Senthil Sundaram, Terns CEO

Eli Lil­ly's transpa­cif­ic bo­som bud­dy Terns bags late-round fund­ing to dri­ve NASH hope­fuls through the clin­ic

In a hot mar­ket mar­ket for NASH, hav­ing big-name back­ers can help shine a spot­light on start­up play­ers look­ing to make a mark. That was cer­tain­ly the case for Terns Phar­ma­ceu­ti­cals and part­ner Eli Lil­ly, which pro­vid­ed seed fund­ing and li­censed three NASH can­di­dates to the ba­by biotech back in 2018.

Now, with two of those can­di­dates in the clin­ic, Terns has bagged new fund­ing to help speed to­ward the fin­ish line.

Af­ter scor­ing $120 mil­lion in two ear­ly rounds, Terns raised an $87 mil­lion Se­ries C fund­ing round with Deer­field Man­age­ment lead­ing along­side Or­biMed Ad­vi­sors, Lil­ly Asia Ven­tures, Vi­vo Cap­i­tal, Sam­sara Cap­i­tal, Su­vret­ta Cap­i­tal Man­age­ment and sev­er­al oth­ers. Lil­ly al­so jumped aboard with a strate­gic eq­ui­ty in­vest­ment.

Terns, co-found­ed by No­var­tis vet­er­an Wei­dong Zhong, is fun­nel­ing the mon­ey in­to three of its NASH pro­grams, one of which — TERN-101 — is ex­pect­ed to pro­duce topline Phase IIa da­ta in the sec­ond half of 2021, and an­oth­er of which — TERN-501 — is head­ed for the clin­ic.

In 2018, Zhong told End­points that the idea for the com­pa­ny was to part­ner a Cal­i­for­nia-based dis­cov­ery team with a small de­vel­op­ment group in Chi­na to ef­fi­cient­ly de­vel­op new drugs pri­mar­i­ly for the Chi­nese mar­ket. Lil­ly Asia Ven­tures sunk in $30 mil­lion to get it go­ing, a move which came about a year af­ter Lil­ly closed its Shang­hai R&D base.

On Wednes­day, af­ter press time, a spokesper­son said Terns has since shift­ed its strat­e­gy, fo­cus­ing more on build­ing a head­quar­ters and de­vel­op­ment team in Cal­i­for­nia. While Terns con­tin­ues to “have an eye on ad­di­tion­al glob­al mar­kets,” their cur­rent fo­cus is on the US, where clin­i­cal tri­als for their three lead pro­grams will oc­cur, the spokesper­son said.

Wei­dong Zhong

“In 2021, we ex­pect to have three promis­ing clin­i­cal-stage ther­a­peu­tic can­di­dates with mean­ing­ful near-term mile­stones,” Terns CEO Senthil Sun­daram said in a state­ment.

TERN-101, the fur­thest along, is a liv­er-di­rect­ed non-bile acid far­ne­soid X re­cep­tor (FXR) ag­o­nist. It’s be­ing test­ed on 96 pa­tients in a Phase IIa study, dubbed LIFT. While Terns faces com­pe­ti­tion from oth­er NASH play­ers like In­ter­cept and Ab­b­Vie, which snagged an FXR ag­o­nist in the Al­ler­gan buy­out, the com­pa­ny thinks its can­di­date’s safe­ty pro­file is where it will stand out. In four Phase I tri­als, none of 119 sub­jects in the treat­ment arm re­port­ed pru­ri­tus, and their serum lipid pro­files were sim­i­lar to those in the place­bo arm at all dos­es, ac­cord­ing to the com­pa­ny’s web­site.

TERN-201, a vas­cu­lar ad­he­sion pro­tein (VAP)-1) in­hibitor, is ex­pect­ed to en­ter a Phase Ib tri­al in the first half of 2021, with a topline da­ta read­out an­tic­i­pat­ed in the first half of 2022. And TERN-501, a thy­roid hor­mone re­cep­tor (THR) be­ta ag­o­nist, is en­ter­ing a Phase I tri­al in the first half of 2021 with topline da­ta com­ing in the sec­ond half of 2021.

Terns, named af­ter the small, tough wa­ter bird, closed an $80 mil­lion Se­ries B in Oc­to­ber 2018 led by Vi­vo Cap­i­tal and Or­biMed. Zhong, who spent some time work­ing in liv­er dis­eases at Gilead, told End­points in 2018 that he liked the idea of go­ing back to the liv­er and bring­ing in on­col­o­gy as a way to dis­tin­guish the start­up in Chi­na.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; 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.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Jason Kelly (Photographer: Kyle Grillot/Bloomberg via Getty Images)

Gink­go nabs $DNA, biotech's most sought af­ter tick­er, for free in sweet­en­er from NYSE

When Ginkgo went comparison shopping for a financial market to list their now $15 billion company, the New York Stock Exchange had a back-pocket sweetener the Nasdaq couldn’t offer: The most sought-after ticker in biotech, $DNA.

DNA — the most famous three letters in biology and the ticker for the world’s first biotech, Genentech, from 1999 until it was bought out by Roche for $48 billion in 2009 — will now be the ticker for Ginkgo, a 12-year-old synthetic biology startup with grand ambitions to change not only how drugs, but also everyday products like meat and perfumes, are made.

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Lark­spur Health Ac­qui­si­tion files to go pub­lic as this year's SPAC flood surges over $14B

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another day, another SPAC vying for a spot on Nasdaq.

On Wednesday, OncoSec Medical CEO Daniel O’Connor filed the S-1 paperwork for a new blank-check company he’s leading called Larkspur Health Acquisition. The former Advaxis chief penciled in a $75 million raise, with plans to offer 7.5 million shares at $10 apiece.

BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.