Art Krieg, Checkmate

Art Krieg’s Check­mate ex­e­cutes a snap­py 1-2 biotech gam­bit — big crossover fol­lowed by an in­stant IPO

Just as ex­pect­ed, Check­mate’s $85 mil­lion ven­ture raise a few weeks ago was a pre­quel to the lat­est biotech IPO to hit the queue on Wall Street.

The com­pa­ny, found­ed by Check­mate CSO Art Krieg, pen­ciled in a $75 mil­lion raise this time, but like­ly has its sights set on a much larg­er sum — in keep­ing with the up­siz­ing now char­ac­ter­is­tic of the biotech class.

Now in mid-stage de­vel­op­ment af­ter a 5-year lead­up, the com­pa­ny is hy­per-fo­cused on one drug: CMP-001, which con­tains a CpG-A oligonu­cleotide that ac­ti­vates the TLR9 path­way to kick up an in­nate im­mune re­sponse to can­cer.

Krieg, who helped blaze the path­way, be­lieves that in­ject­ing the drug in­to a tu­mor will trig­ger a new T cell at­tack against that and oth­er tu­mors in the body, shift­ing the tu­mor mi­croen­vi­ron­ment in a way that ac­ti­vates the im­mune sys­tem. The com­pa­ny’s ap­proach is to part­ner up with a PD-1 — in this case, Op­di­vo and Keytru­da — and set out to prove that they can suc­cess­ful­ly treat a sig­nif­i­cant mi­nor­i­ty of pa­tients who didn’t re­spond to the first round of check­point ther­a­py.

Bar­ry Labinger Check­mate

In a tri­al, re­searchers re­port­ed a 25% over­all re­sponse rate, though Check­mate beefed that up to 28% by in­clud­ing post-pro­gres­sion re­spon­ders in the S-1. They al­so backed an­oth­er Phase III that tried the drug on first-line melanoma pa­tients. And they’ll need to run an­oth­er com­bo tri­al to take a full dataset to the FDA.

Krieg has kept 5.6% of the shares in the com­pa­ny, which is helmed by CEO Bar­ry Labinger. Both earned a to­tal of a lit­tle more than $500,000 last year, based on in­come large­ly de­rived from their salaries.

Sofinno­va and ven­Bio are the 2 big in­vestors here, each with 21.1% of the eq­ui­ty, fol­lowed by No­vo Hold­ings at 10.2% and Lon­gi­tude Ven­ture Part­ners at 8.9%.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,600+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,600+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,600+ biopharma pros reading Endpoints daily — and it's free.

FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

Dutch biotech starts liq­ui­da­tion af­ter end­ing PhI­II in GVHD

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi.

Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,600+ biopharma pros reading Endpoints daily — and it's free.