Novellus becomes Fore Biotherapeutics as it completes pivot from diagnostics to precision oncology

Novellus becomes Fore Biotherapeutics as it completes pivot from diagnostics to precision oncology

NovellusDx started out as a diagnostics company but has been making moves toward becoming a cancer therapeutics biotech in recent months, picking up a BRAF drug from Daiichi Sankyo and raising $57 million to shepherd it through the clinic. Now, it’s wrapping its transformation up with a new name and a new CEO: Fore Biotherapeutics and Usama Malik, a former Immunomedics executive who orchestrated the company’s $21 billion buyout by Gilead. 

The company also appointed Dieter Weinand, a veteran of several Big Pharmas, including Bayer, Sanofi, Pfizer and Bristol Myers Squibb, as chairman of its board. The duo arrives as the Jerusalem-based company prepares to move its headquarters to the U.S. and build a U.S.-based leadership team. Malik takes over from Michael Vidne, Ph.D., who transitions to the chief business officer and chief strategy officer roles. Vidne will continue to run the company's team in Israel, Malik said.

So far, Fore has one clinical-stage program: PLX8394, the class 1/2 BRAF inhibitor it licensed from Daiichi’s Plexxikon unit in June 2020. But its model moving forward involves synthesizing mutations of validated cancer targets, studying those mutations in vitro and in-licensing clinical-stage programs for specific patient groups. In essence, it's a patient-matching system that takes drugs that are in the clinic or on the market and sees where they may be useful in patients with unaddressed mutations, Malik said.

"We're not spending any inordinate time in discovery. It will be really rapid, elucidating disease biology and identifying unaddressed mutations," Malik said. "The focus will be finding clinical-stage compounds that have generated data to match with patients and … develop these for precision populations with speed and get them to market as soon as we can."

The hope is to take advantage of science and development that has already happened and bring that to smaller, more appropriate populations, he added.

"There are some pretty stellar clinical compounds that were in trials that were misdesigned, or they were tested in broad populations, so they didn't end up meeting their endpoints. There is a number of opportunities with large pharma and small companies we can partner with and in-license the compound," Malik said, adding that the company is in discussions with companies and universities on various kinds of assets, including JAK- and PI3K-targeting drugs as well as those aimed at synthetic lethality, among various others.

Fore reeled in a $57 million series C in September from the likes of OrbiMed, Novartis Venture Fund and Wellington Management. Those funds will bankroll the development of PLX8394 and the expansion of Fore’s pipeline. The company aims to finish a phase 1 dose-finding study of the BRAF drug in the coming months and aims to kick off a registrational phase 2 study toward the end of the year, pending discussions with health authorities and advisers.

Along the way, the company hopes to add a few more programs to its pipeline, build out its management team in the U.S., and look into financing options over the course of the year.

Editor's note: This story was updated to correct Michael Vidne's new role as Fore's chief business officer and chief strategy officer, not chief scientific officer.