Amid an FDA overhaul and market volatility, one biotech executive says her public company still operates with the mentality of a private company, while urging the industry to work together with federal health agencies so drug developers can continue to transform cancer care.
“We were probably one of the lucky few that was able to go out last fall and have such a strong and successful IPO,” Bicara CEO Claire Mazumdar, Ph.D., told Fierce Biotech at the end of last week.
“That IPO gives us a significant amount of flexibility,” she said. “We have as of the end of last year over $500 million in the bank, which enables us to fully prosecute our pivotal study that we embarked upon earlier this year. So, we're not necessarily at the mercy of needing to finance again in these turbulent waters.”
Mazumdar credited the upsized $362 million IPO last September to a “great syndicate of crossover investors” and additional public investors who believe in the biotech’s lead asset, a bifunctional antibody dubbed ficerafusp alfa.
The IPO is being used to bankroll a pivotal phase 2/3 trial in head and neck squamous cell carcinoma (HNSCC) that Bicara plans to use to support an accelerated approval submission with the FDA.
Bicara’s cash runway will carry the biotech through the next four years, but it’s not enough to build out a strong commercial footprint if ficerafusp alfa were to snag market approval, according to Mazumdar.
“Should we be close to an approval we would likely look at the environment in several years from now to either finance or find a pharma partner or—I think at that time point there are a number of opportunities we could look at,” the CEO said. “But hopefully two years from now will be a very different world.”
In the meantime, the public company still manages its capital the same way it did as a private biotech, Mazumdar said.
“We continue to operate as if we're in a world where financings are hard to achieve,” she said, with Bicara focusing its resources toward a potential accelerated approval.
In February, Bicara dosed the first patients in the pivotal trial testing out ficerafusp alfa. The bifunctional EGFR/TGF-β antibody is being evaluated in combination with Keytruda among patients with first-line recurrent or metastatic HNSCC.
The biotech expects an interim readout for the trial in early 2027 that could underpin an accelerated approval package, Mazumdar said.
Previously, in a phase 1/1b trial, ficerafusp alfa paired with Keytruda demonstrated a 64% overall response rate, an 18% complete response rate and median progression free survival of 9.8 months in front-line HPV-negative, advanced HNSCC.
Not only does Bicara believe the investigational combo could be first-in-class, but it also has best-in-class potential.
The company plans on sharing updated durability and overall survival data at this year’s American Society of Clinical Oncology conference in Chicago, Mazumdar said.
When asked whether the recent restructuring impacted any of Bicara’s interactions with the FDA, she said the agency has provided guidance on the accelerated approval path.
“So, we continue to build a confidence that we at least have a track record and history of those interactions,” she said. “I think it's too early to know if our review teams will change, but for the time period of this year we feel good about really focused on execution of our study.”
Mazumdar was one of more than 200 biotech stakeholders who signed a letter expressing concern over the FDA’s capacity after mass federal layoffs. The Bicara CEO said she participated given “the significant uncertainty that the administration has caused at the FDA and other regulatory agencies.”
She underscored how important it was that the agency be properly resourced so drug developers feel they are best equipped to get drugs to patients.
“For many clinical-stage companies like ourselves, our No. 1 purpose is delivering these molecules to patients in a timely manner, and we need to work in tandem with the regulatory agencies to do so,” she said.
In the letter—which is addressed to Senate Health, Education, Labor and Pensions (HELP) Committee Chair Bill Cassidy, M.D., R-Louisiana—the biotech leaders urge the government to “quickly preserve and restore its core functions.”
In some cases, biotechs have already seen the effects of the mass FDA layoffs, according to the authors. Examples include submission feedback from a seemingly inexperienced reviewer, an FDA dispute resolution process canceled due to a shortage of senior staffers and conflicting feedback from a review team.
The biotech stakeholders are urging the Senate HELP committee to restore FDA staffing levels to maintain established regulatory timelines and consistency.
“We are lucky to be developing important molecules and important medicines for patients. Many of our peers and colleagues are really changing the future of medicine,” the Bicara CEO concluded. “Drug development is complex. It's time-consuming; it's resource intensive. We as an industry need to work together with the administration, with the regulatory agencies, to really change the landscape for oncology and beyond.”