An­oth­er IPO fren­zy? Two US biotechs head to Hong Kong for a pub­lic mar­ket de­but

Two US-based biotechs, Stealth Bio­Ther­a­peu­tics and AO­Bio­me, have joined the queue to ap­ply for an IPO in Hong Kong — a first since the city’s ex­change changed its rules late April to at­tract pre-rev­enue drug­mak­ers.

While nei­ther com­pa­nies cur­rent­ly have op­er­a­tions in Chi­na, both ex­pressed a keen in­ter­est in cap­i­tal­iz­ing on the mar­ket there, with Stealth ready to set up R&D shop in Shang­hai. The much-watched de­vel­op­ment — an­a­lysts have long pre­dict­ed a string of US biotech uni­corns go­ing for a gold-rush to main­tain their high val­u­a­tions — came on the heels of two IPO ap­pli­ca­tions by Chi­na-based com­pa­nies, In­novent and Mi­cuRx.

Vin­cent Che­ung

Of the two, Stealth has a more ob­vi­ous con­nec­tion to Chi­na. Just days ago, the Boston start­up wel­comed Vin­cent Che­ung to the board as his Nan Fung Group led a $100 mil­lion megaround to fund its pro­grams in rare mi­to­chon­dr­i­al and oth­er age-re­lat­ed dis­eases. BVCF and Morn­ing­side, two high pro­file Chi­na-fo­cused funds, are al­so among its back­ers.

CEO Ree­nie Mc­Carthy re­marked then that they “par­tic­u­lar­ly wel­come the new in­vestors’ deep ex­pe­ri­ence with­in the Chi­na health­care mar­ket, which we view as an im­por­tant fron­tier both for rare mi­to­chon­dr­i­al dis­eases un­der Chi­na’s re­cent rare dis­ease ini­tia­tive, as well as for dis­eases of ag­ing.”

Ree­nie Mc­Carthy

Stealth ex­pects the IPO raise — the ex­act amount of which they would not dis­close at this stage — to last through 2020. By then, the vi­sion goes, the com­pa­ny would have be­gun to com­mer­cial­ize its lead prod­uct, elamipre­tide, in Barth syn­drome and mi­to­chon­dr­i­al my­opa­thy; moved in­to Phase III with the same drug in age-re­lat­ed mac­u­lar de­gen­er­a­tion; and brought a new com­pound in­to the clin­ic.

A sec­ond drug can­di­date, SBT-20, is be­ing de­vel­oped pre­clin­i­cal­ly for neu­rode­gen­er­a­tion.

Jun Wang

AO­Bio­me’s point-per­son in Chi­na is Jun Wang, the young founder and for­mer CEO of Bei­jing Ge­nomics In­sti­tute. Through iCar­bonX, his new ven­ture har­ness­ing da­ta for per­son­al health mon­i­tor­ing, he in­fused $30 mil­lion in­to the mi­cro­bio­me-fo­cused start­up. He was re­cent­ly named chair­man of the board.

The star and name­sake of AO­Bio­me’s pipeline is the am­mo­nia ox­i­diz­ing bac­te­ria, which is be­ing ap­plied to six in­di­ca­tions all in mid or late stage Un­like most biotechs work­ing on the mi­cro­bio­me, which tend to fo­cus on the gut, AO­Bio­me is start­ing out with der­ma­to­log­i­cal ail­ments, with plans to be­gin a Phase III tri­al in ac­ne in 2019 and Phase II eczema and rosacea stud­ies to fol­low.

That fo­cus was in­formed by the com­pa­ny’s ear­ly ex­pe­ri­ence, as it be­gan com­mer­cial­iz­ing sev­er­al AOB-based cos­met­ic prod­ucts in 2014, which it has sub­se­quent­ly sold.

Todd Krueger

By own­ing AI En­ter­prise II (36.32%) and Bio­me Hold­ing (11.64%), Wang is the con­trol­ling share­hold­er of the com­pa­ny, which is led by pres­i­dent and CEO Todd Krueger.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive PhI­II for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma. 

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

BeiGene and Mus­tang nail down spe­cial FDA sta­tus for top drugs; Roche bags added cov­er­age for Hem­li­bra

→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.

→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.