Vaccibody gets a new name and loads up with nearly $1B in biobucks for new vaccine pact with Regeneron

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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