A PhII flop trig­gers an ug­ly rout for mi­cro-cap biotech Aridis; Gen­fit CEO pass­es ba­ton to suc­ces­sor

Vu Truong

Mi­cro-cap biotech Aridis Phar­ma­ceu­ti­cals $ARDS got ham­mered this morn­ing as in­ves­ti­ga­tors re­vealed that one of its clin­i­cal-stage drugs failed a mid-stage study, trig­ger­ing safe­ty fears and forc­ing the com­pa­ny to dump the pro­gram.

The an­ti-in­fec­tive out­fit says that AR-105 — an an­ti­body — failed to beat out a place­bo in treat­ing ven­ti­la­tor-as­so­ci­at­ed pneu­mo­nia caused by gram-neg­a­tive Pseudomonas aerug­i­nosa. And there was an im­bal­ance in deaths and se­ri­ous ad­verse events that left the ther­a­py with a worse safe­ty pro­file.

The fail­ure touched off a rout among in­vestors as the stock plunged more than 30%, carv­ing in­to a mar­ket cap of $104 mil­lion.

Now that the mid-stage pro­gram is gone, Aridis CEO Vu Truong — a Med­Im­mune vet — says they will fo­cus on their Phase III ther­a­py AR-301, al­so for VAP. The in­ter­im da­ta is due in the first half of next year.

A cou­ple months af­ter NASH hope­ful Gen­fit was award­ed or­phan drug sta­tus by US and EU reg­u­la­tors for its ex­per­i­men­tal drug, elafi­bra­nor, to treat pa­tients with pri­ma­ry bil­iary cholan­gi­tis (PBC), CEO Jean-François Mouney is hand­ing the reins to Pas­cal Prignet — who joined the com­pa­ny less than a year and a half ago from GSK as EVP of mar­ket­ing and com­mer­cial de­vel­op­ment. Mouney will re­main as chair­man of the com­pa­ny’s board of di­rec­tors. 

Jean-François Mouney, Gen­fit CEO

Mouney said there was no ex­ter­nal search, hav­ing iden­ti­fied Pri­gent as a nat­ur­al suc­ces­sor. “It’s a per­son­al de­ci­sion tak­en af­ter thought­ful con­sid­er­a­tion, fol­low­ing two decades of in­ten­sive work ded­i­cat­ed to de­vel­op­ing GEN­FIT. I’ve asked Pas­cal to ac­cept the CEO po­si­tion be­cause I’m con­vinced he is best po­si­tioned to over­see our fu­ture cor­po­rate growth.”

Prignet joined the com­pa­ny in May 2018 af­ter var­i­ous stints at Eli Lil­ly and GSK, where he ran their US vac­cines di­vi­sion. In ad­di­tion, the com­pa­ny an­nounced that they will be adding three new board mem­bers (cur­rent­ly uniden­ti­fied) in the next eight to nine months to help steer the com­pa­ny to­wards a stronger pres­ence in the US.

→ T cell ther­a­py play­er Im­munotech Bio­pharm has filed for an IPO in Hong Kong. The list­ing would rep­re­sent the next chap­ter in its sin­gle mis­sion to ad­vance cel­lu­lar im­munother­a­py for can­cer in Chi­na, the com­pa­ny wrote, which be­gan back in 2006. Its lead prod­uct can­di­date, EAL — which con­sists of au­tol­o­gous CD8+ T cells ac­ti­vat­ed and ex­pand­ed ex vi­vo — is cur­rent­ly in a 272-pa­tient Phase II clin­i­cal tri­al for post­sur­gi­cal liv­er can­cer, a preva­lent in­di­ca­tion in Chi­na.

With R&D and man­u­fac­tur­ing sites in Bei­jing as well as a re­search cen­ter in Ko­rea, the com­pa­ny is al­so seek­ing to bring sev­er­al CAR-T treat­ments in­to the clin­ic — the fron­trun­ner be­ing an an­ti-CD19 prod­uct. One of the oth­ers tar­get­ing BC­MA would pit Im­munotech against Leg­end Biotech, a J&J-part­nered play­er owned by CRO Gen­Script (al­so list­ed on HKEX).

The IPO is ex­pect­ed to bring in $100 mil­lion to $200 mil­lion, Reuters‘ IFR re­port­ed. Wang Yu, who had shaped the com­pa­ny as it is known to­day from a pre­de­ces­sor firm dubbed Bei­jing Yong­tai, con­tin­ues to lead Im­munotech’s team of 110 as CEO and co-chief tech­nol­o­gy of­fi­cer.

→ Trou­bled Abeona Ther­a­peu­tics $ABEO an­nounced that Jef­feries will re­main its fi­nan­cial ad­vi­sor for the com­pa­ny’s strate­gic re­view. This comes less than a year af­ter the com­pa­ny boot­ed their CEO, Carsten Thiel, for un­spec­i­fied “per­son­al mis­con­duct” in­volv­ing his in­ter­ac­tions with col­leagues at the com­pa­ny.

“There can be no as­sur­ance this strate­gic re­view will re­sult in the com­ple­tion of any par­tic­u­lar course of ac­tion. There is no de­fined time­line for com­ple­tion of the re­view process and the com­pa­ny does not in­tend to com­ment fur­ther un­less a spe­cif­ic ini­tia­tive is ap­proved by the Board of Di­rec­tors, the re­view process is con­clud­ed, or it is oth­er­wise de­ter­mined that oth­er dis­clo­sure is ap­pro­pri­ate,” the com­pa­ny stat­ed.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

San Diego cou­ple charged with steal­ing trade se­crets, open­ing Chi­nese biotech as DOJ crack­down con­tin­ues

A San Diego couple has been charged with stealing trade secrets from a US hospital and opening a business based off those secrets in China as the controversial industry-wide crackdown on alleged corporate espionage continues. On the same day, the Department of Justice announced they had arrested Beijing representative Zhongsan Liu for allegedly trying to obtain research visas for government recruiters.

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UP­DAT­ED: Bio­gen pulls the plug on prized IPF drug from $562M+ Stromedix buy­out

One of Biogen’s attempts to branch out has flopped as the biotech scraps a mid-stage program for idiopathic pulmonary fibrosis.

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Warts for the win: Aclar­is' lead drug clears piv­otal study

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.