Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Bris­tol My­er­s' next-gen im­munol­o­gy med busts Am­gen's Ote­zla in head-to-head study. Is a show­down com­ing?

In an im­munol­o­gy mar­ket packed with block­buster bi­o­log­ics, Bris­tol My­ers Squibb hopes that its oral drug for milder cas­es could carve out a lu­cra­tive foothold. Now, with its eyes set on bust­ing Am­gen’s Ote­zla, the drug­mak­er is rolling out full da­ta from a pair of late-stage stud­ies that bode well for its can­di­date.

Bris­tol My­ers’ TYK2 in­hibitor deu­cravac­i­tinib sig­nif­i­cant­ly cut pso­ri­a­sis pa­tients’ dis­ease ac­tiv­i­ty and spurred clear­er skin at four months than pa­tients dosed with Am­gen’s Ote­zla or place­bo, ac­cord­ing to da­ta from two Phase III stud­ies pre­sent­ed Fri­day at the vir­tu­al Amer­i­can Acad­e­my of Der­ma­tol­ogy meet­ing.

In terms of PASI 75, a mea­sure of dis­ease sever­i­ty, 58.7% and 53.6% of pa­tients on deu­cravac­i­tinib achieved PASI 75 re­sponse re­spec­tive­ly, in the PO­E­T­YK-PSO-1 and PO­E­T­YK-PSO-2 stud­ies. Mean­while, just 12.7% and 9.4% of place­bo pa­tients and 35.1% and 40.2% of pa­tients on Ote­zla achieved the same.

Even more promis­ing for Bris­tol My­ers, deu­cravac­i­tinib main­tained its edge over Ote­zla be­tween 24 and 52 weeks of treat­ment. At the six-month check-in, 69.0% and 59.3% of pa­tients on deu­cravac­i­tinib hit PASI 75 ver­sus 38.1% and 37.8% on Ote­zla. Of those deu­cravac­i­tinib pa­tients who hit the PASI 75 mark at six months, 82.5% and 81.4% main­tained that re­sponse at the one-year check in.

Deu­cravac­i­tinib showed sim­i­lar­ly high­er rates of skin clear­ance than place­bo and Ote­zla with a slight­ly high­er rate of se­vere side ef­fects than Am­gen’s drug.

Bris­tol My­ers is call­ing the re­sults sig­nif­i­cant even though the da­ta didn’t come with p-val­ues. Ei­ther way, it’s a strong show­ing from its drug, a TYK2 in­hibitor Bris­tol My­ers hopes will ush­er in a next gen­er­a­tion of im­munol­o­gy meds.

The drug­mak­er un­corked top-line da­ta from these stud­ies back in Feb­ru­ary, high­light­ing deu­cravac­i­tinib’s im­por­tant role in dri­ving the com­pa­ny’s pipeline suc­cess. At JP Mor­gan in Jan­u­ary, Bris­tol My­ers tout­ed the drug as one of four ma­jor block­buster pro­grams in the pipeline with the po­ten­tial to earn more than $4 bil­lion a year. The oth­er three were mava­camten, ac­quired in the MyoKar­dia buy­out, along with the ane­mia drug Re­blozyl and the can­cer cell ther­a­py fran­chise.

Un­like the bi­o­log­ics that have come to dom­i­nate the mar­ket, Bris­tol My­ers is aim­ing deu­cravac­i­tinib at milder pa­tients who pre­fer a more con­ve­nient oral dose. Re­searchers hope the TYK2 path­way will of­fer a safer al­ter­na­tive than the JAK class, which has been dogged by safe­ty flags since its in­cep­tion. The case in point there is Pfiz­er’s Xel­janz, which has failed to cap­i­tal­ize on its ear­ly promise with a black box warn­ing for throm­bo­sis and se­ri­ous in­fec­tions, among oth­er things.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Al Sandrock, Biogen R&D chief (Biogen via YouTube)

UP­DAT­ED: Bio­gen push­es in a fresh stack of chips and starts prep­ping a glob­al R&D game plan af­ter watch­ing the cards turn on ear­ly throm­bolyt­ic da­ta

After patiently steering through a decade-long journey for its early-stage clinical work, a small Tokyo biotech has clinched a deal to out-license its lead thrombolytic agent to US heavyweight Biogen — which sees a potentially game-changing impact on the clot-busting field after taking a careful look at some upbeat Phase IIa data.

Three years after Biogen anted up $4 million to gain an option on the drug from TMS, the big US biotech is making a small bet to beef up its stroke portfolio. The BD team inked a deal to go ahead and grab rights to the drug for $18 million, with another $335 million in milestone cash on the table for a successful outcome.

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Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

Distribution of Moderna's Covid-19 Vaccine (Photo by Paul Sancya - Pool/Getty Images)

Opin­ion: Ado­les­cents can wait. The US needs to start do­nat­ing Covid-19 vac­cines to needy coun­tries now.

Now that the US is swimming in Covid-19 vaccines and the supply has officially eclipsed the demand, it’s time for America to lead the world and start shipping these excess doses to countries that desperately need them.

Unlike the IP waiver at the World Trade Organization, which Biden now supports and will likely take years to translate into actual shots in arms, the US could easily donate just a tiny fraction of the more than 60 million doses of Pfizer, Moderna and J&J vaccines sitting on American shelves right now.