I-Mab Announces Poster Presentations of 4-1BB Bispecific Antibody Portfolio at SITC 2023

On November 1, 2023 I-Mab (Nasdaq: IMAB) (the "Company"), a global biotechnology company focused on bringing highly differentiated medicines to patients around the world through the discovery, development, and commercialization of novel immunotherapies and biologics, reported that two poster presentations featuring preclinical data on givastomig (also known as TJ-CD4B/ABL111) and TJ-L14B/ABL503, the Company’s 4-1BB-targeting bispecific antibody assets, will be reported at the 38th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Annual Meeting, taking place November 1-5, 2023, in San Diego, California (Press release, I-Mab Biopharma, NOV 1, 2023, View Source [SID1234636679]).

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The full text of the abstracts has been released on the SITC (Free SITC Whitepaper) website, and the posters will be available on the Company’s website following the conclusion of SITC (Free SITC Whitepaper) 2023. Details of the poster presentations are as follows:

Title:

Givastomig, a novel Claudin18.2/4-1BB bispecific antibody, exerts bystander tumor-killing and synergistic anti-tumor activity with therapeutics in 1L/2L treatment for gastric cancer

Poster #:

792

Presenter:

Dr. Xuejun Liu, I-Mab

Date/Time:

Saturday, November 4, 2023

9:00 a.m. – 8:30 p.m. Pacific Time (12:00 p.m. – 11:30 p.m. Eastern Time)

Full abstract

View Source

Title:

ABL503 (TJ-L14B), PD-L1×4-1BB bispecific antibody, reinvigorates exhausted tumor-infiltrating CD8+ T cells and synergizes with PD-1 blockade

Abstract ID:

845

Presenter:

Dr. Jaeho Jung, ABL Bio

Date/Time:

Friday, November 3, 2023

9:00 a.m. – 7:00 p.m. Pacific Time (12:00 p.m. – 10:00 p.m. Eastern Time)

Full abstract

View Source

About Givastomig

Givastomig, also known as TJ-CD4B/ABL111, is a bispecific antibody designed to bind to Claudin 18.2 (CLDN18.2) as a tumor engager and 4-1BB as a conditional T-Cell activator. It binds to tumor cells expressing various levels of CLDN18.2, i.e., gastric cancer and pancreatic cancer cells, and conditionally activates intra-tumoral T cells at the tumor site through the 4-1BB arm. Givastomig appears to effectively maintain a strong tumor binding property and anti-tumor activity attributable to a synergistic effect of both CLDN18.2 antibody and 4-1BB antibody while avoiding or minimizing liver toxicity and systemic immunotoxicity commonly seen with 4-1BB antibodies as a drug class. Being developed under collaboration between I-Mab and ABL Bio, a clinical-stage biotechnology company in South Korea, givastomig is currently being investigated in a Phase 1 clinical study in the U.S. and China. In March 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for givastomig for the treatment of gastric cancer, including cancer of the gastroesophageal junction.

About TJ-L14B/ABL503

Being developed jointly with ABL Bio (Kosdaq: 298380, hereafter "ABL"), TJ-L14B/ABL503 is a differentiated PD-L1-based bispecific antibody with the PD-L1 arm as the tumor-dependent T-cell activator and the 4-1BB arm as the conditional T cell activator upon tumor engagement. Using ABL’s "Grabody-T" bispecific antibody platform technology, TJ-L14B/ABL503 stimulates 4-1BB activation only in the presence of PD-L1 expressing tumor cells to minimize the risk of off-tumor toxicity. Preclinical studies have demonstrated that the bispecific antibody shows better anti-tumor activity than equimolar doses of single agents alone or in combination. A Phase 1 study is currently being conducted in the U.S. and South Korea.

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.