Novartis on Tuesday gave back the investigational monoclonal antibody tislelizumab to BeiGene, returning worldwide rights to develop, manufacture and commercialize the anti-PD-1 candidate to the cancer-focused biotech.
Also on Tuesday, BeiGene announced that the European Commission had approved tislelizumab for patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who had previously failed platinum-based chemotherapy. The treatment will be marketed under the brand name Tevimbra.
After more than a year of regulatory delay, the FDA has also accepted BeiGene’s Biologics License Application (BLA) for tislelizumab as a first-line treatment option in this indication, according to Tuesday's announcement.
Novartis and BeiGene first entered into a collaboration and license agreement over tislelizumab in January 2021 to develop tislelizumab in ESCC, as well as other malignant diseases such as non-small cell lung cancer and hepatocellular carcinoma.
In July 2022, however, the partners ran into a regulatory roadblock when the FDA decided to defer its action on tislelizumab’s BLA in ESCC until after it had completed an inspection of the company’s facilities in China. A year later, during its R&D day in July 2023, BeiGene announced that the FDA had completed its site inspections, Endpoints News reported.
As part of Tuesday’s hand-off, the companies have mutually agreed to terminate their 2021 contract. Instead, they have inked a new deal that will see Novartis provide transition services to BeiGene in order to avoid disrupting tislelizumab’s development and commercialization plans. This includes manufacturing, regulatory, clinical and safety support. In return, BeiGene will also continue to provide Novartis with tislelizumab supplies for its clinical trials.
With tislelizumab fully within BeiGene’s portfolio again, the company plans to accelerate its regulatory and development plans for the candidate, as well as study its therapeutic potential across a wider range of cancer types, CEO John Oyler said in a statement.
While Novartis is returning the rights to tislelizumab, BeiGene will nevertheless keep working with the Swiss pharma group on “development, regulatory and manufacturing priorities,” Oyler said. “Novartis will manufacture Tevimbra for many markets worldwide and explore its potential in combination with their oncology assets.”
Tislelizumab is a humanized monoclonal antibody that binds to the PD-1 protein and prevents it from interacting with Fc-gamma receptors on macrophages. In turn, tislelizumab helps the body’s immune system to exert its anti-cancer effects and attack tumor cells. The treatment is approved in 11 indications in China, where it also bears the brand name Tevimbra.
https://www.biospace.com/article/novartis-returns-cancer-asset-tislelizumab-to-beigene/
Moderna said on Tuesday it will cut production of mRNA drug substance for its COVID-19 vaccine at Lonza's facility in Switzerland this quarter as part of a plan to align manufacturing of the shots with lower post-pandemic demand.
The U.S. company had said last week it was in talks with its partners that fill vials and syringes globally to downsize vaccine production.
Such a move will help Moderna adjust to the sharp fall in demand for COVID vaccines as payers cut back orders for the shots, partly following the end of the public health emergency for the disease.
Contract drugmaker Lonza's facility in Visp, Switzerland, was dedicated to making vaccine ingredients and help boost the Moderna's deliveries to Europe, Canada and other nations outside the United States.
Moderna expects to absorb the demand currently supported by Lonza at its internal manufacturing site at Norwood in Massachusetts for 2024-25, the company said.
In 2025, Moderna expects additional capacity from its new mRNA manufacturing facilities in the UK, Canada and Australia when completed and also continues to maintain external drug substance capacity at Rovi in Spain.
Rovi, which has a 10-year deal with Moderna to manufacture mRNA-based therapies, had last week said it does not expect to cut down its vaccine production at least this year.
Moderna's other partners include Thermo Fisher, Sanofi and Catalent.
The production ramp down follows Moderna's prediction in August that U.S. demand for the shots would reach 50 to 100 million doses in the fall season, much lower than about 153.8 million shots administered in 2022.
Rival Pfizer pegs the demand in the U.S. to be even lower, at 24% of the U.S. population, or about 82 million people.
https://finance.yahoo.com/news/1-moderna-cut-mrna-drug-150115887.html
T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the T2Biothreat™ Panel. The FDA 510(k) clearance allows the company to immediately begin marketing and selling the T2Biothreat Panel in the U.S. market.
The T2Biothreat Panel is a direct-from-blood molecular diagnostic test that runs on the FDA-cleared T2Dx® Instrument and simultaneously detects six biothreat pathogens, including the organisms that cause anthrax (Bacillus anthracis), tularemia (Francisella tularensis), glanders (Burkholderia mallei), melioidosis (Burkholderia pseudomallei), plague (Yersinia pestis), and typhus (Rickettsia prowazekii). These pathogens have been identified as threats by the U.S. Centers for Disease Control and Prevention and identified as material biological threats under section 319-2(c)(2)(A)(ii) of the Public Health Service Act.
The T2Biothreat Panel is the first and only FDA-cleared product able to simultaneously detect these six high-priority biothreat pathogens, and the only FDA-cleared multi-target biothreat product developed and manufactured by a U.S. owned company. The U.S. clinical evaluation to support the FDA 510(k) submission included testing of the T2Biothreat Panel at MRIGlobal, a Biosafety Level 3 laboratory specializing in biothreat pathogens, and Ochsner Medical Center. The clinical evaluation assessed the sensitivity and specificity of the panel to detect targets in blood samples containing a range of bacterial concentrations. The positive percent agreement for all targets at 1-3 times the limit of detection was 100% for all targets except F. tularensis, which was 94.3%. The negative percent agreement for all six targets in healthy or febrile blood containing no bacteria was 100%.
Patents valid through 2038
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https://finance.yahoo.com/news/scpharmaceuticals-announces-positive-feedback-two-120000866.html
