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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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René Russo, Xilio CEO (Alicia Petitti for Xilio)

Xilio Ther­a­peu­tics goes pub­lic as bio­phar­ma IPOs rum­ble for­ward in Q4

It’s been a busy fall on Wall Street — and this week, we’ve got another biotech going public after Ventyx yesterday.

Massachusetts solid-tumor biotech Xilio Therapeutics made its public debut today, joining 149 other biotechs that have gone public so far this year.

Back on October 1st, Xilio filed its S-1 with the SEC to make its IPO debut for $100 million — the next step in financing after completing a $95 million Series C back in February.

Luc Boblet, Egle Therapeutics CEO

A new Treg play­er emerges with $46M and back­ing from Take­da

In recent years, the chorus of biotechs and Big Pharma backers targeting regulatory T cells — also known as “Tregs” — for cancer and autoimmune diseases has only grown louder.

The newest voice is from Egle Therapeutics, which sang out a $46.4 million Series A round on Friday led by LSP and Bpifrance through their InnoBio 2 fund. Takeda’s venture arm also chipped in, about a year after the pharma struck a research pact with the Paris-based upstart.

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Marty Duvall, Oncopeptides CEO

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

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Pfiz­er pitch­es its Covid-19 vac­cine for younger chil­dren ahead of ad­comm next week

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.