Prelude Therapeutics is trimming its focus to one of two oncology assets and a second intravenous formulation for another therapy, a new direction that will be steered by BeiGene's former hematology chief medical officer, Jane Huang, M.D.
The Wilmington, Delaware biotech will prioritize PRT811 over PRT543 in its PRMT5 program because of the former's "superior safety profile, higher level of target engagement, and unique brain penetrant properties," said CEO Kris Vaddi, Ph.D., in a statement.
Prelude is testing PRT811 in patients with various cancers, including splicing mutated myeloid malignancies, solid tumors, uveal melanoma and others. The biotech will report data from an ongoing phase 1 dose expansion cohort in the second half of this year, Vaddi said.
The news comes after a relatively rough period for PRMT5 inhibitors, which aim to restrict the protein's role in forming tumors. PRMT5 is one of nine members of the PRMT family and helps control the expression of genes that both promote and suppress tumors. Two PRMT5 inhibitors have been chopped from Big Pharma's pipelines in recent weeks: a phase 1 GlaxoSmithKline drug and another early-stage therapy from Pfizer.
Also getting lowered on the priority list at Prelude is an oral formulation of the MCL1 program for myeloid malignancies. The biotech is instead moving forward with the intravenous version of the phase 1 asset PRT1419. Prelude will begin another phase 1 study by mid-year to test the drug in combination with AbbVie and Roche's Venclexta. Data from that combination study is slated for the second half of this year, Vaddi said.
All of these pipeline adjustments come as Huang assumes the chief medical officer role, in place of David Mauro, M.D., Ph.D., who left four months ago. Huang will also tack on the post of president when she joins Prelude on April 4.
The news comes just seven days after Huang handed in her resignation as chief medical officer of hematology at BeiGene. She will leave the Beijing-based biopharma on April 3, but continue on as a consultant until mid-November.
Huang oversaw multiple approvals for BeiGene's cancer drug Brukinsa across more than 45 countries and multiple nods for the lymphoma med tislelizumab in China during her five years at BeiGene. Brukinsa, also known as zanubrutinib, was the first cancer drug discovered in China to win FDA approval in November 2019. BeiGene and partner Novartis await the FDA's decision on tislelizumab as a treatment for esophageal cancer.
When she steps into Prelude, Huang will also oversee a new asset, PRT3645, a CDK4/6 inhibitor, which the company is preparing to ask the FDA to approve a clinical trial for in the middle of this year, the biotech said. Prelude also plans to ask for another clinical trial green light for a protein degrader program dubbed SMARCA2/BRM.