As­traZeneca, Mer­ck her­ald PhI­II prostate can­cer win for Lyn­parza — over­tak­ing Clo­vis, J&J in PARP race

The case for ex­pand­ing Lyn­parza’s use just got stronger as As­traZeneca and Mer­ck claim a late-stage suc­cess in ex­tend­ing the time prostate can­cer pa­tients live with­out pro­gress­ing com­pared to stan­dard of care.

Ri­vals at Clo­vis pro­vid­ed the first re­sound­ing ev­i­dence that PARP in­hibitors could be pow­er­ful against metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer last Oc­to­ber, when it un­veiled at ES­MO that Rubra­ca in­duced a 44% con­firmed ob­jec­tive re­sponse rate among 25 sec­ond-line pa­tients with a BR­CA al­ter­ation. Days pri­or to the pre­sen­ta­tion, the Phase II da­ta had earned the biotech a “break­through” des­ig­na­tion at the FDA.

José Basel­ga As­traZeneca

As­traZeneca and Mer­ck took it a step fur­ther with their Phase III re­sults, tout­ing “a sta­tis­ti­cal­ly-sig­nif­i­cant and clin­i­cal­ly-mean­ing­ful im­prove­ment in the pri­ma­ry end­point of ra­di­ograph­ic pro­gres­sion-free sur­vival (rPFS).” No num­bers were avail­able with the top-line an­nounce­ment, but the phar­ma part­ners em­pha­size it’s a first in the PARP class for this in­di­ca­tion, where the need is high.

“For men with metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer the dis­ease re­mains dead­ly, es­pe­cial­ly in those who have failed on a new hor­mon­al an­ti­cancer treat­ment,” José Basel­ga, As­traZeneca’s head of on­col­o­gy R&D.

The 340 pa­tients re­cruit­ed in the PRO­found study are all con­firmed, via ge­nom­ic test­ing to har­bor mu­ta­tions in one of 15 ho­mol­o­gous re­com­bi­na­tion re­pair genes. They have al­so all pro­gressed fol­low­ing pri­or treat­ment with hor­mon­al ther­a­py.

In the open-la­bel tri­al, pa­tients were ei­ther giv­en Lyn­parza, en­za­lu­tamide or abi­raterone ac­etate.

In their analy­sis in­ves­ti­ga­tors ze­roed in on BR­CA1/2 — a key qual­i­fi­er for pre­vi­ous wins in ovar­i­an, breast and pan­cre­at­ic can­cers — and ATM gene mu­ta­tions. The ef­fects of Lyn­parza, which blocks a self-re­pair mech­a­nism adopt­ed by can­cer cells, on the oth­er pa­tient sub­groups re­main un­clear.

As­traZeneca re­port­ed Lyn­parza sales of $520 mil­lion in H1 2019, far ahead of the $66.1 mil­lion Clo­vis’ Rubra­ca man­aged to gar­ner in the same pe­ri­od. Ze­ju­la sales were around $120 mil­lion, and J&J (which li­censed rights to the prostate can­cer in­di­ca­tion from Tesaro back in 2016) has demon­strat­ed a 40% ORR in a Phase II study for the Glax­o­SmithK­line drug. Clo­vis plans to sub­mit an NDA in the fourth quar­ter of this year.

Mean­while, Mer­ck has kicked off an um­brel­la study pair­ing its PD-1 star Keytru­da with a num­ber of oth­er agents, in­clud­ing Lyn­parza, for prostate can­cer, with an am­bi­tion to move to the front­line.

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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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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Vas Narasimhan, Novartis CEO (Patrick Straub/​EPA-EFE/​Shutterstock)

No­var­tis pays $678M for kick­back scheme as Vas Narasimhan tries to dis­tance phar­ma gi­ant from shady be­hav­ior

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)

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.

No­var­tis los­es biosim­i­lar ap­peal as court up­holds a 31-year mo­nop­oly by Am­gen's En­brel

A new court ruling has strengthened Amgen’s grip on the IP estate around Enbrel, keeping biosimilars of the autoimmune and inflammatory drug at bay until 2029.

Novartis, the patent challenger, isn’t throwing in the towel yet. In a statement noting the failed appeal, its generics division Sandoz noted its reviewing options, “including potential appeal to US Supreme Court.”

It’s been almost four years since the FDA approved Erelzi, Sandoz’s copycat version of Enbrel. While sales of the Pfizer-partnered drug in the US — the market Amgen is in charge of — have dipped slightly during that time, it remains a solid megablockbuster with 2019 revenue slightly above $5 billion.

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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