On September 12, 2024 Turbine, the biological simulation company using AI to build a digital lab for predictive computational models of human cells and tissue, reported that Ono Pharmaceutical Co., Ltd. (Osaka, Japan, "Ono") has selected multiple targets identified using Turbine’s in silico Simulated Cell platform for further development (Press release, Turbine, SEP 12, 2024, View Source [SID1234646555]). Turbine will now lead in vitro validation of the identified targets in one of Ono’s priority cancer biology domains, in consultation with Ono.

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"Achieving this milestone so quickly speaks to the speed and power of our digital laboratory platform, which models foundational protein signaling logic to target disease and position therapeutic assets for clinical success," said Szabolcs Nagy, Turbine’s co-founder and Chief Executive Officer. "All within just a year, we built, trained, and tested the optimal avatars to identify targets within Ono’s priority domain, screened for all relevant perturbations, then filtered and translated millions of in silico experiments to find key hypotheses ready for validation in our wet lab. Our insights included causal factors for each target’s mechanism of action, which should simplify and speed up validation. We’re looking forward to working with our colleagues at Ono to advance this important work."

Under the terms of the collaboration, which was announced in October 2023, Turbine will receive a milestone payment for completing this phase of the research program. As Turbine leads in vitro validation studies of the selected targets in its state-of-the-art wet laboratory facilities, it will consult with Ono’s experts on plans and expected outcomes. Turbine will be eligible for additional payments related to the validation process, as well as for progress of drug development and commercialization by Ono.

"Ono is committed to innovating transformative therapies that improve outcomes for cancer patients, and identifying novel targets with robust scientific support is essential for achieving this goal," said Seishi Katsumata, Corporate Officer/Executive Director, Discovery & Research of Ono. "Turbine has provided multiple targets that have first-in-class potential, along with the biology-driven insights necessary to rapidly validate this potential. We’re excited to move these targets forward and expect that the collaboration will consequently lead to providing a new therapeutic option to cancer patients as soon as possible."

On September 11, 2024 Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, "Median" or "The Company") reported that the Company will attend the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain, from Sep. 13-17 (Press release, MEDIAN Technologies, SEP 11, 2024, View Source [SID1234646522]). Median iCRO and eyonis teams will be present to welcome interested parties at Booth #525, Hall 3, from September 13-16 (exhibition dates). The Company will share the most recent advances for iCRO AI-powered clinical trial imaging services as well as latest developments for eyonis Lung Cancer Screening (LCS) Software as Medical Device (SaMD).

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Median eyonis team will present a peer-reviewed poster presentation of the full positive results of the independent verification study for Median proprietary SaMD eyonis Lung Cancer Screening (LCS). Preliminary results of the study were communicated on January 17, 2024. This independent verification study is part of a process in medical device development required by regulators; it ensures devices meet stringent regulatory standards and defined product requirements. The independent verification study was completed prior to the pivotal independent standalone validation study, REALITY, for which highly positive results were communicated on August 29, 2024.

Poster presentation: #1192P: Optimizing Lung Cancer Screening: Independent Verification of an AI/ML Computer-Aided Detection and Characterization Software as Medical Device

Authors: S. BODARD1, C. M VOYTON2, P. BAUDOT2, E. GEREMIA2, P. SIOT2, G. DE BIE2, V. LE2, D. FRANCIS2, B. RENOUST2, B. HUET2 – [1] Université de Paris Cité, AP-HP, Paris, France, [2] Median Technologies, Valbonne, France.

Onsite display date: Sep 15, 2024

Poster Session: New Diagnostic Tools

About eyonis LCS: eyonis Lung Cancer Screening (LCS) is an artificial intelligence (AI) powered computer aided diagnostic device that uses machine learning (ML) to help analyze imaging data generated with low-dose computed tomography (LDCT) to diagnose cancer at the earliest stages, when it can still be cured in the majority of patients. eyonis LCS has been classified by regulators as "Software as Medical Device", or SaMD, and is the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY (successfully completed – Clinicaltrials.gov identifier: NCT0657623) and RELIVE (ongoing). Filing applications including these pivotal data are scheduled to be submitted for FDA 510(k) premarket clearance and CE marking in H1 2025. Separately, Median’s AI technology is being sold and deployed via Median’s iCRO business unit, to biopharmaceutical companies performing clinical trials of experimental therapeutics, including the world’s leading pharmaceutical companies in cancer.

About ESMO (Free ESMO Whitepaper): The annual European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress is one of the most widely attended and highly regarded global oncology conferences. It attracts clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all over the world for presentations and discussions on the latest cutting-edge research from academia and industry. For more information about the ESMO (Free ESMO Whitepaper) Congress 2024, visit View Source

On September 11, 2024 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company’s novel pyruvate kinase (PK) activator tebapivat (AG-946) for the treatment of myelodysplastic syndromes (MDS) (Press release, Agios Pharmaceuticals, SEP 11, 2024, View Source [SID1234646507]).

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"Receiving orphan drug designation for tebapivat in MDS underscores the importance of bringing new oral treatment options to patients suffering from this rare disease," said Sarah Gheuens, M.D., Ph.D., chief medical officer and head R&D at Agios. "We aim to deliver the first oral therapy that addresses anemia due to ineffective erythropoiesis in lower-risk MDS, which affects approximately 75,000-80,000 patients in the U.S. and EU5 and accounts for approximately 70% of MDS cases."

Agios completed a Phase 2a study of tebapivat in lower-risk MDS late last year and is currently initiating a Phase 2b study of tebapivat in lower-risk MDS.

The FDA’s Office of Orphan Drug Products grants orphan drug designation to support the development of medicines for rare disorders that affect fewer than 200,000 people in the U.S. Under the Orphan Drug Act, orphan drug designation qualifies a company for incentives, including tax credits, exemptions from certain FDA fees for clinical trials, and the potential for seven years of market exclusivity following drug approval.

Mitapivat, the company’s lead PK activator, was previously granted FDA orphan drug designation for the treatment of PK deficiency, thalassemia, and sickle cell disease.

Tebapivat is not approved for use by any regulatory authority.

On September 11, 2024 NeoGenomics, Inc. (NASDAQ: NEO), a leading oncology testing services company, reported that it will present three studies at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain, September 13-17 (booth #438) (Press release, NeoGenomics Laboratories, SEP 11, 2024, View Source [SID1234646523]). NeoGenomics’ data offers key insights into circulating tumor DNA (ctDNA) analysis and next-generation sequencing (NGS), focusing on their role in early diagnosis and treatment optimization.

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"Emerging technologies leveraging ctDNA and NGS are increasing our ability to identify cancers in high-risk patients, which was previously beyond reach," said Dr. Nathan Montgomery, Vice President of Medical Services at NeoGenomics. "Collectively, our findings demonstrate the potential of advanced molecular diagnostics to detect cancer earlier, guide more personalized treatments, and ultimately improve patient outcomes worldwide."

NeoGenomics’ poster presentations include:

Real-World Analysis of Actionable Gene Fusions Identified by NGS and Correlation with IHC in 422 Patients from the Community (78P)
Presentation Date: Sunday, September 15, 2024
Results show that testing for 19 drug-targetable fusions can identify up to four times more patients for matched therapies compared to testing only for NTRK fusions or using IHC, suggesting that NGS testing for multiple fusions could greatly expand treatment options for cancer patients.
ctDNA-Lung-Detect: Profiling of Non-Shedding ctDNA Early Stage Resected Non-Small Cell Lung Cancers (1236P)
Presentation Date: Saturday, September 14, 2024
This study represents one of the largest prospective cohorts of ctDNA assessments in early-stage non-small cell lung cancer (NSCLC), identifying patients at high risk of relapse who may benefit from more aggressive treatment.
CLEAR-Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients with High-Risk Melanoma (226TiP)
Presentation Date: Sunday, September 15, 2024
This Phase II trial evaluated ctDNA as a marker to guide treatment decisions in high-risk melanoma patients. It compares the effectiveness of combining anti-LAG-3 with anti-PD-1 therapy versus anti-PD-1 inhibition alone.
For more details on NeoGenomics’ presentations, visit ESMO (Free ESMO Whitepaper) 2024.

On September 11, 2024 HanX Biopharmaceuticals reported that HX044 had received clinical trial approval from the Bellberry Human Research Ethics Committee (HREC) in Australia (Press release, HanX Biopharmaceuticals, SEP 11, 2024, View Source [SID1234655962]). HanX’ application, which complies with the requirements of the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research (2023), approved the conduct of a Phase I clinical trial: HX044-I-01, A Phase I/IIa, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HX044 in Patients with Advanced Solid Tumor Malignancies.

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HX044 is a first-in-class investigational bispecific antibody for cancer immunotherapy developed independently by Hans-Iitra. Preclinical studies have demonstrated enhanced potency and a wider therapeutic window compared to previous-generation immunotherapy inhibitors , while also demonstrating promising results in tumor models refractory to immunotherapy inhibitors ("cold tumors"). Hans-Iitra has completed all necessary preclinical development, including GMP manufacturing and GLP toxicology studies, and plans to initiate Phase I single-agent dose escalation trials in humans across various solid tumors in Australia and China.

Dr. Qixiang Li, CEO/Chief Scientific Officer of HansItai, said: "The approval of HX044 for clinical trials is a new important milestone for HansItai. H044 is a new type of cancer immunotherapy bispecific antibody that we independently developed from molecular design. Through the close cooperation and efforts of all departments of HansItai, HX044 was approved for clinical trials very smoothly, further strengthening the company’s clinical layout in the cancer immunotherapy pipeline, and fully demonstrating the company’s innovation and R&D strength in cancer immunotherapy. We will quickly advance this clinical trial and look forward to seeing the potential for efficacy as soon as possible and helping patients as soon as possible."