Idera officially puts to rest its Phase III trial in advanced melanoma; BeiGene nabs priority review for sNDA
Idera dropped some disappointing news in late March, when it showed its lead drug failed to hit its primary endpoint in a Phase III trial. Now, Idera, which worked with Bristol Myers Squibb to test the drug, known as tilsotolimod, in combination with ipilimumab versus ipilimumab alone in patients with anti-PD-1 refractory advanced melanoma, is saying that trial will not finish.
“Our conclusion is that the totality of the data, with all patients having completed the study treatment, does not support the likelihood that the combination of tilsotolimod with ipilimumab would achieve a statistically significant OS benefit over ipilimumab alone,” Vincent Milano, Idera’s CEO, said in a statement on Wednesday.
What’s more, Idera’s CMO Elizabeth Tarka also announced she’s leaving the company next week. The company said it will continue to enroll patients in a Phase 2 study of tilsotolimod in combination with BMS’s nivolumab and ipilimumab for patients with microsatellite-stable colorectal cancer and to support AbbVie in providing study drug in their trial for patients with head and neck squamous cell carcinoma. — Zachary Brennan
BeiGene nabs priority review for sNDA
The FDA has agreed to a quicker review of BeiGene’s sNDA for Brukinsa (zanubrutinib) for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy. The agency has until September 19 to make a decision.
“This is our first regulatory submission in MZL, a serious disease diagnosed in more than 2,000 patients every year in the U.S., with no clear standard of care,” the company said in a statement.
FDA previously approved Brukinsa as a second line treatment for mantle cell lymphoma. — Zachary Brennan
Rare disease coalition adds Texas-based Taysha
Taysha Gene Therapies has joined the newly formed Rare Disease Company Coalition, the company announced Wednesday.
The gene therapy company that focuses on AAV-based central nervous system diseases will join a number of others in educating and advocating policymakers of the circumstances of rare disease companies. Its members include Orchard Therapeutics, Agios Pharmaceuticals and Acceleron Pharma.
Over the next month, the coalition will discuss meaningful drug and healthcare policies and regulations, such as drug pricing.
“As we grow to become a leader in the development of gene therapies for the treatment of rare diseases, we have a responsibility to our community, especially to our patients and their families, to advocate for more effective policies and regulations that will encourage innovation around potentially life-saving therapies,” CEO RA Session II said in a statement. — Josh Sullivan
BARDA-funded CARB-X gives grant to Basilea to fight drug-resistant infections
Switzerland-based Basilea Pharmaceuticals has been awarded a grant worth $2.7 million from CARB-X to develop treatments for drug-resistant infections.
Basilea will use the funding to develop new class antibiotic to treat Gram-negative bacteria, such as Acinetobacter baumannii and multi-drug resistant Pseudomonas aeruginosa. Both bacteria are listed as serious threats by the CDC and WHO, and are in need of new antibiotics.
CARB-X — which stands for Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator — is led by Boston University, and receives funding from BARDA. Basilea has successfully launched 2 antibiotic treatments, Cresemba for invasive fungal infections and Zevtera for severe bacterial infections. — Josh Sullivan