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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; 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.

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Vas Narasimhan, Novartis CEO (Thibault Camus/Pool via AP Images)

With gener­ic com­pe­ti­tion heat­ing up, Vas Narasimhan out­lines No­var­tis' growth plans at R&D day

Thursday marks Novartis’ annual R&D day, and with it comes CEO Vas Narasimhan’s attempt to spotlight the company’s pipeline strategy and emerging stars.

The biggest question entering Thursday’s presentation dealt with how the big biopharma will make up revenues from upcoming generic competition — Novartis says within the next five years, generics will eat away roughly $9 billion in sales. To offset this, Narasimhan outlined a strategy for 4% growth or higher until 2026, focusing on six key medicines he believes will see multibillion dollar profits during this time.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Reshma Kewalramani, Vertex CEO (Vertex via YouTube)

Bat­tling a line­up of skep­tics, Ver­tex claims an­oth­er ear­ly clin­i­cal win — this time in kid­ney dis­ease

Vertex claimed its second early-stage win of the fall Wednesday, announcing positive results in a small study on a genetically defined form of kidney disease.

The 16-patient, Phase II trial focused on patients with focal segmental glomerulosclerosis, a rare disease where kidneys are unable to filter blood properly. Over 13 weeks on an experimental pill, the level of protein in the patients’ urine fell by an average of 47.6%.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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