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.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

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FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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Joe Wiley, Amryt CEO

A biotech with a yen for pricey rare dis­ease drugs — and bar­gain base­ment shop­ping — adopts an­oth­er or­phan in lat­est M&A pact

After making it through a long, painful haul to get past a CRL and on to an FDA approval last summer, little Chiasma has found a buyer.

Amryt $AMYT, a company known for its appetite for acquiring expensive drugs for rare diseases at bargain prices, snagged Chiasma and its acromegaly drug Mycapssa (octreotide) capsules in an all-stock deal — with an exchange of 0.396 shares of Amryt for every share of Chiasma.

Ngozi Okonjo-Iweala, Director general of WTO (AP Photo/Keystone/Alessandro Della Bella)

Opin­ion: Waiv­ing Covid-19 vac­cine IP could save lives, but where is the man­u­fac­tur­ing ca­pac­i­ty?

Droves of House Democrats in Washington and members of the European Parliament have now glommed onto a major push by India and South Africa at the WTO to abolish all IP around Covid-19 vaccines.

At first blush, waiving this IP sounds like an easy win: More Covid-19 vaccines made locally for more people means more lives saved. Simple enough, especially as low-income countries have received just a tiny fraction of the world’s vaccine allotment so far.

Thomas Schall, ChemoCentryx CEO (file photo)

Chemo­Cen­tryx plunges as FDA rais­es ques­tions about rare dis­ease drug ahead of ad­comm

ChemoCentryx’s stock price on Wednesday was cut in half by the release of FDA briefing documents ahead of a Thursday adcomm, raising questions on the company’s clinical data to support avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

ANCA-associated vasculitides (AAV) affect small to medium-size blood vessels that can be fatal in less than a year if left untreated, according to FDA. Only Roche’s Rituxan is currently FDA-approved for the treatment of AAV, while glucocorticoids are approved for the broader indication of vasculitis.

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