No­var­tis spin­out resTOR­bio re­verse merges with T cell biotech af­ter big PhI­II fail­ure

The end of their lead pro­gram will, it turns out, spell the end for No­var­tis spin­out resTOR­bio.

Shares for the once well-fund­ed an­ti-ag­ing biotech crum­bled af­ter its lead pro­gram failed a Phase III tri­al last year. The com­pa­ny said they would shift fo­cus to an ear­ly stage Parkin­son’s can­di­date, but that looked like a long shot at the time, and to­day, the com­pa­ny an­nounced they will re­verse merge with Adicet Bio.

Anil Sing­hal

The new biotech will cen­ter around Adicet’s off-the-shelf T cell plat­form. Found­ed by for­mer Kite Phar­ma CEO Aya Jakobovits and now led by Ab­b­Vie alum Anil Sing­hal, the com­pa­ny has so far raised over $130 mil­lion in an ef­fort to build a more po­tent and eas­i­er to man­u­fac­ture CAR-T ther­a­py, along with sev­er­al oth­er T cell-based treat­ments. It’s a crowd­ed field but Adicet has a big name part­ner in Re­gen­eron. The biotech gi­ant has spent the last few years try­ing to catch up fast on im­muno-on­col­o­gy, in­clud­ing by chip­ping in $25 mil­lion for Adicet’s Se­ries B last year.

Adicet’s ap­proach is based around gam­ma-delta T cells, ver­sa­tile im­mune cells that are be­lieved to play an im­por­tant role in rec­og­niz­ing can­cers and cer­tain hard-to-see anti­gens. They were over­looked in the first gen­er­a­tion of au­tol­o­gous CAR-T ther­a­pies be­cause they rep­re­sent on­ly a tiny per­cent­age of the T cells in the blood, but a long list of biotechs — in­clud­ing Juno Ther­a­peu­tics and sev­er­al com­pa­nies that, like Adicet, are built sole­ly around the cell type — are now try­ing to use them to de­vel­op more po­tent cell ther­a­pies.

The dis­ap­pear­ance of resTOR­bio is a loss not on­ly for No­var­tis and Puretech, who set up the com­pa­ny three years ago to ad­vance a pair of mid-stage com­pounds, but al­so for an en­tire cel­lu­lar path­way — called mTOR — that at var­i­ous times has seemed a promis­ing tar­get for a host of dis­eases re­lat­ed to ag­ing, in­clud­ing can­cer. resTOR­bio had been try­ing to de­vel­op a TORC1 in­hibitor, called RTB101, that would boost the pa­tient’s im­mune sys­tem and re­duce the rate of res­pi­ra­to­ry in­fec­tions in the el­der­ly.

They raised $85 mil­lion in an IPO off that idea in 2017 and shares soared the next year af­ter they cleared a Phase II tri­al in pa­tients with asth­ma. But in No­vem­ber a Phase III tri­al showed their drug ac­tu­al­ly per­formed worse than place­bo. In two days, their stock went from a lit­tle over $9 to bare­ly $1.

The stock was 32% — which trans­lat­ed to a 39 cent gain — per mar­ket. Adicet’s lead pro­gram, an off-the-shelf CAR-T tar­get­ing CD-20, is in the pre­clin­i­cal stage.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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CEO Harith Rajagopalan (Fractyl)

Af­ter a decade in the type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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Geoffrey Porges, SVB Leerink

Top an­a­lyst maps a rocky road for Ver­tex — un­less they adopt a $10B M&A cam­paign to save the pipeline

After repeatedly poking Vertex $VRTX execs with pointed criticism of their R&D strategy, top SVB Leerink analyst Geoffrey Porges is now turning up the heat to a full-scale roasting.

In a note out early Monday morning, Porges spotlights the impact of Vertex’s recent follow-up failure on AATD — their treatment hit the endpoint but missed on commercial prospects — rewriting his recommended scenario for CEO Reshma Kewalramani as she grapples with the setback.

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Alexander Vos, VectorY CEO

Start­ing fresh in man­u­fac­tur­ing, For­bion start­up re­fu­els to steer next-gen gene ther­a­py ap­proach for ALS, Alzheimer's in­to clin­ic

Forbion laid out its case for a next-generation gene therapy approach when it took the wraps off VectorY Therapeutics and its vectorized antibody tech in February. Now, the Dutch VC has tapped an experienced hand at cell and gene therapy manufacturing to steer the ship — and pulled a marquee syndicate for a €31 million ($37.6 million) seed round.

Alexander Vos, the new CEO, is a venture partner at BioGeneration Ventures and jumps immediately from VarmX, a BGV portfolio company developing an anticoagulant. But before that, he had led Dutch CDMO PharmaCell for eight years until it was bought out by Lonza.

Lynn Fitch, Mississippi Attorney General (Rogelio V. Solis/AP Images)

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

Mississippi Attorney General Lynn Fitch last week sued the top three insulin manufacturers, which collectively cover almost the entire US insulin market, alleging that they’ve colluded to raise their prices in lockstep, and in some cases by more than 1,000% for drugs that are decades old.

“Because of Manufacturer Defendants’ collusive price increases, nearly a century after the discovery of insulin, diabetes medications have become unaffordable for many diabetics,” the lawsuit says.

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