Hong Kong ex­change picks up steam with two biotech IPOs from In­novent, Mi­cuRx

Amid the IPO fren­zy tak­ing place on the Nas­daq, the stock ex­change in Hong Kong has qui­et­ly caught up with two ap­pli­ca­tions at the end of last week — the third and fourth com­pa­nies to try the route since the city opened up to pre-rev­enue biotechs want­i­ng to list.

Michael Yu

The first can­di­date is In­novent Bi­o­log­ics, a 7-year-old biotech uni­corn long ru­mored to be an­gling for a pub­lic list­ing and hand­ed $150 mil­lion in a Se­ries E crossover round weeks ago. They were joined by fel­low Shang­hai-based drug­mak­er Mi­cuRx Phar­ma, which is look­ing for some help pow­er­ing through var­i­ous stud­ies for its drugs treat­ing mul­ti­ple drug re­sis­tant in­fec­tions.

In an un­usu­al chair­man’s let­ter that starts off the ap­pli­ca­tion doc­u­ment, In­novent founder and CEO Michael Yu re­flect­ed on the found­ing phi­los­o­phy of the com­pa­ny:

The re­al­i­ty is that there is a huge gap be­tween Chi­na’s bio­phar­ma­ceu­ti­cal in­dus­try and in­ter­na­tion­al stan­dards. Chi­na’s bio­phar­ma­ceu­ti­cal pro­duc­tion ca­pac­i­ty is less than one-fifti­eth of that of the Unit­ed States, and not even one-tenth of that of South Ko­rea. Among the top ten best-sell­ing drugs in the world, eight are bi­o­log­ics and five are mon­o­clon­al an­ti­body drugs, while Chi­na’s best­selling drugs are still most­ly chem­i­cal drugs and tra­di­tion­al Chi­nese med­i­cines. Im­port­ed drugs dom­i­nate Chi­na’s an­ti­body drug mar­ket, and for most Chi­nese pa­tients, these life-sav­ing drugs are of­ten un­af­ford­able and out of reach.

His an­swer to that need has now grown to a 510-strong com­pa­ny with a pipeline of 17 drugs, with sev­en in clin­i­cal de­vel­op­ment and four in Phase III tri­als.

Sin­til­imab, a PD-1 in­hibitor cur­rent­ly un­der pri­or­i­ty re­view in Chi­na, is the star here; In­novent is al­so look­ing to start ear­ly-stage tri­als of the drug in the US while us­ing it as a base for two oth­er as­sets they are co-de­vel­op­ing with Eli Lil­ly.

As is stan­dard in these ap­pli­ca­tions, In­novent redact­ed any­thing that could re­mote­ly give the IPO away, so we don’t know whether it is in­deed seek­ing $300 mil­lion to $500 mil­lion, as Reuters pre­vi­ous­ly re­port­ed. What we do know is that sin­til­imab, to­geth­er with three biosim­i­lars — go­ing af­ter block­busters like Avastin, Rit­ux­an and Hu­mi­ra — will claim most of the raise, from tri­als and reg­is­tra­tion fil­ings to com­mer­cial­iza­tion.

Great Biono For­tune, a coali­tion of In­novent em­ploy­ees, owns the largest chunk of stock at 10.22%, fol­lowed by Lil­ly Asia Ven­tures and F-Prime Cap­i­tal, which have 8.86% each.

Zhengyu Yuan

Mi­cuRx, mean­while, has kept its am­bi­tions tight­ly un­der wraps. CEO Zhengyu Yuan found­ed the com­pa­ny af­ter an R&D stint at Vi­curon (merged with Pfiz­er) with the help of then-col­league Mike Gordeev, now CSO.

The com­pa­ny, which has teams in both San Fran­cis­co and Shang­hai, closed a $15 mil­lion fi­nanc­ing last year to com­plete a Phase III for its lead oral an­tibi­ot­ic, con­te­zol­id (MRX-1). The bulk of the raise will go to­ward MRX-4, a pro­drug for­mu­la­tion of MRX-1 dubbed con­te­zol­id ace­fos­amil. While the drug is on­ly be­gin­ning hu­man stud­ies in Chi­na, it’s ready to roll with a Phase II in the US lat­er in the year. Mi­cuRx will al­so in­vest some cash in­to a pre­clin­i­cal polymicin an­tibi­ot­ic backed by CARB-X.

A BVCF sub­sidiary and Morn­ing­side are the largest share­hold­ers, con­trol­ling 29.12% and 26.50% re­spec­tive­ly.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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CEO Lex Rovner (64x Bio)

A George Church spin­out fight­ing the vi­ral vec­tor bot­tle­neck in cell and gene ther­a­py lands $55M

A synthetic biology company spun out of George Church’s lab is set to tackle the gene therapy manufacturing bottleneck, and it just landed $55 million in a Series A financing round to do so.

64x Bio comes out of the Harvard Department of Genetics. CEO Lex Rovner and her team — which right now, sits around 10 people — are looking to tackle a key hurdle for major companies: manufacturing cell and gene therapies.