Lead­ing pro­teomics play­er gets a trio of new part­ners; GV tries to pre­vent cer­vi­cal can­cer

A lit­tle over 6 months ago, John Bak­er got on a call from a CEO with a strange re­quest.

Bak­er is head of in­no­va­tion at Ab­cam, a British com­pa­ny that pro­vides life sci­ence re­search tools to labs and com­pa­nies around the world. A lot of the firm’s work in­volves sup­ply­ing high­ly spe­cif­ic an­ti­bod­ies that al­low sci­en­tists to de­tect the pres­ence of or fish out a spe­cif­ic pro­tein in a sam­ple.

Su­jal Pa­tel, CEO of Nau­tilus Biotech­nol­o­gy, want­ed ba­si­cal­ly the op­po­site. “Their first call to us was, ‘Hey, guys, we’re look­ing for some re­al­ly bad an­ti­bod­ies,’” Bak­er re­called. “‘What have you got be­yond trench­ing in a freez­er for things that had failed?’”

A bad an­ti­body is one that binds to a wide set of tar­gets. To most re­searchers, such a mol­e­cule would be use­less: Put them in a sam­ple and you wouldn’t know if they were bind­ing to the pro­tein you want­ed, or a com­plete­ly un­re­lat­ed pro­tein.

Nau­tilus, though, is one of a hand­ful of com­pa­nies try­ing to win the grow­ing, mul­ti-bil­lion dol­lar pro­teomics race. Sev­er­al well-fi­nanced biotechs are try­ing to de­vise meth­ods to find the ex­act num­ber and type of pro­tein in any giv­en cell or sam­ple, in hopes that it can then point the path to new treat­ments.

Nau­tilus claims the method they’re build­ing, de­signed by Stan­ford pro­fes­sor and now Nau­tilus chief sci­en­tist Parag Mallick, can of­fer greater de­tail than its com­peti­tors. It does so, Mallick said, by im­mo­bi­liz­ing all the pro­teins in a sam­ple, al­low­ing them to be in­ter­ro­gat­ed more close­ly. (Some oth­er meth­ods, such as pep­tide se­quenc­ing, ac­tu­al­ly de­stroy the pro­teins they’re mea­sur­ing.)

Al­though the plat­form is as yet un­proven, the com­pa­ny is work­ing with Genen­tech to an­a­lyze pro­teins on an undis­closed tar­get. They an­nounced two more such part­ner­ships with Am­gen and an undis­closed in­ves­ti­ga­tor at MD An­der­son on Mon­day, the lat­ter of which will fo­cus on a par­tic­u­lar pro­tein tar­get in can­cer.

The idea is that, for ex­am­ple, a can­cer drug may work dif­fer­ent­ly on two pa­tients with the same mu­tant pro­tein be­cause of small dif­fer­ences in the con­for­ma­tion — or shape — of the pro­teins. By un­der­stand­ing those dif­fer­ences, you might de­sign bet­ter pro­teins.

“The rea­son why some of these ther­a­peu­tics work may come down to that lev­el of de­tail,” Mallick said.

To im­mo­bi­lize enough pro­teins in a sam­ple, though, they need­ed an­ti­bod­ies that could bind a long list of them, a dif­fer­ent prob­lem than the one Ab­cam and oth­er re­search com­pa­nies are used to solv­ing. But once Bak­er un­der­stood the is­sue, he agreed it was a fun chal­lenge. The two com­pa­nies are now be­gin­ning to try to de­sign and iso­late the best worst an­ti­bod­ies. — Ja­son Mast

GV backs a biotech aimed at pre­vent­ing cer­vi­cal can­cer 

The vir­tu­al biotech An­ti­va closed a new round of fi­nanc­ing Tues­day morn­ing. An­ti­va raised $31 mil­lion in a Se­ries D eq­ui­ty fi­nanc­ing, the com­pa­ny said, aim­ing to ad­vance its treat­ments for pre­can­cer­ous le­sions caused by HPV.

Tues­day’s raise was led by Ad­ju­vant Cap­i­tal and joined by oth­er promi­nent in­vestors such as Google’s GV. The com­pa­ny said pro­ceeds will go to­ward the lead can­di­date, in­clud­ing ad­vanc­ing it in­to Phase I and Phase IIa clin­i­cal tri­als for high-grade cer­vi­cal in­traep­ithe­lial neo­plasias.

An­ti­va said the mol­e­cule, known as ABI-2280, is a pro­drug of an acyclic nu­cle­o­side phos­pho­nate that di­rect­ly blocks HPV repli­ca­tion.

“As a non-sur­gi­cal treat­ment, ABI-2280 has the po­ten­tial to of­fer a ther­a­peu­tic that can pre­serve women’s re­pro­duc­tive health, be self-ad­min­is­tered at home, and im­prove ac­cess to care in un­der­served com­mu­ni­ties where OB/GYN re­sources are scarce,” CEO Gail Maderis said in a state­ment. — Max Gel­man

Metacrine un­veils more NASH da­ta af­ter re­treat­ing from the field

When Metacrine an­nounced that it will halt de­vel­op­ment of its FXR ag­o­nist MET642 in NASH and fo­cus on the in­flam­ma­to­ry bow­el dis­ease ap­pli­ca­tion in­stead, the biotech in­sist­ed the drug had per­formed well in a Phase IIa tri­al.

Now, the biotech said a sim­i­lar can­di­date — MET409 — has al­so passed a Phase IIa test on safe­ty, tol­er­a­bil­i­ty and phar­ma­col­o­gy.

In the 12-week tri­al, a com­bi­na­tion of MET409 and the SGLT2 in­hibitor Jar­diance spurred a re­duc­tion in liv­er fat con­tent among pa­tients with type 2 di­a­betes and NASH. A to­tal of 132 pa­tients were ran­dom­ized in­to four groups: One of them re­ceived a com­bo while the oth­er three got the in­di­vid­ual treat­ments and place­bo, re­spec­tive­ly.

For Metacrine, the da­ta sup­port a com­bi­na­tion ap­proach that it says will be nec­es­sary to tack­le NASH.

“NASH is close­ly linked to sev­er­al co-mor­bidi­ties, with an es­ti­mat­ed 65% of type 2 di­a­betes pa­tients al­so hav­ing NASH,” CMO Hu­bert Chen said in a state­ment. “These re­sults show­case the mul­ti­ple mech­a­nisms that dri­ve NASH and the promise of nov­el com­bi­na­tion ap­proach­es in bring­ing new ther­a­pies to pa­tients.”

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.