Natera Announces New Signatera™ MRD Data at 2023 AACR Annual Meeting

On April 14, 2023 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported new data on its Signatera molecular residual disease (MRD) test being presented at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) taking place April 14 – 19, 2023 (Press release, Natera, APR 14, 2023, View Source [SID1234630106]).

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Natera and its collaborators will present findings from five studies on Signatera in esophago-gastric adenocarcinoma, muscle-invasive bladder cancer (MIBC), colorectal cancer (CRC) and hepatocellular carcinoma (HCC). Highlights include:

ctDNA prediction of tumor response and recurrence in patients with esophago-gastric carcinoma receiving FLOT + immunotherapy (avelumab) pre- and post-surgery
ctDNA prediction of tumor response and recurrence in patients with MIBC, with and without neoadjuvant therapy, with long term follow-up (median 68 months) after radical cystectomy
Genomic profiling of >13,000 patients with early (≤50 years old) vs late (≥60 years old) onset CRC
Potential of ctDNA to guide imaging-based surveillance strategies in patients after surgery for peritoneal metastases from CRC
ctDNA as a pharmacodynamic and predictive biomarker in patients with resectable HCC treated with immunotherapy (cemiplimab) pre- and post-surgery
"We are pleased to share additional Signatera data at this year’s AACR (Free AACR Whitepaper) annual meeting that continues to highlight the important role of personalized MRD testing in assessing treatment response and predicting relapse across a broad range of indications," said Minetta Liu, M.D., chief medical officer of oncology at Natera. "These data presentations underscore Natera’s commitment to generating novel insights on MRD testing and genomic testing to help advance cancer care."

The full list of Signatera poster presentations at AACR (Free AACR Whitepaper) is below.

Abstract #2178 | April 17, 9:00 AM – 12:30 PM
Presenter: Thomas U. Marron, M.D., Ph.D. – Icahn School of Medicine at Mount Sinai
Circulating tumor DNA (ctDNA) correlates closely with tumor necrosis and relapse-free survival (RFS) in hepatocellular carcinoma (HCC) patients treated with perioperative cemiplimab

Abstract #5600 | April 18, 1:30 – 5:00 PM
Presenter: Sia Viborg Lindskrog – Aarhus University Hospital
Utility of circulating tumor DNA and transcriptomic profiling in predicting outcome in muscle invasive bladder cancer patients

Abstract #5591 | April 18, 1:30 – 5:00 PM
Presenter: Marco Gerlinger, M.D., FRCP – Barts Cancer Institute & St Bartholomew’s Hospital
Circulating tumor DNA for recurrence prediction and efficacy analysis in the ICONIC trial of peri-operative FLOT and avelumab (PD-L1) in localized esophago-gastric adenocarcinoma

Abstract #5604 | April 18, 1:30 – 5:00 PM
Presenter: Kevin Chang, M.S. – University of Iowa
Circulating tumor DNA for predicting peritoneal only disease recurrence in colon cancer

Abstract #6696 | April 19, 9:00 AM – 12:30 PM
Presenter: Eric Lander, M.D. – Vanderbilt University Medical Center
Genomic alterations associated with early-onset and late-onset colorectal cancer

The AACR (Free AACR Whitepaper) abstracts are available here.

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. Signatera is intended to detect and quantify cancer left in the body, at levels down to a single tumor molecule in a tube of blood, to identify recurrence earlier and to help optimize treatment decisions.

Vizgen’s Presentations at AACR 2023 Annual Meeting Showcase Cellular and Subcellular Tumor Characterization Using New Pre-Designed PanCancer Pathways Panel

On April 14, 2023 Vizgen, the life science company dedicated to improving human health by visualizing single-cell spatial genomics information, reported the unveiling of MERSCOPE PanCancer Pathways Panel (Press release, Vizgen, APR 14, 2023, View Source [SID1234630105]). The company will be presenting data generated using the PanCancer Pathways Panel at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 14-19, 2023 in Orlando, Florida.

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The PanCancer Pathways Panel features a list of genes targeting canonical signaling pathways of cancer and is constructed using recognized oncology databases including OncoKB, MutSig, the Cancer Genome Atlas and Hallmarks of Cancer to ensure inclusion of critical cancer genes. The Panel provides a key tool for researchers to study tumor behavior at cellular and subcellular levels across multiple different types of cancers. The PanCancer Pathways Panel features:

Characterization of major oncology signaling pathways including RAS/RTK, PI3K, NOTCH, MYC, Cell Cycle, HIPPO
Inclusion of cell type markers to identify healthy and disease states
Compatibility across multiple cancer types
"While Vizgen is known for the customizability of our platform, this pre-designed panel along with our PanNeuro Cell Type Panel represent an ideal starting point for researchers who are looking for convenient off-the-shelf options to explore adding spatial genomic capabilities into their research," said Terry Lo, President and CEO of Vizgen. "We’re constantly developing new ways to help researchers use this technology to gain new insights, particularly in complex tissues such as solid tumors. These are the first of many panels to come in our product portfolio."

As part of AACR (Free AACR Whitepaper), Vizgen will be presenting four posters, one of which showcases data generated using the new MERSCOPE PanCancer Pathways Panel. The data demonstrates the ability of the MERSCOPE Platform to characterize individual cells in a wide range of human tumor types, including breast, colon, prostate, ovarian, lung and liver cancers. Analysis of expression patterns in tumor cells highlights the panels’ ability to accurately reproduce known transcriptional signatures of hepatocellular carcinoma. In addition to the posters presented by Vizgen, Jonathan Chen, MD, PhD (Broad Institute of MIT and Harvard) will be presenting findings from human lung cancer data generated on the MERSCOPE Platform.

Presentation Details

Title: Characterizing cancer-associated fibroblasts in prostate cancer using Vizgen’s MERSCOPE Platform
Date: Tuesday April 18
Time: 9:00 am – 12:30 pm EDT
Presenter: Ben Patterson, PhD, Vizgen
Poster Number: 4332
Location: Section 37

Title: Spatially resolved single-cell transcriptomic profiling in formalin-fixed paraffin-embedded (FFPE) tissues
Date: Tuesday April 18
Time: 9:00 am – 12:30 pm EDT
Presenter: Jiang He, PhD, Vizgen
Poster Number: 4195
Location: Section 28

Title: Interrogating immuno-oncological interactions in the tumor microenvironment
Date: Tuesday April 18
Time: 1:30 pm – 5:00 pm EDT
Presenter: Ben Patterson, PhD, Vizgen
Poster Number: 5148
Location: Section 23

Title: A pathway-centric approach to characterizing tumour heterogeneity and cell diversity across multiple cancer types
Date: Wednesday April 19
Time: 9:00 am – 12:30 pm EDT
Presenter: Leiam Colbert, PhD, Vizgen
Poster Number: 5885
Location: Section 4

Title: Spatial clustering reveals immune hub interaction with reservoir of stem- like CD8 T cells and predicts immunotherapy response in lung cancer patients
Date: Tuesday April 18
Time: 3:07 pm – 3:22 pm EDT
Presenter: Jonathan Chen, MD, PhD, Broad Institute
Poster Number: 5784
Location: Tangerine Ballroom 1 (WF1) – Convention Center

All presentations and posters will be available to registered attendees for on-demand viewing on the AACR (Free AACR Whitepaper) website on April 14, 2023, beginning at 4:30 PM ET. Following release at AACR (Free AACR Whitepaper), Vizgen’s poster presentations will also be available in the Vizgen Resource Hub on the Vizgen website.

Novocure Announces 27 Presentations, Including Real-World Evidence and Preclinical Research, at American Association for Cancer Research (AACR) Annual Meeting 2023

On April 14, 2023 Novocure (NASDAQ: NVCR) reported 27 presentations on Tumor Treating Fields (TTFields) will be delivered at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, to be held April 14 to 19 in Orlando, Florida (Press release, NovoCure, APR 14, 2023, View Source [SID1234630104]).

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The research described in the presentations includes real-world evidence supporting the safety and efficacy of TTFields therapy in glioblastoma (GBM) and preclinical research spanning 15 tumor types suggesting the broad applicability and effectiveness of TTFields alone and together with other therapies.

Presentation highlights include research on:

the largest global post-marketing safety dataset of more than 25,000 TTFields-treated patients with high-grade glioma from the last decade demonstrating the safety and broad applicability of TTFields therapy regardless of diagnosis, age, or sex
a systematic review and meta-analysis examining the overall survival (OS) benefit of TTFields therapy in newly diagnosed GBM, finding improved overall survival for TTFields-treated patients relative to those not treated with TTFields, and demonstrating that ≥ 75% average TTFields use was consistently associated with longer survival relative to < 75% average TTFields use
preclinical investigations that demonstrated TTFields with cisplatin or paclitaxel increased the effectiveness of both chemotherapies in cervical cancer cells
in vitro and in vivo investigations of TTFields for treatment of spinal metastasis provides first evidence that TTFields could become an effective therapy for spinal metastasis
TTFields selectively enhanced cancer cell membrane permeability, while not affecting normal cells, improving doxorubicin accumulation in vitro and in vivo breast cancer models
adding TTFields to the PULSAR paradigm for radiotherapy and demonstrating it is most effective when added prior to each radiation dose, an effect that is enhanced when also used with an immune checkpoint inhibitor
the application of the ability of TTFields to induce a state of BRCAness (DNA repair deficiency) in ovarian cancer cell lines, and combining TTFields with either carboplatin or PARP inhibitors: demonstrating that TTFields display a synergistic interaction with either of these drugs in a wild type ovarian cell line, and an additive effect in a BRCA mutant cell line
"Through ongoing research, we continue to discover that TTFields therapy has great potential for applicability across many solid tumor types and concomitant use with other therapies," said Moshe Giladi, Novocure’s Chief Science Officer. "We are honored to share new insights about TTFields therapy and participate in the exchange of scientific information with researchers from around the world at the AACR (Free AACR Whitepaper) Annual Meeting."

Presentations from Novocure-sponsored and partner programs include:

(Abstract #: CT061) TRIDENT phase 3 study (EF-32): First-line Tumor Treating Fields (TTFields; 200 kHz) therapy concomitant with chemo-radiation, followed by maintenance TTFields/temozolomide in newly diagnosed glioblastoma. W. Shi. (Phase II and Phase III Clinical Trials in Progress)

(Abstract #: 20) In vitro and in vivo investigation of Tumor Treating Fields for treatment of spinal metastasis. C. E. Tatsui. (Mouse Models of Human Cancer)

(Abstract #: 729) The economic and healthcare resource utilization of metastatic non-small cell lung cancer. C. Koh. (Science and Health Policy/Regulatory Science and Policy)

(Abstract #: 1102) Establishing the cytotoxic benefit of Tumor Treating Fields on radiation sensitive and acquired radiation resistant glioblastoma patient derived xenograft pairs. T. L. Schanel. (Radiation Oncology / Radiation Science)

(Abstract #: 1103) Theoretical basis and formula for Tumor Treating Fields dose-response curves. K. Carlson. (Radiation Oncology / Radiation Science)

(Abstract #: 1371) Tumor Treating Fields exposure causes an imbalance of reactive oxygen homeostasis likely through the cytosolic function of the Fanconi anemia genes. N. Karanam. (Autophagy, Mitochondrial Function, and Ferroptosis)

(Abstract #: 1425) TTFields reduce sensitivity in glioblastoma is associated with the functional expression of the chloride intracellular channel 1 and with voltage dependent sodium channel. S. Castiglione. (Cell Cycle Progression, Checkpoint, and Telomeres)

(Abstract #: 1738) Sensitizing cancer cell to doxorubicin by Tumor Treating Fields (TTFields)-induced, elevated membrane permeability. B. Koltun. (Reversal of Drug Resistance)

(Abstract #: 2279) Tumor Treating Fields induce immune modulation in non-small cell lung cancer. S. Wang. (Immune Response to Therapies)

(Abstract #: 2666) Preclinical investigations of concomitant tumor treating fields (TTFields) with cisplatin or paclitaxel for treatment of cervical cancer. R. Frechtel-Gerzi. (Chemotherapeutic Combinations)

(Abstract #: 2723) Treatment of gastric cancer cells with tumor treating fields (TTFields) and concomitant FOLFOX. N. Flint-Brodsly. (Drug Delivery Systems)

(Abstract #: 2825) Investigation of sponge property for enhanced concurrent Tumor Treating Fields and radiotherapy for glioblastoma. J. Zheng. (Radiosensitizers and Radio-immunomodulators)

(Abstract #: 3213) Association of Tumor Treating Fields (TTFields) with survival in newly diagnosed glioblastoma: A systematic review and meta-analysis. P. Conlon. (Cancer Outcomes 1)

(Abstract #: 3221) Patients with glioblastoma (GBM) treated with Tumor Treating Fields (TTFields) therapy: post-marketing safety data over the last decade. M. M. Mrugala. (Cancer Outcomes 1)

(Abstract #: 3224) TTFields-prolonged the PFS of epithelioid glioblastoma patient: a case report. Y. Ding. (Cancer Outcomes 1)

(Abstract #: 3252) TTFields combined with temozolomide and immunotherapy show long-term PFS on a GBM patients with multiple negative prognostic factors. Z. Li. (Combination Immunotherapies 1)

(Abstract #: 3272) Tumor Treating Fields combined with the PULSAR paradigm for radiotherapy and an immune checkpoint inhibitor enhances antitumor efficacy in vivo. N. Karanam. (Combination Immunotherapies 2)

(Abstract #: CT113) Safety and efficacy of Tumor Treating Fields (TTFields) combined with bevacizumab and systemic chemotherapy in recurrent GBM. X. Kang. (Phase I Clinical Trials in Progress)

(Abstract #: 4573) Evaluation of tumor treating fields (TTFields) effects at 200 kHz on a glioblastoma, an anaplastic ependymoma and an oligodendroglioma sample in a patient-derived ex vivo organoid model. V. Nickl. (3D and Tissue Recombinant Models)

(Abstract #: 4860) PI3K inhibition sensitize cancer cells to tumor treating fields (TTFields). A. Klein-Goldberg. (Anticancer Approaches Targeting Signal Transduction Pathways)

(Abstract #: 4883) Pan cancer transcriptomic response to Tumor Treating Fields (TTFields). K. Wainer-Katsir. (Anticancer Approaches Targeting Signal Transduction Pathways)

(Abstract #: 5050) Case report: A 17-year-old patient developed glioblastoma secondary to intracranial germ cell tumor and was stabilized with chemoradiotherapy combined with Tumor Treating Fields. S. Li. (Theranostics and Radionuclides / Pharmacologic Approaches)

(Abstract #: 5802) The impact of Tumor Treating Fields on cancer stem-like cells isolated from the sub-ventricular zone of glioblastoma patients. Y. Licon Munoz. (Cancer Stem Cells and Therapeutic Resistance)

(Abstract #: 5961) Inhibition of AURKA destabilizes glioblastoma primary cilia and sensitizes cells to Tumor Treating Fields (TTFields) in vitro and ex vivo. J. Tian. (Tumor-Stromal Cell (Including Immune Cell) Interactions and Therapy Responses)

(Abstract #: 6176) Enhancing treatment efficacy of glioblastoma cell lines by adding Tumor Treating Fields (TTFields) to temozolomide and lomustine. H. Fishman. (DNA Damage Response)

(Abstract #: 6182) Tumor Treating Fields (TTFields) concomitant with PARP inhibitors or carboplatin for treatment of ovarian cancer cell lines. A. Martinez-Conde. (DNA Damage Response)

(Abstract #: 6715) CLIC1 and CLIC4 ion channels as bioelectric targets for Tumor Treating Fields in pediatric high-grade glioma. M. Griffin. (Preclinical Therapies and Clinical Observations in Pediatric Oncology)

About Tumor Treating Fields Therapy

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

RenovoRx Presenting Phase III Clinical Trial Interim Analysis Data of the TIGeR-PaC Study at American Association for Cancer Research Annual Meeting Underway in Orlando, Florida

On April 14, 2023 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of solid tumors, reported that Poster #CT084 is presenting detailed, open label, Phase III TIGeR-PaC study interim data analysis of its innovative RenovoGem therapy for pancreatic cancer patients at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, on Monday, April 17, 2023, at 9:00 AM ET in Orlando, Florida (Press release, Renovorx, APR 14, 2023, View Source [SID1234630103]). AACR (Free AACR Whitepaper) is underway through Wednesday, April 19, 2023.

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The interim analysis shows a 6-month median overall survival benefit for patients with locally advanced pancreatic cancer ("LAPC") which is a 60% improvement over systemic chemotherapy, the current standard of care and study control arm (intravenous (IV) administration of gemcitabine and nab-paclitaxel). RenovoGem patients also demonstrated greater than 65% reduction in adverse events. These can include nausea, fatigue, and a decline in white blood cells.

On Monday, April 17, "Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine plus Nab-Paclitaxel following Induction with sequential IV Gemcitabine plus Nab-Paclitaxel and Radiotherapy for Unresectable Locally Advanced Pancreatic Cancer (TIGeR-PaC) – Phase III Trial Interim Analysis," is being presented on Poster #CT084 by Michael Pishvaian, MD, Johns Hopkins Medicine Director of Gastrointestinal, Developmental Therapeutics and Clinical Research Programs, Amer H. Zureikat, MD, Professor of Surgery at the University of Pittsburgh School of Medicine, and other researchers.

This is the first interim analysis of the randomized multi-center Phase III open label TIGeR-PaC clinical trial, designed to investigate the Company’s first product candidate, RenovoGem. In this interim analysis, the control and treatment arms demonstrated divergence in median overall survival for patients. The study is designed to randomize 114 patients (57 in each arm) with all patients receiving upfront induction chemotherapy and stereotactic body radiation therapy (SBRT). The TIGeR-PaC Data Monitoring Committee ("DMC") met and determined the interim data is promising and warrants continuation of this pivotal trial. As of the analysis date, 45 patients from U.S. sites had been randomized in this trial. The survival status of all subjects was used for the analysis.

Twenty-three patients were randomized to intra-arterial gemcitabine (RenovoGem investigational treatment) arm and 22 to continuation of IV gemcitabine and nab-paclitaxel (standard of care control) arm.
The median overall survival in the IV gemcitabine and nab-paclitaxel control arm was 10 months, versus 16 months in the intra-arterial RenovoGem arm from time of randomization. (NOTE: Both arms’ median overall survival calculations do not include 4 to 5-months of life from diagnosis to randomization during the induction chemotherapy and radiation phase of the trial.)
Observed a positive trend in median overall survival by 24-weeks (6 months); in this interim analysis, the statistical significance was not reached to stop the study early (p=0.051).
Observed a 65% reduction in adverse events from control arm to treatment arm.
RenovoRx CEO, Shaun Bagai, commented, "Our RenovoGem therapy has demonstrated the potential to positively change the current standard of care for Locally Advanced Pancreatic Cancer (LAPC). Not only does analysis demonstrate that our therapy may give these patients more time, but it also shows RenovoGem can decrease adverse side effects common with systemic chemotherapy. Our mission is to help patients impacted by difficult-to-treat cancer enjoy better quality of and longer life."

Mr. Bagai added, "We look forward to the TIGeR-PaC researchers presenting this poster at AACR (Free AACR Whitepaper), and continuing strong enrollment with the second interim analysis expected mid to late next year."

About Locally Advanced Pancreatic Cancer (LAPC)

According to American Cancer Society’s Cancer Facts & Figures 2023, Pancreatic cancer has a 5-year combined overall survival rate of 12% (Stages I-IV) and is on track to be the second leading cause of cancer-related deaths before 2030. LAPC is diagnosed when the disease has not spread far beyond pancreas, however, has advanced to the point where it cannot be surgically removed. LAPC is typically associated with patients in stage 3 of the disease as determined by the TNM (tumor, nodes and metastasis) grading system.

About RenovoGem

RenovoGem is the first drug-device combination product candidate that utilizes the RenovoTAMP therapy platform via pressure-mediated delivery technology to deliver gemcitabine, an FDA-approved systemic chemotherapy, locally across the arterial wall to bathe tumor tissue in the chemotherapy. RenovoGem is currently being evaluated in the Phase III TIGeR-PaC clinical trial study in Locally Advanced Pancreatic Cancer (LAPC) patients. The Company plans to investigate RenovoGem in extrahepatic Cholangiocarcinoma (eCCA) in a clinical trial, which is anticipated to begin in the first half of 2023. RenovoGem is currently under investigation for the intra-arterial delivery of gemcitabine and has not been approved for commercial sale.

MiNA Therapeutics Presents Late-Breaking Positive Phase 1b Data for MTL-CEBPA in Combination with an Anti-PD1 Checkpoint Inhibitor at the Annual American Association of Cancer Research (AACR) Meeting

On April 14, 2023 MiNA Therapeutics Limited, the pioneer in small activating RNA (RNAa) therapeutics, reported that it will present positive updated biomarker data from its Phase 1a/b TIMEPOINT study of MTL-CEBPA in combination with the anti-PD1 checkpoint inhibitor, pembrolizumab, in adults with advanced solid tumors at the annual meeting of the American Association of Cancer Research (AACR) (Free AACR Whitepaper) in Orlando, Florida (Press release, MiNA Therapeutics, APR 14, 2023, View Source [SID1234630102]). Findings from the Phase 1b portion of the study validate the clinical proof of mechanism of MTL-CEBPA as a combination treatment and identify a novel predictive biomarker of clinical response. The data will be presented on Tuesday, April 18, during a late-breaking research session beginning at 9:00 am EDT.

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MTL‑CEBPA is the first therapy that specifically up-regulates CCAAT/enhancer binding protein alpha (C/EBP-α), a transcription factor that acts as a master regulator of myeloid cells. Dysregulated myeloid cells are implicated in several diseases including solid tumor cancers. MTL-CEBPA is designed to improve the effectiveness of checkpoint inhibitors and other immunotherapies by enhancing the body’s immune response and ability to attack the cancerous cells. Interim data from an open-label, multi-center study demonstrated the safety, tolerability, immunological and clinical activity of MTL-CEBPA in combination with pembrolizumab.

"Anti-PD1 checkpoint inhibition has significantly advanced the treatment of cancer, but many patients are resistant to treatment and present with tumors that resemble an ‘immune-desert’," said Robert Habib, CEO of MiNA Therapeutics. "The updated analysis of TIMEPOINT shows that MTL-CEBPA used in combination with anti-PD1 checkpoint inhibitors profoundly reprograms the tumor microenvironment, reducing resistance and enabling infiltration of disease-fighting T-cells."

The TIMEPOINT study also identified a novel predictive biomarker of clinical response to the combination treatment, presenting an opportunity for further evaluation as a potential companion diagnostic. The novel biomarker predicted clinical response across multiple tumor types.

MiNA plans to explore out-licensing opportunities for its immuno-oncology portfolio, which uniquely combines the capability to specifically restore or boost any dysregulated gene target with clinically validated in vivo delivery to myeloid immune cells.

MiNA’s immuno-oncology portfolio includes the following programs:

MTL‑CEBPA, which has been cleared for evaluation in a global Phase 2 clinical trial in combination with the tyrosine kinase inhibitor, sorafenib, in advanced hepatocellular carcinoma (HCC or liver cancer) and in a Phase 1 clinical trial in pediatric patients with MPS1 Hurler Syndrome
MTL-STING currently in pre-clinical development
Additional programs currently in discovery
About TIMEPOINT
TIMEPOINT is a global Phase 1a/b clinical study in patients with solid tumor malignancies to assess the safety and tolerability of MTL‑CEBPA in combination with pembrolizumab in patients who are ineligible or resistant to standard therapies. The study has received clearance from the U.S. Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). To learn more about the TIMEPOINT clinical study, visit ClinicalTrials.gov (NCT04105335).

The poster presentation at AACR (Free AACR Whitepaper) entitled, "MTL-CEBPA in combination with pembrolizumab converts an immune desert to an inflamed TME in solid tumors resistant to checkpoint blockade," will be available on MiNA’s website in the Publications section under "RNA Activation".

About MTL-CEBPA
MTL-CEBPA is the first therapy that specifically up-regulates CCAAT/enhancer binding protein alpha (C/EBP-α), a transcription factor that acts as a master regulator of myeloid cell lineage determination and differentiation. Dysregulated myeloid cells have been implicated in several diseases, and in solid tumor cancers these cells have been identified as a critical barrier to induction of clinical response for many therapies. In pre-clinical studies, MTL-CEBPA has been shown to improve the anti-tumor activity of cancer therapies by targeting dysregulated myeloid cells and reducing or eliminating their suppressive effect on immune response and therapies in the tumor microenvironment.