Cel­gene antes up $55M, grabs op­tion to buy the au­toim­mune up­start Anokion

Jef­frey Hubbell, Anokion

Cel­gene’s glo­be­trot­ting busi­ness de­vel­op­ment team has fo­cused on au­toim­mune dis­eases for its lat­est col­lab­o­ra­tion/op­tion-to-buy biotech deal.

The fo­cus this time: Anokion, a spin­out of the Ecole Poly­tech­nique Fédérale de Lau­sanne. The biotech has been work­ing on anti­gen-spe­cif­ic im­mune tol­er­ance tech to re­train the im­mune sys­tem to ig­nore the rogue sig­nals that spark an au­toim­mune re­sponse against healthy tis­sue while al­so re­struc­tur­ing pro­tein ther­a­pies to make them in­vis­i­ble to the im­mune sys­tem, pos­si­bly open­ing a path to us­ing some ther­a­pies that have been dis­card­ed in the past af­ter they trig­gered an im­mune re­sponse.

In the deal, Cel­gene is hand­ing over $45 mil­lion up­front and re­serv­ing an­oth­er $10 mil­lion for un­spec­i­fied pre­clin­i­cal work.

Jeff Hubbell, an in­ves­ti­ga­tor at the Uni­ver­si­ty of Chica­go as well as CSO and chair­man of the com­pa­ny, came up with the idea of dec­o­rat­ing red blood cells with spe­cif­ic anti­gens in vi­vo, train­ing the body to tol­er­ate what had been in­tol­er­a­ble. But over the last 18 months, the biotech’s R&D team, based in Cam­bridge, MA (the com­pa­ny’s HQ is in Lau­sanne) has been de­vel­op­ing an­oth­er ap­proach cen­tered on the liv­er that can al­so in­duce im­mune tol­er­ance.

Tom Woi­wode, Ver­sant

“To in­duce anti­gen spe­cif­ic tol­er­ance has been the Holy Grail for 20 years,” says Ver­sant’s Tom Woi­wode, who’s on the board.

Now, in­stead of rais­ing a Se­ries B, the Anokion team can use non di­lu­tive cash to work their way through both ap­proach­es, study­ing mul­ti­ple tar­gets. One ob­vi­ous tar­get that Cel­gene is in­trigued by, says Hubbell, is mul­ti­ple scle­ro­sis.

In its deal with Cel­gene, Anokion re­mains in charge of R&D un­til the Big Biotech makes a de­ci­sion whether or not to pull the trig­ger on an ac­qui­si­tion. Ver­sant’s Woi­wode says this deal does not come with a pre­set buy­out fig­ure. That num­ber would still have to be ne­go­ti­at­ed in a deal that es­sen­tial­ly gives Cel­gene the right of first re­fusal for do­ing a deal.

Cel­gene’s mon­ey will now back an ex­pan­sion of the Anokion team in Cam­bridge to about 30 peo­ple, who are still fac­ing a 3.5- to 4-year trek for pre­clin­i­cal work. Hubbell tells me that the biotech has worked through some good mouse mod­els on au­toim­mune con­di­tions, and more work has yet to be done on non-hu­man pri­mates be­fore they can get start­ed on a hu­man study.

Astel­las was al­so deeply im­pressed with the work, and in 2015 set up a new com­pa­ny with Anokion called Kanyos Bio to use the plat­form tech to cre­ate new drugs for di­a­betes as well as celi­ac dis­ease. That oth­er com­pa­ny will con­tin­ue its work in Cam­bridge, MA.

Anokion raised a $37.5 mil­lion Se­ries A back in 2014 from Ver­sant, which seed­ed the com­pa­ny, along with No­vo Ven­tures and fel­low Swiss com­pa­ny No­var­tis Ven­ture Fund.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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