Andrew Hopkins, Exscientia CEO (Exscientia)

Lay­ing claim to an­oth­er AI 'first,' Ex­sci­en­tia tees up an I/O drug for the clin­ic

In Jan­u­ary 2020, Ex­sci­en­tia an­nounced that a drug mol­e­cule to treat OCD in­vent­ed by AI was set to en­ter clin­i­cal tri­als for the first time. A lit­tle over a year lat­er, its AI-de­signed mol­e­cule for im­muno-on­col­o­gy will do the same.

The A2a re­cep­tor an­tag­o­nist was co-de­vel­oped with Evotec and has the po­ten­tial to pre­vent adeno­sine from bind­ing to T-cell re­cep­tors, pro­mot­ing an­ti-tu­mor T-cell ac­tiv­i­ty. Ex­sci­en­tia CEO An­drew Hop­kins said in a state­ment that the mol­e­cule was dis­cov­ered with­in 8 months from project ini­ti­a­tion.

That time frame was even faster than the com­pa­ny’s mol­e­cule for OCD treat­ment, which reached the point of en­ter­ing clin­i­cal tri­als with­in just a year, which is the kind of boast that the AI com­pa­nies love to make. In a Jan­u­ary in­ter­view with The Tele­graph, Hop­kins hint­ed that Ex­sci­en­tia was inch­ing to­ward tri­als of its sec­ond drug, and said that the short­cut was pos­si­ble be­cause the AI plat­form — named Cen­taur — is able to help nar­row down the field of po­ten­tial win­ners. In­stead of test­ing hun­dreds or thou­sands of mol­e­cules, the al­go­rithm ze­roes in on those with po­ten­tial for suc­cess.

Ex­sci­en­tia was not able to an­swer ques­tions in time for this sto­ry’s pub­li­ca­tion Fri­day.

Pernille Hansen

The an­nounce­ment comes at a hot time for ar­ti­fi­cial in­tel­li­gence plat­forms. The cost of drug de­vel­op­ment in­volves a de­bate that has rolled on for years, but the AI crowd like to fo­cus on a $2.6 bil­lion es­ti­mate to help back their case. Of course, we won’t know the true ad­van­tage un­til the first AI drug makes it through the clin­ic — and in­to the mar­ket.

In Jan­u­ary, As­traZeneca added its first tar­get gen­er­at­ed by AI to its port­fo­lio, af­ter a col­lab­o­ra­tion with Benev­o­len­tAI that be­gan in April 2019. That work fo­cused on chron­ic kid­ney dis­ease, and fits in­to the com­pa­ny’s broad­er AI strat­e­gy. As­traZeneca’s head of re­nal bio­sciences Pernille Hansen said that AI can be used in ways oth­er than dis­cov­er­ing new tar­gets: in chem­istry, imag­ing and be­yond.

Benev­o­len­tAI’s COO Ivan Grif­fin told End­points News in Jan­u­ary that his com­pa­ny has spent years feed­ing its tech with da­ta from pro­teins, genes and re­sults pub­lished in sci­en­tif­ic jour­nals in an ef­fort to train its al­go­rithm to make con­nec­tions that sci­en­tists may not have no­ticed at first. Sci­en­tists take ad­van­tage of these AI-pre­dict­ed re­la­tion­ships and then in­ter­ro­gate them to see if they hold up, Grif­fin said.

Ivan Grif­fin

In Feb­ru­ary, In­sil­i­co founder Alex Zha­voronkov an­nounced that it brought its first can­di­date in­to IND-en­abling stud­ies. His com­pa­ny’s goal is to launch an in-hu­man tri­al lat­er in 2021, though he wasn’t ready to an­nounce what the tar­get or ex­per­i­men­tal drug is. Its fo­cus will be id­io­path­ic pul­monary fi­bro­sis, some­thing that Benev­o­len­tAI and As­traZeneca have al­so said to be col­lab­o­rat­ing on.

Pre­clin­i­cal da­ta from this project will be pre­sent­ed at the AACR an­nu­al meet­ing.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; 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.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Marshall Fordyce, Vera CEO

Gene ther­a­py play­er turned kid­ney spe­cial­ist Ve­ra drops a dud in lead­up to Nas­daq, pric­ing well be­low range

Vera Therapeutics took a big risk at the start of the year, pivoting away from its gene editing mission statement to chase a lead kidney drug instead — and they doubled down with an IPO just months later. But investors don’t seem impressed with Vera’s promise, and now the biotech is looking at a far more scaled-back offering.

On Friday, Vera priced its 4.35-million-share IPO at $11 per share, well below its targeted range of $14 to $16 and good for $47.58 million in proceeds. The biotech will start trading Monday under the ticker $VERA.

Darren Ji, Elpiscience CEO (Lilly Asia Ventures)

Kept an ocean away from its sci­en­tif­ic ad­vi­sors, Shang­hai's Elpi­science keeps up the clin­i­cal progress, re­fu­els for its I/O pipeline

When Elpiscience pooled $100 million for its Series B in late 2019, CEO Darren Ji promised to move what he described as one of the broadest immuno-oncology pipelines swiftly through the clinic in both the US and China.

Then a pandemic got in the way — but not by much. The Shanghai-based biotech managed to keep testing its 4-1BB/PD-L1 drug, get an OX40 agonist cleared for clinical trials (nabbing a collaboration with Junshi in the process), while in-licensing a Phase I bispecific from California’s TRIGR Therapeutics.

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