Sage, Biogen head to FDA with $3.1B depression drug; Sana puts down $50M to tap Beam's CRISPR tech
Weeks after announcing they would drop a pair of studies deemed unnecessary to file the depression drug zuranolone for approval, Sage and Biogen are going for it.
Following a pre-NDA meeting with the FDA, the partners say they plan to submit an NDA in the second half of 2022 for major depressive disorder, with a second for postpartum depression to follow in 2023.
“We have identified what we believe is the most efficient path forward for an FDA filing and potential approval,” Sage CEO Barry Greene said in a statement.
They will be carrying on that path data from completed studies in the LANDSCAPE and NEST programs, plus results from ongoing clinical and pharmacology studies — although they didn’t specify which ones. It could include the CORAL study, which the companies noted is fully enrolled with topline data expected in early 2022.
Despite an early flop with the MOUNTAIN study and mixed results in the more recent WATERFALL readout, Sage and Biogen (which devised a $3.1 billion deal to team up on the drug) have remained confident about zuranolone.
But then again, Biogen has never shied away from controversial therapies, exemplified by Aduhelm and more recently the ALS drug tofersen.
“The efficacy and safety data planned for FDA submission support our vision of zuranolone being an as-needed, two-week, once-daily treatment option for MDD and PPD that produces rapid relief from symptoms within days,” Al Sandrock, Biogen’s R&D chief, said in a statement. — Amber Tong
Sana puts down $50M to tap Beam’s CRISPR tech
The cell therapy experts at Sana have picked up a new tool to tinker with their cells.
Paying Beam Therapeutics $50 million upfront grants Sana access to its CRISPR Cas12b nuclease system, which enables scientists to knock out and knock in genes in certain cell types — extremely useful for the ex vivo allogeneic T cell and stem cell-derived programs at Sana.
“Gene editing technology is a key component in developing engineered cells as medicines,” Sana CEO Steve Harr said. “The specificity and efficiency of Cas12b make it appealing for Sana’s allogeneic T cell as well as gene-edited pluripotent stem cell programs.”
The first IND involving this technology could be filed as early as next year, he added, with many more to come. — Amber Tong
Boehringer Ingelheim exercises IP option to develop CF cell therapy
German pharma Boehringer Ingelheim announced today that it has exercised options on intellectual property to progress and accelerate development of a potential treatment for cystic fibrosis, or CF.
Boehringer has been working with the IP Group, the UK Cystic Fibrosis Gene Therapy Consortium and Oxford Biomedica on a multi-field partnership since 2018. Now the IP Group, acting on behalf of GTC host universities (Imperial College in London and the Universities of Oxford and Edinburgh), will grant exclusive global rights to Boehringer to develop, manufacture, register and commercialize a lentiviral vector-based gene therapy for the treatment of cystic fibrosis. Oxford Biomedica will be chipping in its manufacturing knowhow.
This deal between academia, biotech and venture capital has centered around BI-3720931, an inhalation-based lentiviral vector which would ideally introduce a healthy CFTR gene into relevant cells.
Per the agreement from August 2018, Boehringer Ingelheim will pay IP Group an option exercise fee and milestone payments, as well as royalties. Oxford Biomedica will receive an option exercise fee of $4.8 million and will be entitled to payments in an aggregate amount of up to $38 million upon reaching various milestones, plus royalties. – Paul Schloesser
Bristol Myers licenses fifth Dragonfly drug
Celgene was the first company to jump on Dragonfly’s TriNKET platform, but the new bosses at Bristol Myers Squibb have licensed more and more of the candidates. Which leads us to Monday, when Dragonfly announced that Bristol Myers licensed its fifth drug candidate from the platform.
That brings the total drug candidates licensed by Bristol Myers to six — including Dragonfly’s IL-12 cytokine BMS-986415.
Dragonfly also announced Monday that the first patients have been dosed in Phase I clinical trials of investigational immunotherapies CC-96191 and CC-92328, both of which are licensed to Bristol Myers.
The immunotherapies are being tested for relapsed or refractory acute myeloid leukemia and relapsed and/or refractory multiple myeloma, respectively. These are the second and third TriNKET candidates in the clinic.
“We believe this recent opt-in decision by Bristol Myers Squibb further validates our drug discovery platform,” said Dragonfly CEO Bill Haney. – Paul Schloesser
Clovis Oncology enlists ITM for long-term radioisotope supply
Radiopharma newbie Clovis Oncology has turned to a more experienced player in the space for a clinical supply agreement, the companies announced Tuesday.
The deal provides Clovis with ITM’s purified radioisotope Lutetium-177 to use in developing FAP-2286, Clovis’ fibroblast activation protein (FAP)-targeting therapeutic candidate.
FAP-2286 is currently being investigated in a Phase I/II study for patients with advanced solid tumors. The deal is initially for five years, and no other details of the arrangement were released.
“Clovis Oncology is committed to advancing FAP-2286’s clinical development program … A critical element to advance this program is ensuring long-term supply of radioisotopes, and this agreement allows us to achieve that goal,” said Clovis president and CEO Patrick Mahaffy. – Paul Schloesser
D&D Pharmatech bags $51M to fuel diabetes, NAFLD trials
South Korean biotech D&D Pharmatech revealed Tuesday that it closed a $51 million Series C round led by Praxis Capital Partners.
Other investors include DS Asset Management, Kudos Ventures and Korea Investment & Securities. The new round comes after a $137.1 million Series B round was completed in August 2019. D&D is planning an IPO in Korea next year.
The funds will be used to advance the dual agonist candidate DD01 into a Phase II trial for obese patients with both diabetes and nonalcoholic fatty liver disease (NAFLD), as well as support Phase II studies of patients with Parkinson’s and Alzheimer’s disease, and patients with fibrotic disorders.
“We are grateful for the ongoing support and confidence of our investors and excited to have had Praxis Capital lead this Series C financing,” said D&D Pharmatech CEO Yoo-Seok Hong in a statement. “We look forward to the ongoing advancement of our clinical candidates.” – Paul Schloesser
OrbiMed joins $33M round for pet gene therapy startup
Pet gene therapy biotech Scout Bio announced the closing of a Series B2 financing, which put $33 million in the bank.
This financing round included new investor OrbiMed and previous Series B1 investors Digitalis Ventures, Frazier, RiverVest Venture, among others.
Proceeds from the financing will advance clinical development of Scout Bio’s product candidates targeting diabetes, feline pain associated with osteoarthritis and CKD-associated anemia, in addition to research on other indications.
“We are pleased to welcome the validating support of world-class investors who share our excitement for innovation in veterinary medicine,” said CEO Mark Heffernan. “Scout Bio is on target to deliver on our platform over the next twelve months, making single-shot therapies expressing validated protein therapeutics a reality.” – Paul Schloesser