invoX Pharma Limited has presented updated findings from its phase 1 study of FS222, showcasing significant anti-tumour activity in patients with advanced solid tumours. The data, revealed at the 2024 American Society of Clinical Oncology Annual Meeting, highlights FS222’s potential as a ground-breaking treatment option. FS222, a CD137/PD-L1 bispecific antibody, is part of invoX’s innovative product pipeline. The phase 1 trial involved 100 subjects and aimed to establish the drug’s safety and maximum tolerated dose. The study also assessed FS222’s anti-tumour activity, pharmacokinetics, and pharmacodynamics. The treatment, administered every four weeks, led to increased T cell proliferation and CD8+ T cell infiltration within tumours. While treatment-related adverse events were dose-dependent, they remained manageable and reversible. Dr Elena Garralda, Director of Early Drug Development at Vall d’Hebron University Hospital, commented on the drug’s potential: “While there have been great advances in immuno-oncology research, existing treatments continue to face challenges with response ...
BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company is committed to developing a new generation of innovative drugs and biosimilars for the treatment of oncology, autoimmune diseases, cardiovascular diseases, ophthalmology and other major diseases that threaten human life or health. The Company today announced that it recently received notification from the European Medicines Agency (EMA) that Avzivi® (BAT1706), a biosimilar developed with reference to Anvitin® (bevacizumab), has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP), which recommended to the European Commission (EC) that it grant marketing authorization for Avzivi® for the treatment of metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, metastatic renal cell carcinoma, epithelial ovarian, fallopian tube or primary peritoneal cancer, and metastatic cervical cancer. The CHMP’s opinion on ...
GSK’s Blenrep has pivotal clinical trial results showing the multiple myeloma therapy reduced the risk of disease progression or death by nearly 50%. The results were presented Sunday during the annual meeting of the America Society of Clinical Oncology.A GSK multiple myeloma drug that was withdrawn from the market is accumulating new clinical data that could support its return — perhaps as an earlier line of therapy. With the latest results, clinicians and GSK executives say they may have figured out how to address a lingering question about how to safely dose the drug, Blenrep. The new data were presented Sunday during the annual meeting of the American Society of Clinical Oncology in Chicago. Blenrep is an antibody drug conjugate (ADC) that targets the BCMA protein on multiple myeloma cells, delivering to them a payload of toxic chemotherapy. There are many multiple myeloma drugs available, but frequent relapse in this ...
A drug approved to treat certain autoimmune diseases and cancers successfully alleviated symptoms of a rare genetic syndrome called autoimmune polyendocrine syndrome type 1 (APS-1). Researchers identified the treatment based on their discovery that the syndrome is linked to elevated levels of interferon-gamma (IFN-gamma), a protein involved in immune system responses, providing new insights into the role of IFN-gamma in autoimmunity. The study, led by researchers at the National Institutes of Health’s National Institute of Allergy and Infectious Diseases, was published today in the New England Journal of Medicine. In a three-stage study, conducted in mice and people, the researchers examined how APS-1 causes autoimmune disease. The syndrome is marked by dysfunction of multiple organs, usually beginning in childhood, and is fatal in more than 30% of cases. This inherited syndrome is caused by a deficiency in a gene that keeps the immune system’s T cells from attacking cells of ...
What is the significance of the Chinese market to leading biopharmaceutical companies? Pablo Soriot, global CEO of AstraZeneca, one of the leading international biopharmaceutical companies, told reporters in an interview on the 26th: “China plays a vital role in the global healthcare industry. It is not only a leader in innovation, but also plays a key role in the global research and development and production of important drugs. For AstraZeneca, the Chinese market is crucial.”Biopharmaceutical Industry International Development Conference” held on the same day , AstraZeneca officially announced that Shanghai would become its fifth global strategic center. The “Shanghai Biopharmaceutical Innovation Enterprise 2024 Overseas Cooperation Plan” was officially released on the same day, enabling local innovative drugs to reach a new level and helping Chinese innovation lead global pharmaceutical innovation. It is reported that in the future, Shanghai, China will become another global strategic center integrating R&D, commercial and production ...
According to the University of Macau (UM) on the 4th, in order to cooperate with the Macao Special Administrative Region Government’s “1+4” moderate economic diversification development strategy and promote the development of Macao’s big health industry, UM and China National Pharmaceutical Group Co., Ltd. (Sinopharm Group) recently signed a strategic cooperation agreement in the field of big health. Both parties hope to promote the transformation of Australia’s scientific research results through closer industry-university-research cooperation, and help enhance the scientific and technological strength of the biomedicine and health strategy. Liu Jingzhen, Chairman of China National Pharmaceutical Group Co., Ltd., led a delegation to visit the University of Adelaide on February 26. The delegation members included leaders of Sinopharm Group and representatives of subsidiaries in different fields such as traditional Chinese medicine , biopharmaceuticals, chemical pharmaceuticals, and medical aesthetics. UM Rector Yonghua Song briefed the delegation on UM’s recent development, strengths and ...
Davy James Breyanzi, a CD19-directed CAR T-cell therapy, granted fourth FDA approval to treat a distinct subtype of non-Hodgkin lymphoma.The FDA has approved Bristol Myers Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel) to treat adults with relapsed or refractory (R/R) mantle cell lymphoma (MCL) who were previously administered at least two lines of systemic therapy that included a Bruton tyrosine kinase (BTK) inhibitor.1 The regulatory action marks the fourth indication for Breyanzi to treat a distinct subtype of non-Hodgkin lymphoma. “With Breyanzi, we are delivering on the promise of cell therapy by offering a definitive treatment option for some of the most difficult-to-treat lymphomas,” Bryan Campbell, senior vice president, head of Commercial, Cell Therapy, BMS, said in a press release. “We are proud of the advances we are making to bring our differentiated CAR T cell therapy to the most patients across indications and lines of therapy to ensure treatment options that ...
Don Tracy, Associate Editor Priority review designation for Keytruda is based on promising results from the Phase II/III IND.227/KEYNOTE-483 trial, which demonstrated improved overall survival in patients with unresectable advanced or metastatic malignant pleural mesothelioma. Merck has announced that the FDA granted Priority Review designation to its application for Keytruda (pembrolizumab) plus chemotherapy as a first-line treatment for patients with unresectable advanced or metastatic malignant pleural mesothelioma. According to the company, the application was a based on positive data from the Phase II/III IND.227/KEYNOTE-483 trial, which found that Keytruda in combination with chemotherapy significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) compared to chemotherapy alone. Further, death was reduced by 21% (HR=0.79 [95% CI, 0.64-0.98]; two-sided p value=0.0324), with a median OS of 17.3 months (95% CI, 14.4-21.3) versus 16.1 months (95% CI, 13.1-18.2) for chemotherapy alone. After a year of treatment, the estimated PFS ...
Merck’s EyeBio acquisition brings a lead program ready for pivotal testing in diabetic macular edema. The therapy could pose competition to Eylea, the blockbuster Regeneron Pharmaceuticals eye drug. By Frank VinluanMerck is on the hunt for drugs with blockbuster potential to make up for declining revenue when its top product, the cancer immunotherapy Keytruda, loses patent protection in the next few years. The pharmaceutical giant is getting a contender through the acquisition of a clinical-stage startup whose lead program is on track to begin pivotal testing in diabetic macular edema. According to deal terms announced Wednesday, Merck is acquiring Eyebiotech Limited, or EyeBio, for $1.3 billion in cash up front. Shareholders of the New York-based company could receive up to $1.7 billion more in milestone payments. EyeBio develops drug for retinal conditions in which inflammation leads to the breakdown of the inner blood-retinal barrier. This breakdown leads to vascular leakage, ...
Johnson & Johnson is acquiring a bispecific antibody that Numab Therapeutics engineered to address two pathways associated with the inflammation and itching of atopic dermatitis. It’s J&J’s second immunology acquisition this month. By Frank Vinluan Johnson & Johnson is building up its immunology pipeline, striking a $1.25 billion deal for a bispecific antibody in development for atopic dermatitis — its second acquisition agreement in the indication in the past two weeks. The deal announced Tuesday will bring J&J a Numab Therapeutics drug codenamed NM26. The pharmaceutical giant is acquiring global rights to the experimental treatment, which is ready to enter Phase 2 testing. Atopic dermatitis, also known as eczema, is the most common inflammatory skin disease. While the disorder typically presents as red and itchy skin, it stems from multiple pathways that vary from one group of patients to another. NM26 is a bispecific antibody designed to address two of ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.