Eli Lil­ly has suf­fered through the biggest set­backs in late-stage drug de­vel­op­ment work for Alzheimer’s — pil­ing up high-pro­file fail­ures for sema­gace­s­tat, solanezum­ab and just months ago lan­abece­s­tat af­ter it be­came ap­par­ent that the BACE ap­proach was a non-starter in symp­to­matic pa­tients. To­day, it’s sig­nal­ing that the com­pa­ny is now ready to fold their hand ear­ly if it doesn’t look like they have a rea­son­able chance to go on to win the pot.

Out in the quar­ter­ly cleanup went a Phase II BACE com­bo in­clud­ing an an­ti­body for N3PG. And the com­pa­ny al­so axed what was termed an SEL BACE 1 Phase I study. N3PG will con­tin­ue on its own.

“There are many vari­abil­i­ties at play with the BACE class and re­cent find­ings from Lil­ly and oth­ers have chal­lenged the BACE hy­poth­e­sis,” notes a spokesper­son from Eli Lil­ly in an email fol­lowup with me. “As a field we are still eval­u­at­ing the class and will con­tin­ue to have ro­bust sci­en­tif­ic dis­cus­sions about its vi­a­bil­i­ty.”

Mer­ck dealt a de­ci­sive blow to BACE with back-to-back Phase III stud­ies in which the drug did what was ex­pect­ed in terms of turn­ing the tap off on amy­loid be­ta, the long­time cul­prit for a dis­ease that wipes out mem­o­ry. With clear ev­i­dence that the strat­e­gy is a non-starter, Lil­ly and its part­ners at As­traZeneca agreed to kill off their late-stage pro­gram for lan­abece­s­tat af­ter re­view­ing the re­sults to date.

But BACE isn’t quite fin­ished yet. 

Back in ear­ly June, Ei­sai and Bio­gen claimed a sig­nif­i­cant suc­cess for their BACE drug, elen­be­ce­s­tat. But while the bio­mark­er for amy­loid be­ta re­duc­tion was hit, the re­searchers failed to see a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in the de­cline of cog­ni­tion. That didn’t stop them from main­tain­ing that they had tracked a re­sponse “sug­gest­ing a de­lay of clin­i­cal symp­tom de­cline in ex­plorato­ry end­points.”

It wasn’t ex­act­ly a big win, rais­ing fresh doubts for two com­pa­nies that con­tin­ue to have a big stake in the amy­loid be­ta the­o­ry.

Ei­sai and Bio­gen have had their hands full de­fend­ing their da­ta on a dif­fer­ent drug, BAN2401, af­ter a change­up in the study de­sign drew a host of crit­ics sug­gest­ing that they had tilt­ed the tri­al to­ward a pos­i­tive out­come. And the crit­ics haven’t backed off af­ter a re­cent at­tempt to de­fend those re­sults.

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.