RA Cap­i­tal, Hill­house join $310M rush to back Ever­est's climb to com­mer­cial heights in Chi­na

Mon­ey has nev­er been an is­sue for Ever­est Med­i­cines. With an es­sen­tial­ly open tab from their founders at C-Bridge Cap­i­tal, the biotech has gone two and a half years rack­ing up drug af­ter drug, bring­ing in top ex­ec af­ter top ex­ec, and is­su­ing clin­i­cal up­date af­ter up­date.

But now oth­er in­vestors want in — and they’re bet­ting big.

Ian Woo

Ever­est is clos­ing its Se­ries C at $310 mil­lion. The first $50 mil­lion comes from the Ji­ashan Na­tion­al Eco­nom­ic and Tech­no­log­i­cal De­vel­op­ment Zone; the re­main­ing C-2 tranche was led by Jan­chor Part­ners, with RA Cap­i­tal Man­age­ment and Hill­house Cap­i­tal as co-lead­ers. Decheng Cap­i­tal, GT Fund, Janus Hen­der­son In­vestors, Rock Springs Cap­i­tal, Oc­ta­gon In­vest­ments all joined.

The biotech might be best known for pay­ing $65 mil­lion up­front to grab Asian rights to Im­munomedics’ an­ti­body-drug con­ju­gate last April — a record for Chi­nese biotechs in-li­cens­ing West­ern drugs. But the oth­er as­sets in their pipeline would ring equal­ly, if not more, fa­mil­iar to a US au­di­ence: Are­na’s S1P re­cep­tor ag­o­nist etrasi­mod, Unit­ed Ther­a­peu­tics’ PAH drug ra­linepag, Tetraphase an­tibi­ot­ic Xer­a­va (er­ava­cy­cline), among oth­ers.

The idea, CFO Ian Woo pre­vi­ous­ly told End­points News, is to go for the crown jew­els of their biotech part­ners — and not the un­want­ed, shelved prod­ucts.

That ap­proach re­quires earn­ing the trust of part­ners, some­thing Ever­est has honed af­ter eight such deals.

Wende Chen

Pi­o­neered by the likes of Zai Lab and BeiGene, bridg­ing the med­ical gap be­tween the US and Chi­na has be­come a pop­u­lar strat­e­gy for do­mes­tic biotechs. Ever­est po­si­tioned it­self right up there with the lead­ers, in­clud­ing CStone and In­novent. The mar­ket’s big enough for al­most every­body with the ex­per­tise to iden­ti­fy the right in­di­ca­tions and pur­sue the op­ti­mal clin­i­cal de­vel­op­ment path, they con­tend.

“We are well-po­si­tioned to ad­vance the clin­i­cal de­vel­op­ment of our ro­bust ther­a­peu­tics pipeline, which spans a num­ber of im­por­tant dis­eases, and we look for­ward to build­ing a strong foun­da­tion on which we will grow our com­mer­cial busi­ness,” said Ker­ry Blan­chard, the Eli Lil­ly vet who was ap­point­ed CEO ear­li­er this year.

He is flanked in the C-suite by Ian Woo, pres­i­dent and CFO; and Wende Chen, chief com­mer­cial of­fi­cer.

Two of the drugs Ever­est holds rights to have been ap­proved in the US. Im­munomedics’ breast can­cer ther­a­py Trodelvy was OK’d in April, trig­ger­ing $60 mil­lion in mile­stone pay­ment, and Ever­est was cleared for Chi­na tri­als that month. Around the same time, they nabbed ap­proval for an­oth­er, Xer­a­va, in Sin­ga­pore for com­pli­cat­ed in­tra-ab­dom­i­nal in­fec­tions.

Here’s a brief overview of the rest:

  • etrasi­mod (Are­na): oral mod­u­la­tor of the sphin­go­sine 1-phos­phate re­cep­tor (S1PR). In Phase III for ul­cer­a­tive col­i­tis
  • tani­bor­bac­tam (Ve­na­torx): in­jectable broad-spec­trum be­ta-lac­ta­mase in­hibitor. In Phase III for com­pli­cat­ed uri­nary tract in­fec­tions
  • ra­linepag XR (Unit­ed): ex­tend­ed re­lease ag­o­nist of the IP re­cep­tor. In Phase III for pul­monary ar­te­r­i­al hy­per­ten­sion
  • Ne­fe­con (Cal­lid­i­tas): oral for­mu­la­tion of budes­onide. In Phase III for IgA nephropa­thy
  • FGF401 (No­var­tis): re­versible-co­va­lent in­hibitor of FGFR4. In Phase Ib/II for he­pa­to­cel­lu­lar car­ci­no­ma
  • SPR206 (Spero): polymyx­in de­riv­a­tive de­signed to re­duce the kid­ney tox­i­c­i­ty that is seen clin­i­cal­ly with polymyx­in B and col­istin

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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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.

#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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Hui Shao, YS Biopharma president and CEO (L) and Yi Zhang, founder and chairman

Chi­na’s Yisheng­Bio is go­ing to Nas­daq, mak­ing the tran­si­tion via $230M SPAC ma­neu­ver

After attempting to make it on the HKEX last year, a Chinese biopharma is finally taking the once-flashy SPAC route to get on the Nasdaq.

YishengBio — which will be renamed YS Biopharma, per a Thursday statement — will be combining with Hong Kong-based Summit Healthcare Acquisition Corp, currently listed on Nasdaq under the ticker $SMIH after launching on the stock exchange last year. If everything goes to plan, the merger will be finished in Q1 next year.