News brief­ing: No­vo eyes the next ki­nas­es in a Finnish start­up; Boehringer In­gel­heim brings a bis­pe­cif­ic to the clin­ic

No­vo Seeds’ Jeroen Bakker thinks he’s found the next ki­nas­es.

The ear­ly stage, Eu­ro­pean VC firm an­nounced yes­ter­day they led a $9 mil­lion seed round for Rapp­ta Ther­a­peu­tics, a Finnish biotech de­vel­op­ing in­hibitors for an en­zyme called PP2A — pro­tein phos­phatase 2 — that Bakker thinks now hold the same kind of drug tar­get­ing po­ten­tial as ki­nas­es did two decades ago for can­cer.

Jeroen Bakker

“Since the in­tro­duc­tion of Gleevec, it’s al­ways been about ki­nas­es,” Bakker told End­points News, re­fer­ring to the best-sell­ing No­var­tis drug, first ap­proved in 2001. “But we’ve for­got­ten that phos­pho­tases are al­so im­por­tant.”

Phos­pho­tases, like ki­nas­es, are en­zymes in­volved in sig­nal­ing through­out the cell. Sci­en­tists have long known that PP2A held po­ten­tial as a can­cer tar­get, but they had strug­gled to drug it be­cause they didn’t un­der­stand the pro­tein’s struc­ture, said CEO Mikko Man­nerkos­ki.

Mikko Man­nerkos­ki

Man­nerkos­ki said, how­ev­er, that Rapp­ta had de­vel­oped a “map” of the pro­tein that should al­low them to find new ways of tar­get­ing it, in­clud­ing al­loster­i­cal­ly. That’s helped give them the kind of struc­tur­al in­sight in­to the pro­tein that sci­en­tists de­vel­oped for ki­nas­es, Bakker ar­gued.

The biotech’s small team has so far de­vel­oped a se­ries of po­ten­tial drug can­di­dates and are en­ter­ing the lead op­ti­miza­tion phase. Man­nerkos­ki de­clined to name the can­cers they’d pur­sue or give a firm time­line but said they would try to en­ter the clin­ic on a nor­mal drug de­vel­op­ment sched­ule — i.e. a cou­ple years.

“It has been ex­treme­ly dif­fi­cult to ad­dress phar­ma­ceu­ti­cal­ly and the main dif­fi­cul­ty has been the lack of struc­tur­al un­der­stand­ing,” he told End­points. “We be­lieve that we now have a ‘map,’ so to speak, that we can use to ra­tio­nal­ly de­sign drugs.” — Ja­son Mast

Boehringer In­gel­heim brings bis­pe­cif­ic in­to the clin­ic

Now that the first pa­tient has been dosed in a Phase I tri­al of a bis­pe­cif­ic an­ti­body for small cell lung car­ci­no­ma and oth­er neo­plasms — with a tar­get dis­cov­ered dur­ing the first phase of a part­ner­ship be­tween Boehringer In­gel­heim and Ox­ford Bio — the col­lab­o­ra­tors are go­ing back to the draw­ing board to­geth­er.

The two groups have ex­pand­ed their ini­tial search for new tu­mor tar­gets the Ger­man phar­ma com­pa­ny can use with its T-cell en­gager, can­cer vac­cine and on­colyt­ic virus plat­forms.

There are no terms on dis­play here, but Boehringer — which has tapped two pro­grams for de­vel­op­ment so far — will have de­vel­op­ment and com­mer­cial­iza­tion rights for any­thing that goes in­to the clin­ic. And OBT didn’t miss the chance of tout­ing their sci­ence.

“We view the hope­ful dis­cov­ery of ad­di­tion­al tu­mor tar­gets as fur­ther con­fir­ma­tion of the val­ue of our OGAP plat­form to iden­ti­fy nov­el tar­gets that can be sub­strates for in­no­v­a­tive new ther­a­pies,” said Chris­t­ian Rohlff, the CEO at OBT. — John Car­roll

Nim­bus brings in 2 new in­vestors to back its lat­est raise as the lead TYK2 drug points to a PhI­Ib

Pe­ter Kolchin­sky

Nim­bus Ther­a­peu­tics has brought in a cou­ple of new in­vestors for their lat­est raise. RA Cap­i­tal — a ubiq­ui­tous play­er that’s been hav­ing a hey­day bat­ting biotechs in­to Nas­daq — joined with BVF to lead a $60 mil­lion round.

Nim­bus made its rep craft­ing new pro­grams bought up by the ma­jor play­ers. Now it’s been build­ing its own pipeline, and the ex­ecs in charge have been tout­ing ear­ly TYK2 da­ta as they line up a Phase IIb tri­al.

Pe­ter Kolchin­sky at RA says the lead pro­gram at Nim­bus is “one of on­ly two clin­i­cal al­losteric ap­proach­es to TYK2 in­hi­bi­tion.” — John Car­roll

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.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

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.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Can South Dako­ta's trans­genic cows help treat the flu?; A speedy re­view for Mer­ck­'s Pre­vnar ri­val in kids

Wednesday brought another win for South Dakota’s biggest transgenic cow so far.

SAB Biotherapeutics, which develops treatments by collecting and distilling antibodies from cows with humanized immune systems, announced that its antibody treatment for flu passed an early-stage challenge study.

Volunteers were intentionally exposed to the flu virus and then given infusions of the SAB antibody treatment or placebo. Those who received the antibody treatment saw a significantly greater reduction in viral load and symptoms than those who received placebo. The company didn’t release numbers but said the p-value was 0.026.

Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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