Enlivex Therapeutics Ltd Stock Price, News & Analysis

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced significant preclinical data at the ESMO Congress 2022, demonstrating that the combination of Allocetra™ with cisplatin resulted in a 55% survival rate in a murine mesothelioma model, compared to 0% in untreated and cisplatin monotherapy groups. These results support the ongoing Phase I/II trial of Allocetra™ combined with chemotherapy for patients with peritoneal metastases from solid tumors. Allocetra™ aims to reprogram macrophages to enhance anti-cancer responses.

Enlivex Therapeutics (Nasdaq: ENLV) announced on Sept. 6, 2022, that it received a Notice of Allowance from the U.S. Patent and Trademark Office for patent application 15/551,284. This patent will enhance the company's intellectual property protection for Allocetra™, extending through at least 2036. Allocetra™ is aimed at inhibiting cytokine release syndrome in CAR T-cell therapy patients. The patent is expected to be granted by Q1 2023. CEO Oren Hershkovitz emphasized the significance of this patent in broadening Enlivex's valuable IP portfolio.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced the issuance of a Notice of Allowance from the Japanese Patent Office for patent application number 2020-198242. This patent will grant intellectual property protection for the use of pooled donor cells in Allocetra™, extending protection until at least 2037. Enlivex aims to bolster its global IP strategy to enhance the commercial potential of Allocetra™, a reprogramming immunotherapy targeting diseases like sepsis and solid tumors. The patent is expected to be issued in Q2 2023, emphasizing Enlivex’s commitment to addressing unmet medical needs.

Enlivex Therapeutics has received regulatory clearance for amendments to its Phase II sepsis trial protocol in Israel, Spain, and Greece. The amendments introduce a frozen Allocetra™ formulation, improving shelf life and scalability, potentially lowering costs. The trial will now include patients with septic conditions beyond pneumonia, addressing a significant medical need, given that sepsis affects 1.7 million adults annually in the U.S. The company anticipates these changes may accelerate regulatory approval and commercialization timelines.

Enlivex Therapeutics announced significant advancements in its oncology and sepsis programs, highlighted by the dosing of the first patient in a Phase I/II trial assessing Allocetra™ with chemotherapy for patients with peritoneal metastases. The Israeli Ministry of Health approved a separate trial for Allocetra™ combined with a PD1 inhibitor. Preclinical studies indicate strong survival benefits in ovarian cancer and mesothelioma using Allocetra™. The company appointed Dr. Roger J. Pomerantz as Vice Chairman and maintains a solid financial position, with $62.5 million in cash as of June 30, 2022.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced the Israeli Ministry of Health has approved a Phase I/II clinical trial for Allocetra™, aimed at patients with advanced solid tumors. This trial follows positive preclinical studies with Yale Cancer Center indicating significant survival benefits when Allocetra™ was combined with PD1 checkpoint inhibition. The trial will enroll up to 48 patients, evaluating safety, tolerability, and preliminary efficacy of Allocetra™ alone and combined with anti-PD1 therapy. The study addresses a significant unmet medical need in cancer treatment.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced a Notice of Allowance from the U.S. Patent and Trademark Office for patent application number 16/594,463 regarding its sepsis treatment, Allocetra™. This patent will extend IP protection until at least 2036, enhancing its commercial potential in a largely underserved multi-billion-dollar market. The ongoing Phase II trial of Allocetra™ aims to assess safety and efficacy, with interim results anticipated in Q1 2023 and top-line data expected in Q3 2023.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has initiated its first Phase I/II clinical trial for Allocetra™, an innovative macrophage reprogramming therapy targeting peritoneal metastases in solid cancer patients. This trial, supported by Sheba Medical Center, aims to evaluate the safety and preliminary efficacy of Allocetra™ combined with standard chemotherapy. Peritoneal cancer has a low survival rate, making new treatments critical. The trial will assess dose escalation and monitor adverse events, with the potential to redefine treatment options for patients with limited responses to existing therapies.

Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has announced a corporate update presentation at the 2022 Jefferies Healthcare Conference on June 9, 2022, at 1:00 PM ET. The company focuses on macrophage reprogramming immunotherapy, particularly its product Allocetra™, designed to treat diseases like sepsis and solid tumors. A webcast of the presentation will be accessible for 90 days. Allocetra™ aims to restore macrophage homeostasis, addressing significant medical needs by reprogramming non-homeostatic macrophages.