Ned Sharpless, NCI director (Tom Williams/CQ Roll Call via AP Images)

Can­cer Re­search UK and NCI to kick off next rounds of Grand Chal­lenges

Over the last five years, Can­cer Re­search UK has splashed £130 mil­lion ($172.6 mil­lion) in­to glob­al on­col­o­gy re­search through its Grand Chal­lenge ini­tia­tive. And there’s more where that came from.

The char­i­ty or­ga­ni­za­tion is join­ing forces with the US Na­tion­al Can­cer In­sti­tute for three ad­di­tion­al rounds. Re­search teams vy­ing for a cut of the fund­ing will take a shot at “chal­lenge ques­tions,” which will be post­ed in Oc­to­ber. From there, a por­tion of ap­pli­cants will re­ceive pi­lot funds to fi­nal­ize their pro­pos­als, and the best teams will be award­ed $25 mil­lion for can­cer stud­ies over the next five years.

“This new part­ner­ship lever­ages the ex­per­tise of the world’s lead­ing fun­ders of can­cer re­search in a bold ef­fort to iden­ti­fy and pur­sue in­no­v­a­tive ideas that ad­dress ma­jor chal­lenges in un­der­stand­ing can­cer,” NCI di­rec­tor Ned Sharp­less said in a state­ment. “We’re thrilled to join Can­cer Re­search UK in this unique col­lab­o­ra­tion to sup­port nov­el can­cer re­search on a glob­al scale.”

Can­cer Grand Chal­lenges funds are de­signed to give teams “the free­dom and scale to in­no­vate and car­ry out cut­ting-edge re­search.” The “chal­lenges” are de­ter­mined through a se­ries of in­ter­na­tion­al work­shops, and a pa­tient com­mit­tee weighs in through­out the process.

Teams from the 2015 Chal­lenges are cre­at­ing vir­tu­al re­al­i­ty maps of tu­mors, re­search­ing new ways to fight in­flam­ma­tion-as­so­ci­at­ed can­cer, work­ing on pre­vent­ing un­nec­es­sary breast can­cer treat­ment, and more. Sev­en teams to­tal were award­ed, in­clud­ing 73 re­search groups across nine coun­tries. So far, Can­cer Re­search UK has grant­ed two rounds of awards to those groups.

Di­nah Singer

For the re­newed Can­cer Grand Chal­lenges, the NCI and Can­cer Re­search UK will co-fund four awards in each round. A new round of chal­lenges will be an­nounced every oth­er year.

Chal­lenge ques­tions for the next round will be post­ed in Oc­to­ber. Then, teams will have un­til April 22 to sub­mit an ex­pres­sion of in­ter­est. A small num­ber of teams will be se­lect­ed in June to com­plete fi­nal ap­pli­ca­tions. In­ter­views will be con­duct­ed in De­cem­ber, and awards will be an­nounced in 2022.

“Many of the on­go­ing Grand Chal­lenge awards align with NCI re­search pri­or­i­ties, and our mis­sions over­lap in many ways,” Di­nah Singer, NCI deputy di­rec­tor for sci­en­tif­ic strat­e­gy and de­vel­op­ment, said in a state­ment. “This ini­tia­tive will ex­pand op­por­tu­ni­ties to iden­ti­fy new chal­lenges based on in­sights from the can­cer re­search com­mu­ni­ty and to fur­ther our un­der­stand­ing of can­cer. We’re look­ing for­ward to the new ideas pro­posed by cre­ative teams from around the world.”

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.

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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.

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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.

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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.

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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.

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