Genprex Provides Business Update and Outlook for 2024
- Successful completion of the Phase 1 portion of the Acclaim-1 clinical trial in lung cancer
- Receipt of a third Fast Track Designation for REQORSA Immunogene Therapy from the FDA
- Process improvements in manufacturing operations and securing new supplies of REQORSA
- None.
Insights
The recent update from Genprex, Inc. regarding their ongoing clinical trials and anticipated regulatory interactions signals a potentially significant advancement in gene therapy treatments for both cancer and diabetes. The reported completion of Phase 1 of the Acclaim-1 clinical trial and the progress towards Phase 2a enrollment are key milestones, as Phase 2 trials are critical for establishing the efficacy of a drug. The multimodal mechanism of action of REQORSA, which includes interrupting cancer cell signaling, promoting apoptosis and modulating immune response, suggests a comprehensive approach to cancer treatment that could offer benefits over existing therapies.
Furthermore, the Fast Track and Orphan Drug Designations by the FDA for REQORSA indicate a recognition of the therapy's potential to address unmet medical needs, potentially expediting its review process. However, it's important to note that the clinical efficacy and safety of REQORSA must be conclusively demonstrated in the ongoing trials before any commercialization can occur. The expansion of patent coverage internationally also enhances the company's intellectual property position, potentially increasing the commercial value of REQORSA upon successful trial outcomes.
Genprex's announcements have direct implications for investors and stakeholders, given that clinical trial advancements and regulatory designations can significantly influence a biotech company's stock performance. The transition from early to later-stage clinical trials typically results in increased investor attention and can affect stock volatility. The company's ability to secure new supplies of REQORSA and improve manufacturing processes can be seen as proactive measures to ensure smooth clinical trial progression and future market supply, which are positive indicators for operational efficiency and risk management.
However, investors should consider the inherent risks associated with clinical-stage biotech investments, including the possibility of trial failures, regulatory hurdles and the challenges of commercialization. The long-term financial impact will be contingent upon successful trial outcomes, regulatory approvals and the ability to capture market share in the competitive oncology and diabetes treatment landscapes.
The strategic expansion of Genprex's patent portfolio to include key markets such as Australia, Chile and China is a significant development. Patents play a crucial role in protecting the commercial interests of biotech firms, preventing competitors from entering the market with similar products. The addition of patents covering the use of REQORSA with immune checkpoint inhibitors broadens the scope of the company's proprietary technology and can be a critical factor in negotiating potential partnerships or licensing agreements.
It's essential to monitor the enforcement and validity of these patents, as well as any future intellectual property litigation, which can impact the company's market exclusivity and revenue potential. Additionally, the company's ongoing research collaborations and presentations at scientific conferences serve not only to validate their technology but also to maintain visibility in the scientific community, which can be beneficial for attracting investment and strategic partnerships.
Acclaim-1 Phase 2a and Acclaim-3 Phase 1 clinical studies opening for enrollment in January 2024
Poised for FDA guidance regarding diabetes gene therapy program in 2024
"We are very proud of what we accomplished in 2023, particularly with the successful completion of the Phase 1 portion of our Acclaim-1 clinical trial in lung cancer," said Rodney Varner, Chairman, President and Chief Executive Officer at Genprex. "In 2023, we also received a third Fast Track Designation for Reqorsa® Immunogene Therapy from the
Oncology Gene Therapy Platform
Genprex's oncology program utilizes its systemic, non-viral Oncoprex® Nanoparticle Delivery System which encapsulates the gene-expressing plasmids using lipid nanoparticles. 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 (quaratusugene ozeplasmid), is being evaluated in three clinical trials as a treatment for non-small cell lung cancer ("NSCLC") and small cell lung cancer ("SCLC"), and each of the three lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population.
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 apoptosis (programmed cell death) in cancer cells, and modulates the immune response against cancer cells. In early studies, REQORSA has been shown to be complementary with targeted drugs and immunotherapies. 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.
Important events of the year included:
- In April, at the 2023 Annual Meeting of the American Association for Cancer Research (AACR 2023), Genprex collaborators presented preclinincal gene therapy data with NPRL2, another tumor suppressor gene, that further validates the ONCOPREX Nanoparticle Delivery System as a platform
- In October, Genprex hosted a Key Opinion Leader virtual event, "Bringing Gene Therapy to the Fight Against Lung Cancers" which discussed the use of gene therapies, including REQORSA, in the fight against lung cancer
- In December, Genprex completed the successful production of a new batch of REQORSA thereby securing REQORSA supply for its Acclaim clinical studies
- Collaborators submitted abstracts in 2023 and are expecting to present data at the American Association for Cancer Research (AACR) Meeting in April 2024
Acclaim-1:
The Acclaim-1 study is a Phase 1/2 clinical trial that has three portions - a Phase 1 dose escalation which has been completed, a Phase 2a expansion, and a Phase 2b randomized portion. Acclaim-1 uses a combination of REQORSA and AstraZeneca's Tagrisso® in patients with late-stage NSCLC that has activating epidermal growth factor receptor mutations and progression after treatment with Tagrisso. This novel approach to targeting lung cancer has demonstrated a strong safety profile with early signs of efficacy.
- In May, Genprex completed the Phase 1 portion of the Acclaim-1 clinical trial and reported encouraging results. The Acclaim-1 Phase 1 study had no Dose Limiting Toxicities and results established a Phase 2 Recommended Dose, as well as provided data showing efficacy of REQORSA in combination with Tagrisso®
- In May, after completion of the Phase 1 portion of the Acclaim-1 trial, the Safety Review Committee ("SRC") approved advancement from the Phase 1 dose escalation portion of the trial to the Phase 2a expansion portion of the trial
- In October, clinical collaborators presented a poster presentation at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics showing the Phase 1 results of the Acclaim-1 study
- In January 2024, Genprex expects to open the Phase 2a expansion portion of the Acclaim-1 study for enrollment
- Genprex expects to complete the enrollment of 19 patients in each cohort of the Phase 2a expansion portion of the study by the end of 2024
Acclaim-2:
The Acclaim-2 study is a Phase 1/2 clinical trial that has three portions - a Phase 1 dose escalation portion, a Phase 2a expansion portion, and a Phase 2b randomized portion. The Acclaim-2 trial uses a combination of REQORSA and Merck & Co.'s Keytruda® in patients with late-stage NSCLC whose disease has progressed after treatment with Keytruda. Patients are treated at the 0.06 mg/kg dose level in the first cohort of patients and, subject to the Acclaim-2 SRC approval, will be treated at successive dose levels of 0.09 mg/kg and 0.12 mg/kg.
- Expanding on the previously granted patents in the
U.S. ,Japan ,Mexico andRussia , Genprex was granted patents inAustralia ,Chile andChina to cover the use of REQORSA in combination with immune checkpoint inhibtors, e.g., PD1 and PDL1 inhibitors. These patents are applicable to Genprex's Acclaim-2 and Acclaim-3 clinical trials. - In the second half of 2024, Genprex expects to complete enrollment in the Phase 1 dose escalation portion of the Acclaim-2 study
Acclaim-3:
The Acclaim-3 study has two portions - a Phase 1 dose escalation portion and a Phase 2 expansion portion. In November 2022 Genprex filed with the FDA the protocol for the Phase 1/2 Acclaim-3 clinical trial using a combination of REQORSA and Genentech, Inc.'s Tecentriq® as maintenance therapy for patients with extensive stage small cell lung cancer ("ES-SCLC") who develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced.
- In June, the FDA granted Fast Track Designation for the Acclaim-3 treatment combination of REQORSA and Tecentriq as maintenance therapy in patients with ES-SCLC who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment
- In August, the FDA granted Orphan Drug Designation to REQORSA for the treatment of SCLC
- In January 2024, Genprex expects to open the Phase 1 portion of the Acclaim-3 study for enrollment, and expects to complete the Phase 1 portion of the study by the second half of 2024
- In the second half of 2024, Genprex expects to start the Phase 2 portion of the Acclaim-3 study
Diabetes Gene Therapy Platform
Genprex's diabetes gene therapy approach is comprised of an infusion process that uses an adeno-associated virus ("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-003 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells. Genprex has exclusively licensed from the University of
- In February, Genprex's research collaborators at the University of Pittsburgh presented preclinical data in a NHP model of Type 1 diabetes highlighting the therapeutic potential of GPX-002. These data, presented during an oral presentation at the 16th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2023), showed statistically significant decreases in insulin requirements, increased c-peptide levels and improved glucose tolerance compared to baseline.
- In April, the Company hosted a Key Opinion Leader virtual event, "Novel Gene Therapy to Treat Type 1 Diabetes," which discussed preclinical data reported at ATTD 2023 supporting gene therapy to treat Ttype 1 diabetes
- Finalized the components of the diabetes construct to take forward for nonclinical studies
- In December, Genprex submitted a request to meet with the FDA to obtain their guidance on the nonclinical studies needed to file an Investigational New Drug application and initiate first-in-human studies. As a result of the FDA's response, the Company will continue with its planned additional nonclinical studies before requesting regulatory guidance in 2024 for the IND-enabling studies.
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® Nanoparticle Delivery System which encapsulates the gene-expressing plasmids using lipid nanoparticles. 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® Immunogene Therapy (quaratusugene ozeplasmid), is being evaluated in three clinical trials as a treatment for NSCLC and SCLC. Each of Genprex's three 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-003 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, 2022.
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: 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; 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
investors@genprex.com
GNPX Media Contact
Kalyn Dabbs
media@genprex.com
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SOURCE Genprex, Inc.
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