Affini­vax, Astel­las be­gin clin­i­cal quest to beat Pfiz­er's Go­liath with a new kind of pneu­mo­coc­cal vac­cine

Days af­ter the FDA blessed Mer­ck’s ef­fort to chal­lenge Pfiz­er’s mega-block­buster Pre­vnar 13 with a break­through des­ig­na­tion, Affini­vax is mak­ing the leap in­to the clin­ic with its own take on the pneu­mo­coc­cal vac­cine.

It’s no small feat for a biotech play­er that got start­ed with $4 mil­lion in seed fund­ing from the Gates Foun­da­tion in 2014 and has been run­ning pure­ly on grants as well as part­ner­ship dol­lars from Astel­las — which is shoul­der­ing much of clin­i­cal work in the Phase I/II study.

“We’ve done in less than five years at Affini­vax what the big vac­cine play­ers like Mer­ck and Pfiz­er and Sanofi and GSK have been try­ing to do for over 20 years,” CEO Steve Brug­ger tells me. “We have ac­tu­al­ly de­vel­oped a true next gen­er­a­tion tech­nol­o­gy for vac­cines.”

Rick Mal­ley

Hav­ing spent the past few years in­dus­tri­al­iz­ing the tech­nol­o­gy that came out of Rick Mal­ley’s lab at Boston Chil­dren’s Hos­pi­tal, Brug­ger and his crew of 68 are con­fi­dent that its prod­uct, ASP3772, can pro­vide “broad­er pro­tec­tion than any vac­cine in the mar­ket or any vac­cine that we’re aware of in clin­i­cal test­ing to­day.”

The spe­cif­ic num­ber of serotypes it will cov­er, though, will be kept se­cret for a lit­tle longer.

Dubbed the mul­ti­ple anti­gen pre­sent­ing sys­tem, or MAPS, Affini­vax’s tech plat­form fore­goes tra­di­tion­al con­ju­gate chem­istry al­to­geth­er in fa­vor of a bi­otin-rhiza­vidin bond, thus re­duc­ing cross-link­ing be­tween pro­teins and poly­sac­cha­rides. More im­por­tant­ly, the pro­teins — mere car­ri­ers in tra­di­tion­al vac­cines — are de­signed to elic­it B and T cell re­spons­es along­side the poly­sac­cha­rides they are bound to.

It’s an ap­proach that’s sup­posed to sep­a­rate Affini­vax from both the big guys and small­er chal­lengers like SutroVax, which has $170 mil­lion to push its own first-in-class con­ju­gate vac­cine to the clin­ic.

That will all be put to the test in the 618-pa­tient tri­al, as ASP3772 gets ad­min­is­tered to both adults and el­der­ly, and com­pared against Pre­vnar 13 as well as Pneu­movax.

Mean­while, the launch of the tri­al has trig­gered a mile­stone pay­ment from Astel­las — $10 mil­lion in cash that will fund Affini­vax’s oth­er bac­te­r­i­al vac­cine projects and some ear­ly, ex­plorato­ry work on im­muno-on­col­o­gy, where the abil­i­ty to present mul­ti­ple im­mune-re­sponse in­duc­ing anti­gens seems to hold promise.

“We stayed home for the first four years and fo­cused on let’s get the lead flag­ship pro­gram in­to the clin­ic, let’s val­i­date the tech­nol­o­gy clin­i­cal­ly, which we’re on track to do,” Brug­ger says. “Now as we look at be­gin­ning of 2019, where else can we ap­ply this tech­nol­o­gy?”

Im­age: Steve Brug­ger.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at with any issues.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.

FDA asks why No­var­tis took two months to launch for­mal in­ter­nal probe, af­ter AveX­is flagged da­ta ma­nip­u­la­tion

And the plot thickens. Novartis $NVS officials are reportedly now scrambling to explain to the FDA why it took them two months to open an internal investigation into data discrepancies for their $2.1 million gene-therapy for spinal muscular dystrophy — the world’s most expensive drug.

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Build­ing on suc­cess­ful PD-1 pact, Eli Lil­ly li­cens­es di­a­betes drug to Chi­nese part­ners at In­novent

Eli Lilly is expanding its partnership with China’s Innovent in a deal involving a diabetes drug sitting in its Phase I reserves.

The two companies had jointly developed one of China’s first homegrown PD-1 agents, scoring an approval for Tyvyt (sintilimab) late last year for relapsed/refractory classical Hodgkin’s lymphoma. This time around, Lilly is out-licensing a piece of its diabetes pipeline, a leading franchise that has historically produced the top-selling Trulicity and Humalog.

Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.