Six years sep­a­rat­ed from a ra­bies vac­cine scan­dal, Chi­na’s Yisheng­Bio grabs $130M to go big in in­fec­tious dis­eases, can­cer

In an­oth­er boost to the glob­al vac­cine field, top in­vestors in Chi­na have hud­dled to­geth­er to in­ject $130 mil­lion in­to Bei­jing-based Yisheng­Bio.

David Shao

Co-led by Ocean­pine and Or­biMed, the Se­ries B now gives the biotech an en­vi­able list of mar­quee do­mes­tic VCs: EightRoad, F-Prime Cap­i­tal, 3W Cap­i­tal, Hill­house Cap­i­tal, MSA Cap­i­tal, AI­HC, Epiphron Cap­i­tal, Su­per­string Cap­i­tal and Haitong In­ter­na­tion­al. The stand­out here is Ad­ju­vant Cap­i­tal, a pub­lic-health-mind­ed crew with ties to the Gates Foun­da­tion.

“Chi­nese biotech com­pa­nies are play­ing an in­creas­ing­ly sig­nif­i­cant role in the in­no­va­tion era of the whole world,” Iris Wang, man­ag­ing di­rec­tor of Or­bimed Asia-Pa­cif­ic, said in a state­ment.

Found­ed in 1992, Yisheng­Bio’s sig­na­ture prod­uct is YS­JA, an alum-free lyophilized ra­bies vac­cine that it says has in­oc­u­lat­ed 16 mil­lion peo­ple in Chi­na.

It was the sub­ject of a scan­dal in 2014 when the Chi­na FDA told their sub­sidiary, Liaon­ing Yisheng, that three batch­es of their ra­bies vac­cine had failed steril­i­ty tests. But ex­ecs, in­clud­ing founder Zhang Yi, said that had come af­ter al­most two years of seek­ing reg­u­la­to­ry ap­proval, which amount­ed to a dere­lic­tion of du­ty and a “bar­ri­er against tech­no­log­i­cal in­no­va­tion” on the of­fi­cials’ part.

Zhang Yi

Six years and a se­ries of sweep­ing re­forms lat­er, Yisheng­Bio is op­er­at­ing in a much dif­fer­ent Chi­na. It now has a foot in the USA and Sin­ga­pore, with 500 em­ploy­ees in to­tal. And the new pro­grams in the pipeline — which spans in­fec­tious dis­eases and can­cer — are de­vel­oped on the PI­KA plat­form. Ac­cord­ing to the com­pa­ny, the tech­nol­o­gy “aug­ments both in­nate and adap­tive im­mune re­spons­es through the TLR3, RIG-I and MDA5 path­ways.”

CEO David Shao is eye­ing a glob­al mul­ti­cen­ter Phase III tri­al for a new ra­bies vac­cine de­signed for post-ex­po­sure im­mune pro­tec­tion.

“This new round of cap­i­tal will ac­cel­er­ate the build­ing of our man­age­ment and R&D teams and will fa­cil­i­tate the growth of our pipeline and con­struc­tion of pro­duc­tion sites both at home and abroad,” he said in a state­ment.

Re­ports sug­gest it would al­so set the stage for a quick IPO that could fetch $200 mil­lion.

Yisheng is al­so work­ing on PI­KA YS-SC2-010, a pro­phy­lac­tic and ther­a­peu­tic vac­cine can­di­date against Covid-19. Oth­er prod­ucts in­clude:

  • YS-ON-001 for the treat­ment of ad­vanced sol­id tu­mors
  • YS-HBV-001 for he­pati­tis B
  • PI­KA YS-HBV-002 for chron­ic HBV
  • PI­KA YS-ON-002 for sol­id tu­mor

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?

Chris Gibson (Photo By Vaughn Ridley/Sportsfile for Web Summit via Getty Images)

Re­cur­sion founders gin for­tunes as IPO back­ers show­er $436M on one of the biggest boasts in AI -- based on some very small deals

In the AI drug development world, boasting often comes with the territory. Yet few can rival Recursion when it comes to claiming the lead role in what company execs like to call the industrialization of drug development, with promises of continued exponential growth in the number of drugs it has in the pipeline.

On Friday, the Salt Lake City-based biotech translated its unicorn-sized boasts into a killer IPO, pricing more than 24 million shares at the high end of its range and bringing in $436 million — with a large chunk of that promised by some deep-pocket backers.

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Covid-19 vac­cine halt drags on, an FDA ap­point­ment at long last, the great CRO con­sol­i­da­tion, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Conference season is upon us, and while we’d much prefer to be wandering down the hallways and presentation rooms in person, the team is ready to cover the most consequential data coming out of these scientific meetings. Get in touch early if you have news to share.

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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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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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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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Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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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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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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