Mati Gill, AION Labs CEO

Big Phar­ma com­pa­nies join hands with Ama­zon on new Is­rael-based AI in­cu­ba­tor

What do Mer­ck, Pfiz­er, As­traZeneca and Te­va have in com­mon with Ama­zon? As of Wednes­day, they’re all join­ing forces with the Is­rael Biotech Fund to launch a new in­cu­ba­tor for star­tups walk­ing the line be­tween AI and drug de­vel­op­ment — and they’re gear­ing up to make some big in­vest­ments.

AION Labs plans to seed be­tween four and six new biotech com­pa­nies per year, start­ing in ear­ly 2022, CEO Mati Gill told End­points News. The funds should sup­port two to four years of run­way for each start­up.

“We have com­peti­tors that are work­ing to­geth­er…be­cause the chal­lenge of har­ness­ing AI and com­pu­ta­tion­al ca­pa­bil­i­ties for phar­ma is so im­mense and it re­al­ly hasn’t been tapped in­to,” Gill said in an in­ter­view.

AION’s roots trace back to Te­va where Gill was most re­cent­ly a se­nior ex­ec­u­tive in charge of out­reach. The phar­ma com­pa­ny was ini­tial­ly look­ing to strength­en its ties with Is­rael’s ro­bust tech com­mu­ni­ty when it came up with the idea for the col­lab­o­ra­tion. Then in De­cem­ber, they won more than $9 mil­lion in an Is­raeli gov­ern­ment ten­der to get start­ed.

How will it work? AION is copy­ing its mod­el from Bio­Med X, a part­ner and bio­med­ical in­cu­ba­tor based in Hei­del­berg, Ger­many. Each year, AION’s phar­ma part­ners will se­lect at least four of the biggest chal­lenges faced by drug­mak­ers in the AI space and is­sue calls for so­lu­tions. Five to 10 fi­nal­ists will be of­fered a chance to spend a week in Is­rael at a boot­camp, where they’ll de­vel­op their pro­pos­als. In the end, the win­ners will be of­fered seed fund­ing to form a com­pa­ny around their ideas.

Jim Weather­all

Gill ex­pects to an­nounce the first round of ap­pli­ca­tions lat­er this month.

“Da­ta, an­a­lyt­ics and AI are al­ready start­ing to trans­form the way we dis­cov­er and de­vel­op new med­i­cines and I be­lieve we are on­ly at the tip of the ice­berg in terms of its promise,” Jim Weather­all, As­traZeneca’s VP of da­ta sci­ence and AI R&D, said in a state­ment.

This isn’t the first in­stance of Big Phar­ma dip­ping its toes in the AI space. Back in May, Bris­tol My­ers Squibb ex­pand­ed a Cel­gene-era deal with AI out­fit Ex­sci­en­tia. And be­fore that, back in Feb­ru­ary, As­traZeneca said it added the first tar­get gen­er­at­ed by AI to its port­fo­lio, com­ing out of a col­lab­o­ra­tion with the Lon­don-based com­pa­ny, Benev­o­len­tAI.

Sev­er­al oth­er biotechs have cropped up with big promis­es to speed up the drug de­vel­op­ment process us­ing ma­chine learn­ing and oth­er AI-fo­cused mod­els, in­clud­ing In­sil­i­co, Deep Ge­nomics, Re­cur­sion, XtalPi and oth­ers.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Suresh Katta, Saama CEO (via YouTube)

As AI con­tin­ues to en­tice Big Phar­ma, a Car­lyle-led drug­mak­er syn­di­cate shells out $430M for cloud com­put­ing play­er

The AI revolution permeating Big Pharma took a big financial step forward Wednesday, with VCs and major drugmakers coming together to acquire a cloud-focused company.

Led by the Carlyle Group, the investors will put up $430 million for a majority stake in Saama, a company that collects patient data to help speed along the drug development process. The investment arms of Pfizer, Merck, Amgen and McKesson all participated in the financing, in addition to other prominent life sciences VCs like Northpond.

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René Russo, Xilio CEO (Alicia Petitti for Xilio)

Xilio Ther­a­peu­tics goes pub­lic as bio­phar­ma IPOs rum­ble for­ward in Q4

It’s been a busy fall on Wall Street — and this week, we’ve got another biotech going public after Ventyx yesterday.

Massachusetts solid-tumor biotech Xilio Therapeutics made its public debut today, joining 149 other biotechs that have gone public so far this year.

Back on October 1st, Xilio filed its S-1 with the SEC to make its IPO debut for $100 million — the next step in financing after completing a $95 million Series C back in February.