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.

Hal Barron and Rick Klausner (GSK, Lyell)

Ex­clu­sive: GSK’s Hal Bar­ron al­lies with Rick Klaus­ner’s $600M cell ther­a­py start­up, look­ing to break new ground blitz­ing sol­id tu­mors

LONDON — Chances are, you’ve heard little or nothing about Rick Klausner’s startup Lyell. But that ends now.

Klausner, the former head of the National Cancer Institute, former executive director for global health at the Gates Foundation, co-founder at Juno and one of the leaders in the booming cell therapy field, has brought together one of the most prominent teams of scientists tackling cell therapy 2.0 — highlighted by a quest to bridge a daunting tech gap that separates some profound advances in blood cancers with solid tumors. And today he’s officially adding Hal Barron and GlaxoSmithKline as a major league collaborator which is pitching in a large portion of the $600 million he’s raised in the past year to make that vision a reality.

“We’ve being staying stealth,” Klausner tells me, then adding with a chuckle: “and going back to stealth after this.”

“Cell therapy has a lot of challenges,” notes Barron, the R&D chief at GSK, ticking off the resistance put up by solid tumors to cell therapies, the vein-to-vein time involved in taking immune cells out of patients, engineering them to attack cancer cells, and getting them back in, and more. “Over the years Rick and I talked about how it would be wonderful to take that on as a mission.”

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First place fin­ish: Eli Lil­ly just moved to fran­chise leader with their sec­ond mi­graine drug OK in 1 year

In a rare twist for Eli Lilly’s historically slow-moving R&D group, the pharma giant has seized bragging rights to a first-in-class new drug approval. And all signs point to an aggressive marketing followup as they look to outclass some major franchise rivals hobbled by internal dissension.

The FDA came through with an OK for lasmiditan on Friday evening, branding it as Reyvow and lining it up — once a substance classification comes through from the DEA — for a major market release. The oral drug binds to 5-HT1F receptors and is designed to stop an acute migraine after it starts. That makes it a complementary therapy to their CGRP drug Emgality, which has a statistically significant impact on preventing attacks.

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Patrick Mahaffy, Getty Images

Court green-lights Clo­vis case af­ter de­tail­ing ev­i­dence the board ‘ig­nored red flags’ on false safe­ty and ef­fi­ca­cy da­ta

Clovis investors have cleared a major hurdle in their long-running case against the board of directors, with a Delaware court making a rare finding that they had a strong enough case against the board to proceed with the action.

In a detailed ruling at the beginning of the month that’s been getting careful scrutiny at firms specializing in biotech and corporate governance, the Delaware Court of Chancery found that the attorneys for the investors had made a careful case that the board — a collection of experts that includes high-profile biotech entrepreneurs, a Harvard professor and well-known investigator as well as Clovis CEO Patrick Mahaffy — repeatedly ignored obvious warnings that Mahaffy’s executive crew was touting inflated, unconfirmed data for their big drug Roci. Serious safety issues were also reportedly overlooked while the company continued a fundraising campaign that brought in more than a half-billion dollars. And that leaves the board open to claims related to their role in the fiasco.

The bottom line:

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Allogene HQ Open House on September 17, 2019 in South San Francisco. (Jeff Rumans, Endpoints News)

The next 10 years: Where is biotech head­ed?

The last 10 years have seen a revolution in drug development. Timelines have shortened, particularly in oncology. Regulators have opened up. Investment has skyrocketed. China became a player. Biotechs have multiplied as gene and cell therapy has exploded — offering major new advances in the way diseases are treated, and sometimes cured.

So where are we headed from here? I journeyed out to San Francisco in September to discuss the answer to that question at Allogene’s open house. If the last 10 years have been an eye-opener, what does the next decade hold in store?

George Scangos / Credit: Cornell University

ARCH, Soft­Bank-backed Vir Biotech­nol­o­gy un­der­whelms with $143 mil­lion IPO

George Scangos went back to Wall Street, and came back 700 million pennies short.

Scangos’ vaunted startup Vir Biotechnology raised $143 million in an IPO they hoped would earn $150 million. Shares were priced at $20, the low-end of the $20-$22 target.

Launched with backing from ARCH Venture’s Robert Nelsen, Masayoshi Son’s SoftBank Vision Fund, and the Bill & Melinda Gates Foundation, the infectious disease startup was one of a new wave of well-resourced biotechs that emerged with deep enough coffers to pursue a full R&D line rather than slowly build their case by picking off a single lead program.

Ex-Ab­b­Vie part­ner Prin­cip­ia posts en­cour­ag­ing PhII re­sults for its BTK-in­hibitor

Months after their breakup with high-profile partner AbbVie, Principia announced positive preliminary results from the second half of a Phase II trial on their lead drug.

The San Francisco biotech announced data from part B of its Phase II open-label trial testing the BTK inhibitor PRN1008 on patients with pemphigus vulgaris, a rare autoimmune disease affecting the skin and mucous membranes. Of 15 enrolled patients, 6 achieved complete responses and 4 remain on the therapy.

Roche vice-chair: Let's re­pair the dam­age that short-term prof­it dri­ve has done to the plan­et

In his latest push for environmental advocacy, the vice chairman of Roche’s board of directors has told a group of business executives that “short-term profit maximization has destroyed the planet, environmentally and socially.”

Andre Hoffman
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In re­ver­sal, NICE backs Rubra­ca af­ter Clo­vis agrees to a price cut

NICE has changed its mind, agreeing to cautiously endorse Clovis Oncology’s Rubraca after the drugmaker agreed to cut its price — about two months after the UK cost-effectiveness agency’s initial rejection.

Rubraca, known chemically as rucaparib, is approved for use in the EU as monotherapy for the maintenance treatment of adult patients with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have relapsed after platinum-based chemotherapy.

Bill Gates backs Gink­go Biowork­s' $350M raise to fu­el the buzzy syn­thet­ic bi­ol­o­gy 'rev­o­lu­tion'

If you want to understand Ginkgo Bioworks, the name should suffice: Bioworks, a spin off “ironworks,” that old industrial linchpin devoted to leveraging scale as a wellspring for vast new industries capable of remaking society. Ginkgo wants to be the ironworks for the revolution it’s heralded with as much fanfare as they can, playing off of one of the buzziest technologies in biotech.

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