Less than a month after the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee handed down a unanimous vote in favor of Eli Lilly and Co.’s Alzheimer’s disease (AD) candidate, donanemab, the agency approved the drug as a once-monthly injection for adults with early symptomatic disease. Branded Kisunla, the beta-amyloid antagonist marks the second approved AD drug that has demonstrated in clinical trials an ability to slow cognitive decline, going up against Leqembi (lecanemab) from Biogen Inc. and Eisai Co. Ltd., which won full approval in July 2023. Indianapolis-based Lilly, however, is hoping to differentiate Kisunla, noting it’s the first anti-amyloid therapy that offers patients a chance to complete the treatment regimen once amyloid plaques are no longer seen on imaging scans. The benefit would be fewer infusions and, as a result, lower treatment costs.

Curevac enters ‘new chapter’ with $1.6B GSK deal, restructuring

Curevac AG is casting off the deadweight of its pandemic push to translate its mRNA technology into a marketed COVID-19 vaccine, in a new €1.45 billion (US$1.6 billion) deal in which GSK plc will acquire full rights to infectious disease vaccines the two were co-developing. At the same time, Tubingen, Germany-based Curevac is cutting 30% of its workforce as it pivots its resources back to the cancer vaccines on which it previously was focused, and it is unwinding outsourcing agreements, pushing out its cash runway into 2028. “Now we can embark on a new chapter for Curevac,” said CEO Alexander Zehnder.

Biosecure Act leaves biopharmas less confident in Chinese partners  

Confidence in working with Chinese biopharma companies has dropped by 30% to 50% for U.S.-based life sciences companies, with Chinese contract development and manufacturing organizations (CDMOs) the hardest hit, according to a recent LEK survey of global life sciences companies on the impact of the pending U.S. Biosecure Act. As reported by BioWorld, legislation is advancing that would prohibit government contracts with certain Chinese biotechs because they are increasingly seen as national security threats. The Senate Homeland Security Committee introduced S.3558 on March 6, and H.R. 7085, known as the “Biosecure Act,” was passed in the House on March 13.

Opthalmic gene therapy firm Beacon raises $170M series B

One year after arriving on the scene with a $120 million series A, ophthalmic gene therapy specialist Beacon Therapeutics Ltd. has raised $170 million in a series B. The round was announced just after the first patient was dosed in the pivotal phase II/III trial of the lead product, AGTC-501, a treatment for X-linked retinitis pigmentosa. The new money will fund completion of this study, leaving a financial cushion after the hoped-for filing of a BLA in 2026. The company also will advance a second program in dry age-related macular degeneration (AMD) into phase I.

Lotte Biologics to build $3.3B South Korea biomanufacturing plant

Lotte Biologics Co. Ltd. broke ground on its contract development and manufacturing organization (CDMO) plant at its Songdo Bio Campus in Incheon, South Korea, on July 3 to grow its production capacity and set “a new standard” for Korean CDMOs in the global market. According to its timeline, Lotte Biologics expects all three plants at the Songdo Bio Campus to be fully operational by 2034, with plant one to be GMP-ready by the second half of 2026, plant two by the second half of 2028 and plant three by the second half of 2030. 

Holiday notice

BioWorld's offices will be closed in observance of Independence Day in the U.S. No issue will be published Thursday, July 4.

Also in the news

Altos, Alvotech, Anbogen, Annovis, Aptevo, Atossa, Biodexa, Biogen, Biosenic, Cartesian, Checkpoint, Codexis, Crosswalk, Eli Lilly, Heron, Human Immunology Biosciences, Inovio, Inozyme, Ipsen, Irlab, Johnson & Johnson, Kanvas, Medsenic, Phebra, Radionetics Oncology, Recce, Repair, Rondo, Serac, Skye, Sobi, Vertex