Gilead rac­ing to FDA with a new HIV cock­tail boast­ing megablock­buster po­ten­tial

Gilead’s R&D team brought home a clean sweep for its four Phase III stud­ies adding the ex­per­i­men­tal drug bicte­gravir to its back­bone HIV ther­a­py.

Their cock­tail ther­a­py adding bicte­gravir to its main­stays emtric­itabine/teno­fovir alafe­namide (200/25mg) (FTC/TAF) proved non-in­fe­ri­or to do­lute­gravir and oth­er an­ti­retro­vi­ral ther­a­pies in the 4 late-stage stud­ies, set­ting up a new drug ap­pli­ca­tion in a mat­ter of weeks as Gilead races to a near-term mar­ket­ing OK.

That’s a clear win for Gilead, ac­cord­ing to some of the an­a­lysts who have been watch­ing this late-stage pro­gram ad­vance at a rapid pace. Gilead is a dom­i­nant play­er in HIV, and bicte­gravir is seen as a key piece in its megablock­buster mar­ket puz­zle for main­tain­ing its edge against a vi­brant Vi­iV, ma­jor­i­ty-owned by GSK.

Some GSK in­vestors, though, had been jit­tery that Gilead’s late-stage da­ta would re­flect su­pe­ri­or re­sults over do­lute­gravir (Tivicay). So when the da­ta came in as non-in­fe­ri­or, GSK back­ers let out a sigh of re­lief and drove up the phar­ma gi­ant’s shares 2.25% Tues­day morn­ing.

Gilead’s stock $GILD bare­ly edged up on the news, which met min­i­mum ex­pec­ta­tions.

Ge­of­frey Porges

Leerink’s bull­ish Ge­of­frey Porges ex­pects the big biotech, in bad need of some pos­i­tive R&D de­vel­op­ments af­ter a string of set­backs last year, will use a pri­or­i­ty re­view vouch­er to hus­tle this drug to a quick de­ci­sion at the FDA, which he now ex­pects to ar­rive be­fore the end of 2017.

Our fore­cast for bicte­gravir starts lat­er than this im­plied time­line (Q3 2018) but ramps to more than $10bn in glob­al sales based on the prod­uct’s con­ve­nience, safe­ty and tol­er­a­bil­i­ty and ef­fi­ca­cy. This dis­clo­sure ap­pears to be con­sis­tent with that po­ten­tial, and with the $12-13/share in val­ue con­tributed by bicte­gravir in our cur­rent com­pa­ny mod­el and val­u­a­tion.

Added Bar­clay’s Ge­off Meacham:

Bicte­gravir to­geth­er with TAF (a nu­cleotide re­verse tran­scrip­tase in­hibitor) are key dri­vers of Gilead’s strat­e­gy to pro­tect its HIV fran­chise against the head­winds of the up­com­ing TDF patent ex­piry and com­pe­ti­tion from do­lute­gravir, Vi­iV’s new in­te­grase in­hibitor.

Nor­bert Bischof­berg­er

“This in­ves­ti­ga­tion­al sin­gle tablet reg­i­men brings to­geth­er the po­ten­cy of an in­te­grase in­hibitor, bicte­gravir, with the demon­strat­ed ef­fi­ca­cy and safe­ty pro­file of the FTC/TAF back­bone,” said Nor­bert Bischof­berg­er, ex­ec­u­tive vice pres­i­dent, re­search and de­vel­op­ment and chief sci­en­tif­ic of­fi­cer, Gilead Sci­ences. “Based on the re­sults from these Phase 3 stud­ies, the com­bi­na­tion of bicte­gravir and FTC/TAF could rep­re­sent an im­por­tant ad­vance in triple-ther­a­py treat­ment for a broad range of HIV pa­tients, and we look for­ward to sub­mit­ting reg­u­la­to­ry ap­pli­ca­tions in the U.S. and EU this year.”

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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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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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

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.

On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.