Bing Li, Debra Yu and Konstantin Poukalov, LianBio

Per­cep­tive births its first in-house start­up — and it's a Chi­na play

Per­cep­tive Ad­vi­sors is go­ing to Chi­na.

Adam Stone

The de­ci­sion dates back two years, chief in­vest­ment of­fi­cer Adam Stone tells End­points News, when the firm be­gan to fig­ure out how it can, in hedge fund-speak, strate­gi­cal­ly in­crease its ex­po­sure to a grow­ing bio­phar­ma mar­ket poised to be a key ge­o­graph­ic area in the next sev­er­al decades. It was a bit of a blindspot for Per­cep­tive, he ad­mits.

As “glob­al­ized sci­en­tist-in­vestors, we just couldn’t af­ford to have that blindspot in place,” he says.

A deep dive point­ed to cre­at­ing a new com­pa­ny based on an in-li­cens­ing mod­el, lever­ag­ing Per­cep­tive’s ex­ten­sive biotech net­work in the US, and they re­cruit­ed two sea­soned ex­ec­u­tives — CEO Bing Li and De­bra Yu, pres­i­dent and CBO — to get things start­ed in Oc­to­ber. Bare­ly a year lat­er, Lian­Bio is burst­ing out the gate with 30 staffers, sev­er­al late-stage as­sets and a big port­fo­lio deal.

Bridge­Bio and MyoKar­dia have signed up as the an­chor­ing part­ners. For $26.5 mil­lion in near-term pay­ments and $505 mil­lion in po­ten­tial mile­stones, Neil Ku­mar’s ge­net­ics-fo­cused shop is hand­ing over two tar­get­ed on­col­o­gy drug can­di­dates and giv­ing Lian pref­er­en­tial fu­ture ac­cess to 20-plus pro­grams in its port­fo­lio. The lat­ter deal cen­ters around mava­camten, the car­diomy­opa­thy drug that CEO Tas­sos Gi­anakakos said was “good to go” af­ter clinch­ing a cru­cial Phase III win ear­li­er this year. The up­front comes in at $40 mil­lion, with an­oth­er $147.5 mil­lion on the ta­ble.

Pi­o­neers like Zai Lab and Ever­est paved the way to fill the in­no­va­tion gap by bring­ing ex­per­i­men­tal and new drugs from the US and Eu­rope to Chi­na — with a promise to com­plete the lo­cal clin­i­cal work re­quired for ap­proval as well as the com­mer­cial troops need­ed to field the treat­ments.

But these days, with a horde of Chi­nese play­ers clam­or­ing for West­ern as­sets, it has be­come an in­creas­ing­ly chal­leng­ing area. You need a next-gen­er­a­tion mod­el to tap in­to tru­ly “par­a­digm shift­ing as­sets,” Li says.

“My ex­pe­ri­ence clear­ly tells me that this is prob­a­bly the on­ly way to make this mod­el work, to pair the man­age­ment team with a very strong busi­ness de­vel­op­ment en­gine, which Per­cep­tive pro­vides.” he adds.

Hav­ing fa­cil­i­tat­ed the ac­qui­si­tion of Am­bryx by Chi­nese in­vestors in 2015 and helped set up the Fo­s­un/Kite CAR-T joint ven­ture, Li had just stepped down from the CEO post at Chi­na Bi­o­log­ic when Yu in­tro­duced him to Per­cep­tive. Yu, the for­mer head of strat­e­gy at WuXi AppTec, had been go­ing around the US do­ing what she calls “Chi­na 101” meet­ings with state­side in­vestors. Per­cep­tive stood out as “or­ders of mag­ni­tude off the spec­trum so­phis­ti­cat­ed” in how they were think­ing about the mar­ket.

The in­vestor group — his­tor­i­cal­ly a pas­sive in­vestor that en­joys clin­i­cal-stage in­vest­ments and crossover rounds — al­so made its first for­ay in­to the com­pa­ny for­ma­tion and Se­ries A space late last year, set­ting up a $210 mil­lion ear­ly-stage VC fund with Xon­toge­ny. That part­ner­shp gave it ac­cess to Chris Garabe­di­an’s in­cu­ba­tor and a taste of start­up build­ing.

With heavy help from Kon­stan­tin Poukalov, man­ag­ing di­rec­tor at Per­cep­tive, and his col­leagues, Yu says her group is able to soup up the BD for­mu­la and present tai­lor-made de­vel­op­ment pro­pos­als to each part­ner.

“We talk to KOLs, we do analy­sis up­side down, back­wards and for­wards if you will,” she says.

Yu now man­ages a small of­fice in Prince­ton, New Jer­sey tasked with han­dling BD and al­liances, while Li spends the bulk of his time with the core team in Shang­hai.

“They are think­ing cre­ative­ly about this,” Ku­mar writes in an email to End­points. “This is ex­em­pli­fied by their work on our FGFR in­hibitor in­fi­gra­tinib and their plans to ex­pand in­di­ca­tions in­to ar­eas like gas­tric can­cer.”

Oth­er than the Phase III drug, which is housed in QED, Lian is notch­ing Chi­na and se­lect­ed Asian rights to Navire’s SHP2 in­hibitor BBP-398.

Poukalov, who’s al­so ex­ec­u­tive chair­man of Lian, notes that MyoKar­dia and Bridge­Bio will be­come share­hold­ers in the car­diore­nal and on­col­o­gy sub­sidiaries. Ku­mar and Gi­anakakos will join the board and play a part in guid­ing fu­ture in-li­cens­ing de­ci­sions, which can in­volve com­pounds in even ear­li­er stages.

Look­ing fur­ther down the road, Lian may set up more sub­sidiaries fo­cused on neu­rol­o­gy, in­flam­ma­to­ry dis­eases and even oph­thal­mol­o­gy.

The ex­act tim­ing will de­pend in part on the pace of Chi­na’s on­go­ing reg­u­la­to­ry re­forms. From the re­vi­sion of the rare dis­ease list to new re­im­burse­ment ap­proach­es, the Lian team sees pos­i­tive trends all around.

“We just saw the break­through des­ig­na­tion pol­i­cy im­ple­ment­ed and in fact they just grant­ed the first one to Leg­end Biotech. So you can see that clear­ly, they are still adding more el­e­ments sim­i­lar to the US,” Li says. “The big di­rec­tion is there, but there’s more de­tails and re­fin­ing that’s com­ing.”

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Image: Shutterstock

Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

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Pascal Soriot (AstraZeneca via YouTube)

Af­ter be­ing goad­ed to sell the com­pa­ny, Alex­ion's CEO set some am­bi­tious new goals for in­vestors. Then Pas­cal So­ri­ot came call­ing

Back in the spring of 2020, Alexion $ALXN CEO Ludwig Hantson was under considerable pressure to perform and had been for months. Elliott Advisers had been applying some high public heat on the biotech’s numbers. And in reaching out to some major stockholders, one thread of advice came through loud and clear: Sell the company or do something dramatic to change the narrative.

In the words of the rather dry SEC filing that offers a detailed backgrounder on the buyout deal, Alexion stated: ‘During the summer and fall of 2020, Alexion also continued to engage with its stockholders, and in these interactions, several stockholders encouraged the company to explore strategic alternatives.’

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Alise Reicin (L) and Tim Springer

Har­vard bil­lion­aire Tim Springer has lined up his lat­est biotech launch. And he's re­cruit­ed a star R&D ex­ec to man­age their break­through game plan

Tectonic Therapeutic isn’t your average biotech startup story. For all sorts of reasons.

There’s your billionaire Harvard scientist and philanthropist who’s personally bankrolling much of the operation. The CEO is one of the most prominent women involved in the global drug hunting business. And they have enough collective cachet between them to command virtually as much cash as they might dream of, at a time that biotech dreams are running beyond the fantastic.

But this story isn’t about them right now, so much as it is about a scientist who’s never quite been center stage in the floodlights of biostardom. There’s a whole group of prominent players, though, who believe that’s about to change. Players perfectly happy to gamble some significant coin to give that hope every chance possible of becoming a reality.

Andrew Kruse may not be an immediately recognizable name to you. But to his Harvard colleague Tim Springer, he’s a rock star. They co-founded the Institute for Protein Innovation together, a non-profit that the internationally renowned Springer has been funding with a fortune earned from a remarkable run of successful startups, from his first $100 million out of Millennium to the gusher of wealth that followed his decision to back Stéphane Bancel and the crew at mRNA pioneer Moderna.

Kruse has specialized in work revolving around GPCRs, or G protein-coupled receptors, that make up about a third of all — while still only scratching the surface of potential targets. He was a student of Brian Kobilka at Stanford, who won the Nobel Prize in 2012 for his contribution on the work on GPCRs. And Kruse has published extensively on his lab’s structural analysis of GPCRs, which Springer believes will open the door to a whole new field of drug R&D that can crack open a slew of currently “undruggable” targets to biologics — covering a gamut of both agonists and antagonists.

“We just have unparalleled experience in the biochemistry and biophysics of GPCRs,” says Springer about this new venture of his. “Andrew Kruse is a real star. He went from being a PhD student at Stanford to an assistant professor at Harvard Medical School — he had many papers out of his PhD — and he’s gone on to full professor at Harvard Medical School in 7 years. That is a record at least in modern times. The guy is just amazing. And he’s a nice guy.”

Springer is so convinced by the potential of Kruse’s research that he put up the first $5 million to seed the company 18 months ago. Terry McGuire — the co-founder at Polaris who goes back a long way with Springer — chipped in a million.

Which brings us to the nut of today’s news story.

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As­traZeneca-Alex­ion merg­er slides through FTC re­view af­ter sup­posed M&A crack­down pos­es no bar­ri­ers

The AstraZeneca-Alexion megamerger received a good sign Friday, despite warning signs of the tides turning against large M&A pharma deals.

US regulators at the FTC have cleared the acquisition for approval, AstraZeneca announced, all but signing off on the deal to go through once it officially closes in the third quarter. AstraZeneca originally said it was planning to buy out Alexion back in December for $39 billion.

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J&J faces CDC ad­vi­so­ry com­mit­tee again next week to weigh Covid-19 vac­cine risks

The CDC’s Advisory Committee on Immunization Practices punted earlier this week on deciding whether or not to recommend lifting a pause on the administration of J&J’s Covid-19 vaccine, but the committee will meet again in an emergency session next Friday to discuss the safety issues further.

The timing of the meeting likely means that the J&J vaccine will not return to the US market before the end of next week as the FDA looks to work hand-in-hand with the CDC to ensure the benefits of the vaccine still outweigh the risks for all age groups.

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Osman Kibar (Samumed, now Biosplice)

Os­man Kibar lays down his hand at Sa­mumed, step­ping away from CEO role as his once-her­ald­ed an­ti-ag­ing biotech re­brands

Samumed made quite the entrance back in 2016, when it launched with some anti-aging programs and a whopping $12 billion valuation. That level of fanfare was nowhere to be found on Thursday, when the company added another $120 million to its coffers and quietly changed its name to Biosplice Therapeutics.

Why the sudden rebrand?

“We did that for obvious reasons,” CFO and CBO Erich Horsley told Endpoints News. “The name Biosplice echoes our science much more than Samumed does.”

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Sanjiv Patel, Relay CEO

In one of their first ever ac­qui­si­tions, Re­lay bets $85M cash on a new AI-based screen­ing ap­proach

Although they’ve never been short for cash, Relay Therapeutics hasn’t been one for acquisitions in its 5-year history, focusing instead on developing its own tools to study how proteins move and advancing molecules off those insights.

On Friday, though, the Third Rock-spun biotech plunked down $85 million in cash and another $185 million in milestones to acquire the small, two-year-old, Google-partnered machine learning company ZebiAI. The deal will allow Relay to add a critical new technology to its early-stage discovery tools now that, with three candidates in the clinic, they’ve shown those tools can pay off, said CEO Sanjiv Patel.

Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

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