Just a few days af­ter open­ing up its new US head­quar­ters on Boston har­bor in prep for what they be­lieve is the im­mi­nent ap­proval of a new CAR-T ri­val, Mor­phoSys says that its top sci­en­tist is step­ping down and they’re re­or­ga­niz­ing R&D un­der de­vel­op­ment chief Malte Pe­ters.

Markus En­zel­berg­er Mor­phoSys

We don’t know the de­tails about what’s up, aside from the fact that they said in an an­nounce­ment that 17-year com­pa­ny vet­er­an Markus En­zel­berg­er is leav­ing his job as chief sci­en­tif­ic of­fi­cer to ex­plore new op­por­tu­ni­ties. And with his de­par­ture, they will be “in­te­grat­ing” re­search in­to the de­vel­op­ment op­er­a­tion.

This is the lat­est in a pair of high-pro­file change­ups in the ex­ec­u­tive crew at Mor­phoSys this year. CEO Si­mon Mo­roney an­nounced he would step aside near the be­gin­ning of the year. He was re­placed by Jean-Paul Kress, the for­mer CEO at Boston-based Syn­tim­mune, which was bought out by Alex­ion.

The Ger­man biotech has been beef­ing up its US com­mer­cial team in prepa­ra­tion for the like­ly ap­proval of their CD19-tar­get­ing an­ti­body taf­a­sita­m­ab — or MOR208. Com­bined with lenalido­mide they be­lieve they can of­fer a more ap­peal­ing al­ter­na­tive to Kym­ri­ah and Yescar­ta — the first 2 CAR-Ts, af­ter a tri­al showed that pa­tients suf­fer­ing from treat­ment-re­sis­tant DL­B­CL, a com­mon form of non-Hodgkin’s lym­phoma, pro­duced a me­di­an on pro­gres­sion-free sur­vival rate 12.1 months with a me­di­an du­ra­tion of re­sponse at 21.7 months. The over­all re­sponse rate among 80 pa­tients was 60% with a 43% com­plete re­sponse rate.

They’ve been dis­cussing a mid-2020 mar­ket launch in the US.

The global pandemic set off a frenzy of R&D activity as biotechs around the world scrambled to see if they could come up with a new medication or vaccine to help fight back. But even as the mRNA standouts are highlighting the market El Dorado open to successful teams, the failures are starting to pile up.

Thursday afternoon it was Apellis’ $APLS turn to deep-six a new drug.

The biotech reports that their C3 therapy APL-9 had failed to move the needle on mortality when combined with standard of care, as compared to SOC alone.

As head of R&D at Gilead, Norbert Bischofberger shelved the SYK inhibitor entospletinib after it proved to need too lengthy a development cycle to win approval. The FDA heard those concerns and will now give entospletinib, once again under Bischofberger’s watchful eye at Kronos, a faster shot on goal.

Kronos has reached an agreement with the FDA to conduct a Phase III trial with a unique primary endpoint, the company announced Thursday, one that it hopes will accelerate entospletinib’s path forward in a certain type of acute myeloid leukemia. The endpoint is measurable residual disease (MRD) negativity, which Kronos says can paint a clearer picture when it comes to the study’s complete response rate.