On November 13, 2023 MBQ Pharma Inc., a pioneering clinical-stage biopharmaceutical company dedicated to advancing innovative treatments for solid tumor cancers, reported a significant milestone in its journey (Press release, MBQ Pharma, NOV 13, 2023, View Source [SID1234637903]). We are proud to announce that we have dosed the first participant in our Phase 1 clinical trial of MBQ-167. MBQ-167 is the first-in-class drug as a dual inhibitor designed to target two GTPase proteins: Rac and Cdc42. Overexpression of these proteins in cancer cells are considered the primary drivers of solid tumor cancer spread and of cancer cells developing resistance to treatment. MBQ Pharma is extremely proud that MBQ-167 was discovered at the University of Puerto Rico by innovative scientists and that MBQ Pharma has successfully initiated this trial for patients who need additional options after all possible standard cancer therapies have been attempted. This exciting development marks a decisive step forward in the fight against Advanced Breast Cancer (ABC). MBQ Pharma is grateful to the volunteer participants and referring oncologists.
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"We are thrilled to have provided this first dose to our first participant in this important study," said Dr. José F. Rodríguez-Orengo, CEO of MBQ Pharma Inc. "We want to recognize and thank the patient volunteers who are suffering from this horrible disease, their family members and caregivers that support them. Additionally, I want to thank our team members and collaborators who have worked tirelessly to bring this innovative drug to eligible patients enduring a hard battle against ABC. We are committed to advancing MBQ-167 into the clinic with the hope of delivering a new safe and effective treatment option for patients with Advanced Breast Cancer who have failed all available standard of care therapies."
This Phase 1 clinical trial is an open-label, dose-escalation study aimed at establishing the maximum tolerated dose (MTD) of MBQ-167 in patients with ABC. MBQ-167 will be administered orally twice daily for a continuous period of 21 days. Eligible participants may continue to take MBQ-167 twice a day until stopping the drug due to disease progression or other reasons. The trial is being conducted by investigators at FDI Clinical Research in San Juan, PR. You can find further details about the Phase 1 trial of MBQ-167 and contact information for FDICR by visiting ClinicalTrials.gov and using the identifier NCT06075810.
In November 2022, the Congressional Directed Medical Research Program (CDMRP) administered by the US Department of Defense awarded a breakthrough multimillion-dollar grant to MBQ Pharma to initiate the clinical phase of this promising product, aimed at improving patient care for participants with advanced cancer involving metastatic disease. The grant’s support enables the rigorous testing and evaluation within this First-in-Human trial, bringing the innovative solution closer to becoming a reality for those in need.
About MBQ-167
MBQ-167 represents a highly potent and selective small molecule inhibitor, specifically targeting GTPases Rac and Cdc42. We intend to demonstrate in this clinical trial that the inhibition of Rac and Cdc42 GTPases achieved by MBQ-167 can have a profound impact on cancer cells in humans by impeding the proliferation, migration, and invasion of these cells and effectively reducing or preventing their spread to other organs. Preclinical data have demonstrated that this inhibition not only curtails new metastasis but can also have a remarkable inhibition of tumor growth (90%).
Notably, in participants with Advanced Breast Cancer (ABC) and in patients who suffer with many other common cancers such as Lung, Ovarian, Melanoma, Bladder and Pancreatic, the overexpression of Rac and Cdc42 in tumor cells is associated with elevated mortality rates, primarily due to an increased tendency for metastasis.
Additional preclinical investigations have showcased the remarkable effectiveness of MBQ-167, as it exhibited potent and highly selective inhibition of the proliferation of various breast cancer cell lines, encompassing both HER2+ and TNBC (Triple-Negative Breast Cancer) subtypes and in a Pancreatic cancer cell line. MBQ Pharma’s extensive preclinical data reveal, not only the robustness of this inhibition, but also its capacity to deliver enduring antitumor effects with minimal associated toxicity. These findings underscore the promising potential of MBQ-167 as an alternative therapeutic option both as a single-agent and in combination therapy for a broad spectrum of breast cancer patients and potentially many other highly metastatic cancer types.