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.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Al Sandrock, Biogen R&D chief (Biogen via YouTube)

UP­DAT­ED: Bio­gen push­es in a fresh stack of chips and starts prep­ping a glob­al R&D game plan af­ter watch­ing the cards turn on ear­ly throm­bolyt­ic da­ta

After patiently steering through a decade-long journey for its early-stage clinical work, a small Tokyo biotech has clinched a deal to out-license its lead thrombolytic agent to US heavyweight Biogen — which sees a potentially game-changing impact on the clot-busting field after taking a careful look at some upbeat Phase IIa data.

Three years after Biogen anted up $4 million to gain an option on the drug from TMS, the big US biotech is making a small bet to beef up its stroke portfolio. The BD team inked a deal to go ahead and grab rights to the drug for $18 million, with another $335 million in milestone cash on the table for a successful outcome.

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Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

Distribution of Moderna's Covid-19 Vaccine (Photo by Paul Sancya - Pool/Getty Images)

Opin­ion: Ado­les­cents can wait. The US needs to start do­nat­ing Covid-19 vac­cines to needy coun­tries now.

Now that the US is swimming in Covid-19 vaccines and the supply has officially eclipsed the demand, it’s time for America to lead the world and start shipping these excess doses to countries that desperately need them.

Unlike the IP waiver at the World Trade Organization, which Biden now supports and will likely take years to translate into actual shots in arms, the US could easily donate just a tiny fraction of the more than 60 million doses of Pfizer, Moderna and J&J vaccines sitting on American shelves right now.