No­var­tis ties up with the vir­tu­al biotech Parvus to try a new ap­proach on Type 1 di­a­betes

Parvus CEO Jan­ice LeCocq

No­var­tis has turned to a small, vir­tu­al biotech in Cana­da for some fresh in­spi­ra­tion on how it might one day de­feat Type 1 di­a­betes.

The phar­ma gi­ant’s No­var­tis In­sti­tute of Bio­med­ical Re­search now has the ex­clu­sive li­cense to use Parvus Ther­a­peu­tics’ plat­form for di­a­betes, com­ing in with an un­spec­i­fied pack­age of mile­stones, an up­front, re­search sup­port and an eq­ui­ty stake to seal the deal.

That’s a very big deal for Parvus, which has been op­er­at­ing for the last few years on about $20 mil­lion in re­search grants and $5 mil­lion in an­gel in­vest­ments with a few full-time staffers to guide the work be­ing done in Pere San­ta­maria’s lab at the Uni­ver­si­ty of Cal­gary.

San­ta­maria, the CSO and founder at Parvus, was run­ning an imag­ing ex­per­i­ment us­ing nano-sized bits of iron ox­ide when he made a serendip­i­tous dis­cov­ery. As he went on to lat­er write in Na­ture:

(S)ys­temic de­liv­ery of nanopar­ti­cles coat­ed with au­toim­mune­ dis­ease ­rel­e­vant pep­tides bound to ma­jor his­to­com­pat­i­bil­i­ty com­plex class II (pMHCII) mol­e­cules trig­gers the gen­er­a­tion and ex­pan­sion of anti­gen­spe­cif­ic reg­u­la­to­ry CD4+ T cell type 1 (TR1)­like cells in dif­fer­ent mouse mod­els, in­clud­ing mice hu­man­ized with lym­pho­cytes from pa­tients, lead­ing to res­o­lu­tion of es­tab­lished au­toim­mune phe­nom­e­na.

Those re­pro­grammed reg­u­la­to­ry T cells were able to stop the au­toim­mune at­tack – in mice – with­out flat­ten­ing the im­mune sys­tem.

That’s what got No­var­tis’ in­ter­est.

Jay Brad­ner, NI­BR

“There had been in­for­mal con­tacts with No­var­tis fair­ly ear­ly on in the life of the com­pa­ny,” CEO Jan­ice LeCocq told me.

San­ta­maria’s first pa­per on this was pub­lished in 2010 with the sec­ond ap­pear­ing last year, and he’s been work­ing in the lab for years to com­plete the pre­clin­i­cal work need­ed to get an IND ready for the FDA, he says. A joint com­mit­tee with No­var­tis will now over­see that step, with the phar­ma gi­ant tak­ing charge of the clin­i­cal pro­gram.

LeCocq isn’t pro­vid­ing any time­lines on de­vel­op­ment right now.

Like a lot of vir­tu­al biotechs, Parvus de­pends on a net­work of con­sul­tants for much of the heavy lift­ing that needs to get done at the com­pa­ny. And now with No­var­tis’ sup­port the team will al­so get to start adding a de­vel­op­ment group, which can turn to one of the oth­er po­ten­tial au­toim­mune dis­ease tar­gets on the menu for their tai­lored Navacims.

Mul­ti­ple scle­ro­sis is the fur­thest along on that list, but LeCocq says they have made no fi­nal de­ci­sions on what Parvus will turn to next as NI­BR fo­cus­es on Type 1 di­a­betes.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

[via AP Images]

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

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.