Xen­cor, UCLA to part­ner for new ther­a­peu­tic an­ti­bod­ies; Schrödinger ex­pands part­ner­ship with Google Cloud

Seek­ing to build on the 20 clin­i­cal-stage drug can­di­dates al­ready in its pipeline, Cal­i­for­nia on­col­o­gy and au­toim­mune dis­ease-fo­cused biotech Xen­cor an­nounced on Thurs­day a part­ner­ship with near­by UCLA and the uni­ver­si­ty’s Tech­nol­o­gy De­vel­op­ment Group.

The two will col­lab­o­rate to de­vel­op nov­el ther­a­peu­tic an­ti­bod­ies, pair­ing nov­el tar­gets pro­posed by sci­en­tists at UCLA with Xen­cor’s XmAb tech­nol­o­gy plat­forms that en­gi­neer mon­o­clon­al an­ti­bod­ies to cre­ate new pro­tein struc­tures. No fi­nan­cial terms of the agree­ment were dis­closed, but any se­lect­ed drug can­di­dates re­sult­ing from the part­ner­ship will use a frame­work of “pre­de­fined terms to en­ter spon­sored re­search agree­ments and po­ten­tial li­cense agree­ments,” the or­ga­ni­za­tions said.

“With this col­lab­o­ra­tion, we aim to ac­cel­er­ate the de­vel­op­ment of po­ten­tial new bi­o­log­ic med­i­cines, lever­ag­ing Xen­cor’s pro­tein en­gi­neer­ing tech­nolo­gies and ex­per­tise and the on­go­ing sci­en­tif­ic dis­cov­er­ies and in­sights in­to dis­ease bi­ol­o­gy made at UCLA, with the ul­ti­mate goal to im­prove pa­tient out­comes and qual­i­ty of life,” Mark Wis­niews­ki, the se­nior di­rec­tor of bio­phar­ma­ceu­ti­cals at UCLA TDG, said in a state­ment. —Con­ner Mitchell

Schrödinger ex­pands deal with Google Cloud

Schrödinger is re­vis­it­ing an old part­ner­ship with an ex­pan­sion that both par­ties hope will be fruit­ful.

The New York, NY-based biotech an­nounced Thurs­day it has broad­ened its deal with Google Cloud to fur­ther in­crease the speed and ca­pac­i­ty of its plat­form for drug dis­cov­ery. Pre­vi­ous­ly, the en­ti­ties had agreed to a three-year deal in 2019, but Thurs­day’s agree­ment re­places that with a new, five-year part­ner­ship.

Fi­nan­cial terms of the new deal were not dis­closed. With the ex­pan­sion, Schrödinger says it will gain hun­dreds of mil­lions of graph­ics pro­cess­ing unit (GPU) hours, which will es­sen­tial­ly triple its pre­vi­ous ca­pac­i­ties.

“Our in­creased com­mit­ment pro­vides un­matched com­pu­ta­tion­al scale to en­able rapid, ef­fi­cient and ac­cu­rate ex­plo­ration of chem­i­cal space, with a goal of ad­vanc­ing de­vel­op­ment pro­grams for our pipeline,” CIO Shane Brauner said in a state­ment.

Thurs­day’s news comes rough­ly three months af­ter Schrödinger signed on to a col­lab­o­ra­tion with Bris­tol My­ers Squibb that saw the big phar­ma pay $55 mil­lion and promise up to $2.7 bil­lion in po­ten­tial mile­stones. That deal’s ini­tial tar­gets in­clude HIF-2 al­pha and SOS1/KRAS for a type of kid­ney can­cer and KRAS-dri­ven can­cers, re­spec­tive­ly. — Max Gel­man

Spring­Works re­ports in­ter­im da­ta from first 20 pa­tients in Phase IIb NF1 ther­a­peu­tic tri­al

Con­necti­cut biotech Spring­Works on Thurs­day re­leased a small set of da­ta from the Phase IIb tri­al of its in­ves­ti­ga­tion­al MEK in­hibitor mir­dame­tinib, which seeks to treat adults and chil­dren with NF1-as­so­ci­at­ed plex­i­form neu­rofi­bro­mas.

As of a Jan 22 cut­off date, half of the 20 pa­tients achieved an ob­jec­tive re­sponse ac­cord­ing to a blind­ed, in­de­pen­dent cen­tral re­view, and 16 of 20 re­mained on the study, which re­port­ed a me­di­an treat­ment time of rough­ly 10 months.

Spring­Works CEO Saqib Is­lam said in a state­ment the com­pa­ny was pleased with the da­ta, and ex­pects to fin­ish en­rolling a full 100-pa­tient tri­al by the sec­ond half of 2021.

“We are very en­cour­aged by these emerg­ing da­ta from our on­go­ing ReNeu tri­al, as they reaf­firm our be­lief that mir­dame­tinib has the po­ten­tial to be a best-in-class treat­ment for pa­tients with NF1-PN,” Is­lam said.—Con­ner Mitchell

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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No­vo Nordisk touts an­oth­er once-week­ly in­sulin win; Mere­o's board bat­tle heats up again

Novo Nordisk has completed the posting of topline results across its six Phase IIIa clinical trials in the ONWARDS program, rounding out a full-fledged effort to bring another diabetes treatment to market.

In ONWARDS 5, once-weekly insulin icodec was found to be non-inferior to once-daily basal insulin in reducing HbA1c, the Danish Big Pharma reported Monday. With that, the 52-week open-label trial met its primary endpoint at the end of the study.

Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; 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.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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