Scott Byrd, Sudo Biosciences CEO (Frazier Healthcare Partners)

Bris­tol My­ers got the first TYK2 ap­proval. Fra­zier’s new biotech Su­do hopes to get many more

Ear­li­er in Sep­tem­ber, the FDA ap­proved a TYK2 in­hibitor for the first time, a drug from Bris­tol My­ers Squibb for pso­ri­a­sis, with­out slap­ping on the black box safe­ty warn­ing that has cast a shad­ow on the larg­er fam­i­ly of an­ti-in­flam­ma­to­ry drugs it comes from, the JAK in­hibitors.

While Bris­tol My­ers won the first ap­proval, it’s fol­lowed by a suite of oth­ers with TYK2 pro­grams. Now, Fra­zier’s join­ing the fray.

Wednes­day morn­ing, the in­vest­ment firm de­buted Su­do Bio­sciences, which is start­ing out with $37 mil­lion in Se­ries A fund­ing. Su­do’s pro­grams are fo­cused on a spe­cif­ic part of TYK2 — the pseudok­i­nase do­main. (Which al­so serves as in­spi­ra­tion for the biotech’s name.)

“Pseudok­i­nase is a reg­u­la­to­ry do­main with­in TYK2 that one can tar­get and mod­u­late and achieve in­hi­bi­tion of TYK2 very specif­i­cal­ly with­out ul­ti­mate­ly hav­ing an im­pact on the rest of the JAK ki­nas­es, which we know to be as­so­ci­at­ed with a whole host of ad­verse events and po­ten­tial safe­ty con­cerns,” Su­do’s CEO Scott Byrd told End­points News.

Su­do has four lead pro­grams — though it is on­ly dis­clos­ing one, an oral TYK2 pseudok­i­nase in­hibitor. Byrd did not want to talk about what in­di­ca­tions the biotech was pur­su­ing, though he did say it would be­gin with more “ob­vi­ous op­por­tu­ni­ties” that oth­ers are al­so go­ing af­ter, such as pso­ri­a­sis and lu­pus.

But he added that Su­do could al­so go af­ter “some of the in­di­ca­tions that are a lit­tle bit fur­ther back in the pipeline and maybe ar­eas where BMS has not been able to pur­sue in ul­cer­a­tive col­i­tis and Crohn’s.” Last Oc­to­ber, Bris­tol My­ers’ drug failed a Phase II study in ul­cer­a­tive col­i­tis.

In Sep­tem­ber of this year, Bris­tol My­ers’ deu­cravac­i­tinib, now mar­ket­ed as So­tyk­tu, was ap­proved for pso­ri­a­sis. But un­like oth­er JAK in­hibitors, it didn’t have a black box safe­ty warn­ing. JAK in­hibitors have been tied to an in­creased risk of heart is­sues, can­cer, blood clots, and death. When the drug won ap­proval, Bris­tol My­ers’ chief med­ical of­fi­cer Samit Hi­rawat em­pha­sized in an in­ter­view with End­points that TYK2 “is not a JAK in­hibitor,” not­ing al­so there are no JAK in­hibitors ap­proved for pso­ri­a­sis.

Byrd added that there was a lot of room for growth for TYK2 drugs. “There’s so much un­tapped po­ten­tial. We’ve got one ap­proved prod­uct with one ap­proved in­di­ca­tion at this point,” Byrd said. “There’s cer­tain­ly room for more than one prod­uct in the space.”

But he de­clined to give a time­line of when Su­do an­tic­i­pates it will be in the clin­ic with its drugs.

Oth­ers are al­so de­vel­op­ing TYK2 in­hibitors. Fore­site has in­cu­bat­ed its own TYK2 start­up, known as Alu­mis. And fol­low­ing Bris­tol My­ers’ ap­proval, Ven­tyx sought to raise $176 mil­lion for its own TYK2 pro­gram. Pfiz­er al­so has a spin­out ded­i­cat­ed to its TYK2 in­hibitor.

“It seems pret­ty clear that TYK2 in­hibitors are now emerg­ing as the next ma­jor class of an­ti-in­flam­ma­to­ry ther­a­peu­tics,” Byrd said. “So we’re part of a big wave.”

Velos­i­ty Cap­i­tal al­so par­tic­i­pat­ed in the Se­ries A.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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CRO start­up Vial scores $67M Se­ries B led by Gen­er­al Cat­a­lyst

Vial, a CRO specializing in offering clinical trial services to biotech companies, raised $67 million in a new round of funding, bringing its total money raised to $100 million.

The San Francisco-based company’s Series B round was led by General Catalyst and supported others such as Byers Capital and BoxGroup.

Vial co-founder and CEO Simon Burns said the company will use the funding to expand its clinical operations and strategy teams in the US and across the European Union and Asia-Pacific in order to support its clients globally.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.