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.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.

Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.

Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.

Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

UP­DAT­ED: Feds clear the road for J&J to start de­liv­er­ing mil­lions of dos­es of their Covid-19 vac­cine — but frets linger about run­ner-up sta­tus

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.