Roche posts pos­i­tive PhII re­sults for bis­pe­cif­ic an­ti­body eye drug, join­ing No­var­tis in ri­val­ry with Eylea

As No­var­tis bat­tles Re­gen­eron for a piece of its block­buster Eylea fran­chise, Roche/Genen­tech $RHH­BY is com­ing up qui­et­ly with a next-gen bis­pe­cif­ic an­ti­body which post­ed en­cour­ag­ing Phase II re­sults late Sun­day.

RG7716 is a dual an­ti-VEGF/an­ti-an­giopoi­etin-2 an­ti­body that tar­gets reti­nal eye dis­eases. The BOULE­VARD study com­pared two dos­es of it to Roche’s own VEGF-tar­get­ing ranibizum­ab (Lu­cen­tis) and found a sig­nif­i­cant im­prove­ment in ad­just­ed best cor­rect­ed vi­su­al acu­ity (BC­VA), there­by meet­ing its pri­ma­ry end­point. The ad­just­ed mean im­prove­ment are 13.9 chart let­ters from base­line for pa­tients giv­en 6 mg RG7716; 11.7 let­ters for those giv­en 1.5 mg RG7716; and 10.3 among those dosed with 0.3 mg ranibizum­ab, re­spec­tive­ly. The p-val­ue came in at 0.03.

While the tri­al was fo­cused on di­a­bet­ic mac­u­lar ede­ma (no small in­di­ca­tion on its own), it has larg­er im­pli­ca­tions for eye dis­eases, a mar­ket cur­rent­ly dom­i­nat­ed by Eylea. DME, one of the com­pli­ca­tions of di­a­bet­ic retinopa­thy, af­fects rough­ly 750,000 peo­ple in the US.

Leerink’s Ge­of­frey Porges, though, came out swing­ing in de­fense of Re­gen­eron this morn­ing, tack­ling its two big ri­vals at No­var­tis and now Roche.

As we have al­lud­ed to in the past, No­var­tis’ (NVS, MP) brolu­cizum­ab (RTH258) piv­otal tri­al is con­fus­ing, and the da­ta in­com­plete, and we have se­ri­ous doubts about the drug’s ap­prov­abil­i­ty. Sec­ond­ly, the ad­di­tion of Ang2 in­hi­bi­tion to VEGF in­hi­bi­tion, while the­o­ret­i­cal­ly in­trigu­ing, has so far been of mod­est ben­e­fit de­spite Roche’s pos­tur­ing.

Oth­ers aren’t so sure.

In ad­di­tion to cheer­ing on brolu­cizum­ab, or RTH258 as it’s usu­al­ly called, No­var­tis has al­so re­cent­ly backed Swiss biotech Oculis, which is mak­ing an eye­drop al­ter­na­tive for in­jectable eye drugs.

San­dra Horn­ing

“For the first time in di­a­bet­ic mac­u­lar ede­ma, a clin­i­cal­ly mean­ing­ful and sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in vi­su­al acu­ity com­pared to an­ti-VEGF alone has been demon­strat­ed by si­mul­ta­ne­ous­ly neu­tral­iz­ing both An­giopoi­etin-2 and VEGF-A with a bis­pe­cif­ic an­ti­body,” said Roche CMO San­dra Horn­ing in a state­ment. “These Phase II re­sults show the po­ten­tial of RG7716 for peo­ple liv­ing with di­a­bet­ic mac­u­lar ede­ma, a lead­ing cause of vi­sion loss in work­ing-age adults.”

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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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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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.

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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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.

Douglas Love, Annexon CEO (Annexon)

IPO bound? A Bay Area biotech grabs a mega-round on the road to a piv­otal neu­rode­gen­er­a­tion pro­gram

South San Francisco-based Annexon has added $100 million to its cash reserves, along with a new roster of marquee investors backing their play on the classical complement pathway involved in neurodegeneration. And that may well fit the profile for an IPO — though right now everything seems to be working on that score.

Eighteen months after Bain and their syndicate partners put up $75 million to fuel clinical work, Annexon is back at the trough. And this time they’re adding Redmile Group for the lead role, with supporting investments from these new arrivals: BlackRock, Deerfield Management Company, Eventide Asset Management, Farallon Capital Management, Janus Henderson Investors and Logos Capital.

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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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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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