ALK positive Lung Cancer

Research to Study TUSC2 Combined with ALK-Inhibitors Collaboration with Non-Profit Patient-Focused Research Group Expands Potential Lung Cancer Patient Population for Reqorsa® Gene Therapy AUSTIN, Texas , Oct. 24, 2024 /PRNewswire/ -- 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, today announced the Company has entered into a Sponsored Research Agreement (SRA) with the University of Michigan Rogel Cancer Center to study TUSC2, the tumor suppressor gene used in Genprex's lead drug candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), in combination with ALK-inhibitors in ALK-EML4 positive translocated lung cancer. The Company also announced its collaboration with ALK Positive, a non-profit patient-driven research organization dedicated to improving the life expectancy and quality of life for ALK-positive (ALK+) lung cancer patients. As a part of this collaboration, both Genprex and ALK Positive will share the cost of the SRA with the University of Michigan Rogel Cancer Center. "We are excited to collaborate with the University of Michigan Rogel Cancer Center and ALK Positive, a group that is dedicated to helping patients with this specific subset of lung cancer, to further study how REQORSA in combination with ALK-inhibitors may be a potential therapeutic treatment for ALK+ lung cancer," said Ryan Confer, President and Chief Executive Officer at Genprex. "TUSC2 is often deleted or inactivated in certain types of cancer. Our preclinical data in cell lines with ALK translocations indicate that REQORSA may be effective in combination with ALK inhibitors, and the work in this SRA will build on our earlier studies." As the Company further expands its research program to new tumor targets, REQORSA in combination with ALK-inhibitors could be a potential therapeutic treatment for ALK+ lung cancer. TUSC2 is a tumor suppressor gene that is frequently deleted in lung cancer. In fact, approximately 82% of all non-small cell lung cancers (NSCLCs) have decreased amounts of the TUSC2 tumor suppressor protein. ALK translocations are found in approximately 5% of NSCLCs. Research collaborators at the Rogel Cancer Center's Judith Tam ALK Lung Cancer Research Initiative presented positive preclinical data at the April 2024 American Association for Cancer Research (AACR) Annual Meeting, reporting that REQORSA induced apoptosis in alectinib resistant EML4-ALK positive NSCLC cell lines. Alectinib is an ALK-inhibitor commonly used to treat patients with ALK rearrangements such as EML4-ALK positive NSCLCs. Researchers found that overexpressing TUSC2 using REQORSA treatment in ALK+ lung cancer cell lines inhibited the ability of the cells to form colonies. Ultimately, the study found that the use of REQORSA or a TUSC2-containing plasmid to overexpress TUSC2 in ALK+ NSCLC cell lines was effective in decreasing cell growth and proliferation through the activation of apoptotic pathways. Researchers believe the results of this preclinical work support further clinical study of REQORSA as an anti-ALK NSCLC treatment strategy. Genprex believes this research suggests that REQORSA may be an effective treatment in patients progressing on alectinib. To review the poster presented at the April 2024 AACR Annual meeting, visit Genprex's website. ALK+ lung cancer is a subset of NSCLC that impacts young and relatively healthy individuals. Since the discovery of the ALK-EML4 translocation, there has been research into targeting and treating this malignancy, which has led to approval by the U.S. Food and Drug Administration (FDA) of various ALK-targeted therapies including crizotinib, alectinib and lorlatinib. Although these compounds provide significant benefit in treating ALK-EML4-driven malignancies initially, resistance ultimately develops. The 5-year survival rate of ALK-EML4 translocated lung cancers is 40.9%, which is higher than other types of lung cancer, but the Company believes this percentage leaves substantial room for improvement. About Reqorsa® Gene Therapy REQORSA (quaratusugene ozeplasmid) for NSCLC and small-cell lung cancer (SCLC) consists of the TUSC2 gene expressing plasmid encapsulated in non-viral nanoparticles made from lipid molecules (Genprex's ONCOPREX® 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, such as the ALK pathway, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, decreases cancer cell energy production by decreasing glycolysis, and modulates the immune response against cancer cells. Genprex's strategy is to develop REQORSA in combination with currently approved therapies and believes that REQORSA's unique attributes position it to provide treatments that improve on these current therapies for patients with NSCLC, SCLC, and possibly other cancers. About Genprex, Inc. Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex's technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex's oncology program utilizes its systemic, non-viral Oncoprex® Delivery System which encapsulates the gene-expressing plasmids using lipid-based nanoparticles in a lipoplex form. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company's lead product candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), is being evaluated in two clinical trials as a treatment for NSCLC and SCLC. Each of Genprex's lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex's SCLC program has received an FDA Orphan Drug Designation. Genprex's diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body's immune system. In a similar approach, GPX-002 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells. Interested investors and shareholders are encouraged to sign up for press releases and industry updates by visiting the Company Website, registering for Email Alerts and by following Genprex on Twitter, Facebook and LinkedIn. Cautionary Language Concerning Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex's reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under "Item 1A – Risk Factors" in Genprex's Annual Report on Form 10-K for the year ended December 31, 2023. Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: REQORSA's potential as a therapeutic treatment in combination with ALK-inhibitors for ALK-positive lung cancer; Genprex's ability to advance the clinical development, manufacturing and commercialization of its product candidates in accordance with projected timelines and specifications; the timing and success of Genprex's clinical trials and regulatory approvals; the effect of Genprex's product candidates, alone and in combination with other therapies, on cancer and diabetes; the effects of any strategic research and development prioritization initiatives, and any other strategic alternatives or other efforts that Genprex takes or may take in the future that are aimed at optimizing and re-focusing Genprex's diabetes, oncology and/or other clinical development programs including prioritization of resources, and the extent to which Genprex is able to implement such efforts and initiatives successfully to achieve the desired and intended results thereof; Genprex's future growth and financial status, including Genprex's ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market and to continue as a going concern and to obtain capital to meet its long-term liquidity needs on acceptable terms, or at all; Genprex's commercial and strategic partnerships, including those with its third party vendors, suppliers and manufacturers and their ability to successfully perform and scale up the manufacture of its product candidates; and Genprex's intellectual property and licenses. These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law. Genprex, Inc. (877) 774-GNPX (4679) GNPX Investor Relations [email protected] GNPX Media Contact Kalyn Dabbs [email protected] SOURCE Genprex, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Roche’s Alecensa (alectinib) has been recommended by the National Institute of Health and Care Excellence (NICE) as the first targeted treatment to reduce the risk of anaplastic lymphoma kinase (ALK)-positive lung cancer returning after complete tumour removal. The drug has been specifically recommended by the health technology assessment agency as an adjuvant treatment for adults with stage 1B to 3A ALK-positive non-small cell lung cancer (NSCLC). Lung cancer is the third most common cancer in the UK and NSCLC accounts for approximately 90% of all cases. ALK-positive NSCLC is an aggressive form of the disease and is common in younger patients with little or no smoking history. Just under 100 people in England will be eligible to receive Alecensa, which is taken orally twice daily and designed to specifically target the ALK gene. NICE’s decision was supported by positive results from the late-stage ALINA study, in which Alecensa reduced the risk of disease recurrence or death by 76% compared with standard-of-care platinum-based chemotherapy in patients with completely resected 1b to 3a ALK-positive NSCLC. Alecensa also showed a meaningful delay in central nervous system recurrence or death compared with chemotherapy and appeared to be generally well-tolerated with a manageable toxicity profile. Ouali Omani, UK lead for lung, Roche Products, said: “ALK-positive NSCLC is an aggressive form of lung cancer. Despite currently available treatments, the risk of disease recurrence in those with ALK-positive early-stage NSCLC remains high, so there is still a significant unmet need for treatments for these patients.” The recommendation comes four months after Alecensa was granted approval by the European Commission as an adjuvant treatment for ALK-positive NSCLC patients. Levi Garraway, Roche’s chief medical officer and head of global product development, described the EU regulator’s decision as a “landmark approval for people who have historically faced a high risk of their cancer returning after surgery”. The drug was also recently approved by the US Food and Drug Administration (FDA) as an adjuvant treatment following tumour resection for patients with ALK-positive NSCLC, as detected by an FDA-approved test.

Four newly inducted members represent the lived experience of lung cancer, advocacy, health equity, and business leadership WASHINGTON, July 22, 2024 /PRNewswire/ -- Today, LUNGevity Foundation, the nation's leading nonprofit dedicated to transforming how people are diagnosed and live with lung cancer through research, education, and support, is proud to announce the expansion of its Board of Directors. The four new members are Bob Newman, chairman of ASM Global; Terri Ann DiJulio, three-time lung cancer survivor and advocate; Barry Nelson, retired risk management professional and lung cancer survivor; and Frank Sierawski, general director of Union Pacific Railroad and long-term lung cancer survivor. New LUNGevity board member Terri Ann DiJulio is a three-time lung cancer survivor, a stroke survivor, and a member of a multigenerational lung cancer family. She actively promotes early detection through her speaking events and media platforms and shares how her experiences have profoundly changed her perspective and gratitude for every day. New LUNGevity board member Barry Nelson is a retired risk management professional who has found meaning in his lung cancer diagnosis through passionate advocacy. He is an experienced speaker at conferences, where he draws from his personal journey as a cancer survivor and clinical trial participant. New LUNGevity board member Bob Newman, chairman of ASM Global, one of the most respected executives in the venue industry in both the public and private sectors. Bob has a personal family connection to cancer that motivates his advocacy and philanthropy. New LUNGevity board member Frank Sierawski, general director of Union Pacific Railroad, is a 10+ year late-stage lung cancer survivor who has been the beneficiary of biomarker testing and breakthrough technologies. Frank actively advocates for LUNGevity and the ALK+ lung cancer community.