Af­ter pi­lot project, Take­da inks $500M pact to tap in­to a Ke­van Shokat pro­tégé's co­va­lent small mol­e­cule fish­ing plat­form

As new tech­nolo­gies open up new av­enues to­ward tar­gets wide­ly con­sid­ered un­drug­gable by small mol­e­cules, Take­da is tak­ing a chance on a low-pro­file drug dis­cov­ery play­er with promis­es of up to $500 mil­lion in biobucks.

Ping Cao

Over the next two years, Sun­ny­vale, CA-based Brid­Gene will de­ploy its chem­i­cal pro­teomics-based plat­form for five pro­grams against tar­gets of in­ter­est, start­ing with one im­pli­cat­ed in neu­rode­gen­er­a­tive dis­eases.

It all start­ed, ac­cord­ing to Brid­Gene CEO Ping Cao, with an in-per­son meet­ing at JP Mor­gan last Jan­u­ary.

“If you talk to a chemist or sci­en­tist in a large firm, they al­ways say we are tar­get hun­gry,” he said.

Cao, who spent enough years at Am­gen’s San Fran­cis­co site to be ap­proach­ing lif­er sta­tus, knew the is­sue well. With the low-hang­ing fruit al­ready picked, re­main­ing dis­ease-caus­ing pro­teins of­ten have pock­ets that are ei­ther too shal­low (think KRAS) or tran­sient, pre­sent­ing them­selves on­ly in live cells (think tran­scrip­tion fac­tor).

Take­da was no dif­fer­ent. The phar­ma gi­ant has a large phe­no­typ­ic screen­ing fa­cil­i­ty in Japan where sci­en­tists iden­ti­fy phe­no­typ­ic changes caused by mol­e­cules in their li­brary, but there’s a ma­jor hur­dle in fig­ur­ing out what ex­act­ly caused the change. Once Cao pre­sent­ed their tech­nol­o­gy, it took lit­tle time to kick­start a pi­lot project in which Take­da hand­ed over some of their clin­i­cal can­di­dates for Brid­Gene to pro­file.

“We use co­va­lent small mol­e­cules as a bait,” he said. “So we fish in­side live cells. So live cells are like an ocean; each pro­tein is just like a fish there. Dif­fer­ent small mol­e­cules, they will fish out dif­fer­ent tar­gets or dif­fer­ent pro­teins.”

Chao Zhang

The core tech­ni­cal ex­per­tise came from sci­en­tif­ic founder Chao Zhang’s lab at the Uni­ver­si­ty of South­ern Cal­i­for­nia. Hav­ing trained with Ke­van Shokat, the in­ven­tor of one of the ear­li­est KRAS G12C in­hibitors, Zhang came up with his own method of min­ing co­va­lent ki­nase in­hibitors, col­lab­o­rat­ing with Prin­cip­ia co-founder Jack Taunton along the way. That com­pa­ny, which boasts of BTK in­hibitors, sold to Sanofi for $3.7 bil­lion. Shokat, mean­while, is on the sci­en­tif­ic ad­vi­so­ry board.

From March to Sep­tem­ber, Brid­Gene’s team of 10 put sev­er­al Take­da can­cer drugs through its plat­form and came up with a re­port de­tail­ing how many pro­teins bound to those small mol­e­cules — some pre­vi­ous­ly un­known to the phar­ma part­ner.

“Take­da was re­al­ly hap­py with the re­sults be­cause this re­port helped them to — they can de­cide if they want to pur­sue oth­er in­di­ca­tions that cov­er oth­er tar­gets they didn’t know be­fore,” he said. “It al­so gave them (a) broad full view of the po­ten­tial tox­i­c­i­ty con­cerns down the road.”

It paved the way for the cur­rent col­lab­o­ra­tion, Cao said, which takes the same tech­nol­o­gy in a slight­ly dif­fer­ent di­rec­tion. The biotech will be tasked with iden­ti­fy­ing new tar­gets that are re­spon­si­ble for a spe­cif­ic dis­ease phe­no­type that Take­da pin­points as un­der­ly­ing a neu­rode­gen­er­a­tive con­di­tion, or oth­er ail­ments in the fu­ture phas­es of the pact.

The undis­closed up­front cash, added to a pre-A round they’ve raised, would help fund Brid­Gene’s in­ter­nal pipeline of on­col­o­gy pro­grams, Cao added.

For Take­da, the al­liance marks the lat­est in a dis­cov­ery deal spree cov­er­ing every­thing from RNA-bind­ing small mol­e­cules and ri­bo­some drug test­ing ma­chines to CRISPR-screened cell ther­a­pies and LNP gene de­liv­ery.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Peter Greenleaf, Aurinia CEO

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

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Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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