Bris­tol My­ers Squibb is look­ing to ex­pand Breyanzi in­to more in­di­ca­tions — and the phar­ma’s newest da­ta read­out makes progress on that front.

The Big Phar­ma put out word Thurs­day that the CAR-T cell ther­a­py met the pri­ma­ry end­point of com­plete re­sponse rate com­pared to his­tor­i­cal con­trol in a sub­set of pa­tients with re­lapsed or re­frac­to­ry chron­ic lym­pho­cyt­ic leukemia (CLL) that were re­frac­to­ry to a BTK in­hibitor and pre­treat­ed with a BCL-2 in­hibitor.

The over­all tri­al was a Phase I/II, open-la­bel and sin­gle-arm study in pa­tients with both re­lapsed or re­frac­to­ry CLL or SLL. While com­plete specifics re­gard­ing the tri­al have not been made pub­lic yet, Bris­tol My­ers said in a state­ment that the phar­ma will eval­u­ate the da­ta and work with in­ves­ti­ga­tors to present re­sults at a fu­ture med­ical meet­ing, as well as dis­cuss said re­sults with cer­tain health au­thor­i­ties.

A Bris­tol My­ers spokesper­son told End­points News that the Phase II por­tion of the tri­al test­ed Breyanzi at a dose of 100 mil­lion T-cells based off re­sults from the Phase I monother­a­py arm.

The ther­a­py, ac­quired by Bris­tol My­ers when it bought out Cel­gene for $74 bil­lion in 2019, was first ap­proved back in 2021 for pre-treat­ed dif­fuse large B cell lym­phoma, with ex­pan­sions since then in­to more lym­phoma in­di­ca­tions. And while a spokesper­son told End­points that the Big Phar­ma is pur­su­ing op­por­tu­ni­ties to ex­pand Breyanzi even more, Bris­tol My­ers’ head of cell ther­a­py de­vel­op­ment Anne Ker­ber said in the tri­al an­nounce­ment Thurs­day that with CLL’s “com­plex bi­ol­o­gy and im­mune dys­reg­u­la­tion,” the cur­rent­ly in­cur­able dis­ease makes de­vel­op­ing T cell-based ther­a­pies for CLL “very chal­leng­ing.”

Any po­ten­tial ap­proval for Breyanzi in CLL would mean im­me­di­ate com­pe­ti­tion against the likes of Ab­b­Vie and John­son & John­son’s BTK in­hibitor Im­bru­vi­ca. The FDA just ex­pand­ed the po­ten­tial ther­a­pies avail­able for the dis­ease af­ter giv­ing the thumbs-up to BeiGene’s Brukin­sa last week, af­ter BeiGene showed at ASH last year the oral ther­a­py beat then-stan­dard-of-care Im­bru­vi­ca in a head-to-head test.

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Dallas-based biotech Nanoscope Therapeutics unveiled Phase II results on its gene therapy for a rare eye disease Thursday morning.

In the RESTORE trial, 18 patients with retinitis pigmentosa got a gene therapy called MCO-010 while nine got placebo. On a vision test called the MLYMT, the treatment group had a one-point greater change over one year in their score compared to the placebo group, the primary endpoint of the study. However, the 95% confidence interval was 0.0 to 3.0, meaning the result was not statistically significant. The p-value was not provided.

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

Belgian biotech Confo Therapeutics has landed $183 million, plus potential royalties, in a drug-discovery deal with Daiichi Sankyo.

Early Thursday, Confo Therapeutics put out word of the deal that will be focused on small molecule antagonists to go after an undisclosed target that the company says is associated with CNS diseases.

Confo CEO Cedric Ververken told Endpoints News that Daiichi originally reached out to learn about the biotech’s technology. He added that Confo, founded in 2015, will use its platform to drug a GPCR target that Daiichi has struggled with internally.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.