As uter­ine race with Ab­b­Vie heats up, My­ovant eyes FDA ap­proval with tri­al re­sults from prostate can­cer

My­ovant has long had a se­cret weapon in its uter­ine ri­val­ry with Ab­b­Vie: Men.

Lynn Seely My­ovant

While the small Swiss biotech has jock­eyed with the Illi­nois-based gi­ant for a foothold in the en­dometrio­sis and uter­ine fi­broid ther­a­py mar­ket, the com­pa­ny has been de­vel­op­ing the same lead com­pound, re­l­u­golix, for use in one of the most com­mon can­cers for the uterus-less: prostate can­cer. To­day, My­ovant is out with pos­i­tive topline re­sults from its big Phase III tri­al on the go­nadotropin-re­leas­ing hor­mone (GnRH) an­tag­o­nist. They say they’ve reached every pri­ma­ry and sec­ondary end­point with p val­ues less than .0001.

“It works quick­ly,” CEO Lynn Seely told End­points News. “It’s an oral pill and it sup­press­es hor­mone pro­duc­tion and when you stop it, your hor­mones come back and you have the po­ten­tial for im­proved qual­i­ty of life.”

My­ovant’s stock is up 95% pre­mar­ket, from $6.06 to $11.80 per share

The tri­al test­ed a re­l­u­golix arm along­side a stan­dard-of-care, le­upro­lide, arm in their abil­i­ty to sup­press testos­terone in pa­tients with ad­vanced prostate can­cer. Testos­terone fu­els prostate can­cer’s growth. The pri­ma­ry end­point was the per­cent­age of men who reached and main­tained med­ical cas­tra­tion, or less than 50 nanograms of testos­terone per deciliter, over 48 weeks.

Re­l­u­golix achieved that in 96.7% of pa­tients — safe­ly clear­ing the FDA’s stat­ed bench­mark for ap­proval of 90%, Seely said. For Japan­ese and Eu­ro­pean ap­proval, they need­ed to show non-in­fe­ri­or­i­ty and did so, with their le­upro­lide arm show­ing on­ly an 88% re­sponse rate.

The re­sults set up an FDA ap­pli­ca­tion in Q2 of 2020 and Eu­ro­pean and Japan­ese ap­pli­ca­tions short­ly there­after, adding to the com­pa­ny’s im­mi­nent US ap­pli­ca­tion for uter­ine fi­broid ther­a­py.

The un­der­ly­ing mech­a­nism be­hind the two ther­a­pies is es­sen­tial­ly in­versed. Le­upro­lide is a GnRH ag­o­nist and de­sen­si­tizes the re­cep­tor by hit­ting it re­peat­ed­ly. Re­l­u­golix blocks it di­rect­ly.

My­ovant’s pitch cen­ters around the speed at which the drug worked, its pill form — rather than le­upro­lide, which is in­ject­ed every three months — and the ta­per­ing of some side ef­fects, which can be lengthy when it comes to testos­terone sup­pres­sion, in­clud­ing hot flash­es, fa­tigue, loss of mus­cle mass, sex­u­al dys­func­tion and de­pres­sion. Doc­tors have some­times giv­en “drug hol­i­days” to man­age the clin­i­cal ben­e­fit against the costs.

“Low­er­ing the testos­terone is bet­ter for treat­ing prostate can­cer,” Seely said. “But it’s not great for the man.”

The ad­verse event ra­tio for both drugs was around 93%, but Seely not­ed a low­ered rate of ma­jor car­dio­vas­cu­lar events in the re­l­u­golix group, 2.9% com­pared to 6.2%. The biotech al­so said hor­mone lev­els re­turned to nor­mal 90 days af­ter treat­ment in the re­l­u­golix group while some­times re­main­ing re­duced at that point or longer for le­upro­lide pa­tients — al­though they did not an­nounce spe­cif­ic num­bers.

So why isn’t Ab­b­Vie, My­ovant’s uter­ine ri­val, pur­su­ing a prostate treat­ment? Seely’s best guess is that it’s be­cause Ab­b­Vie’s GnRH an­tag­o­nist’s half-life is much short­er than My­ovant’s. Ab­b­Vie re­quires high­er dos­es in their uter­ine treat­ments than My­ovant gives — which would mean even high­er dos­es in the prostate ther­a­pies, she said.

The ques­tion, though, is if le­upro­lide is still large­ly ef­fec­tive and the side ef­fects most­ly the same, will doc­tors pre­scribe a new pill in­stead?

“I think the biggest con­cern is that le­upro­lide … has been in the field for decades,” she said. “Some peo­ple ques­tion if on­col­o­gists and urol­o­gists will change their prac­tice.”

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.