Johnston Erwin, TRexBio CEO

Big Phar­ma back­ers jump on board 'Treg' car­tog­ra­pher's lead round with up to six can­di­dates in the pipe

Among the wealth of emerg­ing tar­gets in on­col­o­gy, im­mune sys­tem sup­press­ing reg­u­la­to­ry T cells — bet­ter known as “Tregs” — have earned some big-name in­ter­est in re­cent years. Now, a West Coast start­up map­ping Tregs in hu­man tis­sue has scored a slate of Big Phar­ma back­ers to dri­ve its grow­ing pipeline in­to the clin­ic.

South San Fran­cis­co-based TRexBio emerged from stealth Tues­day with a $59 mil­lion Se­ries A and the back­ing of in­vest­ment funds from Big Phar­ma gi­ants Eli Lil­ly, J&J and Pfiz­er, the biotech said in a re­lease.

Car­ol Gal­lagher

TRex’s plat­form maps the bi­ol­o­gy and func­tion of hu­man tis­sue Tregs to iden­ti­fy tar­gets in on­col­o­gy and au­toim­mune dis­or­ders. The com­pa­ny’s “deep bi­ol­o­gy” plat­forms pro­duce high-res­o­lu­tion pro­fil­ing of hu­man tis­sues to cre­ate “tis­sue-like” Tregs, the com­pa­ny said.

The biotech says it has six pre­clin­i­cal can­di­dates cur­rent­ly in its pipeline and is on pace to name its two lead drugs with­in the next year. TRex’s plat­form has iden­ti­fied 20 nov­el tar­gets so far, it said.

The biotech will be led by chair­man Car­ol Gal­lagher, the for­mer CEO of Cal­is­to­ga Phar­ma­ceu­ti­cals and a part­ner at New En­ter­prise As­so­ci­ates for the last sev­en years, and John­ston Er­win, a 36-year Lil­ly vet­er­an who will take the role of CEO. Er­win most re­cent­ly worked as VP of cor­po­rate busi­ness de­vel­op­ment.

“The com­pa­ny has a sig­nif­i­cant foun­da­tion in place, with a com­pelling vi­sion, ded­i­cat­ed team and ro­bust sci­ence,” Er­win said in a state­ment. “I am ex­cit­ed to lead the com­pa­ny in­to its next stage of de­vel­op­ment and ul­ti­mate­ly trans­form the lives of pa­tients by bring­ing a new gen­er­a­tion of im­mune-based ther­a­pies to the world.”

Ovid Tri­fan

Mean­while, TRex’s clin­i­cal pro­gram will be led by Ovid Tri­fan, most re­cent­ly CMO and VP of de­vel­op­ment at Apex­i­gen. Pri­or to that, Tri­fan held se­nior roles in clin­i­cal re­search at Bris­tol My­ers Squibb and J&J, fo­cus­ing on the on­col­o­gy space. Tri­fan will gear up to bring TRex’s lead pro­grams in­to the clin­ic by the end of the year.

The found­ing team is al­so joined by CSO Melanie Klein­schek, who will dri­ve the boat on TRex’s dis­cov­ery plat­form.

Tap­ping in­to im­muno­sup­pres­sant reg­u­la­to­ry T cells, which con­trol the pro­lif­er­a­tion of cy­tokines and T cells to main­tain what’s called tis­sue home­osta­sis, has seen a wealth of in­ter­est in re­cent years as com­pa­nies look to tamp down over­ac­tive im­mune sys­tems.

Melanie Klein­schek

In Feb­ru­ary, Mer­ck signed away $1.85 bil­lion to ac­quire Pan­dion Phar­ma­ceu­ti­cals and its pipeline of drugs tar­get­ing Tregs for au­toim­mune con­di­tions with the lead com­pound look­ing to bind with IL-2. That lead drug, dubbed PT101, will go af­ter ul­cer­a­tive col­i­tis and scored a win in a Phase Ia tri­al ear­li­er this year. In that 56-pa­tient study, PT101 in­creased Treg lev­els by 260% and in­creased the lev­el of high CD25-ex­press­ing Tregs, known as CD25 bright Tregs, by a whop­ping 6,250%, Pan­dion said. The drug al­so hits its marks on safe­ty and tol­er­a­bil­i­ty.

On a much small­er scale, No­var­tis and RA Cap­i­tal backed a $20 mil­lion seed round back in Au­gust for a com­pa­ny called Gen­tiBio, which is al­so look­ing to de­vel­op Treg can­di­dates. But those cer­tain­ly aren’t the on­ly two play­ers in that race.

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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Graphic: Alexander Lefterov for Endpoints News

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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Brian Thomas, Metagenomi CEO

Gen 2: Berke­ley spin­out lands $175M megaround to keep it on the cut­ting edge of the boom­ing gene-edit­ing field

The big bucks keep pumping into the gene-editing field.

This morning Metagenomi, allied with one of the biggest names in the mRNA field with a company DNA that includes the ubiquitous Jennifer Doudna, is showing off a $175 million B round that will pay for a rapid swelling of its staff in pursuit of some of the cutting-edge tech that keeps this field in the spotlight. And they’re aligning themselves with some major industry players with an eye on the clinic while getting behind some startups to help expand the work into new fields.

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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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