On April 2, 2024 NeoVirTech reported the company in partnership with Imactiv-3D, the ImPACT team from the Cancer Research Center of Toulouse and the National Veterinary School of Toulouse, obtains funding from AAP France 2030 organized by the French Government and the Occitanie region for the development of an innovative theranostic platform for cancer virotherapy, in strong collaboration with CHU de Toulouse and Oncopole Claudius Régaud (Press release, NeoVirTech, APR 2, 2024, View Source [SID1234641703]).

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This program, called Perseverance, supported by Transgene, aims to accelerate the preclinical development of oncolytic viruses (OV), viruses modified and armed to specifically destroy cancer cells. The program is organized into different work tasks, involving the design of ANCHORTM autofluorescent VO candidates for in vivo monitoring of infection and replication of VOs, their production and validation. ANCHOR VOs are then used to perform a virogram on different cancer cell lines to achieve precise mapping of oncolytic activities. The VOs are then optimized and tested for their interaction with pre-existing treatments. Finally, ANCHORTM VOs are tested on organoids derived from patients tumors, the infection of which is analyzed by deep learning and AI processes, and tested on animal models (mouse/rabbit).

At the end of the program, Perseverance offers a clear vision of the efficiency of a given VO on the most relevant models and close to the patient, in order to accelerate their development and guide clinical and therapeutic decisions.

The program is open to any VO of interest, regardless of their stage of development. For more information: [email protected]

On April 2, 2024 NANOBIOTIX, a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported completion of the dose escalation part of a Phase 1 study evaluating potential first-in-class radioenhancer NBTXR3 for patients with non-small cell lung cancer ("NSCLC") that cannot be treated by surgery ("inoperable"), and has come back ("recurrent") (Press release, Nanobiotix, APR 2, 2024, View Source [SID1234641702]). whom have previously been treated with definitive radiation therapy and are amenable to re-irradiation. The Phase 1 study ("Study 2020-0123") is being conducted by The University of Texas MD Anderson Cancer Center ("MD Anderson") as part of an ongoing strategic collaboration with Nanobiotix.

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"NBTXR3 is designed as a product candidate with the potential to improve treatment outcomes for patients with cancer in any setting where radiotherapy is a part of the treatment regimen. While these patients experience different cancer types and are each faced with unique challenges, what they share is an urgent need for therapeutic innovation with the chance to make a difference," said Louis Kayitalire, MD, Chief Medical Officer at Nanobiotix. "We believe the injection feasibility and favorable safety profile we have observed from the completed dose escalation part of this Phase 1 lung cancer study could pave the way for additional clinical development of NBTXR3 for patients with inoperable, recurrent lung cancer and patients amenable to re-irradiation."

The completed dose escalation part of Study 2020-0123 established the recommended Phase 2 dose after determination of injection feasibility and observation of a favorable safety profile. The expansion part of the study, further evaluating safety and early signals of efficacy, is ongoing.

About MD ANDERSON STUDY 2020-0123
MD Anderson Study 2020-0123 (NCT04505267) is a Phase 1 study evaluating the best dose and observing the adverse effects of NBTXR3 activated by radiation therapy ("RT") for the treatment of non-small cell lung cancer ("NSCLC") that cannot be treated with surgery ("inoperable"), and has come back ("recurrent"), in patients who have previously been treated with definitive RT. The primary objectives of the study include a safety assessment of re-irradiation in these patients and determination of the recommended Phase 2 dose of NBTXR3 activated by RT. The re-irradiation safety assessment part and the dose-finding part of the study have completed. An expansion part evaluating additional signals of safety, feasibility, anti-tumor response, and time-to-event outcomes is ongoing.

About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized phase III study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the phase III study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies evaluating NBTXR3 across tumor types and therapeutic combinations. In 2023 Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV, a Johnson & Johnson company.

On April 2, 2024 Labcorp, a global leader of innovative and comprehensive laboratory services, reported the company will present abstracts in the areas of immunology, cellular biology, genomics and liquid biopsy at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in San Diego (April 5-10, 2024) (Press release, LabCorp, APR 2, 2024, View Source [SID1234641701]).

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The depth and breadth of Labcorp’s oncology research solidifies the company’s commitment to delivering guideline-based, biomarker-driven testing solutions, strengthening existing evidence of clinical utility and supporting the pharmaceutical industry from discovery to companion diagnostics development through commercialization to facilitate patient access to novel targeted therapies.

"Labcorp is advancing cancer care through our pioneering research in precision oncology and our global collaborations with pharmaceutical, biotechnology and clinical research partners. Our robust presence at this year’s AACR (Free AACR Whitepaper) Annual Meeting is a testament to our dedication to leading with science, showcasing our commitment to innovation, and highlighting our role in shaping the future of personalized medicine," said Shakti Ramkissoon, M.D., Ph.D., vice president, medical lead for oncology at Labcorp. "Our research initiatives are focused on transforming the diagnostic landscape, enhancing patient care, and fueling a new era of targeted, effective treatments that will improve health and improve lives."

Of the 21 abstracts to be presented at the AACR (Free AACR Whitepaper) Meeting, 13 were internal studies by Labcorp researchers and eight were conducted in collaboration with research partners from premiere academic institutions and medical centers.

Spotlight Theater
Title: Biomarker solutions for all: Innovative solid tumor MRD detection and immune profiling solutions for advanced drug development
Date: Tuesday, April 9
Time: 10:00 a.m. PT
Location: Spotlight Theater A

Oral Presentations
Abstract #6559: Clinical validity of post-surgery circulating tumor DNA testing in stage III colon cancer patients treated with adjuvant chemotherapy: The PROVENC3 study
Date: Tuesday, April 9
Time: 3:10 p.m. – 3:25 p.m. PT
Location: Ballroom 6 CF – Upper Level – Convention Center

Poster Presentations
Track: Immunology
Session: Biomarkers, Immune Monitoring and Immune Assays
Abstract #83: NK cell ADCC assays: Leveraging flow cytometry and reporter cell lines for enhanced biological relevance and throughput
Date: Sunday, April 7
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 3

Track: Molecular/Cellular Biology and Genetics
Session: Cellular Stress Responses 1
Abstract #379: Landscape of HIF-1α expression across 24,186 solid tumors using comprehensive immune profiling
Date: Sunday, April 7
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 16

Track: Clinical Research
Session: Circulating Nucleic Acids 1
Abstract #970: Liquid biopsy-informed precision oncology clinical trial to evaluate the utility of ctDNA comprehensive genomic profiling
Date: Sunday, April 7
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 40

Track: Clinical Research
Session: Predictive Biomarkers 1
Abstract #2496: Molecular characterization of stage III colon cancer patients with recurrence after adjuvant chemotherapy
Date: Monday, April 8
Time: 9:00 a.m. – 12:30 p.m. PT
Section: 43

Track: Clinical Research
Session: Biomarkers in Clinical Trials
Abstract #3629: Prevalence of claudin18.2 expression in gastric/gastroesophageal junction adenocarcinoma among patients in TranStar101 and TranStar102 clinical trials
Date: Monday, April 8
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 40

Track: Clinical Research
Session: Biomarkers in Clinical Trials
Abstract #3652: Spatial transcriptomic study of the tumor microenvironment in HNSCC
Date: Monday, April 8
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 40

Track: Experimental and Molecular Therapeutics
Session: Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes
Abstract #4628: Validation of an Automated, Scalable Comprehensive Genomic Profiling Assay for Hematologic Malignancies
Date: Tuesday, April 9
Time: 9:00 a.m. – 12:30 p.m. PT
Section: 26

Track: Clinical Research
Session: Circulating Nucleic Acids 4
Abstract #5020: Pre-analytical characterization of cell-free DNA to enable liquid biopsy for solid tumors
Date: Tuesday, April 9
Time: 9:00 a.m. – 12:30 p.m. PT
Section: 40

Track: Clinical Research
Session: Circulating Nucleic Acids 4
Abstract #5022: MEDOCC-CrEATE trial: Feasibility of measuring circulating tumor DNA after surgery to guide adjuvant chemotherapy in stage II colon cancer patients
Date: Tuesday, April 9
Time: 9:00 a.m. – 12:30 p.m. PT
Section: 40

Track: Clinical Research
Session: Circulating Nucleic Acids 4
Abstract #5017: Analytical performance of contrived samples for validation of liquid biopsy assays
Date: Tuesday, April 9
Time: 9:00 a.m. – 12:30 p.m. PT
Section: 40

Track: Tumor Biology
Session: Models to Study Immune Cells in the Tumor Microenvironment
Abstract #4204: Subcutaneous vs. orthotopic tumor models: a comparative assessment
Date: Tuesday, April 9
Time: 9:00 a.m. – 12:30 p.m. PT
Section: 10

Track: Tumor Biology
Session: Tumor Evolution Models and Technologies
Abstract #4305: Analysis of tumor heterogeneity in syngeneic models; CT26.WT colon carcinoma and 4T1-Luc2-1A4 breast carcinoma in female BALV/cAnNHsd mice
Date: Tuesday, April 9
Time: 9:00 a.m. – 12:30 p.m. PT
Section: 13

Track: Immunology
Session: Adoptive Cell Therapies 3: CAR-T Cells
Abstract #4002: Investigating CAR-T cell efficacy and activation in the disseminated NALM6-luc human B-cell acute lymphoblastic leukemia model
Date: Tuesday, April 9
Time: 9:00 a.m. – 12:30 p.m. PT
Section: 2

Track: Clinical Research
Session: Predictive Biomarkers 6
Abstract #6443: Enhanced detection of ctDNA molecular response for immunotherapy treated non-small cell lung cancer through analyses of cell-free and matched white blood cell DNA
Date: Tuesday, April 9
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 44

Track: Clinical Research
Session: Adoptive Cellular Therapy 2
Abstract #6334: Metabolic reprogramming enhances expansion and potency of CAR T cells
Date: Tuesday, April 9
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 40

Track: Tumor Biology
Session: Spatial Resolution of the Tumor Microenvironment
Abstract #5493: Digital spatial profiling of MC38 colon carcinoma following checkpoint inhibition
Date: Tuesday, April 9
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 10

Track: Experimental and Molecular Therapeutics
Session: Novel Therapeutics and Preclinical Models
Abstract #6005: Generation of new oncology cell models through long-term acclimation under hypoxic and hyperbaric culture conditions
Date: Tuesday, April 9
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 28

Track: Clinical Research
Session: Predictive Biomarkers 5
Abstract #6393: The predictive role of TNF-related genes in patients receiving immune checkpoint inhibitors
Date: Tuesday, April 9
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 43

Track: Prevention/Early Detection/Interception, Population Sciences
Session: Biomarker-Based Screening
Abstract #6079: Comparison of FIT and ctDNA tests for detection of individuals with colorectal cancer in population-based screening
Date: Tuesday, April 9
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 31

Track: Clinical Research; Molecular/Cellular Biology and Genetics
Session: Immune Checkpoint Inhibitor Therapy
Abstract #7526: Landscape of TIGIT and PD-L1 co-expression in solid tumors
Date: Wednesday, April 10
Time: 9:00 a.m. – 12:30 p.m. PT
Section: 42

On April 2, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported early efficacy results showing tumor stabilization in the third patient enrolled in the Company’s Deltacel-01 Phase 1 clinical trial (Press release, Kiromic, APR 2, 2024, View Source [SID1234641697]). Deltacel-01 is evaluating Deltacel (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.

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Preliminary imaging results for this last patient in the first cohort, obtained six weeks after beginning treatment, show a favorable safety and tolerability profile, and promising early efficacy for the Deltacel treatment. While this patient presented with active disease at the time of enrollment, PET/CT, diagnostic CT and MRI scans showed disease stabilization at all tumor sites with no new sites of metastatic disease. This patient is being treated at the Beverly Hills Cancer Center (BHCC).

Additionally, the Deltacel-01 Safety Monitoring Committee (SMC) convened to analyze all preliminary patient data received to date and to determine the next phase of the trial. After reviewing safety and efficacy findings from the first cohort of three patients, the SMC recommended not to escalate the cell dose level and instead to treat the next cohort of patients at the initial dose level. This unanimous recommendation was based on encouraging preliminary data supporting Deltacel safety and tolerability, and evidence of anti-tumor activity.

"Early findings from the first three patients enrolled in Deltacel-01 – especially the consistent favorable safety profile and signs of efficacy – reinforce our commitment to advancing Deltacel as a potential off-the-shelf, Gamma Delta T-cell therapy. We are particularly pleased to observe a growing body of evidence that Deltacel could be a significant step forward in treating cancer. Our team is inspired by these results and remains dedicated to further testing the therapeutic potential of Deltacel, as confirmed by SMC’s recommendation not to increase the Deltacel dose level. Achieving a therapeutic effect with the initial dose level will benefit patients, while not having to test additional dose levels will shorten the overall length of the Phase 1 clinical trial," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the Deltacel-01 trial is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.

About Deltacel

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of all lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

On April 2, 2024 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 have published positive preclinical data for the NPRL2 tumor suppressor gene, utilizing the Company’s non-viral Oncoprex Delivery System, in KRAS/STK11 mutant anti-PD1 resistant non-small cell lung cancer (NSCLC) in a humanized mouse model (Press release, Genprex, APR 2, 2024, View Source [SID1234641694]).

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NPRL2 is a tumor suppressor gene whose expression is reduced in many cancers including lung, renal, colorectal, glioma, gastric, and hepatocellular carcinoma, and it has been closely correlated with poor clinical outcomes.

Genprex’s Oncoprex Delivery System is a novel non-viral approach that utilizes lipid-based nanoparticles in a lipoplex form to deliver tumor suppressor genes 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. Genprex believes this system allows for delivery of a number of cancer-fighting genes, alone or in combination with other cancer therapies, to combat multiple types of cancer.

The manuscript, titled, "NPRL2 gene therapy induces effective anti-tumor immunity in KRAS/STK11 mutant anti-PD1 resistant metastatic non-small cell lung cancer (NSCLC) in a humanized mouse model," was published on the bioRxiv biology preprint server.

"These positive preclinical data are very encouraging and support NPRL2 gene therapy as a potential treatment for a sub-group of NSCLC in which patients traditionally are resistant to existing therapies," said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex. "We believe this data could support the potential for a new drug candidate in our pipeline, and it also provides further evidence that the Oncoprex Delivery System has the ability to be successful using genes other than the TUSC2 gene we are already using in clinical trials with Reqorsa."

The studies evaluated the intravenous injection of NPRL2 gene-loaded cationic lipoplexes (DOTAP-NPRL2) with or without anti-PD1 drugs (pembrolizumab). The studies used a KRAS/STK11 mutant anti-PD1 insensitive cell line, as well as syngeneic mouse LLC2 tumors, which are also anti-PD1 resistant. In both of these mouse models, NPRL2 showed a significantly strong anti-tumor effect whereas anti-PD1 (pembrolizumab) was not effective. The anti-tumor effect was greater in humanized mice than non-humanized mice, suggesting that an immune response contributed to anti-tumor activity.

Additionally, a dramatic anti-tumor effect was mediated by NPRL2 treatment with or without a pembrolizumab combination. Bioluminescence imaging on mice showed that 7 out of 10 mice contained an extremely low amount of tumor burden in the NPRL2 treatment group, which was significantly different than in the control or pembrolizumab group.

Unlike previous experiments with Reqorsa Immunogene Therapy (quartusugene ozeplasmid), the Company’s lead drug candidate using the TUSC2 tumor suppressor gene, the anti-tumor efficacy of DOTAP-NPRL2 did not involve Natural Killer (NK) cells. The studies also found that tumors with stable NPRL2 expression exhibited significantly slower growth compared to controls. In conclusion, researchers reported that NPRL2 gene therapy induces anti-tumor activity through dendritic cell-mediated antigen presentation and cytotoxic immune cell activation.