Selecta turns to synbio player for $1.1B capsid deal; BioNTech signs $790M immunotherapy deal
Selecta Biosciences has turned to one of the recent darlings in the synbio biz for its latest collaboration.
Ginkgo Bioworks has signed on to a biobucks-heavy deal to work on next-gen gene therapy viral capsids for Selecta, a hot topic in an industry that has identified a full slate of issues with the early-gen AAV vehicles that have dominated the first-gen programs. This is their second capsid-focused collaboration.
Carsten Brunn, CEO of Selecta Biosciences, said:
By combining ImmTOR with next-generation, fit-for-purpose AAV vectors, we hope to further improve the safety and efficacy of AAV mediated gene therapies.
There are some unspecified upfronts in the deal package, which tots up to $200 million per program and $1.1 billion in total, provided everything goes perfectly.
Ginkgo shares $DNA are down about 9% this morning, and way off from their IPO price — the company went public in a $17.5 billion SPAC deal —as the stock dived in recent months. — John Carroll
BioNTech signs $790M I/O collab with Crescendo
Like its mRNA counterpart, BioNTech is looking to expand its fortunes beyond its wildly successful Covid-19 vaccine. And on Monday, the company signed a new partnership to that effect.
BioNTech will team up with Crescendo Biologics to develop immunotherapies for cancers and other diseases, the companies announced Monday. BioNTech will pay $40 million upfront and promise up to $750 million in milestones for multiple programs.
“Crescendo’s platform provides excellent properties for exploiting novel targets and target combinations which we believe has great potential for the development of multi-specific mRNA and engineered cell-based therapies in a variety of disease areas,” BioNTech CEO Ugur Sahin said in a statement.
Crescendo has developed a platform that aims to deliver “fully human heavy-chain antibody domains,” which BioNTech hopes can pair well with its mRNA capabilities.
It’s not the first big-name company with which Crescendo has partnered. Back in 2016, the biotech collaborated with Takeda in a nearly $800 million deal, with $36 million upfront and $754 million in promised milestones if every condition had been met. — Max Gelman
Amgen’s Lumakras gets conditional approval in the EU
Lumakras has finally gotten the thumbs up in the EU, under the name Lumykras.
More than seven months after getting the landmark seal of approval in the US for patients with KRAS-G12C mutated NSCLC, Amgen announced this morning that the European Commission granted Amgen’s blockbuster conditional marketing authorization, reserving it for patients both with the mutation and who have had at least one prior line of systemic therapy.
According to Amgen, continued approval for Lumykras may be contingent upon verification and description of clinical benefit in at least one confirmatory trial.
The EC gave its okay after the CHMP recommended the drug’s approval, citing its review of data from the Phase II CODEBREAK100 study, which showed sotorasib posting a 37.1% overall response rate among 126 patients with advanced NSCLC and the KRAS G12C mutation.
With the drug approved in the US and conditionally in the EU, Amgen has submitted pending authorization requests in numerous other countries, such as Australia, Israel and Singapore. — Paul Schloesser
Coherus nabs Junshi’s TIGIT drug in expanded I/O pact
As Coherus and Junshi await word from the FDA on their partnered PD-1, toripalimab, the transpacific buddies are starting a new project together.
Coherus, a Redwood City, CA-based biosimilar maker that has been dipping its toes in novel drug R&D, is exercising its option to license JS006, Junshi’s TIGIT-targeted antibody. It will pay the Shanghai company $35 million upfront and reserve up to $255 million in milestones, on top of 18% royalty on net product revenue should the drug be approved.
JS006 is being tested in combination with toripalimab as part of a dose-escalation, dose-expansion trial, they noted.
In following up a PD-1 pact with a deal around TIGIT — one of the most promising checkpoint targets emerging in the immuno-oncology space — Coherus’ moves closely parallel those of Novartis, which has now obtained both a PD-1 and a TIGIT drug from BeiGene.
“Blockade of the TIGIT pathway may be a crucial underlying mechanism for overcoming resistance to checkpoint inhibition. We believe the dual immuno-therapy approach of TIGIT with PD-1 could enhance PD-1 efficacy and create a new standard-of-care for multiple tumor types,” said Theresa LaVallee, chief development officer at Coherus. — Amber Tong