Gates-backed Affini­vax grabs $10M up­front and a ma­jor league part­ner for a ground­break­ing at­tempt to beat Pfiz­er’s su­per­star vac­cine

Over the past three years Steve Brug­ger and the crew at Cam­bridge, MA-based Affini­vax have been work­ing steadi­ly on a next-gen plat­form for vac­cine de­vel­op­ment, lay­ing the ground­work — with key sup­port from the Bill & Melin­da Gates Foun­da­tion — for the first clin­i­cal tri­al of what they be­lieve can be a break­through in the vac­cines field.

This morn­ing, Brug­ger is un­veil­ing a col­lab­o­ra­tion with Astel­las, which had ear­li­er signed on to col­lab­o­rate on a very ear­ly-stage vac­cine pro­gram at the biotech. Now Astel­las has come in with $10 mil­lion to front their pact on the lead ef­fort, sign­ing off on an undis­closed set of mile­stones and roy­al­ties while agree­ing to shoul­der the full cost of the clin­i­cal pro­gram that lies ahead.

The deal cen­ters on a suc­ces­sor to Pfiz­er’s megablock­buster pneu­mo­coc­cus vac­cine Pre­vnar 13, which brought in about $6 bil­lion last year.

The biotech was or­ga­nized back in 2014 with tech de­vel­oped at Boston Chil­dren’s and a mis­sion to break clear of the con­ju­ga­tion chem­istry that lies at the heart of Pre­vnar 13.

“We do not use con­ju­ga­tion chem­istry,” Brug­ger tells me in no un­cer­tain terms. The tra­di­tion­al con­ju­ga­tion path­way of link­ing poly­sac­cha­rides to pro­teins in vac­cine de­vel­op­ment is lim­it­ing, he says. Affini­vax’s plat­form tech — the Mul­ti­ple Anti­gen Pre­sen­ta­tion Sys­tem, or MAPS — al­lows for bind­ing mul­ti­ple poly­sac­cha­rides to pro­teins. It cov­ers the use of bi­otin and rhiza­vidin tags to lock mul­ti­ple poly­sac­cha­rides and pro­teins to­geth­er so their vac­cine can cov­er a full spec­trum of 90 strains of pneu­mo­coc­cus in­stead of the 13 out­lined for Pre­vnar 13. And in­stead of us­ing the pro­teins sim­ply as a car­ri­er, Affini­vax’s pro­teins are de­signed to elic­it B and T cell re­spons­es, amp­ing up the ef­fi­ca­cy.

Back in the fall of 2015, Astel­las joined Affini­vax and ClearPath De­vel­op­ment to use the biotech’s tech­nol­o­gy to de­vel­op new vac­cines to treat noso­co­mi­al in­fec­tions. And what­ev­er the Japan­ese com­pa­ny learned along the way ap­par­ent­ly opened the door to the more ad­vanced ef­fort re­lat­ed to the Pre­vnar 13 suc­ces­sor.

“It’s a nat­ur­al fit,” says Brug­ger. “They are try­ing to es­tab­lish a big­ger foot­print in the glob­al vac­cine space.” And that leaves Astel­las open to break­ing free from the tech­nol­o­gy that has dic­tat­ed de­vel­op­ment at the dom­i­nant vac­cine play­ers.

“We’re not dis­clos­ing the time­lines,” the CEO tells me. “What I can say is that we de­clared the fi­nal de­vel­op­ment can­di­date and we’re march­ing to an IND sub­mis­sion.” And that in­cludes com­plet­ing pre­clin­i­cal stud­ies and fi­nal­iz­ing man­u­fac­tur­ing GMP plans.

Affini­vax got to this stage with­out ever rais­ing a ven­ture round. Gates has helped fi­nance their work, along with fund­ing for the noso­co­mi­al ef­fort. And now with the $10 mil­lion up­front and new lead Astel­las pro­gram they have a fund­ing source for the clin­i­cal de­vel­op­ment work and a clear path to ramp­ing up new ef­forts.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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