Phase­Bio rais­es $34M to test or­phan dis­ease strat­e­gy — fo­cus­ing first on As­traZeneca drug

Af­ter spend­ing the past three years repo­si­tion­ing it­self as an or­phan dis­ease-fo­cused biotech, Phase­Bio is ready to roll with a fresh $34 mil­lion raise.

The Malvern, PA-based com­pa­ny owes its name to its elastin-like polypep­tides plat­form tech­nol­o­gy, which cre­ates ther­a­peu­tic fu­sion pro­teins that un­der­go a ful­ly re­versible phase tran­si­tion — there­by sig­nif­i­cant­ly ex­tend­ing their half lives.

Jonathan Mow

Phase­Bio once saw an ap­pli­ca­tion for that tech in di­a­betes as well as car­dio, at­tract­ing phar­ma gi­ants As­traZeneca and John­son & John­son’s ven­ture arm, as well as VC play­ers New En­ter­prise As­so­ci­ates, Hat­teras Ven­ture Part­ners and Fletch­er Spaght Ven­tures for its 2015 Se­ries C, in which it got $40 mil­lion to, among oth­er things, ad­vance a once-week­ly, long-act­ing basal in­sulin.

But that drug, like its long-act­ing GLP-1 that de­liv­ered seem­ing­ly ap­prov­able but not great Phase IIb re­sults, has now been set aside.

“For type 2 di­a­betes, if you’re not gonna be first in class or best in class, it’s chal­leng­ing, es­pe­cial­ly as a small biotech com­pa­ny de­vel­op­ing as­sets for that space,” CEO Jonathan Mow tells me.

In­stead, Mow’s team of 20 has now found a new lead drug in PB2452, a re­ver­sal agent for the blood thin­ner Bril­in­ta (tica­grelor) for use in acute sit­u­a­tions where pa­tients are ex­pe­ri­enc­ing ac­tive bleed­ing or re­quire ur­gent surgery.

“It’s very anal­o­gous to what Por­to­la did with An­dexxa, al­though An­dexxa is in a dif­fer­ent class of agents — it’s re­vers­ing fac­tor Xa, and we are re­vers­ing tica­grelor which is P2Y12 an­tag­o­nist,” Mow says.

John Sharp

While Phase­Bio on­ly li­censed the drug from As­traZeneca — which mar­kets Bril­in­ta — late last year and is still in the mid­dle of a proof-of-con­cept study, Mow sees his team wrap­ping up a Phase II and ini­ti­ate a Phase III around the end of 2019.

“PB2452, can be de­vel­oped in a much short­er time pe­ri­od, and it will pay for us to de­vel­op PB1046,” their in-house as­set for pul­monary ar­te­r­i­al hy­per­ten­sion that’s been in the pipeline for a while, he says. “So even though it’s on­ly in Phase I, we will get to the lat­er stages of de­vel­op­ment much more quick­ly than we will with PB1046.”

That com­bi­na­tion of a short de­vel­op­ment time­line and a plat­form tech is what drew their new in­vestors — Cor­morant As­set Man­age­ment, Rock Springs Cap­i­tal and Moun­tain Group Part­ners — to par­tic­i­pate in the round, CFO John Sharp says. Old sup­port­ers al­so came back for more.

The fund­ing will al­so pay for a Phase II with PB1046 in PAH. It’s not an easy mar­ket to break in­to, but Mow says their ana­log va­soac­tive in­testi­nal pep­tide — with its 60 hour half life and nov­el mech­a­nism of ac­tion — will make room for it­self along­side the likes of Unit­ed Ther­a­peu­tics, Acte­lion and Gilead.

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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[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.

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

Genen­tech sub­mits a plan to near­ly dou­ble 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.

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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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.

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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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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.