Bicara’s BCA101 showed an 89% disease control rate in patients with head and neck squamous cell carcinoma (HNSCC) in interim data from the ongoing Phase I/II clinical trial. Credit: Pormezz via ShutterStock.

Boston-based Bicara Therapeutics has raised $165m in a Series C financing round to advance its EGFR/TGF-β fusion protein inhibitor BCA101. 

The Series C finance round was co-led by Braidwell LP and TPG, with new investors, including Deerfield Management, Fairmount, and Aisling Capital. 

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BCA101 is a fusion protein that is meant to increase antitumour activity through increased activation of natural killer cells, and preventing epithelial-mesenchymal transition and metastasis through inhibition of EGFR and TGF-β. The company has been presenting clinical updates with this drug at conferences this year. 

In October, Bicara presented interim data from the Phase I/II (NCT04429542) study at the European Society for Medical Oncology (ESMO) Congress in Madrid, Spain, following another presentation at the American Society of Clinical Oncology (ASCO) conference in June, in Chicago. Data presented at ESMO highlighted that out of 39 patients evaluable for efficacy, 57% had a response while the disease control rate was 89%. In addition, the drug candidate maintained a tolerable safety profile in frontline HNSCC.

Bicara reported that for the patients with HPV-negative disease, median progression-free survival (mPFS) has not been reached, as of August 27. 

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The fusion protein is under development for the treatment of solid tumours, including human papillomavirus (HPV)-negative, recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), advanced squamous non-small cell lung cancer (SqNSCLC) and cutaneous squamous cell carcinoma. 

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In the announcement accompanying the funding, Bicara chief executive officer Claire Mazumdar said: “With additional data readouts anticipated in 2024, we remain excited about the overall potential of BCA101 to help patients with HPV-negative R/M HNSCC, as well as other solid tumour types.” 

According to a report on GlobalData’s Pharma Intelligence Centre, global market sales for HNSCC drugs are forecast to reach $5.25bn.  

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