IPOs abound in the time of coro­n­avirus, as For­ma Ther­a­peu­tics pen­cils in $150M Nas­daq de­but

The IPO en­gine is thriv­ing, nev­er mind the ram­page of the coro­n­avirus cri­sis on R&D time­lines.

On Fri­day, along with syn­thet­ic lethal­i­ty-fo­cused biotech Re­pare Ther­a­peu­tics, an­oth­er Bris­tol My­ers part­ner For­ma Ther­a­peu­tics al­so un­veiled its plans to vault on to the Nas­daq — pen­cil­ing in a tar­get of $150 mil­lion.

Frank Lee

The Wa­ter­town, Mass­a­chu­setts-based com­pa­ny — which poached se­nior Genen­tech ex­ec­u­tive Frank Lee to take over the reins last year af­ter more than a decade un­der founder Steve Tre­gay — raised a plump $100 mil­lion late last year, while shep­herd­ing its sick­le cell dis­ease (SCD) drug through an ear­ly-stage tri­al.

Last No­vem­ber, the FDA ush­ered in the ap­proval of two SCD ther­a­pies, in­ject­ing some op­ti­mism in­to an oth­er­wise bar­ren treat­ment land­scape for pa­tients with the blood dis­or­der that is char­ac­ter­ized by atyp­i­cal he­mo­glo­bin mol­e­cules, which can dis­tort red blood cells in­to a sick­le, or cres­cent, shape. No­var­tis’ ther­a­py, Adakveo, is de­signed to pre­vent pe­ri­od­ic episodes of sear­ing pain called va­so-oc­clu­sive crises (VOCs) that de­prive the de­prive the body of oxy­gen-rich blood, while Glob­al Blood Ther­a­peu­tics’ vox­elo­tor is de­signed to work by in­creas­ing he­mo­glo­bin’s affin­i­ty for oxy­gen.

In­stead of ad­dress­ing symp­toms of SCD, For­ma’s lead ther­a­py, FT-4202, is de­signed to change the course of the dis­ease as an ac­ti­va­tor of the en­zyme pyru­vate ki­nase-R (PKR) to im­prove red blood cell me­tab­o­lism, func­tion and sur­vival, po­ten­tial­ly re­sult­ing in both in­creased he­mo­glo­bin lev­els and few­er VOCs. For­ma is in a crowd­ed field of ther­a­pies in de­vel­op­ment, with oth­er drug­mak­ers in­clud­ing blue­bird bio, Imara, and part­ners CRISPR Ther­a­peu­tics and Ver­tex, al­so work­ing on their own drugs.

Mean­while, For­ma al­so plans to eval­u­ate the use of FT-4202 in be­ta tha­lassemia. The com­pa­ny al­so has a brim­ming pipeline, in­clud­ing an AML drug and a NASH ther­a­py in mid-stage de­vel­op­ment, as well as ear­li­er-stage com­pounds for NASH, NHL (part­nered with Bris­tol My­ers Squibb)  and sol­id tu­mors (in col­lab­o­ra­tion with Boehringer In­gel­heim).

There has been a flur­ry of bio­phar­ma IPO’s in re­cent­ly — Gen­er­a­tion Bio, Avid­i­ty and Vax­cyte set their sights on a com­bined $325 mil­lion and the week be­fore ADC Ther­a­peu­tics raked in $233 mil­lion in an up­sized of­fer­ing — de­spite the gen­er­al pan­de­mo­ni­um on Wall Street due to Covid-19. But the life sci­ences sec­tor has emerged large­ly im­mune from the rout.

Swe­den’s Cal­lid­i­tas, which last week said it was eye­ing a $75 mil­lion raise (a mod­est sum com­pared to some of the splashier pub­lic de­buts seen in re­cent weeks), on Mon­day in­di­cat­ed it was com­menc­ing an in­vestor road­show. The com­pa­ny, which is de­vel­op­ing a ther­a­py for an or­phan kid­ney dis­ease, al­ready has a Swedish list­ing.

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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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.

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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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.

James Sabry (Roche)

Roche's James Sabry inks his sec­ond AI deal in back-to-back pacts — this time part­ner­ing Genen­tech with Stan­ford spin­out Gen­e­sis Ther­a­peu­tics

Less than a week after Roche joined forces with Dyno Therapeutics to develop gene therapies using artificial intelligence, its giant subsidiary Genentech is hopping on the AI bandwagon with a different player.

Genentech has inked a deal with Stanford spinout Genesis Therapeutics to harness its AI power for drug development and discovery. Genesis is getting an upfront payment and milestones, but the companies are keeping the details under wraps for now. The Burlingame, CA-based biotech also stands to earn future royalties on any approved Genentech drugs that come from the deal.