Yes­ter­day, we of­fered up a look at the broad range of im­muno-on­col­o­gy stud­ies now un­der­way the world over, as gath­ered by re­searchers at the Can­cer Re­search In­sti­tute for their sec­ond an­nu­al ex­am­i­na­tion of the land­scape. But be­fore we turn the page, I thought it would be in­struc­tive to fo­cus on one crit­i­cal as­pect of the re­port that has ma­jor im­pli­ca­tions for this boom­ing R&D sec­tor.

The CRI’s as­sess­ment not on­ly breaks out the 2,250 PD-1/L1 stud­ies now in the clin­ic — up by 748 tri­als from a year ago — they al­so break out which com­bos are most pop­u­lar.

De­spite some re­al is­sues that have come up with sig­nif­i­cant set­backs on CT­LA-4 com­bos — with Yer­voy and As­traZeneca’s treme­li­mum­ab flunk­ing big tests — CT­LA-4 re­mains the hottest add-on to the check­point crowd. Chemo, which has done ex­treme­ly well by Mer­ck, ranks sec­ond. And even IDO re­mains a play­er.

Here’s the break­out from CRI on the 6 ap­proved check­points now on the mar­ket, watch­ing their spi­ral­ing growth among the lead­ers.

While that fren­zy of ac­tiv­i­ty has con­tributed to the rapid growth in their use, with some clear ben­e­fits for the pa­tients who re­spond, it comes with a sig­nif­i­cant cau­tion.

Look­ing at 533 PD-1/L1 stud­ies, the re­searchers found that while the tri­als are at­tract­ing pa­tient re­cruits faster than oth­er types of on­col­o­gy drugs, the num­ber of pa­tients re­cruit­ed per site has dropped from 1.15 per site per month four years ago to 0.35 pa­tients per site per month in 2018.

That trend, says the CRI, sug­gests this par­tic­u­lar field is fac­ing a se­ri­ous is­sue on new pa­tient re­cruit­ment.

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”