Labcorp to Present Diverse Portfolio of Precision Oncology Research at the Annual Meeting of the American Association for Cancer Research

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

Kiromic BioPharma Reports Favorable Safety, Tolerability, and Early Efficacy from Third Patient in Deltacel-01 Clinical Trial

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.

Genprex Collaborators Publish Positive Preclinical Data with NPRL2 Gene Therapy Utilizing Oncoprex® Delivery System

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.

Domain Therapeutics to participate at premier investor and healthcare conferences

On April 2, 2024 Domain Therapeutics ("Domain" or "the Company"), a global clinical-stage biopharmaceutical company developing innovative drug candidates in immuno-oncology targeting G Protein-Coupled Receptors (GPCRs), reported its President and Chief Executive Officer, Anthony Johnson, M.D., and its Chief Business Officer, Sean A. MacDonald, will participate in the following investor, partnering and healthcare industry conferences in April-May, 2024 (Press release, Domain Therapeutics, APR 2, 2024, View Source [SID1234641692]):

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Bloom Burton & Co. Healthcare Investor Conference – April 16-17
Location: Metro Toronto Convention Centre (North Building), Toronto, Canada

Presentation slot: Wednesday, April 17, 3:30 PM ET, Room 104 A
LSX World Congress – April 29-30
Location: Business Design Centre, London, UK

Bio€quity Europe – May 12-14
Location: Kursaal Elkargunea Center, San Sebastián, Spain

Presentation slot: to be announced at a later date
The portfolio currently boasts the following novel drug candidates in the rapidly evolving cancer field of resistance in the tumor micro-environment:

DT-7012, a best-in-class Treg-depleting anti-CCR8 monoclonal antibody
DT-9045, a first-in-class, PAR2 biased ligand Negative Allosteric Modulator, small molecule
DT-9081, an EP4R antagonist program, small molecule currently in Phase I ascending dose study

Bio-Path Holdings Provides 2024 Clinical and Operational Update

On April 2, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported a clinical development and operational update for 2024 (Press release, Bio-Path Holdings, APR 2, 2024, View Source [SID1234641691]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"The new year is off to a strong start as we build off positive data generated in 2023 that compel us to advance these studies as quickly as possible and to file for regulatory designations that could accelerate our path to approval," said Peter H. Nielsen, President and Chief Executive Officer of Bio-Path. "There is no greater challenge than the battle against cancer, and developing effective new medicines for patients suffering with few treatment options is what drives us every day. The substantial progress we have made gives us further confidence that our DNAbilize platform is ushering in a new path of DNA-powered medicines that can make a difference in the lives of these patients."

Clinical Program Overview

Bio-Path’s clinical development program consists of one Phase 2 clinical trial and three Phase 1 or 1/1b clinical trials. Bio-Path is developing a molecular biomarker package to accompany prexigebersen treatment and expects to evaluate prexigebersen for the treatment of obesity. In addition, one further drug candidate is in the final stages of preclinical development, which may be submitted to the U.S. Food and Drug Administration (FDA) later in the year in an Investigational New Drug (IND) application.

Development of Molecular Biomarkers – Bio-Path is developing a molecular biomarker package to accompany prexigebersen treatment, the goal of which is to identify patients with a genetic profile more likely to respond to treatment thereby improving probability of success for this program. The emerging role of biomarkers has been enhancing cancer development over the past decade and has become a more common companion to many cancer development programs. Bio-Path expects to develop molecular biomarker packages to accompany its new programs.

Prexigebersen Phase 2 Clinical Trial – Bio-Path’s Phase 2 clinical trial is treating Acute Myeloid Leukemia (AML) patients. This trial is comprised of three separate cohorts of patients and treatments, each separately approvable by the FDA as a new drug indication. The first two cohorts are treating patients with the triple combination of prexigebersen, decitabine and venetoclax. The first cohort includes untreated AML patients, and the second cohort includes relapsed/refractory AML patients. Finally, the third cohort is treating relapsed/refractory AML patients, who are venetoclax-resistant or intolerant, with the two-drug combination of prexigebersen and decitabine. Based on positive interim data for safety and efficacy, the Company plans to pursue FDA Fast Track designation for the accelerated approval of prexigebersen for the treatment of fragile AML patients who are unable to tolerate intensive chemotherapy and thus experience very poor clinical outcomes. Outcomes for these older patients, who are unable to receive intensive chemotherapy due to the challenging side effect profile, remain suboptimal with a median survival of only 5 to 10 months.

Phase 1/1b Clinical Trial in BP1001-A in Advanced Solid Tumors – A Phase 1/1b clinical trial of BP1001-A in patients with advanced or recurrent solid tumors, including ovarian and uterine, pancreatic and breast cancer, is ongoing. BP1001-A is a modified product candidate that incorporates the same drug substance as prexigebersen but has a slightly modified formulation designed to enhance nanoparticle properties. The Phase 1 study has advanced to the second, higher dose level. The Phase 1b portion of the study is expected to commence after successful completion of the three BP1001-A monotherapy dose level cohorts and is intended to assess the safety and efficacy of BP1001-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors. Phase 1b studies are also expected to be opened in combination with gemcitabine in Stage 4 pancreatic cancer and combination therapy in breast cancer.

Phase 1/1b Clinical Trial in BP1002 in Relapsed/Refractory AML – A Phase 1/1b clinical trial for BP1002 to treat relapsed/refractory AML patients, including venetoclax-resistant patients, is ongoing. BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. The drug venetoclax treats AML patients by

blocking the activity of the Bcl-2 protein in AML patients. However, patients become resistant to venetoclax. BP1002 treats the Bcl-2 target by blocking the cell’s ability to produce Bcl-2, and could have the potential to eliminate the need for venetoclax. AML patients that fail frontline venetoclax-based therapy have very poor prognosis with median overall survival of less than three months. The first dose cohort consisted of a starting dose of 20 mg/m2, and there were no dose limiting toxicities. Enrollment is now open for patients for the second dose cohort of 40 mg/m2.

Phase 1 Clinical Trial in BP1002 in Refractory/Relapsed Lymphoma and Chronic Lymphocytic Leukemia (CLL) – A Phase 1 clinical trial to evaluate the ability of BP1002 to treat refractory/relapsed lymphoma and refractory/relapsed chronic lymphocytic leukemia (CLL) patients is currently ongoing. The Phase 1 clinical trial is being conducted at the Georgia Cancer Center while two additional clinical trial sites are currently being activated for inclusion in the study, The University of Texas Southwestern and New York Medical College. In January 2024, Bio-Path announced successful completion of the first dose cohort in the Phase 1 clinical trial. A total of six evaluable patients are scheduled to be treated over two dose levels with BP1002 monotherapy in a standard 3+3 design, unless there is a dose limiting toxicity which would require an additional three patients to be tested. There were no dose limiting toxicities in the first dose cohort (20 mg/m2). Enrollment is now open for patients for the second BP1002 dose cohort of 40 mg/m2.

Preclinical Work for BP1003 – The Company continues to advance its drug candidate, BP1003, for the treatment of advanced solid tumors, including pancreatic cancer. BP1003 is an antisense RNAi nanoparticle targeting the STAT3 protein. Plans are to conduct a Phase 1 study of BP1003 in patients with refractory, metastatic solid tumors (pancreatic, non-small cell lung cancer).

Prexigebersen as Potential Treatment for Obesity and Obesity-related Cancers – The RNAi target of prexigebersen is the Grb2 protein, which is involved in activating the RAS/ERK pathway for cell growth. By blocking the cell’s ability to produce Grb2, prexigebersen treatment may limit cell growth. In obesity, two such pathways are related to leptin and insulin. Activation of leptin or insulin receptors can stimulate the RAS/ERK pathway via Grb2i.

Bio-Path believes development of prexigebersen for the treatment for obesity and obesity-related cancers could be accelerated given the large amount of safety data from prexigebersen treatment of leukemia patients and the continued unmet medical need. The Company expects to evaluate prexigebersen for the treatment of obesity as soon as corporate resources are sufficient.

Intellectual Property Protection

Bio-Path’s composition of matter patents protect encroachment from third parties on its proprietary products. This technology is solely owned by Bio-Path. These composition patents allow the Company to apply its core technology to new protein targets and receive new 20-year patents. Bio-Path’s patent portfolio is as follows:

● Composition and methods of use patents issued cover DNAbilize technology, solely owned by Bio-Path.
● Five issued patents in the U.S. and 53 issued patents in foreign jurisdictions, providing protection in 21 countries.