Cel­gene signs Jounce as its new biotech star in $2.6B ‘im­muno-on­col­o­gy 2.0’ pact

Over the past year Cel­gene has com­mit­ted $1.25 bil­lion in cash – plus bil­lions more in mile­stones – to a pair of ma­jor im­muno-on­col­o­gy deals with Juno and Agios. To­day, Cel­gene has cho­sen its new star part­ner for can­cer R&D, step­ping up with a rich­ly front-end­ed $2.56 bil­lion deal to col­lab­o­rate with up­start Jounce Ther­a­peu­tics’ on its lead I/O pro­gram, plus a pack­age of treat­ments in dis­cov­ery.

It’s a clas­sic Cel­gene deal, swing­ing for the fences for a po­ten­tial block­buster or two while ag­gres­sive­ly woo­ing up-and-com­ing de­vel­op­ers with an open check­book and an open mind about leav­ing lead re­search ef­forts on the drugs to their new dance part­ner. More such deals are on the way, as top ex­ecs at Cel­gene pave the way to new pacts de­signed to take them well past the first wave of check­point in­hibitors, as well as the T cell treat­ments now in late-stage de­vel­op­ment, to com­mand a lead­ing role for it­self in the field.

Cel­gene is pay­ing $225 mil­lion in the up­front, adding $36 mil­lion in eq­ui­ty and com­mit­ting up to $2.3 bil­lion in mile­stones to com­plete the deal. In turn the big biotech gets dibs on a 40% share of U.S. prof­its for Jounce’s lead drug, the pre­clin­i­cal JTX-2011, plus a 75% share for its un­named suc­ces­sor and a split on three more pro­grams. There’s al­so an opt-in avail­able on an ex­per­i­men­tal check­point pro­gram tak­ing shape at Jounce.

Once Cel­gene choos­es to opt in, the two com­pa­nies will divvy up ex­pens­es the same way they plan to share prof­its. And Cel­gene gets all ex-U.S. rev­enue with a roy­al­ty stream for Jounce.

Rob Her­sh­berg, CSO of Cel­gene

“We love deals like this,” Cel­gene CSO Rob Her­sh­berg tells me. “ICOS is the most ad­vanced in the (Jounce) pipeline, dri­ving the eco­nom­ics, but it is way be­yond a T-cell deal. Agios is a per­fect ex­am­ple, push­ing the en­ve­lope be­yond the con­ven­tion­al check­point sto­ry.”

Her­sh­berg sees Agios as the best in can­cer meta­bol­ics. And now he’s been deeply im­pressed by the team at Jounce – im­muno-on­col­o­gy rock star Jim Al­li­son is a sci­en­tif­ic co-founder – and its abil­i­ties to iden­ti­fy bio­mark­ers while clear­ly defin­ing pa­tient sub­groups most like­ly to ben­e­fit.

“The qual­i­ty of the sci­ence and the peo­ple is re­al­ly good,” says the CSO.

Cel­gene has a col­lab­o­ra­tion in place with As­traZeneca’s PD-L1 dur­val­um­ab, adds Her­sh­berg. But when the check­points can re­li­ably help about 25% of pa­tients as a sin­gle agent, Cel­gene has a big fo­cus on that oth­er 75% of the mar­ket.

Adds Her­sh­berg: “We don’t want to com­pete with 500 oth­er tri­als in com­bi­na­tion with a check­point.”

Rich Mur­ray, CEO Jounce Ther­a­peu­tics

“This is re­al­ly go­ing to al­low us to ex­pand the way we need to,” says Jounce CEO Rich Mur­ray. Cur­rent­ly op­er­at­ing with a staff of 60, Mur­ray ex­pects to add 20 more em­ploy­ees lat­er in the year, with the lead drug go­ing to its first, four-part adap­tive study that starts with safe­ty and PK and leads to the ef­fi­ca­cy stage in the sec­ond half of next year.

That lines up with a pop­u­lar strat­e­gy on can­cer drug de­vel­op­ment, where the tra­di­tion­al break­down in tri­als has now blend­ed in­to a rel­a­tive­ly fast shot at piv­otal re­sults.  The lead pro­gram will be test­ed as a sin­gle agent and in com­bo with a PD-1 check­point in­hibitor. And Jounce plans to push its own check­point pro­gram in­to the clin­ic as a “log­i­cal com­po­nent” of a larg­er on­col­o­gy ef­fort like this.

The plat­form com­pa­ny was launched by Third Rock, ring­ing up $103 mil­lion in two ven­ture rounds from in­vestors deeply im­pressed by its mar­quee sci­en­tif­ic co-founders, Al­li­son and Pam Shar­ma.

The lead drug says a lot about Jounce. It’s fo­cused on ICOS, AKA the In­ducible T cell CO-Stim­u­la­tor, a pro­tein on the sur­face of T cells Jounce — and now Cel­gene — be­lieves can spur an im­mune re­sponse against a pa­tient’s can­cer.  Im­muno-on­col­o­gy has been at the cross­roads of a mul­ti­tude of deals over the past three years, and Cel­gene clear­ly wants to be in the front end of the sec­ond wave — what Mur­ray calls im­muno-on­col­o­gy 2.0 — af­ter Bris­tol-My­ers and Mer­ck led the way with Op­di­vo and Keytru­da for check­point in­hi­bi­tion.

Cel­gene has a big fo­cus on on­col­o­gy, with fran­chis­es for Revlim­id and Abrax­ane fund­ing a large pipeline ef­fort that in­cludes pacts for Juno’s JCAR015 and JCAR017. Af­ter that comes im­munol­o­gy and in­flam­ma­tion.

Mur­ray says Jounce start­ed off 2016 with a va­ri­ety of op­tions on the ta­ble, pri­mar­i­ly re­volv­ing around an IPO or a ma­jor pact. The mar­ket hasn’t co­op­er­at­ed, yet, on the IPO, and af­ter try­ing out var­i­ous “fla­vors” of po­ten­tial deals, Jounce opt­ed for a big scoop of Cel­gene.

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

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The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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Joan Perelló, Sanifit CEO

Joan Perel­ló set out 17 years ago to de­vel­op a drug. And to­day he's be­ing re­ward­ed with a $424M biotech buy­out

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

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