Articles from Enlivex Therapeutics Ltd

Ness-Ziona, Israel, Dec. 11, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Israeli Ministry of Health authorized the initiation of an investigator-initiated Phase I trial to evaluate the safety, tolerability and initial efficacy of Allocetra™ for injection into the temporomandibular joint (TMJ) in patients suffering from TMJ osteoarthritis.

Nes-Ziona, Israel, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced positive interim efficacy data from the Phase I stage of its randomized, multi-country Phase I/II Allocetra™ trial in patients with moderate to severe knee osteoarthritis.

Nes-Ziona, Israel, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Company’s Board of Directors approved the purchase of up to $1 million of Bitcoin as part of its cash management strategy. 

Nes-Ziona, Israel, Nov. 14, 2024 (GLOBE NEWSWIRE) --  Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the completion of the dosing and initial follow-up period for the first patient in its Phase I clinical trial evaluating the safety, tolerability and potential therapeutic effect of Allocetra™ following injection into an affected joint in patients with psoriatic arthritis. No safety concerns were recorded following the dosing of the first patient.

Nes-Ziona, Israel, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the enrollment and dosing of the first 10 patients in the randomized Phase II stage of the Company’s multi-country Phase I/II Allocetra™ trial in patients with moderate to severe knee osteoarthritis. The initiation of patient dosing follows the recently announced recommendation by the independent Data and Safety Monitoring Board to proceed with the randomized Phase II stage at the highest tested dose, as well as the Danish Medicines Agency’s authorization to initiate this next trial stage.

Nes-Ziona, Israel, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Japanese Patent Office issued a notice of allowance for patent application number 2022-512861 titled “THERAPEUTIC APOPTOTIC CELLS FOR TREATMENT OF OSTEOARTHRITIS”. Once issued, the resulting patent will provide Enlivex with added intellectual property (IP) protection through at least 2040. The Company expects that this new patent will be formally issued in Japan by the end of the second quarter of 2025.

Nes-Ziona, Israel, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Danish Medicines Agency authorized the initiation of the Phase II stage of the Company’s multi-country Phase I/II trial in moderate and severe knee osteoarthritis.  This approval follows the recently announced recommendation by the independent Data and Safety Monitoring Board (DSMB) that the Company may move forward to the Phase II stage of the trial.

Nes-Ziona, Israel, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the independent Data and Safety Monitoring Board (DSMB) has completed an interim data review at the conclusion of the Phase I safety run-in stage of the Company’s ongoing Phase I/II clinical trial of Allocetra™ in up to 160 patients with moderate to severe knee osteoarthritis. Patients in the Phase I safety run-in were treated with three sequential injections of Allocetra™ at escalating doses, and no serious adverse reactions were reported during or following the treatment. Following review of the data, the DSMB confirmed that the safety profile of Allocetra™ allows the Company to move forward to the Phase II stage of the Phase I/II trial, which is a double-blind, randomized evaluation of the safety and efficacy of intra-articular knee injections of Allocetra™ compared to placebo. The DSMB has also indicated that in light of the observed safety profile, the Phase II stage may proceed with the highest dose of Allocetra™ injections tested in the Phase I safety run-in.

•   First study of AllocetraTM in psoriatic arthritis, a chronic inflammatory condition that causes joint pain, swelling and stiffness, affects as many as 30% of people with psoriasis1, and has limited treatment options

 

Ness-Ziona, Israel, June 20, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company” or “Enlivex”), a clinical-stage macrophage reprogramming immunotherapy company, is pleased to invite investors to a webinar on June 25, 2024, at 4:15 p.m. ET.

Key Highlights

Nes-Ziona, Israel, May 29, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the closing of its previously announced registered direct offering to a single healthcare-focused institutional investor of an aggregate of 3,571,429 ordinary shares (or ordinary share equivalents in lieu thereof) and clinical milestone-linked warrants, composed of Series A warrants to purchase up to 3,571,429 ordinary shares and Series B warrants to purchase up to 3,571,429 ordinary shares, at a purchase price of $1.40 per ordinary share (or ordinary share equivalents in lieu thereof) and associated warrants, for aggregate gross proceeds of approximately $5.0 million.

Nes-Ziona, Israel, May 28, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the issuance and sale in a registered direct offering of an aggregate of 3,571,429 ordinary shares (or ordinary share equivalents in lieu thereof) and clinical milestone-linked warrants, composed of Series A warrants to purchase up to 3,571,429 ordinary shares and Series B warrants to purchase up to 3,571,429 ordinary shares, at a purchase price of $1.40 per ordinary share (or ordinary share equivalents in lieu thereof) and associated warrants.  

Nes-Ziona, Israel, April 29, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company” or “Enlivex”), a clinical-stage macrophage reprogramming immunotherapy company, today issued the following update to shareholders from Chief Executive Officer, Oren Hershkovitz.

Nes-Ziona, Israel, April 22, 2024 (GLOBE NEWSWIRE) --  Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first two patients have been dosed in the Company’s multi-country, randomized, controlled Phase I/II trial evaluating AllocetraTM in up to 160 patients with moderate to severe knee osteoarthritis.

Nes-Ziona, Israel, April 16, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Danish Medicines Agency (DKMA) authorized the expansion into Denmark of the Company’s multi-country, randomized, controlled Phase I/II trial evaluating AllocetraTM in up to 160 patients with moderate to severe knee osteoarthritis. As previously announced, the Company received its first regulatory approval for this trial from the Israeli Ministry of Health (IMOH) in January.

Nes-Ziona, Israel, April 11, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it will host a conference call and webcast on April 12, 2024, at 8:30am ET (15:30 IL time) to discuss topline results from its Phase II trial of Allocetra™ in patients with sepsis, in which 120 patients enrolled.  During the call, members of Enlivex’s leadership team will discuss the results. A live Q&A session will follow the Company’s prepared remarks.

Nes-Ziona, Israel, April 11, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced positive indication of effect and safety results from its Phase II study of Allocetra™ in patients with sepsis, in which 120 patients enrolled.

Nes-Ziona, Israel, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd., (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the U.S. Patent and Trademark Office issued a new patent, number US 11,883,429, covering AllocetraTM, the Company’s immunotherapy product candidate. The new patent is expected to provide added intellectual property protection in the United States for the product’s composition and manufacturing method.

Nes-Ziona, Israel, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Israeli Ministry of Health (IMOH) authorized the initiation of a Company-sponsored multi-country, double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the efficacy, safety and tolerability of Allocetra™ following injections into the target knee joint of up to 160 moderately to severely symptomatic osteoarthritis patients.

Nes-Ziona, Israel, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company announced today a strategic reprioritization plan and its financial results for the second quarter ended June 30, 2023.

Nes-Ziona, Israel, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage macrophage reprogramming immunotherapy company, today announced that company management will present a corporate update at the H.C. Wainwright 25th Annual Global Investment Conference, which will take place at the Lotte New York Palace Hotel in New York City, NY Sep 11-13. The presentation will take place on Sep 12, 2023, at 5:00 PM Eastern Time. A webcast of the presentation will be available at https://journey.ct.events/view/dc294789-d2ab-4130-ac2c-3c5e9cdd7514, and will be archived for 90 days.

Data published in Frontiers in Immunology show a robust safety profile and rapid resolution from ARDS and parallel resolution of inflammation markers and elevated cytokines/chemokines, as well as substantial improvements in mortality in 21 Allocetra-treated patients with COVID-19 vs. matched historical controls

Nes-Ziona, Israel, July 31, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first patient has been dosed under the amended protocol for the Company’s Phase II trial evaluating Allocetra™ in patients with sepsis. As previously announced, the amended protocol allows a higher SOFA score inclusion range, which allows the recruitment of patients with higher levels of sepsis severity.  Additionally, the amended protocol provides for two cohorts (treatment and placebo) rather than the  prior protocol’s four-cohort structure.

Nes-Ziona, Israel, June 26, 2023 (GLOBE NEWSWIRE) --  – Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, on June 16, 2023, filed with the SEC its financial results and related management’s discussion for the first quarter ended March 31, 2023.

Nes-Ziona, Israel, June 06, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage macrophage reprogramming immunotherapy company, today announced that company management will present a corporate update at the 2023 Jefferies Healthcare Conference, which is taking place at the Marriott Marquis in New York, NY. The presentation will take place on June 9, 2022, at 11:30 AM Eastern Time. A webcast of the presentation will be available at https://wsw.com/webcast/jeff281/enlv/1860430, and will be archived for 90 days.

Nes-Ziona, Israel, May 31, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages, today announced three poster presentations, including a selected Elevator Pitch Presentation at the 2023 Annual Meeting of the International Society for Cell & Gene Therapy (ISCT), which is taking place from May 31, 2023 through June 03, 2023 in Paris, France.

Nes-Ziona, Israel, May 08, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the issuance of a European patent, numbered 3865189, entitled, “Combination Immune Therapy and Cytokine Control Therapy for Cancer Treatment.” The patent provides added intellectual property protection in Europe into at least 2037, with claims covering the use of for Allocetra™ for the prevention or amelioration of cytokine storms in cancer patients receiving CAR T-Cell therapy.

Nes-Ziona, Israel, April 19, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages, today announced that the U.S. Patent and Trademark Office issued a Notice of Allowance for patent application number 16/076,026. Once issued, the resulting patent will provide Enlivex with added intellectual property protection through at least 2036 with claims covering methods of using Allocetra™ in combination with chimeric antigen receptor (CAR) T-cell therapy to treat, ameliorate or allveiate tumors. The Company expects that this new patent will be issued in the United States during 2023.

Nes-Ziona, Israel, April 17, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the appointment of Andrew Singer to its Board of Directors. Mr. Singer brings more than 25 years of experience in biotechnology, corporate finance, mergers and acquisitions, and business strategy from his extensive investment banking and executive management career.

Nes-Ziona, Israel, April 03, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, “Enlivex”), a clinical-stage macrophage reprogramming immunotherapy company, today announced a clinical collaboration with BeiGene. to evaluate the safety and efficacy of Allocetra™, an investigational macrophage-reprogramming cell therapy, in combination with tislelizumab, an anti-PD-1 immune checkpoint inhibitor, for the treatment of patients with advanced-stage solid tumors.

Nes-Ziona, Israel, March 20, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that an independent Data and Safety Monitoring Board (DSMB) has completed an interim data review for the first cohort of patients in the Company’s ongoing Phase I/II clinical trial of Allocetra™ in patients with advanced-stage peritoneal metastasis arising from solid tumors as an add-on to the standard of care (SoC) chemotherapy administered via Pressurized Intraperitoneal Aerosol Chemotherapy (clinicaltrials.gov Identifier: NCT05431907). The Israeli Ministry of Health (IMOH) also reviewed the interim data and provided regulatory clearance to continue the study and open the study’s next cohort. In addition, the safety profile supported a protocol amendment to start new patients in the second cohort with higher initial doses of Allocetra™. This IMOH clearance follows a previously-reported IMOH clearance to the Company’s second Phase I/II clinical trial, which is evaluating Allocetra™ as monotherapy and in combination with anti-PD1 checkpoint inhibitors in patients with advanced-stage solid tumors.

Nes-Ziona, Israel, Feb. 23, 2023 (GLOBE NEWSWIRE) --  Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Spanish Agency of Medicines and Medical Devices (AEMPS) has authorized the expansion of the Company’s Phase I/II of AllocetraTM in patients with advanced solid malignancies. The clearance of the Phase I/II by the AEMPS follows recent announcements by the Company that (i) the study received IND clearance from the U.S. Food And Drug Administration for recruitment of patients in the U.S., (ii) the independent Data Safety Monitoring Board has completed its prespecified data review for the first cohort of patients in the Phase I/II trial and (iii) the Israeli Ministry of Health had reviewed the data and provided regulatory clearance to continue the study and open the subsequent high dose monotherapy and combination cohorts.

Nes-Ziona, Israel, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the issuance of an Israeli patent, numbered 284985, entitled, “Combination Immune Therapy and Cytokine Control Therapy for Cancer Treatment.” The patent provides added intellectual property protection in Israel into at least 2037, with claims covering the use of for Allocetra™ for prevention or amelioration of cytokine storms in cancer patients receiving CAR-T therapy, as well as in patients whose cytokine storms result from infectious diseases or non-infectious sources.

Nes-Ziona, Israel, Jan. 25, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that an independent Data and Safety Monitoring Board (DSMB) has completed its prespecified data review for the first cohort of patients in the Company’s ongoing Phase I/II cell therapy clinical trial of AllocetraTM in patients with advanced-stage solid tumors (clinicaltrials.gov Identifier: NCT05581719). The Israeli Ministry of Health (IMOH) also reviewed the data and provided regulatory clearance to continue the study and open the study’s additional cohorts.

Nes-Ziona, Israel, Jan. 04, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) and the Belgian Federal Agency for Medicines and Health Products (FAMHP) have cleared the amended protocol of the Company’s Phase II trial evaluating Allocetra™ in patients with sepsis. The approved protocol, which previously received clearances in Israel, Greece and Spain, enables the treatment of newly recruited patients with a frozen Allocetra™ formulation, as well as an expansion of the study’s target population, which was originally limited to patients with pneumonia-associated sepsis, to include patients whose septic condition stems from biliary, urinary tract or abdominal infections.

Nes-Ziona, Israel, Dec. 05, 2022 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, on December 2, 2022 filed with the SEC its financial results and related management’s discussion for the third quarter ended September 30, 2022.

Nes-Ziona, Israel, Nov. 28, 2022 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the U.S. Food & Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to study Allocetra™ in patients with advanced solid malignancies. The FDA’s Phase I/II clearance follows a recent announcement by the Company that the first patient has been dosed in a Phase I/II multi-center clinical trial in Israel designed to evaluate the safety, tolerability and preliminary efficacy of Allocetra™ stand-alone, and in combination with a PD1 checkpoint inhibitor, in patients with advanced solid tumors.

Nes-Ziona, Israel, Nov. 15, 2022 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first patient has been dosed in a Phase I/II clinical trial designed to evaluate the safety, tolerability and preliminary efficacy of Allocetra™ alone, and in combination with a PD1 checkpoint inhibitor, in patients with advanced solid tumors.

Nes-Ziona, Israel, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced a poster presentation at the 37th Annual Meeting of the Society For Immunotherapy Of Cancer, which is taking place both virtually and in-person from November 8, 2022 through November 12, 2022 in Boston, Massachusetts.

Nes-Ziona, Israel, Oct. 03, 2022 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that company management will participate in, and present at, the 4th Macrophage-directed Therapies Summit, which is taking place in Boston, Massachusetts from October 4-6, 2022.