Eli Lil­ly hands transpa­cif­ic biotech up­start Terns pieces to an ex­per­i­men­tal NASH puz­zle

Wei­dong Zhong

For Wei­dong Zhong, the fastest part of start­ing up a transpa­cif­ic biotech was find­ing the mon­ey.

Al­most im­me­di­ate­ly af­ter step­ping out of No­var­tis’ ear­ly-stage re­search group a year ago, the long­time in­ves­ti­ga­tor with a back­ground that in­cludes a stint in­volv­ing liv­er dis­eases at Gilead had the en­thu­si­as­tic back­ing of Lil­ly Asia Ven­tures, a busy ven­ture group which pro­vid­ed the $30 mil­lion need­ed to get go­ing.

“They very much liked the idea,” Zhong tells me. “We didn’t even have time to dis­close that (Se­ries A) be­cause every­thing hap­pened so quick­ly.”

Now, the rest of it is com­ing to­geth­er quick­ly as well, with a pipeline that’s be­ing swelled to­day by an in-li­cens­ing deal with Eli Lil­ly de­liv­er­ing three pro­grams for NASH. So it’s a good time, Zhong feels, to make the de­but they had missed a year ago.

The ba­sic idea at Terns Phar­ma­ceu­ti­cals was that a Cal­i­for­nia-based dis­cov­ery team al­lied with a small de­vel­op­ment group in Chi­na could as­sem­ble a pipeline and ef­fi­cient­ly de­vel­op new drugs pri­mar­i­ly for the Chi­nese mar­ket.

“We can short­en the time it takes to de­vel­op drugs for the Chi­na mar­ket,” says the CEO, who feels they are well po­si­tioned to trans­late the rapid­ly im­prov­ing reg­u­la­to­ry process in Chi­na. Eli Lil­ly plans to learn from their progress.

With an in­tro from their col­leagues at Lil­ly Asia Ven­tures, they were able to ink an agree­ment with the moth­er com­pa­ny that cov­ers a clin­i­cal-stage far­ne­soid X re­cep­tor (FXR) ag­o­nist, TERN-101, a semi­car­bazide-sen­si­tive amine ox­i­dase (SSAO) in­hibitor, TERN-201 — which is near­ing IND sub­mis­sion — and an undis­closed pre­clin­i­cal can­di­date. And they are com­bin­ing the NASH work with on­col­o­gy, build­ing on the 5 pro­grams pieced to­geth­er by their in-house group in Shang­hai.

101 seems well de­signed to ad­vance in Chi­na, says the sci­en­tist, as the var­i­ous play­ers be­gin to as­sem­ble the unique com­bi­na­tions that he be­lieves will be need­ed to ad­dress var­i­ous stages of NASH, as well as pos­si­bly dif­fer­ent ge­net­ic groups. 201, though, he be­lieves has the kind of first-in-class po­ten­tial that they could work on for both the US and the Chi­nese mar­kets si­mul­ta­ne­ous­ly.

The move to out li­cense drugs point­ed pri­mar­i­ly to Chi­na comes about a year af­ter Lil­ly opt­ed to shut down its R&D base in Shang­hai, fol­low­ing a pat­tern of big phar­ma ex­its that al­so in­clud­ed GSK. Lil­ly now is fo­cus­ing on al­liances like this one to ad­vance new drugs in the boom­ing Asian mar­ket.

Zhong likes the idea of go­ing back in­to liv­er dis­eases and match­ing it with on­col­o­gy as a good way of dis­tin­guish­ing the start­up in a boom­ing Chi­nese biotech field. And he has every in­ten­tion of stay­ing in the fast lane.

Their pro­jec­tion for the SSAO drug is to get it in­to the clin­ic in ear­ly 2019, with a shot at com­plet­ing the proof-of-con­cept stage in 2021 that could — if every­thing works out — leave them on the thresh­old of a late-stage pro­gram.

That’s am­bi­tious for a com­pa­ny that cur­rent­ly to­tals about 15 full timers, plus CRO help. But Zhong feels that the com­pa­ny can op­er­ate like the small, tough lit­tle wa­ter bird it’s named af­ter, built for long mi­gra­tions. 

They may be small, but Terns plans to go far.

Nick Galakatos, Blackstone global head of life sciences

Nick Galakatos and the Black­stone team now have a record $4.6B to in­vest in bio­phar­ma, with a big fo­cus on push­ing com­pa­nies over the top

Nick Galakatos and his team at Blackstone Life Sciences have seen their biggest opportunities swell up in mostly established players who don’t have all the money they need to accomplish everything on the to-do list. And right now, with the industry booming, that’s a long list with some hefty needs.

The Blackstone team has neatly tied up the largest private fund ever raised in life sciences for making big dreams come true in biopharma. Late Thursday, Blackstone put out word that they had closed their highly anticipated fund with the projected $4.6 billion all in.

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Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Andrew Kruegel, Kures president and co-founder (Columbia Tech Ventures via Vimeo)

Af­ter psilo­cy­bin and ke­t­a­mine, a new biotech comes along de­vel­op­ing a drug Scott Got­tlieb fought

Andrew Kruegel was six years into his chemistry work at Columbia University, when, one day in August 2016, he learned he might have only 30 days before the government made him destroy his research.

Kruegel had been studying kratom, a leaf long used in Southeast Asia as a stimulant or for pain. It had opioid-like properties, he found, but seemed to offer pain relief without the addictive potential or respiratory side effects of traditional opioids — a riddle that might help illuminate how human opioid receptors work.

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Top biotech an­a­lyst projects a gloomy out­look for Pfiz­er's JAK port­fo­lio

Many in the pharma world are hoping — better yet, expecting — JAK inhibitors to provide one of the next big boons for the industry. Few have invested as heavily in this area as Pfizer, which boasts a portfolio including Xeljanz and at least five mid-to-late stage candidates in the pipeline.

But a top Wall Street analyst is pumping the brakes on just how much good fortune is in store for the Big Pharma.

Gilead boasts of pos­i­tive remde­sivir da­ta on mor­tal­i­ty — but their analy­sis pro­vokes the skep­tics

Gilead is surging again off data that suggest its antiviral remdesivir might improve survival.

The new data come from an analysis Gilead conducted comparing the death rate and recovery time of patients in one of its remdesivir trials to a group of 800 patients “with similar baseline characteristics and disease severity” who received only standard-of-care around the same time. The result, they said, suggested that patients who received remdesivir had a 62% better chance at surviving than those who did not.

Hal Barron, GSK

Win or lose on the mar­ket­ing OK, the FDA just gunned down GSK’s bright hopes for their BC­MA ther­a­py

The FDA’s ODAC — the Oncologic Drugs Advisory Committee — has a well-known bias in favor of adding new cancer drugs to the market, even if efficacy is at best marginal and serious safety issues demand careful management.

Doctors want as many arrows in their quiver as they can get. And when patients are dying after failing multiple drugs, why not give it a go one more time?

GlaxoSmithKline, though, is about to test out how their new BCMA antibody drug conjugate belantamab mafodotin can do after being mauled in an in-house FDA review, ahead of the Tuesday expert panel discussion. Even if the agency goes ahead with an expected green light, this drug will likely be constrained to a small niche — icing any plans they may have for making waves in oncology anytime soon.

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Covid-19 roundup: BioN­Tech go­ing head-to-head with Mod­er­na as PhI­II mR­NA launch looms; Tri­al on Shin­zo Abe’s once-fa­vorite an­tivi­ral is in­con­clu­sive

It’s a race to the Phase III finish line now for the 2 leading mRNA vaccines in the pipeline for Covid-19.

BioNTech chief Ugur Sahin told the Wall Street Journal that his company will start Phase III testing of their vaccine later this month, setting them up to lateral the data to regulators before the end of this year.

That puts them essentially on the exact same schedule as Moderna is dedicated to. The Massachusetts rival to BioNTech also expects to launch Phase III this month. Lots of rumors have circulated about delays and conflict among the scientists advancing the Moderna jab, but the biotech has consistently stuck to its plan to start a late-stage pivotal this month.

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Noubar Afeyan, Flagship CEO and Tessera chairman (Victor Boyko/Getty Images)

Flag­ship ex­ecs take a les­son from na­ture to mas­ter ‘gene writ­ing,’ launch­ing a star-stud­ded biotech with big am­bi­tions to cure dis­ease

Flagship Pioneering has opened up its deep pockets to fund a biotech upstart out to revolutionize the whole gene therapy/gene editing field — before gene editing has even made it to the market. And they’ve surrounded themselves with some marquee scientists and execs who have crowded around to help shepherd the technology ahead.

The lead player here is Flagship general partner Geoff von Maltzahn, an MIT-trained synthetic biologist who set out in 2018 to do CRISPR — a widely used gene editing tool — and other rival technologies one or two better. Von Maltzahn has been working with Sana co-founder Jake Rubens, another synthetic biology player out of MIT who he describes as his “superstar,” who’s taken the CSO role.

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