- Initiated dosing of three patients in first cohort of Phase 1 clinical trial of QN-302 for treatment of advanced or metastatic solid tumors
- Phase 1a patient recruitment ongoing; company anticipates sharing update on safety and preliminary efficacy in second quarter of 2024
- Expect to select lead Pan-RAS inhibitor candidate for IND enabling studies in first quarter of 2024
Highlights:
QN-302
- Announced first cohort of three patients initially dosed in the Phase 1 clinical trial of QN-302 for treatment of advanced or metastatic solid tumors
- Presented scientific data on QN-302 at
AACR Special Conference : Pancreatic Cancer, inOctober 2023 :- “The Pan G-Quadruplex experimental drug QN-302 in PDAC: identification of potential biomarkers for clinical studies” by
Ahmed Ahmed ,Tariq Arshad , andStephen Neidle .- Studies showed that increased expression of S100P and CX3CL1 correlated with human pancreatic ductal adenocarcinoma (PDAC) disease progression – both gene targets previously proposed as potential biomarkers (Poster).
- “Target genes in pancreatic cancer cells of the Pan G-Quadruplex clinical candidate compound QN-302 revealed by comparative transcriptome profiling” by
Ahmed Ahmed ,Tariq Arshad ,Maria Roman-Escorza ,Dan Neidle , andStephen Neidle .- Studies showed that administering QN-302 to PDAC cells produced significant changes in the pattern of down-regulated G-quadruplex (G4) genes (Poster).
- “The Pan G-Quadruplex experimental drug QN-302 in PDAC: identification of potential biomarkers for clinical studies” by
- Partnered with TD2 for Phase 1 clinical development of QN-302 for the treatment of advanced or metastatic solid tumors.
Pan-RAS
- Presented poster highlighting Qualigen Therapeutics’ Pan-RAS inhibitor platform at
AACR Special Conference : Advances in Breast Cancer, inOct 2023 :- “Pan-RAS Inhibitors to Treat Luminal B Breast Cancer” by
Geoff Clark ,Raphael N. Jigo , Howard Donninger.- Our RAS inhibitors suppressed the interaction of RAS with its downstream mitogenic effectors and suppressed RAS signaling pathways (MAPK and RAL pathways) in Luminal B breast cell model systems (Poster).
- Our RAS inhibitors suppressed the interaction of RAS with its downstream mitogenic effectors and suppressed RAS signaling pathways (MAPK and RAL pathways) in Luminal B breast cell model systems (Poster).
- “Pan-RAS Inhibitors to Treat Luminal B Breast Cancer” by
Dear Shareholders:
In the third quarter to date this year, we completed our transition from a diversified life science company to a streamlined clinical stage therapeutics company focused on execution and judicious capital deployment toward our differentiated oncology pipeline for the benefit of patients worldwide. In July we announced the divestiture of our FastPack® diagnostics business for approximately
Our team and collaborators have worked diligently to advance our QN-302 program on time and within budget. We are excited to announce the initiation of dosing of not only our first patient, but of our first cohort of three patients in the Phase 1a dose escalation portion of our clinical trial of QN-302, an investigational G4-selective transcription inhibitor. This follows the announcement of QN-302 receiving US FDA Investigational New Drug (IND) clearance to initiate the clinical trial in July and the announcement of first patient dosed last week. Our Pan-RAS inhibitor platform continues to present compelling in vivo data in multiple cancer models as we make progress toward identifying a lead candidate for IND-enabling studies under our sponsored research collaboration with the University of
About Our Phase 1 Clinical Trial for QN-302
As stated above, our focus in 2023 has been the swift execution of business priorities. We initiated IND-enabling studies for QN-302 in
Details of our Phase 1 study are as follows:
Title: A Phase I, Multicenter, Open-label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacodynamics, and Pharmacokinetics of Intravenous QN-302 in Patients With Advanced or Metastatic Solid Tumors
Pending the Company’s ability to secure additional capital, up to 36 patients will be enrolled in the dose escalation (Phase 1a) portion of the study. The exact number of patients to be enrolled will depend on the observed safety profile. The dose expansion (Phase 1b) cohort may enroll up to an additional 20 patients with advanced, metastatic solid tumors. The expansion cohort will further evaluate safety and assess for antitumor effect of QN-302.
The primary objectives of this Phase 1a study are:
- To determine the MTD and the dose-limiting toxicities (DLTs) of QN-302 monotherapy in patients with advanced or metastatic solid tumors that have not responded to or have recurred following treatment with available therapies.
- To establish the dose of QN-302 recommended for future studies (the Recommended Phase 2 Dose [RP2D]).
The secondary objectives of the Phase 1a study are:
- To determine the pharmacokinetics of QN-302.
- Explore the pharmacodynamic effects of QN-302 on selected tumor biomarkers.
- To observe patients for any evidence of antitumor activity of QN-302 by objective radiographic assessment.
About Our Pan-RAS Inhibitor Platform
We continue to build our data package for our lead optimization stage Pan-RAS inhibitor platform. Along with our team at the
We believe RAS continues to be a promising target. RAS is the most common cancer oncogene and activating mutations occur in one of the three human RAS gene isoforms (KRAS, HRAS, or NRAS) are present in about one-fourth of all cancers. In fact, mutant KRAS is found in 98% of pancreatic ductal adenocarcinomas, 52% of colon cancers, and 32% of lung adenocarcinomas. We believe a Pan-RAS inhibitor can complement other therapeutic approaches in development and are looking to advance potential partnerships for this compelling platform. Our goal is to select a lead compound for IND-enabling studies in the first quarter of 2024 and to present new data at major conferences throughout the year.
We are proud of what our team and collaborators have accomplished in the third quarter this year and beyond. For the remainder of the fourth quarter and into 2024 our plan is to continue to execute and deploy capital judiciously on what we believe will be the highest return on investment activities without sacrificing quality, and most importantly, activities for patients who are relying on new therapeutic treatment options. We are encouraged by the feedback we have received at our two active clinical trial sites and welcome potentially adding additional sites next year. We plan to share updates with our QN-302 program and Pan-RAS inhibitor platform in Q1 next year, as well as provide an update on safety and preliminary efficacy for our Phase 1a study for QN-302 in the first half of 2024.
Thank you again for your support.
Sincerely,
About
Forward-Looking Statements
This news release contains forward-looking statements by
The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
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ir@qlgntx.com.
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