ProPhase Labs provides update on Linebacker-1 cancer co-therapy program

ProPhase Labs provided an update regarding its progress and development strategy for Linebacker-1, LB-1, a small molecule PIM kinase inhibitor that is being developed by the Company’s wholly owned subsidiary, ProPhase BioPharma, as a potential therapy enhancer for traditional chemotherapeutic agents to both increase efficacy and decrease toxicity in current cancer treatments. "We are excited to provide this update on our progress with the Linebacker-1 cancer co-therapy program, a platform which we believe has multi-billion-dollar potential in oncology as well as significant potential in other areas," commented Ted Karkus, ProPhase Lab’s Chief Executive Officer. "We look forward to sharing additional updates on our progress throughout the year as we advance toward a potential IND application submission in mid-2024." In January 2023, REPROCELL completed its independent review of Linebacker-1, which included testing of 25 cell lines with LB-1 and confirmed previous in vitro studies conducted by Charles River. These cell lines confirmed efficacy of LB-1 on ovarian, kidney, colon and lung adenocarcinoma/small cells. The two-year research collaboration for Linebacker-1 with Dana-Farber Cancer Institute and Harvard Medical School has officially commenced, with cell culture studies currently ongoing. The ongoing studies are focused on identifying the most effective combination of cancer cell lines and agents with LB-1. ProPhase expects to initiate the preclinical requirements for investigational new drug application submission in the fourth quarter of 2023. These requirements include: Study Protocol Design: select optimized co-therapy combo from animal study and complete the protocol design for IND submission; Toxicity Testing: toxicological studies on small animals according to study protocol; Dosing Studies: dosing studies on small animals according to study protocol; Large Animal Studies: combined therapy studies on large animals according to study protocol. ProPhase aims to submit its IND application for Linebacker-1 in mid-2024. The Company plans to operate its own Phase 1 safety study for LB-1 and will seek a strategic partner for future development following Phase 1. The Company estimates that the total cost for development prior to exploring a strategic partner will be $3 – $5 million.