Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Bris­tol My­ers builds the case for pso­ri­a­sis hope­ful as it waits in reg­u­la­to­ry lim­bo

Bris­tol My­ers Squibb con­tin­ues to tout more da­ta for its ex­per­i­men­tal pso­ri­a­sis drug that it hopes will shake up the mar­ket.

The phar­ma­ceu­ti­cal gi­ant post­ed two-year re­sults from a long-term ex­ten­sion study of deu­cravac­i­tinib, show­ing the drug re­mained ef­fec­tive af­ter two years. The drug, which an­a­lysts pre­dict can bring in bil­lions in sales by 2026, is an oral TYK2 in­hibitor for adult pa­tients with mod­er­ate to se­vere plaque pso­ri­a­sis.

Ac­cord­ing to the lat­est da­ta, clin­i­cal ef­fi­ca­cy was main­tained through up to two years of treat­ment, with re­sponse rates at week 60 of 77.7% and 58.7% for PASI 75, a mea­sure of the dis­ease’s sever­i­ty. The safe­ty pro­file al­so re­mained con­sis­tent and no new is­sues popped up.

Thurs­day’s re­sults were con­sis­tent with the Phase III pso­ri­a­sis tri­als, dubbed PO­E­T­YK PSO-1 and PO­E­T­YK PSO-2 post­ed in 2021. Bris­tol My­ers may find it more dif­fi­cult to ex­pand in­to oth­er in­di­ca­tions, how­ev­er, as the drug failed a Phase II hur­dle in ul­cer­a­tive col­i­tis.

Jonathan Sadeh

Jonathan Sadeh, se­nior vice pres­i­dent of im­munol­o­gy and fi­bro­sis de­vel­op­ment at Bris­tol My­ers, said in a state­ment that the long-term fol­low-up re­sults on­ly add to the grow­ing body of ev­i­dence for the drug.

The hype start­ed ramp­ing up in Feb­ru­ary 2021 when BMS cleared an­oth­er Phase III study. Full re­sults weren’t post­ed un­til the fol­low­ing April, but Bris­tol My­ers not­ed that tri­al con­clud­ed by dis­play­ing 58.7% and 53.6% of pa­tients on deu­cravac­i­tinib achiev­ing PASI 75 re­sponse in the PO­E­T­YK-PSO-1 and PO­E­T­YK-PSO-2 stud­ies, re­spec­tive­ly. Mean­while, just 12.7% and 9.4% of place­bo pa­tients and 35.1% and 40.2% of pa­tients on Ote­zla achieved the same re­sults.

How­ev­er, de­spite the pos­i­tiv­i­ty, the drug will like­ly go un­der a fine-tooth comb at the FDA and the EMA. The FDA has pre­vi­ous­ly tak­en the ham­mer to a sim­i­lar drug class in JAK in­hibitors such as Pfiz­er’s Xel­janz, find­ing an in­creased risk of se­ri­ous heart-re­lat­ed events. The FDA al­so changed the JAK class’ la­bel af­ter a re­view of Ab­b­Vie’s Rin­voq to lim­it use to cer­tain pa­tients who are not treat­ed ef­fec­tive­ly or who ex­pe­ri­ence se­vere side ef­fects with the TNF block­ers.

Amer­i­can reg­u­la­tors have set a Sept. 10, 2022 PDU­FA date for deu­cravac­i­tinib.

Deu­cravac­i­tinib would be the first TYK2 drug ap­proved by the FDA and Bris­tol My­ers is hop­ing the dif­fer­en­ti­at­ed path­way — and os­ten­si­bly more ef­fi­ca­cious re­sults — will help in its ri­val­ry with Am­gen. Cur­rent­ly, Am­gen’s Ote­zla is the first and on­ly oral treat­ment ap­proved in adult pa­tients with plaque pso­ri­a­sis across all sever­i­ties, in­clud­ing mild, mod­er­ate and se­vere.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Try­ing to shake up the Parkin­son's par­a­digm, Ab­b­Vie sub­mits NDA for con­tin­u­ous, 24-hour in­fu­sion ther­a­py

AbbVie is approaching the FDA with a new therapy to potentially treat Parkinson’s disease, using prodrugs of two medications commonly used for the condition.

The Big Pharma submitted its NDA for ABBV-951, a solution of levodopa and carbidopa prodrugs being evaluated in advanced Parkinson’s patients who don’t respond well to oral therapy, AbbVie announced Friday morning. Researchers are hoping a positive Phase III study that reads out in late October will help move things along quickly at the agency.

Rob Etherington, Clene CEO

Mary­land of­fers loan to Clene de­spite ALS tri­al bumps

Even after Utah-based Clene failed to hit its primary endpoints for its ALS drug last year, the state of Maryland is putting its money at least behind Clene’s manufacturing facility.

The Maryland Board of Public Works has finalized a $3 million, 60-month loan facility with Clene Nanomedicine. The loan was provided by the state’s Neighborhood BusinessWorks program within the Maryland Department of Housing and Community Development.

Armon Sharei, SQZ founder and CEO

SQZ's out­side-the-box man­u­fac­tur­ing method slash­es pro­duc­tion time in ear­ly in study

At ASCO 2021 in June of last year, SQZ Biotech showcased a glimpse of its unorthodox cell therapy manufacturing tech. And on Wednesday, the Watertown, MA, company announced that its first-generation system showed comparable or better performance than a conventional clean-room-based manufacturing process.

The study was non-clinical. Clinical trials are expected by the first half of 2023.

SQZ’s device opens up a temporary window by cell-squeezing to deliver cargoes into cells. Its average processing time was less than six hours per batch, which is more than half the time than conventional methods. The company is planning to use the technology in its first red blood cell derived program for celiac disease. That IND is set to be submitted in the first half of 2023, the company said.

Chuck Grassley (R-IA) (via AP Images)

Bi­par­ti­san trio of sen­a­tors ask FTC to look at PBMs and tac­tics to keep in­sulin prices high

Just this week, the Senate voted 51-50 along party lines (with tie breaker from VP Kamala Harris) to make President Biden appointee Alvaro Bedoya the deciding vote on a split 2-2 Federal Trade Commission. And now that it is no longer split, a group of senators wants the commission to actually move forward on investigating pharmacy benefit managers.

Republican senators Chuck Grassley (IA) and Mike Braun (IN), alongside Democrat senator Ron Wyden (OR), submitted a letter to FTC chair Lina Khan earlier this week, after the commissioners remained deadlocked in a 2-2 vote in February to formally look into anti-competitive practices at the hands of PBMs.