Astel­las finds an­oth­er col­lab­o­ra­tor in small UK start­up; Two Japan­ese biotechs align on gene ther­a­pies

Af­ter an im­muno-on­col­o­gy an­ti­body deal,  a can­cer im­munother­a­py tie-up and a pro­tein pact, Astel­las Phar­ma is on to its next part­ner­ship, this time with a small UK biotech to treat eye dis­eases.

The Japan­ese phar­ma will team up with Mo­gri­fy to find in vi­vo re­gen­er­a­tive med­i­cine ap­proach­es to treat­ing sen­sorineur­al hear­ing loss. The goal is to find new com­bi­na­tions of tran­scrip­tion fac­tors to help de­vel­op new cochlear hair cells.

Astel­las will foot the re­search costs and lend its AAV ex­per­tise through its gene ther­a­py di­vi­sion, and Mo­gri­fy will pro­vide its screen­ing and val­i­da­tion process to help find po­ten­tial ther­a­pies, the com­pa­nies said Tues­day, with­out dis­clos­ing fi­nan­cial de­tails. Mo­gri­fy picked up $17 mil­lion in ad­di­tion­al fi­nanc­ing last May. — Kyle LaHu­cik 

Mit­subishi Tan­abe part­ners with small biotech on CNS gene ther­a­pies 

Mit­subishi Tan­abe Phar­ma, which re­cent­ly re­ceived an FDA green light for its oral ALS drug, will part­ner with a lit­tle-known Japan­ese biotech on po­ten­tial gene ther­a­pies for an undis­closed cen­tral ner­vous sys­tem tar­get.

Ed­it­Force could re­ceive more than 20 bil­lion yen ($147 mil­lion) as part of the agree­ment, in ex­change for giv­ing the ex­clu­sive rights to Mit­subishi Tan­abe for drug can­di­date mol­e­cules world­wide. Mit­subishi Tan­abe will han­dle pre­clin­i­cal, clin­i­cal, man­u­fac­tur­ing and com­mer­cial­iza­tion work.

The duo kept many de­tails un­der wraps, in­clud­ing nam­ing the spe­cif­ic CNS dis­ease and time­lines for clin­i­cal en­try. The gene ther­a­pies will be de­vel­oped us­ing Ed­it­Force’s PPR pro­tein plat­form, the com­pa­nies said. — Kyle LaHu­cik 

Brii Bio­sciences elects to snag Vir’s HBV an­ti­body in Chi­na

Af­ter orig­i­nal­ly com­ing to­geth­er in May 2018, Brii Bio­sciences likes what it sees in part­ner Vir Biotech­nol­o­gy and has de­cid­ed to act up­on its op­tion to ac­quire Greater Chi­na rights to de­vel­op and mar­ket an HBV mon­o­clon­al an­ti­body.

The an­ti­body, dubbed both VIR-3434 and BRII-877, is cur­rent­ly in Phase II de­vel­op­ment and is the sec­ond op­tion ex­er­cise un­der the mul­ti-year deal. Two more op­tions re­main un­der the in­fec­tious dis­ease agree­ment.

“Re­cent­ly an­nounced da­ta by Vir showed that BRII-835 (VIR-2218) and BRII-877 (VIR-3434) are ad­di­tive to each oth­er re­sult­ing in a ro­bust re­duc­tion of he­pati­tis B sur­face anti­gen (HB­sAg), with no clin­i­cal­ly sig­nif­i­cant safe­ty sig­nals for the com­bi­na­tion,” Brii CMO Li Yan said in a state­ment. — Kyle LaHu­cik

Dr. Red­dy’s sub­sidiary nets pact with EQRx

In­dia-based biotech Au­ri­gene has a new part­ner to work with.

Au­ri­gene is team­ing up with EQRx to de­vel­op on­col­o­gy and im­mune-in­flam­ma­to­ry dis­ease drugs, the biotechs an­nounced in a state­ment Tues­day. Au­ri­gene will lead dis­cov­ery and pre­clin­i­cal ef­forts while EQRx, which is all about get­ting fast-fol­low drugs to the mar­ket at an af­ford­able price, will take on clin­i­cal de­vel­op­ment, man­u­fac­tur­ing and reg­u­la­to­ry/com­mer­cial­iza­tion ef­forts. Fi­nan­cial de­tails of the agree­ment were not dis­closed.

“This agree­ment with EQRx fur­ther val­i­dates Au­ri­gene’s proven ex­per­tise in dis­cov­ery and pre­clin­i­cal de­vel­op­ment of nov­el ther­a­peu­tics and moves Au­ri­gene for­ward in­to build­ing a glob­al on­col­o­gy fran­chise par­tic­i­pat­ing in the end-to-end val­ue chain,” Au­ri­gene CEO Mu­rali Ra­machan­dra said in a state­ment.

A sub­sidiary of drug man­u­fac­tur­ing gi­ant Dr. Red­dy’s Lab­o­ra­to­ry, Au­ri­gene is based in Ben­galu­ru and Kuala Lumpur. The com­pa­ny says it has con­tributed to 16 dif­fer­ent drugs cur­rent­ly in clin­i­cal tri­als and pre­vi­ous­ly part­nered with Ex­elix­is back in 2019. — Max Gel­man

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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