Enlivex Therapeutics Ltd. Ordinary Shares - ENLV STOCK NEWS

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced the issuance of an Israeli patent numbered 284985, valid until at least 2037. This patent covers the use of Allocetra™ for mitigating cytokine storms in cancer patients undergoing CAR-T therapy and those affected by various infectious diseases. The CEO, Oren Hershkovitz, expressed satisfaction with the expansion of Enlivex's intellectual property portfolio. Allocetra™ aims to reprogram macrophages into their homeostatic state, potentially benefiting severe conditions like solid cancers and sepsis.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced that an independent Data and Safety Monitoring Board (DSMB) has completed its data review for the first cohort of patients in its Phase I/II trial of Allocetra™ for advanced solid tumors. No safety concerns were identified, and the Israeli Ministry of Health has granted regulatory clearance to proceed with additional patient cohorts. The trial will evaluate higher doses of Allocetra™ as both monotherapy and in combination with anti-PD1 therapy, with a total of 48 patients expected to be enrolled. Key endpoints include safety, tolerability, and various efficacy measures.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced that ANSES and FAMHP approved the amended protocol for its Phase II trial of Allocetra™ in sepsis patients. The study's scope expands to include septic patients from biliary, urinary tract, or abdominal infections. The trial will enroll 80 to 160 participants across four cohorts, assessing safety and efficacy over 28 days. Previous Phase Ib results indicated improved clinical outcomes with Allocetra™ compared to standard care. CEO Oren Hershkovitz highlighted this regulatory achievement as validation of the trial's design.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced FDA clearance for its frozen-formulation Allocetra™ IND aimed at treating patients with advanced solid tumors. The IND includes a multi-center clinical trial in Israel, evaluating Allocetra™ alone and with a PD1 checkpoint inhibitor. Notable preclinical data showed a 55% survival rate in combination therapy for a mesothelioma model. The company also received regulatory approvals in Europe for amendments to its Phase II sepsis trial, expanding the patient population. As of September 30, 2022, Enlivex reported a net loss of $5.7 million and cash reserves of $57.7 million.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has announced that the FDA approved its Investigational New Drug (IND) application to study its cell therapy, Allocetra™, in patients with advanced solid tumors. This IND clearance follows positive preclinical studies in collaboration with Yale Cancer Center, showing significant survival benefits in murine models. The Phase I/II clinical trial aims to evaluate Allocetra™ alone and in combination with PD1 checkpoint inhibitors for patients with relapsed or refractory malignancies. This regulatory clearance marks a pivotal milestone in Enlivex's development trajectory.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has initiated a Phase I/II clinical trial for Allocetra™, targeting advanced solid tumor patients. This multi-center trial aims to assess the safety, tolerability, and preliminary efficacy of Allocetra™ as both monotherapy and in combination with the PD1 checkpoint inhibitor. The trial builds on promising preclinical results that indicated significant survival benefits in murine models. The trial will enroll up to 48 patients, evaluating different dosing strategies to monitor impacts on overall survival and immune profiling.

Enlivex Therapeutics (Nasdaq: ENLV) announced a poster presentation at the 37th Annual Meeting of the Society for Immunotherapy of Cancer from November 8-12, 2022, in Boston. The presentation titled “Synergistic anti-tumor effect of Allocetra–OTS, a cellular immune-therapy” is scheduled for November 10 and 11. Enlivex focuses on immunotherapy with its product Allocetra™, designed to reprogram macrophages to enhance immune response against cancer. For conference registration, visit the provided link.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced its participation at the 4th Macrophage-directed Therapies Summit in Boston from October 4-6, 2022. The company's presentation is scheduled for October 6 at 2:30 PM ET, where management will discuss clinical programs targeting sepsis and solid cancers, along with supporting data. The summit will cover strategies to enhance macrophage therapies and facilitate discussions on clinical applications. Interested parties can register for the event here.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced its participation in multiple investor conferences in September 2022. The company will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 13, 2022, at 11:00 AM ET, and at Baird’s 2022 Global Healthcare Conference on September 14, 2022, at 3:10 PM ET. Additionally, Enlivex will engage in a panel discussion at the Cantor Cell and Genetic Medicines Conference on September 15, 2022, at 9:20 AM ET. Management will also be available for one-on-one meetings during these events.