Ken Song, Ablaze chairman and RayzeBio CEO

Af­ter Big Phar­ma sparked in­ter­est in the US, Ablaze looks to bring ra­dio­phar­ma­ceu­ti­cals over­seas

Thanks in part to in­ter­est from Big Phar­ma play­ers like Bay­er and No­var­tis over the last decade, there’s been no short­age in cash for new com­pa­nies look­ing to slay tu­mor cells with tar­get­ed ra­dioiso­topes. Now a transpa­cif­ic up­start has hooked $75 mil­lion to bring the in­creas­ing­ly pop­u­lar drugs to Chi­na.

Ablaze Phar­ma­ceu­ti­cals emerged from stealth on Mon­day with a Vi­vo Cap­i­tal and Ad­van­Tech Cap­i­tal-led Se­ries A round and a li­cens­ing pact with Ver­sant-backed Rayze­Bio. The goal? In­tro­duce tar­get­ed ra­dio­phar­ma­ceu­ti­cal ther­a­pies (TRTs) to the Chi­nese mar­ket.

“Tar­get­ed ra­dio­phar­ma­ceu­ti­cal ther­a­pies rep­re­sent the next foun­da­tion­al modal­i­ty to treat can­cer,” Ken Song, Rayze­Bio CEO and chair­man of the board at Ablaze, said in a state­ment. “In form­ing Ablaze, we re­al­ized to be suc­cess­ful, it was crit­i­cal to have a com­pa­ny fo­cused on the Chi­na mar­ket and fo­cused on ra­dio­phar­ma­ceu­ti­cals.”

Un­like ra­di­a­tion ther­a­py, which is ad­min­is­tered by an ex­ter­nal beam of high-en­er­gy rays, ra­dio­phar­ma­ceu­ti­cals de­liv­er ra­dioiso­topes to tu­mors via the blood­stream. Song told End­points News back in June that the over­all con­cept is sim­i­lar to that of an an­ti­body-drug con­ju­gate. You start with a binder, a link­er and a pay­load — ex­cept in­stead of an an­ti­body, there are small­er pep­tides, and in­stead of a chemother­a­peu­tic pay­load, there’s a ra­dioac­tive par­ti­cle which is “many or­ders of mag­ni­tude” more po­tent. By switch­ing ra­dioiso­topes, sci­en­tists can al­so per­form imag­ing di­ag­no­sis, Ablaze says.

Bay­er was one of the ear­ly en­trants in this space, with an Al­ge­ta-part­nered ra­dionu­clide ther­a­py that was shown to boost the over­all sur­vival of cas­tra­tion-re­sis­tant prostate can­cer pa­tients with symp­to­matic bone metas­tases. Bay­er snapped up Al­ge­ta just be­fore the drug, Xofi­go, was ap­proved by the FDA. Mean­while, No­var­tis se­cured its place in the race through multi­bil­lion-dol­lar buy­outs of Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions and En­do­cyte, giv­ing it FDA-ap­proved Lu­tathera among oth­er pro­grams.

Alex Qiao

Then there are the small­er play­ers, like San Diego-based Rayze­Bio, MPM-found­ed Ak­tis On­col­o­gy, and now Ablaze, which has lo­ca­tions in both Shang­hai and San Diego. CEO Alex Qiao says Ablaze is al­ready in the clin­ic, though he of­fered few de­tails on the com­pa­ny’s pro­grams. In ad­di­tion to the Rayze­Bio pro­grams, the com­pa­ny has one part­nered pro­gram with an aca­d­e­m­ic in­sti­tu­tion, he said.

The Se­ries A — which al­so saw par­tic­i­pa­tion from RAYZ In­vest­ments, Nan Fung Life Sci­ences, Piv­otal bioVen­ture Part­ners Chi­na, ven­Bio Part­ners, Sam­sara Bio­Cap­i­tal and Ven­rock Health­care Cap­i­tal Part­ners — will be used to es­tab­lish a pipeline of TRTs for the treat­ment of sol­id tu­mors, ex­pand the team, and build up in­fra­struc­ture, ac­cord­ing to Qiao.

It’s al­so ex­plor­ing oth­er part­ner­ships, the CEO said. But for now, in­vestors are con­fi­dent the com­pa­ny will be able to break in­to the mar­ket over­seas.

“TRT is an emerg­ing field that has al­ready demon­strat­ed tremen­dous clin­i­cal ef­fi­ca­cy in treat­ing can­cer world­wide,” Hong­bo Lu, man­ag­ing part­ner of Vi­vo Cap­i­tal, said in a state­ment.

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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