The U.S. FDA’s effort to push companies toward more and better randomized, controlled trials ahead of accelerated approvals – apparently driven by the lack of confirmatory studies done afterward – is “an important and meaningful move by the agency,” said Day One Pharmaceuticals Inc. CEO Jeremy Bender. “The industry’s history in that space has been a little mixed.” Bender’s remarks came Aug. 9 as part of a wide-ranging panel discussion hosted by analyst Robert Driscoll during the Wedbush Pacgrow Healthcare Conference.
As it moves into phase II testing with the lead candidate from its hematologic pipeline, privately held Disc Medicine Inc. is also moving to the public markets via a reverse merger agreement with struggling biotech Gemini Therapeutics Inc. Concurrent with a $53.5 million financing from investors, the deal is expected to provide Disc with a cash runway into 2025.
Bristol Myers Squibb Co. has agreed to pay up to $1.9 billion plus royalties, plus an up-front payment of undisclosed value, for Gentibio Inc.’s expertise in engineered regulatory T cells (Tregs) to treat inflammatory bowel diseases (IBD). The agreement follows soon after BMS’ $4.1 billion acquisition of cancer biotech Turning Point Therapeutics Inc., as well as an expansion of its oncology partnership with Bridgebio Pharma Inc. to the tune of $905 million.
Central nervous system specialist Cerevance Inc. has announced a multiyear strategic research collaboration with Merck & Co. Inc. to identify novel targets for Alzheimer’s disease in a deal worth more than $1.1 billion, plus royalties. Boston-based Cerevance will receive $25 million up front with the $1.1 billion due when certain development and commercial milestones are achieved.
Shionogi & Co. Ltd. has in-licensed Japan rights to Grunenthal GmbH’s intra-articular injectable, resiniferatoxin, for the treatment of pain associated with osteoarthritis of the knee. Currently in phase III trials, RTX is a transient receptor potential vanilloid 1 agonist, which can reversibly desensitize TRPV1-expressing nociceptors. This mechanism may result in long-lasting pain relief.
Innovent Biologics Inc. has formed a partnership with Sanofi SA to jointly develop and commercialize two of Sanofi’s oncology candidates in combination with sintilimab in China, namely SAR-408701 (tusamitamab ravtansine) and SAR-444245.
Mersana Therapeutics Inc. is getting $100 million up front in an option deal with GSK plc for preclinical-stage antibody-drug conjugate (ADC) XMT-2056, which could bring up to $1.36 billion more in an option exercise payment, development, regulatory and commercial milestones. It’s the second potential $1 billion-plus ADC deal for Cambridge, Mass.-based Mersana in 2022 and the first for its Immunosynthen platform, which uses a STING agonist payload specifically designed for ADCs.
Shares of Poseida Therapeutics Inc. (NASDAQ:PSTX) closed Aug. 3 at $4.51, up $2.08, or 85%, as a result of the collaboration and licensing deal with Roche Holding AG that brings $110 million up front as well as the same amount in near-term milestone payments described by CEO Mark Gergen as “highly achievable,” and the arrangement could be worth as much as $6 billion if goals farther down the road are met.
Epigenetic test company Volitionrx Ltd. appointed contract research organization (CRO) Diagnostic Oncology CRO LLC (DXOCRO) to conduct development and clinical validation studies for its Nu.Q product portfolio in the U.S. DXOCRO will carry out large-scale finding studies across the U.S. using Henderson, Nev.-based Volition's cancer tests to determine clinical utility in sepsis and cancer. The trials are aimed at U.S. FDA approval of the products.
Pfizer Inc. plans to pay about $5.8 billion – total equity value – for Global Blood Therapeutics Inc. (GBT) and its oral sickle cell disease (SCD) treatment Oxbryta (voxelotor). The company reported the enterprise value as $5.4 billion, which includes debt and net cash. If completed, the GBT buy would be the second largest M&A in 2022 after Pfizer’s $6.7 billion buyout of Arena Pharmaceuticals Inc. Oxbryta, which netted about $195 million in sales in 2021, gained U.S. FDA approval in November 2019 for the treatment of SCD in adults and pediatric patients ages 12 and up. The FDA later expanded Oxbryta’s approved uses to SCD patients 4 years of age and older in December 2021.
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