On November 5, 2021 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 (Press release, Reven Holdings, NOV 5, 2021, View Source [SID1234594611]).
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Reven reported the publication of a peer-reviewed article in the prestigious medical journal Frontiers in Oncology. The article reports a systematic analysis of the antibody responses to COVID-19 vaccination in cancer patients. This analysis was completed in collaboration with the Hacettepe University Cancer Institute team in Ankara/Turkey and Ares Pharmaceuticals, LLC in St. Paul, MN. COVID-19 vaccine seroconversion rates (i.e., antibody development success) were substantially lower in patients with hematologic malignancies (example: leukemias and lymphomas) and cancer patients receiving chemotherapy or immunosuppressive treatments than controls who did not have cancer.
The article, "Antibody Responses to COVID-19 Vaccination in Cancer: A Systematic Review," has been published in Frontiers in Oncology, and it is available online. To view the online publication, click here: http://journal.frontiersin.org/article/10.3389/fonc.2021.759108/full?&utm_source=Email_to_authors_&utm_medium=Email&utm_content=T1_11.5e1_author&utm_campaign=Email_publication&field=&journalName=Frontiers_in_Oncology&id=759108
Citation: Guven DC, Sahin TK, Kilickap S and Uckun FM (2021) Antibody Responses to COVID-19 Vaccination in Cancer: A Systematic Review. Front. Oncol. 11:759108. doi: 10.3389/fonc.2021.759108
The corresponding author, Executive Vice-President for Global Medical Affairs and Chief Medical Officer of Reven, Dr. Fatih Uckun MD PhD, explained: "We are reporting the challenges for oncology patients in achieving adaptive immunity against COVID-19. This report illustrates the importance of developing effective treatments against high-risk COVID-19 and COVID-19-associated cytokine release syndrome (CRS) considering the poor performance of vaccinations in cancer patients. Reven’s clinical development efforts for our lead COVID-19 drug candidate RJX are aimed at reducing the risk of life-threatening complications of COVID-19 and accelerating the full recovery of high-risk patients, such as those with cancer."
"This paper illustrates the importance of our randomized trial to address unmet needs in COVID-19 therapy," added Peter Lange, the CEO of Reven.
Reven had recently announced the successful completion of Part 1 of the Two-Part, Two Cohort Multi-Center Phase I/II trial of RJX in hospitalized high-risk COVID-19 patients. 12 hospitalized adult patients with symptomatic high-risk COVID-19 pneumonia and abnormally elevated inflammation markers in the blood were treated with daily intravenous infusions of RJX in combination with standard of care. Nine (9) of the 12 patients, including 3 patients with hypoxemic respiratory failure, had shown rapid clinical recovery with normalization of the abnormally elevated inflammation markers in the blood and were discharged from hospital at a median of 5 days. All patients tolerated their RJX infusions without any side effects. An Independent Data and Safety Monitoring Board (DSMB) that oversees and acts independently from the Reven project team had reviewed the clinical data in all 12 patients, and approved the initiation of the randomized, double-blind Part 2 portion of the Phase 2 study.
10 patients have already been enrolled and dosed in the randomized, double-blind, placebo-controlled Part 2 portion of the Phase 2 study (ClinicalTrials.gov Identifier: NCT04708340; View Source). This FDA-approved controlled clinical trial is aimed at evaluating the efficacy and safety of RJX in side-by-side comparison with a placebo as an adjunct to standard of care in hospitalized COVID-19 patients. Michael Volk, Director and Chief Strategy Officer of Reven, stated, "We are excited about the rapid progress in our clinical program against COVID-19."
"We are expecting topline data from this very important study by end of 2021," said Brian Denomme, Reven’s President.
"We are diligently advancing the clinical development of RJX," said Fatih Uckun, MD PhD.
RJX is an intravenous (IV) formulation of a patented first-in-class pharmaceutical composition containing a specific mixture of antioxidant and anti-inflammatory ingredients that is being developed for more effective treatment of patients with inflammatory disorders, including COVID-19 patients with viral sepsis, multi-system inflammation, cytokine release syndrome (CRS), shock, ARDS, and multi-organ failure. The FDA-approved clinical trial is aimed at evaluating the efficacy and safety of RJX as an adjunct to standard of care in hospitalized COVID-19 patients, who have high-risk features for progression to severe disease and ARDS and patients with hypoxemic respiratory failure receiving either non-invasive positive pressure ventilation (NIPPV) or high flow oxygen, who have not yet developed ARDS to require mechanical ventilation. Since RJX is a potent anti-oxidant and anti-inflammatory agent that has been shown to reduce the tissue-level oxidative stress in multiple organs in animal models of severe systemic inflammation, shock, cytokine storm, and multiorgan failure, Reven hopes that it will contribute to prevention of progression of COVID-19 and its faster resolution in high-risk patients.
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).