Malte Peters, Endpoints UK Bio

Mor­phoSys’ chief sci­en­tist hits the ex­it, trig­ger­ing R&D re­or­ga­ni­za­tion as they shift fo­cus to US in an­tic­i­pa­tion of loom­ing FDA ap­proval

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.

Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.

David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Eli Lil­ly claims a TKO in its long-run­ning ti­tle fight with No­vo Nordisk for the block­buster di­a­betes mar­ket — but there’s a hitch

Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.

Let’s start with the latest data from Lilly.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.

Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.

As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slapdown, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.

Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.

Cedric Francois, Apellis CEO (Apellis)

Apel­lis joins the grow­ing num­ber of bio­phar­mas scrap­ping a failed Covid-19 pro­gram af­ter an ear­ly flop

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.

Norbert Bischofberger (Kronos)

Kro­nos seals pact with reg­u­la­tors to hunt AML with pre­vi­ous­ly off-lim­its bio­mark­er end­point

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.