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.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Harith Rajagopalan (Fractyl)

Af­ter a decade in the Type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way Type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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Is­rael's VBL Ther­a­peu­tics hit with CMC de­lays in ovar­i­an can­cer study; No­vo Hold­ings buys out di­ag­nos­tics play­er BBI

VBL Therapeutics has hit a roadblock in its Phase III study for platinum-resistant ovarian cancer.

Batches of the VB-111 compound being evaluated in the study are still being reviewed by the FDA’s CMC group, the company announced Tuesday, with regulators trying to compare VB-111 manufacturing between different sites. As a result, supply will be limited and VBL is pausing enrollment of the 400-patient study until the batches can be cleared.

Lynn Fitch, Mississippi Attorney General (Rogelio V. Solis/AP Images)

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

Mississippi Attorney General Lynn Fitch last week sued the top three insulin manufacturers, which collectively cover almost the entire US insulin market, alleging that they’ve colluded to raise their prices in lockstep, and in some cases by more than 1,000% for drugs that are decades old.

“Because of Manufacturer Defendants’ collusive price increases, nearly a century after the discovery of insulin, diabetes medications have become unaffordable for many diabetics,” the lawsuit says.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia spends Soft­Bank's cash in bid to edge out AI ri­vals

Exscientia is sprinting to win the great AI biotech race.

The UK company, having long labored on small discovery deals with large pharmas, raised up to $525 million in a Series D led by the infamous Japanese conglomerate SoftBank in April and followed it up less than a month later with a Bristol Myers Squibb deal that paid $50 million cash and $1.2 billion in milestones.

Now, the Oxford spinout is splurging on a shiny new tool. On Monday they announced they purchased the three-year-old molecule-screening biotech Allcyte, a longtime collaborator, for $60.6 million in cash and stock.

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