Or­biMed-backed Pre­lude Ther­a­peu­tics rais­es $60M to tack­le re­sis­tance to can­cer treat­ments

Back in 2016 Kris Vad­di left a 12-year ca­reer at In­cyte to start his own ef­fort div­ing in­to re­sis­tance mech­a­nisms in can­cer at Pre­lude Ther­a­peu­tics. Three years lat­er, he has a first pro­gram to show for it, as well as a $60 mil­lion Se­ries B and two new re­cruits to the C-suite.

Kris Vad­di Pre­lude

Co-led by Or­biMed and an­oth­er un­named ex­ist­ing in­vestor, the B round will pay for clin­i­cal proof-of-con­cept stud­ies of Pre­lude’s PRMT5 in­hibitor. PRMT5, or pro­tein argi­nine methyl­trans­ferase 5, is be­lieved to play a cen­tral role in sev­er­al path­ways for can­cer cell pro­lif­er­a­tion, cell cy­cle pro­gres­sion and re­sis­tance to apop­to­sis.

An on­go­ing dose es­ca­la­tion tri­al is test­ing PRT543 across sol­id tu­mors, myeloid ma­lig­nan­cies and lym­phomas.

David Mau­ro Pre­lude

David Mau­ro has jumped from Check­mate Phar­ma to help Vad­di with that as well as IND fil­ing of oth­er as­sets next year, in­clud­ing both ad­di­tion­al PRMT5 com­pounds and can­di­dates ad­dress­ing dif­fer­ent tar­gets. The new CMO had worked in on­col­o­gy teams at Bris­tol-My­ers Squibb and Mer­ck be­fore tak­ing up a role at Ad­vax­is.

Ad­di­tion­al­ly, Shire vet Bri­an Piper is join­ing at CFO af­ter a stint at Ae­vi Ge­nom­ic Med­i­cine.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 91,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 91,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 91,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

IN8bio CEO William Ho (IN8bio)

Bring­ing their ge­net­i­cal­ly mod­i­fied gam­ma delta T cells to Nas­daq, IN8bio files for $86M IPO

The biotech IPO parade continues marching forward as 2020 turns toward the fourth quarter.

IN8bio, a New York-based company focused on genetically modified gamma delta T cell therapies, filed to go public Friday seeking an $86 million raise. The company has two clinical-stage candidates being studied in glioblastoma and leukemia, respectively.

By any stretch of the imagination, 2020 has already been a huge year for biotech, and nowhere does it appear more obvious than the vast amounts of companies hitting the public market.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 91,900+ biopharma pros reading Endpoints daily — and it's free.

News brief­ing: Ab­b­Vie and Roche's Ven­clex­ta scores an­oth­er FDA OK; Im­muno­Gen nabs Chi­na deal with $40M cash

AbbVie and Roche’s Venclexta has gotten a new FDA thumbs up.

The pair announced Monday that regulators have approved the drug in combination with azacitidine or low-dose cytarabine for newly-diagnosed acute myeloid leukemia in adults who are 75 or older or those who can’t undergo intensive chemotherapy. This follows the drug’s accelerated approval in 2018 and positive data from two Phase III confirmatory trials.