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

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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