Medicxi kick­starts a new can­cer drug de­vel­op­er with $19M launch round

Af­ter seed­ing work for a new can­cer ther­a­py in the lab of Uni­ver­si­ty of Toron­to pro­fes­sor Patrick Gun­ning, Medicxi is step­ping up with a $19 mil­lion launch round to kick­start a new biotech charged with tak­ing their ap­proach in­to the clin­ic.

Patrick Gun­ning

Gun­ning has been do­ing con­sid­er­able work on STAT3 and STAT5, an ab­bre­vi­a­tion for the sig­nal trans­duc­er and ac­ti­va­tor of tran­scrip­tion pro­teins that play a role in dri­ving the de­vel­op­ment of can­cer. In his pub­lished work, Gun­ning has linked STAT3, for ex­am­ple, for its role in pro­mot­ing tu­mor growth and drug re­sis­tance in glioblas­toma.

Jan­pix will be work­ing on putting a brake on that process.

Work­ing out of Cam­bridge, MA un­der the guid­ing hand of Medicxi ad­vis­er Ro­man Fleck, the start­up Jan­pix will look to be­come a rec­og­nized play­er with an in­hibitor that can play a role in the tu­mor mi­croen­vi­ron­ment — a hot field in on­col­o­gy — where Gun­ning says STAT3 and STAT5 in­hibitors demon­strate re­al promise in blood, brain and breast can­cers.

Ac­cord­ing to a re­port from the Uni­ver­si­ty of Toron­to, Jan­pix plans to en­ter the clin­ic in 18 to 24 months.

Gio­van­ni Marig­gi, a prin­ci­pal at Medicxi and board mem­ber of Jan­pix, not­ed:

Jan­pix has made great progress in de­vel­op­ing tractable com­pounds that in­hib­it these dif­fi­cult-to-tar­get pro­teins. The role of STATs in mul­ti­ple tu­mour types is sup­port­ed by vast da­ta and the emerg­ing ev­i­dence of their role in tu­mour im­mu­ni­ty adds an ex­tra di­men­sion to the po­ten­tial im­pact these new drugs could have on pa­tients.

With some ma­jor league back­ing from J&J, Glax­o­SmithK­line and more re­cent­ly No­var­tis and Ver­i­ly, Medicxi has been step­ping up its biotech game around the world. It’s known for a lean-and-mean ap­proach to drug de­vel­op­ment, with a tough-mind­ed ap­proach to killing off what­ev­er doesn’t pan out as quick­ly as pos­si­ble.

A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And it’s for can­cer?

Over the past 7 years, Calico has been so much more than your average, run-of-the-mill secretive biotech players. It’s a riddle, wrapped in a mystery, inside an enigma, to repurpose an old Winston Churchill line dating from the time he confronted the Iron Curtain surrounding Stalin’s thoughts.

Launched by industry legend Art Levinson of Genentech fame, with the infinitely deep pockets of Google for support, one of the few big headlines the anti-aging biotech has sparked focused on a major alliance with AbbVie — a giant outfit that conversely likes to show off its drug prospects whenever it can. Together, they’ve been focused on diseases that limit life span — quite an arc of ailments.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Af­ter near­ly a year of de­bate, the Covid-19 vac­cine chal­lenge tri­als are of­fi­cial­ly com­ing

After nearly a year of public advocacy and often rancorous ethical debate, human challenge trials for Covid-19 vaccines are getting off the ground in London.

The UK government’s Covid-19 Vaccine Taskforce and the contract research firm Open Orphan announced today £10 million ($13 million) plan to test experimental Covid-19 vaccines in volunteers whintentionally exposed to the novel coronavirus. The studies, which won’t launch until early 2021, come after 9 months of debate over whether such studies were safe and would actually hasten vaccine development, and they follow a long history of researchers using challenge models to study other respiratory viruses, including flu and the coronaviruses that cause the common cold.

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Derek Chalmers, Cara Ther

Cara lines up a $440M deal for US rights to its late-stage drug for se­vere itch, with $150M cash on the ta­ble

With plans afoot to file an NDA for what could be its first approved drug, Cara Therapeutics is pivoting its focus to commercialization. And Swiss company Vifor Pharma is willing to surrender up to $440 million to market the candidate in the US.

Cara $CARA CEO Derek Chalmers said an NDA submission is coming this quarter for their intravenous drug Korsuva in chronic kidney disease-associated pruritus (CKD-aP), a severe itching condition. The Stamford, CT-based biotech read out positive topline data from a Phase III pivotal study back in April, and announced plans to approach EMA regulators shortly after filing with the FDA.

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Covid-19 roundup: Pars­ing Bourla, a top an­a­lyst sees im­proved chances for Pfiz­er vac­cine; Fau­ci: No sur­prise that Trump was hit by Covid-19

With a medley of adverse events hobbling the late-stage development of vaccines and drugs, Pfizer CEO Albert Bourla’s latest — extended — timeline for the mRNA approach they’re working on with BioNTech is giving some top analysts added confidence that the pharma giant can come up with the regulatory goods next month.

Parsing Bourla’s language in his comments last week, SVB Leerink’s Geoffrey Porges notes that Bourla’s decision to say they “may” be able to nail down the positive efficacy of their vaccine in a matter of days — a big change from his earlier certainty — may also indicate a delay on that to early November.

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CAR-plus: Irish biotech re­cruits Kite alum Chris Now­ers to prep dual-tar­get­ing NK cell ther­a­py for the clin­ic

Soon after Chris Nowers left Cell Medica — freshly rebranded Kuur Therapeutics — in February, the Kite Pharma alum was introduced to another cell therapy player.

The basic idea of building an off-the-shelf allogeneic platform with a CAR-NK approach was familiar to him, riding on the same wave as Takeda, J&J-backed Fate, Nkarta and others. But then there was something else that stood out: a membrane-bound TNF related apoptosis inducing ligand variant, or TRAIL variant, that’s also engineered onto the NK cell for a dual-targeted attack.

New Dewpoint Therapeutics CEO Ameet Nathwani (Sanofi)

A long-haul biotech with some im­pres­sive back­ers and big goals re­cruits a ma­jor league R&D ex­ec to the helm. What’s next?

A few weeks ago Kite and Allogene founder Arie Belldegrun jumped into the expanded syndicate for a Boston-based biotech called Dewpoint Therapeutics — a Polaris-birthed venture that’s styled itself as a drug development pioneer out to craft a major pipeline.

That round — which also added deep-pocket player ARCH to the list of backers — came up with $77 million for the next step in the long journey toward the clinic, a nice add to the A round that launched the company. Now we hear that Dewpoint has recruited Ameet Nathwani to the executive suite as the new CEO, who’s taking the helm from Polaris managing partner Amir Nashat, who brought the company into existence.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Gilead feels the heat as close al­ly Gala­pa­gos re­ports a big set­back on one of their top ex­per­i­men­tal drugs

The bad news keeps stacking up at Galapagos — which quite likely just lost control of a billion-dollar deal — and by extension their close partners at Gilead.

The biotech $GLPG reported after the bell Thursday that GLPG1972, one of their top development programs, flat failed a mid-stage study for osteoarthritis, flunking the primary and all secondary endpoints.

Testing 3 different doses of their drug, which relies on ADAMTS-5 inhibition, investigators concluded that none of them triggered a statistically significant response — as measured by cartilage thickness.

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