Reven Holdings Announces the Launch of Its Translational Oncology Program: Targeting Tumor Microenvironment to Improve Treatment Outcomes in Cancer

WESTMINSTER, Colo.–(BUSINESS WIRE)–Reven Holdings, Inc. (“Reven”) is a privately held clinical stage biotechnology and pharmaceutical company dedicated to the discovery and development of novel treatment platforms for cancer, viral illnesses, including COVID-19 – and inflammatory disorders.

Reven has launched its translational oncology program as a new drug discovery and development initiative that is aimed at changing the therapeutic landscape for difficult-to-treat forms of cancer. The overarching goal of this program is to treat cancer patients more effectively by altering the immediate surroundings of their tumor tissue, also known as the tumor microenvironment (TME). That is because TME is a key contributor to disease progression and metastasis. Several cells in the TME prevent patient’s immune system elements from mounting a strong immune response against cancer cells. Reven Pharmaceuticals is committed to developing new strategies aimed at overcoming the immunosuppressive TME. Specifically, Reven will employ its lead compound RJX for targeting the TGF-beta signaling in cancer patients. Transforming growth factor (TGF)-beta can limit the T-cell infiltration to the TME and inhibits T-cells as well as NK-cells with leads to a markedly diminished anti-tumor immune response within the TME. In addition to the TGF pathway, The SYK-PI3K-AKT signaling pathway is also critical for the survival of cancer cells. Reven Pharmaceuticals will explore new generation inhibitors of this biochemical signaling pathway as a new class of anti-cancer drugs.

Another oncology platform being explored by Reven Pharmaceuticals targets the so-called “Lactate Shuttle” in the TME. Cancer cells specifically use lactate to mediate several environment changes that support tumor growth and stimulate more lactate production. Targeting the “lactate shuttle” by facilitating lactate clearance may eliminate the contribution of lactate to the immunosuppressive TME in cancer patients. It is noteworthy that ingredients of Reven’s anti-inflammatory, investigational drug product RJX have been shown to facilitate lactate clearance.

Dr. Fatih Uckun, the Chief Medical Officer of Reven Pharmaceuticals reviews the proof of concept and clinical impact potential of such innovative strategies aimed at the TME in cancer patients with multiple myeloma in a recent article that was published in the prestigious peer-reviewed high-impact biomedical journal Cancers. The article was published on April 22, 2021:

Uckun, F.M. Overcoming the Immunosuppressive Tumor Microenvironment in Multiple Myeloma. Cancers 2021, 13, 2018. https://www.mdpi.com/2072-6694/13/9/2018#cite

“Scientific data from multiple studies suggest a tremendous therapeutic potential for the RJX platform and provide the foundation for our optimism regarding the commercialization potential of RJX,” said Brian Denomme, Co-founder, President and Chief Operating Officer. “This new article emphasizes our commitment to advancing our pipeline for cancer patients through our translational oncology program,” stated Michael Volk, Chief Strategy Officer of Reven. CEO Peter Lange added: “Our goal is to leverage the most recent R&D discoveries about health benefits of TME targeting strategies in our efforts aimed at building a rich product pipeline that includes rationally designed anti-cancer agents that are optimized for specific target indications”.

About Rejuveinix (RJX)

RJX is an intravenous (IV) formulation of physiologically compatible compounds that is being developed for more effective treatment of patients with sepsis, including COVID-19 patients with viral sepsis and acute respiratory distress syndrome (ARDS). The clinical safety and tolerability of RJX was confirmed in a recently completed double blind, placebo-controlled Phase 1 dose-escalation study in healthy volunteers (ClinicalTrials.gov Identifier: NCT03680105). It is currently being evaluated as a COVID-19 drug candidate in high risk COVID-19 patients (ClinicalTrials.gov Identifier: NCT NCT04708340; https://clinicaltrials.gov/ct2/show/NCT04708340).

About Dr. Uckun

Dr. Uckun is an elected Member of the American Society for Clinical Investigation (ASCI), an honor society for physician-scientists, and an active member of several professional organizations. He received numerous awards for his work on monoclonal antibodies, recombinant cytokines and fusion proteins, radiation sensitizers, kinase inhibitors and targeted therapeutics for difficult-to-treat cancers, including the Stohlman Memorial Award of the Leukemia Society of America, the highest honor given to a Leukemia Society Scholar. He has served as a member of several editorial boards and National Institutes of Health grant review/special emphasis panels.

Dr. Uckun earned his doctoral degrees at the University of Heidelberg, Germany where he also served as an active member of the autologous bone marrow transplant and peripheral stem cell transplant clinical research teams of the Tumor Center. Dr. Uckun completed his residency training in pediatrics, clinical fellowship training in Hematology/Oncology/Blood and Bone Marrow Stem Cell Transplantation, as well as postdoctoral research training in immunology and microbiology at the University of Minnesota. Dr. Uckun has more than thirty years of professional experience in developmental therapeutics with a special emphasis on targeted therapeutics/precision medicines and biopharmaceuticals. He has published more than 500 peer-reviewed papers, authored numerous review articles and book chapters, and is an inventor on numerous patents.

For eleven years, Dr. Uckun worked as a Professor of Bone Marrow Transplantation, Therapeutic Radiology-Radiation Oncology, Pharmacology, and Pediatrics as well as Director of the Biotherapy Institute at the University of Minnesota, where he became the first recipient of the Endowed Hughes Chair in Biotherapy. At the Keck School of Medicine of the University of Southern California, he was a Professor and Head of Translational Research in Leukemia and Lymphoma of the CCBD and a Principal Investigator of the Stem Cell-Regenerative Medicine Initiative for six years. From 2012 to 2015, Dr. Uckun served as chair of the Biotargeting Working Group and a Member of the Coordination and Governance Committee of the National Cancer Institute Alliance for Nanotechnology in Cancer.

Dr. Uckun has held executive positions in multiple biotechnology companies and has extensive regulatory experience. Prior to joining Reven as its Chief Medical Officer and Chief Scientific Officer, Dr. Uckun served as Vice President of Scientific Solutions at Worldwide Clinical Trials, Chief Medical Officer of Oncotelic and Mateon Therapeutics, Head of Immuno-Oncology at Ares Pharmaceuticals, and as Executive Medical Director and Strategy Lead in Global Oncology and Hematology at Syneos Health. Previously, he was Vice President of Research and Clinical Development at Nantkwest, and Chief Scientific Officer of both Jupiter Research Institute and Paradigm Pharmaceuticals. Dr. Uckun is a former Vice Chair of the New Agents Committee as well as a Member of the Leukemia Steering Committee of the Children’s Cancer Study Group, an NCI-funded cooperative clinical trials consortium that coordinated pediatric and adolescent/young adult leukemia trials at 120 institutions in the U.S., Canada, Australia and Europe.

Dr. Uckun has deep knowledge and experience in the treatment of infectious diseases and their complications as well. In particular, he has extensive experience in viral, fungal, and bacterial infections of immunocompromised hosts, septic shock, ARDS, systemic capillary leak syndrome and cytokine release syndrome (CRS). He served as the Principal Investigator of a virus neutralizer project funded by the Defense Advanced Research Projects Agency (DARPA) as part of its unconventional countermeasures program. Dr. Uckun directed several federally funded virology/innate immunity projects and published numerous peer-reviewed papers on RNA viruses and anti-viral agents.

About Reven Holdings, Inc.

Reven Holdings, Inc., a Delaware corporation, through its Golden, Colorado based operating company Reven, LLC, is a biopharmaceutical company. Reven’s vision is to make a difference in the world by making its products accessible to everyone suffering the effects of vascular and metabolic related diseases. Reven is committed to being the premier, research-intensive biopharmaceutical company that advances the health and well-being of people around the world. Its primary product, Rejuveinix (RJX), targets patients suffering from COVID-19, sepsis, vascular and metabolic related diseases as well as specific patient populations suffering PAD and other cardiovascular related medical conditions.

Reven’s Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as “may”, “on-track”, “expect”, “anticipate” “hope”, “vision”, “optimism”, “design”, “exciting”, “promising”, “will”, “conviction”, “estimate,” “intend,” “believe” and similar expressions are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about future plans, the progress, timing, clinical development, scope and success of future clinical trials, the reporting of clinical data for the company’s product candidates and the potential use of the company’s product candidates to treat various disease indications. Each of these forward-looking statements involves risks and uncertainties, and actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing market competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates, and unexpected litigation or other disputes. These risks are not exhaustive; the company faces known and unknown risks, including the risk factors described in the company’s periodic SEC filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether as a result of new information regarding future events, or otherwise.

Contacts

Michael Volk, Chief Strategy Officer

[email protected]