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: A small, ob­scure biotech just won big with their IPO. In this mar­ket. Are you kid­ding me?

How could a small, largely unknown biotech that emerged from stealth mode just months ago with early-stage cancer programs jump onto Wall Street in the middle of a Category 6 financial hurricane and sail through with a $165 million IPO?

And what does that mean for the rest of the industry waiting to see just how much damage global lockdowns will wreak on clinical development?

The biotech is a company called Zentalis. The crew there nabbed an $85 million crossover round late last year — notably waiting 5 years before waving the numbers around to attract attention, according to my read of a FierceBiotech story. Perceptive joined in, but the syndicate was not in general the kind of marquee affair that gets tongues wagging.

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Gilead CEO Daniel O'Day attends a meeting with the President and other biopharma leaders at the White House on March 2, 2020 (AP Photo)

Ramp­ing up glob­al pro­duc­tion of remde­sivir, Gilead CEO Dan O’Day de­tails plans to dis­trib­ute 1.5M dos­es to fight Covid-19 — for free

Gilead is still some days away from turning the card on its first round of data on remdesivir’s ability to fight severe cases of Covid-19, but the big biotech is ramping up an emergency supply of a million courses of therapy as it starts free distribution of the drug to tens of thousands of patients under their compassionate use and expanded access program as well as clinical trials.

In his latest open letter posted over the weekend, Gilead CEO Dan O’Day outlined how the company has been successful in cutting production time on remdesivir while repurposing some of their own facilities and turning to contract manufacturers to build a near-term supply of 1.5 million doses. They are still working on efficacy and dosing, but that supply could cover 140,000 courses of treatment. That supply, he added, would be more widely available following a potential approval.

Bob Nelsen at the Milken Institute Global Conference on April 29, 2019 in Beverly Hills, California. (Photo by Michael Kovac/Getty Images)

ARCH chief Bob Nelsen has $1.5B to prove 2 sim­ple points: ‘We’re in the most in­no­v­a­tive time ever’ and in­vestors are stay­ing

ARCH co-founder and managing director Bob Nelsen has a well known yen for the home run swing, betting big on potentially transformative meds and tech and the biotech teams he helps bring together. He thrives and bleeds on the cutting edge. And now Nelsen and the ARCH group have debuted 2 big funds to prove that this is the time for the best of biotech to shine — deadly pandemic be damned.

Two new funds, ARCH Venture Fund X and ARCH Venture Fund X Overage, gathered a combined $1.46 billion. And that’s a record. ARCH Venture Fund IX and ARCH Venture Fund IX Overage closed in 2016 with a combined $1.1 billion. ARCH Venture Fund VIII and ARCH Venture Fund VIII Overage closed in 2014 with a combined $560 million.

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Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Aaron Royston, venBio

In­vest­ing in the time of coro­n­avirus: the good, the bad and the hope­ful, as biotech VC firms close funds worth $3B

Apart from disrupting biopharma R&D and regulatory timelines, the coronavirus pandemic has inevitably ravaged financial markets and eroded investor risk appetite. Investing in the time of coronavirus feels reckless, but if biotech venture funds are any indication, the time is ripe.

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Drug dis­cov­ery in the age of coro­n­avirus

Developing new drugs is incredibly hard. That’s why, despite superhuman efforts from the industry, we’re still looking at 12-18 months minimum before we can realistically hope for a vaccine for Covid-19, and probably months before there’s a proven viable drug treatment.

But our increasing ability to begin to industrialize the drug discovery and development process through an engineering approach means that we have more hope for speeding up this process than ever before — and not just to defeat coronavirus, but to benefit the development of all new medicines in the future.