Zheng Wei, Connect Biopharma CEO

Con­nect Bio­phar­ma cel­e­brates a mid-stage win for its Dupix­ent ri­val, but shares tank af­ter in­vestors clam­or for da­ta

A suite of drug­mak­ers is look­ing to top­ple Dupix­ent in the eczema mar­ket — and on Thurs­day, Chi­na-based Con­nect Bio­phar­ma un­corked some mid-stage re­sults it says will pave the way to a piv­otal tri­al. But in­vestors want hard num­bers, and with­out any to share, the com­pa­ny’s stock $CNTB plunged more than 50% on Fri­day.

Con­nect’s mon­o­clon­al an­ti­body CBP-201 met the pri­ma­ry end­point in a Phase II tri­al, show­ing sig­nif­i­cant im­prove­ments in Eczema Area and Sever­i­ty In­dex (EASI) scores in all three dose groups, ac­cord­ing to the biotech. The treat­ment arms — 300 mg every two weeks, 150 mg every two weeks, or 300 mg every four weeks — were all sta­tis­ti­cal­ly su­pe­ri­or to place­bo at Week 16, and all showed sig­nif­i­cant im­prove­ments in the pro­por­tion of pa­tients achiev­ing at least a 50% or 75% re­duc­tion in EASI score (EASI-50 or EASI-75, re­spec­tive­ly).

The com­pa­ny al­so said, again with­out show­ing hard da­ta, the 300 mg dose giv­en every two weeks met key sec­ondary end­points, in­clud­ing the pro­por­tion of pa­tients achiev­ing an In­ves­ti­ga­tor Glob­al As­sess­ment (IGA) score of 0 or 1 (clear or al­most clear) and a re­duc­tion of ≥2 points from base­line at Week 16. Pa­tients who took CBP-201 al­so saw a sig­nif­i­cant change from base­line in week­ly av­er­age Peak Pru­ri­tus Nu­mer­i­cal Rat­ing Scale (PP-NRS), Con­nect re­port­ed.

The biotech promised to spell out the da­ta in a con­fer­ence call be­fore the end of Jan­u­ary — but for some in­vestors, that’s not soon enough. Con­nect shares were down more than 53% by mid-morn­ing, pric­ing in at $5.64.

CEO and co-founder Zheng Wei re­mained pos­i­tive, an­nounc­ing plans to launch a Phase III tri­al in mid-2022.

“This glob­al Phase 2 tri­al is al­so an im­por­tant mile­stone in in­form­ing us of the po­ten­tial of CBP-201 in oth­er in­di­ca­tions cur­rent­ly be­ing stud­ied, in­clud­ing mod­er­ate-to-se­vere per­sis­tent asth­ma and chron­ic rhi­nos­i­nusi­tis with nasal polyps,” he said in a state­ment.

The in­ci­dence of se­ri­ous and treat­ment-re­lat­ed side ef­fects was sim­i­lar in both the treat­ment and place­bo arms, Con­nect said. About 1.8% of pa­tients who took the drug ex­pe­ri­enced in­jec­tion site re­ac­tions, and 3.5% came down with con­junc­tivi­tis.

Wei met Con­nect’s oth­er co-founder, William Pan, in a mol­e­c­u­lar bi­ol­o­gy study group in col­lege in Guangzhou, Chi­na. They’ve come a long way since found­ing Con­nect in 2012, com­plet­ing a $115 mil­lion Se­ries C round last Au­gust to pro­pel their pipeline in­to Phase III. The com­pa­ny’s oth­er lead can­di­date, CBP-307, is in Phase II for ul­cer­a­tive col­i­tis and Crohn’s dis­ease.

CBP-201 works by in­hibit­ing IL-4Rα sig­nal­ing, thus con­trol­ling the sig­nal­ing of IL-4 and IL-13, two cy­tokines in­volved in the gen­er­a­tion of al­ler­gic dis­eases, the biotech says.

Dupix­ent, first ap­proved to treat eczema in adults back in 2017, al­so tar­gets IL-4Rα, pulling in more than $3.9 bil­lion in 2020. De­pend­ing on which dose Con­nect choos­es to move for­ward with, it could have the up­per hand in con­ve­nience — Dupix­ent is typ­i­cal­ly ad­min­is­tered in 300 mg dos­es every oth­er week.

Oth­er ri­vals, like Eli Lil­ly, Pfiz­er and Am­gen, are a bit fur­ther along than Con­nect. Lil­ly said in Au­gust that its mon­o­clon­al an­ti­body le­brik­izum­ab met the pri­ma­ry end­point in two Phase III tri­als, with more than half of pa­tients on the drug achiev­ing EASI-75. That same month, Pfiz­er re­port­ed re­sults from a head-to-head study that sug­gest­ed its JAK in­hibitor Cib­in­qo was “sta­tis­ti­cal­ly su­pe­ri­or” to Dupix­ent. A month lat­er, it was ap­proved in the UK to treat mod­er­ate to se­vere atopic der­mati­tis.

Am­gen bet $400 mil­lion up­front on Ky­owa Kirin’s an­ti­body back in June, and an­nounced in Oc­to­ber that the can­di­date met its pri­ma­ry end­point in a Phase II study.

Sens­ing that com­pe­ti­tion was afoot, Sanofi and Re­gen­eron read out piv­otal da­ta for the treat­ment of chil­dren be­tween 6 months to 5 years old back in Au­gust. When giv­en Dupix­ent on top of stan­dard of care top­i­cal cor­ti­cos­teroids, 28% of pa­tients achieved clear or al­most clear skin com­pared to 4% of those on place­bo, meet­ing the pri­ma­ry end­point.

“Even with Dupix­ent, there’s still a lot of space to be im­proved,” Wei told End­points News last sum­mer, adding that Con­nect hopes to beat the block­buster drug in ef­fi­ca­cy mea­sures.

Alexander Lefterov/Endpoints News

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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In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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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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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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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.

Steve Worland, eFFECTOR CEO

Sur­prise piv­ot rocks eF­FEC­TOR's I/O plans — al­though ex­ecs promise big­ger slice of the NSCLC mar­ket in the long run

When eFFECTOR Therapeutics went public last summer on the coattails of a reverse merger with Locust Walk’s SPAC, the potential of its lead drug, tomivosertib, as a combo agent with Merck’s flagship PD-1 Keytruda was hailed as the main draw.

But the biotech is now axing those plans and essentially starting over.

In a surprise move, San Diego-based eFFECTOR said it’s halting the development of tomivosertib in non-small cell lung cancer patients who have already progressed on Keytruda monotherapy after running into enrollment challenges in a Phase IIb trial.

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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.