LONDON – Nerre Therapeutics Ltd. will have another go at delivering proof of efficacy for its chronic cough treatment, after raising £20 million (US$27.6 million) in a series B2 round.
DUBLIN – Skysona (elivaldogene autotemcel, Lenti-D), Bluebird Bio Inc.’s gene therapy for cerebral adrenoleukodystrophy, received a nod from the EMA’s Committee for Human Medicinal Products (CHMP) during its May meeting this week, paving the way for a formal European authorization in the coming weeks. It will constitute the first approval for the product. An FDA approval is some way behind – the company will not complete its BLA filing with the FDA until around midyear.
In the final part of its three-day meeting on accelerated approvals granted to anti-PD-1/PD-L1 antibodies, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously to continue the accelerated approval for Merck & Co. Inc.’s Keytruda (pembrolizumab) as a therapy for patients with advanced hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (Nexavar, Bayer AG).
During a panel discussion at Biocom California's Global Life Sciences Partnering Conference, business development executives at various pharmaceutical companies advised biotech companies on everything from funding to manufacturing to deal structure.
DUBLIN – Curevac AG has entered a global alliance with Bayer AG to accelerate its efforts to bring a third, desperately needed mRNA-based COVID-19 vaccine to market. The vaccine in question, CVnCoV, began a pivotal phase IIb/III trial on Dec. 14.
Atara Biotherapeutics Inc. licensed a pair of mesothelin-directed CAR T treatments, ATA-2271 and ATA-3271, to Bayer AG for $60 million up front with the potential for $610 million in development, regulatory and commercialization milestone payments. Atara is also eligible for tiered royalties that peak in the low double-digit percentage of net sales of the two drugs. South San Francisco-based Atara will provide translational and clinical manufacturing services for the two drugs that will be reimbursed by Bayer.
LONDON – Bayer AG is making a major move into gene therapy with the $4 billion acquisition of one of the pioneers of the field, Asklepios Biopharmaceutical Inc. The deal will give the German pharma access to an adeno-associated viral vector platform that has generated multiple commercial and clinical stage assets across a broad range of indications from rare diseases to chronic conditions. The in-house portfolio includes treatments for Pompe and Parkinson’s diseases and congestive heart failure. Asklepios (Askbio) also has spun out programs in hemophilia and Duchenne muscular dystrophy.
Deals by Bayer AG’s “impact investment unit” called Leaps that build upon each other let the Leverkusen, Germany-based firm “basically renew [the company’s] technology platform” by tapping fresh sources, said Leaps head Jurgen Eckhardt. And the unit is casting nets widely.
Recursion Inc.’s combination of machine learning and artificial intelligence, coupled to its wet lab work, caught Bayer AG’s attention so solidly that its investment unit, Leaps by Bayer, led the charge on Recursion’s new and oversubscribed $239 million series D financing.
HONG KONG – Hua Medicine Ltd. has signed a commercialization and partnership deal with Bayer AG for a new diabetes treatment in China. Hua’s dorzagliatin, a first-in-class dual-acting glucokinase activator, is designed to control the progressive degenerative nature of diabetes by restoring glucose homeostasis in patients with type 2 diabetes (T2D).
