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Enlivex Therapeutics Ltd. (NASDAQ: ENLV) is an Israel-based clinical-stage immunotherapy company focused on developing innovative allogeneic drugs to rebalance the immune system. The company's flagship product candidate, Allocetra™, is under development for multiple severe and critical conditions.
Allocetra™ is currently in a Phase IIB clinical trial targeting patients with severe sepsis, a life-threatening condition caused by the body's response to infection. Additionally, it is being investigated in a Phase II clinical trial for the treatment of COVID-19 patients with severe and critical conditions. The company is also exploring Allocetra™ in a Phase IIA trial for the prevention of graft versus host disease (GVHD) in patients undergoing allogeneic hematopoietic stem cell transplants (HSCT).
Enlivex is advancing Allocetra™ as a potential treatment for complications associated with bone marrow transplants, acute multiple organ failure, and as a combination therapy with various anti-cancer treatments to enhance efficacy. The immunotherapy works by reprogramming macrophages to their homeostatic state, thus rebalancing the immune system.
Recently, the Israeli Ministry of Health authorized a new trial for Allocetra™ targeting osteoarthritis, a chronic inflammatory condition affecting millions worldwide. This multi-country, double-blind, placebo-controlled Phase I/II trial aims to evaluate the safety and efficacy of Allocetra™ injections in knee osteoarthritis patients.
The company has shown promising results in its Phase II study of Allocetra™ in sepsis patients, demonstrating a favorable safety profile and potential effectiveness. With approvals from the Danish Medicines Agency and other international regulators, Enlivex is extending its clinical trials across multiple countries to further evaluate Allocetra™'s broad therapeutic potential.
Enlivex Therapeutics has announced the appointment of Tzvi Palash as Project Lead for the construction of its new cGMP AllocetraTM manufacturing plant. With over 35 years of experience, including roles at Gamida Cell and Protalix Biotherapeutics, Palash is expected to enhance manufacturing capacity for upcoming clinical trials and potential commercialization. AllocetraTM aims to reprogram macrophages, addressing critical health needs in conditions like sepsis and COVID-19, aligning with Enlivex’s goal of leading in cell therapies.
Enlivex Therapeutics (Nasdaq: ENLV) announced that its CEO, Dr. Oren Hershkovitz, will participate in the Improvate Life-Saving Technologies International Conference 2021 on July 22, 2021. Dr. Hershkovitz's interview, scheduled for 5:15 AM EDT, will focus on the company's AllocetraTM macrophage reprogramming cell therapy platform, aimed at addressing life-threatening unmet medical needs. Attendees can access the live broadcast by registering on the conference's website.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced its participation in the ARDS Drug Development Summit on July 15, 2021. The Company will present AllocetraTM, a promising therapy for acute respiratory distress syndrome (ARDS), a condition with limited effective treatments. The inaugural summit aims to address drug development challenges for both COVID-19 and non-COVID-19 related ARDS. AllocetraTM is designed to reprogram macrophages to restore immune balance, potentially serving life-threatening conditions.
Enlivex Therapeutics has announced the initiation of design and construction for a new cGMP manufacturing plant in Israel, aimed at expanding production capacity for its immunotherapy product Allocetra. This facility, initially planned to be 17,000 square feet with potential expansion to 21,500 square feet, will support ongoing and future clinical trials, along with initial commercial production upon regulatory approvals. CEO Oren Hershkovitz emphasized that this expansion is crucial for advancing clinical readiness for sepsis and COVID-19 treatments.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced participation in A.G.P.’s Virtual Summer Healthcare Symposium on June 17, 2021. The event includes 1-on-1 virtual meetings with investors interested in the company’s management team.
Enlivex is developing Allocetra™ as a universal cell therapy aimed at reprogramming macrophages to restore their homeostatic state, potentially addressing various serious conditions, including solid cancers and COVID-19.
Enlivex Therapeutics (Nasdaq: ENLV) announced the issuance of European patent No. 3,258,943 for AllocetraTM, enhancing its intellectual property portfolio. This patent covers a combination immune therapy aimed at controlling cytokine storms associated with CAR-T therapies for cancer. CEO Oren Hershkovitz expressed satisfaction with the patent grant in Europe, reinforcing the potential of Allocetra in cancer treatment. Allocetra is designed to reprogram macrophages to address severe conditions like sepsis, COVID-19, and solid tumors.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced its participation in the Jefferies 2021 Virtual Healthcare Conference on June 4, 2021, at 10:00 EDT. The presentation will be accessible via the conference website.
Enlivex is focused on Allocetra™, a universal cell therapy aimed at reprogramming macrophages to restore immune system balance. This therapy has potential applications in treating solid cancers, sepsis, and COVID-19, targeting unmet medical needs with an innovative immunotherapeutic approach.
Enlivex Therapeutics (Nasdaq: ENLV) announced the issuance of Canadian Patent No. 2,893,962 for its immunotherapy product candidate AllocetraTM, providing additional protection for its pharmaceutical compositions and manufacturing methods. The patent enhances Enlivex's intellectual property portfolio, contributing to its focus on treating life-threatening diseases such as sepsis, COVID-19, and solid tumors. CEO Oren Hershkovitz emphasized the importance of this patent in supporting their clinical development efforts aimed at addressing significant unmet medical needs.
Enlivex Therapeutics has received a $1.1 million grant from the Israel Innovation Authority, bringing its total non-dilutive funding to approximately $6.6 million for clinical trials and product development. This funding supports Enlivex's ongoing Phase IIb clinical trial of Allocetra for treating organ dysfunctions related to sepsis. Allocetra is designed to reprogram macrophages into their homeostatic state to combat severe diseases, including sepsis and COVID-19, addressing unmet medical needs.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has partnered with Yale Cancer Center to explore the efficacy of Allocetra™ in combination with immune checkpoint inhibitors to target hard-to-treat solid tumors. This collaboration aims to conduct pre-clinical studies assessing the synergies between Allocetra™ and approved therapies. Enlivex recently reported positive Phase Ib and II results for Allocetra™ in COVID-19 and plans to initiate a Phase IIb study in sepsis. This strategic alliance emphasizes the potential of Allocetra™ to rebalance anti-tumor macrophages in the tumor microenvironment.
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