AI upstart grabs $40M launch round; Sanofi backs a gene therapy player; Axsome hits a snag at the FDA
Boston AI-focused biotech DeepCure closed a $40 million Series A, according to a company announcement this morning — adding more than five times the amount of money the company had before: from $7 million raised since the company’s founding in 2018 to $47 million total.
Their goal? To have an R&D process that has drugs fully designed, synthesized and tested by AI, according to a company statement.
The round was led by Morningside Ventures — eliciting participation from previous investors such as TLV Partners, Sapir Venture Partners, and Benon Group.
“We are delighted to welcome a top-tier syndicate of leading healthcare investors led by Morningside Ventures that support our vision of developing an end-to-end drug discovery pipeline designed, optimized, synthesized, and analyzed by AI,” said DeepCure CEO and co-founder Kfir Schreiber.
The money will be used to expand DeepCure’s pipeline with five additional oncology programs and develop an automated robotic wet lab to further its goal of AI-involved R&D. The funding will also be used to hire more drug discovery scientists and technologists — double what the company currently has in tandem with DeepCure’s planned global expansion with the launch of two new sites in Greece and Israel.
“This investment positions us to advance our first novel small molecule compound to file for IND, advance our pipeline and realize our vision of making a significant impact for patients,” added DeepCure’s CSO and other co-founder Joseph Jacobson. — Paul Schloesser
UK biotech Gyroscope to receive equity investment from Sanofi six months after abruptly postponing IPO
Gyroscope Therapeutics announced that Sanofi has committed up to $60 million in an equity investment.
The eye disease-focused gene therapy biotech said this morning in a statement that the French Big Pharma will invest $40 million as an initial equity investment into Gyroscope initially, at a premium to Gyroscope’s previous $148 million Series C financing. The additional $20 million will be invested based on a future qualifying investment round — and subject to certain closing conditions.
The biotech startled investors and analysts after postponing its IPO in May, citing market conditions.
“We are thrilled to welcome Sanofi onboard as an investor in Gyroscope,” said Gyroscope CEO Khurem Farooq. “We believe our lead investigational gene therapy, GT005, has the potential to be the first gene therapy for geographic atrophy.”
Geographic atrophy is chronic progressive degeneration of the back of the eye and can be seen as part of late-stage age-related macular degeneration, or AMD.
An unnamed Sanofi R&D executive will join Gyroscope’s clinical advisory board to advise on matters related to the development of GT005 for geographic atrophy. Additionally, Gyroscope has granted Sanofi exclusive right of first refusal on certain potential future transactions for GT005 in select markets.
Gyroscope plans to use proceeds from this investment to support funding of ongoing clinical trials of GT005, as the drug has been granted fast track designation by the FDA. — Paul Schloesser
Selecta shows promising results in gene therapy delivery and re-dosing patients in Phase I trial
Gene therapy scientists see a benefit in redosing patients after the first dose of a therapy. But the issue of an immune response against adeno-associated viruses (AAVs) has pushed companies to try and get around it.
Selecta Biosciences thought it found a way to tamp down the body’s immune response back in October — and Takeda doled out more than $1 billion to get in on the action.
Now today, the biotech revealed results from a Phase I trial looking into the body’s immune response to their ImmTOR platform — and the results may be promising.
With AskBio, Selecta unveiled top-line results this morning from a Phase I randomized, placebo controlled, double blind, dose-escalation study. The goal is to evaluate Selecta’s ImmTOR platform in mitigating the formation of neutralizing antibodies against an AAV8 capsid — which is used in gene therapies.
At day 30, in subjects who were administered a single 0.3 mg/kg dose of ImmTOR, Selecta observed a median anti-AAV8 neutralizing antibody titer of 1:5 — 250 times lower than that observed in subjects dosed with AAV8 capsid alone, according to a Selecta statement.
“We look forward to leveraging these exciting and novel findings in the clinic across our wholly owned gene therapy pipeline and alongside our world class gene therapy partners to achieve our goal of improving the lives of those living with monogenic diseases,” said Selecta president and CEO Carsten Brunn.
In the Phase I study, researchers evaluated the administration of a single IV dose of a AAV8 empty capsid containing no DNA with and without a single dose of ImmTOR in 23 subjects. — Paul Schloesser
Axsome depression drug hits a CMC hurdle at the FDA
Axsome’s depression drug AXS-05 has hit a snag at the FDA.
The biotech $AXSM reported Monday morning that regulators notified the company that they will not hit the PDUFA target action date — set all the way back on Aug. 22 — after citing CMC deficiencies.
According to their statement:
The Company was recently informed of two deficiencies related to analytical methods in the Chemistry, Manufacturing, and Controls (CMC) section of the NDA, which must be addressed prior to the FDA taking action on the NDA. The Company believes these deficiencies are addressable and is confirming the details of the request with the FDA.
— John Carroll