env

Top-line results from Phase 1 study expected in second quarter of 2025 JUPITER, Fla., Sept. 6, 2024 /PRNewswire/ -- Cytonics Corporation, a private biotechnology company developing biologic therapies for inflammatory musculoskeletal conditions, today announced completion of enrollment for their Phase 1 clinical study of CYT-108, a recombinant variant of the alpha-2-macroglobulin blood serum protease inhibitor, as a putative disease-modifying therapy for osteoarthritis (OA). This first-in-human clinical trial is a multi-center, 6-month, double-blind RCT (n=22, randomized 1:1 between treatment and placebo groups) evaluating the safety and efficacy of CYT-108 in patients with unilateral, mild-to-moderate, primary OA of the knee. The primary safety endpoints will measure CYT-108's tolerability when delivered via intra-articular injection directly into afflicted joints. The secondary efficacy endpoints will assess improvement in self-reported pain and mobility in the treated joint, and an exploratory endpoint will quantify peptide fragments found in blood serum as a biomarker for cartilage degradation. To date, no drug-related adverse events have been reported and CYT-108 appears well-tolerated in all patients. "We are thrilled to have completed enrollment of all 22 patients across our three clinical sites in Australia, beating our recruitment forecast by more than a month. This will expedite the Phase 1 clinical study report and our IND filing with the FDA in 2025, bringing us one step closer to developing the first and only disease-modifying therapy for osteoarthritis. We are thoroughly impressed by the recruitment efficiency of our clinical sites and look forward to continuing working with these researchers and clinicians as we advance into Phase 2." ~ Joey Bose, President & CEO, Cytonics Corp. About CYT-108 CYT-108 is a recombinant variant of the endogenous alpha-2-macroglobulin (A2M) blood serum protein. The "bait" region of the protein, which serves as a substrate for proteases, was engineered to increase its affinity for specific proteases that are known to play a significant role in the molecular pathogenesis of osteoarthritis. The combination of both highly specific and broad-spectrum protease inhibition activity of CYT-108 differentiates this novel biologic from other attempts to develop small molecule inhibitors that target a single proteases, positioning CYT-108 as an ideal disease-modifying candidate for osteoarthritis. The development of CYT-108 is predicated on the success of Cytonics' first-generation therapy, the Autologous Protease Inhibitor Concentrate (APIC) system, which is a 510(k) medical device that selectively enriches autologous A2M for intra-articular injection into joints containing articular cartilage (knee, shoulder, spine, hip, etc.). The clinical and commercial success of APIC uniquely de-risks the development of CYT-108 because it is already understood that high concentrations of A2M can be introduced into arthritic joints without significant side effects, and the treatment has achieved clinical and commercial success since it was first cleared by the FDA as a 510(k) device and sold in 2015. About Cytonics Corp. Cytonics, founded in 2006, is a private research and development company focused on developing molecular diagnostics and therapeutics for chronic musculoskeletal diseases such as osteoarthritis. The company's flagship product was a diagnostic test (the Fibronectin-Aggrecan Complex Test, FACT) which helps identify the source of joint pain and assists physicians in determining the most appropriate course of treatment. Cytonics then developed the Autologous Platelet-Integrated Concentrate (APIC) system which concentrates a therapeutic blood protein, A2M, from patients' own blood and injects the A2M-rich concentrate into damaged joints. APIC has been used to treat over 8,000 patients nationwide, saving thousands of patients from invasive joint replacement surgeries. The company has raised over $25M in private funding and was awarded $1.8M in grants from the NIH to pursue their innovative research. The company is currently pursuing Phase 1 clinical studies for their lead drug candidate, CYT-108, a recombinant variant of the endogenous alpha-2-macroglobuling protease inhibitor. If approved, CYT-108 may be the first and only disease-modifying therapy for osteoarthritis. Forward Looking Statements This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the progress of and plans related to the Company's product candidates, clinical studies and preclinical research and development programs, the therapeutic and market potential of the Company's research and development programs and product candidates, the Company's clinical and product development strategy, and the Company's expectations regarding progress and timelines. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company's research and development programs and product candidates may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company's product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company's product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company's product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company's ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company's product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, and the risk that the Company may incur operating expenses in amounts greater than anticipated. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company's periodic filings with the Securities and Exchange Commission (), including but not limited to the Company's most recently filed periodic report, and from time to time in the Company's press releases and other investor communications. Cytonics Corporation is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise. SOURCE Cytonics Corporation

Some HIV-1 carriers who have received an early antiretroviral treatment during several years are able to control the virus for a long term after treatment interruption. However, the mechanisms enabling this post-treatment control have not been fully elucidated. Scientists have now investigated and revealed how neutralizing antibodies, including those described as broadly neutralizing, contribute to virus control. A clinical trial involving the use of broadly neutralizing antibodies should begin in France before the end of 2023. Some HIV-1 carriers who have received an early antiretroviral treatment during several years are able to control the virus for a long term after treatment interruption. However, the mechanisms enabling this post-treatment control have not been fully elucidated. For the first time, teams of scientists from the Institut Pasteur, Inserm and the Paris Public Hospital Network (AP-HP), supported by ANRS | Emerging Infectious Diseases, have investigated and revealed how neutralizing antibodies, including those described as broadly neutralizing, contribute to virus control. These key findings were published in the journal Cell Host & Microbe on July 10, 2023. A clinical trial involving the use of broadly neutralizing antibodies should begin in France before the end of 2023. "Post-treatment controllers" is the term used to describe the rare HIV-1 carriers who, having initiated treatment early and maintained it for several years, are able to control the virus for years after that the treatment has been discontinued. These individuals were identified several years ago in part through the VISCONTI[1] study, which assembled the largest cohort of long-term post-treatment controllers in France. Although the mechanisms of viral control enabling the long-term remission from HIV-1 infection without antiretroviral therapy have not been fully elucidated, the identification of these cases provides a unique opportunity to refine our understanding of the factors associated to HIV-1 infection control. A study conducted by the Institut Pasteur's Humoral Immunology Unit led by Dr. Hugo Mouquet in collaboration with the team led by Dr. Asier Sáez-Cirión, Head of the Institut Pasteur's Viral Reservoirs and Immune Control Unit, is now contributing to efforts to describe these mechanisms in more detail. Asier Saéz-Cirión explains: "Our investigation published in 2020 on the immune response in post-treatment controllers marked a major first step in demonstrating an effective and robust antibody response to HIV-1 in some of these individuals, which may contribute to this control[2]. This knowledge has now been further advanced by our new study. By investigating the role of antibodies in a specific "post-treatment controller" case with particularly high serum levels of broadly neutralizing antibodies, we discovered that remission was probably linked to the activity of this type of antibodies." Hugo Mouquet describes the discovery: "Our study describes for the first time in a post-treatment controller a family of broadly neutralizing antibodies (bNAbs) targeting the HIV-1 envelope protein, of which the antibody EPTC112 is one of the most active member." The antibody EPTC112 neutralizes about a third of the 200 viral variants of HIV-1[3] tested in vitro and is able to induce the elimination of infected cells in the presence of natural killer (NK) cells, the immune cells eliminating abnormal cells in the body. This study therefore provides important insights on how neutralizing antibodies modify the course of HIV-1 infection in this individual from the VISCONTI cohort. Although the HIV-1 virus circulating in this subject was found to be resistant to EPTC112 neutralization due to mutations in the region targeted by this antibody, it was effectively neutralized by other antibody populations isolated from the blood of the individual. Hence, the study suggests that neutralizing antibodies from the EPTC112 family impose a selective pressure on the HIV-1 virus. Although the virus escaped the action of these bNAbs, it remained susceptible to the neutralization by other anti-HIV-1 antibodies produced in this individual. This observation suggests the existence of a cooperation between the various populations of neutralizing antibodies. "The fact that we discovered a potential link between the production of neutralizing antibodies, including bNAbs, and the HIV-1 control is exciting to better understand the underlying mechanisms of viral control, particularly by studying additional post-treatment controllers with similar pro Indeed, we wish to continue investigating on a short term whether the antibody responses in other 'post-treatment' controllers also contribute to long-term remission from the infection," explains Hugo Mouquet. This discovery paves the way for new avenues of HIV-1 therapy and fuels hopes of therapeutic approaches for increasing the chances of remission without antiretroviral treatment through the use of broadly neutralizing antibodies. To this end, a clinical trial involving the administration of broadly neutralizing antibodies[4] should begin in France before the end of 2023. "This Phase II trial conducted by the ANRS RHIVIERA consortium through a partnership between the Institut Pasteur, AP-HP, Inserm and the Rockefeller University in New York, will investigate the combination of an antiretroviral therapy in the primary infection phase with two long-acting HIV-1 bNAbs versus placebo to determine whether these antibodies contribute to establishing viral remission after antiretroviral treatment discontinuation. 69 patients in the primary HIV-1 infection[5] phase are planned to be enrolled. They will first receive a short-term antiretroviral treatment, followed by a therapy with the two bNAbs targeting two different regions of the virus envelope protein. It will be possible to stop therapy after a year of close monitoring based on a detailed set of criteria. This trial will enable us to determine whether this therapeutic strategy is able to induce a sufficient immune response to control the infection after the discontinuation of antiretroviral therapy," concludes Hugo Mouquet. [1] HIV: The Antibodies of "Post-treatment Controllers" [2] Transient viral exposure drives functionally coordinated humoral immune responses in HIV-1 post-treatment controllers study, Nature Communication, April 11, 2022 [3] There are two types of HIV: HIV-1 and HIV-2 that differ from each other at molecular level. Variants occurring within these two types exhibit different levels of transmissibility, virulence and immunogenicity due to the various mutations associated with them. [4] [5] Primary infection: early phase of HIV-1 infection during which the viral load is high. The HIV virus invades the body, attacking the immune system and destroying its CD4 lymphocyte reservoirs.

Uvax Bio-owned vaccines demonstrated significant improvement in immune response compared with current vaccine strategies Phase 1 clinical trial sponsored by National Institutes of Health expected to commence in2024 NEWARK, Del., April 26, 2023 (GLOBE NEWSWIRE) -- Uvax Bio, LLC, a privately held, preclinical-stage vaccine company, today announced that its HIV vaccine candidates have shown significant improvement in immune response compared with current vaccine strategies, according to results from preclinical studies described in a paper published in Nature Communications titled, “Single-component multilayered self-assembling protein nanoparticles presenting glycan-trimmed uncleaved prefusion optimized envelope trimers as HIV-1 vaccine candidates.” Based on these results, the National Institutes of Health (NIH) has agreed to sponsor a Phase 1 clinical trial in healthy volunteers which is expected to launch in the first quarter of 2024. “With this design we appear to have solved a big piece of the HIV vaccine puzzle,” said Jiang Zhu, Ph.D., senior author of the study, associate professor in the Department of Integrative Structural and Computational Biology at Scripps Research, and Co-Founder of Uvax Bio. The single-component self-assembling protein nanoparticle (1c-SApNP®) platform vaccine technology and the lead HIV vaccine candidates utilized in the studies have been exclusively licensed to Uvax Bio under a comprehensive agreement with Scripps Research. The novel vaccine design uses tiny protein “nanoparticles” to display multiple copies of HIV’s envelope glycoprotein (Env), mimicking HIV particles and inducing a strong immune response in hosts without causing HIV infection. The key innovation can be attributed to flexible sugar molecules called glycans, which normally cover Env on the real virus but are shortened in the new design allowing the antigens to be further exposed to the human immune system to induce functional antibodies. “Dr. Zhu and his team at Scripps Research have made tremendous innovations in HIV vaccine design that we believe have the potential to improve outcomes in patients,” said Ji Li, Ph.D., Chief Executive Officer of Uvax Bio. Uvax Bio is currently conducting two final preclinical studies in preparation for the submission of an Investigational New Drug (IND) application. GMP lot manufacturing was completed earlier this year on the two vaccine candidates which will be used in the Phase 1 clinical trial. Stability testing is underway with two months of stability at standard refrigeration and under accelerated conditions reported to date. About HIV/AIDS The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates that 38.4 million people worldwide are currently living with HIV, and 1.5 million people became newly infected with HIV in 2021 alone. According to the latest estimates from the Centers for Disease Control and Prevention (CDC), approximately 34,800 new HIV infections occurred in the United States in 2019. Apart from very rare cases involving bone marrow transplants, there is no cure for the infection, which must be held in check indefinitely with antiviral drugs to keep it from progressing to the deadly immune deficiency condition known as AIDS. About Uvax Bio Uvax Bio, a spin-off vaccine company from Scripps Research, employs proprietary 1c-SApNP® platform technology invented by Dr. Jiang Zhu of Scripps Research to develop and commercialize prophylactic vaccines for challenging infectious diseases. Uvax Bio holds the exclusive worldwide rights to the 1c-SApNP® platform and an expanding portfolio of 12 patented preclinical vaccine candidates. In addition to the leading candidates in HIV, Uvax is also working to advance its vaccines for Universal Flu and RSV. The company’s technology enables the production of virus-like protein particles that can display 20-60 stabilized antigens targeting a wide range of viral and bacterial diseases. The vaccines are produced using a single step, universal, cell-based manufacturing process. For more information, visit . Contact Kevin O’Neill SVP, Corporate Strategy info@uvaxbio.com 302-595-2285