Michael Engsig, Nykode CEO

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

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.”

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Watch out, Roche: No­var­tis inks $1.5B deal to chase down promi­nent Parkin­son’s tar­get

Novartis is plopping down $150 million in cash to pick up an experimental Parkinson’s drug and grab an option to another, a move that puts it on an increasingly popular path in the field’s search for disease-modifying therapies.

Belgium’s UCB is its partner of choice, supplying two small molecule alpha-synuclein misfolding inhibitors in a deal that can add up to nearly $1.5 billion.

Out of the pair, UCB0599 is already in Phase II trials, making Novartis confident enough to pull the trigger on co-development and commercialization, including to foot half of the R&D bill. The pharma giant will make a decision on UCB7853 once UCB wraps the ongoing Phase I program.

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Glax­o­SmithK­line, Ox­ford un­veil new part­ner­ship pit­ting buzzy R&D ad­vances against neu­ro­log­i­cal dis­ease

When GlaxoSmithKline trumpeted its return to neuroscience with a $700 million upfront deal with Alector this summer, it touted its early investments in functional genomics as a key guidepost for that deal. Now, the drug giant has partnered up with Oxford to hopefully add jet fuel to its hunt for breakthroughs in the brain.

GSK and Oxford have kickstarted a five-year collaboration aimed at spurring R&D breakthroughs across a range of hard-to-treat diseases like Alzheimer’s and Parkinson’s through the use of genomic testing and machine learning, the partners said Wednesday.

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With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi snaps up new vac­cine can­di­date and de­vis­es mR­NA game plan around it — but not for what you think

Paul Hudson has spotlighted vaccines, immunology and dermatology as some of the top R&D focuses at Sanofi. His latest deal brings all of them together.

The French pharma giant isn’t sharing any financial details about the buyout of Origimm, a low-profile, private Austrian biotech whose technology promises to identify antigens causing skin disease and build vaccines against them. Their lead candidate targets acne vulgaris.

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