De­spite in­vestor doubt in al­lo­gene­ic cell ther­a­py, 2023 will be an “im­por­tant” year for both au­tol­o­gous and al­lo­gene­ic im­mune-cell-based ther­a­pies in mul­ti­ple myelo­ma and non-Hodgkin’s lym­phoma, SVB an­a­lysts pre­dict.

With drug can­di­dates like mo­sune­tuzum­ab, glofi­ta­m­ab and ep­cori­ta­m­ab mak­ing their way through clin­i­cal tri­als, SVB Se­cu­ri­ties an­a­lysts are pre­dict­ing the com­mer­cial­iza­tion of bis­pe­cif­ic CD3 T-cell en­gagers will be­gin to be a part of treat­ment par­a­digms as these drugs get ap­proved.

“We ex­pect mat­u­ra­tion of these mar­kets will be mul­ti-year jour­neys, im­pact­ed by (lack of) nec­es­sary in­fra­struc­ture and train­ing in the com­mu­ni­ty set­ting to de­liv­er TCEs, slow re­lease of man­u­fac­tur­ing con­straints for au­to CAR-T, as well as on­go­ing da­ta dis­clo­sures in ear­li­er lines, from com­bi­na­tions, and with class se­quenc­ing,” SVB an­a­lysts wrote in a lengthy re­port re­leased Tues­day.

An­a­lysts al­so had a cri­tique for the Amer­i­can So­ci­ety for Hema­tol­ogy (ASH) meet­ing where there was un­due in­vestor pes­simism to­ward al­lo­gene­ic ther­a­pies: “For us, this is over­done, with much of the al­lo­gene­ic crit­i­cism pre­ma­ture, giv­en al­lo­gene­ic cell ther­a­pies are in the nascent stages of clin­i­cal de­vel­op­ment.”

Al­lo­gene­ic T-cell ther­a­py took a big step for­ward in Eu­rope last month with the ap­proval of the first one on the con­ti­nent. The Eu­ro­pean Com­mis­sion signed off on Ebval­lo, made by Atara Bio­ther­a­peu­tics, for pa­tients with post-trans­plant lym­pho­pro­lif­er­a­tive dis­ease who are pos­i­tive for Ep­stein-Barr virus. Oth­er clin­i­cal tri­als with Ebval­lo are on­go­ing.

Al­so last month, Beam Ther­a­peu­tics got the go-ahead from the FDA to con­tin­ue with hu­man test­ing for a base-edit­ed, off-the-shelf CAR-T ther­a­py in a cer­tain type of leukemia. Beam can now in­ves­ti­gate its can­di­date BEAM-201 as a po­ten­tial treat­ment for pa­tients with re­lapsed/re­frac­to­ry T-cell acute lym­phoblas­tic leukemia (T-ALL)/T-cell lym­phoblas­tic lym­phoma (T-LL). Beam is one of sev­er­al biotechs work­ing on an al­lo­gene­ic CAR-T ther­a­py, which re­quires donor cells rather than a pa­tient’s own cells.

The SVB an­a­lysts al­so took a look at what’s com­ing for non-Hodgkin’s lym­phoma treat­ment, in­clud­ing mo­sune­tuzum­ab, which just earned an FDA ac­cel­er­at­ed ap­proval. An­a­lysts are al­so keep­ing tabs on oth­er FDA ac­tions yet to come: the first po­ten­tial bis­pe­cif­ic en­gager ap­provals for 3L+ large B-cell lym­phoma like ep­cori­ta­m­ab, which was grant­ed pri­or­i­ty re­view, and an an­tic­i­pat­ed Ju­ly 2023 PDU­FA date for Roche’s glofi­ta­m­ab.

“We al­so an­tic­i­pate nu­mer­ous Ph 1/2 up­dates from the bis­pecifics and the au­tol­o­gous and al­lo­gene­ic cell ther­a­pies through­out the year,” the analy­sis reads. “Of these, ini­tial Ph 1 da­ta from DTIL’s (Not Rat­ed) sec­ond-gen­er­a­tion al­lo­gene­ic CD19-CAR-T can­di­date, PB­CAR19B, in 1Q23 could prove a par­tic­u­lar­ly im­por­tant cat­a­lyst for all al­lo cell ther­a­py de­vel­op­ers, giv­en that the pro­gram in­cor­po­rates mul­ti­ple im­mune eva­sion, or “stealth”, modal­i­ties.”

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.