Shortly after Bicara Therapeutics raised more than $360 million in an IPO, the cancer biotech and its former parent company have been hit with accusations of intellectual property theft.
Biocon allegedly purloined confidential information—which was protected under a nondisclosure agreement—to file patents around a novel immunotherapy approach, according to a new lawsuit filed by the South San Francisco-based biotech Y-Trap. Biocon then launched Bicara to develop and commercialize the tech, the suit says.
Y-Trap’s legal team asserts that Bicara was “created in order to usurp and monetize” a patent family tied to technology its co-founders invented, hindering Y-Trap’s ability to secure funding, forge partnerships and develop its own immunotherapy candidate.
Now, Y-Trap is seeking credit on Biocon’s patents, injunctions against Biocon and Bicara from making “disparaging and untrue statements” about the inventorship of the patent family in question and monetary damages. To make its case, Y-Trap is also pushing for a jury trial.
Bicara is aware of Y-Trap's complaints and believes the claims are "without merit," a company spokesperson said over email. The spokesperson added that Bicara is confident in its position.
Biocon, for its part, did not immediately respond to Fierce Pharma’s request for comment.
According to the legal complaint, biotech startup Y-Trap is the exclusive licensee of a family of patents co-invented by its co-founders Atul Bedi and Rajani Ravi, who assigned their inventions to Johns Hopkins University (JHU).
Specifically, Bedi and Ravi invented a family of bifunctional antibody-ligand traps, known as Y-Traps, designed to restore the ability of the immune system to attack cancer cells, according to the lawsuit. This led to the development of a fusion protein made up of a targeting antibody that binds epidermal growth factor receptor (EGFR) and an immunomodulatory moiety that is a ligand-binding sequence of the extracellular domain of TGFβRII, the suit explains.
Back in 2010—after Bedi and Ravi had filed the patent application for their invention—Bedi shared information about his fusion protein under a confidential agreement with Indian drugmaker Biocon and its chairperson and founder, Kiran Mazumdar-Shaw, the complaint says.
From June 2010 to April 2012, Muzumdar-Shaw is alleged to have “repeatedly pressured” Bedi to help Biocon obtain a license to the related patent family from JHU. Then, Biocon opted to file a “copy-cat version” of the patent family, known as ‘789 Bedi IP, while “falsely claiming inventorship of identical subject matter,” the lawsuit contends.
Y-Trap’s lawyers argue Biocon concealed its plans to develop its own EGFR/TGF-β-binding fusion protein until 2021, when it launched Bicara with $40 million to develop and commercialize its candidate ficerafusp alfa, also known as BCA101.
Bicara “profited handsomely from their conspiracy and unfair competition,” the suit argues, citing a series of fundraising rounds that ultimately brought the Biocon-founded company’s market capitalization to more than $1 billion.
Y-Trap’s legal complaint comes a little more than a month after Bicara made its $362 million debut on the Nasdaq stock exchange.
Upon filing IPO paperwork in late August, Bicara said it was seeking cash to fund a pivotal phase 2/3 trial of its candidate ficerafusp alfa in head and neck squamous cell carcinoma (HNSCC). If all goes to plan, Bicara would use the data from that trial to support a filing for FDA approval of its bifunctional antibody.
Bicara is hoping to kick off its phase 2/3 study around the end of 2024 and to conduct an interim overall response rate (ORR) analysis in 2027.
The company is also running a phase 1/1b study looking at the effect of its candidate and Merck & Co.’s Keytruda as a first-line therapy in recurrent or metastatic HNSCC. At an interim analysis, the trial showed the combo yielded an ORR of 54% among 39 patients. Taking patients with human papillomavirus (HPV) out of the mix, ORR was 64% and median progression-free survival was 9.8 months.