December 6, 2019 07:49 AM EST
R&D

On the heels of a PhI­II im­plo­sion, can­cer biotech Molo­gen is turned over to the liq­uida­tor

John Carroll

Editor & Founder

The 31 staffers left at Ger­man biotech Molo­gen are now work­ing for a liq­uida­tor. And the fo­cus now is on find­ing buy­ers for any­thing it has left that can be sold.

Molo­gen filed for in­sol­ven­cy a few days ago, months af­ter its lead drug — the TLR9 ag­o­nist lefi­tolimod — failed bad­ly in Phase III.

Back in Au­gust the com­pa­ny re­port­ed that their drug pro­duced a near mir­ror im­age re­sult for me­di­an over­all sur­vival in com­par­i­son to the con­trol group in a Phase III. Their OS rate was 22 months when the drug was used as a sec­ond-line ther­a­py for col­orec­tal can­cer. That com­pared to 21.9 months for the com­par­i­son group. And sec­ondary end­points didn’t pro­vide any rea­son to hope for some­thing bet­ter.

Molo­gen — which had part­nered on the drug with Chi­na-backed On­colo­gie — couldn’t re­cov­er from the blow.

Its mar­ket cap $MGNK has dwin­dled to €2.35 mil­lion. Nine­teen years ago it was trad­ing at €292. To­day it’s €0.19.

In a state­ment, Chris­t­ian Köh­ler-Ma, of the Berlin of­fice of GT Re­struc­tur­ing not­ed:

Be­ing a pi­o­neer in im­mune ther­a­py, Molo­gen AG has unique knowhow when it comes to de­vel­op­ing in­no­v­a­tive and dif­fer­en­ti­at­ed TLR9 ag­o­nists, a group of new in­gre­di­ents from the class of im­mune mod­u­la­tors de­signed to be used against can­cer and in­fec­tion dis­eases. I will con­tin­ue op­er­a­tions with all 31 em­ploy­ees for the time be­ing. I was al­ready ap­proached by sev­er­al po­ten­tial pur­chasers of the en­tire com­pa­ny or in­di­vid­ual parts and prod­ucts in de­vel­op­ment. Ini­tial meet­ings with these in­ter­est­ed par­ties give rea­son for con­fi­dence.

AUTHOR

John Carroll

Editor & Founder

john@endpointsnews.com @JohnCendpts
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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.

Alaa Halawaa, executive director at Mubadala’s US venture group
March 22, 2023 08:00 AM EDT
Bioregnum
Discovery

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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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.

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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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.

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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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Vipin Garg, Altimmune CEO
March 21, 2023 11:24 AM EDT
R&D

Al­tim­mune’s shares halved af­ter in­ter­im look at PhII weight loss drug da­ta

Kyle LaHucik

Associate Editor

Altimmune’s attempt to catch up to Novo Nordisk and Eli Lilly’s GLP-1 drugs hit an investor snag Tuesday after the biotech shared interim Phase II weight loss data.

The Maryland biotech’s pemvidutide is a GLP-1/glucagon dual receptor agonist meant to activate GLP-1 receptors to squash appetite and glucagon to ramp up energy use. The 2.4 mg dose showed a placebo-adjusted weight loss of 9.7% at week 24 of 48, which Jefferies analysts said would be comparable to Novo Nordisk’s semaglutide (Wegovy) and Eli Lilly’s tirzepatide (Mounjaro).

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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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On the heels of a PhI­II im­plo­sion, can­cer biotech Molo­gen is turned over to the liq­uida­tor

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

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

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

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

Kite's head of re­search leaves for Flag­ship start­up Sonata

Al­tim­mune’s shares halved af­ter in­ter­im look at PhII weight loss drug da­ta

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