Dominique Bridon, Diaccurate CEO

Mer­ck KGaA en­trusts se­cre­tive start­up with a mid-stage can­cer drug tar­get­ing mas­ter sig­nal­ing path­way

A se­cre­tive French biotech has im­port­ed a drug from Ger­many’s Mer­ck KGaA that will leapfrog the small com­pa­ny right in­to mid-stage test­ing against can­cer.

Di­ac­cu­rate has in-li­censed Mer­ck KGaA’s M2698 — now dubbed DI­ACC3010 — a “PAM” in­hibitor that is geared up for Phase II stud­ies in both sol­id tu­mors and hema­to­log­i­cal ma­lig­nan­cies, the French biotech said ear­ly Wednes­day morn­ing.

Fi­nan­cial terms of the deal were not dis­closed, but Mer­ck KGaA said in a re­lease it chose to work with Di­ac­cu­rate af­ter a “high­ly com­pet­i­tive se­lec­tion process” that re­ward­ed the biotech’s “strong sci­en­tif­ic back­ground.” Mer­ck KGaA will be­come a share­hold­er in Di­ac­cu­rate as part of the part­ner­ship, the com­pa­nies said.

DI­ACC3010 tar­gets what’s known as the PAM sig­nal­ing path­way — an um­brel­la des­ig­na­tion cov­er­ing the PI3K, AKT and mTOR ki­nas­es — and has shown pre­clin­i­cal and ear­ly hu­man ef­fi­ca­cy in cross­ing the blood-brain bar­ri­er, po­ten­tial­ly of­fer­ing ben­e­fit in neu­ro­log­i­cal ma­lig­nan­cies, Di­ac­cu­rate said. The drug it­self is a dual in­hibitor specif­i­cal­ly tar­get­ing AKT1/3 and p70S6, which Di­ac­cu­rate thinks could have ef­fect on a broad range of sol­id tu­mors and hema­to­log­ic ma­lig­nan­cies.

DI­ACC3010 does have some clin­i­cal da­ta to show, but not much to get ex­cit­ed about on the monother­a­py front. In a 101-pa­tient Phase I test, the drug post­ed a 27.4% sta­ble dis­ease rate as a monother­a­py in sol­id tu­mors with no par­tial re­spons­es re­port­ed. Two breast can­cer pa­tients in sep­a­rate com­bo reg­i­men arms post­ed par­tial re­spons­es but those da­ta weren’t pow­ered for ef­fi­ca­cy. Mean­while, the drug was most­ly well tol­er­at­ed on the safe­ty front.

Di­ac­cu­rate’s clin­i­cal plans, it says, are two-pronged: The biotech plans to launch a Phase II sol­id tu­mor pro­gram ini­tial­ly fo­cused around triple-neg­a­tive breast can­cer and gas­tric can­cers — both of which ex­hib­it a high preva­lence of PAM mu­ta­tions — as well as blood can­cers in which the PI3K path­ways play a ma­jor role (po­ten­tial­ly re­lapsed/re­frac­to­ry B cell and T cell lym­phomas). Both of those stud­ies are ex­pect­ed to launch in the sec­ond half of 2022, and Di­ac­cu­rate said “fur­ther de­tails on the clin­i­cal pro­gram will be pro­vid­ed in due time.”

Philippe Poulet­ty

“Di­ac­cu­rate is lay­ing the foun­da­tions of a suc­cess­ful mod­ern biotech com­pa­ny with a new high­ly spe­cial­ized port­fo­lio ap­proach,” co-founder Philippe Poulet­ty said in a state­ment. “This is an ex­cit­ing agree­ment that will take the Com­pa­ny to the next lev­el, bring­ing the best of med­ical sci­ence in­no­va­tion to pa­tients.”

Di­ac­cu­rate is still a most­ly un­known name: The biotech was co-found­ed by Paris-based ven­ture firm Truf­fle Cap­i­tal and is be­ing ad­vised by Tasuku Hon­jo, a win­ner of the No­bel Prize in Med­i­cine in 2018. The com­pa­ny sports two oth­er can­di­dates — a KIF20A in­hibitor chemother­a­py and a CD4 im­munother­a­py — and said in a re­lease it has ex­ist­ing part­ner­ships with Mer­ck KGaA, France’s In­sti­tut Pas­teur and the In­sti­tut Paoli-Cal­mettes.

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.

Martin Landray, Protas CEO (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Those big bil­lion-dol­lar PhI­II stud­ies? Mar­tin Lan­dray says they can be done for a tiny frac­tion of the cost

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

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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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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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Astel­las' hot flash­es drug will get speedy re­view at FDA; US opts out of Val­ne­va vac­cine

The FDA will decide on Astellas’ menopausal symptom drug by Feb. 22 of next year, as the Japanese pharma disclosed it had paid about $97 million to get a priority review voucher to speed up the review.

Astellas said the agency has accepted the pharma’s application for fezolinetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS includes hot flashes and/or night sweats. The company said as many as 80% of women in the US experience those symptoms during or after the menopausal transition.

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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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.