Pfiz­er and Mer­ck KGaA have hit the tri­fec­ta for PD-L1 fail­ure in ovar­i­an can­cer.

The two part­ners said late to­day that they are shut­ter­ing the Phase III JAVELIN Ovar­i­an PARP 100 study, their third straight fail in the ovar­i­an can­cer sec­tor in re­cent months. The de­ci­sion to close the tri­al, they added, was due to its ear­li­er set­backs as well as the ap­proval of As­traZeneca’s dom­i­nant PARP Lyn­parza in front­line cas­es.

David Hung

Re­searchers had hoped to find promis­ing da­ta for their com­bi­na­tion of Baven­cio with ta­la­zoparib, the PARP Pfiz­er $PFE ob­tained in the Medi­va­tion buy­out, which had been bru­tal­ly hyped by the biotech’s CEO David Hung as he sought to round up the sales price for the com­pa­ny. 

Re­searchers had hoped to make a case that the im­muno-on­col­o­gy drug plus chemo, fol­lowed by a main­te­nance round of Baven­cio plus ta­la­zoparib, would prove a big help to front­line pa­tients.

The lat­est set­back, which fol­lows a long line­up of fail­ures for the part­ners, will on­ly un­der­score the grow­ing sense of dread about Baven­cio’s fu­ture. Pfiz­er paid $850 mil­lion in a cash up­front for rights to this drug, which Re­gen­eron R&D chief George Yan­copou­los — who’s been pump­ing the fu­ture of their PD-1 ri­val — re­cent­ly told me was the worst of a bad lot.

There’s been a lot of buzz about Baven­cio in the in­dus­try, and none of it is par­tic­u­lar­ly good.

Mer­ck’s $MRK Keytru­da and Bris­tol-My­ers’ $BMY Op­di­vo were the first two PD-1/L1 drugs to be ap­proved, and they are by far way ahead in mar­ket share, with bil­lions in added rev­enue from each every year. As Re­gen­eron $REGN, Chi­na-based drug mak­ers and many oth­ers fol­low up with their own check­points in the field, and while PARPs duke it out against Lyn­parza, it will get tougher and tougher for new ther­a­pies to make a mark. And the in­dus­try is rife with new clin­i­cal pro­grams around the world.

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.”