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HADASSAH MEDICAL ORGANIZATION (CC)

🇮🇱Israel
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BCG Vaccine Under Trial to Prevent Alzheimer's Disease in Israel

• A clinical trial in Israel is testing the century-old BCG vaccine, originally for tuberculosis, to assess its potential in slowing Alzheimer's disease. • The trial is based on the theory that the BCG vaccine may stimulate immune cells in the brain, offering protection against Alzheimer's. • Participants undergo cognitive and blood tests to evaluate biomarkers, with potential vaccine administration for those showing Alzheimer's risk indicators. • Researchers aim to identify systemic factors driving Alzheimer's, contributing to the development of new drugs and preventive strategies.

NAYA Biosciences Initiates Phase 1/2a Trial of NY-303 for Hepatocellular Carcinoma

• NAYA Biosciences has commenced a Phase 1/2a clinical trial for NY-303, a GPC3-targeted NK Engager bispecific antibody, in patients with hepatocellular carcinoma (HCC). • The trial will evaluate the safety and efficacy of NY-303 as a monotherapy in HCC patients who have not responded to first-line immunotherapy, starting in Israel. • The Phase 1 portion will focus on dose escalation, while Phase 2a aims to assess objective response rate and progression-free survival, potentially expanding to the U.S. and Europe. • NY-303's novel mechanism targets both NK cells and GPC3, offering a new approach for patients with limited treatment options and poor survival rates.

NAYA Biosciences Initiates Phase 1/2a Trial of NY-303 for Hepatocellular Carcinoma

• NAYA Biosciences has commenced a Phase 1/2a clinical trial for NY-303, a GPC3-targeting NK Engager bispecific antibody, in patients with hepatocellular carcinoma (HCC). • The trial will assess the safety and efficacy of NY-303 as a monotherapy in patients who have not responded to first-line immunotherapy. • Phase 1 will focus on dose escalation, while Phase 2a will expand to the US and Europe to evaluate objective response rate and progression-free survival. • NY-303's novel mechanism targets both NK cells and GPC3, potentially overcoming resistance to checkpoint inhibitors in HCC.

NAYA Biosciences Initiates Phase 1/2a Trial of NY-303 for Hepatocellular Carcinoma

• NAYA Biosciences has commenced a Phase 1/2a clinical trial for NY-303, a GPC3-targeted NK Engager bispecific antibody, in patients with hepatocellular carcinoma (HCC). • The trial will evaluate the safety and efficacy of NY-303 as a monotherapy in patients who have not responded to first-line immunotherapy. • The Phase 1 portion will focus on dose escalation, while Phase 2a will assess objective response rate and progression-free survival in the US and Europe. • NY-303's unique mechanism targets both NK cells and GPC3, potentially overcoming resistance to checkpoint inhibitors in HCC patients.

Nexcella's NXC-201 Shows Promise in Relapsed/Refractory Multiple Myeloma and AL Amyloidosis

• Nexcella's NXC-201, a BCMA-targeted CAR-T therapy, demonstrates promising clinical data in relapsed/refractory multiple myeloma and AL amyloidosis. • Updated clinical data on NXC-201 will be presented at the 20th International Myeloma Society Annual Meeting in Athens, Greece. • The NEXICART-1 trial, a Phase 1b/2a study, evaluates the safety and efficacy of NXC-201 in adults with relapsed/refractory multiple myeloma and AL amyloidosis. • Nexcella plans to submit data to the FDA for NXC-201 in relapsed/refractory multiple myeloma and AL amyloidosis after treating a target number of patients.

Nexcella's NXC-201 CAR-T Therapy Shows 100% Response in Darzalex-Relapsed AL Amyloidosis

• Nexcella's NXC-201, a BCMA-targeted CAR-T cell therapy, demonstrated a 100% overall response rate in AL amyloidosis patients relapsed or refractory to Darzalex-based regimens. • The Phase 1b/2a NEXICART-1 study showed a 63% complete response rate and a 75% organ response rate in treated patients with AL amyloidosis. • The CAR-T therapy was well-tolerated, with no grade 4 cytokine release syndrome events reported, suggesting a favorable safety profile in this patient population. • The best responder in the study had a duration of response of 16.5 months, with the response ongoing at the data cutoff, indicating sustained efficacy.
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