Lonnie Moulder
March 23, 2021 04:00 AM EDTUpdated 08:22 AM
Startups

Ex­clu­sive: Two M&A deals and $9B lat­er, Lon­nie Moul­der is ramp­ing up his lat­est biotech start­up. And this one comes with glob­al vi­sion built in

John Carroll

Editor & Founder

Lonnie Moulder may have been in silent running mode in the 2 years since he closed the $5 billion sale of Tesaro to GlaxoSmithKline. But he hasn’t been idle.

Today during the China Healthcare Investment Conference in Shanghai, where Endpoints News is playing a co-sponsor role, Moulder’s taking the wraps off a biotech startup he’s put together that has assembled a pipeline with 7 drugs in it, a plan to add several more therapies and a quick vault into the clinic for a company with a small but fast-expanding team that is growing roots in China and the US — with Europe soon to be added to its global frame.

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SPONSORED
March 20, 2023 06:00 AM EDT

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

Sean Dodge

Healthcare Technology Analyst, RBC Capital Markets

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat
March 22, 2023 06:30 AM EDT
Financing
Startups

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Kyle LaHucik

Associate Editor

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

Endpoints News

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Rohan Palekar, 89bio CEO
March 22, 2023 07:00 AM EDT
R&D

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

Kyle LaHucik

Associate Editor

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

Josep Bassaganya-Riera, NImmune Biopharma
March 22, 2023 06:00 AM EDTUpdated 06:47 AM
Startups

Ex­clu­sive: Af­ter get­ting his drug back, Lan­dos founder as­sem­bles new start­up for the big PhI­II test

Amber Tong

Senior Editor

By the time Josep Bassaganya-Riera stepped down as founding CEO of Landos Biopharma in 2021, the company had racked up Phase II data for its top autoimmune program, completed what he called a positive end-of-Phase-II meeting with the FDA and plans to launch pivotal Phase III trials.

Since then, though, the new leaders at Landos have reshuffled their plans for the drug, omilancor, first announcing they will run a Phase IIb ahead of a Phase III and eventually shelving it altogether.

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Francesco Marincola, newly-appointed Sonata Therapeutics CSO
March 21, 2023 07:28 AM EDTUpdated 01:44 PM
People
Startups

Kite's head of re­search leaves for Flag­ship start­up Sonata

Nicole DeFeudis

Editor

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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March 22, 2023 07:23 AM EDT
R&D

Roche and Lil­ly team up to de­vel­op blood test to de­tect ear­ly signs of Alzheimer's

Katherine Lewin

News Reporter

Eli Lilly is teaming up with Roche to help develop a blood test to detect early signs of Alzheimer’s disease and determine whether a patient should go for further confirmatory testing.

Roche’s Elecsys Amyloid Plasma Panel (EAPP) measures pTau 181 protein assay and APOE E4 assay in human blood plasma – elevations in pTau 181 are present in the early stages of Alzheimer’s, while the presence of APO E4 is the most common genetic risk factor for the disease.

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March 20, 2023 11:47 AM EDTUpdated 11:58 AM
R&D
FDA+

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Max Gelman

Senior Editor

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)
March 18, 2023 07:00 AM EDT
Deals
R&D

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

John Carroll

Editor & Founder

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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March 21, 2023 05:42 PM EDTUpdated 1 hour ago
Pharma
Law

NIH re­jects an­oth­er at­tempt to 'march-in' on Astel­las' prostate can­cer drug over ex­ces­sive price

Zachary Brennan

Senior Editor

The National Institutes of Health has again declined to use so-called “march-in” rights to lower the price of Astellas and Pfizer’s prostate cancer drug Xtandi despite being invented at UCLA with grants from the US Army and NIH.

“Given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug,” NIH told prostate cancer patients Robert Sachs and Clare Love, in a letter shared with Endpoints News. The institutes’ analyses found Xtandi “to be widely available to the public,” an indication that there was not a pressing need for the US to act.

Ex­clu­sive: Two M&A deals and $9B lat­er, Lon­nie Moul­der is ramp­ing up his lat­est biotech start­up. And this one comes with glob­al vi­sion built in

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

Ex­clu­sive: Af­ter get­ting his drug back, Lan­dos founder as­sem­bles new start­up for the big PhI­II test

Kite's head of re­search leaves for Flag­ship start­up Sonata

Roche and Lil­ly team up to de­vel­op blood test to de­tect ear­ly signs of Alzheimer's

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

NIH re­jects an­oth­er at­tempt to 'march-in' on Astel­las' prostate can­cer drug over ex­ces­sive price