Scynex­is' lead drug scores in vagi­nal yeast in­fec­tion tri­al

An­ti­fun­gal drug de­vel­op­er Scynex­is, which burst in­to the zeit­geist as one of the sole US-based com­pa­nies with a Can­di­da au­ris ther­a­py in hu­man tri­als, on Thurs­day dis­closed that the same ex­per­i­men­tal drug had hit the main goal in a late-stage tri­al in pa­tients with vagi­nal yeast in­fec­tions.

The oral drug, ibrex­a­fungerp, was be­ing test­ed in the 376-pa­tient, place­bo-con­trolled VAN­ISH-303 tri­al. Pa­tients en­rolled had ex­pe­ri­enced an acute episode of vul­vo­vagi­nal can­didi­a­sis (VVC), with signs and symp­toms score of four or greater on a scale of ze­ro to 18.

The drug in­duced a ‘clin­i­cal cure’ (de­fined as com­plete res­o­lu­tion — or score of 0 — at the test-of-cure vis­it on day 10), rate of 50.5%, mark­ing a sta­tis­ti­cal­ly sig­nif­i­cant per­for­mance over the place­bo arm (p=0.001), Scynex­is said.

The sec­ondary end­point of my­co­log­i­cal erad­i­ca­tion was al­so met. On the safe­ty side, se­vere ad­verse events were rare, but there were more cas­es re­port­ed in the place­bo group than the ibrex­a­fungerp group, the com­pa­ny added.

An­oth­er twin late-stage study test­ing ibrex­a­fungerp, called VAN­ISH-306, is be­ing con­duct­ed — and da­ta is ex­pect­ed next year. As­sum­ing it is pos­i­tive, re­sults from both tri­als will be used to sub­mit a mar­ket­ing ap­pli­ca­tion in the sec­ond half of 2020. (The drug is al­so be­ing eval­u­at­ing for use in the CAN­DLE study in pa­tients with re­cur­rent VVC — the re­sults are ex­pect­ed in 2021. )

Mar­co Tagli­et­ti Scynex­is

“We be­lieve that ibrex­a­fungerp, as a nov­el, non-azole, oral ther­a­py, can ad­dress large un­met med­ical needs for women with VVC who may not re­spond to flu­cona­zole, the on­ly oral op­tion cur­rent­ly avail­able, which is fungista­t­ic against Can­di­da and al­so has well-doc­u­ment­ed con­cerns around drug-drug in­ter­ac­tions and em­bryo-fe­tal tox­i­c­i­ty for women of child­bear­ing age,” Scynex­is chief Mar­co Tagli­et­ti said in a state­ment on Thurs­day.

Ibrex­a­fungerp, if ap­proved, could end up as the on­ly oral al­ter­na­tive to flu­cona­zole ap­proved for acute VVC in­fec­tions, al­though My­covia is test­ing an­oth­er ther­a­py, VT-1161, for pa­tients with re­cur­rent VVC, Need­ham’s Alan Carr wrote in a note, adding that he ex­pects ibrex­a­fungerp to launch in 2021.

“Our da­ta sug­gest 15% of pts re­turn to their physi­cian be­cause ex­ist­ing treat­ments are in­ad­e­quate…physi­cian in­ter­est in a new drug is high and we es­ti­mate even mod­est (25%) pen­e­tra­tion of the sec­ond-line set­ting gen­er­ates peak sales (for ibrex­a­fungerp) of over $450M.”

It has been decades since a fresh fam­i­ly of an­ti­fun­gals has come on to the mar­ket — at the mo­ment there are three class­es of an­ti­fun­gals in clin­i­cal use, in­clud­ing azoles and echinocan­dins. The most pop­u­lar an­ti­fun­gals in use to­day were in­tro­duced in the 1980s and this class is in­creas­ing­ly los­ing its po­ten­cy, as fun­gal pathogens be­come more re­sis­tant.

Scynex­is’s ibrex­a­fungerp be­longs to a new class of an­ti­fun­gals called glu­can syn­thase in­hibitors, and has shown to be ef­fec­tive against a broad range of fun­gal in­fec­tions, in­clud­ing re­sis­tant strains, Tagli­et­ti told End­points News in a pri­or in­ter­view.

One of the biggest chal­lenges fac­ing the field of an­ti­fun­gal drug de­vel­op­ment is the lack of in­cen­tives, such as those af­ford­ed to com­pa­nies in the an­tibac­te­r­i­al and an­tivi­ral space, he said, adding that when Scynex­is ap­proached BAR­DA for fund­ing, they were told an­ti­fun­gals were not a pri­or­i­ty in Wash­ing­ton.

“I hope this aware­ness will now reach Wash­ing­ton.”

George Yancopoulos (Regeneron)

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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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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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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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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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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Randy Schatzman, Bolt CEO (Bolt Biotherapeutics)

Bolt Bio­ther­a­peu­tics nabs $93.5M to push Provenge in­ven­tor's new idea deep­er in the clin­ic

A cancer-fighting concept from the inventor of the first cancer vaccine is nearing prime time, and its biotech developer has received a significant new infusion of cash to get it there.

Bolt Biotherapeutics announced a $93.5 million Series C round led by Sofinnova Investments and joined by more than 9 others, including Pfizer Ventures and RA Capital Management. That money will go toward pushing the San Francisco biotech’s platform of innate immune-boosting warheads through its first trial on metastatic solid tumors and into several more.

Days af­ter In­ter­cept re­jec­tion, Akero surges on ‘un­prece­dent­ed‘ NASH da­ta

A year and a half after scoring a $70 million Series B and a top Gilead executive as CEO, Akero Therapeutics has announced new data on their NASH drug. And with the field still reeling from a surprise FDA rejection this week, the news was enough to send their stock surging.

Akero had already said in March that its lead drug had beaten placebo in its Phase II trial, reducing liver fat by 14% in the highest dose group compared to 0.3% in placebo, according to MRI scans. But although NASH is an obesity-related condition and results from fatty buildup in the liver, the real immediate question for any therapy is whether it can resolve the fibrosis and inflammation that results from that buildup. Those data require biopsying the patients, a longer and more invasive process that was further complicated by a pandemic.