Our Pipeline: First-In-Class

Bicara has more than a platform: We have a deep pipeline of promising bifunctional antibodies and other biologics for treating solid tumors, including a lead program that’s already in the clinic.

  • PROGRAM
    TARGET
    DISCOVERY
    IND-ENABLING
    PHASE 1
    PHASE 2
    PHASE 3
    Indication
  • BCA101
    EGFR / TGF-β
    monotherapy
    combination with pembrolizumab
    EGFR / TGF-β
    cSCC

    HNSCC, SCAC
  • BCA356
    precision
    immunocytokine
    precision
    immunocytokine
    Solid Tumors
  • BCA600
    precision immune
    cell engager
    precision immune
    cell engager
    Solid Tumors
  • BCA500
    Undisclosed
    Undisclosed
    Solid Tumors

We have taken a pragmatic approach to building our pipeline. We seek out a powerful biological rationale and strong potential to address significant unmet needs, which include patients who are refractory to immune checkpoint inhibitors and first-line targeted therapies.

Posters and Publications

Poster Presentation: Development of BCA101, a Bifunctional Antibody Capable of Simultaneously Disabling EGFR and TGF-β Signaling, as a Novel Single-agent Immunotherapy

Society for Immunotherapy of Cancer (SITC) 2021 Annual Meeting, November 2021

Digital Presentations: First-in-human Phase I Study of the Bifunctional EGFR/TGFβ Fusion Protein BCA101 in Patients with EGFR-driven Advanced Solid Cancers

American Society of Clinical Oncology, June 2021

Our Lead Program: BCA101

First-in-class EGFR / TGFβ-trap bifunctional antibody

Epidermal growth factor receptor (EGFR), a protein expressed on the surface of several tumor types, is one of the most extensively validated tumor-associated antigens.

Monoclonal antibodies directed at EGFR suppress the proliferation of EGFR-driven tumor cells and restrict tumor growth and metastasis. Inhibiting EGFR alone is inadequate to achieve durable therapeutic responses. Our solution: Simultaneous inhibition of EGFR and TGFβ — a signaling molecule that promotes tumor growth in the presence of EGFR and that plays a key role in suppressing the immune response in the tumor microenvironment.

Our lead program is thus a dual-action bifunctional antibody that both inhibits EGFR and disables TGFβ directly at the site of the tumor. With this approach, we hope to achieve superior anti-tumor efficacy with an improved therapeutic window.

Phase 1/2 Clinical Study

We have completed dose escalation studies evaluating BCA101 as a single-agent and in combination with pembrolizumab, and have initiated the dose expansion arm of our clinical study.

BCA101 will be administered in combination with pembrolizumab as first-line therapy in patients with unresectable, recurrent or metastatic HNSCC and as second-line therapy in patients with advanced SCAC who have received prior chemotherapy. A third cohort of patients with advanced or incurable cSCC who have received previous anti-PD-1 therapy will be treated with BCA101 as a single agent.

For more information, please visit clinicaltrials.gov.

Enrolling trial sites

  • Houston, TX

  • New York, NY

  • Boston, MA

  • Toronto, ON

  • New York, NY

  • Pittsburgh, PA

  • Charleston, SC

  • Los Angeles, CA

  • San Diego, CA

  • Tampa, FL

  • Cleveland, OH

  • Providence, RI