Search Results for “antibody” – Page 22 – media

Qilu Pharmaceutical’s Three Clinical Studies on Cancer Immunotherapy Presented at ASCO 2024

JINAN, China, June 6, 2024 /PRNewswire/ — The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting convened from May 31 to June 4, 2024 in Chicago, USA, adopting a hybrid format. Among the presented works, three clinical studies from Qilu Pharmaceutical were selected for poster sessions. These studies introduced novel immunotherapeutic agents, specifically QLF31907, a bispecific antibody targeting PD-L1/4-1BB; iparomlimab and tuvonralimab, a MabPair product targeting PD-1/CTLA-4; and iparomlimab, a monoclonal antibody targeting PD-1. The research involved treatments for advanced solid tumors and lymphoma, nasopharyngeal carcinoma, as well as solid tumors characterized by either DNA mismatch repair (dMMR) deficiency or high microsatellite instability (MSI-H). QLF31907, developed by Qilu Pharmaceutical, combines two mechanisms: blockade of PD-L1 to restore T-cell receptor (TCR) signaling, while binding to 4-1BB to provide costimulatory signals essential for T-cell activation. This dual-action mechanism fosters T-cell proliferation and activation, enhancing the anti-tumor immune response. The study, led ...
- Source: drugdu
- 88
- June 12, 2024
Astellas Confirms FDA Acknowledgement of Zolbetuximab Resubmission

Mike Hollan The drug had previously been submitted, but required resubmission due to production issues. FDA acknowledged that Astellas has resubmitted zolbetuximab for a Biologics License Application (BLA).1 The drug is a first-in-class claudin 18.2-targets monoclonal antibody and is designed to treat various forms of gastric cancer. According to a press release issued by Astellas, FDA has set November 9, 2024, as its new target action date. The drug had been previously submitted, but had to be resubmitted after Astellas received a complete response letter from FDA in January, 2024. While the agency did not state any issues with the clinical data, efficacy, or safety of the drug, it required resubmission due to third-party manufacturing deficiencies. Astellas resubmitted the drug on May 9, 2024, but only just announced confirmation from FDA. In a press release, Astellas’ senior vice president and head of immuno-oncology development Moitreyee Chatterjee-Kishore, PhD, MBA, said, “Astellas ...
- Source: drugdu
- 119
- June 7, 2024
Data Presented at ASCO Show Improved Complete Response with Jemperli as a First-Line Treatment for Locally Advanced Rectal Cancer in Patients with Mismatch Repair Deficient Status

Don Tracy, Associate Editor Results of the Phase II AZUR-1 trial show that 100% of participants achieved a clinical complete response when treated with Jemperli for locally advanced rectal cancer in patients with mismatch repair deficient status. Updated results from the Phase II AZUR-1clinical trial of Jemperli (dostarlimab) show the promise of the medication as a treatment for mismatch repair deficient (dMMR) locally advanced rectal cancer in offering an alternative to surgery, according to GSK. The trial, performed in partnership with Memorial Sloan Kettering Cancer Center (MSK), found that Jemperli produced a 100% clinical complete response (cCR) in participants administered the drug, according to data presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.1 “The data showing no evidence of disease in 42 patients is remarkable. These results bring us one step closer to understanding the potential of dostarlimab in this curative-intent setting for patients with dMMR ...
- Source: drugdu
- 104
- June 6, 2024
invoX Pharma’s FS222 delivers encouraging solid tumour treatment results

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 ...
- Source: drugdu
- 62
- June 6, 2024
At ASCO, AstraZeneca Adds Data Supporting Expanded Use of Its Drugs in Lung Cancer

AstraZeneca’s Tagrisso and Imfinzi helped patients live longer in separate pivotal clinical trials evaluating the drugs in two different types of lung cancer. The results will be presented Sunday during the annual meeting of the American Society of Clinical Oncology. By Frank VinluanAstraZeneca, which already has a strong presence in lung cancer, is poised to deepen its reach in the disease with clinical data that support expanding the use of two of its approved therapies in ways that clinicians say will change the standard of care for many patients. The data are set for presentation Sunday during the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. First up is the targeted therapy osimertinib, which is marketed under the brand name Tagrisso. The small molecule blocks mutated forms of the EGFR protein, which drives cancer growth. The drug is already approved for use as a first-line treatment ...
- Source: drugdu
- 98
- June 5, 2024
New UCL-developed immunotherapy shows promising results in treating bone cancer

Bone cancer affects more than 150,000 people in the UK and is often resistant to chemotherapy A new type of immunotherapy developed by researchers from University College London (UCL) has demonstrated promising preclinical results in treating bone cancer. Published in Science Translational Medicine, the OPS-gdT treatment platform outperformed conventional immunotherapy when controlling the growth of osteosarcoma, a form of bone cancer. Affecting more than 150,000 people in the UK, cancer that begins or spreads to the bones is hard to treat as it is frequently resistant to chemotherapy and is the leading cause of cancer-related death. Researchers used a small subset of immune cells known as gamma-delta T (gdT) cells, a type of immune cell that can be made from healthy donor immune cells, to provide an efficient and cost-effective solution for treating this condition. gdT cells work to kill antibody-labelled targets safely from person to person without risking graft-versus-host ...
- Source: drugdu
- 71
- June 5, 2024
GSK’s Quest to Bring Myeloma Drug Back to the Market Stops for a Data Drop at ASCO

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 ...
- Source: drugdu
- 117
- June 4, 2024
EMA endorses AbbVie’s Skyrizi for ulcerative colitis

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has granted AbbVie’s ulcerative colitis (UC) drug Skyrizi (risankizumab) a positive recommendation for approval. The committee’s recommendation was based on results from two Phase III studies. In the INSPIRE trial (NCT03398148), 20.3% of patients in the Skyrizi treatment group achieved clinical remission, compared to 6.2% in the placebo group. Furthermore, in the Phase III COMMAND study (NCT03398135), 51% of patients treated with Skyrizi 180 mg and 48% of patients treated with Skyrizi 360mg demonstrated endoscopic improvement in week 52. Skyrizi is a monoclonal antibody therapy that inhibits interleukin-23 (IL-23). This reduces anti-inflammatory processes. In the 31 May press release, Dr Edouard Louis, the head of gastroenterology at University Hospital CHU of Liège Belgium said: “These results suggest that risankizumab may help patients coping with the challenging symptoms of ulcerative colitis, which include abdominal pain, bowel urgency and ...
- Source: drugdu
- 111
- June 4, 2024
FDA Grants Priority Review to Jazz Pharmaceuticals’ Zanidatamab for Multiple Forms of HER-2 Positive Biliary Tract Cancer

Don Tracy, Associate Editor Submission for the FDA approval of zanidatamab was based on promising data from the Phase IIb HERIZON-BTC-01 clinical trial in patients with previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer. Jazz Pharmaceuticals announced that the FDA has granted Priority Review to zanidatamab, a bispecific antibody being evaluated for previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC). According to the company, the submission was based on positive results from Cohort 1 of the Phase IIb HERIZON-BTC-01 clinical trial, which showed a confirmed objective response rate (cORR) of 41.3%. The FDA assigned the application with a Prescription Drug User Fee Act target action date of November 29, 2024. A Phase III trial, HERIZON-BTC-302, is evaluating zanidatamab in combination with standard-of-care therapy against standard-of-care therapy alone in first-line advanced or metastatic HER2-positive BTC.1 “The priority review designation for zanidatamab underscores the critical ...
- Source: drugdu
- 107
- June 3, 2024
Merck Sees Pipeline Diversification Opportunity in $1.3B EyeBio Acquisition

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, ...
- Source: drugdu
- 99
- June 1, 2024

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