On April 11, 2023 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported that it is presenting data on the use of INB03, a dominant-negative TNF inhibitor of soluble TNF (sTNF) in the treatment of high-risk MUC4 expressing HER2+ and triple negative breast cancer (Press release, INmune Bio, APR 11, 2023, View Source [SID1234629948]). Roxana Schillaci Ph.D. of Instituto de Biología y Medicina Experimental in Buenos Aries, Argentina, will present data at the American Association of Cancer Research Annual Meeting 2023 in Orlando Florida and has published a paper in Cancers as part of the Special Issue: Targeted Therapeutic Options and Future Perspectives for HER2-Positive Breast Cancer.

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MUC4, an easily measured glycoprotein on the cell surface of approximately one third of women with HER2+ or TNBC, predicts poor survival and treatment resistant disease with increased metastatic potential. Several resistance mechanisms are active in MUC4-expressing tumors including resistance to trastuzumab-based antibody drug conjugates such as trastuzumab-deruxtecan (Enhertu). Neutralizing soluble TNF with INB03, a dominant negative inhibitor of sTNF, decreases MUC4 expression, improves function of trastuzumab based immunotherapies, increases anti-tumor macrophage function, increases tumor infiltrating lymphocyte populations, and decreases the metastatic potential of these high-risk tumors. These changes should improve the response to immunotherapy.

"We understand how MUC4 causes resistance to HER2-targeted therapies and have developed a strategy to overcome this resistance," said Roxana Schillaci Ph.D., lead scientist on the program from the Instituto de Biología y Medicina Experimental in Buenos Aires, Argentina. "We believe reversing expression in MUC4 in TNBC may provide therapeutic benefits. Reversing drug therapy resistance mechanisms by targeting soluble TNF alpha with INB03 may be a more efficient and safer way to improve response to therapy in women with relapsing breast cancer."

"Despite recent innovations in the treatment of HER2+ and triple-negative breast cancer, an unacceptably high number of women have resistant disease," said RJ Tesi M.D., CEO of INmune Bio. "MUC4 expression can be determined before treatment is initiated. Modifying the treatment to account for this new resistance mechanism may make is difference in the care of these woman."

Session title: Immune Response to Therapy

Poster Title: Soluble TNFα blockade enhances trastuzumab deruxtecan antitumor effect in HER2-positive breast cancer

Session Date/Time: Monday April 17, 2023 / 9.00 am to 12.30pm
Poster Board Number/Abstract Presentation Number: 20 / 2273
Location/Poster Board Number: Section 43 / 20

Session title: Metastasis Promoting and Suppressing Genes

Poster Title: New Therapeutic approach for triple negative breast cancer: TNF blockade and MUC4 expression as a prognostic biomarker

Session Date/Time: Monday April 17, 2023 / 9.00 am to 12.30pm

Poster Board Number/Abstract Presentation Number: 29/1306
Location/Poster Board Number: Section 4/29

About INB03

INB03 is a DN-TNF inhibitor that neutralizes soluble TNF (sTNF) without affecting trans membrane TNF (tmTNF) or TNF receptors. Compared to currently available non-selective TNF inhibitors, INB03 preserves the immune response to cancer by decreasing immunosuppressive cells in the TME including TAM and MDSC while promoting recruitment of anti-tumor immune cells including cytolytic CD8+ lymphocytes, NK cells and anti-tumor macrophages. INB03 has completed an open label dose-escalation Phase I trial in patients with advanced cancer. In that trial, INB03 was found to be safe and well tolerated – no dose limiting toxicity was found. INB03 decreased blood biomarkers of inflammation in patients with advanced cancer. INMB is planning a Phase II trial that uses IN03 as part of combination therapy.

On April 11, 2023 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, reported that the company will present seven posters collectively highlighting data out of five of its liver disease programs at the European Association for the Study of the Liver (EASL) Congress 2023, taking place in Vienna, Austria, June 21 – 24, 2023 (Press release, Aligos Therapeutics, APR 11, 2023, View Source [SID1234629945]). The presentations will be available on the Scientific Presentations and Conferences page on Aligos’ corporate website following the meeting.

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"We are pleased to present seven abstracts at this year’s EASL meeting," said Lawrence Blatt, Ph.D., MBA, Chairman & CEO of Aligos Therapeutics. "We believe these programs demonstrate the potential to serve as best-in-class compounds with significant value to patients and shareholders. We look forward to sharing additional detail at the time of the conference and further results throughout the year."

Poster presentation details are below.

Chronic hepatitis B

CAM-E ALG-000184
Abstract title: Treatment for up to 24 weeks with the capsid assembly modulator ALG-000184 results in dose related reductions in HBsAg in subjects with HBeAg positive chronic hepatitis B
Presenter: Jinlin Hou, M.D.

siRNA ALG-125755
Abstract title: Safety, pharmacokinetics, and antiviral activity of single ascending doses of ALG-125755, a GalNAc-conjugated small interfering RNA, in subjects with chronic hepatitis B
Presenter: Alina Jucov, M.D., Ph.D.

Abstract title: Pharmacodynamic durability of ALG-125755, a GalNAc-conjugated siRNA, correlated with total and RNA induced complex (RISC) bound siRNA in mouse liver
Presenter: Kusum Gupta

Small molecule PD-L1 inhibitor ALG-093702
Abstract title: Preclinical pharmacokinetic, pharmacodynamic and efficacy relationships of ALG-093702, a liver targeted PD-L1 small molecule inhibitor, in different in vivo models
Presenter: Tongfei Wu, Ph.D.

siRNA PD-L1 inhibitor
Abstract title: A potent human PD-L1 siRNA leads to significant reduction of AAV-HBV infected hepatocytes via immune activation in human PD-1/PD-L1 double knock in mice
Presenter: Jin Hong, Ph.D.

Hepatitis B virus model system
Abstract title: An in vivo duck hepatitis B virus model recapitulates key aspects of nucleic acid polymer treatment outcomes in chronic hepatitis B patients
Presenter: Yannick Debing, Ph.D.

Hepatocellular carcinoma
Abstract title: Selective inhibition of human β-catenin DNA transactivation activity using splice switching oligonucleotides for an improved therapeutic window in treating hepatocellular carcinoma
Presenter: Jin Hong, Ph.D.

On April 11, 2023 Immunocore Holdings Plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious diseases and autoimmune conditions, reported that management will present at the 22nd Annual Needham Virtual Healthcare Conference (Press release, Immunocore, APR 11, 2023, View Source [SID1234629943]).

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The presentation is scheduled for Monday, April 17, 2023, at 3:45 p.m. Eastern Daylight Time (EDT).

The presentation will be webcast live and will be available in the ‘Investors’ section of Immunocore’s website at www.immunocore.com. Following the event, a replay of the presentation will be made available for a limited time.

On April 11, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that it will present data from 14 studies highlighting advances in precision oncology and cancer screening at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 14-19 in Orlando, Florida (Press release, Guardant Health, APR 11, 2023, View Source [SID1234629941]).

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"We look forward to sharing new data at AACR (Free AACR Whitepaper), in particular research demonstrating the tremendous possibilities of epigenomic analysis in biomarker discovery and cancer care," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "These presentations show how gaining deeper insights into the tumor microenvironment can help us identify new potential biomarker targets for therapy and predictive markers for treatment resistance, quantify circulating tumor DNA, and contribute to better-informed patient care."

Multiple studies to be presented at the meeting highlight the new GuardantINFINITY sequencing platform and demonstrate the utility of its methylation sequencing and epigenomic analysis capabilities in biomarker discovery, therapy selection and response monitoring. In particular, studies show that:

Methylome sequencing with a liquid-only approach using the GuardantINFINITY platform can quantify circulating tumor DNA level and change with greater sensitivity and precision than genomic sequencing, making longitudinal ctDNA monitoring accessible to a broader range of patients. (Abstract 3123)
Cancer genomics alone provides little information on tumor phenotype or functional state, which are governed by epigenetic mechanisms, notably methylation of regulatory regions. The analytical validation of the GuardantINFINITY genomic and epigenomic liquid biopsy platform showed its potential for ultra-sensitive ctDNA detection for minimal residual disease and recurrence surveillance, tumor fraction quantitation for therapy monitoring, oncogenic virus detection, immunogenotyping, epigenotyping, and tumor phenotype characterization, representing a new standard in biomarker discovery. (Abstract 6601)
Full List of Guardant Health Presentations

Abstract
Poster

Title

Product

Sunday, April 16 | 1:30 – 5:00 pm

1052

29

Background variability in plasma ctDNA levels in patients with advanced lung cancer in the absence of treatment

Guardant360

Monday, April 17 | 9:00 am – 12:30 pm

LB123

6

Poorer outcomes in EGFR L858R-driven NSCLC treated with osimertinib may be addressed with novel combination of BLU-945 and osimertinib

GuardantINFORM

Monday, April 17 | 1:30 – 5:00 pm

3331

6

Highly sensitive blood-based multi-cancer screening device with tiered specificity based on diagnostic workflow

Shield

3123

9

A method for quantifying circulating tumor DNA level and molecular response using methylome sequencing

GuardantINFINITY

3128

14

Using Kmerizer, a germline and somatic genotyper for immune associated complex alleles in GuardantINFINITY, for immunotherapy response prediction using cfDNA

GuardantINFINITY

3125

21

Validation of a bioinformatic model for classifying non-tumor variants in a cell-free DNA liquid biopsy assay

GuardantINFINITY

Tuesday, April 18 | 1:30 – 5:00 pm

5573

30

Use of circulating tumor DNA (ctDNA) for early assessment of treatment response in patients with non-small cell lung cancer (NSCLC): A real-world (RW) analysis incorporating baseline ctDNA level and molecular response

GuardantINFORM

4264

13

The genomic landscape of RET fusions in non-small cell lung cancer and the impact of co-occurring genomic alterations on the efficacy of selective RET inhibitors

Guardant360

CT278

18

ERBB2 amplification detected in ctDNA as a surrogate for tumor tissue FISH analysis of HER2 status in a phase 1 study with zanidatamab for the treatment of locally advanced or metastatic HER2 expressing cancers

Guardant360

Wednesday, April 19 | 9:00 am – 12:30 pm

6087

27

Mutation and co-mutation landscape of ERBB2 alterations in advanced NSCLC

Guardant360

6744

4

Cell-free DNA detection of alterations in the MAPK pathway in metastatic hormone receptor positive breast cancer: a multi-institutional analysis of incidence and clinical outcomes

Guardant360

6094

2

Longitudinal analysis of PARP inhibitor and platinum resistance in BRCA1/2m breast cancer using liquid biopsy

GuardantINFINITY

6601

6

Analytical validation of a robust integrated genomic and epigenomic liquid biopsy for biomarker discovery, therapy selection, and response monitoring

GuardantINFINITY

6603

8

BRCA1 promoter methylation in sporadic breast cancer patients detected by liquid biopsy

GuardantINFINITY

The full abstracts for Guardant Health and a list of all abstracts being presented at the meeting can be found at the AACR (Free AACR Whitepaper) website here.

For more information and updates from the meeting, follow Guardant Health on LinkedIn and Twitter or visit AACR (Free AACR Whitepaper) booth #2465.

On April 11, 2023 Genomic Testing Cooperative, LCA (GTC) reported that it will be presenting data at the 2023 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating that its targeted transcriptomic profiling correlates with immunohistochemistry (IHC)-based testing (Press release, Genomic Testing Cooperative, APR 11, 2023, View Source [SID1234629940]). Targeted transcriptomic data generated in GTC’s routine genomic profiling of tumors is used to quantify various IHC-based biomarkers including HER2, PD-L1, estrogen Receptor (ER), androgen receptor and others. GTC studies demonstrate that RNA sequencing of clinically relevant genes using next generation sequencing (NGS) provides reliable quantitative data that can be interpreted objectively. This data when used in artificial intelligence (AI) algorithms can predict levels of PD-L1 not only in tumor cells, but also in inflammatory cells. The current data suggests that transcriptomic data can replace the need for some IHC test and potentially may better address clinically relevant questions such as determining low HER2 level and others.

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"We believe that transcriptomic profiling is essential in today’s molecular profiling of cancers. Targeted transcriptomic allows us to focus on the clinically relevant genes and provides better dynamic range." stated Dr. Maher Albitar, founder, chief medical officer, and chief executive officer of GTC. "The generated data when used in AI algorithms allows us to develop new clinical applications and answer clinical questions that few years ago, we thought not possible to answer in routine clinical testing. GTC is leading in this field" added Dr. Albitar.

This data will be presented in the following three posters:

– Predicting PD-L1 status in solid tumors using transcriptomic data and artificial intelligence algorithms: Session Date and Time: Tuesday Apr 18, 2023 9:00 AM – 12:30 PM (4337 / 12)

– Real-world transcriptomic biomarkers as replacement for immunohistochemistry and FISH studies in breast cancer: Session Date and Time: Sunday Apr 16, 2023 1:30 PM – 5:00 PM(967 / 18)

– The molecular landscape of premenopausal versus postmenopausal breast cancer in patients without inherited predisposition mutations: Session Date and Time: Sunday Apr 16, 2023 1:30 PM – 5:00 PM (929 / 12)

Visit GTC booth #1775 at AACR (Free AACR Whitepaper) for more detail and highlights on this work and on how to become a member of the Co-Op.