Im­mu­sanT scores a $40M round for PhII celi­ac study, with biotech vet Tom Daniel join­ing the board

Cel­gene vet Tom Daniel’s role as a part­ner at Arch Ven­ture will take him to the board at Cam­bridge, MA-based Im­mu­sanT, a biotech start­up that has now raised a $40 mil­lion B round from Arch and Vat­era. The mon­ey is be­ing ear­marked to get the biotech’s lead ther­a­py through Phase II, with da­ta ex­pect­ed around the mid­dle of 2019.

The biotech is spe­cial­iz­ing in cre­at­ing im­mune sys­tem tol­er­ance to thwart au­toim­mune dis­eases. And it’s go­ing af­ter celi­ac dis­ease as its lead pro­gram in a first step to­ward us­ing the same tech for type 1 di­a­betes and oth­er ail­ments.

In celi­ac dis­ease, the im­mune sys­tem mounts an er­rant as­sault on the small in­testines when­ev­er pa­tients con­sume even trace amounts of gluten, a com­mon in­gre­di­ent in a wide range of foods. For now, the on­ly treat­ment is an ab­solute­ly strict di­et, but every ac­ci­dent and at­tack can dam­age the in­testines, lead­ing to long range health prob­lems.

“Scour­ing 17,000 pep­tides, we were able to cre­ate a hi­er­ar­chy of the key com­po­nents that trig­ger the T cell re­sponse,” says CEO Leslie Williams. “Celi­ac is a great mod­el for dis­ease be­cause we know the anti­gen.”

The ba­sic idea here is that their ther­a­peu­tic vac­cine Nex­vax2 is de­signed to grad­u­al­ly in­struct the im­mune sys­tem to ig­nore the red flag.

Says Williams: “When pa­tients are ex­posed to Nex­vax2, they re­act­ed as if they ate the gluten… If we can il­lic­it an im­mune re­sponse, we can mod­u­late it.”

Tom Daniel

Williams found­ed the com­pa­ny back in 2010, raised seed cash and then a $20 mil­lion round from Vat­era. Get­ting an A-list ven­ture group like Arch, and a board mem­ber like Daniel — the for­mer head of re­search at Cel­gene — is a big plus for the com­pa­ny and its pro­file. Arch man­ag­ing di­rec­tor Steven Gillis — a well known im­mu­nol­o­gist — is al­so join­ing the board and lend­ing a hand.

For now, Im­mu­sanT’s 7-mem­ber team is in base­ment digs in Kendall Square, but Williams is plan­ning to dou­ble the size of her staff as the com­pa­ny jour­neys through a mid-stage tri­al. Af­ter that comes through, she’ll be able to look at an ex­pand­ed set of pro­grams as well as the da­ta to see which di­rec­tion the com­pa­ny should take. And it’s all on the ta­ble: from an­oth­er round to an IPO or strate­gic deal.


Im­age: Leslie Williams. Im­mu­sanT

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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Severin Schwan, outgoing Roche CEO (via Getty Images)

Roche hires new di­ag­nos­tics chief from with­in, ahead of C-suite shake-up

More than two months after Severin Schwan announced he’s leaving Roche and handing the reins to diagnostics chief Thomas Schinecker, the pharma giant has revealed who’s taking Schinecker’s place.

Matt Sause, who currently leads Roche’s North American diagnostics business, is popping the cork on the big global promotion to take effect on March 15. The 20-year Roche veteran has served a handful of roles across the company’s diagnostics and pharma units, including a stint at Genentech where he was lifecycle leader for blockbuster Tecentriq’s head and neck cancer programs.

Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; 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.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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