No­var­tis plots 'next fron­tier' of MS treat­ment — and it could spell a buy­out for a small Swiss play­er

A cou­ple of months af­ter get­ting its self-ad­min­is­tered mul­ti­ple scle­ro­sis drug Kes­imp­ta cleared by EU reg­u­la­tors, No­var­tis has found what it be­lieves is “the next fron­tier” of MS treat­ment at a Uni­ver­si­ty of Zurich spin­out — and it’s al­ready lay­ing the ground­work for a buy­out.

No­var­tis struck a deal to de­vel­op Cellerys’ cell ther­a­py CLS12311, which is de­signed to in­duce anti­gen-spe­cif­ic im­mune tol­er­ance in MS pa­tients, the phar­ma said on Tues­day. The drug­mak­ers have been in talks for sev­er­al years, ac­cord­ing to a No­var­tis spokesper­son, and up­on com­ple­tion of a Phase II tri­al in “com­ing years,” the phar­ma will have a chance to ac­quire Cellerys.

The drug­mak­ers didn’t re­lease many de­tails, oth­er than to say that No­var­tis will “sup­port the de­vel­op­ment” of CLS12311, and they’re keep­ing the fi­nan­cial terms of the deal un­der wraps for now.

“Im­mune tol­er­ance ther­a­pies of­fer the po­ten­tial to in­ter­vene ear­ly and de­ci­sive­ly in the de­vel­op­ment of MS, to po­ten­tial­ly stop pro­gres­sion of the dis­ease,” the spokesper­son told End­points News in an email.

Cellerys was found­ed in 2015 by Uni­ver­si­ty of Zurich pro­fes­sors and MS spe­cial­ists Roland Mar­tin and An­dreas Lut­terot­ti. CLS12311 was shown to be safe and well-tol­er­at­ed in a Phase I tri­al at the Uni­ver­si­ty Hos­pi­tal Zurich, ac­cord­ing to No­var­tis, and it’s now in Phase II for re­laps­ing MS — the same in­di­ca­tion that Kes­imp­ta snagged an FDA ap­proval for back in Au­gust.

Kes­imp­ta — No­var­tis’ B-cell ther­a­py al­so known as ofa­tu­mum­ab — was ap­proved by the EC in March, sev­er­al months af­ter it was giv­en the OK in the US. No­var­tis orig­i­nal­ly got the drug from Glax­o­SmithK­line in their big vac­cines-for-can­cer ther­a­pies swap, but had a hard time sell­ing it as a leukemia ther­a­py. In MS, the drug showed a 51% and 59% re­duc­tion in an­nu­al­ized re­lapse rate com­pared to Sanofi’s Auba­gio in AS­CLE­PIOS I and II, win­ning over reg­u­la­tors af­ter a de­layed de­ci­sion.

The treat­ment can be ad­min­is­tered at home, which gave it a leg up on ri­vals that re­quire a trip to an in­fu­sion cen­ter — and No­var­tis charges for that con­ve­nience. Back in Au­gust, the phar­ma an­nounced Kes­imp­ta’s whole­sale price would be $83,000. That’s much high­er than Roche’s ri­val Ocre­vus, which hit the mar­ket at a dis­count­ed price of $65,000. In Q1 of this year, Kes­imp­ta pulled in $50 mil­lion.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

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Tadataka Yamada (Photographer: Kiyoshi Ota/Bloomberg via Getty Images)

Sci­ence pi­o­neer, phar­ma re­search chief, glob­al health ad­vo­cate and biotech en­tre­pre­neur Tadata­ka ‘Tachi’ Ya­ma­da has died

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

Thomas Lingelbach, Valneva CEO

A small vac­cine de­vel­op­er fa­vored by the UK gov­ern­ment in Covid-19 touts a PhI­II first in chikun­gun­ya

Before Valneva garnered the favor of the UK government as a potential supplier of Covid-19 vaccines, the French biotech prided itself on being the first company to bring a chikungunya vaccine into Phase III.

It now has positive pivotal results to back up the breakthrough therapy designation the FDA granted just weeks ago.

There are currently no approved jabs to prevent chikungunya virus infection despite decades of R&D efforts, a fact that underscores just how arduous traditional vaccine development can be, particularly for neglected tropical disease. In a absence of a major commercial market, the US government and NGOs such as CEPI have deployed various grants and incentives to spur on a small crew of academics and industry players, with Merck, via its acquisition of Themis, claiming a spot in that race.

Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

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Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

UP­DAT­ED: Sanofi buys mR­NA play­er Trans­late Bio for $3.2B. And the price fits a pop­u­lar range for biotech M&A

Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio $TBIO a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines, Sanofi closed the deal with a buyout early Tuesday, spending $38 a share in a $3.2 billion buyout.

Translate’s stock $TBIO soared after the market closed Monday when Reuters reported the first word of the acquisition just hours ahead of the formal announcement. The wire service, though, didn’t have a price to report in its scoop, and investors chased the stock up 78% in the wild ride that followed. Once the price was announced, gains shriveled to 29% ahead of the bell.

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Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

Zymer­gen's sud­den im­plo­sion shocked biotech. A lin­ger­ing loan could make things even worse

As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising efforts — could make the situation worse, according to public documents.

In December 2019, more than a year before Zymergen filed for what would eventually become a $500 million IPO, the “biofacturing” firm signed a $100 million credit facility with Perceptive to help supplement the nearly $700 million the company had raised across four VC rounds.

Bio­gen, Ei­sai are push­ing for an­oth­er ac­cel­er­at­ed Alzheimer's OK — this time for BAN2401

Now that the door at the FDA has been opened wide for Alzheimer’s drugs that can demonstrate a reduction in amyloid, Biogen and its partners at Eisai are pushing for a quick OK on the next drug to follow in the controversial path of aducanumab.

In a presentation to analysts, Eisai neurology chief Ivan Cheung outlined some bullish expectations for their newly-approved treatment and set the stage for what he believes will be a fast follow for BAN2401 (lecanemab) — after a dry spell in new drug development that’s lasted close to 20 years.

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