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.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.

As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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RA Cap­i­tal, Hill­house join $310M rush to back Ever­est's climb to com­mer­cial heights in Chi­na

Money has never been an issue for Everest Medicines. With an essentially open tab from their founders at C-Bridge Capital, the biotech has gone two and a half years racking up drug after drug, bringing in top exec after top exec, and issuing clinical update after update.

But now other investors want in — and they’re betting big.

Everest is closing its Series C at $310 million. The first $50 million comes from the Jiashan National Economic and Technological Development Zone; the remaining C-2 tranche was led by Janchor Partners, with RA Capital Management and Hillhouse Capital as co-leaders. Decheng Capital, GT Fund, Janus Henderson Investors, Rock Springs Capital, Octagon Investments all joined.