Ficerafusp alfa Clinical Bispecific, Immunoconjugate

Antibody Information

Entry ID	405
INN	Ficerafusp alfa
Status	Clinical
Drug code(s)	BCA101
Brand name	None
mAb sequence source	mAb - source TBD
General Molecular Category	Bispecific, Immunoconjugate
Format, general category	TBD
Format details	TBD
Isotype (Fc)	IgG1
Light chain isotype	TBD
Linker	None
Ave. DAR	None
Conjugated/fused moiety	TGFbeta receptor II ECD
Discovery method/technology	None

Therapeutic information

Target(s)	EGFR, TGF beta
Indications of clinical studies	Head and Neck Squamous Cell Carcinoma, EGFR-Driven Advanced Solid Tumors
Primary therapeutic area	Cancer

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Phase 2/3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	June 01, 2020
Start of Phase 2
Start of Phase 3	December 20, 2024
Date BLA/NDA submitted to FDA
Year of first approval (global)	None
Date of first US approval
INN, US product name	None
US or EU approved indications	None

Company information

Company	Bicara Therapeutics
Licensee/Partner	None
Comments about company or candidate	NCT06788990 in Head and Neck Squamous Cell Carcinoma started in Dec 2024. Aug 2024: We intend to initiate a pivotal Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab as a first-line therapy in recurrent/metastatic, or R/M, HNSCC excluding patients associated with human papillomavirus infection, or HPV-positive patients, with oropharyngeal squamous cell carcinoma, or OPSCC, late in the fourth quarter of 2024 or early in the first quarter of 2025. (https://www.sec.gov/Archives/edgar/data/2023658/000119312524205393/d821336ds1.htm) Results of Phase 1/1b trial of BCA101 as a monotherapy and in combination with pembrolizumab presented in an oral presentation session at the European Society for Medical Oncology (ESMO) Congress 2022, NCT04429542 is a First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGFβ Fusion Protein BCA101 Alone and in Combination With Pembrolizumab in Patients With EGFR-Driven Advanced Solid Tumors March 2021: Cambridge-based Bicara Therapeutics launched with a $40 million investment from its parent company, Biocon, to advance its bifunctional antibodies targeting both tumors and the immune system in cancer patients who are refractory to checkpoint inhibitors.
Full address of company	245 Main Street, Cambridge North America United States of America https://www.bicara.com/about-us/

Description/comment

Described as Bifunctional EGFR / TGFβ-trap bifunctional antibody.
BCA101, an anti-EGFR IgG1 monoclonal antibody linked to an extracellular domain of human TGF-βRII. The TGF-β “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. https://doi.org/10.1158/0008-5472.CAN-21-4425

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None