J&J buys in­to Pro­tag­o­nist’s next-gen pep­tide sto­ry with $50M up­front and $940M in mile­stones

J&J’s ven­ture arm par­tic­i­pat­ed in the start­up rounds for Pro­tag­o­nist Ther­a­peu­tics’ ear­ly de­vel­op­ment, fu­el­ing its work on a new group of oral pep­tide ther­a­pies built to with­stand a per­ilous jour­ney in the gut. And that front row seat J&J took is now pay­ing added div­i­dends with a Big Phar­ma li­cens­ing pact for the Newark, CA-based biotech’s $PT­GX sec­ond drug in the pipeline.

J&J has come in with a $50 mil­lion up­front — a siz­able amount for a pre­clin­i­cal pro­gram — and a full slate of mile­stones worth up to $940 mil­lion to gain ex­clu­sive world­wide li­cens­ing rights to Pro­tag­o­nist’s PTG-200. The IL-23 pep­tide an­tag­o­nist is be­ing built to treat Crohn’s dis­ease, one of its top in­flam­ma­to­ry bow­el dis­ease tar­gets.

Pro­tag­o­nist’s shares shot up 37% on the news.

This drug has a long way to go. It’s slat­ed to go in­to a Phase I tri­al with healthy hu­mans be­fore be­ing steered in­to an IBD study. But Pro­tag­o­nist has a more ad­vanced lead drug in the clin­ic, which like­ly pro­vid­ed some of the proof-of-con­cept da­ta J&J was look­ing for on the drug class.

Pro­tag­o­nist will part­ner with J&J on the de­vel­op­ment work through Phase II, giv­ing the phar­ma gi­ant rights to car­ry it on from there. And the lit­tle biotech is hang­ing on to co-de­tail mar­ket­ing rights in the US.

In an 8-K fil­ing Tues­day morn­ing, Pro­tag­o­nist pro­vid­ed some key de­tails on the pact you won’t find in the re­lease.  J&J is pay­ing 80% of the shared de­vel­op­ment costs on this drug. If the phar­ma part­ner de­cides to stay on af­ter Phase IIa, J&J will hand over $125 mil­lion. And if it picks up the op­tion for Phase III, J&J will add $200 mil­lion more.

Di­nesh Pa­tel

Pro­tag­o­nist CEO Di­nesh Pa­tel took the com­pa­ny pub­lic in 2016, watched shares dou­ble up and then slide to a lack­lus­ter $8.22 on Fri­day’s close, well be­low its IPO price.

As Pa­tel told me a cou­ple of years ago, the biotech set out to build a new kind of oral pep­tide ther­a­py which could with­stand the harsh en­vi­ron­ment of the stom­ach to do its work. Its lead ther­a­py is PTG-100, an al­pha-4-be­ta-7 (α4β7) in­te­grin-spe­cif­ic pep­tide drug now in a mid-stage pro­gram for ul­cer­a­tive col­i­tis.

Su­san B. Dil­lon, the im­munol­o­gy chief at Janssen, says this part­ner­ship is the lat­est in sev­er­al steps the biotech and phar­ma gi­ant have tak­en to­geth­er.  “To­geth­er with John­son & John­son In­no­va­tion, we have forged a strong re­la­tion­ship with the Pro­tag­o­nist Ther­a­peu­tics team over the course of sev­er­al years.”

“Our oral pep­tide PTG-200 works by block­ing the IL-23 path­way, a mech­a­nism which has been proven by in­jectable an­ti­bod­ies, in­clud­ing an ap­proved drug and oth­ers in dif­fer­ent stages of clin­i­cal de­vel­op­ment,” said David Y. Liu, Pro­tag­o­nist’s chief sci­en­tif­ic of­fi­cer and head of R&D. “As ev­i­denced by PTG-200, we be­lieve our tech­nol­o­gy plat­form is val­i­dat­ed in its abil­i­ty to gen­er­ate po­ten­tial first-in-class oral pep­tides as the next gen­er­a­tion of tar­get­ed ther­a­py drugs for IBD.”

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.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.

Viatris employees rang the Nasdaq bell on Nov. 16, marking the one-year anniversary of the merged Mylan and Pfizer Upjohn company

Start­ing from scratch: Vi­a­tris’ new brand, cul­ture set­tle in 1 year af­ter My­lan, Up­john merg­er

When Mylan and Pfizer’s Upjohn unit merged last year, headlines touted the $12 billion deal and newly named Viatris as the largest generic drugmaker in the world. But that’s not exactly how the company wanted to be known.

So Viatris — which rhymes with Beatrice — began working to create a new brand and culture from scratch around its distinct mix of old pharma blockbusters while layering in a massive portfolio of generic and OTC meds and building up a fresh pipeline of biosimilars.

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Jeff Dachis, founder and CEO, One Drop

Q&A: One Drop founder Jeff Dachis, from dig­i­tal agency to healthtech en­tre­pre­neur, catch­es the wave again

Jeff Dachis knows how to pick a business wave — although it may be more accurate to say he knows how to create them. The founder and CEO of digital health platform One Drop is working to transform the industry with predictive analytics and sophisticated tools. Alongside partner Bayer, which has now invested enough to own a third of the company, Dachis and One Drop are advancing data-driven personalized self-care for chronic disease management.

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Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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