Welcome to our dedicated page for Enlivex Therapeutics Ltd. Ordinary Shares news (Ticker: ENLV), a resource for investors and traders seeking the latest updates and insights on Enlivex Therapeutics Ltd. Ordinary Shares stock.
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 Ltd. (Nasdaq: ENLV) announced a significant advancement in its patent strategy. The U.S. Patent and Trademark Office has issued a Notice of Allowance for patent application number 16/076,026. This patent will extend intellectual property protection for the company's Allocetra™ therapy in combination with CAR T-cell therapy until at least 2036. Allocetra™ is designed to reprogram macrophages, potentially addressing unmet medical needs in diseases like solid cancers and sepsis. The patent is expected to be formally issued in 2023, enhancing the company's position in the competitive field of immunotherapy.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced the appointment of Andrew Singer to its Board of Directors on April 17, 2023. With over 25 years in biotechnology and corporate finance, Singer previously served as EVP and CFO of Epizyme and held senior roles at major investment banks. He has led transactions exceeding $13 billion in the biopharmaceutical sector. Singer expressed enthusiasm about joining Enlivex at a critical time for the company, emphasizing the potential of its macrophage reprogramming therapy, Allocetra, which aims to address unmet medical needs in various serious conditions. Executive Chairman Shai Novik highlighted Singer's extensive experience as a perfect fit for Enlivex's strategic vision.
H.C. Wainwright & Co. has reaffirmed a buy rating for Enlivex Therapeutics Ltd. (NASDAQ:ENLV) with a 12-month price target of $15 per share, valuing the company at $320 million. While a net loss of $1.75 per share is anticipated in 2023 due to elevated R&D expenses, the company's cash reserves of $50.2 million should sustain operations through mid-2024. Enlivex is set to present topline data from its clinical trials for the immunotherapy Allocetra, including a collaboration with BeiGene Ltd to amend its phase 1/2a trial. Positive interim results could broaden Allocetra's applications in treating solid tumors, potentially overcoming previous failures in the checkpoint inhibitor market.
Enlivex Therapeutics Ltd (NASDAQ:ENLV) announced a clinical collaboration with Beigene Ltd to explore a new combination therapy targeting advanced-stage solid tumors. This collaboration aims to integrate Allocetra, Enlivex's macrophage reprogramming immunotherapy, with tislelizumab, an anti-PD-1 immune checkpoint inhibitor from Beigene. The amended Phase 1/2a trial will include approximately 48 patients and assess the safety and efficacy of the combination therapy. A successful outcome could enhance immune system response against cancer. Previous preclinical studies have shown promising results, with an 83% increase in survival rate observed in ovarian cancer models. The trial's enrollment is set to conclude by the end of Q2 2023.
Enlivex Therapeutics (Nasdaq: ENLV) reported its full-year 2022 financial results and unveiled updates on clinical programs. A collaboration with BeiGene was announced on April 3, 2023, to explore Allocetra™, a cell therapy, in treating advanced-stage solid tumors. The company plans to amend its sepsis trial protocol to broaden patient inclusion and shift from four cohorts to two. Positive recommendations were received to continue two Phase I/II trials, with data readouts expected by Q2 2024. Research expenses rose to $18.6 million, with a net loss of $31 million for the fiscal year 2022. Cash reserves stood at $50.2 million as of year-end.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced a clinical collaboration with BeiGene to integrate Allocetra™, a macrophage-reprogramming cell therapy, into an ongoing Phase I/II trial for patients with advanced solid tumors. This trial will evaluate Allocetra in conjunction with tislelizumab, an anti-PD-1 immune checkpoint inhibitor. The study will involve up to 48 patients with escalated doses administered intravenously or intraperitoneally. Tislelizumab, developed to minimize binding to macrophages, aims to enhance anti-tumor activity. The collaboration underscores the potential of combinatorial cancer treatments and the unique properties of Allocetra.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) reported that an independent Data and Safety Monitoring Board has completed an interim review for its Phase I/II trial of Allocetra™, a macrophage reprogramming therapy, in patients with advanced-stage peritoneal metastasis. The Israeli Ministry of Health approved the continuation of the trial and allowed the escalation of Allocetra™ doses for the next patient cohort. No safety concerns were identified in the first cohort of three patients, supporting a move to higher doses. The trial seeks to evaluate safety and efficacy, with a total enrollment of 12 patients.
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