Bil­lion­aire-backed Chi-Med de­clares PhI­II suc­cess for pi­o­neer­ing can­cer drug in Chi­na, seek­ing quick OK

Chris­t­ian Hogg

Hutchi­son Chi­na MediTech has turned an im­por­tant cor­ner, scor­ing pos­i­tive over­all sur­vival and pro­gres­sion-free sur­vival in a Phase III study of fruquin­tinib, its lead on­col­o­gy drug, in colon can­cer. The top-line suc­cess — da­ta will come out this sum­mer at AS­CO — puts Chi-Med on a di­rect path with its part­ners at Eli Lil­ly to an NDA fil­ing with Chi­nese reg­u­la­tors in a few months.

In­ves­ti­ga­tors re­cruit­ed 416 pa­tients with lo­cal­ly ad­vanced or metasta­t­ic colon can­cer who had failed at least two chemother­a­pies for this study. The pa­tients were then divvied be­tween the drug arm and a group treat­ed with place­bo plus best stan­dard of care.

“It’s a re­mark­ably se­lec­tive VEG­FR in­hibitor,” Chi-Med CEO Chris­t­ian Hogg tells me. “We’ve al­ways had con­fi­dence in shut­ting down that tar­get…We have al­ways been su­per con­fi­dent that fruquin­tinib is as clean as you’re go­ing to get.”

Chi-Med’s stock $HCM surged 11% on the news.

Hogg start­ed out as CEO of the com­pa­ny when it launched 17 years ago. He was the first staffer and fruquin­tinib came out of its labs with the back­ing of bil­lion­aire Li Ka-shing. Now Chi-Med, domi­ciled in Hong Kong for tax rea­sons, list­ed in Lon­don and on Nas­daq (with a $1.55 bil­lion mar­ket cap}, has 330 sci­en­tists and staff in Shang­hai. And, if the da­ta hold up, Hogg ex­pects Chi­nese reg­u­la­tors could well come through with an ac­cel­er­at­ed ap­proval.

“There has nev­er been a main­stream on­col­o­gy drug — I’m talk­ing syn­thet­ic med­i­cine, small mol­e­cules or an­ti­bod­ies — but nev­er a main­stream on­col­o­gy drug cre­at­ed in Chi­na by a Chi­nese com­pa­ny tak­en to a pos­i­tive read­out,” he tells me in a phone in­ter­view from his of­fice in Shang­hai.

And he doesn’t plan for it to be the last. While Chi-Med is set­ting up a bridg­ing study in the US for fruquin­tinib, re­searchers are ad­vanc­ing a late-stage pro­gram for non-small cell lung can­cer. Out­side of Chi­na, Hogg ex­pects to fo­cus con­sid­er­ably on com­bi­na­tion stud­ies for his lead drug.

Chi-Med has eight drugs in 30 clin­i­cal stud­ies around the world, says the CEO, with a fol­low-up pro­gram that could pro­vide piv­otal da­ta fair­ly soon for savoli­tinib, part­nered with As­traZeneca. That in­cludes four Phase III stud­ies now un­der­way and 4 more get­ting ready to launch.

Eli Lil­ly has played a key role, ink­ing an $86.5 mil­lion deal in 2013 for fruquin­tinib and pay­ing 70% of the clin­i­cal tri­al costs. Lil­ly has com­mer­cial­iza­tion rights in Chi­na, and has win­dows com­ing up that could al­low it to grab an op­tion on glob­al rights.

Chi­na, says Hogg, has 30% of the world’s can­cer pa­tients and is set to be­come the world’s sec­ond largest phar­ma­ceu­ti­cals mar­ket. And reg­u­la­tors, he says, are keen to ad­vance new drugs in­to the mar­ket.

“We were in the right place at the right time,” says Hogg. “It will on­ly get big­ger and bet­ter.”

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

Jan van de Winkel, Genmab CEO

Seat­tle Ge­net­ics, Gen­mab turn on TV for a high­light reel in cer­vi­cal can­cer — but a ri­val biotech promis­es a bet­ter show

Seattle Genetics $SGEN and their partners at Genmab $GMAB polished up some positive Phase II numbers for their antibody drug conjugate tisotumab vedotin — you can call it TV — for recurrent cervical cancer. And while they mapped out a shortcut to a potential quick approval, the big challenge for this team is being presented by a rival biotech which muscled its way into the spotlight for the same indication a year ago.

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Dan Gold, MEI Pharma CEO

De­vel­op­ment part­ners at MEI, Helsinn dump a high-risk PhI­II AML study af­ter con­clud­ing it would fail sur­vival goal

Four years after Switzerland’s Helsinn put $25 million of cash on the table for an upfront and near-term milestone to take MEI Pharma’s drug pracinostat into a long-running Phase III trial for acute myeloid leukemia, the partners are walking away from a clinical pileup.

The drug — an HDAC inhibitor — failed to pass muster during a futility analysis, as researchers concluded that pracinostat combined with azacitidine wasn’t going to outperform the control group in the pivotal.