On April 19, 2023 Onchilles Pharma, a private biotech company developing novel cancer therapeutics that leverage myeloid biology, reported new preclinical data on N17350, a first-in-class biologic therapeutic inspired by ELANE, a protein found in neutrophils that is part of a newly discovered innate cancer-killing pathway (Press release, Onchilles Pharma, APR 19, 2023, View Source [SID1234630310]). The data demonstrate N17350, as a monotherapy or in combination with checkpoint inhibitors, abrogates tumor growth, induces a robust immune signature with the potential to establish durable remission, and demonstrates no acquired resistance. These data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 taking place in Orlando.

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"While significant therapeutic innovation has occurred in immuno-oncology, it’s clear that we need to continue to explore new treatment paradigms that can selectively kill tumors and yield durable therapeutic responses. When we discovered the ELANE pathway, we saw the potential for a novel approach in immuno-oncology that combines broad activity in cancer cells but not in normal cells, robust immune system activation with immunological memory, and an inability to develop resistance," said Lev Becker, Ph.D., Scientific Founder and Board Member of Onchilles Pharma. "N17350 was specifically designed to mobilize the ELANE-mediated cancer-killing pathway, and in addition to its potent single agent activity, we believe it could enhance most immunotherapies, lead to global responses, and represent a new treatment modality in immuno-oncology."

Data presented at AACR (Free AACR Whitepaper) show that in the CT26 tumor model, a single dose of N17350 abrogated tumor growth, maintained tumor-free status upon 90-day rechallenge with no observed toxicity, and enhanced survival compared to standard of care chemotherapy. Also presented were data from the 4T1 tumor model, where a single dose of N17350 demonstrated tumor regression and an abscopal effect driven by CD8+ T cells to control lung metastases. Furthermore, in the 4T1 model, N17350 in combination with anti-CTLA4 antibody treatment, demonstrated the potential to enable immune checkpoint inhibitor efficacy in an immunologically "cold" tumor model.

"We have generated a substantial amount of preclinical data demonstrating N17350 is unlike any other immuno-oncology therapeutic approach," Court R. Turner J.D., Co-Founder & Executive Chair of Onchilles Pharma. "These data compel us to move N17350 into the clinic to help patients with limited treatment options."

Click here to download the poster.

About N17350 and the ELANE Pathway

First described in research published in Cell from the lab of Onchilles’ Co-Founder Lev Becker, human neutrophils release catalytically active neutrophil elastase, called ELANE, which initiates a complex killing mechanism that culminates in cancer cell apoptosis at the initial tumor site as well as increases adaptive immunity that attacks distant metastases. ELANE selectively kills cancer cells by proteolytically liberating the CD95 death domain, which interacts with histone H1. This starts a complex cell death program only active in cancer cells that suppresses cell survival pathways, induces DNA damage, elevates mitochondrial reactive oxygen species production, and ultimately activates apoptosis effectors. The team at Onchilles translated the ground-breaking scientific discovery of ELANE, into a proprietary set of molecules including N17350, that mobilize the ELANE-mediated cancer-killing pathway and have the potential to treat a wide variety of tumor types with an optimal safety and efficacy profile.

On April 19, 2023 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immunotherapy and next-generation vaccines, reported that a poster highlighting the Company’s DNA-based immunotherapy IMNN-001 was presented on April 18 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Orlando (Press release, IMUNON, APR 19, 2023, View Source [SID1234630309]). IMNN-001 (formerly GEN-1) is a DNA-based interleukin-12 (IL-12) immunotherapy currently in Phase 2 clinical development for the localized treatment of advanced ovarian cancer. The poster was presented by Jean Boyer, Ph.D., IMUNON’s vice president of preclinical research, and can be found on the company’s website.

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The poster is titled "Efficacy of IMNN-001, an Interleukin-12 Immune Gene Therapy, at Different Dose Frequencies." In the study, IMNN-001 dosing regimens were examined for efficacy in ID8 tumor-bearing mice either weekly, every two weeks or every three weeks. The control group of 15 mice were injected with 2.5 million cancer cells and remained untreated. Six animals from each group dosed were harvested for translational research (TR) after five weekly (three every two-week and two every three-week) treatments, respectively. The remaining four animals in each group were followed for weight change (tumor burden) and survival.

Additionally, TR evaluated change in ascites T cell populations. There was a gradual rise in tumor burden and mortality in all treatment groups with comparable rates between the once weekly and once every two weeks regimen. The once every three weeks regimen had a relatively higher mortality rate and higher tumor burden. There were similar or higher increases in T cells and B cells with reduced treatment frequency with lesser increases in myeloid cell density with reduced treatment frequency.

Researchers concluded that IMNN-001 demonstrated stimulation of the immune response in the ID8 ovarian tumor model. Of the three dosing regimens tested, the once every 2-week regimen demonstrated comparability to the weekly regimen while showing superiority to the once every 3-week regimen, particularly with respect to mortality and tumor burden. Thus, exploring once every 2-week dosing of IMNN-001 in human studies is warranted.

Commenting on the presentation, Dr. Corinne Le Goff, president and chief executive officer of IMUNON, said, "We are delighted that our work was selected for presentation at the AACR (Free AACR Whitepaper) Annual Meeting, a very prestigious industry conference. This research in mice will underpin the dosing frequency being investigated in our upcoming Phase 1/2 combination study with IMNN-001 and bevacizumab following neoadjuvant chemotherapy in advanced ovarian cancer, along with any additional combination studies we may pursue in the future."

On April 19, 2023 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that Fred Schwarzer, Chief Executive Officer, will participate in a virtual fireside chat at the Stifel 2023 Targeted Oncology Days on Wednesday, April 26, 2023, at 3:00 p.m. EDT (Press release, IGM Biosciences, APR 19, 2023, View Source [SID1234630308]).

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On April 19, 2023 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that the company will participate in investor meetings at the Van Lanschot Kempen Life Sciences Conference being held in Amsterdam, April 25 – 26, 2023 (Press release, Hookipa Biotech, APR 19, 2023, View Source [SID1234630307]).

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On April 19, 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 its research collaborators presented positive preclinical data for the NPRL2 gene (also known as the TUSC4 gene) (Press release, Genprex, APR 19, 2023, View Source [SID1234630306]). The studies used the Company’s non-viral ONCOPREX Nanoparticle Delivery System in KRAS/STK11 mutant anti-PD1 resistant metastatic human non-small cell lung cancer (NSCLC) humanized mouse models and were presented at the 2023 American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, which took place from April 14-18, 2023 in Orlando, Florida.

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"We are pleased to have these positive data that support the therapeutic potential of our non-viral delivery system, which is being used in our current REQORSA clinical oncology programs, presented before some of the world’s leading cancer researchers," said Rodney Varner, President and Chief Executive Officer at Genprex. "The use of the ONCOPREX Nanoparticle Delivery System to deliver the NPRL2 tumor suppressor gene positions Genprex to expand our clinical pipeline with a new drug candidate."

"The preclinical data also provide further evidence that the ONCOPREX 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," stated Varner. "These compelling outcomes give us 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."

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 toxicity often associated with viral delivery systems.

Featured Genprex-supported posters presented at AACR (Free AACR Whitepaper) 2023 include:

Event: Americal Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting

Session Category: Immunology

Session Title: Combination Immunotherapies 2

Location: Section 22

Session Date and Time: Tuesday, April 18 from 1:30-5:00 p.m. ET

Title: "NPRL2 gene therapy induces effective antitumor immunity in KRAS/STK11 mutant anti-PD1 resistant metastatic human NSCLC in a humanizedmouse model"

Presenters: Jack A. Roth, MD, The University of Texas MD Anderson Cancer Center

Poster Board Number: 23

Abstract Presentation Number: 5120

The abstract entitled, "NPRL2 gene therapy induces effective antitumor immunity in KRAS/STK11 mutant anti-PD1 resistant metastatic human non-small cell lung cancer (NSCLC) in a humanized mouse model," is available on the AACR (Free AACR Whitepaper) website. The presentation reported results from this study, which investigated the antitumor immune responses to NPRL2 gene therapy on anti-PD1 resistant KRAS/STK11 mutant NSCLC in a humanized mouse model. In the study, humanized mice were treated with NPRL2 gene therapy, immunotherapy pembrolizumab (Keytruda), or the combination. A dramatic antitumor effect was mediated by NPRL2 treatment, whereas pembrolizumab was ineffective. A significant antitumor effect was also found in non-humanized NSG mice, although the antitumor effect was greater in humanized mice, suggesting that the immune response played a role in inducing antitumor activity.

The study data suggest that NPRL2 gene therapy induces antitumor activity on KRAS/STK11 mutant anti-PD1 resistant tumors through DC mediated antigen presentation and cytotoxic immune cell activation.

A KRAS mutation occurs in approximately 25% of patients with NSCLC, and one study found that KRAS/STK11 combination mutations were found in approximately 6.5% of NSCLC patients.

"These data are encouraging because they not only validate Genprex’s non-viral oncology platform to deliver a variety of tumor suppressor genes, but they also provide further evidence of the important role that tumor suppressor genes play in cancer, particularly NSCLC," said Mark Berger, MD, Chief Medical Officer at Genprex. "KRAS is the most frequent oncogene mutated in NSCLC, and KRAS mutations are often associated with resistance to drug therapy[i]. Targeting KRAS/STK11 mutant NSCLC with the NPRL2 gene, and potentially with anti-PD1 as well, may provide therapeutic potential for this group of lung cancer patients."

Genprex currently has three clinical trials evaluating the Company’s lead drug candidate, REQORSA Immunogene Therapy (quaratusugene ozeplasmid) in lung cancer. The Acclaim-1 clinical trial, which 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 ("EGFR") mutations whose disease progressed after treatment with Tagrisso. The Acclaim-2 clinical trial, which 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 Acclaim-3 clinical trial, expected to open for enrollment by the end of the third quarter of 2023, is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Tecentriq (atezolizumab) in patients with extensive-stage small-cell lung cancer (SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as an initial treatment.

The AACR (Free AACR Whitepaper) abstract has been made available on Genprex’s website here.