Bank­ing on Shang­hai's biotech boom, this Eli Lil­ly-backed play­er grabs $100M to push next-gen I/O ther­a­pies

Every six months for the past two years or so, five renowned sci­en­tists and biotech vets — David Shen of NGM Bio, Ar­lene Sharpe and Vi­jay Kuchroo of Har­vard, Juno co-founder Phil Green­berg and Uni­ver­si­ty of Chica­go’s Tom Gajew­s­ki — would meet. There (most re­cent­ly at Na­pa Val­ley over wine), as a sci­en­tif­ic ad­vi­so­ry board, they would of­fer ad­vice to a biotech start­up based an ocean away in Shang­hai, on their quest to un­cov­er new tar­gets and new an­ti­body ther­a­peu­tics for im­muno-on­col­o­gy.

Dar­ren Ji

That com­pa­ny, Elpi­science, is now tak­ing the wraps off a $100 mil­lion Se­ries B to ush­er two of its 12 com­pounds through clin­i­cal tri­als, bring a cou­ple in­to the clin­ic, and in-li­cense more from glob­al part­ners.

Mean­while, thanks to a RMB$150 mil­lion ($21.4 mil­lion) col­lab­o­ra­tion with Bank of Chi­na and Agri­cul­tur­al Bank of Chi­na, they will al­so be build­ing their own man­u­fac­tur­ing fa­cil­i­ties — big enough to even­tu­al­ly trans­fer all pro­duc­tion back from con­tract man­u­fac­tur­ers.

Elpi­science found it­self in the right place at the right time, CEO Dar­ren Ji told End­points News, as Shang­hai es­tab­lish­es it­self as a biotech hub on par with both the Cam­bridges or the Bay Area.

“I told my in­vestors es­sen­tial­ly I will have my man­u­fac­tur­ing ca­pa­bil­i­ties, with all equip­ment and peo­ple in a year with­out spend­ing in­vestors’ mon­ey yet,” he said.

By this time next year, Ji added, he ex­pects to have grown his team from 50 to 120, in­clud­ing more staffers on the chem­istry, man­u­fac­tur­ing and con­trol as well as clin­i­cal and reg­u­la­to­ry sides.

Hong­tao Lu

The cur­rent team is heav­i­ly geared to­ward dis­cov­ery, with around 30 of them work­ing on Elpi­science’s three tech plat­forms: Elpisource for tar­get screen­ing and iden­ti­fi­ca­tion; Im­munoshine to as­sess po­ten­tial drug can­di­dates on im­mune cell lines; and AbLego to for­mu­late their own bis­pecifics.

Ji re­cent­ly wooed the ex­ec­u­tive di­rec­tor of No­var­tis In­sti­tute for Bio­med­ical Re­search in Chi­na, Robert Arch, to be­come Elpi­science’s head of re­search. Arch re­ports to Hong­tao Lu, co-founder and CSO, who brought sim­i­lar ex­pe­ri­ence build­ing a pipeline in Zai Lab’s ear­li­est days.

A new CMO will soon join from the US, Ji said, to help steer clin­i­cal pro­grams for ES101 and ES102, with an ini­tial fo­cus on lung can­cer. Elpi­science had in-li­censed the two com­pounds — the first a bis­pe­cif­ic hit­ting 4-1BB se­lec­tive­ly up­on PD-L1 bind­ing, the sec­ond an OX40 ag­o­nist — from La Jol­la-based In­hi­brx.

By re­cruit­ing from all over the world and putting to­geth­er a stel­lar sci­en­tif­ic ad­vi­so­ry board, Elpi­science is cir­cum­vent­ing a bar­ri­er that Ji be­lieves Shang­hai, or Chi­na for that mat­ter, needs to over­come for its biotech scene to re­al­ly boom. He calls it “brain­pow­er.”

“Aca­d­e­m­ic in­no­va­tion, aca­d­e­m­ic cal­iber, is re­al­ly the foun­da­tion for both sci­en­tif­ic dis­cov­ery and de­vel­op­ment and al­so peo­ple sup­ply,” he said. “These years, Chi­nese acad­e­mia has been re­al­ly ad­vanc­ing strong with pub­li­ca­tions, in­no­va­tions, all those, but be­ing able to trans­late those in­to com­mer­cial­ly vi­able tech­nolo­gies or ther­a­pies, there’s still a gap — a gap be­tween both tech­nol­o­gy trans­fer and al­so the gap be­tween trans­la­tion­al per­son­nel.”

Lil­ly Asia Ven­tures, where Ji is a part­ner, bought on­to the vi­sion ear­ly by launch­ing the start­up with the help of Hill­house Cap­i­tal Group and CHD In­vest­ments. Hyfin­i­ty In­vest­ments led the cur­rent round with new in­vestors Ten­cent, GT­JA In­vest­ment Group, Dy­ee Cap­i­tal, Oriza Hold­ings, Ming Bioven­tures, Wis­doMont, Park­way Glob­al and oth­ers.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

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Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Chi­nese biotech Ever­est signs $550M+ li­cens­ing deal for BTK in­hibitors on heels of Covid-19 pact

Everest Medicines is on a roll with two licensing deals in one week.

The Shanghai-based biotech has paid Sinovent and SinoMab $12 million upfront for the rights to a BTK inhibitor for renal diseases, the company announced Thursday. The deal comes just days after Everest came away with rights to a Covid-19 vaccine in China, Taiwan, Singapore, Thailand and Indonesia.

Everest will pay Sinovent and SinoMab up to $549 million in milestone payments and royalties. The agreement includes tech transfer of Sinovent and SinoMab’s manufacturing process for the candidate, named XNW1011.

Skin tu­mors in mice force Pro­tag­o­nist to halt lead pro­gram, crush­ing stock

Protagonist Therapeutics just can’t catch a break.

Six months after the Newark, CA-based biotech unveiled grand plans to launch its lead candidate for blood disorders into a Phase III trial, the FDA has slapped the program with a clinical hold. The halt — which applies to all trials involving the candidate, rusfertide — comes after skin tumors were discovered in mice treated with the drug, according to Protagonist.

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