EMA backs sev­en ther­a­pies, in­clud­ing Mer­ck­'s Ebo­la vac­cine

The first-ever Ebo­la vac­cine is on the precipice of ap­proval af­ter the Eu­ro­pean Med­i­cine’s Agency (EMA) backed the Mer­ck prod­uct in this week’s ros­ter of rec­om­men­da­tions.

The drug­mak­er $MRK be­gan de­vel­op­ing the vac­cine, chris­tened Erve­bo, dur­ing the West African out­break that oc­curred be­tween 2014 and 2016, killing more than 11,000.

The cur­rent out­break in the De­mo­c­ra­t­ic Re­pub­lic of Con­go (DRC) has shown case fa­tal­i­ty rates of ap­prox­i­mate­ly 67%, the agency es­ti­mat­ed. Ear­li­er this year, the WHO de­clared the out­break — which so far has in­fect­ed more than 3,000 peo­ple — a pub­lic health emer­gency of in­ter­na­tion­al con­cern.

Erve­bo, whose con­di­tion­al mar­ket­ing ap­pli­ca­tion has been grant­ed a pos­i­tive opin­ion by the EMA, is a ge­net­i­cal­ly en­gi­neered, at­ten­u­at­ed live vac­cine. It has been test­ed in rough­ly 16,000 in­di­vid­u­als in tri­als con­duct­ed in Africa, Eu­rope, and the Unit­ed States — and da­ta sug­gest the vac­cine is ef­fec­tive against the Zaire Ebo­la virus that cir­cu­lat­ed in West Africa in 2014-2014, as well as the cur­rent out­break in DRC. The vac­cine is al­so un­der FDA re­view.

On Fri­day, the EMA al­so is­sued pos­i­tive rec­om­men­da­tions on Eli Lil­ly’s $LLY di­a­betes treat­ment, Baqsi­mi, which has al­ready se­cured FDA ap­proval; Melin­ta’s an­tibi­ot­ic Quofenix — which is sold as Baxdela in the US — for use in acute bac­te­r­i­al skin and skin struc­ture in­fec­tions; Ab­b­Vie’s $AB­BV oral JAK1 in­hibitor Rin­voq, a po­ten­tial block­buster that was ap­proved by the FDA rough­ly two months ago with a dread­ed black box warn­ing; J&J’s $JNJ Pres­i­dent Trump-en­dorsed (and FDA green­lit) phar­ma­ceu­ti­cal ver­sion of the hal­lu­cino­genic anes­thet­ic ke­t­a­mine — Spra­va­to — for de­pres­sion; and an­oth­er biosim­i­lar for Am­gen’s $AMGN white blood cell boost­er Neu­las­ta.

The Nether­lands-based agency al­so changed its mind to back FDA-ap­proved Am­gen’s se­vere post­menopausal os­teo­poro­sis med­i­cine, Eveni­ty, af­ter ini­tial­ly is­su­ing a neg­a­tive opin­ion last June, cit­ing safe­ty con­cerns.

Two drugs earned un­fa­vor­able de­ci­sions.

D&A Phar­ma’s Hopveus — de­signed to treat al­co­hol de­pen­dence — was de­nied the EMA’s back­ing on grounds that the agency found sev­er­al draw­backs in the de­sign and analy­sis of the stud­ies sub­mit­ted to pro­cure ap­proval. The reg­u­la­tor al­so took is­sue with the mis­use and abuse po­ten­tial of the med­i­cine.

Mean­while, Dai­ichi Sankyo’s Van­fly­ta was spurned by the EMA for use in rare cas­es of acute myeloid leukemia, af­ter the agency un­der­scored that the drug had con­ferred ‘mar­gin­al im­prove­ments’ in over­all sur­vival and that the main tri­al used in the mar­ket­ing ap­pli­ca­tions had ‘im­por­tant lim­i­ta­tions.’ The FDA re­ject­ed the drug in June, al­though Japan­ese reg­u­la­tors have cleared its use.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and fully exited just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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As­traZeneca pub­lish­es Covid-19 vac­cine PhI­II pro­to­cols in lock­step with Mod­er­na and Pfiz­er. How are they dif­fer­ent?

Following in the steps of Moderna and Pfizer, the other two American drugmakers currently in Phase III trials for their Covid-19 vaccines, AstraZeneca posted its own study protocols over the weekend. The move is the latest in a series of rare peeks behind the curtain, as such blueprints are typically shared once such trials are completed.

“Given the unprecedented global impact of the Coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial. As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials. AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company said in a statement.

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Sebastian Nijman (file photo)

Roche looks to ge­net­ic mod­i­fiers for new drug tar­gets, team­ing up with Dutch biotech in $375M deal

Roche is gambling on a new way of discovering drug targets and, ultimately, promising to infuse more than $375 million into a small biotech if all goes well.

A spinout of the Netherlands Cancer Institute and Oxford University, Scenic Biotech set out to pioneer a field that’s gaining some traction among top VCs in the US: to harness the natural protecting powers of genetic modifiers — specific genes that suppress a disease phenotype.