On September 13, 2024 Nxera Pharma and Cancer Research UK reported an upcoming presentation on the ongoing Phase 1/2a clinical trial (NCT05944237) of Nxera’s immunotherapy drug HTL0039732 (also known as NXE0039732) at the European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper) 2024, taking place on 13–17 September in Barcelona, Spain (Press release, Nxera Pharma, SEP 13, 2024, View Source [SID1234646620]).

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The trial’s co-chief investigator, Dr. Debashis Sarker from Guy’s and St Thomas’ NHS Foundation Trust, will present a "Trial in Progress 1 " poster at ESMO (Free ESMO Whitepaper) 2024 on Saturday 14 September (presentation 679TiP, available on the ESMO (Free ESMO Whitepaper) website here).

The first-in-human trial is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of HTL0039732 as a monotherapy and in combination with the checkpoint inhibitor atezolizumab, in patients with advanced solid tumors.

HTL0039732 is an oral small molecule drug candidate that was rationally designed using Nxera’s NxWave platform and evaluated through rigorous translational and preclinical studies. HTL0039732 works by blocking signaling through a specific type of prostaglandin receptor, the prostaglandin E2 (PGE2)-type prostanoid receptor 4 (EP4). PGE2 acts in the tumor microenvironment to trigger cancer cells to evade the immune system. Targeting EP4 to block the effects of PGE2 increases the ability of the immune system to detect and control cancer cells and makes HTL0039732 a potential candidate to treat patients with cancers that generally do not respond well to current immunotherapies.

Cancer Research UK’s Centre for Drug Development is sponsoring and managing the trial, which is led by chief investigator Dr Bristi Basu, University of Cambridge, and Dr Sarker. The first patient was dosed in August 2023 and the trial is currently open for recruitment at Addenbrooke’s Hospital in Cambridge, Guy’s Hospital in London, and the Christie Hospital in Manchester

Dr. Debashis Sarker says: "We are excited to present this ‘Trials in Progress’ poster at ESMO (Free ESMO Whitepaper), outlining the
scientific rationale and design of the clinical trial of HTL0039732, given alone and in combination with immunotherapy for patients with advanced solid cancers. HTL0039732 targets an important protein within the tumor immune microenvironment called EP4, triggering cancer cells to evade the immune system. Targeting EP4 potentially increases the ability of the immune system to detect and control cancer cells. Enrolment to the trial began in the UK in August 2023 and is ongoing across multiple cancer types.

"We are hopeful that this trial will identify a novel way to target the immune system and improve treatment
options for patients with a range of different solid cancers."

On September 13, 2024 Celyad Oncology (Euronext: CYAD) (the "Company"), reported its financial results for the first half year 2024 ended June 30, 2024, and provides a business update (Press release, Celyad, SEP 13, 2024, View Source [SID1234646603]).

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Michel Lussier, interim Chief Executive Officer of Celyad Oncology, commented: "Celyad Oncology continues to make remarkable progress in developing cutting-edge technologies for chimeric antigen receptor (CAR) T-cell therapy. Our groundbreaking multiplex platform is revolutionizing the potential of CAR T-cells, while our pioneering NKG2D-based multispecific CAR T-cell platform is further paving the way to conquer current limitations of this transformative class of immunotherapy."

H1-2024 Business highlights

The Company is pursuing a strategy of continued research and development, with a particular focus on intellectual property (IP). Monetization of its innovative approaches and technologies is a key objective. Celyad Oncology is progressing in this regard and is currently in discussion with potential partners for out-licensing deals;
With its research focus, the Company has made concrete progress by providing proof-of-concept of the multiplex short hairpin RNAs (shRNAs) non-gene edited technology platform and the multispecific NKG2D-based CAR T-cell platform, which provide unique options to tackle the major current limitations of CAR T-cell therapies. Options to further explore or validate these data through strategic partnerships, and/or to incorporate these technologies into clinical CAR-T candidates are actively pursued by the Company;
The Company continues to share and discuss its latest advances at international scientific conferences throughout the first half of 2024 with updated results provided at the 27th ASGCT (Free ASGCT Whitepaper) 1 Annual Meeting and the Recent insights into Immuno-Oncology VIB conference 2.
The Company is also focusing on sharing data and views with the scientific community and has published a review highlighting the interest of non-gene editing technologies for allogeneic CAR T-cell therapies in Cells 3 and another review providing an overview of all engineering strategies to safely drive CAR T-cells into the future in Frontiers in Immunology 4, two well-renowned peer-reviewed scientific journals;
In response to the request expressed by several companies and academic institutions engaged in gene and cell therapies for cardiac applications, the Company has re-initiated the manufacturing and commercialization of C-Cath, an intra-myocardial injection catheter developed and owned by the Company.
H1-2024 operational highlights

Multiplex shRNA non-gene edited technology – The Company developed a chimeric micro-RNA (miRNA) cluster to enable multiplexing of shRNAs, designed for easy, efficient, and tunable downregulation of up to four target genes simultaneously in CAR T-cells.
Data successfully demonstrated the feasibility and effectiveness of the multiplex approach to improve allogeneic CAR T-cell viability by avoiding graft-versus-host disease (GvHD) via knocking down of CD3ζ, avoiding host-versus-graft (HvG) reaction and promoting cell persistence via knocking-down of β2M and CIITA, and avoiding CD95L-induced autophagy via knocking-down of CD95;
Another multiplex cassette focusing on the knock-down of co-inhibitory receptors (PD-1, LAG-3, TIM-3 and CD95) was also developed to decrease the expression of exhaustion markers at the surface of CAR T-cells.
Multispecific NKG2D-based CAR T-cell platform – Different NKG2D-based multispecific CAR T-cells were developed to provide the proof-of-concept that NKG2D ligands (NKG2DL) are valuable targets in a multispecific CAR approach to counteract relapses due to antigen loss or antigen heterogeneity.
PSMA/NKG2DL tandem CAR T-cells, that encompass the extracellular domain of the natural NKG2D receptor fused to an anti-PSMA CAR to overcome antigen heterogeneity and improve anti-tumor efficacy against prostate cancer were developed and demonstrated functionality in vitro against prostate cancer cell lines expressing or not the tumor-associated antigen PSMA;
In vivo proof-of-concept of the company’s CD19/NKG2DL tandem CAR T-cell candidate was also provided in a B-ALL relapse model, showing that this multi-specific CAR T-cell candidate has an enhanced anti-tumor efficacy against heterogeneous lymphoma tumors, or to counteract antigen loss, as compared to currently existing treatment options.
First Half 2024 financial review

As of June 30, 2024, the Company’s Treasury position amounts to €6.2 million.

After due consideration of detailed budgets and estimated cash flow forecasts for the years 2024 and 2025, the Company projects that its existing cash and cash equivalents will be sufficient to fund its estimated operating and capital expenditures into the third quarter of 2025.

On September 13, 2024 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company and its research collaborators will present data from several studies utilizing Guardant technology to advance precision oncology at the European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper) in Barcelona, Spain, Sept. 13-17, 2024 (Press release, Guardant Health, SEP 13, 2024, View Source [SID1234646602]).

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Data on the Guardant Reveal minimal residual disease test in locally advanced rectal cancer patients enrolled in the NO-CUT trial will be presented in a proffered paper session during Presidential Symposium III. Other presentations will include findings from studies evaluating Guardant360 for therapy selection in advanced breast cancer and other solid tumors, and the Guardant Infinity platform for response monitoring in advanced non-small cell lung cancer (NSCLC).

"Our latest data featured at ESMO (Free ESMO Whitepaper) further highlight the value of Guardant’s technology in precision oncology and the critical role liquid biopsy can play in informing therapy selection and treatment management across multiple tumor types," said Craig Eagle, M.D., chief medical officer at Guardant Health. "We look forward to sharing how Guardant tests can contribute to improved outcomes across all stages of cancer care."

Complete list of Guardant Health and collaborator presentations at ESMO (Free ESMO Whitepaper) 2024

Abstract

Title (Hall 6, unless otherwise noted)

Product

Saturday, September 14 | 9:00 – 17:00

1295P

EP0031 a next-generation selective RET inhibitor (SRI): Correlation of molecular and clinical responses in patients with RET alteration positive solid tumours naïve to or following prior SRI

Guardant Infinity

Sunday, September 15 | 9:00 – 17:00

127P

Clinical utility of circulating tumor DNA (ctDNA) next generation sequencing (NGS) to inform treatment decisions for patients (pts) with advanced solid tumors

Guardant 360

Monday, September 16 | 9:00 – 17:00

418P

Concordance of PI3K-AKT pathway alterations between tumor and ctDNA in metastatic breast cancer

Guardant 360

419P

Prevalence of gene rearrangement on ctDNA NGS and its targetability in patients with advanced breast cancer

Guardant 360

Monday, September 16 | 17:04 – 17:16

509O

Total neoadjuvant treatment (TNT) with non-operative management (NOM) for proficient mismatch

repair locally advanced rectal cancer (pMMR LARC): first results of NO-CUT Trial

Proffered Paper Session: Presidential Symposium III: Eyes to the future, Barcelona Auditorium, Hall 2

Guardant Reveal

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

For information and updates from the conference, follow Guardant Health on LinkedIn, X (Twitter) and Facebook or visit Guardant on-site at booth #510.

On September 13, 2024 BostonGene a leading provider of artificial intelligence (AI)-driven molecular and immune profiling solutions, reported that it will present three abstracts at ESMO (Free ESMO Whitepaper) Congress 2024 (Press release, BostonGene, SEP 13, 2024, View Source [SID1234646601]). This globally recognized oncology event brings together clinicians, researchers, patient advocates and healthcare professionals to share and discuss the latest advancements in translational cancer research. The Congress aims to highlight potentially practice-changing data and foster multidisciplinary discussions to enhance treatment options for cancer patients.

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The ESMO (Free ESMO Whitepaper) Congress 2024 will take place from September 13 to 17 in Barcelona, Spain, at the Fira Barcelona Gran Via.

BostonGene session details are as follows:

Abstract: 1115P
Title: Multiomics clustering of patients with cutaneous melanoma to reveal survival trends based on tumor immune evasion features
Date: Saturday, September 14, 2024

Multiomic analysis of genomic and transcriptomic data related to immune escape in a cutaneous melanoma cohort revealed five distinct tumor-immune microenvironment (TiME) types that influence patient survival.

Abstract: 1773P
Title: Genomic and transcriptomic analysis of chondrosarcomas to explore new potential treatment options
Date: Saturday, September 14, 2024

Comprehensive profiling of a chondrosarcoma (CS) cohort identified potential biomarkers and drug targets. Tumor microenvironment analysis revealed a high prevalence of non-immune-enriched subtypes, suggesting that non­immunotherapeutic treatment options may be more appropriate.

Research conducted in collaboration with Sarcoma Oncology Research Center, Massachusetts General Hospital Cancer Center, The University of Texas MD Anderson Cancer Center, and Sarah Cannon Research Institute

Abstract: 1777P
Title: Molecular profiling from next-generation sequencing (NGS) reveals new potential therapeutic targets in patients with pediatric-type sarcomas
Date: Saturday, September 14, 2024

Comprehensive molecular profiling revealed targetable events that could benefit older patients with pediatric-type fusion-driven sarcoma by expanding potential therapeutic options and allowing for inclusion in biomarker-driven trials without strict age limits.

Research conducted in collaboration with The University of Texas MD Anderson Cancer Center, Massachusetts General Hospital Cancer Center, and Sarcoma Oncology Research Center

To learn more or to schedule a meeting with BostonGene during the event, please contact Maria Proia at [email protected]. For more information, please visit the ESMO (Free ESMO Whitepaper) Congress 2024 website.

On September 13, 2024 CDR-Life reported significant clinical progress in its M-gager portfolio for solid tumors, marking important milestones in the company’s mission to deliver innovative, antibody-fragment based immunotherapies for difficult-to-treat cancers (Press release, CDR-Life, SEP 13, 2024, View Source [SID1234646600]).

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First patient dosed with CDR404
The first patient was dosed with CDR404, a novel, bispecific and bivalent antibody fragment-based T cell engager (TCE) targeting MAGE-A4, an intracellular cancer-specific protein that is cleaved into smaller peptide fragments and presented on HLA-A*02:01 molecules at the surface of cancer cells.

The Phase 1 study (NCT06402201) is enrolling HLA-A *02:01+ patients with MAGE-A4+ solid cancers in the U.S. and Europe. The trial is evaluating the safety, tolerability and preliminary anti-tumor activity of CDR404 in several common cancers including squamous cell carcinomas in which MAGE-A4 is highly enriched.

New clinical candidate targeting PRAME
Preferentially Expressed Antigen in Melanoma (PRAME) is a tumor-specific therapeutic target that is expressed in a wide range of solid tumors including lung, ovarian, melanoma, and endometrial cancers, while exhibiting only minimal expression in healthy tissues.

CDR-Life has identified and characterized an antibody fragment-based TCE as a clinical candidate targeting PRAME called CDR813. This TCE binds potently and bivalently to an HLA-A*02-restricted PRAME peptide on the surface of cancer cells. Pre-clinical studies have shown that CDR813 has very favorable pharmacological and manufacturability properties with best-in-class potential for the clinic.

A poster will be presented at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, in Barcelona, Spain.

Poster Presentation Details
Title: Highly potent and specific bivalent T cell engager (TCE) targeting PRAME on HLA-A*02:01
Date and Time: Saturday, September 14, 2024, 12 – 1 pm CET
Abstract Number: 5132, Poster 1020P

"The clinical advancement of CDR404 and the excellent progress we have made in advancing CDR813 into a clinically viable drug are significant milestones in our quest to develop life-changing, antibody fragment-based cancer medicines for patients with the HLA-A*02:01 genotype, the most prevalent HLA genotype in the U.S. and Europe, using our proprietary M-gager technology," said Swethajit Biswas, Chief Medical Officer of CDR-Life. "This current suite of T cell engagers targeting cancer-specific peptides presented on HLA underscores our ambitions in solid tumor oncology to create an innovative pipeline of highly specific and potent antibody fragment-based molecules targeting a wide range of cancer-specific antigens including challenging cell surface resident proteins, which are known to be directly involved in tumor growth."