Long­time Ver­tex CEO Jef­frey Lei­den is tak­ing on a new role.

Jeff Lei­den

Lei­den has been ap­point­ed chair­man of Tmu­ni­ty’s board of di­rec­tors, the com­pa­ny an­nounced Mon­day. The move comes about a year and a half af­ter Lei­den an­nounced he’d be step­ping down from his po­si­tion at Ver­tex.

Ver­tex saw im­mense growth un­der Lei­den, lead­ing the com­pa­ny from its ex­it out of he­pati­tis C, when cures were mov­ing in, and in­to cys­tic fi­bro­sis. The com­pa­ny’s cys­tic fi­bro­sis triple com­bo ther­a­py Trikaf­ta is al­ready its best-sell­er, reach­ing the dis­tinc­tion just six weeks af­ter launch and record­ing the strongest first quar­ter of sales for any drug, per some es­ti­mates.

Tmu­ni­ty is cur­rent­ly eval­u­at­ing its T-cell en­gi­neer­ing ap­proach­es in the clin­ic with three pro­grams.

The first tar­gets metasta­t­ic cas­trate re­sis­tant prostate can­cer, at­tack­ing the Prostate Spe­cif­ic Mem­brane Anti­gen. The sec­ond, mean­while, fo­cus­es on pa­tients suf­fer­ing with pan­cre­at­ic, ovar­i­an, non-small cell lung and triple neg­a­tive breast can­cers by tar­get­ing Tn Mu­copolysac­cha­ride-1. And the third fo­cus­es on pa­tients suf­fer­ing from pan­cre­at­ic, ovar­i­an and lung can­cer by tar­get­ing Mesothe­lin.

Op­di­vo plus Cabome­tyx wins ap­proval for ad­vanced RCC

Bris­tol My­ers Squibb’s cash cow Op­di­vo has won a new in­di­ca­tion.

The FDA ap­proved the drug in com­bi­na­tion with Cabome­tyx for the first-line treat­ment of pa­tients with ad­vanced re­nal cell car­ci­no­ma. Pa­tients can take Op­di­vo as an in­jectable every two weeks at 240 mg, or every four weeks at 480 mg, while al­so tak­ing Cabome­tyx pills once dai­ly.

Fri­day’s ap­proval was based on a Phase III study com­par­ing the com­bi­na­tion to Pfiz­er’s Su­tent in pa­tients with ad­vanced RCC. Pa­tients treat­ed with Op­di­vo and Cabome­tyx lived twice as long with­out their tu­mors pro­gress­ing as those treat­ed with Su­tent, notch­ing a me­di­an pro­gres­sion-free sur­vival of 16.6 months com­pared to 8.3 months.

A to­tal of 651 pa­tients were en­rolled in the dou­ble-blind­ed study and were ran­dom­ized 1 to 1.

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Mesoblast faced rough waters in 2020, but on Monday were thrown a financial lifeline.

The Australian stem cell therapy player has raised $110 million in a private placement, the company announced, offering 60 million shares to the US investor group SurgCenter Development. SurgCenter received the shares at a 6.5% discount from Mesoblast’s closing price on Feb. 25.

Mesoblast plans to use the funds to boost supply of its lead candidate remestemcel-L ahead of what they hope is a potential approval in pediatric GvHD when they return to the FDA, as well as advancing manufacturing and development of their rexlemestrocel-L platform for chronic heart failure and chronic low back pain.

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.