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.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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CEO Pascal Soriot via Getty Images

As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.