Langer, Ciechanover god­fa­ther the lat­est AI up­start; Ipsen forges $446M AML de­vel­op­ment pact

There’s a new AI play­er jump­ing in­to the drug dis­cov­ery game. And they have some high-pow­ered sci­en­tif­ic ad­vi­sors in their cor­ner.

Tel Aviv-based Quris has built what it calls a “pa­tient-on-a-chip” AI plat­form that it’s tout­ing as a way to cir­cum­vent un­re­li­able an­i­mal test­ing with a more ef­fi­cient way to judge safe­ty and ef­fi­ca­cy. An­i­mal test­ing, par­tic­u­lar­ly in­volv­ing mice, has proven a no­to­ri­ous­ly un­re­li­able way to do pre­clin­i­cal test­ing — though it is well-es­tab­lished with reg­u­la­tors.

“Us­ing a break­through way to test drug can­di­dates on minia­tur­ized pa­tients on chips, Quris can demon­strate their safe­ty and ef­fi­ca­cy, or lack there­of, through pre­lim­i­nary chip-based clin­i­cal tri­als. This has nev­er been done be­fore, and Quris is chart­ing the path,” mar­vels No­bel Lau­re­ate Aaron Ciechanover, one of the up­start’s sci­ence guides.

Ciechanover is joined by the ubiq­ui­tous Bob Langer, the oft-quot­ed MIT pro­fes­sor — and bil­lion­aire Mod­er­na co-founder — who has some­how found the time to help god­fa­ther a mul­ti­tude of biotechs along the way.

The com­pa­ny gar­nered a $9 mil­lion seed round led by Ju­dith Richter and Ko­bi Richter, with par­tic­i­pa­tion from Moshe Yanai and strate­gic an­gel in­vestors.

There’s been con­sid­er­able boast­ing in the AI field in the last few years, which has tend­ed to be damp­ened by re­al­i­ty. — John Car­roll

Ipsen lands pre­clin­i­cal AML drug in $446M deal

Ipsen is beef­ing up the on­col­o­gy seg­ment of its pipeline with a new, $446 mil­lion deal with Ac­cent Ther­a­peu­tics.

The Paris-based play­er has signed off on a world­wide deal pack­age that gives it rights to Ac­cent’s pre-clin­i­cal stage MET­TL3 pro­gram for AML. The part­ners didn’t break out the up­front, but most of these pre­clin­i­cal deals are heav­i­ly back-end­ed with mile­stones.

“We are de­light­ed to part­ner with Ac­cent to progress the MET­TL3 pro­gram as we con­tin­ue our ex­pan­sion in­to hema­to­log­ic on­col­o­gy,” not­ed Ipsen ear­ly de­vel­op­ment chief Chris­telle Huguet. — John Car­roll

Centes­sa sub signs up for dis­cov­ery pact with Schrödinger

One of Centes­sa’s biotech subs has signed on with Schrödinger for a dis­cov­ery deal.

Orex­ia Ther­a­peu­tics is jump­ing on the com­pu­ta­tion­al com­pa­ny’s tech plat­form in search of ther­a­peu­tics that can hit the orex­in-2 re­cep­tor tar­get, a path­way that plays a key role in sleep dis­or­ders. This is the first time Schrödinger’s tech­nol­o­gy will be ap­plied in an orex­in ag­o­nist set­ting at scale.

Schrödinger gets an un­spec­i­fied up­front and a pack­age of mile­stones in the deal.

“While pre­vail­ing treat­ment ap­proach­es on­ly ad­dress the symp­toms as­so­ci­at­ed with nar­colep­sy type 1 (NT1), we be­lieve orex­in ag­o­nists of­fer a dis­rup­tive ap­proach, with the ca­pac­i­ty to ad­dress the un­der­ly­ing pathol­o­gy of the dis­or­der. Orex­ia’s uti­liza­tion of OX2R sta­bi­lized re­cep­tors pro­vides the foun­da­tion for R&D which could sig­nif­i­cant­ly ben­e­fit pa­tients with NT1. We look for­ward to part­ner­ing with Schrödinger to com­ple­ment the dis­cov­ery and de­vel­op­ment work we are con­duct­ing at Orex­ia,” said Saurabh Sa­ha, the CEO at Centes­sa. — John Car­roll

In­novent claims PhI­II win in EGFR-mu­tat­ed non­squa­mous NSCLC

In­novent is mak­ing noise Mon­day af­ter a Phase III study for its sin­til­imab pro­gram achieved the pri­ma­ry end­point. The biotech said the com­bi­na­tion of sin­til­imab and the an­ti-VEGF an­ti­body be­va­cizum­ab demon­strat­ed sig­nif­i­cant pro­gres­sion-free sur­vival im­prove­ment when al­so com­bined with chemother­a­py, com­pared to chemother­a­py alone.

In­novent en­rolled pa­tients with EGFR-mu­tat­ed non­squa­mous non-small cell lung can­cer that has pro­gressed af­ter treat­ment with an EGFR ty­ro­sine ki­nase in­hibitor. The biotech is al­so still wait­ing for da­ta look­ing at on­ly a sin­til­imab and chemo com­bo to ma­ture.

The study will con­tin­ue, as it did not reach the fu­til­i­ty stop­ping point, In­novent said. — Max Gel­man

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.