TG Therapeutics scores priority review for PI3Kδ inhibitor; Galapagos searches for IBD targets in new pact
TG Therapeutics’ pitch for umbralisib as a safer PI3Kδ inhibitor has convinced the FDA to put it on the fast lane.
Regulators have accepted the NDA for the once-daily drug, a dual inhibitor of PI3K-delta and CK1-epsilon first aimed at two indications: marginal zone lymphoma patients who have received at least one anti-CD20-based regimen, and follicular lymphoma patients who have gone through at least two lines of systemic therapies.
As the MZL use was designated “breakthrough” therapy, the FDA is also granting priority review and setting a PDUFA date of February 15, 2021. The FL decision has a deadline in June.
“The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss this application,” TG Therapeutics wrote, usually a positive sign.
The data package came mostly from the UNITY-NHL Phase IIb trial, the company added, where both the MZL and FL cohorts met the 40%-50% target on overall response rate, the primary endpoint. The single-agent study was specifically designed to model the studies that brought accelerated FDA approval for other PI3Kδ drugs, CEO Michael Weiss previously noted.
Galapagos inks target discovery deal focused on inflammatory bowel disease
Taking the precision medicine approach on autoimmune diseases, Galapagos has enlisted Boston-based Scipher Medicine to identify new targets and pathways that can lead to new treatments for inflammatory bowel disease.
Galapagos — whose own drugs for inflammation and fibrosis have inspired multibillion-dollar deals from Gilead — has the option to move up the targets into drug discovery and development. Scipher retains the rights to opt in, on top of receiving upfront and milestone payments.
“Our breakthrough approach combines extensive patient-level molecular data with AI methods to discover novel targets with the potential to treat specific groups of patients, including those not responding to therapies currently available,” said Alif Saleh, CEO of Scipher.
RedHill finds a manufacturer for AstraZeneca drug — which is also funding R&D work
RedHill Biopharma has tied a few more knots with its Dublin-based partners at Cosmo, lining up a manufacturing deal as well as some cash for two experimental drugs.
Three drugs are covered in the deal: Movantik, the treatment for opioid-induced constipation RedHill recently licensed from AstraZeneca; RHB-204, an oral combination of clarithromycin, rifabutin, and clofazimine designed to tackle pulmonary nontuberculous mycobacteria (NTM) infections; and a yet unnamed drug for H. pylori infections.
Cosmo has agreed to fund the pivotal Phase III study for RHB-204, with $5 million due upon signing and $7 million divided between two milestone payments, in exchange for 15% royalty payments. It’s also paying $7 million upfront to license European rights to the unnamed experimental compound and committing $2 million upon approval, while footing 30% of the clinical trial costs in both the US and Europe. RedHill will be entitled to 30% royalties.
As part of the agreement, RedHill is also hiring Cosmo to be the sole manufacturer of both these drugs as well as Movantik. The Israeli biotech is paying €5.5 million for the tech transfer, formulation and development work.