Malcolm Weir, Sosei vice chairman

Glax­o­SmithK­line joins So­sei's who's-who list of clients with glob­al li­cens­ing pact for IBD small mol­e­cules

Big drug­mak­ers are on the hunt for nov­el ther­a­peu­tics in a range of ul­tra-com­pet­i­tive ther­a­peu­tic ar­eas. Japan’s So­sei Hep­tares has emerged in re­cent years as a sought-af­ter part­ner for Big Phar­mas seek­ing nov­el neu­ro can­di­dates — but now Glax­o­SmithK­line wants to try the pre­clin­i­cal R&D ex­pert’s work in in­flam­ma­to­ry bow­el dis­ease.

GSK has tapped So­sei Hep­tares for dis­cov­ery work tar­get­ing IBD and oth­er gas­troin­testi­nal im­mune dis­or­ders with small-mol­e­cule ag­o­nists for GPR35, an or­phan G pro­tein-cou­pled re­cep­tor (GPCR) with a ge­net­ic link to those con­di­tions, the com­pa­nies said Sun­day.

As part of the deal, So­sei will lead pre­clin­i­cal R&D on ag­o­nists iden­ti­fied by its struc­ture-based drug de­sign plat­form and pro­pri­etary StaR tech­nol­o­gy, and will hand clin­i­cal work, man­u­fac­tur­ing and com­mer­cial­iza­tion to GSK. The British drug gi­ant will hold glob­al com­mer­cial li­cens­ing rights to any win­ning can­di­dates and will hand an ini­tial $44 mil­lion for near-term de­vel­op­ment mile­stones and re­search fund­ing. So­sei will al­so be due up to $437 mil­lion pend­ing a se­ries of de­vel­op­ment, reg­u­la­to­ry and com­mer­cial­iza­tion mile­stones.

“Us­ing ge­net­ics to pri­ori­tise po­ten­tial treat­ments for a chal­leng­ing im­mune dis­or­der like IBD ex­em­pli­fies the ap­proach we are tak­ing at GSK to de­vel­op nov­el trans­for­ma­tive med­i­cines,” John Lep­ore, GSK’s se­nior VP of re­search, said in a re­lease. “So­sei Hep­tares is a world leader with an es­tab­lished track record in GPCR drug dis­cov­ery, so we are con­fi­dent in our po­ten­tial to joint­ly iden­ti­fy high qual­i­ty clin­i­cal can­di­dates to de­liv­er im­por­tant new med­i­cines for the mil­lions of pa­tients who are wait­ing.”

It’s a big-name pick­up for So­sei, which has made its name in li­cens­ing out ear­ly-stage GPR tar­get­ing can­di­dates to ma­jor drug­mak­ers, most no­tably Ab­b­Vie and Roche’s Genen­tech. Mal­colm Weir, So­sei’s vice chair­man, tout­ed GSK’s ex­ist­ing ex­per­tise in IBD and ex­ten­sive clin­i­cal ex­pe­ri­ence as a ma­jor draw for So­sei’s li­cens­ing strat­e­gy.

“In our minds, (this deal) was very dri­ven by a group that we can work with and col­lab­o­rate ef­fec­tive­ly,” Weir said. “But, it’s a project that still needs to work it­self out in the clin­ic.”

Weir pre­dict­ed a clutch of So­sei can­di­dates would see the clin­ic in the “near-term” fu­ture but de­clined to guess on ex­act­ly when that would be. The Japan­ese com­pa­ny has made its name iden­ti­fy­ing GPCR can­di­dates, most­ly spe­cial­iz­ing in neu­ro­science, Weir said. While IBD is a most­ly new en­deav­or, So­sei thinks there’s po­ten­tial in that ther­a­peu­tic area.

“What we did was looked at a fair num­ber of nov­el tar­gets and there was ev­i­dence of ge­net­ic as­so­ci­a­tions with dis­eases like ul­cer­a­tive col­i­tis and oth­er dis­or­ders,” Weir said. “We were very struck by that and struck by the promise of that.”

Back in June, Ab­b­Vie tapped So­sei in a very sim­i­lar deal, agree­ing to pay $32 mil­lion up­front for a range of in­flam­ma­to­ry and au­toim­mune dis­eases with po­ten­tial op­tion, de­vel­op­ment and com­mer­cial pay­ments of up to $377 mil­lion. That deal could ex­pand, how­ev­er, if Ab­b­Vie choos­es to ex­e­cute on all four tar­gets in the pact; in that case, the agree­ment could grow in­to the bil­lion-dol­lar range, a So­sei spokesper­son said at the time.

That was ac­tu­al­ly So­sei’s sec­ond deal with Ab­b­Vie af­ter the com­pa­ny signed a deal with Al­ler­gan — which Ab­b­Vie ac­quired in mid-2019 — back in 2016 for a slate of sub­type-se­lec­tive mus­carinic re­cep­tor ag­o­nists. In that deal, So­sei got $125 mil­lion up­front with a $50 mil­lion com­mit­ment to­ward Phase II stud­ies in ad­di­tion to over $3 bil­lion in promised mile­stones.

In Ju­ly 2019, Genen­tech al­so jumped on board with So­sei, agree­ing to front $26 mil­lion in up­front and near-term pay­ments, in ad­di­tion to fu­ture mile­stone pay­ments that may ex­ceed $1 bil­lion, as well as po­ten­tial roy­al­ties. The tar­get­ed ther­a­peu­tic ar­eas weren’t dis­closed in that deal. So­sei has al­so signed pre­vi­ous pacts with British drug­mak­ers As­traZeneca and No­var­tis, among a suite of oth­er Big Phar­mas.

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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Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.

UP­DAT­ED: Feds charge an­oth­er CRO staffer with fak­ing da­ta in a Glax­o­SmithK­line pe­di­atric asth­ma study

A Florida woman has been indicted as part of a clinical trial fraud scheme over a GlaxoSmithKline pediatric asthma study, the Justice Department announced Tuesday, the latest development in a case where three individuals have already pleaded guilty.

Jessica Palacio was charged with participating in a plot to falsify medical records, giving off the appearance that trial participants were making their scheduled visits to a Miami CRO and taking an experimental asthma medication as required. Palacio was also charged with lying to FDA investigators about her conduct.

Sanofi, Cel­lec­tis team up to pair Lem­tra­da with al­lo­gene­ic CAR-Ts; Bris­tol My­ers joins Evotec's dri­ve to ad­vance UK sci­ence

Sanofi is partnering up with Cellectis on their allogeneic CAR-Ts.

Cellectis struck a deal to use the French pharma’s drug alemtuzumab (Lemtrada, an MS agent) as part of its lymphodepletion regimen — used to sideline host immune cells and improve CAR-T cell expansion and persistence.

The Sanofi drug is already used in some clinical trials, and now the pharma giant is on the hook for clinical studies as they engage in negotiations over a commercial pact. — John Carroll

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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