Venky Soundararajan (via Medium)

A for aug­ment­ed: Cam­bridge AI com­pa­ny out to cap­ture bio­med­ical knowl­edge gets $60M from Mayo, Sil­i­con Val­ley VC

The Mayo Clin­ic is join­ing hands with a Sil­i­con Val­ley VC firm to in­ject $60 mil­lion in­to nfer­ence, a Cam­bridge, MA-based play­er in the gold rush to cap­i­tal­ize on bio­phar­ma’s grow­ing in­ter­est — and urge — to ac­cel­er­ate drug dis­cov­ery and de­vel­op­ment us­ing the lat­est ma­chine learn­ing tools.

While nfer­ence os­ten­si­bly be­longs to a gen­er­a­tion of soft­ware star­tups that cropped up around 2013, it doesn’t see it­self as part of the AI main­stream, founder and CSO Venky Soundarara­jan tells End­points News. That’s why the A in their AI stands for aug­ment­ed, not ar­ti­fi­cial.

“To put it blunt­ly, we are not in the busi­ness of re­plac­ing hu­man ex­perts,” he said.

Rather, nfer­ence is in­ter­est­ed in teach­ing soft­ware to comb through un­struc­tured bio­med­ical in­for­ma­tion — clin­i­cal notes, case re­ports, sci­en­tif­ic lit­er­a­ture, pathol­o­gy im­ages, ECG wave­forms and ge­nom­ic se­quences — and ren­der them com­putable. By cap­tur­ing and syn­the­siz­ing dif­fer­ent bod­ies of knowl­edge, the goal is to of­fer a one-stop shop that re­searchers can con­sult at any point of the R&D process, whether they are try­ing to make new com­pounds or de­sign­ing a clin­i­cal tri­al.

Soundarara­jan sug­gest­ed that’s the type of AI com­pa­ny that Bill Gates said he would build if he were to start a new ven­ture in this age, one “whose goal would be to teach com­put­ers how to read, so that they can ab­sorb and un­der­stand all the writ­ten knowl­edge of the world,” in the Mi­crosoft founder’s words.

Two of the top 10 bio­phar­ma com­pa­nies are al­ready on board as part­ners, ac­cord­ing to Soundarara­jan. With the Se­ries B, he hopes to add a new ser­vice around “con­text rich phe­no­types,” which would en­able the map­ping of ge­nom­ic da­ta to phe­no­types.

An­drew Danielsen

“Our strate­gic in­vest­ment in nfer­ence is a re­flec­tion of our con­fi­dence that a holis­tic knowl­edge syn­the­sis plat­form, that puts pa­tient pri­va­cy first, is the so­lu­tion for ef­fec­tive­ly lever­ag­ing re­al world ev­i­dence to spur in­no­va­tion to ben­e­fit pa­tient care,” An­drew Danielsen, chair of Mayo Clin­ic Ven­tures, said in a state­ment.

In fact, the re­search cen­ter has been so con­fi­dent in the tech that it’s set up a joint ven­ture with nfer­ence –dubbed Qra­tiv — to re­pur­pose ther­a­pies for rare dis­eases.

NTT Ven­ture Cap­i­tal joined Mayo for the round, which al­so in­clud­ed ex­ist­ing in­vestors Ma­trix Part­ners and Ma­trix Cap­i­tal Man­age­ment.

Out­side their head­quar­ters in Cam­bridge, nfer­ence’s 150-strong staff is spread be­tween Ban­ga­lore, Toron­to and Min­neso­ta, Soundarara­jan added, and he’s ex­plor­ing an ex­pan­sion to Eu­rope.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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