Puma shares ripped af­ter grow­ing grade 3 di­ar­rhea threat is high­light­ed in an ab­stract

Simos Sime­oni­dis, RBC Cap­i­tal

The skep­tics ripped in­to Puma Biotech­nol­o­gy $PBYI to­day, tear­ing a 20% chunk out of its share price by ear­ly af­ter­noon on Mon­day af­ter get­ting a glimpse of its lead can­cer drug’s con­tin­u­ing prob­lems spurring se­vere cas­es of di­ar­rhea in pa­tients.

The re­ac­tion quick­ly set in af­ter Puma post­ed an ab­stract for an up­com­ing can­cer sym­po­sium which spelled out the in­creas­ing rates in ner­a­tinib tri­als. RBC’s Simos Sime­oni­dis sat down to com­pare the num­bers, and reached a few un­set­tling con­clu­sions. Here’s a note he post­ed Mon­day af­ter­noon:

In an ab­stract re­leased this morn­ing, Puma dis­closed da­ta from the Phase II CON­TROL tri­al in the ex­tend­ed ad­ju­vant set­ting show­ing that treat­ment with lop­eramide helps low­er the ~40% Grade 3 (G3) di­ar­rhea seen in the Ex­teNET Phase III tri­al. How­ev­er, the num­bers re­leased to­day show that the G3 rates went up com­pared to what was dis­closed last year… Specif­i­cal­ly, in pa­tients in the orig­i­nal lop­eramide pro­to­col, the rate of G3 di­ar­rhea in­creased to 21.4% from 18.5%. Fur­ther­more, in the amend­ed pro­to­col arm, the amount of G3 di­ar­rhea more than dou­bled from 13% to 28.6%. Over­all, the blend­ed rate be­tween these two arms was 27.1% vs. 16% last year.

The com­pa­ny had re­cent­ly dis­closed they had added a new arm to the study, com­bin­ing the cor­ti­cos­teroid budes­onide to help with the pro­phy­lax­is reg­i­men. To­day’s re­lease of the wors­en­ing (vs. last year’s da­ta) di­ar­rhea, helps ex­plain the need for this change in the tri­al. While we view the 12.5% rate of G3 di­ar­rhea as po­ten­tial­ly promis­ing, we point to the small n (16 pa­tients) and to the fact that these da­ta are still ear­ly (i.e. it is pos­si­ble that they ac­tu­al­ly get worse over time, just as the da­ta from arms 1 and 2 did). The up­date in San An­to­nio should have slight­ly more ma­ture da­ta; how­ev­er, we view the fact that lop­eramide alone no longer ap­pears suf­fi­cient to pro­phy­laxe against se­vere di­ar­rhea as a sig­nif­i­cant neg­a­tive for ner­a­tinib and the stock.

One key point here: Sime­oni­dis has been cau­tious but pos­i­tive about ner­a­tinib’s prospects as a new treat­ment for breast can­cer as it un­der­goes scruti­ny at the FDA. Datasets on 5-year sur­vival and lop­eramide pro­phy­lax­is had im­proved sen­ti­ment around the com­pa­ny’s chances, he not­ed last Sep­tem­ber 20, when the FDA ac­cept­ed Puma’s ap­pli­ca­tion for re­view.

The bear po­si­tion on Puma is that the drug could be too tox­ic even for the FDA, which has proven will­ing to put up with sig­nif­i­cant threats for drugs ini­tial­ly aimed at dy­ing pa­tients. Bulls be­lieve that the safe­ty bar is low enough to clear.

In­vestors were way ahead of Sime­oni­dis to­day, dri­ving down the com­pa­ny stock as Twit­ter quick­ly spread the word to any­one who hadn’t heard al­ready.

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

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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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.

Credit: AP Images

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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Ken Frazier, AP Images

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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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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