Two weeks af­ter Pfiz­er jumped in­to an R&D part­ner­ship with Im­cyse, the Bel­gian biotech re­ports that the phar­ma gi­ant has helped con­tribute to a new, $26 mil­lion add-on raise to their B round.

Im­cyse re­ports Wednes­day morn­ing that the added cash will go to help fund its work on a pipeline of im­munother­a­pies. Biogeno­sis, Epimede, LSP, Noshaq, So­ciété Ré­gionale d’In­vestisse­ment de Wal­lonie (SRIW), So­ciété Fédérale de Par­tic­i­pa­tions et d’In­vestisse­ment (SF­PI) and KU Leu­ven all par­tic­i­pat­ed.

Pfiz­er signed up for a col­lab­o­ra­tion in ear­ly Feb­ru­ary cov­er­ing rheuma­toid arthri­tis, a move that led it to take an un­spec­i­fied eq­ui­ty stake in the com­pa­ny.

“Our aim is to be a ma­jor play­er in ac­tive spe­cif­ic im­munother­a­py,” says CEO De­nis Bedoret in a pre­pared state­ment. “In this pur­suit, we have tak­en our lead Imo­tope can­di­date in­to Phase II for type 1 di­a­betes and have four oth­er pro­grams run­ning in mul­ti­ple scle­ro­sis, neu­romyelitis op­ti­ca spec­trum dis­or­ders, celi­ac dis­ease and rheuma­toid arthri­tis.” — John Car­roll

Han­soh li­cens­es an an­ti-fun­gal for a mys­te­ri­ous in­fec­tion

Chi­nese phar­ma pow­er­house Han­soh has a new part­ner, team­ing with the New Jer­sey biotech Scynex­is to de­vel­op a drug that has re­cent­ly gained at­ten­tion for its po­ten­tial to treat drug re­sis­tant and dif­fi­cult-to-treat in­fec­tions, in­clud­ing a par­tic­u­lar form of fun­gus.

Han­soh will pay Scynex­is $10 mil­lion up­front, $112 mil­lion in po­ten­tial mile­stones and dou­ble-dig­it roy­al­ties to li­cense ibrex­a­fungerp, a broad-spec­trum an­ti­fun­gal, for Chi­na and neigh­bor­ing re­gions. It would not be a ma­jor deal for most biotechs, but it rep­re­sents a sig­nif­i­cant in­vest­ment for com­pa­nies in the in­fec­tious dis­ease space, who have his­tor­i­cal­ly strug­gled. (Un­less you fo­cus on virus­es; virus com­pa­nies are do­ing just fine right now.)

Scynex­is de­vel­oped ibrex­a­fungerp most promi­nent­ly for vagi­nal in­fec­tions, but it gained world­wide at­ten­tion in 2019 for its po­ten­tial to treat Can­di­da Au­ris, a dead­ly fun­gus that mys­te­ri­ous­ly cropped out in a hand­ful of pa­tients in dis­parate lo­ca­tions across the globe. Some sci­en­tists now sus­pect cli­mate change is the cul­prit.  — Ja­son Mast

Lil­ly presents full tirzepatide PhI­II da­ta

Eli Lil­ly re­vealed full da­ta from its tirzepatide Type 2 di­a­betes study, da­ta it hopes can prove to be win­ners in front of the FDA.

The pro­gram sig­nif­i­cant­ly re­duced A1C and body weight from base­line in adults with type 2 di­a­betes, Lil­ly an­nounced Thurs­day morn­ing. In the topline re­sults of two Phase III tri­als, tirzepatide met all pri­ma­ry and sec­ondary end­points.

One of the tri­als com­pared the can­di­date to titrat­ed in­sulin degludec over 52 weeks, while the oth­er pit­ted it against place­bo on top of titrat­ed in­sulin glargine through 40 weeks.

In the first tri­al, the high­est dose of tirzepatide (15 mg) re­duced A1C by 2.37% and body weight by 12.9 kg (13.9%), while it re­duced A1C by 2.59% and body weight by 10.9 kg (11.6%) in the sec­ond. The place­bo tri­al al­so saw 62.4% of par­tic­i­pants achieve an A1C of less than 5.7%, the lev­el seen in peo­ple with­out di­a­betes.

The com­pound it­self is a once-week­ly dual glu­cose-de­pen­dent in­sulinotrop­ic polypep­tide (GIP) and GLP-1 re­cep­tor ag­o­nist. — Max Gel­man

Once a promising $725 million play in immunology, Gilead’s big bet on filgotinib effectively disintegrated in December when the drugmaker reworked its partnership with Galapagos. Now, Galapagos is sporting safety data that will come as a relief — but will it make a difference on filgotinib’s chances in the US?

In a study designed to compare filgotinib’s effect on sperm count with placebo, Galapagos’ JAK inhibitor saw fewer patients post a 50% or more reduction in sperm concentration after 13 weeks of treatment, according to data from the MANTA and MANTA-RAy studies unveiled Thursday.

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

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.