Mubadala Cap­i­tal-backed on­col­o­gy biotech adds more cash to Se­ries A; Opti­nose shares pooled da­ta on nasal spray

Look­ing for a new way to re­de­fine pre­ci­sion on­col­o­gy by us­ing pa­tient tu­mor tis­sue grown in a petri dish, a North Car­oli­na biotech backed by blue-chip in­vestors is adding more to its cof­fers.

Backed by sov­er­eign wealth fund Mubadala Cap­i­tal, Xilis put out word Wednes­day that it added $19 mil­lion more to its Se­ries A round, orig­i­nal­ly worth $70 mil­lion and an­nounced back in 2021. So far, the funds will be used to ad­vance its plat­form — which es­sen­tial­ly en­tails that by tak­ing a piece of tu­mor tis­sue from a pa­tient and grow­ing it in a petri dish, founder and CEO Xil­ing Shen told End­points News last year that re­searchers can test thou­sands of ther­a­pies or drug com­bi­na­tions to see how the tu­mor might re­act.

As an added ben­e­fit, the com­pa­ny can al­so get clin­i­cian in­put on how they’d pre­fer to treat their pa­tients.

Fun­ders on this ex­ten­sion in­clude lead in­vestor FPV Ven­tures, bring­ing along sev­er­al pre­vi­ous back­ers such as Mubadala Cap­i­tal, EQT, GV, and Catalio.

“De­spite un­prece­dent­ed mar­ket con­di­tions in the biotech sec­tor, we raised this ex­ten­sion at a step-up val­u­a­tion and from sev­er­al of the most rep­utable glob­al in­vestors,” Shen said in a state­ment. — Paul Schloess­er

Opti­nose drops more da­ta to sup­port up­com­ing FDA fil­ing for ex­pand­ed nasal spray in­di­ca­tion

Ear­li­er this year, Opti­nose cel­e­brat­ed two Phase III wins for its nasal polyps treat­ment, mar­ket­ed as Xhance, in chron­ic si­nusi­tis.

To­day, the Yard­ley, PA-based biotech un­veiled pooled analy­sis of its two chron­ic si­nusi­tis Phase III tri­als sug­gest­ing that pa­tients who used the nasal spray twice a day saw their num­ber of ex­ac­er­ba­tions go down by two-thirds com­pared to place­bo.

An ap­proval in chron­ic si­nusi­tis, in which si­nus in­flam­ma­tion lingers over a long pe­ri­od of time, would ex­pand Opti­nose’s mar­ket — cur­rent­ly just pa­tients with nasal polyps — by 10 times.

The first Phase III tri­al looked at pa­tients with both chron­ic si­nusi­tis and nasal polyps, but the sec­ond tri­al, which Opti­nose read out in June, in­clud­ed on­ly pa­tients with­out nasal polyps, who rep­re­sent a larg­er share of the chron­ic si­nusi­tis pop­u­la­tion.

Opti­nose CEO Pe­ter Miller pre­vi­ous­ly said the com­pa­ny was look­ing to file an sN­DA by the end of 2022. — Lei Lei Wu

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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