Optimization of treatable neoplastic conditions within unsaturated areas.Opportunities for synergies with existing, but underwhelming, commercial medicines.Maximum Tolerated Dose (MTD) studies and safety confirmations.Cross-over analysis and machine learning to elucidate most affected signaling pathways.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: 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. 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. The decision to further mine existing results for valuable and directed data is therefore a priority for us. Often times, scientific data is under appreciated in the pharmacological space. 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.Īt ProPhase we believe in following biological foundations. 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. 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. 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. 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. 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. We believe the unique interplay of Linebacker with multiple cancer-dependent pathways will be a true differentiator within current treatment paradigms. 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. 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). ProPhase was excited to learn that numerous critically important kinase targets were inhibited more than 99%. 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. 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. (“PBIO”), as a potential mono-therapy and co-therapy option for hard-to-treat cancers. Linebacker is a small molecule, multi-kinase inhibitor that is being developed by the Company’s wholly owned subsidiary, ProPhase BioPharma, Inc. (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). Garden City, NY, (GLOBE NEWSWIRE) - ProPhase Labs, Inc.
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