More questions than answers for biopharma after UK election; Intercept gets FDA advisory date, and a PDUFA delay
→ On Thursday, voters in the UK handed Boris Johnson’s Conservative government, and its aggressive Brexit stance, a clear majority. Urte Jakimaviciute, GlobalData‘s senior director of market research, weighed in on the biotech implications.
“The pharma sector has been allocating significant amounts of money to deal with any potential consequences of Brexit, and with Conservatives winning the election, Boris Johnson’s withdrawal agreement should be backed by the UK’s parliament. Even though the UK is set to leave by January 31, it is unclear what kind of relationship with the EU Boris Johnson will seek. No matter what contingency plans are in place and how much funds pharma companies are allocating to deal with the consequences of Brexit, it is very hard to be ready for whatever is going to happen due to an enormous degree of uncertainty surrounding the process. You cannot fully prepare for something that you cannot control.”
→Intercept Pharmaceuticals $ICPT, one of the leading players in the heated race to get a NASH drug approved, reported late-stage data earlier this year that showed its experimental drug met the main goal of improving scores on liver fibrosis, but not NASH resolution. Buoyed by its degree of success in a field littered with failure, the company submitted an FDA marketing application. On Friday, it said the FDA had set its advisory committee data to deliberate on the approvability of the drug for April 22, 2020 — which will likely delay the agency’s final decision on the drug by three months. “This is unfortunately after the current PDUFA of March 26, 2020 and thus we (and ICPT) expect the PDUFA will likely get pushed from March to June 2020 now,” Jefferies analyst Michael Yee wrote in a note. “We had previously flagged this potential change in notes and our video but don’t think it’s a big deal, is similar to the AMRN situation, and reflects the difficulties of getting Adcom’s organized.” Separately, Intercept said it has also submitted an application to market the drug in Europe.
→OncoSec $ONCS announced interim results from a phase II trial testing their interleukin 12 therapy TAVO in combination with Merck‘s Keytruda. The overall response rate was 28.5%, with 4 out of 14 evaluated patients experiencing partial responses that were characterized as “rapid tumor reductions.” Data is still being collected, they said, with all patients having undergone 6 to 9 months of treatment.
→Transgene $TNG announced that a phase II trial testing TG4010 in non-small cell lung cancer has failed — so it is abandoning the experimental IL-2 drug. The French biotech did not release specific results. It’s their second clinical failure, following the Phase III flop of the oncolytic virus program they ran with partner SillaJen. The company also signed a $13 million partnership with AstraZeneca in May.
→Anixa Biosciences $ANIX is delaying its preclinical CAR–T treatment, citing the need for genetic engineering. The company, in its former guise as Itus Corporation, licensed The Wistar Institute’s CAR-T tech for solid tumors, focusing first on ovarian cancer. Now, citing their lead scientist and inventor of their CAR-T tech, Jose Conejo-Garcia, Anixa said the tech could use enhanced genetic engineering that would improve the viral vector and promote more follicle-stimulating hormone on the transformed T-Cells. “This optimization work may take an additional year,” they wrote, “resulting in the filing of the IND in late 2020, with clinical trials to commence in 2021.”