MEK3

Results affirm the advantages of Prota's remission peanut OIT treatments, which lead to significant and sustained benefits including substantially improved Health Related Quality of Life Study underscores the need to aim for remission as the optimal treatment outcome. Highlights significant long-term benefits provided by two high-dose peanut oral immunotherapy treatments that induce remission of allergy. MELBOURNE, Australia, Aug. 14, 2024 /PRNewswire/ -- Prota Therapeutics Pty Ltd (Prota), an Australian clinical-stage biotechnology company focused on the development of novel oral immunotherapy treatments that induce remission of allergy, today announced publication in the journal Allergy of the first long-term study directly comparing remission and desensitization endpoints following food allergen oral immunotherapy (OIT). The Phase 2b follow-on study also reports 2-year post-treatment outcomes for Prota's remission-inducing high-dose peanut oral immunotherapies: PRT120, a standalone high-dose OIT, and PRT100, a probiotic OIT combination treatment, which were previously shown to induce remission of peanut allergy in 51% and 46% of treated patients, respectively. Continue Reading Groundbreaking Study Reveals Long-Term Benefits of Achieving Remission with Prota Therapeutics’ Novel Peanut Allergy Treatments: The latest findings from the PPOIT-003LT study highlight the enduring benefits of Prota’s high-dose remission-inducing oral immunotherapies, including substantially improved health related quality of life. The PPOIT-003LT study, a continuation of the Phase 2b PPOIT-003 randomized, multi-center trial, provides significant insights into the long-term outcomes of children who received one of two remission-inducing high-dose peanut oral immunotherapies: a Peanut Oral Immunotherapy on its own (OIT) or a combined Probiotic Peanut Oral Immunotherapy (PPOIT). The study directly compared the long-term benefits and risks associated with the different treatment outcomes -- remission, desensitization and allergy, and also reported long-term outcomes for OIT and PPOIT compared to placebo. Findings validate remission as a preferred outcome to desensitization. Participants who achieved remission following treatment were able to stop treatment and safely consume peanuts freely. At two years after completing treatment, remission participants reported fewer peanut ingestion reactions, with no moderate or severe reactions, no rescue epinephrine injector use, and most importantly, significantly greater improvement in quality of life compared to participants who only achieved desensitization. Participants who were only desensitized had difficulty maintaining their required daily peanut ingestion dose and continued to report severe reactions that required rescue epinephrine treatment. They did not experience any improvement in quality of life compared to the allergic group. Findings also confirmed that both the high-dose OIT (PRT120) and the combination PPOIT (PRT100) treatments provide lasting benefits that persist or are improved upon during the 2-year period after stopping treatment. At 2-years after completing treatment with either PRT120 or PRT100, children experienced fewer reactions over time, and continued to enjoy significantly improved health related quality of life (HRQOL) compared to the placebo group. Key Findings A standalone high-dose peanut oral immunotherapy (OIT) and a combination probiotic high-dose peanut oral immunotherapy (PPOIT) that induced remission of peanut allergy in 51% and 46% of treated patients, respectively, were shown to provide lasting benefits at 2-years after treatment, including significantly improved quality of life compared with placebo-treated patients. Participants with remission were half as likely to have an allergic reaction to peanut compared with desensitized patients (15.9% in the remission group, 36.8% in the desensitized group). In the 2nd-year after treatment, remission participants had no moderate or severe reactions and no rescue epinephrine use; whereas 24% of reactions in desensitized participants were moderate or severe, and 14.3% of desensitized participants required rescue epinephrine to treat reactions. Participants who achieved remission reported substantial and clinically meaningful improvement in health-related quality of life (HRQOL) compared with both desensitized participants and those who remained allergic; whereas participants who were only desensitized (without remission) showed no improvement in HRQOL compared with allergic participants. Study Design Participants: 151 of the 176 (86%) eligible children aged 1-10 with confirmed peanut allergy who completed the Phase 2b PPOIT-003 randomized trial. Study endpoints: Comparison of long-term outcomes by clinical allergy status: remission, desensitization (without remission) and persistent allergy; comparison of long-term outcomes by treatment group: High-dose peanut oral immunotherapy (OIT), Probiotic Peanut Oral Immunotherapy (PPOIT), and placebo. Outcomes Measured: Peanut ingestion, reactions, and health-related quality of life (HRQOL) at 1-year and 2-years after treatment. Summary The follow-on study, PPOIT-003LT, showed two key findings: Remission is a demonstrably better outcome for patients than only being desensitized or remaining allergic. Remission participants reported fewer and milder allergic reactions to peanut (with no requirement for rescue epinephrine) compared to desensitized patients and, most importantly, experienced substantially better quality of life compared to both desensitized and allergic participants. The clinical benefits of both the high-dose OIT (Prota's lead product, PRT120) and PPOIT are sustained or even improved upon in the long-term, with continuing reductions in reactions to peanut over time, particularly for remission participants, and lasting quality of life improvements compared with placebo treatment. Among benefits of achieving remission Freedom from ongoing treatment. Reduction in allergic reactions, and in severity of reactions. Substantial HRQOL improvements. Positive attitudes toward peanut consumption. Psychological benefits including reduced anxiety. According to the study Principal Investigator, Paxton Loke, Ph.D., Research Clinician in the Allergy Immunology group at the Murdoch Children's Research Institute (MCRI), "Remission offers a more favorable long-term outcome in terms of reduced reactions and improved quality of life compared to desensitization without remission or persistent allergy. This study underscores the need to aim for remission as the optimal clinical outcome." "The findings from the PPOIT-003LT study highlight the significant benefits of achieving remission through PRT120 treatment, a high-dose rapid escalation oral immunotherapy for peanut allergies," said Lead Investigator Professor Mimi Tang, Ph.D., Director of the Allergy Translation Centre and Head of Allergy Immunology at the Murdoch Children's Research Institute (MCRI), and CEO of Prota Therapeutics. About Prota Therapeutics Prota Therapeutics is an Australian proprietary limited late clinical-stage biotech company dedicated to advancing allergen oral immunotherapies for treating food allergies, particularly addressing the prevalent and potentially life-threatening issue of peanut allergy. Established in 2016 to develop and commercialize novel oral immunotherapy treatments, Prota holds an exclusive license to the proprietary food immunotherapy technology developed at the Murdoch Children's Research Institute (MCRI). For more information please visit: . About Murdoch Children's Research Institute Murdoch Children's Research Institute is the largest child health research institute in Australia committed to making discoveries and developing treatments to improve child and adolescent health in Australia and around the world. They are pioneering new treatments, trialling better vaccines and improving ways of diagnosing and helping sick babies, children and adolescents. It is one of the only research institutes in Australia to offer genetic testing to find answers for families of children with previously undiagnosed conditions. SOURCE Prota Therapeutics

Garden City, NY, May 03, 2023 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (Formerly Known as Quigley Corporation) (NASDAQ: PRPH) (“ProPhase”), a next-generation biotech, genomics and diagnostics company, today provided an update regarding its progress and development strategy for Linebacker-1 (LB-1). Linebacker is a small molecule, multi-kinase inhibitor that is being developed by the Company’s wholly owned subsidiary, ProPhase BioPharma, Inc. (“PBIO”), as a potential mono-therapy and co-therapy option for hard-to-treat cancers. Originally viewed as a co-therapy, the pre-clinical data generated has given PBIO reason to believe that LB-1 will also be very effective as a mono-therapy. In Q1 of 2023, ProPhase collaborated with Eurofins, a globally recognized leading drug discovery company, to execute an in-depth analysis (KINOMEscan™ Profiling Service) of Linebacker-1 to determine how many cancer-relevant kinases were affected by Linebacker-1 out of a possible 468 enzymes. ProPhase was excited to learn that numerous critically important kinase targets were inhibited more than 99%. Some of the most inhibited pathways are those well known to promote tumorigenesis, such as the phosphoinositide 3-kinase family (e.g., PIKfyive, PIP5k1 and 2) and the mitogen-activated protein kinase family (e.g., MEK3, 4, and 5). Importantly, the Eurofins analysis revealed several unique targets affected by Linebacker-1 that cancer research organizations highlight as critically important, for which no other pharmaceutical company has developed drugs to treat. We believe the unique interplay of Linebacker with multiple cancer-dependent pathways will be a true differentiator within current treatment paradigms. Kinase families have been explored since the very beginning of targeted cancer therapies, as they are often upregulated and/or dysregulated in a number of cancer situations. There are 538 kinases encoded into the human genome and many of them have already been targeted as key areas for intervention in this multi-billion-dollar space. The largest targeted drugs starting with Novartis’s Gleevec and extending to Nexavar, Xalkori, Tasigna, and many others have led the way toward treating many types of cancers as chronic conditions. Billions of development dollars have gone into this area, but there are still many untargeted areas in the kinase space, providing a unique opportunity for Linebacker-1 to become a breakthrough drug in the fight against cancer. In line with these impressive results, Linebacker-1 has demonstrated strong preclinical potential in a number of difficult diseases, including tough-to-treat lung and gastric cancers. As development continues, we intend to position Linebacker-1 as a potential new option for cancer patients suffering from a current lack of quality treatment options. At ProPhase we believe in following biological foundations. Often times, scientific data is under appreciated in the pharmacological space. The decision to further mine existing results for valuable and directed data is therefore a priority for us. Analyzing the current Linebacker results against over 200 cancer models and 500 protein-protein interactions, ProPhase will now embark into a cutting-edge, machine learning stage in which all Linebacker-driven interactions and outcomes will be cross-referenced in a manner that further elucidates specific pathways particularly impacted by this one-of-a-kind molecule. This will allow for a more accurate and more likely-to-succeed path towards the clinic, ultimately saving time, money, and most importantly, patients’ lives. We intend to focus a majority of 2023 on developing a more in-depth understanding of the unique pathways we believe Linebacker may impact, as well as taking the necessary steps to meet the requirements for an IND submission to the FDA including: Cross-over analysis and machine learning to elucidate most affected signaling pathways Maximum Tolerated Dose (MTD) studies and safety confirmations Opportunities for synergies with existing, but underwhelming, commercial medicines Optimization of treatable neoplastic conditions within unsaturated areas “The two-year bear market for microcap companies has led to some phenomenal opportunities in the biotech and life sciences space and specifically for our company,” said Ted Karkus, CEO of ProPhase Labs. “The financial success of our diagnostic business over the past two years enabled us to acquire some fantastic under-valued assets, while strengthening our company’s core infrastructure. We are confident that we will be able to leverage this infrastructure and platform to develop our new, exciting initiatives with multi-billion-dollar potential, including our development of the Linebacker portfolio. These continuing positive preliminary results from the Linebacker-1 pre-clinical studies continue to bolster our confidence and support the new directions that we are taking with our company with the goal of continuing to significantly grow the underlying value. We look forward to providing updates in the coming weeks on additional Linebacker pre-clinical studies that are being conducted in parallel. We also look forward to providing updates on other strategic initiatives that have so much potential.” About Linebacker Linebacker is a modified polyphenol. Polyphenols are substances found in many nuts, vegetables and berries. Linebacker compounds are modified Myricetin, which is a common plant-derived flavonoid. Myricetin exhibits a wide range of activities that include strong antioxidant, anti-cancer, antidiabetic and anti-inflammatory activities. It displays activities that are related to the central nervous system. LB-1 is Mono-chlorinated Myricetin with a Chlorine atom substituted for the Hydroxy group at 5’ (position 5 on the B-ring). LB-2 is Di-chlorinated Myricetin with Chlorine atoms substituted for the Hydroxy groups at 5’ and 7 (position 5 on the B-ring and position 7 on the A-ring). About Eurofins Eurofins Discovery has supported Drug Discovery research for over 40 years. They are recognized as the industry leader for providing drug discovery researchers with the largest and most diverse portfolio of standard and custom in vitro safety & pharmacology assays and panels for drug screening and profiling. In addition to their in vitro safety pharmacology strengths, they also offer a broad portfolio of over 3500 drug discovery services and 1800 products. These include medicinal and synthetic chemistry, in vitro pharmacology, safety pharmacology & efficacy, ADME-Tox, cell-based phenotypic assays, and custom proteins and assay development capabilities. Eurofins supports a variety of drug discovery targets such as GPCRs, Kinases, Ion Channels, Nuclear Hormone Receptors and other proteins & enzymes. Their broad global service capabilities and decades of experience in providing drug discovery services result in the delivery of high quality, reproducible study performance with few repeats and high client satisfaction. Eurofins Discovery's capabilities, expertise, knowledge and skill sets enable them to provide their clients with the benefit of being able to work with a single outsourcing provider (CRO) for their drug discovery programs. About ProPhase Labs ProPhase Labs, Inc. (Nasdaq: PRPH) (“ProPhase”) is a next-generation biotech, genomics and diagnostics company. Our goal is to create a healthier world with bold action and the power of insight. We’re revolutionizing healthcare with industry-leading Whole Genome Sequencing solutions, while developing potential game changer diagnostics and therapeutics in the fight against cancer. This includes a potentially life-saving cancer test focused on early detection of esophageal cancer and potential breakthrough cancer therapeutics with novel mechanisms of action. Our world-class CLIA labs and cutting-edge diagnostic technology provide wellness solutions for healthcare providers and consumers. We develop, manufacture, and commercialize health and wellness solutions to enable people to live their best lives. We are committed to executional excellence, smart diversification, and a synergistic, omni-channel approach. ProPhase Labs’ valuable subsidiaries, their synergies, and significant growth underscores our multi-billion dollar potential. Forward Looking Statements Except for the historical information contained herein, this document contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our strategy, plans, objectives and initiatives and our beliefs regarding the potential of Linebacker-1 to treat various hard-to-treat cancers. Management believes that these forward-looking statements are reasonable as and when made. However, such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. These risks and uncertainties include but are not limited to our ability to obtain and maintain necessary regulatory approvals, general economic conditions, consumer demand for our products and services, challenges relating to entering into and growing new business lines, the competitive environment, and the risk factors listed from time to time in our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and any other SEC filings. The Company undertakes no obligation to update forward-looking statements except as required by applicable securities laws. Readers are cautioned that forward-looking statements are not guarantees of future performance and are cautioned not to place undue reliance on any forward-looking statements. For more information, visit . Media Relations and Institutional Investor Contact: ProPhase Labs, Inc. 267-880-1111 investorrelations@prophaselabs.com Retail Investor Relations Contact: Renmark Financial Communications John Boidman 514-939-3989 Jboidman@renmarkfinancial.com Source: ProPhase Labs, Inc. ###