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.”

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.