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.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia ter­mi­nates Bay­er pact half a year ear­ly, col­lect­ing small por­tion of €240M promised

Bayer and Exscientia are winding down their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further.

London-based Exscientia revealed in its Q2 update that the partners have “mutually agreed to end” their collaboration, which kicked off in early 2020, after recently achieving a drug discovery milestone. In an SEC filing, Exscientia said it terminated the pact on May 30, about six months early.

Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Atomwise CEO and co-founder Abraham Heifets (left) and co-founder Izhar Wallach

A cou­ple bil­lion for Ex­sci­en­tia was on­ly part of Sanofi's AI am­bi­tions, as the Big Phar­ma adds Atom­wise to the ta­ble

Sanofi made clear its AI ambitions were real at the beginning of this year when the Big Pharma took its drug discovery collaboration with Exscientia to the next level, inking a pact that could birth 15 drugs and deliver $5.3 billion to the UK partner.

Seven months later, the AI blueprint is far from over at the French Big Pharma, as another of the much-hyped drug discovery startups is coming to the table in a five-drug deal. Sanofi will pay Atomwise $20 million to kick off the hunt for up to five targets, which are aimed at leading to the creation of new small molecules. Another $1 billion is on the line — as are royalties — and the companies kept mum on the specific diseases or broader therapeutic areas of interest.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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