On October 4, 2023 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that research collaborators will present positive clinical and preclinical data from studies of its lead product candidate, REQORSA (quaratusugene ozeplasmid) used for the treatment of lung cancers, at the 2023 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) taking place from October 11-15, 2023 at the Hynes Convention Center in Boston (Press release, Genprex, OCT 4, 2023, View Source [SID1234635638]). REQORSA is a non-viral gene therapy that leads to expression of the TUSC2 tumor suppressor gene in cancers.
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"The encouraging Phase 1 results in the Acclaim-1 trial document REQORSA’s favorable safety profile thus far and show early efficacy in patients with non-small cell lung cancer (NSCLC) whose disease has progressed on Tagrisso. Importantly, there were no Dose Limiting Toxicities. Based on these results, the Safety Review Committee has recommended that we move forward with the Phase 2 expansion portion of the study, which moves us one step closer to our goal of bringing this potentially life-saving therapy to patients," said Rodney Varner, Chairman, President and Chief Executive Officer at Genprex. "In addition, the preclinical data presented by our research collaborators is very encouraging, as we know that despite the broader success of immunotherapies, such as checkpoint inhibitors, they have limited efficacy in the treatment of small cell lung cancer. We look forward to evaluating REQORSA in combination with a checkpoint inhibitor to treat SCLC in our upcoming Acclaim-3 clinical trial, where we have both FDA Fast Track and Orphan Drug Designations for this patient population."
Details of the presentations are outlined below:
Title: "Completion of Acclaim-1 dose escalation: Recommended Phase 2 dose of quaratusugene ozeplasmid gene therapy and osimertinib"
Poster Number: AO65
Date/Time: Thursday, October 12, 2023 from 12:30 pm – 4:00 pm ET
Presenter: Alexander I. Spira, M.D., PhD, Virginia Cancer Specialists, Fairfax, VA
Dr. Spira’s presentation will focus on the results of the Phase 1 dose escalation portion of the Acclaim-1 clinical trial of REQORSA in combination with Tagrisso (osimertinib) to treat late-stage NSCLC. Results showed REQORSA was generally well tolerated with no Dose Limiting Toxicities. Of the 12 patients treated with escalating doses of REQORSA and standard doses of Tagrisso, all of whom had progressed on Tagrisso containing regimens, two patients experienced prolonged time to progression, including one with continuing partial response. While REQORSA administration was associated with delayed infusion-related reactions of muscle aches, fever and chills in some patients, this was managed with prophylactic steroids, acetaminophen and diphenhydramine, and symptoms decreased with repeat cycles.
The study’s Safety Review Committee met and determined that the recommended Phase 2 dose for REQORSA in combination with Tagrisso in patients with NSCLC progressing after Tagrisso treatment will be 0.12 mg/kg. This was the highest dose level delivered in the Phase 1 portion and is twice the highest dose level delivered in Genprex’s prior clinical trial combining REQORSA with Tarceva (erlotinib) for the treatment of late-stage NSCLC. The SRC also recommended the trial advance to the Phase 2 expansion portion of the study.
The combination of REQORSA and Tagrisso received U.S. Food and Drug Administration’s (FDA) Fast Track Designation for treatment of the Acclaim-1 patient population.
Title: "TUSC2 immunogene therapy enhances checkpoint blockade through increased cytotoxic immune activation in chemo-resistant small cell lung cancer (SCLC) in humanized mice"
Poster Number: AO66
Date/Time: Thursday, October 12, 2023 from 12:30 pm – 4:00 pm ET
Presenter: Ismail Meraz, Ph.D., Senior Research Project Manager, The University of Texas MD Anderson Cancer Center
The study evaluated REQORSA, referred to as TUSC2 gene therapy in the abstract, in combination with the immune checkpoint inhibitor Tecentriq (atezolizumab) for the treatment of chemotherapy resistant SCLC tumors in humanized mice. The use of humanized mice allowed an evaluation of the human immune cell subtypes that infiltrated the tumor.
Study authors concluded that TUSC2 expression is reduced in almost all SCLC tumors and absent in 41%. The researchers investigated the antitumor response to TUSC2 gene therapy in combination with Tecentriq. The data show that TUSC2 gene therapy in combination with Tecentriq induces strong antitumor activity in a chemo-resistant SCLC through cytotoxic CD8 T- and NK-cell activation, as the study found that CD8 T and NK-cell infiltration in the tumor was increased by REQORSA.
The combination of REQORSA and the checkpoint inhibitor Tecentriq received FDA Fast Track and Orphan Drug Designations for treatment of the Acclaim-3 patient population.
Genprex’s ONCOPREX Nanoparticle Delivery System is a novel non-viral approach utilizing lipid nanoparticles to deliver tumor suppressor genes that have been deleted during the course of cancer development. The platform allows for the intravenous delivery of various tumor suppressor genes, and potentially other genes, to achieve a therapeutic affect without the risk of the type of toxicity often associated with viral delivery systems.
The aforementioned 2023 AACR (Free AACR Whitepaper)-NCI-EORTC posters will be available on Genprex’s website here following the completion of their live presentations.
About the Acclaim Clinical Trials in Lung Cancers
Genprex currently has three clinical trials evaluating the Company’s lead drug candidate, REQORSA (quaratusugene ozeplasmid) in lung cancer. The Acclaim-1 clinical trial, whose patient population received FDA Fast Track Designation, is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Tagrisso (osimertinib) in patients with late-stage NSCLC with activating epidermal growth factor receptor mutations whose disease progressed after treatment with Tagrisso. The Acclaim-2 clinical trial, whose patient population received FDA Fast Track Designation, is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Keytruda (pembrolizumab) in patients with late-stage NSCLC whose disease progressed after treatment with Keytruda. The upcoming Acclaim-3 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Tecentriq (atezolizumab) as maintenance therapy in patients with extensive-stage SCLC who did not develop tumor progression after receiving Tecentriq and chemotherapy as an initial treatment. The FDA granted both Fast Track and Orphan Drug Designation for REQORSA in the Acclaim-3 patient population.
About REQORSA Immunogene Therapy
REQORSA (quaratusugene ozeplasmid) for NSCLC and SCLC consists of the TUSC2 gene expressing plasmid encapsulated in non-viral nanoparticles made from lipid molecules (Genprex’s ONCOPREX Nanoparticle Delivery System) with a positive electrical charge. REQORSA is injected intravenously and specifically targets cancer cells, which generally have a negative electrical charge. REQORSA is designed to deliver the functioning TUSC2 gene to cancer cells while minimizing their uptake by normal tissue. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells.