Alex Zhavoronkov and Feng Ren, Insilico co-CEOs

As their first clin­i­cal da­ta test looms, glob­al AI play­er In­sil­i­co bumps up a GSK vet to co-CEO in charge of de­vel­op­ment

Days af­ter top­ping up In­sil­i­co Med­i­cine’s cash re­serves with a $60 mil­lion round, the glob­al AI play­er is re­design­ing its ex­ec­u­tive struc­ture with an un­usu­al twist as it shifts from pure drug de­sign and dis­cov­ery and builds out the pipeline with clin­i­cal stage as­sets.

A lit­tle more than a year af­ter step­ping in as the CSO, Feng Ren, the Har­vard grad and GSK vet with ex­pe­ri­ence in Philadel­phia and Shang­hai, is step­ping up to a co-CEO role. He’ll be in charge of the de­vel­op­ment work, as they start test­ing more of their drugs in hu­mans and put their promise of a more ef­fi­cient ap­proach to drug hunt­ing to the ul­ti­mate test.

He’ll be op­er­at­ing along­side Alex Zha­voronkov, the al­ways out­spo­ken com­pa­ny founder who’s cham­pi­oned all things AI, with new ro­bot­ics op­er­a­tions be­ing added to the dis­cov­ery mix as they raised more than $300 mil­lion in new mon­ey over the past year. Zha­voronkov stays in charge of the AI side of things.

He of­fered a thumbs up to his new “co-cap­tain,” promis­ing to set new records in speed­ing drugs in­to the clin­ic.

The move comes as In­sil­i­co push­es to­ward a promised Phase II for their fi­bro­sis drug and looks to add more to the pipeline as they ad­vance their pre­clin­i­cal work. Af­ter years of tout­ing the po­ten­tial of AI, the in­dus­try is get­ting to the point where hu­man da­ta will pro­vide hard proof for an in­dus­try niche that has at­tract­ed bil­lions in in­vest­ment. And In­sil­i­co is in the front ranks of that trend, poised to start of­fer­ing an ob­jec­tive grade on their ef­forts.

“We are at a piv­otal mo­ment. We have a clin­i­cal pro­gram, and we are hope­ful that many oth­er pro­grams will soon reach the clin­i­cal stage. We are al­so in the process of es­tab­lish­ing a ful­ly au­to­mat­ed AI-dri­ven ro­bot­ics lab, a cut­ting-edge tech­nol­o­gy to ac­cel­er­ate our drug R&D,” says Ren.

That will like­ly leave both CEOs with plen­ty on the to-do list.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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Sergio Traversa, Relmada Therapeutics CEO

Rel­ma­da makes 'crit­i­cal changes' to PhI­II tri­al to try and save de­pres­sion drug

Relmada Therapeutics is making changes to its Phase III study of its lead drug for major depressive disorder, in an attempt to avoid problems with a prior trial that showed little difference between the drug and a placebo.

That failure in October wiped 80% from Relmada’s stock price, and was followed by another negative readout a few months later. In both cases, the company said that there had been trial sites that were associated with what it called surprising placebo effects that skewed the results compared with the drug, REL-1017.

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Peter Hecht, Cyclerion Therapeutics CEO

Hard pressed for cash, Cy­cle­ri­on looks for help fund­ing rare dis­ease drug

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Geoff McDonough, Generation Bio president and CEO

Mod­er­na part­ners on non-vi­ral gene ther­a­py with Gen­er­a­tion Bio af­ter swing­ing gene edit­ing deals

Moderna has inked a five-year partnership with gene therapy biotech Generation Bio, it announced Thursday morning, wading deeper into the genetic medicines space as it navigates beyond its vaccine work.

Moderna will pay Generation Bio $40 million upfront and invest another $36 million into the gene therapy biotech. In exchange, Moderna can license Generation Bio’s non-viral gene therapy platforms for two immune cell programs and two liver programs, with an option for a fifth program. Moderna will fund all the research work under the partnership, and could be on the hook for milestone, fee and royalty payments totaling up to $1.8 billion, a company spokesperson tells Endpoints News.

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Paul Song, NKGen Biotech CEO

NK cell ther­a­py-fo­cused biotech eyes SPAC deal

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

In­cyte hit by CRL on ex­tend­ed-re­lease JAK tablets, mud­dy­ing plans for Jakafi fran­chise ex­pan­sion

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”