AI-Powered Tumor Microenvironment Analysis Predicts Treatment Outcomes in NSCLC Patients with EGFR Mutation: Groundbreaking Studies to be Presented by Lunit at SITC 2023

On November 1, 2023 Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, reported the presentation of six studies at the upcoming SITC (Free SITC Whitepaper) (Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)) 2023 Annual Meeting, taking place from November 1 to 5, in San Diego, California (Press release, Lunit, NOV 1, 2023, View Source [SID1234636678]).

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During this year’s meeting, Lunit plans to highlight the predictive value and analytical power of its Lunit SCOPE suite in various types of cancer, such as non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC).

A collaborative study with the Samsung Medical Center assessed tumor-infiltrating lymphocytes (TILs) using AI-powered spatial analysis with Lunit SCOPE IO in EGFR-mutated non-small cell lung cancer (NSCLC) patients pre- and post-tyrosine kinase inhibitors (TKI) treatment. The study found that EGFR-TKI affects the immune landscape of EGFR-mutated NSCLC as higher PD-L1 expression and differential immune phenotypes. Patients with an inflamed immune phenotype after EGFR-TKI treatment showed a more favorable response to subsequent immune checkpoint inhibitors (ICI) treatment. The study found that inflamed immune phenotype after EGFR-TKI treatment showed a higher overall response (OR; 40.0% vs. 7.5%) and better progression-free survival (PFS; 4.1 vs. 1.4 months) than other immune phenotype groups (excluded and desert type) to ICI treatment.

In another study, Lunit assessed the distribution of TILs in six subtypes of triple-negative breast cancer (TNBC) and their association with driver mutations. By analyzing The Cancer Genome Atlas breast cancer dataset using Lunit SCOPE IO, the study found that the immunomodulatory (IM) subtype of TNBC has a significantly higher mean intratumoral (iTIL), stromal (sTIL), and total TIL (tTIL) score than other TNBC subtypes. Additionally, TNBC samples with PIK3CA mutation/amplification or PTEN loss and BRCA1 or BRCA2 mutation each showed a higher total TIL score than those without mutation. This demonstrates that the TIL distribution can be a valuable biomarker for navigating the optimal treatment strategy in TNBC.

Lunit also explored the correlation between methylation burden and AI-based immune phenotype in The Cancer Genome Atlas (TCGA) Pan-Cancer Atlas dataset, which included 22 tumor types and a total of 6243 samples. The study found that the degree of methylation aberrancy in cancer is linked with TIL infiltration in the tumor microenvironment (TME) assessed by Lunit SCOPE IO.

Another study investigated the effect of tumor fragmentation index (TFI), the number of tumor fragments per total tumor area, in TME. In the study, a total of 7,472 TCGA H&E whole-slide images across 23 cancer types were analyzed with Lunit SCOPE IO. The study found that tumors with high TFI are closely correlated with high fibroblast infiltration but showed low IFNG, IL1A, and IL17A, genes that trigger inflammation as cancer grows.

"We are excited to be back to this year’s SITC (Free SITC Whitepaper) with our six groundbreaking studies that demonstrate the potential of our Lunit SCOPE suite in guiding treatment strategies for NSCLC and TNBC. We’ve also found valuable biomarkers and correlations that could lead to predictive information about patients’ immune response and the metastatic potential of the cancer tumor," said Brandon Suh, CEO of Lunit. "Through our participation in the SITC (Free SITC Whitepaper) conference, we will continue to back the efficacy of our Lunit SCOPE suite. At the same time, we are committed to seeking collaborations with healthcare giants worldwide to further our mission of advancing tailored cancer treatment."

Visit Lunit’s booth at SITC (Free SITC Whitepaper) 2023 at Booth #227 to learn more about these pioneering studies. To schedule a meeting with the Lunit team, please reach out to [email protected].

Lunit’s Abstracts at SITC (Free SITC Whitepaper) 2023

No.

Abstract
No. #

Title

Type

1

202

Spatial analysis of tumor-infiltrating lymphocytes in tumor microenvironment in non-small cell lung cancer patients who have resistance after EGFR tyrosine kinase inhibitors

Poster

2

961

Tumor-infiltrating lymphocytes in tumor microenvironment assessed by artificial intelligence powered H&E image analyzer is correlated with immunomodulatory subtype of triple-negative breast cancer

Poster

3

1446

Pan-cancer methylation analysis reveals a significant correlation of immune-desert phenotype with methylation aberrancy

Poster

4

1293

Fragmented pattern of tumor mass is related to fibroblast activation mitigating spatial interaction between tumor and immune cells

Poster

5

1308

Artificial intelligence (AI)-powered immune phenotyping based on programmed death ligand 1 (PD-L1) immunohistochemistry (IHC) in triple negative breast cancer (TNBC)

Poster

6

614

Safety and efficacy of YBL-006, a novel anti-PD-1 antibody, in advanced solid tumors including G3 NET/NEC: Results from a phase 1/2a study

Poster

IDEAYA Biosciences Announces Plans for Investor R&D Day and Participation in Jefferies London Healthcare Conference

On November 1, 2023 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in the Jefferies London Healthcare Conference and its plans to host an Investor R&D Day in December 2023 (Press release, Ideaya Biosciences, NOV 1, 2023, View Source [SID1234636677]).

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Jefferies London Healthcare Conference
Tuesday, November 14th, 2023 at 8:00 AM GMT | 3:00 AM ET

Fireside chat with Yujiro S. Hata, Chief Executive Officer, hosted by Maury Raycroft, Ph.D. Equity Research Analyst, Biotechnology
IDEAYA Biosciences Investor R&D Day
Monday, December 4th, 2023 at 8:00 AM ET

The IDEAYA Investor R&D Day will include participation from GSK and a key opinion leader that will showcase scientific insights and clinical development opportunities across IDEAYA’s synthetic lethality pipeline, including IDE397 (MAT2A) in Phase 2, IDE161 (PARG) in Phase 1, and the GSK partnered programs. In addition, IDEAYA will highlight its next generation initiatives in MTAP-deletion, including a wholly-owned program where a development candidate nomination is targeted in 2024, further advancing IDEAYA’s multi-pronged strategy.

Pre-registration will be available through IDEAYA’s investor relations events page at View Source
A live audio webcast of conference events, as permitted by conference host, will be available at the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at View Source. A replay of available webcasts will be accessible for 30 days following the live event.

Nuvalent to Participate in the BMO Virtual BioPharma Spotlight Series: Oncology Day

On November 1, 2023 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that James Porter, Ph.D., Chief Executive Officer, and Alexandra Balcom, Chief Financial Officer, will participate in a fireside chat during the BMO Virtual BioPharma Spotlight Series: Oncology Day on Wednesday, November 8, 2023, at 1:00 p.m. ET (Press release, Nuvalent, NOV 1, 2023, View Source [SID1234636676]).

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A live webcast will be available in the Investors section of the company’s website at www.nuvalent.com, and archived for 30 days following the presentation.

Sapience Therapeutics Announces Poster Presentation with New Clinical Data for ST101 in GBM at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting

On November 1, 2023 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported that data from the Phase 2 portion of its Phase 1-2 study of ST101 will be presented at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting, taking place November 15-19, 2023, in Vancouver, Canada (Press release, Sapience Therapeutics, NOV 1, 2023, View Source [SID1234636675]).

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Poster Presentation Details:

Title: "Neoadjuvant treatment with monotherapy ST101, C/EBPβ antagonist, triggers necrosis as a pathological response in newly diagnosed glioblastoma patients. Tissue-based analysis from a surgical window of opportunity clinical trial."
Poster Number: CTNI-44
Date and Time: Friday, November 17, 2023, 7:30 pm – 9:30 pm PT
Presenter: Fabio M. Iwamoto, Division of Neuro-Oncology, New York-Presbyterian/Columbia University Medical Center

More information can be found on the 2023 SNO website.

About ST101

ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). In the ongoing Phase 2 dose expansion part of the study, ST101 has demonstrated clinical proof-of-concept in recurrent GBM (rGBM) with a mRANO-confirmed partial response and long-lasting stable disease in several additional patients. In the ongoing neo-adjuvant GBM sub-study, ST101 is being evaluated as a monotherapy in rGBM and in combination with radiation and temozolomide in newly diagnosed GBM (ndGBM).

ST101 has been granted Fast Track designation for rGBM from the U.S. FDA and orphan designations for glioma from the U.S. FDA and the European Commission.

Illumina launches advanced liquid biopsy assay to enable comprehensive genomic profiling of solid tumors

On November 1, 2023 Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, reported a new generation of its distributed liquid biopsy assay for genomic profiling (Press release, Illumina, NOV 1, 2023, View Source [SID1234636674]). The new TruSight Oncology 500 ctDNA v2 (TSO 500 ctDNA v2) is a research assay that enables noninvasive comprehensive genomic profiling (CGP) of circulating tumor DNA (ctDNA) from blood when tissue testing is not available, or to complement tissue-based testing.

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Key improvements include a faster sample-to-answer turnaround time of less than four days, higher sensitivity with lower cell-free DNA (cfDNA) input requirements, and a more streamlined workflow, which will be further enabled with automation in the first half of 2024.

"Leading cancer centers are increasingly adopting the use of liquid-biopsy-based CGP, and with the TSO 500 ctDNA v2 assay we’ve aimed to make it easier for customers to integrate and enable deeper insights for cancer research," said Kevin Keegan, general manager of Oncology at Illumina.

Key improvements

Total turnaround time decreased to less than four days. Library preparation has been reduced to a single day, with improved chemistry requiring a single hybridization step, driving total turnaround time down to less than four days. Most ctDNA CGP assays have a turnaround time of one week or more, but in order for biomarker results to be the most valuable, users need insights sooner to better inform precision oncology efforts.
More analytically sensitive assay with decreased input amounts. The assay enables analysis from as little as 5 to 30 nanograms (ng) of cfDNA input. At 20 ng input, it shows more than 95% analytical sensitivity with 99.9995% specificity. At 10 ng input, it shows more than 95% sensitivity for hot-spot mutations with 99.9995% specificity. Improved performance can be attributed to both innovations in chemistry and the advanced variant analysis powered by DRAGEN.
Flexible, streamlined, complete solution. The assay offers broader access to a sample-to-answer distributed solution in both manual and, coming in 2024, automated formats. Workflow improvements reduce hands-on time for library preparation, and automated bioinformatics features further streamline the experience. The assay provides additional flexibility with sequencing compatibility on the NovaSeq 6000 (NovaSeq 6000Dx in research mode and NovaSeq X coming in 2024), as well as local and cloud-based bioinformatics options accommodating the range of institutional preferences.
Nine institutions are participating in Illumina’s global early-access customer program to trial TSO 500 ctDNA v2. Giancarlo Pruneri, professor of Pathology at the University of Milan School of Medicine and chair of the Department of Pathology and Laboratory Medicine at the National Cancer Institute of Milan, noted that preliminary testing of the new version of the TSO500 ctDNA panel in their labs "undoubtedly represented an improvement over the previous version."

"In particular, the optimization of library preparation protocol saves one working day, thus enabling a faster delivery of the molecular analysis," he said, "while the increased assay sensitivity allows the analysis of samples with reduced DNA content (20 ng), potentially broadening the utility of liquid biopsy testing."

Growing evidence on the utility and efficacy of liquid biopsy CGP is leading to its inclusion in recommended professional guidelines in oncology. Most notably, liquid biopsy testing in non-small-cell lung cancer has proven useful when tissue results are either unavailable or delayed. This trend is expected to continue for other solid tumor malignancies, which supports the consideration of broad tumor profiling from cfDNA from blood even before tissue analysis.

"Traditional tissue-based analyses are frequently still limited by tissue availability, often involving costly and invasive biopsy procedures," Pruneri said. "In this context, Illumina’s new panel emerges as a solution to address the dependency on tissue availability."

Expected in the first half of 2024, automation-enabled kits and method for TSO 500 ctDNA v2 will allow laboratories to scale with the growing demand for this technology.

About TruSight Oncology 500 ctDNA v2
TSO 500 ctDNA v2 is a research-use-only comprehensive pan-cancer assay designed to identify 523 known and emerging tumor biomarkers from blood plasma. TSO 500 ctDNA v2 uses cfDNA from liquid biopsy samples to identify key variants critical for cancer development and progression, such as small DNA variants (SVs), copy number variants (CNVs), short and long insertions and deletions (indels), and immuno-oncology gene signatures like tumor mutational burden (bTMB) and microsatellite instability (bMSI). The content and design of this comprehensive liquid biopsy genomic profiling assay are similar to the tissue-based assay TSO 500, offering a portfolio of solutions. Advanced bioinformatics powered by DRAGEN contribute to the performance and flexiblity of the TSO 500 ctDNA v2 solution. To learn more about TSO 500 ctDNA v2, click here.