mechanisms.
The safety profile appears consistent with EGFR inhibition, showing primarily dermatologic adverse events including dermatitis acneiform (74%), epistaxis (30%), dry skin (30%), and fatigue (30%).
The preclinical data suggesting potential reversal of acquired resistance to KRAS G12C inhibitors in lung cancer further expands the therapeutic possibilities, addressing another significant challenge in precision oncology where resistance frequently develops to targeted therapies.
Bicara's positive clinical data across multiple tumor types strengthens its competitive position in important oncology markets with significant unmet needs.
The clinical data package presented by Bicara significantly strengthens their competitive positioning in the oncology space. The efficacy demonstrated in second-line cutaneous squamous cell carcinoma - 30.4% response rate and 82.6% clinical benefit rate in anti-PD-1 refractory patients - addresses a clear market gap with no currently approved options.
Bicara's strategic development of ficerafusp alfa across multiple indications (cSCC, HNSCC, and potentially KRAS G12C-mutant lung cancer) diversifies their clinical risk while maximizing potential commercial opportunities. The bifunctional antibody platform targeting both EGFR and TGF-β pathways provides a differentiated mechanism of action in the competitive solid tumor landscape.
The translational biomarker data showing effective TGF-β blockade and prevention of resistance mechanisms provides scientific validation for their approach. This mechanistic understanding supports both monotherapy strategies in post-immunotherapy settings and combination approaches with pembrolizumab in treatment-naïve patients.
The exploratory work in KRAS G12C resistance mechanisms expands their potential addressable market into another high-value oncology segment where current targeted therapies face significant limitations due to acquired resistance. This multi-indication strategy with a single asset demonstrates efficient research and development resource allocation.
BOSTON, April 28, 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 multiple presentations related to ficerafusp alfa at the American Association for Cancer Research (AACR) Annual Meeting 2025. Ficerafusp alfa is a first-in-class 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) and is being evaluated across multiple solid tumor types.
“We are excited to present several datasets at AACR this year that underscore the broad therapeutic potential of ficerafusp alfa,” said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. “This includes new translational data that further support the ability of ficerafusp alfa to effectively block TGF-β signaling in the tumor microenvironment and underscore its potential to prevent resistance mechanisms and prolong therapeutic durability in HPV-negative recurrent/metastatic head and neck squamous cell carcinoma. We are also pleased to share encouraging clinical data from our Phase 1/1b dose expansion cohort in second line metastatic or advanced cutaneous squamous cell carcinoma, where we’re excited by the potential to continue to investigate ficerafusp alfa as a monotherapy as well as in combination with immunotherapy in the front-line setting. Additionally, we are sharing new preclinical data that offer 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 RAS mutations. We look forward to advancing ficerafusp alfa and believe it has the potential to provide meaningful and durable clinical benefit across multiple solid tumor types where there is a strong biologic rationale for the dual inhibition of both EGFR and TGF-β.”
Dual blockade of EGFR and TGF-β with ficerafusp alfa has the potential to overcome resistance mechanisms in 1L R/M HNSCC in combination with pembrolizumab
Presentation Highlights:
- Preliminary findings from a translational medicine biomarker dataset from Bicara’s ongoing Phase 1/1b trial of ficerafusp alfa in 1L (first line) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) demonstrate that ficerafusp alfa effectively blocks TGF-β signaling in the tumor and prevents key mechanisms associated with drug resistance.
- Spatial transcriptomics revealed downregulation of epithelial-mesenchymal transition and hypoxia pathways in human papillomavirus (HPV)-negative tumors with ficerafusp alfa and pembrolizumab, supporting the potential role of TGF-β inhibition in preventing the mesenchymal phenotype associated with EGFR-targeted resistance, with complementary clinical data highlighting enhanced durability in HPV-negative R/M HNSCC to be presented at the 2025 American Society of Clinical Oncology Annual Meeting.
- These data further support the synergistic effects of targeting TGF-β, EGFR, and PD-1 in the tumor microenvironment, and to combine ficerafusp alfa with pembrolizumab in HPV-negative R/M HNSCC.
Dose expansion results of single agent ficerafusp alfa (BCA101), a bifunctional EGFR/TGF-β inhibitor in patients with metastatic or advanced cutaneous squamous cell carcinoma (cSCC)
Presentation Highlights:
- As of the data cut-off date of March 20, 2025, the single-arm, multicenter dose expansion cohort from an ongoing Phase 1/1b trial evaluating ficerafusp alfa monotherapy enrolled 23 patients with 2L+ metastatic or advanced cutaneous squamous cell carcinoma (cSCC) who had received (or been intolerant to or ineligible for) prior anti–PD-1 therapy.
70% of patients (16/23 patients) had progressive disease as best response to prior anti–PD-1 therapy. - The overall response rate (ORR) was
30.4% (7/23 patients) and the clinical benefit rate (complete response, partial response, and stable disease lasting for ≥5 weeks) was82.6% (19/23 patients). - Median progression-free survival (mPFS) was 7.0 months (
95% CI, 2.7-8.9 months), and the PFS rate at 12 months was25.4% , demonstrating improvements over historical treatment in cSCC. - Tolerable safety profile with the most common treatment-related adverse events of any grade including dermatitis acneiform (17/23 patients;
74% ), epistaxis (7/23 patients;30% ), dry skin (7/23 patients;30% ), and fatigue (7/23 patients;30% ).
“Cutaneous squamous cell carcinoma is the second most common skin cancer, and its rising incidence underscores the growing need for effective treatment options,” said Deborah Wong, MD, PhD, Director of the Head and Neck Medical Oncology Program at the University of California, Los Angeles. “While anti–PD-1 therapies have brought significant advances for patients with advanced or metastatic disease, there remains a critical gap for those whose disease progresses or is refractory to these therapies, with no approved second-line options. The ficerafusp alfa monotherapy data are encouraging, demonstrating responses that appear to improve upon historical benchmarks in this setting.”
Ficerafusp alfa reverses acquired resistance to the KRAS-G12C inhibitor sotorasib in KRAS-G12C-mutated lung tumors
Presentation Highlights:
- In in vitro and in vivo preclinical studies, ficerafusp alfa + a KRAS-G12C inhibitor (G12Ci) was shown to be more effective than G12Ci alone, with G12Ci-resistant lung cancer cells remaining susceptible to this combination.
- This presentation supports the hypothesis that TGF-β inhibition by ficerafusp alfa helps reverse G12Ci resistance and highlights the potential of combining G12Ci with ficerafusp alfa in drug-resistant KRAS-G12C-mutated cancers, including lung cancer.
Following the meeting, the poster presentations will be available on the Bicara website under the Presentations & Publications section.
About Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma (cSCC) is the second most prevalent skin tumor, with an increasing incidence attributed to multiple factors, including exposure to ultraviolet light, genetic predisposition, and environmental elements. For patients whose disease progresses on anti–PD-1 therapy or is refractory to anti–PD-1 therapy, there is no approved second-line therapy. cSCC is estimated to result in up to 8,800 deaths annually in the U.S. alone.
About Ficerafusp Alfa
Ficerafusp alfa is a first-in-class 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-b signaling within the tumor microenvironment.
Ficerafusp alfa is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial 1L (first line) 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 www.bicara.com 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 preclinical studies and presentation of results, the clinical development of ficerafusp alfa and presentation of data from a Phase 1/1b dose expansion cohort of ficerafusp alfa monotherapy in second line or later cSCC, the clinical development of ficerafusp alfa in combination with pembrolizumab, and the expected therapeutic potential and clinical benefits of ficerafusp alfa, including potential efficacy 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.
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FAQ
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