Genprex Releases New Video Featuring Chief Medical Officer Discussing Positive Patient Outcomes in Two Lung Cancer Clinical Trials
Genprex (NASDAQ: GNPX) has released a new video featuring Chief Medical Officer Dr. Mark Berger discussing positive patient outcomes in two lung cancer clinical trials. The Acclaim-1 trial, evaluating Reqorsa® Gene Therapy with Tagrisso® for late-stage NSCLC, showed remarkable prolonged Progression Free Survival in two patients. In the Acclaim-3 trial, testing Reqorsa with Tecentriq® for extensive stage small cell lung cancer, the first patient achieved a partial remission during maintenance therapy.
Dr. Berger highlighted the significance of these results and announced updates to the oncology clinical development program. Genprex is streamlining its efforts by removing a cohort in Acclaim-1's Phase 2a and closing Acclaim-2 to further enrollment due to slow recruitment. The company aims to focus resources on advancing Reqorsa through the clinic efficiently.
Genprex (NASDAQ: GNPX) ha pubblicato un nuovo video in cui il Chief Medical Officer, Dr. Mark Berger, discute i risultati positivi dei pazienti in due studi clinici sul cancro ai polmoni. Lo studio Acclaim-1, che valuta la terapia genica Reqorsa® con Tagrisso® per il NSCLC a stadio avanzato, ha mostrato un notevole prolungamento della sopravvivenza senza progressione in due pazienti. Nel trial Acclaim-3, che testa Reqorsa con Tecentriq® per il cancro ai polmoni a piccole cellule in stadio esteso, il primo paziente ha raggiunto una remissione parziale durante la terapia di mantenimento.
Il Dr. Berger ha sottolineato l'importanza di questi risultati e ha annunciato aggiornamenti al programma di sviluppo clinico oncologico. Genprex sta semplificando i suoi sforzi eliminando un gruppo nello studio Acclaim-1 di Fase 2a e chiudendo Acclaim-2 a ulteriori arruolamenti a causa della lenta reclutazione. L'azienda mira a concentrare le risorse per far avanzare Reqorsa nella clinica in modo efficace.
Genprex (NASDAQ: GNPX) ha lanzado un nuevo video en el que el Director Médico, Dr. Mark Berger, discute los resultados positivos en pacientes en dos ensayos clínicos de cáncer de pulmón. El ensayo Acclaim-1, que evalúa la terapia génica Reqorsa® con Tagrisso® para el NSCLC en estadios avanzados, mostró un notable prolongamiento de la supervivencia sin progresión en dos pacientes. En el ensayo Acclaim-3, que prueba Reqorsa con Tecentriq® para el cáncer de pulmón de células pequeñas en etapa extensa, el primer paciente logró una remisión parcial durante la terapia de mantenimiento.
El Dr. Berger destacó la importancia de estos resultados y anunció actualizaciones al programa de desarrollo clínico oncológico. Genprex está simplificando sus esfuerzos eliminando un cohort en la Fase 2a de Acclaim-1 y cerrando Acclaim-2 para más inscripciones debido a la lenta captación. La compañía tiene como objetivo concentrar recursos en avanzar Reqorsa en la clínica de manera eficiente.
Genprex (NASDAQ: GNPX)은 최고 의료 책임자인 Dr. Mark Berger가 두 개의 폐암 임상 시험에서 환자의 긍정적인 결과에 대해 이야기하는 새로운 비디오를 공개했습니다. 후기 단계의 NSCLC에 대해 Tagrisso®와 함께 Reqorsa® 유전자 치료를 평가하는 Acclaim-1 시험에서는 두 환자에서 눈에 띄게 연장된 진행 없는 생존 기간이 나타났습니다. Acclaim-3 시험에서는 광범위한 단계의 소세포폐암에 대해 Tecentriq®와 함께 Reqorsa를 테스트했고, 첫 번째 환자는 유지 치료 중 부분 관해에 도달했습니다.
Dr. Berger는 이러한 결과의 중요성을 강조하고 종양학 임상 개발 프로그램에 대한 업데이트를 발표했습니다. Genprex는 Acclaim-1의 2a상에서 코호트를 제거하고 느린 모집으로 인해 Acclaim-2의 추가 등록을 종료하고 있습니다. 이 회사는 리소스를 집중하여 Reqorsa를 효과적으로 임상에서 발전시키는 것을 목표로 하고 있습니다.
Genprex (NASDAQ: GNPX) a publié une nouvelle vidéo dans laquelle le directeur médical, Dr. Mark Berger, discute des résultats positifs chez les patients dans deux essais cliniques sur le cancer du poumon. L'essai Acclaim-1, qui évalue la thérapie génique Reqorsa® avec Tagrisso® pour le NSCLC à un stade avancé, a montré une survie sans progression considérablement prolongée chez deux patients. Dans l'essai Acclaim-3, qui teste Reqorsa avec Tecentriq® pour le cancer du poumon à petites cellules à un stade avancé, le premier patient a atteint une rémission partielle pendant la thérapie d'entretien.
Dr. Berger a souligné l'importance de ces résultats et a annoncé des mises à jour du programme de développement clinique en oncologie. Genprex rationalise ses efforts en supprimant un groupe dans la phase 2a d'Acclaim-1 et en fermant Acclaim-2 à de nouvelles inscriptions en raison d'un recrutement lent. L'entreprise vise à concentrer ses ressources sur l'avancement de Reqorsa dans la clinique de manière efficace.
Genprex (NASDAQ: GNPX) hat ein neues Video veröffentlicht, in dem der Chief Medical Officer Dr. Mark Berger über positive Patientenergebnisse in zwei klinischen Studien zu Lungenkrebs spricht. Die Acclaim-1-Studie, die die Reqorsa®-Gentherapie mit Tagrisso® für fortgeschrittenes NSCLC bewertet, zeigte eine erheblich verlängerte progressionsfreie Überlebenszeit bei zwei Patienten. In der Acclaim-3-Studie, die Reqorsa mit Tecentriq® für weit fortgeschrittenen kleinzelligen Lungenkrebs testet, erreichte der erste Patient während der Erhaltungstherapie eine partielle Remission.
Dr. Berger hob die Bedeutung dieser Ergebnisse hervor und kündigte Updates zum klinischen Entwicklungsprogramm für Onkologie an. Genprex strafft seine Bemühungen, indem es eine Kohorte in der Phase 2a von Acclaim-1 eliminierte und Acclaim-2 wegen langsamer Rekrutierung für weitere Einsätze schloss. Das Unternehmen will die Ressourcen konzentrieren, um Reqorsa effizient im klinischen Bereich voranzutreiben.
- Two patients in Acclaim-1 trial showed prolonged Progression Free Survival, with one maintaining benefit for over two years
- First patient in Acclaim-3 trial achieved partial remission during maintenance therapy
- Company is streamlining clinical development program to advance Reqorsa more quickly
- Removal of a cohort in Acclaim-1 Phase 2a to accelerate progress
- Acclaim-2 study closed to further enrollment due to slow recruitment
- Company facing resource limitations, necessitating focus on specific trials
The reported patient outcomes in the Acclaim-1 and Acclaim-3 trials are intriguing, particularly the prolonged Progression Free Survival (PFS) in Acclaim-1 and the partial remission (PR) in Acclaim-3. However, it's important to note that these are individual case reports, not comprehensive trial results. While promising, we need larger datasets to draw meaningful conclusions.
The decision to streamline the clinical development program by removing a cohort in Acclaim-1 and closing Acclaim-2 to further enrollment is a strategic move. This could potentially accelerate the development timeline for REQORSA, but also narrows the scope of investigation. The focus on Acclaim-1 and Acclaim-3 suggests Genprex is prioritizing the most promising combinations.
The reported outcomes are indeed noteworthy. In Acclaim-1, a 2-year PFS in a patient who previously progressed on Tagrisso is exceptional for late-stage NSCLC. Similarly, in Acclaim-3, achieving a PR during maintenance therapy in ES-SCLC is unusual and encouraging. However, we must exercise caution in interpreting these results.
The diminishing side effects over time in the Acclaim-1 patient is particularly interesting, as it suggests a potentially favorable long-term safety profile. This could be a significant advantage if replicated in larger patient populations. The company's strategic decisions to focus resources on the most promising trials could expedite the path to more comprehensive data, which is important for assessing REQORSA's true potential in lung cancer treatment.
Chief Medical Officer Provides Overview of Recent Positive Clinical Patient Outcomes
Video Highlights Recent Oncology Clinical Development Program Updates
Click here to watch the video.
The Acclaim-1 clinical trial is evaluating the combination of the Company's lead drug candidate, Reqorsa® Gene Therapy, and AstraZeneca's Tagrisso® to treat patients with late-stage NSCLC who have activating EGFR mutations and disease progression after treatment with Tagrisso.
The Acclaim-3 clinical trial is evaluating the combination of REQORSA and Genentech's Tecentriq® as a maintenance therapy to treat patients with extensive stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment.
Dr. Berger remarked on the two positive patient outcomes in Acclaim-1:
"Both of these patients' outcomes are fairly remarkable in terms of their prolonged Progression Free Survival (PFS) among patients in the study who were progressing on their previous treatment when they came into the study. It's very compelling, particularly, that one of those patients has maintained this benefit for more than two years. And over time, the patients' side effects with the combination of REQORSA and Tagrisso have diminished rather than increased over time."
Dr. Berger's commentary on the positive patient outcome in Acclaim-3:
"In the Acclaim-3 study, the first patient treated in the Phase 1 dose escalation portion of the trial has had a positive response since enrollment and starting maintenance therapy. The patient has a partial remission (PR) from the start of maintenance therapy until after the second course, which is when the first CT scan is done. This is the first dose group in this study, and there is a second higher dose group to come. The patient's response is remarkable, and it is very unusual to have a PR during maintenance therapy. We believe these results bode very well for the study."
On recent updates to the Company's oncology clinical development program, Dr. Berger stated:
"To build on these positive patient results, we are making changes to our clinical development program both in the Acclaim-1 and Acclaim-2 studies. In the Acclaim-1 study, we are removing one of the cohorts in Phase 2a, which will allow us to advance more quickly. The Acclaim-2 study is being closed to further enrollment. It has been slow to enroll patients, mainly because there are hundreds of other very similar studies that evaluate new treatments after patients have progressed on Keytruda®. We certainly intend to continue to treat patients in this study until they have disease progression. We also believe closing to further enrollment is the right thing to do so that we can focus our limited resources on the fastest way to being able to enroll patients and get clinical data.
We're very excited by these positive patient responses, and we look forward to advancing REQORSA through the clinic. We believe that streamlining our efforts to do so is the best way to use our resources and to move our program forward."
To watch the video, please visit Genprex's website at https://www.genprex.com/videos/.
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: the initial patient responses to REQORSA treatments and the potential and promise of these responses, which are demonstrating early evidence of efficacy with a favorable safety profile; 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 efforts that Genprex takes or may take in the future that are aimed at optimizing and re-focusing Genprex's 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.
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FAQ
What positive outcomes were reported in Genprex's (GNPX) Acclaim-1 lung cancer trial?
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How is Genprex (GNPX) modifying its clinical development program for Reqorsa?
Why did Genprex (GNPX) decide to close the Acclaim-2 study to further enrollment?
