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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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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Vir's CMO says he's sur­prised that a low dose of their he­pati­tis B drug ap­pears promis­ing in ear­ly slice of da­ta — shares soar

Initial topline data from a Phase I study of a new therapeutic for chronic hepatitis B virus was so promising that it surprised even the CMO of the company that produces it.

Vir Biotechnology on Tuesday announced that its VIR-3434 molecule reduced the level of virus surface antigens present in a blinded patient cohort after eight days of the trial with just a single 6 mg dose. Six of the eight patients in the cohort were given the molecule, and the other two a placebo—all six who received the molecule saw a mean antigen reduction of 1.3 log10 IU/mL, Vir said.

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Eli Lil­ly demon­strates that 2 an­ti­bod­ies beat 1 for guard­ing against se­vere Covid-19. But can that solve the first an­ti­body’s prob­lem amid slow up­take?

It seems safe to say that two antibodies are better than one.

Eli Lilly released the largest results yet on Tuesday for their Covid-19 neutralizing antibody cocktail, announcing that the combo reduced deaths and hospitalizations in coronavirus patients by 70%. Across 1,000 patients, there were 11 such events in the treatment group and 36 in the placebo group.

The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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Drug­mak­ers 'inch­ing ahead' in in­creas­ing ac­cess to drugs world­wide, with Glax­o­SmithK­line lead­ing the pack

Top drug developers are “inching ahead” in improving access to much-needed drugs around the world — an issue that has been underscored by the Covid-19 pandemic. But there’s still more work to do, Access to Medicine Foundation executive director Jayasree Iyer said.

Every two years, the Access to Medicines Index ranks the top 20 biotechs leading the push for better access to medicines in low- and middle-income countries. This year’s report, published Tuesday, looks at drug access in 106 countries.