Hit by tri­al set­back, Aslan slash­es staff and a study — hun­ker­ing down in wait for piv­otal da­ta

Two weeks af­ter re­port­ing the fail­ure of a key Phase II study of their lead drug, Aslan Phar­ma­ceu­ti­cals $ASLN is re­struc­tur­ing, slash­ing staff and shut­ter­ing a tri­al as they aim for a piv­otal win.

Bertil Lind­mark

Out the ex­it goes Bertil Lind­mark, the chief med­ical of­fi­cer, now head­ed back to Eu­rope. The CMO is leav­ing with 30% of the staff as the biotech slash­es its burn rate in half. In oth­er staff moves Chih-Yi Hsieh, the VP Med­ical and GM Tai­wan, will take the role of act­ing CMO while COO Mark McHale be­comes head of R&D.

The Sin­ga­pore-based biotech will now fo­cus much of its at­ten­tion on a piv­otal study of var­l­i­tinib in sec­ond-line bil­iary tract can­cer, with da­ta ex­pect­ed in the sec­ond half of the year. They’ll shut­ter an­oth­er BTC tri­al in Chi­na now, with plans to file for ap­provals in the US and Chi­na and oth­er re­gions on the sur­viv­ing piv­otal study. And they’ll be pray­ing for more da­ta like the Phase Ib re­sults they tout­ed in front­line BTC, which ap­peared promis­ing.

Carl Firth

Af­ter go­ing pub­lic last May the Aslan stock peaked at more than $10 last sum­mer and has been slid­ing steadi­ly ever since. It al­so took a hit ear­li­er in the month on the fail­ure of the gas­tric can­cer study, rais­ing doubts about the drug they ob­tained from Ar­ray. The Nas­daq stock end­ed Tues­day’s ses­sion at $3.51. 

Aslan needs a suc­cess this year — a big one — to win back in­vestors.

Ear­ly- and mid-stage work on ASLAN003 in AML and ASLAN004 in atopic der­mati­tis will con­tin­ue.

CEO Carl Firth not­ed:

We are ap­proach­ing sev­er­al sig­nif­i­cant mile­stones in 2019 and be­yond, so it is im­por­tant we com­plete key stud­ies over the next two years. Re­struc­tur­ing the or­gan­i­sa­tion has in­volved some tough de­ci­sions. It is dif­fi­cult to lose out­stand­ing mem­bers of the team who have con­tributed to ASLAN over the years and have tack­led some of the most chal­leng­ing ob­sta­cles to ad­vanc­ing new treat­ments for can­cer.

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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Fol­low­ing US, Chi­na hos­pi­tal ef­forts, Gilead plots its own PhI­II tri­als for close­ly watched Covid-19 drug

Gilead is launching its own Phase III trials of remdesivir, the repurposed antiviral that a WHO official called the “one drug right now we think may have real efficacy” against Covid-19 as the novel coronavirus originating from Wuhan, China ravages the world.

Announced just a day after the NIH and the University of Nebraska Medical Center registered their US-based trial online, Gilead’s program will comprise two studies enrolling around 1,000 patients beginning in March. They will recruit primarily in Asian countries but will also include patients from other locations with “high numbers of diagnosed cases,” the company said.

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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In at least one life-sci hub, gen­der and di­ver­si­ty ini­tia­tives haven’t made a dent

Gender and racial diversity at the top of UK life science companies has hardly budged over the last seven years despite repeated advocacy efforts, according to a new report.

The report, from the recruiting firm Liftstream, found that 14.8% of directors on life sciences boards were women and 21.1% of top executives were women. That’s a modest bump from the 9.8% of directors and 18.1% of executives Liftstream identified in their last report from 2014. The percentage of women CEOs moved from 8% to 9.8%.

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Will a 'risk-of­f' mind­set has­ten cell ther­a­py M&A? Io­vance surges on buy­out chat­ter

Is it time for some cell therapy M&A?

Investors of Iovance Biotherapeutics certainly thought so, sending its stock $IOVA up as much as 40% after Bloomberg reported that the cancer-focused biotech is talking to potential buyers.

While 2019 saw a number of high-profile gene therapy company takeovers — led by Roche’s $4.3 billion bid of Spark as Astellas went for Audentes, Biogen snapped up Nightstar and Vertex absorbed Exonics — large players appeared to prefer partnering on the cell therapy front, particularly when it comes to cancer. Hal Barron put his weight behind Rick Klausner’s startup as he rebuilt GlaxoSmithKline’s cancer pipeline. Takeda turned to MD Anderson to license their natural killer cell therapy.

One less ri­val for Im­muno­vant, as Alex­ion aban­dons FcRn in­hibitor

Less than one year after Alexion parted with $25 million upfront to secure access to a second anti-FcRn asset, it is abandoning the experimental drug. The discontinuation, disclosed at the SVB Leerink Global Healthcare Conference in New York during a fireside chat, bodes well for rival Immunovant.

The drug (ABY-039), partnered for development with Sweden’s Affibody, was forsaken on the basis of early-stage data that was not viewed favorably, Baird and SVB Leerink analysts noted.