GSK poised to leap back in­to the on­col­o­gy mar­ket with more pos­i­tive be­lan­tam­ab mafodotin re­sults — but BC­MA ri­vals are swarm­ing in be­hind

Glax­o­SmithK­line took an im­por­tant step to­ward a key new ap­proval Mon­day night, post­ing their sec­ond pos­i­tive round of piv­otal da­ta for the BC­MA-tar­get­ing mul­ti­ple myelo­ma con­ju­gate be­lan­tam­ab mafodotin (GSK2857916). And with up­beat DREAMM-2 da­ta, they’ve filed for an ap­proval with hopes of get­ting a pri­or­i­ty re­view for their “break­through” drug can­di­date.

But af­ter the stel­lar rounds of new da­ta in the BC­MA field at ASH a few days ago, don’t ex­pect a tremen­dous lev­el of ex­cite­ment to greet them over the out­come.

To be sure, a 31% over­all re­sponse rate among 97 very sick pa­tients with 3 com­plete re­spons­es in the bunch is like­ly enough to war­rant an FDA OK — giv­en reg­u­la­tors’ track record when it comes to pa­tients and op­tions. But the re­sults leave open the ques­tion of what the long-term com­mer­cial prospects can be as GSK makes its way back in­to the on­col­o­gy mar­ket af­ter a long and painful ab­sence.

Me­di­an du­ra­tion has not been es­tab­lished yet.

For ‘7916, the new da­ta batch marks a sig­nif­i­cant drop from the 60% ORR in DREAMM-1, though in­ves­ti­ga­tors note that this new tri­al in­clud­ed a much sick­er set of pa­tients with dwin­dling op­tions. At ASH we al­so saw a CAR-T from J&J that de­liv­ered a 100% re­sponse rate in the BC­MA field for mul­ti­ple myelo­ma. That came with a jaw drop­ping 69% com­plete re­sponse rate. Re­gen­eron im­pressed with its bis­pe­cif­ic REGN5458, while blue­bird and Bris­tol-My­ers Squibb lead the boom­ing BC­MA field, and now add their bis­pe­cif­ic CC-92369 to the list of am­bi­tious can­di­dates. The list goes on.

And out in front, Darza­lex con­tin­ues to make new progress in com­bi­na­tion with oth­er drugs for mul­ti­ple myelo­ma. At ASH Am­gen post­ed a 37% re­duc­tion in the risk of pro­gres­sion of mul­ti­ple myelo­ma for pa­tients treat­ed with a com­bi­na­tion of Kypro­lis and the block­buster Darza­lex from J&J and Gen­mab, com­pared to ei­ther alone.

Game over for GSK?

Not quite.

Ax­el Hoos

Ax­el Hoos, the GSK on­col­o­gy R&D chief who kept the flame of ear­ly-stage can­cer R&D burn­ing af­ter a big pipeline/com­mer­cial swap with No­var­tis, read­i­ly agrees that both the CAR-Ts as well as the bis­pecifics have a lot of ex­cit­ing da­ta be­hind them. They al­so have fur­ther to go in the clin­ic, he adds, and in CAR-T’s case, se­ri­ous cy­tokine re­lease syn­drome safe­ty is­sues as well as a con­tin­u­ing set of man­u­fac­tur­ing ob­sta­cles that con­tin­ues to drag back the pi­o­neers.

Move back to a con­ju­gate like theirs, Hoos says, and there are re­al ad­van­tages in scal­a­bil­i­ty and ac­cess that gives GSK a re­al shot at mak­ing a mark in the field — soon.

“We think we have a more po­tent agent and that should play out as you start com­bin­ing,” he adds, im­por­tant in a field where com­bi­na­tions are king. In the mean­time, every­thing from DREAMM-3 to DREAMM-10 are in the works, un­der­scor­ing a com­mit­ment to amp up their com­mit­ment to drugs that have po­ten­tial.

Armed with a break­through ther­a­peu­tic des­ig­na­tion at the FDA, and PRIME from the EMA, it’s like­ly that GSK won’t have to wait much longer be­fore it starts to put its toe back in the can­cer drug mar­ket. And with Luke Miels lead­ing the com­mer­cial charge fol­low­ing the Tesaro PARP buy­out, every­one at GSK knows they have a lot to prove as R&D chief Hal Bar­ron and CEO Em­ma Walm­s­ley take new steps to prove they’ve re­vived a stag­nant phar­ma R&D group.

Here we go.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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A low-pro­file biotech bests Re­gen­eron in high-pro­file patent suit

For nearly a decade now, the low-profile Cambridge biotech Kymab has been battling in US, UK, Japanese and Australian courts with the biotech behemoth Regeneron.

Regeneron has turned itself into a $70 billion company off of a platform of transgenically humanized mice they can use to make antibodies for anything from Ebola to colorectal cancer. The technology took decades and billions to build, 20 years from the company’s founding to the first approved drug. And the company guards and touts it zealously, breaking their production process down into various branded components — Velocimmune, Velocigene, Velocimouse and four other Velocis — and sometimes suing would-be copycats. In 2014, most notably, they sued two Pfizer-backed entities for patent infringement.