Andrew Radin, Aria Pharmaceuticals CEO (Aria)

An­drew Radin or­ches­trates his AI dis­cov­ery plat­for­m's piv­ot to R&D with a har­mo­nious name change and eyes on the clin­ic

An­drew Radin was a straight A stu­dent. So when he stopped turn­ing in as­sign­ments in Nigam Shah’s class at Stan­ford Uni­ver­si­ty, the pro­fes­sor knew some­thing was up.

“If you don’t hand in as­sign­ments, you’re gonna fail,” Radin re­calls Shah say­ing one day af­ter class. “Every­thing al­right at home?”

Vi­jay Pande

Lit­tle did Shah know that a project Radin did for an­oth­er class had piqued the in­ter­est of An­dreessen Horowitz’s Vi­jay Pande, who al­so taught at the uni­ver­si­ty. As a bio­med­ical in­for­mat­ics stu­dent, Radin was look­ing at how tech­nol­o­gy could be used to comb through large swaths of da­ta and find drug-tar­get match­es — and Pande of­fered him the first in­vest­ment from his new $200 mil­lion biotech fund to turn the plat­form in­to a com­pa­ny.

So Radin dropped his stud­ies, and in 2015 of­fi­cial­ly launched AI-fo­cused twoXAR. Shah, who’s now on the sci­en­tif­ic ad­vi­so­ry board, called it the “best F ever.”

The com­pa­ny now boasts mul­ti­ple biotech part­ner­ships and near­ly as many pro­grams as it has em­ploy­ees (19 staffers ver­sus 18 pro­grams) — all ac­com­plished with a mod­est $14 mil­lion in VC funds. And as it tran­si­tions from part­ner­ing on drug dis­cov­ery re­search to ad­vanc­ing its own pipeline, it’s chang­ing its name to Aria Phar­ma­ceu­ti­cals.

“An aria, it’s this cap­stone of the mu­si­cal piece that’s typ­i­cal­ly re­served for a very tal­ent­ed per­former,” Radin, the firm’s CEO, told End­points News. “And yet, the aria doesn’t stand alone. It works with­in the con­text of a larg­er piece of mu­sic.”

The “aria” in this case, is the com­pa­ny’s drug dis­cov­ery plat­form, he said: “ex­cep­tion­al­ly gift­ed in its own right,” but more pow­er­ful when cou­pled with ex­per­tise and the right team to bring drugs to pa­tients.

To date, Aria has iden­ti­fied 18 po­ten­tial can­di­dates for com­plex dis­eases like lu­pus, glioblas­toma, chron­ic kid­ney dis­ease and glau­co­ma, four of which are be­ing de­vel­oped with part­ners. No can­di­dates have reached the clin­ic, but the team is prepar­ing for INDs in sev­er­al pro­grams.

Us­ing AI tech­nol­o­gy, Aria has been able to com­plete pre­dic­tions, se­lect hits and be­gin in vi­vo test­ing in an av­er­age of four weeks — a process which nor­mal­ly takes years us­ing tra­di­tion­al dis­cov­ery meth­ods,  ac­cord­ing to Radin.

The ma­chine learn­ing space is packed with play­ers look­ing to rev­o­lu­tion­ize the way new drugs are found and de­vel­oped. Just last week, Ex­sci­en­tia raised a fresh half-bil­lion dol­lars for its AI plat­form and pipeline. Mi­crosoft backed a new AI start­up called 1910 Ge­net­ics back in March. And ear­li­er that month, Daphne Koller pulled in $400 mil­lion for her ma­chine learn­ing start­up, in­sitro.

“What’s spe­cial about our method­olo­gies, is … peo­ple will typ­i­cal­ly use one type of da­ta or maybe, you know, a few types of da­ta to­geth­er in con­cert to try to make a dis­cov­ery,” Radin said. “We in­cor­po­rate dozens of un­re­lat­ed datasets in our pre­dic­tion sys­tems, and what that does is give us a very wide swath of in­for­ma­tion to ba­si­cal­ly un­cov­er new mod­els of patho­gen­e­sis.”

To lead the charge, Aria re­cent­ly tapped Mark Eller, for­mer head of R&D at Jazz Phar­ma­ceu­ti­cals, as se­nior VP of R&D; and An­jali Pandey, who was most re­cent­ly CSO at Bridge­Bio sub­sidiaries TheRas and Fer­ro, as se­nior VP of non­clin­i­cal R&D and chem­istry.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

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Joe Wiley, Amryt CEO

A biotech with a yen for pricey rare dis­ease drugs — and bar­gain base­ment shop­ping — adopts an­oth­er or­phan in lat­est M&A pact

After making it through a long, painful haul to get past a CRL and on to an FDA approval last summer, little Chiasma has found a buyer.

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Ngozi Okonjo-Iweala, Director general of WTO (AP Photo/Keystone/Alessandro Della Bella)

Opin­ion: Waiv­ing Covid-19 vac­cine IP could save lives, but where is the man­u­fac­tur­ing ca­pac­i­ty?

Droves of House Democrats in Washington and members of the European Parliament have now glommed onto a major push by India and South Africa at the WTO to abolish all IP around Covid-19 vaccines.

At first blush, waiving this IP sounds like an easy win: More Covid-19 vaccines made locally for more people means more lives saved. Simple enough, especially as low-income countries have received just a tiny fraction of the world’s vaccine allotment so far.

Thomas Schall, ChemoCentryx CEO (file photo)

Chemo­Cen­tryx plunges as FDA rais­es ques­tions about rare dis­ease drug ahead of ad­comm

ChemoCentryx’s stock price on Wednesday was cut in half by the release of FDA briefing documents ahead of a Thursday adcomm, raising questions on the company’s clinical data to support avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

ANCA-associated vasculitides (AAV) affect small to medium-size blood vessels that can be fatal in less than a year if left untreated, according to FDA. Only Roche’s Rituxan is currently FDA-approved for the treatment of AAV, while glucocorticoids are approved for the broader indication of vasculitis.

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