Matt Shair and Jim Porter (Nuvalent)

Months af­ter emerg­ing from stealth, Nu­va­lent fol­lows up with $135M Se­ries B — backed by some ac­tive play­ers on the biotech IPO scene

When Matt Shair un­veiled a $50 mil­lion Se­ries A for his lat­est tar­get­ed ther­a­py start­up ear­li­er this year, the Har­vard pro­fes­sor was pleased with how cap­i­tal ef­fi­cient they man­aged to be.

“I think a lot of com­pa­nies would take that $50 mil­lion and make some progress,” Shair, who had co-found­ed In­fin­i­ty Phar­ma years ago, told End­points News then. “But we’ve tak­en that $50 mil­lion and with a small num­ber of peo­ple, have two com­pounds head­ed in­to the clin­ic in three years, and have oth­er pro­grams in dis­cov­ery phase.”

That tight time­line is clear­ly still some­thing Nu­va­lent holds it­self to.

Bare­ly three months af­ter throw­ing it­self in­to the spot­light, the biotech has re­loaded with $135 mil­lion in Se­ries B. Bain Cap­i­tal Life Sci­ences led a crossover-heavy syn­di­cate for the round, many of whom have demon­strat­ed ea­ger­ness to jump right in­to the red hot IPO mar­ket. (The com­pa­ny turned down a re­quest for in­ter­view.)

Just last month, Nu­va­lent bur­nished the pro­file of its par­al­lel lead can­di­dates by pre­sent­ing them at AACR. Both are de­signed to ful­fill the wish list of physi­cians they had con­sult­ed — such as brain pen­e­tra­tion — through re­view­ing a lot of crys­tal struc­tures and rel­e­vant in­for­ma­tion to un­der­stand mu­ta­tions around tar­gets and the in­ter­ac­tion be­tween small mol­e­cule and lig­and.

NLV-520 is billed as a high­ly se­lec­tive ROS1 in­hibitor that works against the G2032R sol­vent front mu­ta­tion; while NLA-655 is an ALK in­hibitor that should have an ef­fect even on the lor­la­tinib-re­sis­tant G1202R/L1196M com­pound mu­ta­tion.

ROS1 and ALK, ac­cord­ing to Shair, are just the “tip of the spear” giv­ing peo­ple a taste of the rich pipeline to come.

The com­mit­ment, CEO Jim Porter has not­ed, is “that we will de­sign a so­lu­tion specif­i­cal­ly for that prob­lem and not try to de­sign a mul­ti­pur­pose so­lu­tion that can go af­ter a num­ber of dif­fer­ent can­cers.”

Deer­field gave them the ini­tial fund­ing to get start­ed a cou­ple of years back. It’s al­so chipped in for the new fi­nanc­ing.

New in­vestors in­clude Fi­deli­ty, Welling­ton, Viking Glob­al In­vestors, Janus Hen­der­son In­vestors, Avoro Cap­i­tal Ad­vi­sors, Box­er Cap­i­tal of Tavi­s­tock Group, Ven­rock Health­care Cap­i­tal Part­ners, Fair­mount Funds Man­age­ment, Driehaus Cap­i­tal Man­age­ment and Lo­gos Cap­i­tal.

“Nu­va­lent’s fo­cused ap­proach to drug de­vel­op­ment has led to a promis­ing pipeline of nov­el drug can­di­dates with spe­cif­ic, ra­tio­nal de­signs and op­por­tu­ni­ty for mean­ing­ful clin­i­cal im­pact,” said An­drew Hack, a man­ag­ing di­rec­tor at Bain who is join­ing the board.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

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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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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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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George Church (courtesy EnPlusOne BioSciences)

George Church, Wyss sci­en­tists and North­pond chal­lenge con­ven­tion­al RNA man­u­fac­tur­ing with new biotech

RNA medicine has been at the forefront for the past few years, with the first RNA silencing therapy approved in 2018, and mRNA Covid vaccines following after. But flying under the radar has been the process of actually making RNA for these treatments.

That’s what Daniel Wiegand and Jonathan Rittichier have been working on in George Church’s lab for the past six years.

Friday morning, they unveiled EnPlusOne Biosciences, a biotech built on their RNA synthesis platform. Wiegand will serve as the Watertown, MA-based biotech’s CEO, and Rittichier will be CSO. And no different from his other startups, Church will be acting as scientific advisor. Its fourth co-founder, Dan Ahlstedt, joined through a Harvard Business School program, and will be COO.

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Up­dat­ed: Al­ny­lam re­in­forces APOL­LO-B patisir­an da­ta be­fore head­ing to the FDA

Weeks after uncorking some mostly positive data for patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, Alnylam is bolstering its package with new exploratory and subgroup data before shipping it off to regulators.

The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced on Friday afternoon, including age, baseline tafamidis use, ATTR amyloidosis type, baseline six-minute walk test score and others.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Jerome Durso, Intercept Pharmaceuticals CEO

In­ter­cep­t's OCA fails a PhI­II NASH tri­al, rais­ing fresh doubts about its years­long quest for an OK

Intercept Pharmaceuticals has run into another big setback in its yearslong quest to win an approval for OCA in NASH. The biotech put out word Friday morning that its Phase III REVERSE study failed the primary endpoint for the liver disease, sending its share price into a tailspin.

There was no significant improvement in fibrosis among the patients suffering from cirrhosis who were treated with obeticholic acid, with investigators hunting for a minimum 1-stage histological improvement in the disease after 18 months of therapy.

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