The company’s syndicate now includes - along with new investor Medicxi - OrbiMed, HBM Healthcare Investments, Novartis Venture Fund, 3B Future Health Fund, Cormorant Asset Management, Wellington Management and Samsung Securities who were all existing investors. In connection with the financing, Giovanni Mariggi, partner at Medicxi, has joined FORE Biotherapeutics’ board of directors.
Proceeds from the financing will be used to accelerate the development of plixorafenib, the company’s investigational, small-molecule, next-generation, orally available selective inhibitor of BRAF alterations.
BRAF alterations are most commonly missense mutations or aberrant fusions. These mutations are observed in numerous primary central nervous system (CNS) tumors as well as metastases.
Positive updated data from the Phase 1/2a trial evaluating plixorafenib in patients with BRAF-altered advanced solid and central nervous system tumors were recently presented at the American Society of Clinical Oncology (ASCO) meeting.
Plixorafenib demonstrated both promising antitumor activity with durable responses and favorable tolerability as a single agent in patients with advanced BRAF-altered tumors.
Matthew Foy, partner at SR One, said: “We invest in companies turning truly innovative discoveries into transformational new therapies in areas with significant unmet clinical needs.
“FORE Biotherapeutics is well-positioned to deliver on the promise of plixorafenib, which has demonstrated promising single-agent activity against BRAF-altered tumors, including primary central nervous system tumors. We look forward to continuing to support the company as it further progresses its ongoing Phase 2 FORTE global, registrational trial.”
In conjunction with the Series D financing, Matthew Ros will step down from his role as chief executive officer and member of the board of directors to redirect his energy toward other professional pursuits, effective September 1, 2023.
Shawn Leland, current advisor to SR One and former founder, president, and chief executive officer of elevation oncology, has been appointed to the board of directors and will transition into the role of interim chief executive officer overseeing the day-to-day activities of the company in collaboration with the management team, until a CEO successor is identified.
“On behalf of the Board of Directors, I would like to sincerely thank Matt for his leadership, dedication and many contributions toward the advancement of plixorafenib to its next seminal phase of clinical development,” said Dieter Weinand, chairman of the board of FORE Biotherapeutics.
“We welcome Shawn as interim CEO and Board member as we enter this next phase of growth for the company. We are also thrilled to welcome Giovanni to our Board as his expertise will be invaluable in advancing the clinical development strategy for plixorafenib.”
Plixorafenib is an investigational, novel, small-molecule, next-generation, orally available selective inhibitor of mutated BRAF. It was designed to target a wide range of BRAF mutations while sparing wild-type forms of RAF.
Preclinical studies and clinical trials have shown that its unique mechanism of action effectively inhibits not only the constitutively active BRAFV600 monomers targeted by first-generation RAF inhibitors but also disrupts constitutively active dimeric BRAF class 2 mutants, fusions, splice variants and other alterations found in a range of cancers.
Unlike first-generation RAF inhibitors, plixorafenib does not induce paradoxical activation of the RAF/MEK/ERK pathway. As a ‘paradox breaker,’ plixorafenib could therefore treat acquired resistance to current RAF inhibitors and, more generally, yield improved safety and more durable efficacy than first-generation RAF inhibitors.