Art Krieg comes down from the moun­tain with a $27M round for Check­mate Phar­ma­ceu­ti­cals

Art Krieg’s ski trip to Deer Val­ley in Utah last Feb­ru­ary was good for a lot more than mas­ter­ing the moguls.

Ben Aus­pitz from F-Prime joined the trip or­ga­nized by Krieg’s orig­i­nal back­ers at Sofinno­va Ven­tures, and their con­ver­sa­tions on and around the slopes led Aus­pitz and F-Prime to take the lead on a $27 mil­lion B round for Check­mate Phar­ma­ceu­ti­cals, an­nounced Thurs­day evening.

“We weren’t in any kind of a hur­ry to raise more mon­ey,” Krieg tells me. So it was a re­laxed time to start go­ing over Check­mate’s Phase Ib study, now un­der­way and look­ing at its drug’s abil­i­ty to help melanoma pa­tients who had failed Keytru­da.

The $27 mil­lion sets Check­mate up for the next 18 months, says the CEO. That will get them well past the point of en­ter­ing an ex­pan­sion phase of the study, with plans to bring in about 100 more pa­tients and start to bet­ter gauge the im­pact of their drug — which ac­ti­vates toll-like re­cep­tor 9 (TLR9) — in dri­ving a T cell re­sponse to can­cer cells.

That’s a com­ple­men­tary strat­e­gy to the PD-(L)1 check­point drugs like Keytru­da, which take the brakes off the im­mune sys­tem so T cells can swarm can­cer cells. Krieg ob­tained the drug af­ter Cy­tos had tried, and failed, with it in asth­ma.

Check­mate prob­a­bly won’t start talk­ing spe­cif­ic da­ta on its com­bo of their drug with Keytru­da un­til lat­er in the fall of this year, when it gets some­thing to present at a sci­en­tif­ic con­fer­ence. But Krieg tells me that they’ve al­ready had a chance to track tu­mor re­gres­sion in pa­tients. They’re not a pub­lic com­pa­ny, he adds, so there’s no need to re­lease lit­tle batch­es of da­ta along the way.

Krieg is very as­set-fo­cused, and he has been work­ing hard to keep the com­pa­ny team small. Check­mate has grown to about 18 staffers now, with most in Cam­bridge, MA. A few are scat­tered around the globe. Check­mate doesn’t have a lab and doesn’t plan on get­ting one. While Krieg — a long­time biotech vet and RNA ex­pert — ex­pects to add an­oth­er 6 to a dozen staffers with this round, he still doesn’t ex­pect to get big at any time.

“The most like­ly out­come down the road is M&A,” he says, af­ter the biotech snags more hu­man da­ta. But on the oth­er hand, he has a group of back­ers — which al­so in­cludes his old Pfiz­er boss Corey Good­man at ven­Bio — who have the cash to go in­to piv­otal work and be­yond. They could al­so do an IPO down the road, so no one course has been set yet.

“We will be ap­ply­ing for break­through ther­a­py in the next few months,” adds Krieg, who did a short stint as CSO at Sarep­ta be­fore he and then CEO Chris Garabe­di­an had a falling out, 10 months be­fore Garabe­di­an fol­lowed him out the ex­it.

That BTD dis­cus­sion, he says, will al­so give Check­point the chance to start a di­a­logue with the agency about what a reg­is­tra­tion path­way looks like.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

IPO track­er: 2021 gets start­ed with a flur­ry of new of­fer­ings

A global pandemic couldn’t slow down what turned out to be a record year for biotech IPOs. With the calendar turning toward 2021, the Endpoints News team is prepped to track each new filing this year, and the outcome. We’re off to another hot start at least.

Below, you’ll find the companies that have filed to go public, in addition to those that have already priced. Through the first two business weeks of January, there have already been 9 biotechs that have filed or priced, and the number is only expected to grow. We’ll keep the tracker updated as it does.

Matt Gline (L) and Vivek Ramaswamy

Vivek Ra­maswamy and Matt Gline pen share­hold­er let­ters about the changes now un­der­way at Roivant

Friends and colleagues,

I am writing to provide our annual update on Roivant. These updates are usually restricted to our shareholders, but we are sharing this year’s letter more broadly to announce an upcoming change in my role from CEO to Executive Chairman and the promotion of Matt Gline to Chief Executive Officer.

Reflections on 2020

Much has transpired in the world and at our company since my last annual update in January 2020. One year ago we had just completed our $3 billion transaction with Sumitomo Dainippon Pharma (DSP), and we were evaluating how to reinvest in our business. At the same time, SARS-CoV-2 was still a distant virus barely on our minds. Today it has afflicted the entire world sparing literally no one from its effects.

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Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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