Photo: Amber Tong, Endpoints News

In a bid to get to Chi­nese pa­tients faster, Shang­hai's I-Mab plans $100M Nas­daq IPO

Aim­ing to be the next Chi­nese com­pa­ny to list on Nas­daq af­ter Zai Lab’s de­but two years ago, the Shang­hai drug de­vel­op­er I-Mab is gun­ning for a $100 mil­lion IPO.

The com­pa­ny — which has raised more than $400 mil­lion in the last three years — has a shrewd strat­e­gy for bi­o­log­ic de­vel­op­ment: it first con­ducts its proof-of-con­cept tri­als in the Unit­ed States and works to­wards get­ting FDA clear­ance for in-hu­man stud­ies.  The da­ta gen­er­at­ed are then used to ad­vance clin­i­cal de­vel­op­ment in Chi­na. Even­tu­al­ly, af­ter the ex­per­i­men­tal drug has been clin­i­cal­ly val­i­dat­ed in the Unit­ed States, the com­pa­ny re­tains Chi­nese rights for fur­ther de­vel­op­ment and com­mer­cial­iza­tion — while re­tain­ing the op­tion to out-li­cense glob­al­ly.

I-Mab’s ap­proach could al­low Chi­nese pa­tients to ac­cess treat­ments con­cur­rent­ly or soon af­ter their mar­ket ap­provals else­where, par­tic­u­lar­ly since Chi­nese of­fi­cials have carved out a path­way for the fast-track ap­proval of drugs sup­port­ed by sol­id over­seas clin­i­cal da­ta and grant­ed pri­or­i­ty re­views. Zai Lab, which has ac­quired a slate of late-stage and com­mer­cial prod­ucts to quick­ly build its port­fo­lio, has ben­e­fit­ed from these Chi­nese re­forms.

I-Mab, mean­while, has a slate of ten clin­i­cal and pre­clin­i­cal bi­o­log­ics for au­toim­mune dis­ease and can­cer, which is on the rise in Chi­na due to pol­lu­tion and lofty rates of smok­ing. Growth in Chi­na’s bi­o­log­ics mar­ket has sur­passed the glob­al bi­o­log­ics mar­ket and is ex­pect­ed to reach $189.4 bil­lion in sales by 2030, I-Mab said, cit­ing a Frost & Sul­li­van re­port.

The com­pa­ny’s glob­al port­fo­lio hous­es mon­o­clon­al an­ti­bod­ies and bi-spe­cif­ic an­ti­bod­ies. Three drugs: TJM2, TJC4 and TJD5 are in phase 1 tri­als in the Unit­ed States — and ap­pli­ca­tions to test TJC4 and TJD5 in hu­mans was grant­ed by Chi­na’s Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion (NM­PA) ear­li­er this year.

In its Chi­na port­fo­lio, the com­pa­ny has five home-grown in­ves­ti­ga­tion­al drugs that are in or ready for phase II or phase III tri­als in Chi­na, hav­ing met the re­lat­ed pre-set safe­ty and pre­lim­i­nary ef­fi­ca­cy end­points in ear­ly or mid-stage stud­ies in Eu­rope or the Unit­ed States. TJ202 is in two piv­otal tri­als test­ing its use in mul­ti­ple myelo­ma in Tai­wan, while the NM­PA has en­dorsed test­ing the drug for the same in­di­ca­tions in hu­mans in Chi­na. Da­ta on TJ101 is be­ing com­piled for an ap­pli­ca­tion to test in a reg­is­tra­tional tri­al in Chi­na. For enobli­tuzum­ab, an IND is be­ing prepped for 2020 for a mid-stage tri­al or a piv­otal tri­al. Al­to­geth­er, the com­pa­ny is vy­ing to sub­mit a slate of mar­ket­ing ap­pli­ca­tions come 2021.

The com­pa­ny was es­tab­lished in June 2016 and has inked a num­ber of col­lab­o­ra­tions, in­clud­ing Mor­phoSys, Genex­ine, Macro­Gen­ics, and Fer­ring. It in­tends to list on the Nas­daq with the sym­bol $IMAB.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Joe Jimenez, Getty

Ex-No­var­tis CEO Joe Jimenez is tak­ing an­oth­er crack at open­ing a new chap­ter in his ca­reer — and that in­cludes a new board seat and a $250M start­up

Joe Jimenez is back.

The ex-CEO of Novartis has taken a board seat on Century Therapeutics, the Versant and Bayer-backed startup focused on coming up with a brand new twist on cell therapies for cancer — a field where Jimenez made his mark backing the first personalized CAR-T approved for use.

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Can we make the an­tibi­ot­ic mar­ket great again?

The standard for-profit model in drug development is straightforward. Spend millions, even billions, to develop a medicine from scratch. The return on investment (and ideally a tidy profit) comes via volume and/or price, depending on the disease. But the string of big pharma exits and slew of biotech bankruptcies indicate that the model is sorely flawed when it comes to antibiotics.

The industry players contributing to the arsenal of antimicrobials are fast dwindling, and the pipeline for new antibiotics is embarrassingly sparse, the WHO has warned. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments are typically priced cheaply, and often lose potency over time as microbes grow resistant to them.

Top Har­vard chemist caught up in FBI’s 'T­hou­sand Tal­ents' drag­net, ac­cused of ly­ing about Chi­nese con­nec­tions, pay

The FBI’s probe into the alleged theft of R&D secrets by Chinese authorities has drawn Harvard’s top chemist into its net.

The agency accused Charles M. Lieber, who chairs the university’s chemistry and chemical biology department, with lying about his involvement in China’s Thousand Talents campaign, which was established as a way of drawing in innovators from around the world. And the scientist, 60, was charged with making false statements about his ties to China.

The US attorneys office in Boston also announced charges against two Chinese nationals for helping the Chinese government.

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Eye­ing a trio of tri­al ini­ti­a­tions, Jim Wilson's gene ther­a­py start­up woos Bruce Gold­smith from Deer­field as CEO

Passage Bio — Jim Wilson’s self-described “legacy company” — has wooed a seasoned biotech executive to steer the clinical entry of its first three gene therapy programs.

Bruce Goldsmith jumps to the helm of Passage after a brief CEO stint at Civetta, a cancer-focused startup he helped launch while a venture partner at Deerfield. He takes over from OrbiMed partner and interim chief Stephen Squinto, who will now lead the R&D team.

The FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. They plan to squash it — and per­ma­nent­ly ex­ile him

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition. And their lawsuit is asking that Shkreli — with several years left on his prison sentence — be banned permanently from the pharma industry.

UP­DAT­ED: Ac­celeron res­ur­rects block­buster hopes for so­tater­cept with pos­i­tive PhII — and shares rock­et up

Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

“We’re thrilled to report such positive topline results from the PULSAR trial,” Acceleron CEO Habib Dable said in a statement. The company said in a conference call they plan on discussing a Phase III trial design with regulators.

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Short at­tack­er Sahm Ad­ran­gi draws crosshairs over a fa­vorite of Sanofi’s new CEO — with PhII da­ta loom­ing

Sahm Adrang Kerrisdale

Kerrisdale chief Sahm Adrangi took a lengthy break from his series of biotech short attacks after his chief analyst in the field pulled up stakes and went solo. But he’s making a return to drug development this morning, drawing crosshairs over a company that’s one of new Sanofi CEO Paul Hudson’s favorite collaborators.

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Amber Saltzman (Ohana)

Flag­ship's first ven­ture of 2020 is out, and it's all about sperm

A couple years ago, Amber Salzman got a call as she was returning East full-time after a two-year stint running a gene therapy company in California.

It was from someone at Flagship Pioneering, the deep-pocketed biotech venture firm. They had a new company with a new way of thinking about sperm. It had been incubating for over a year, and now they wanted her to run it.

“It exactly fit,” Salzman told Endpoints News. “I just thought I had to do something.”