- Genprex Chief Medical Officer, Dr. Mark Berger, was featured in a recent Bell2Bell Podcast episode, where he discussed the company’s recent announcements
- In May, the company received Safety Review Committee (“SRC”) approval to advance to the Phase 2 expansion portion of its Acclaim-1 clinical trial of its lead candidate, REQORSA(R) Immunogene Therapy
- The Phase 1 dose escalation portion of the study showed that REQORSA(R) was generally well tolerated, and there were no dose-limiting toxicities; Genprex also reported encouraging evidence of efficacy in this portion
- In April, Genprex announced that its research collaborators presented in vivo mouse data showing that Genprex’s non-viral ONCOPREX(R) Nanoparticle Delivery System could be successfully used to deliver a second tumor suppressor gene with strong pre-clinical evidence of efficacy
- Based on these findings, Dr. Berger states that the ONCOPREX Nanoparticle Delivery System has been validated as a platform for reexpressing tumor suppressor gene proteins in cancer cells
Mark Berger, M.D., Chief Medical Officer of Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing gene therapies for patients with cancer and diabetes was featured in a recent Bell2Bell Podcast episode (https://nnw.fm/oT7Wu).
Dr. Berger talked about the Safety Review Committee (“SRC”) approval to advance to the Phase 2 expansion portion of Genprex’s Acclaim-1 clinical trial of REQORSA(R) , Genprex’s lead drug candidate, in combination with AstraZeneca’s Tagrisso (osimertinib) to treat late-stage non-small cell lung cancer (“NSCLC”) He also spoke about the news that the company’s non-viral ONCOPREX(R) Nanoparticle Delivery System has shown preclinical evidence of successusing a second tumor suppressor gene.
“We’re very excited about both of these events. I think it portends a great deal of other progress through the course of this year, and that’s what we hope to be able to bring to you and talk to you about at other times during the year,” said Dr. Berger.
Announced May 30, the SRC approval was based on preliminary safety data from the Phase 1 dose escalation portion of its Acclaim-1 clinical trial that showed that REQORSA was generally well tolerated and that there were no dose-limiting toxicities (https://nnw.fm/t6uw0). As a result, the committee determined that the recommended Phase 2 dose of REQORSA will be 0.12 mg/kg, the highest dose level delivered in the Phase 1 portion. And as Dr. Berger further explained during the conversation, “The number won’t mean much, but it is twice the dose used previously in our prior studies and was found to be safe during these evaluations.”
The company announced the positive preliminary clinical data from the Phase 1 portion in an abstract published at the 2023 American Society of Clinical Oncology (“ASCO”) Annual Meeting, from where Dr. Berger was speaking to Bell2Bell Podcast listeners. ASCO, Dr. Berger conveyed, is the largest clinical oncology meeting of the year. Last year, it brought together 42,000 clinical oncologists, 30,000 of whom attended physically, with the rest listening virtually. “We expect the same number today. So, this is a huge meeting with lots of information and new data,” Dr. Berger said.
In addition to announcing the safety and tolerability profile of REQORSA, Genprex also reported encouraging evidence of efficacy in the Phase 1 portion of the Acclaim-1 study. With the SRC approval granted, Genprex expects to begin the Phase 2 expansion portion of the study in Q3 of 2023. This portion is expected to enroll about 66 patients, divided into two cohorts. The first cohort, comprising half the enrolled number, will include patients who received only prior Tagrisso treatment. The other cohort will be made up of patients who received Tagrisso treatment and chemotherapy. This enrollment format is intended to help the company determine toxicity profiles of patients with different eligibility criteria, as well as efficacy and other endpoints. Genprex will also conduct an interim analysis for each cohort following the treatment of 19 patients in that cohort.
Meanwhile, Genprex announced in April that its research collaborators presented positive preclinical data for the reexpression of the NPRL2 gene. The collaborators conducted the studies using the ONCOPREX(R) Nanoparticle Delivery System to deliver the NPRL2 gene to KRAS/STK11 mutant, anti-PD1 resistant, human NSCLC metastases in humanized mouse models, presenting the data at the 2023 American Association of Cancer Research (“AACR”) annual meeting, held in April.
According to Genprex President, Chairman and CEO Rodney Varner, the use of ONCOPREX(R) to deliver the NPRL2 tumor suppressor gene “positions Genprex to expand our clinical pipeline with a new drug candidate” and gives the company “further confidence in the potentially broad-based application of our non-viral delivery system, which may provide a multitude of potential pipeline opportunities in the future.”
“The preclinical data also provide further evidence that the ONCOPREX(R) Nanoparticle Delivery System has the ability to be successful using genes other than the TUSC2 gene that we are already using in clinical trials with REQORSA(R),” Varner continued in the company’s April 19 news release (https://nnw.fm/uLVkC).
So far, and through testing involving TUSC2 and NPRL2, the company has shown major detrimental preclinical effects on the growth and survival of cancer cells. Thus, the ONCOPREX(R) Nanoparticle Delivery System has emerged as “really a platform for delivering tumor suppressor gene expression into cancer cells,” according to Dr. Berger.
For more information, visit the company’s website at www.Genprex.com.
NOTE TO INVESTORS: The latest news and updates relating to GNPX are available in the company’s newsroom at http://nnw.fm/GNPX
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