The Hebrew University Hadassah Medical School

Data published today by Dana-Farber Cancer Institute and Hebrew University-Hadassah Medical School to be presented at the American Association of Cancer Research (AACR) Annual Meeting 2024 BROOKLINE, Mass.--(BUSINESS WIRE)-- Edgewood Oncology, a clinical-stage biotechnology company focused on delivering BTX-A51 to patients with hematologic malignancies and genetically-defined solid tumors, today announced the publication of new preclinical data from a study of BTX-A51 in human liposarcoma (LPS) conducted by Dana-Farber Cancer Institute and Hebrew University-Hadassah Medical School to be presented at the AACR Annual Meeting 2024 in San Diego. BTX-A51 is a first-in-class, small molecule, multi-selective kinase inhibitor of casein kinase 1 alpha (CK1α) as well as the transcriptional regulators cyclin-dependent kinases 7 and 9 (CDK7 and CDK9) that synergistically co-targets master regulators of cancer to promote programmed cell death, or apoptosis. The presentation (Abstract 604), “Targeting casein kinase 1 alpha (CK1alpha) and transcriptional CDKs (CDK7/9) in human liposarcomas,” highlighted findings for BTX-A51 in preclinical human models of LPS. The data demonstrate that BTX-A51 has preclinical efficacy in treating patient-derived LPS in cell lines and human xenograft models and provides insight into the synergy gained by inhibiting both CK1α and CDK9. “Dedifferentiated liposarcomas (DDLPS) are rare tumors derived from precursors of fat cells which can occur anywhere in the body. Patients with metastatic DDLPS face a life-threatening disease in need of more effective therapeutic options, which we hope to develop by taking advantage of vulnerabilities in LPS that have been uncovered by recent research on the abnormal DNA and other molecular characteristics of LPS,” said George Demetri, M.D., Professor of Medicine and director of the Sarcoma Center at Dana-Farber. “Based on these data, we believe that it is justified to move BTX-A51 into a clinical trial for patients with LPS, which we will plan to open soon for enrollment.” Liposarcomas are universally characterized by amplification of the mouse double minute 2 homolog (MDM2) gene, which leads to destruction of the normal (non-mutated, also known as “wild type”) p53. The data demonstrate that BTX-A51 significantly reduces the abnormal overexpression of MDM2 in multiple patient-derived LPS cell lines, leading to upregulation of p53 expression and ultimately apoptosis. Finally, BTX-A51 was demonstrated to be well-tolerated and effective in an LPS patient-derived xenograft model. “We’re pleased that investigators at Dana-Farber have taken an interest in BTX-A51, which is currently being evaluated in a Phase 2 combination study with azacitidine in patients with relapsed or refractory (R/R) AML,” said David N. Cook, Ph.D., chief executive officer of Edgewood Oncology. “These data also suggest the potential for BTX-A51 in cancers with MDM2 amplifications, a group of genetically defined tumors that span multiple tissue types suggesting broader potential.” Additional Details about the Study Using three different CDK9-selective inhibitors in human LPS cell lines, the authors showed that CDK9 inhibition suppressed cell growth and induced apoptosis by decreasing MDM2 levels while inducing expression of p53. It was also demonstrated that the potency of CDK9 inhibitors is significantly enhanced upon CK1α depletion. These data led to the investigation of BTX-A51, which targets CK1α and CDK9 as well as CDK7, in LPS cells and has previously been shown to inhibit these kinases with nanomolar efficacy in AML models. BTX-A51 potently reduced expression of MDM2 with marked induction of p53, resulting in apoptosis of LPS cells. BTX-A51 also reduces expression of MCL1 and primes LPS cell lines and primary LPS cells for BIM-induced apoptosis, as demonstrated by BH3 profiling. Importantly, preliminary in vivo data in an LPS patient-derived xenograft model reveal that BTX-A51 is well-tolerated under conditions that inhibit tumor growth. About Edgewood Oncology Edgewood Oncology is a clinical-stage biotechnology company that was founded to deliver on the promise of BTX-A51 for patients with hematologic malignancies and genetically-defined solid tumors. BTX-A51 is a novel small molecule, multi-kinase inhibitor that synergistically co-targets master regulators of cancer to activate programmed cell death, or apoptosis. BTX-A51 holds promise in acute myeloid leukemia and genetically-defined solid tumors, which are the focus of ongoing clinical programs. For more information, please visit , and follow us on LinkedIn. View source version on businesswire.com: Contacts Tracy Lessor TLOW Communications, LLC 617-519-9827 tracy@tlowcommunications.com Source: Edgewood Oncology View this news release online at:

IRVINE, Calif., Oct. 23, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the appointment of Eliezer Katz, M.D., FACS as Chief Medical Officer with responsibility for leading the company’s clinical development programs. “We are pleased to welcome Dr. Katz to the Eledon team,” said David-Alexandre C. Gros, M.D., Eledon Chief Executive Officer. “Dr. Katz brings a wealth of knowledge in the surgical transplantation field together with extensive experience designing and overseeing clinical trials for immunosuppressive treatments. We look forward to his leadership and contributions as we continue to advance tegoprubart for the prevention of rejection in patients undergoing transplantation procedures.” Dr. Katz is an experienced transplant surgeon with significant clinical development experience. Most recently, he was Chief Medical Officer at eGenesis where he helped lead the clinical development of eGenesis’ xenotransplantation programs. Prior to eGenesis, Dr. Katz was Vice President of Clinical Development first at Viela Bio and then at Horizon Therapeutics following its acquisition of Vielo Bio. At Horizon and Viela Bio, Dr. Katz led the clinical development of inebilizumab in multiple autoimmune indications and oversaw the regulatory submission and approval of UPLIZNA®(inebilizumab) to treat neuromyelitis optica spectrum disorder in adults. Prior to Viela Bio, Dr. Katz served as Senior Director of Clinical Development at MedImmune Inc. where he oversaw the clinical development of three different biologics. Prior to MedImmune, Dr. Katz served as Senior Director of Transplantation with the Medicine Development Group at Pfizer. At Pfizer, he oversaw multiple research programs with rapamycin, an anti-rejection drug, and was instrumental in the regulatory submission and FDA approval of rapamycin as a treatment for lymphangioleiomyomatosis (LAM), a rare and fatal lung disease. Before joining industry, Dr. Katz spent two decades as a transplant surgeon. He was director of the abdominal transplantation division at Integris Baptist Medical Center in Oklahoma City, and an associate professor of surgery and the director of the liver transplantation division at the University of Massachusetts Medical Center, Worcester, MA. Dr. Katz spearheaded liver transplantation advances at these institutions and was actively involved with policy making in organ donation and allocation. Dr. Katz earned his M.D. at Hadassah Hebrew University Medical School in Jerusalem. “With tegoprubart, Eledon is well positioned to meet the critical need for innovative transplantation immunosuppressant therapies,” said Dr. Katz. “I’m excited to join Eledon as the company continues to realize its vision to significantly improve the functional life of transplanted organs and address the side effects of current immunosuppressive treatments.” About Eledon Pharmaceuticals and tegoprubart Eledon Pharmaceuticals is a clinical stage biotechnology company with immunology expertise that is developing therapies to protect and prevent rejection of transplanted organs, as well as to treat amyotrophic lateral sclerosis (ALS). The Company’s lead compound in development is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target with broad therapeutic potential. Eledon is headquartered in Irvine, California. For more information, please visit the company’s website at www.eledon.com. Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter Investor Contact: Stephen JasperGilmartin Group(858) 525 2047stephen@gilmartinir.com Media Contact: Jenna UrbanBerry & Company Public Relations(212) 253 8881jurban@berrypr.com Source: Eledon Pharmaceuticals

Data published in Frontiers in Immunology show a robust safety pro 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, Aug. 02, 2023 (GLOBE NEWSWIRE) --Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the peer-reviewed publication of clinical and exploratory data from a Phase Ib and a Phase IIa clinical trial in Frontiers in Immunology. The paper, entitled “Apoptotic cells for treatment of acute respiratory distress syndrome (ARDS) associated with COVID-19” describes a multicenter study that was published in collaboration with researchers at Hadassah-Hebrew University Medical Center, Barzilai Medical Center and Ziv Medical Center Israel. Data presented in the paper was derived from 21 severe and critical COVID-19 patients treated with a single dose of AllocetraTM in addition to standard of care during the peak of the COVID-19 pandemic. 19 out of the 21 treated patients had mild-to-severe ARDS with their COVID-19. The Phase I/II clinical trials evaluated the safety pro Allocetra treatment as well as recovery from ARDS, intensive care unit (ICU) and hospital length-of-stay inflammatory parameters and cytokine/chemokine profile. The mortality rate was compared to a matched control group hospitalized during the same period at Hadassah Medical Center. “This study had excellent results, leading to early discharge from a hospital of 17 out of 19 patients with ARDS along with resolution of the cytokine storms observed in these patients. We believe that the current peer-reviewed publication provides an additional important external validation for AllocetraTM and its broadly applicable mechanism of action in treating ARDS that manifested due to viral infection complications such as severe and critical COVID-19,” said Prof. Dror Mevorach, M.D., Chief Scientific Officer of Enlivex and lead author of the publication. “ARDS is a difficult disease indication with poor treatment options for patients. The global ARDS market size is estimated at approximately $1 billion, and is expected to reach more than $2 billion by 2030,” stated Oren Hershkovitz, CEO of Enlivex. “We believe AllocetraTM could potentially become a leading therapy for ARDS patients, and while Enlivex’s clinical development slate is currently full with multiple clinical trials ongoing and planned for 2024, we will be seeking out-licensing or partnering opportunities to potentially continue via a third party the clinical development of AllocetraTM for ARDS.” Key data and conclusions from the paper include: Allocetra-treated patients (17/19) exhibited rapid resolution from their ARDS. Allocetra-treated patients (N=21) had a mortality rate of 0% with complete recovery of 19/21 patients at the end of the study’s 28-day follow-up period, compared to a mortality rate of 3.8%−8.9% for age- and gender-severe COVID-19-matched patients, and 39%−55% for critical patients. Average duration of hospitalization post-administration of AllocetraTM for discharged patients was 5.6 days All patients had elevated pro- and anti-inflammatory cytokines, chemokines, and additional immune modulators that steadily decreased following AllocetraTM treatment. No serious related adverse events were reported with AllocetraTM treatment with an overall favorable safety profile. ABOUT ALLOCETRA™ Allocetra™ is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra™ has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents. ABOUT ENLIVEX Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. For more information, visit Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would”, “could,” “intends,” “estimates,” “suggests,” “has the potential to” and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRATM programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRATM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission, including in the Company’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law. ENLIVEX CONTACT Shachar Shlosberger, CFO Enlivex Therapeutics, Ltd. shachar@enlivexpharm.com INVESTOR RELATIONS CONTACT Eric Ribner LifeSci Advisors eric@lifesciadvisors.com