On March 26, 2024 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported a new publication validating the company’s NeXT Personal test, an ultra-sensitive, tumor-informed circulating tumor DNA (ctDNA) assay (Press release, Personalis, MAR 26, 2024, View Source [SID1234641466]). NeXT Personal is designed to help detect minimal residual disease (MRD), monitor therapy response, and identify recurrence with high analytical sensitivity and accuracy, enhancing the decision-making process and ultimately improving patient outcomes in the ongoing battle against cancer.

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"The robust validation results in this publication provide a foundational building block towards achieving Medicare coverage for NeXT Personal," said Richard Chen, MD, MS, Chief Medical Officer and Executive Vice President, R&D of Personalis. "We are laser-focused on developing and publishing data to establish NeXT Personal as a leading MRD test."

In the analytical validation study published in Oncotarget, scientists from Personalis evaluated NeXT Personal by testing samples from over 120 patients across nine cancer types and paired tumor and normal cell lines. The NeXT Personal technology leverages whole genome sequencing (WGS) and advanced noise suppression with NeXT SENSE technology to identify a unique genetic signature derived from a patient’s tumor based on up to ~1,800 variants. Through NeXT Personal, a custom panel is created to detect trace amounts of ctDNA from patient blood samples.

The analytical range measurements demonstrated a detection threshold of 1.67 parts per million (PPM) of ctDNA with a LOD95 of 3.45 PPM, highlighting NeXT Personal’s ultra-high analytical sensitivity. Results of the study showed 100% measured analytical specificity, with a confidence interval spanning 99.92 to 100%.

"We designed NeXT Personal to enable another big leap in ctDNA sensitivity and specificity," said Chen. "Taken together, the results show NeXT Personal’s capability for ultra-sensitive detection of ctDNA in patient plasma samples and the test’s potential to reliably inform clinicians and patients on residual cancer, cancer treatment response, and cancer recurrence through ctDNA detection, earlier than conventional detection approaches," Chen noted.

At the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, initial findings showed that NeXT Personal’s significantly improved detection rates could translate into clinical benefit in early-stage lung cancer, including lung adenocarcinoma (LUAD), one of the most common and challenging subtypes of non-small cell lung cancer (NSCLC) to identify in blood samples. This data from the TRACERx Study demonstrated the assay was able to find cancer nearly a year ahead of imaging and was predictive of clinical outcomes in early-stage lung cancer patients.

On March 26, 2024 ImmPACT Bio USA, Inc. ("ImmPACT Bio"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases, reported that it will participate at the 2024 Cell and Gene Meeting on the Med, to be held from April 9-11, 2024 in Rome, Italy (Press release, ImmPACT-Bio, MAR 26, 2024, View Source [SID1234641465]).

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Sumant Ramachandra, M.D., Ph.D., ImmPACT Bio’s chief executive officer, will provide a company presentation on Tuesday, April 9, 2024 at 12:00 PM CET. Dr. Ramachandra will also participate in an individual presentation and panel discussion entitled, "Advances in Targeting Autoimmune Disease," on Wednesday, April 10, 2024 at 10:45 AM CET.

Virtual attendance is available which includes a livestream of ImmPACT Bio’s presentation and the ability to view all conference sessions on-demand. Please visit View Source for full information including registration.

On March 26, 2024 STORM Therapeutics Ltd. (STORM), the clinical stage biotechnology company discovering and developing novel small molecule therapies targeting RNA modifying enzymes (RMEs) for oncology and other diseases, reported that Alexandra Sapetschnig, Group Leader at STORM, will present late breaking data on STORM’s METTL1 inhibitors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in San Diego, California, held 5-10 April 2024 (Press release, STORM Therapeutics, MAR 26, 2024, View Source [SID1234641464]).

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The presentation entitled ‘First-in-class inhibitors of the tRNA methyltransferase METTL1 for the treatment of cancer’ details the discovery of STORM’s first-in-class inhibitors of METTL1 tRNA methyltransferase and supporting evidence of its potential as a novel target for anti-cancer drugs.

Oliver Rausch, Chief Scientific Officer at STORM Therapeutics, said: "We are looking forward to presenting these data on our first-in-class METTL1 inhibitor at the AACR (Free AACR Whitepaper) Annual Meeting. As we continue to develop our pipeline of therapies inhibiting RNA modifying enzymes, we are pleased with the progress we are making with METTL1 and are looking forward to advancing this candidate towards clinical development."

Details of the late breaking poster presentation are as follow:

Poster Title: First-in-class inhibitors of the tRNA methyltransferase METTL1 for the treatment of cancer
Presenter: Alexandra Sapetschnig, Group Leader at STORM
Authors: Alexandra Sapetschnig1, Beth Thomas1, Eliza Yankova2, Harry Fischl1, Aleksandra Azevedo1, Sarah Bucknell1, Richard Fosbeary1, Sapphire Sawyer1, Sian Evans2, Carmen Livi1, Byron Andrews1, Jack Rogan1, Natalie Webster1, Matthew Fyfe1, Konstantinos Tzelepis2, Oliver Rausch1
Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 2
Session Date and Time: Monday Apr 8, 2024 1:30 PM – 5:00 PM
Location: Poster Section 52
Poster Board Number: 17
Abstract Presentation Number: LB171

1 Storm Therapeutics Ltd, Babraham Research Campus, Cambridge CB22 3AT, United Kingdom
2 Wellcome-MRC Cambridge Stem Cell Institute, Jeffrey Cheah Biomedical Centre, University of Cambridge, Puddicombe Way, Cambridge CB2 0AW, United Kingdom

Late breaking abstracts will be available in an online itinerary planner here on the 5 April and will be available in on online only supplement to the AACR (Free AACR Whitepaper) journal Cancer Research one month after the conference.

On March 26, 2024 Biond Biologics Ltd., a pioneering clinical-stage biopharmaceutical company, developing innovative immunotherapies for cancer and a transformative platform for the intracellular delivery of biologics, reported that it’s BND-35 program has been selected for presentation at the esteemed American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, scheduled for April 5 – 10, 2024, in San Diego Convention Center, San Diego, CA, USA (Press release, Biond Biologics, MAR 26, 2024, View Source [SID1234641463]). BND-35 is distinguished as a humanized IgG4, ILT3 (LILRB4) antagonist antibody, designed to modulate the tumor microenvironment (TME) from immunosuppressive to pro-inflammatory, thereby counteracting tumor growth. BND-35 phase 1 trial includes a unique clinical design, that will be presented in the ACCR, and is based on Biond’s extensive pre-clinical work and the ability of BND-35 to block interactions with the various ligands of ILT3.

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The presentation, titled "BND-35, a novel anti-ILT3 antibody for remodulation of the tumor microenvironment", will be part of the session on "Immune Targets and Therapies." It is scheduled for Monday, Apr 8th, 2024, at 4:05 PM. The session will highlight Biond Biologics’ comprehensive preclinical characterization of BND-35, emphasizing its potential as a transformative treatment for solid tumors.

BND-35 Oral Presentation Highlights at 2024 AACR (Free AACR Whitepaper) Annual Meeting

Biond Biologics’ pivotal research on BND-35 demonstrates its specificity in binding ILT3 with high affinity, without affecting other ILT-family receptors. The specific blocking of ILT3’s interaction with key ligands significantly enhances the pro-inflammatory activity of myeloid cells and effectively reverses ILT3-mediated immune suppression of T cells. The presentation will detail how BND-35, as a standalone therapy and in combination with anti-PD-1 and anti EGFR agents, has shown promising results in restoring T and NK cell activity and inducing a pro-inflammatory TME in various in vitro, ex vivo, and in vivo models.

"ILT3 is a clinically validated target that in the past several years have been the focus of several clinical programs. The findings we’re presenting at AACR (Free AACR Whitepaper) 2024 represent the unique features of BND-35 and why we believe it has the potential to surpass other ILT3 targeting agents," said Motti Hakim, Ph.D., VP R&D at Biond Biologics. "BND-35’s ability to remodel the immunosuppressive environment into a pro-inflammatory one, opens new doors for treating solid tumors and our research in this field brings a significant leap forward in our understanding of immune regulation within the TME," Tsuri Peretz, BND-35 project manager at Biond Biologics, added, "We are eager to share our latest advancements with the scientific community. BND-35’s compelling preclinical results pave the way for its upcoming first-in-human clinical trial, marking a pivotal step in our quest to provide innovative solutions for patients with solid tumors."

In addition to the spotlight on BND-35, Biond Biologics continues to advance its Immuno-Oncology pipeline, including the pre-clinical-stage BND-67 program, and the innovative INspire platform for intracellular delivery of biologics. The presentation will underscore Biond’s commitment to groundbreaking research and development, aiming to unlock new pathways for cancer treatment.

On March 26, 2024 Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, reported the publication of a new study featuring Lunit SCOPE IO, Lunit’s AI-powered analyzer for quantitative immune phenotyping from H&E (Press release, Lunit, MAR 26, 2024, View Source [SID1234641462]). The study was recently published in Clinical Cancer Research (CCR), an international journal by the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

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Led by researchers of Yonsei Cancer Hospital Head and Neck Cancer Center Department of Oncology (Prof. Hye Ryun Kim, Min Hee Hong, Chang Gon Kim, Hyun Wook Kim), Department of Otolaryngology (Prof. Yoon Woo Koh, Da hee Kim), and Department of Pathology (Prof. Sun Och Yoon) from Yonsei University College of Medicine, Seoul, Korea, the study focuses on the efficacy of neoadjuvant immunotherapy for head and neck squamous cell carcinoma (HNSCC) patients. This investigation addresses the current lack of exploration into the clinical implications of neoadjuvant immunotherapy in HNSCC patients with resectable tumors, utilizing Lunit SCOPE IO to examine the changes in tumor microenvironment when treated with durvalumab and tremelimumab.

In this phase II randomized clinical trial, 48 HNSCC patients were enrolled, with 24 receiving preoperative durvalumab and 24 receiving a combination of durvalumab plus tremelimumab before surgical resection. Both treatment groups demonstrated favorable safety profiles, affirming the feasibility of preoperative immunotherapy in resectable HNSCC without causing delays in surgery.

The study findings revealed that patients treated with the combination of durvalumab and tremelimumab exhibited significantly better 4-year distant recurrence-free survival (DRFS) compared to those receiving durvalumab monotherapy (91.1% vs. 53.3%), suggesting the potential benefits of combining durvalumab with tremelimumab in improving patient outcomes. Similarly, the 4-year overall survival (OS) was notably higher in patients receiving combination therapy (83.1% vs. 67.5%). Additionally, Lunit SCOPE IO’s AI analysis backed the remarkable shift in the tumor microenvironment towards an inflamed phenotype, characterized by increased immune activity within the tumor area, in patients receiving combination therapy. This was in contrast to those treated with durvalumab monotherapy or cytotoxic chemotherapy.

Moreover, analysis of circulating immune cells revealed that patients receiving both durvalumab and tremelimumab showed increased activity and proliferation of certain immune cells, indicating a unique immune response induced by the combination therapy compared to durvalumab alone.

"Through this prospective clinical study, we have confirmed the clinical utility of preoperative immunotherapy for treating locally advanced head and neck cancer," said Professor Kim Hye Ryun, head of the research. "This discovery has the potential to revolutionize future treatment paradigms and significantly enhance patient outcomes. We are committed to offering this promising treatment method."

"In this study, Lunit SCOPE IO provides deeper insights into the tumor microenvironment and immune response, empowering healthcare professionals with invaluable information to make more informed treatment decisions. Additionally, the study addresses a longstanding gap in our understanding of the clinical effectiveness of neoadjuvant immunotherapy in HNSCC, which is the seventh most common cancer worldwide," said Brandon Suh, CEO of Lunit. "Moving forward, Lunit will continue to innovate and enhance Lunit SCOPE’s capabilities to further improve patient outcomes and revolutionize personalized cancer treatment through AI."

This study underscores the importance of leveraging AI technology, such as Lunit SCOPE IO, in understanding the complex interplay between the immune system and cancer, ultimately leading to more effective treatment approaches and improved patient outcomes.