Can­cer cell-based ther­a­pies com­ing in­to 'im­por­tan­t' year for R&D, say SVB an­a­lysts

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.”

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Teresa Graham, incoming Roche Pharmaceuticals CEO

In­com­ing Roche CEO builds out his top team, tap­ping Genen­tech vet to lead phar­ma di­vi­sion

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.

Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

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.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

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.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

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 CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

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.

BeiGene's new website helps direct cancer patients and caregivers to a wide variety of sources for help.

BeiGene re­veals men­tal health and can­cer care gap in study, de­buts dig­i­tal re­sources

One-fourth of cancer patients are living with depression — and another 20% suffer from anxiety. That’s according to new study results from BeiGene, conducted by Cancer Support Community (CSC), about the mental and emotional health of cancer patients.

While the fact that people with cancer are also dealing with depression or anxiety may not be surprising, what is — and was to BeiGene — is that a majority of them aren’t getting support. 60% of respondents said they were not referred to a mental health professional, and even more concerning, two in five who specifically asked for mental health help did not get it. CSC, a nonprofit mental health in cancer advocacy group, surveyed more than 600 US cancer patients.

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One of the paintings from Gilead's latest campaign making AI art to help MBC patients be 'seen and heard.'

Gilead com­bines ar­ti­fi­cial in­tel­li­gence and art to draw at­ten­tion and hope to MBC

What if you could “see” the emotions and feelings of people living with metastatic breast cancer? That’s what Gilead Sciences’ agency VMLY&R Health did last year, using artificial intelligence and sound analytics to turn the interviews of three women living with metastatic triple-negative breast cancer into works of art.

Using the sound waves, a robotic painting device translated their stories of struggle and hope into colors, contours and brush strokes. The result? An art exhibition called “Paintings of Hope” that was first displayed at ESMO in September in Paris, but has since traveled to hospitals and medical conferences in Europe and Spain.

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