Michael Engsig, Nykode CEO
Vaccibody who? A little over a year after securing a $700 million-plus deal with Roche for its neoantigen cancer vaccine, the Norwegian biotech has attracted yet another Big Pharma partner with deep pockets — and with it, a new name and facelift.
Regeneron is betting nearly $1 billion on five new vaccine programs from Vaccibody, now called Nykode Therapeutics. The deal will double Nykode’s current pipeline, adding three programs in cancer and two in infectious disease.
CEO Michael Engsig maintains that the new name and logo ‘signify a new phase of growth and development.’
‘We continue our exciting transformation from a two-asset focused company to a fully-fledged platform biotech company,’ he said in a statement. ‘During the past year, we have increased the number of talented colleagues, made important additions to our senior management team, invested strategically, and expanded internationally. This positive evolution, combined with our future ambitions, inspired the need to revisit our brand.’
Regeneron is shelling out $30 million upfront, plus a $20 million equity investment and more than $875 million in biobucks to collaborate on the five programs, which will combine Nykode’s vaccine platform with Regeneron’s antigen selection expertise and VelociSuite in vivo models. Last October, Nykode’s chief innovation and strategy officer Agnete Fredriksen (formerly Vaccibody’s CSO) said the development of cancer vaccines has been largely limited by the ability to efficiently present antigens — molecules that induce an immune response — to the immune system. She thinks Regeneron can help with that.
‘Regeneron has generated unique know-how in selecting and validating immunogenic antigens from extensive analysis of patient material,’ Fredriksen said in a statement on Tuesday.
Nykode is on the hook for vaccine generation and characterization, and product supply through Phase I. But Regeneron is picking up the tab for research and clinical, regulatory, manufacturing and commercialization activities.
This won’t be Engsig’s first Big Pharma rodeo. Last October, he joined forces with Roche to develop a personalized vaccine candidate VB10.NEO in the US and Europe. That candidate’s still in Phase I with Genentech for locally advanced metastatic tumors, and Phase II with Genentech and Nektar for melanoma, lung, bladder, renal, and head and neck cancer.
We’re still waiting to see the data from those programs — but two years ago, Vaccibody read out what it said was ‘promising clinical data that showed that ability to raise a strong neoantigen-specific T-cell response against the majority of epitopes,’ Engsig said. The company says clinical responses were seen in 50% of patients across tumor types.
Nykode also recently launched its Covid-19 candidate into the clinic, and is expecting interim Phase II data for its HPV16-positive cervical cancer program in the first half of next year.
This won’t be Regeneron’s first dive into cancer vaccines. Last August, the company jumped in for a Phase II study combining its PD-1 Libtayo with BioNTech’s FixVac candidate in a no-money-down alliance.
And the new name? That’s inspired by Nykode’s Norwegian roots, Engsig said, translating to ‘new code.’
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Joan Perelló, Sanifit CEO
Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.
Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.
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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)
As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.
GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.
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In an effort to up its development of microbial-derived proteins, Swiss CDMO Lonza will invest in its manufacturing capacities in its home country.
The extension will be good to go by the end of this year, the company said. The expanded development will strengthen the upstream, downstream and process analytics support for new projects. The microbial footprint at its Visp site will be consolidated, and new high-throughput equipment and automation processes will be added to increase efficiency and project delivery. That will include three liquid handling workstations, and the upgrades will help improve data generation.
The FDA’s backlog of drug manufacturing facility inspections continues to be a sore spot for the agency, as FDA said Monday that a total of 52 new drug (but no biologics) applications still remain delayed due to the backlog from the pandemic.
And while the agency has maintained that it won’t issue a CRL for a delayed inspection, the number of delayed applications is rising as FDA said in May that 48 new drug applications have been delayed due to FDA’s inability to conduct pre-approval, pre-market, or pre-license inspections as of last March.
AstraZeneca’s Cambridge R&D center
One of the biggest projects that Pascal Soriot initiated, all the way back in 2013, after he first took over as AstraZeneca’s CEO is finally complete.
AstraZeneca is formally unveiling its $1.34 billion (£1 billion) R&D campus in Cambridge, UK, a shiny new facility spanning 19,000 square meters in the southern part of the city. On top of 2,200 research scientists, it will also host a suite of robotics, high-throughput screening and AI-driven technology.
Stephen Hahn and Donald Trump, AP Images
The House Select Subcommittee on the Coronavirus Crisis on Monday questioned former FDA commissioner Stephen Hahn on whether he acquiesced to political pressure in authorizing the use of hydroxychloroquine and convalescent plasma early in the pandemic, despite limited evidence of their effectiveness.
Hahn publicly disavowed any political interference in any of his agency’s EUA decisions, but behind the scenes, the pressure clearly caught up with him.
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Most people know if they’re ‘Team Pfizer’ or ‘Team Moderna,’ but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.
And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novovax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as ‘Covid-19 Vaccine Janssen.’
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Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)
Back in June, Sanofi unveiled a big project to reshape its R&D around the future of mRNA, and followed that up Monday by taking a step toward achieving that goal.
The French drugmaker signed a deal with Chinese tech giant Baidu to access its AI algorithm for mRNA-based therapeutics, Baidu said Monday morning. It’s for an undisclosed sum, but Baidu noted its platforms will be used to ‘contribute to the optimization of mRNA sequences’ in Sanofi’s drug development processes.
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https://endpts.com/vaccibody-gets-a-new-name-and-loads-up-with-nearly-1b-in-biobucks-for-new-vaccine-pact-with-regeneron/
