Simon Read, Curie Therapeutics CEO

Look­ing to run with Big Phar­ma, a ra­dio­phar­ma start­up with back­ing from At­las, RA thinks it has the chops to com­pete

Amid a re­nais­sance in the field of ra­dio­phar­ma­ceu­ti­cals, a grow­ing cho­rus of bio­phar­ma play­ers is rush­ing the stage to cap­i­tal­ize on tech break­throughs. Biotech blue-chip­pers RA Cap­i­tal and At­las Ven­ture, sens­ing an op­por­tu­ni­ty, are now set­ting up their own start­up to chal­lenge the big boys.

Curie Ther­a­peu­tics un­cloaked from stealth Wednes­day with $75 mil­lion in Se­ries A fund­ing from At­las, RA and Ac­cess Biotech­nol­o­gy, with the goal of lever­ag­ing a sea­soned team of ex­perts to get the jump on the grow­ing class of can­cer ther­a­peu­tics, the biotech said.

In an un­usu­al arrange­ment, Curie was in­cu­bat­ed by all three of its found­ing fun­ders, run­ning for about 18 months in stealth mode be­fore mak­ing its de­but. Ac­cord­ing to CEO Si­mon Read, for­mer­ly chief sci­en­tif­ic of­fi­cer at Ra Phar­ma be­fore its ac­qui­si­tion by UCB in ear­ly 2020, the Curie team in that time built a lead­er­ship team of 15 spe­cial­iz­ing in all as­pects of ra­dio­phar­ma­ceu­ti­cals, which link ra­dioac­tive iso­topes to a small mol­e­cule to tar­get tu­mors.

While pipeline de­tails are slim, Curie’s mis­sion is broad — and that’s not an ac­ci­dent. The team sees ra­dio­phar­ma­ceu­ti­cals as a po­ten­tial­ly ex­pan­sive class of ther­a­peu­tics and has spent its year and a half be­hind the scenes div­ing deep not on­ly in­to ra­dio­chem­istry and bi­ol­o­gy but al­so CMC, sup­ply and clin­i­cal trans­la­tion. The class has his­tor­i­cal­ly suf­fered from both sup­ply chain is­sues — it’s hard to con­tin­u­ous­ly source the ra­dioac­tive ma­te­r­i­al used in these drugs — as well as at the bed­side, with ear­li­er-gen­er­a­tion ra­dio­phar­ma­ceu­ti­cals do­ing a poor job of tar­get­ing spe­cif­ic tis­sues.

“Sol­id tu­mors are re­al­ly poor­ly treat­ed by ex­ist­ing tar­get­ed tech­nolo­gies, and al­though there are some ad­van­tages, there are still chal­lenges with tech­nolo­gies like CAR-T, BiTEs, AD­Cs in sol­id tu­mors,” Read said. “So we be­gan to sit up and take no­tice, I think, of some of the da­ta that was com­ing from break­through ther­a­pies … (that) gal­va­nized the en­thu­si­asm to be­gin think­ing about ra­dio­phar­ma­ceu­ti­cals.”

Where Curie hopes to set it­self apart is in its holis­tic strat­e­gy for ra­dio­phar­ma­ceu­ti­cal de­vel­op­ment, look­ing at the drug’s PD and PK prop­er­ties as a whole rather than op­ti­miz­ing each mod­u­lar el­e­ment of a drug’s com­po­si­tion be­fore con­sid­er­ing its po­ten­tial ef­fi­ca­cy in hu­mans. Mean­while, the com­pa­ny is fo­cus­ing on both pep­tide and non-pep­tide lig­ands to iden­ti­fy the best pos­si­ble so­lu­tions for deep tis­sue pen­e­tra­tion, hope­ful­ly lim­it­ing off-tar­get side ef­fects in or­gans like the kid­ney.

Read ad­mits the class — which has seen some big break­throughs in re­cent years from the likes of No­var­tis’ Lu­tathera and Lu-PS­MA-617, a ra­dio­phar­ma­ceu­ti­cal tar­get­ing a prostate can­cer re­cep­tor with a ra­dioac­tive form of lutetium — has grown in­creas­ing­ly con­gest­ed in re­cent years. But Curie’s ex­pert sci­en­tif­ic team could help it get a head start on the grow­ing field.

“We be­lieved that if we could get lead­ers from all of those spaces un­der one roof, we would be able to tru­ly build best-in-class type med­i­cines,” he said. “Curie be­gan with that ba­sic con­cept of build­ing the com­pa­ny in the space and fo­cus­ing on not can you do it, but how do you do it the best.”

So far, Curie’s pipeline re­mains a mys­tery with Read stay­ing mum on ex­act­ly which tar­gets are in the gun­sights first and the com­pa­ny’s re­lease on the mat­ter ref­er­enc­ing on­ly “high un­met need sol­id tu­mors.” How­ev­er, a pipeline had be­gun to round in­to form dur­ing Curie’s stealth mode, and Read ex­pects that more would be on the way on that front in the com­ing year.

Read hint­ed that the biotech would uti­lize both al­pha-emit­ting ra­dioiso­topes for its ther­a­pies — the modal­i­ty du jour in the space — but al­so fo­cus on be­ta emit­ters, like lutetium, which he said could still have a place in clin­i­cal prac­tice in tack­ling larg­er tu­mors.

Mean­while, the team of 15 is ex­pect­ed to in­crease to 45 by this time next year, Read said, as the com­pa­ny ap­proach­es hu­man tri­als.

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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