Aslan's lat­est can­cer fo­cus al­so flops, leav­ing just two ma­jor pro­grams for the trou­bled biotech

Aslan $ASLN has stum­bled back in­to the fail­ure pit.

When their lead drug failed to treat gas­tric can­cer, Aslan Phar­ma­ceu­ti­cals an­nounced they were go­ing to fo­cus on an­oth­er type: bil­iary tract can­cer (BTC). When the gas­tric fail­ure forced them to cut 30% of their staff, they again em­pha­sized the new tar­get as one of three re­main­ing pro­grams.

But Aslan’s BTC tri­al has now failed on both pri­ma­ry end­points. The re­sults showed an im­proved re­sponse rate for Aslan’s var­l­i­tinib over the con­trol arm, but not sig­nif­i­cant­ly.  The drug arm had a pro­gres­sion-free sur­vival rate of 2.83 months com­pared to 2.79 in the con­trol arm — ba­si­cal­ly a one-day dif­fer­ence.

The fail­ure leaves Aslan with two ma­jor pro­grams left — one for acute myeloid leukemia (AML) and one for atopic der­mati­tis (AD) — and a pre­car­i­ous fi­nan­cial sit­u­a­tion. In their Q3, Aslan re­vealed they were burn­ing through $7 mil­lion per quar­ter and had just $8 mil­lion left in cash and cash equiv­a­lents.

With Mon­day’s news, their stock tum­bled 56%, from $2.08 per share to $0.91. Mar­ket cap fell to $21 mil­lion.

Carl Firth Aslan

Last month the Sin­ga­pore-based com­pa­ny se­cured a $3 mil­lion loan from the board and ma­jor in­vestors in­tend­ed, CEO Carl Firth said at the time, to buoy the com­pa­ny in ad­vance of these da­ta and re­sults com­ing ear­ly next year on AD. Aslan did not say ex­plic­it­ly they are now aban­don­ing the BTC pro­gram but they made no ref­er­ence to fu­ture plans, and to­day Firth said in a state­ment:

“I would like to ex­tend our thanks to the pa­tients, tri­al in­ves­ti­ga­tors and site per­son­nel who par­tic­i­pat­ed in the study and to the ASLAN team for their com­mit­ment to the de­vel­op­ment of var­l­i­tinib. ASLAN re­mains fo­cused on the promis­ing mol­e­cules in its port­fo­lio, in­clud­ing the on­go­ing study in atopic der­mati­tis of ASLAN004, our IL-13 re­cep­tor an­ti­body which blocks sig­nalling through IL-4 and IL-13.”

Much is hang­ing on the 2020 atopic der­mati­tis re­sults. Aslan be­gan dos­ing for the sec­ond part of a Phase I study on its an­ti­body last month, with plans for a fol­low-up study on the most ef­fi­ca­cious dose.

Aslan has com­plet­ed the first part of a Phase II study for their drug for AML, a no­to­ri­ous­ly eva­sive drug tar­get, and said some pa­tients ex­pe­ri­enced up to 98% re­duc­tion in pe­riph­er­al blood blast cells. But since re­port­ing that in their Q2, the com­pa­ny has said lit­tle about the pro­gram.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

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

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

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

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.

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

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

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

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

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

Kite's head of re­search leaves for Flag­ship start­up Sonata

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

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

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

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

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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