Mi­rati wins over a Chi­nese part­ner for KRAS hope­ful, look­ing to tail Am­gen's break­through win

In a gun­shot heard across on­col­o­gy, the FDA hand­ed Am­gen a break­through win for a first-of-its-kind KRAS in­hibitor — once con­sid­ered “un­drug­gable” — late last week. The drug’s biggest com­peti­tor, not con­tent to rest on its lau­rels, has now signed a ma­jor mar­ket­ing deal in Chi­na as it eyes a fil­ing of its own.

Mi­rati will take home $65 mil­lion in cash and up to $273 mil­lion in biobucks from Chi­na’s Zai Lab for an ex­clu­sive li­cense to KRAS-G12C hope­ful ada­gra­sib in the Greater Chi­na re­gion, the com­pa­nies said Tues­day. The deal will al­so come with roy­al­ties worth some­where in the “high-teens to low-twen­ties-per­cent.”

Mi­rati will hold an op­tion to co-com­mer­cial­ize ada­gra­sib in Chi­na if it so choos­es and re­tains full com­mer­cial rights else­where. Zai Lab will al­so help dri­ve en­roll­ment in reg­is­tra­tion en­abling glob­al stud­ies for the drug.

Charles Baum

Earn­ing the sup­port of one of Chi­na’s biggest on­col­o­gy play­ers bodes well for Mi­rati’s goals to plant its flag in the re­gion, where lung can­cer killed near­ly three-quar­ters of a mil­lion peo­ple in 2020, ac­cord­ing to the World Health Or­ga­ni­za­tion. Zai Lab’s ex­pe­ri­ence in bring­ing on­col­o­gy as­sets to mar­ket was a draw for Mi­rati.

“Zai Lab has an es­tab­lished record of rapid and high qual­i­ty de­vel­op­ment and com­mer­cial­iza­tion of in­no­v­a­tive on­col­o­gy prod­uct can­di­dates in Chi­na,” Mi­rati CEO Charles Baum said in a re­lease. “Their ca­pa­bil­i­ties po­si­tion Mi­rati to fur­ther de­vel­op ada­gra­sib for pa­tients with can­cer who har­bor the KRASG12C mu­ta­tion around the world.”

In­vestor Brad Lon­car summed up the dy­nam­ics be­hind the tie-up best on Twit­ter:

Mi­rati has nipped at Am­gen’s heels in the race for the first small-mol­e­cule KRAS in­hibitor, but as of Fri­day, the biotech will of­fi­cial­ly chase the drug­mak­er to mar­ket af­ter the FDA gave a land­mark nod to Lumakras (so­tora­sib). Mi­rati has long tout­ed its drug’s su­pe­ri­or da­ta — par­tic­u­lar­ly in col­orec­tal can­cer, where Am­gen’s drug has shown lim­it­ed promise — but with two Phase III tri­als still re­cruit­ing, it could take a bit for that ad­van­tage to play out. Mi­rati plans to sub­mit its NDA as soon as the end of 2021.

The FDA based its Lumakras ap­proval on da­ta from Phase II CODE­BREAK100 study show­ing so­tora­sib post­ed a 36% over­all re­sponse rate among 124 pa­tients with ad­vanced NSCLC. There were three com­plete re­spons­es and 43 par­tials, with a me­di­an du­ra­tion of re­sponse of 10 months. Pro­gres­sion-free sur­vival hit 6.8 months.

How­ev­er, re­sults in oth­er tu­mor types were less than im­pres­sive. In a Phase I tri­al in col­orec­tal, so­tora­sib post­ed just a 7.1% re­sponse rate, with the ma­jor­i­ty of the 42 pa­tients in the tri­al had re­ceived at least three pri­or lines of ther­a­py. In oth­er tu­mors out­side of NSCLC and col­orec­tal, the drug fared even worse, with just three of 22 pa­tients show­ing par­tial re­spons­es sev­en weeks af­ter treat­ment.

Mean­while, ada­gra­sib hit a 43% re­sponse rate in a Phase I/Ib test in NSCLC with a me­di­an treat­ment du­ra­tion of 8.2 months as of an Oc­to­ber up­date. Half of that study’s pa­tients were still on ther­a­py, and five of six re­spon­ders were still re­spond­ing to the drug.

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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