The launch of Fore Biotherapeutics in the U.S. reflects an evolved biotech business model focused on matching patients with unaddressed tumor mutations with the right oncology medicines in the clinic, the company said.
Israel-based NovellusDx is rebranding and setting up shop in the United States under the operating name Fore Biotherapeutics U.S. The new business location has yet to be announced.
The launch of Fore Biotherapeutics in the U.S. reflects an evolved biotech business model focused on matching patients with unaddressed tumor mutations with the right oncology medicines in the clinic, the company said.
Using an integrated functional genomics and machine learning drug discovery engine, Fore Biotherapeutics synthesizes a wide range of mutations across validated oncological targets and in-licenses clinical-stage small molecule assets to develop for hyper-targeted populations.
The U.S.-based Fore will be helmed by Chief Executive Officer Usama Malik, who recently helmed Immunomedics until its acquisition by Gilead Sciences. NovellusDx’s previous CEO, Michael Vidne, will assume the role of chief business and strategy officer. Dieter Weinand, who has held executive leadership roles at Bayer, Sanofi, Pfizer, Bristol Myers Squibb and other companies, will serve as chairman of the board of directors. Weinand also currently serves as chairman of the board at Replimmune.
Vidne said the next phase of NovellusDx’s journey is aimed at making the company a world leader in targeted oncology drug development. The company’s lead program is PLX-8394, a BRAF inhibitor with a differentiated mechanistic profile licensed from Plexxikon, a Daiichi Sankyo company. PLX-8394’s development is aimed at clinical settings for which there are currently no FDA-approved BRAF inhibitors, including BRAF fusions and certain BRAF-mutated gliomas. When PLX8394 was licensed in June 2020, the asset was in a Phase I/II study in patients with advanced, unresectable solid tumors.
Vidne touted the leadership capabilities of Malik and Weinand.
“Their expertise will be invaluable as we begin leveraging our functional genomic platform to build our pipeline of clinical development oncology programs. I look forward to working closely with both and contributing to the continued growth of the company,” Vidne said in a statement.
Malik said the company is at the forefront of redefining drug development in precision oncology.
“Our highly differentiated and proprietary functional genomics platform allows us to characterize a wide range of mutations on target genes and test their response to candidate compounds. This, in turn, enables us to home in on exciting clinical assets that have a higher probability of success for precision populations,” Malik said in a statement.
As Fore finds a toehold in the U.S., the company said it intends complete its Phase 1 dose-finding study in the coming months, and then a pivotal Phase II study of PLX8394.
“The company represents an exciting story in precision oncology today. With the backing of leading life science funds, and on the strength of its clinical Class I/II BRAF inhibitor, I believe the company is poised to change the drug development paradigm, and has the potential to deliver tangible benefits to currently underserved populations of cancer patients,” Weinand said in a statement.
The rebranding follows a $57 million Series C financing round in September of 2020. The round was led by Pontifax, and joined by OrbiMed Advisors, HBM Healthcare Investments, Wellington Management, Cormorant Asset Management, Novartis Venture Fund (NVF), SR One, as well as existing investors.
