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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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