Seagen gets August PDUFA for Padcev expansions; Adaptate pulls in new cash for gamma delta T cell antibodies
Seagen is riding the wave of two new priority reviews straight to the FDA.
The Bothell, WA-based biotech and their partners at Astellas announced Monday that two supplemental BLAs for Padcev had been accepted by US regulators. FDA has set Aug. 17 as the PDUFA date for the reviews.
“With our recent regulatory submissions, we intend to provide the highest level of clinical evidence supporting Padcev use — overall survival data from a randomized Phase III trial — and expand availability in multiple countries where there is unmet medical need,” said Astellas oncology chief Andrew Krivoshik.
The first sBLA is based on a Phase III trial that sought to convert Padcev’s accelerated approval to regular approval. The second sBLA, meanwhile, is centered around another pivotal trial second cohort, requesting an expansion of the current indication to include a new subset of urothelial cancer patients.
Padcev first won accelerated approval back in late 2019 to treat urothelial cancer in later-line, locally advanced or metastatic settings.
Adaptate gets new cash for gamma delta T cell antibodies
Following their first raise back in late 2019, Adaptate has closed some new funding.
The London biotech announced what it’s calling a Series A2 round, coming in the form of $18 million from existing investors Abingworth and Takeda. Funds will be used to accelerate Adaptate’s lead antibody program towards the clinic and to expand its internal product pipeline, the company said.
“The funding is a great vote of confidence from our existing investors and testimony to the hard work and rapid progress we have made in the novel field of gamma delta T cell targeting antibodies,” CEO Natalie Mount said in a statement.
The antibody concept behind Adaptate is an increasingly popular form of therapy. AbbVie, Eli Lilly, Regeneron, and Sanofi, among a long list of others, are each developing bispecific antibodies.
Rezolute takes out $30 million loan
California-based drug developer Rezolute has entered into a new debt financing agreement. Rezolute will receive $30 million in the loan agreement with investment affiliates managed by SLR Capital Partners.
Half of the $30 million loan was funded upon closing with an interest only period of 24 months. The remaining $15 million may be funded upon Rezolute achieving certain predetermined milestones and conditions.
Per the company’s 8-K detailing the loan, the second $15 million is divided up into two tranches of $7.5 million each, which will be paid before Sept. 25, 2022. Each portion of the loan matures in April 2026. Rezolute noted that the cash will go toward general business purposes.