Bicara Therapeutics Presents Data from Dose Escalation Portion of Ongoing Phase 1/1b Trial of Lead Bifunctional Program, BCA101, at the American Society of Clinical Oncology 2022 Annual Meeting

• Durable responses achieved in highly refractory patients as monotherapy (one patient with relapsed squamous cell lung cancer) and in combination with pembrolizumab (several subjects with relapsed squamous cell carcinoma of the anal canal and head and neck squamous cell carcinoma)

• Dose escalation portion of the study has completed and recommended dose declared, as monotherapy and in combination with pembrolizumab

• BCA101 has a manageable safety profile, a predictable PK and peripheral and tumor PD markers that support mechanisms of action

CAMBRIDGE, Mass., June 3, 2022 – Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to modulate the tumor microenvironment to elicit a potent and durable anti-tumor response, today announced the presentation of new clinical data on BCA101, a bifunctional antibody designed to target the TGF-β trap to EGFR+ tumors. Data from the dose escalation phase of the ongoing Phase 1/1b trial of BCA101 as a monotherapy and in combination with the immune checkpoint inhibitor pembrolizumab will be presented in a poster discussion session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.

“We observed durable responses across three different indications in a heavily pretreated and advanced cancer population, including a partial response in one patient with relapsed squamous cell lung cancer who was treated with BCA101 as monotherapy. Additionally, observed biomarkers support the mechanisms of action for BCA101 and demonstrate clear remodeling of the tumor microenvironment,” said Liviu Niculescu, M.D., Chief Medical Officer of Bicara Therapeutics. “The findings from the dose escalation phase of the ongoing Phase 1/1b trial are compelling and support our view that BCA101 offers a potentially more efficacious and durable treatment option for patients with several types of solid tumors, particularly in combination with other immunotherapies.”

“BCA101 is a first-in-class antibody with a unique mechanism of anti-tumor activity that has demonstrated encouraging safety, pharmacokinetic, pharmacodynamic and efficacy profiles,” said Philippe L. Bedard, M.D., Staff Medical Oncologist at Princess Margaret Cancer Centre in Toronto.

BCA101 Data Highlights:

• A confirmed partial response was observed in one patient with squamous-cell lung cancer (SQCLC) (refractory to chemo and PD-1) who received BCA101 monotherapy treatment. The patient continues in the study.
• Durable confirmed responses were achieved with four patients treated with BCA101 in combination with pembrolizumab: two patients with head and neck squamous cell carcinoma (HNSCC) (one refractory to cetuximab, PD-1 and chemotherapy) and two patients with squamous cell carcinoma of the anal canal (SCAC).
• BCA101 was safe at all tested dose levels as monotherapy and in combination with pembrolizumab.
• BCA101 achieved dose-proportional PK and demonstrated definitive target engagement in both plasma and tumor tissue for both EGFR and TGF-b.
• The recommended dose was declared at 1500 mg once weekly for BCA101 as monotherapy and in combination with pembrolizumab.

BCA101 is currently being evaluated in a Phase 1/1b study as monotherapy and in combination with pembrolizumab as a first-line therapy in patients with unresectable, recurrent or metastatic HNSCC and as a second-line therapy in patients with advanced SCAC who have received prior chemotherapy. A third cohort of patients with advanced or incurable cutaneous squamous cell carcinoma who have received previous anti-PD-1 therapy will be treated with BCA101 as a monotherapy. Bicara initiated the dose expansion arm of this study in February 2022. Primary results are expected in the second half of 2022. 

ASCO Presentation Details

• Title: A phase 1 trial of the bifunctional EGFR/TGF-β fusion protein BCA101 alone and in combination with pembrolizumab in patients with advanced solid tumors
• Abstract: 2513
• Session Type/Title: Poster Session/Developmental Therapeutics – Immunotherapy
• Session Date and Time: Sunday, June 5, 2022, 12:30 – 2:00 p.m. EDT

About BCA101

BCA101 is a first-in-class EGFR / TGF-β-trap bifunctional antibody designed to modulate the tumor microenvironment by binding to the well-validated EGFR antigen and disabling TGF-β, a signaling molecule that plays a key role in suppressing the immune response within the tumor microenvironment. Promising preclinical data suggest that BCA101 is superior to the anti-EGFR antibody cetuximab and single-agent TGF-b inhibitors in preventing tumor recurrence, as well as in remodeling the tumor microenvironment and restoring immune activation. An ongoing Phase 1/1b dose-escalation clinical trial of BCA101 was initiated in July 2020 and has enrolled patients with various advanced solid tumors both as a single agent, as well as in combination with pembrolizumab, a PD-1 inhibitor. A recommended dose for expansion has been declared and the expansion phase of the study is currently enrolling. For more information, please visit study number NCT04429542 at www.clinicaltrials.gov.

About Bicara Therapeutics

Bicara Therapeutics is a clinical-stage biotechnology company developing first-in-class biologics engineered to bring together the precision of targeted therapy and the power of tumor modulation. The company’s bifunctional antibodies are designed to deliver a payload directly to the tumor microenvironment for an improved therapeutic window and long-lasting efficacy. Bicara’s lead asset, BCA101, a first-in-class EGFR / TGF-β-trap bifunctional antibody, is currently enrolling patients in a Phase 1/1b study. Bicara’s experienced team brings deep expertise across oncology, clinical development, business development and operational strategy.

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