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.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; 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.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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Bo Cumbo, AavantiBio CEO

Scoop: A small gene ther­a­py biotech, flush with ex-Sarep­ta and blue­bird lead­ers, guts CMC

En route to entering the clinic with its first AAV-based gene therapy for a rare neuromuscular disease, AavantiBio has let go of 30 employees, Endpoints News has learned.

The move comes after a year stacking its executive bench with ex-Sarepta and bluebird bio leaders and inking multiple partnerships with the likes of Aldevron, Catalent and Resilience. The biotech also formed a scientific advisory board in February.

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Susan Galbraith, AstraZeneca EVP, oncology R&D

Catch­ing up with Bris­tol My­ers and Mer­ck, As­traZeneca de­clares neoad­ju­vant win for PD-L1/chemo com­bo

When AstraZeneca started the Phase III AEGEAN trial for Imfinzi in 2018, it was, alongside several Big Pharma brethren, hoping to push the use of PD-(L)1 therapies into earlier lines of treatment. Three and a half years later, the British drugmaker has nabbed promising data in a type of lung cancer.

Topline results from an interim analysis showed that adding Imfinzi to chemotherapy before surgery spurred a “statistically significant and meaningful” improvement in pathologic complete response for patients with resectable non-small cell lung cancer compared to chemotherapy alone.

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Anand Parikh, Faeth Therapeutics CEO

Sid Mukher­jee, Lew Cant­ley be­hind new can­cer biotech with food+drug com­bo treat­ment am­bi­tions 

Famed oncologist Sid Mukherjee and repeat biotech co-founder Lew Cantley have teamed up to form Faeth Therapeutics, a startup aiming to treat cancer the way other conditions are addressed: pairing nutrition with therapeutics.

The goal is to transform cancer treatment with nutrition and make it the fourth “pillar” in the oncology regimen, which to date has centered on radiotherapy, surgery and drugs, Faeth CEO Anand Parikh told Endpoints News. Other conditions have already been addressed with a side of nutrients or diet, he said, pointing to diabetes, irritable bowel syndrome and other diseases.

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Nassim Usman, Catalyst Biosciences CEO

Fac­ing set­backs for months and an ac­tivist at­tack, Cat­a­lyst Bio­sciences pre­pares to call it quits

After downsizing for several months, Catalyst Biosciences is getting ready to tap out.

The San Francisco biotech announced Wednesday that it would be liquidating and distributing cash back to shareholders, with total proceeds expected to reach $65 million. Catalyst intends to return the money “as soon as practicable,” the company said, as it has ceased all R&D activities, CEO Nassim Usman said in a statement.

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Barry Quart, Heron Therapeutics CEO

An­oth­er biotech grabs the axe, chop­ping R&D in a ma­jor re­or­ga­ni­za­tion as drug sales dis­ap­point

Heron Therapeutics has been sorely tested in its transition from an R&D company to a commercialization focus, losing 70% of its market cap $HRTX in Nasdaq’s storm-tossed waters since the beginning of the year.

Now it’s time to shake things up in the interest of buying itself more time, joining the downsizing movement in the midst of a bear market. And the axe is falling primarily on R&D.