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.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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[via AP Images]

Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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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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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA.