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 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that it will highlight new data from across its approved and investigational cancer therapies during the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress being held in Barcelona, Spain on 13-17 September (Press release, Astellas, SEP 11, 2024, View Source [SID1234646508]). Eight abstracts across a broad range of cancer types will be presented, reinforcing Astellas’ commitment to making a meaningful difference to people living with advanced and hard-to-treat cancers. Six abstracts include data spanning prostate, urothelial, gastric and gastroesophageal junction (GEJ), and pancreatic cancers. Two abstracts feature Phase 1 data presented for the first time from immuno-oncology and targeted protein degradation assets.

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Tadaaki Taniguchi, MD, PhD, Chief Medical Officer, Astellas:
"The data presented at ESMO (Free ESMO Whitepaper) are an exciting demonstration of the strength of our portfolio and the transformative potential of our pipeline to help deliver outcomes that matter for patients. Astellas has made a long-term commitment to helping people living with hard-to-treat cancers by both investing in next-generation modalities like targeted protein degradation and immuno-oncology, and by maximizing the number of patients that could benefit from our approved medicines."

Highlights at the ESMO (Free ESMO Whitepaper) Congress 2024 include:

Data from the Phase 3 EV-302 study, evaluating Nectin-4 expression and response to first-line treatment of enfortumab vedotin in combination with pembrolizumab in previously untreated locally advanced or metastatic urothelial cancer (la/mUC). These results support the combination as a first-line advancement across la/mUC patient subgroups, regardless of Nectin-4 expression.
Five-year follow-up data from the Phase 1/2b EV-103 DE/A study, analyzing durable responses and meaningful survival to enfortumab vedotin in combination with pembrolizumab in patients with first-line cis-ineligible la/mUC. These results further support the broad suitability, regardless of cis-eligibility, and long-term benefits of this regimen in la/mUC.
Final pooled overall survival data from the Phase 3 SPOTLIGHT and GLOW trials, evaluating zolbetuximab plus chemotherapy as a first-line treatment in patients with HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma whose tumors are Claudin 18.2-positive.
Updates involving a Phase 2 trial in progress assessing zolbetuximab in combination with gemcitabine and nab-paclitaxel (GN) versus GN monotherapy as first-line treatment of Claudin 18.2-positive metastatic pancreatic cancer.
Phase 3 EMBARK post-hoc analyses, evaluating enzalutamide in combination with leuprolide and as monotherapy versus leuprolide alone in patients with high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer. These results support the benefits of enzalutamide both in combination with leuprolide and as monotherapy in patients aged <70 and ≥70 years.
Clinical data from lead pipeline assets: Phase 1 data from ASP3082, the first protein degrader targeting KRAS G12D mutant to enter clinical trials, in patients with advanced pancreatic, colorectal, and non-small cell lung cancer; and preclinical, translational/early clinical data from ASP1570, a novel DGKζ inhibitor, in patients with advanced solid tumors. The results support continued study of these investigational therapies for the treatment of various cancer types.

Astellas Presentations at 2024 ESMO (Free ESMO Whitepaper) Congress

Enfortumab vedotin

Presentation title

Speaker

Presentation details

EV-302: Exploratory Analysis of Nectin-4 Expression and Response to 1L Enfortumab Vedotin (EV) + Pembrolizumab (P) in Previously Untreated Locally Advanced or

Metastatic Urothelial Cancer (la/mUC)

T. Powles

Type: Mini Oral Session
Abstract Number: 1966MO
Date: September 15

Study EV-103 Dose Escalation/Cohort A (DE/A): 5y Follow-Up Of First-Line (1L)

Enfortumab Vedotin (EV) + Pembrolizumab (P) in Cisplatin (cis)-Ineligible Locally

Advanced Or Metastatic Urothelial Carcinoma (la/mUC)

J. Rosenberg

Type: Poster
Abstract Number: 1968P
Date: September 15

Epidemiology and treatment patterns of patients with locally advanced or metastatic

urothelial cancer in France: a non-interventional database study

F. Joly

Type: Poster
Abstract Number: 2001P
Date: September 15

Zolbetuximab

Presentation title

Speaker

Presentation details

First-line (1L) zolbetuximab + chemotherapy in patients (pts) with claudin 18.2 (CLDN18.2) +, HER2–, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma: A pooled final analysis of SPOTLIGHT + GLOW

Y-K Kang

Type: Poster
Abstract Number: 1438P
Date: September 16

Zolbetuximab With Gemcitabine + Nab-Paclitaxel (GN) in First-Line Treatment of Claudin 18.2–Positive Metastatic Pancreatic Cancer (mPC): Phase 2, Open-Label, Randomized Study

W. Park

Type: Poster
Abstract Number: 1532TiP
Date: September 16

Enzalutamide

Presentation title

Speaker

Presentation details

Enzalutamide (enza) with or without leuprolide in patients (pts) with high-risk biochemically recurrent (hrBCR) prostate cancer (PC): EMBARK post-hoc analysis by age

N. D. Shore

Type: Poster
Abstract Number: 1638P
Date: September 15

Pipeline

Presentation title

Speaker

Presentation details

Phase 1/2 Trial of ASP1570, a Novel Diacylglycerol Kinase ζ Inhibitor, in Patients With Advanced Solid Tumors

D. Olsen

Type: Poster
Abstract Number: 1004P
Date: September 14

Preliminary safety and clinical activity of ASP3082, a first-in-class, KRAS G12D selective protein degrader in adults with advanced pancreatic (PC), colorectal (CRC), and non-small cell lung cancer (NSCLC)

W. Park

Type: Proffered Paper Session
Abstract Number: 608O
Date: September 15

On September 11, 2024 Radiant Biotherapeutics, a preclinical biotechnology company developing an antibody platform to deliver transformative therapies for patients facing life-changing disease, reported it has closed a $35 million Series A financing (Press release, Radiant Biotherapeutics, SEP 11, 2024, View Source [SID1234646524]). The round is co-led by the Bill & Melinda Gates Foundation and Amplitude Ventures of Canada.

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Additional participants in the Series A include new investors BDC Capital, the investment arm of the Business Development Bank of Canada, through its Thrive Venture Fund, and abrdn, an investment fund managed by abrdn Inc.; and existing investors FACIT, Alexandria Venture Investments and Toronto Innovation Acceleration Partners (TIAP).

Radiant has built a best-in-class, proprietary, multi-valent, multi-specific antibody platform called Multabody. The funds will enable Radiant to further develop the company’s lead clinical candidate, 4-1BB, and move it towards clinical trials.

"These supportive investors share our vision of delivering powerful, multi-functional biologics with the potential to advance treatments for patients suffering from debilitating and life-threatening illnesses," said Arthur J. Fratamico, President and CEO of Radiant. "This investment enables us to further demonstrate the unique power and breadth of our platform across multiple therapeutic areas with a focus in oncology, inflammation and immunology, and global health and infectious disease including HIV."

Multabody therapeutics are able to overcome the shortcomings of existing antibody approaches by leveraging remarkable avidity, or binding strength, on their intended targets. Multabodies also exploit multi-specificity, enabling targeting of different disease-modifying proteins as well as multiple epitopes on the same target. Together, these qualities give Multabody therapeutics exceptional potency against both solid tumors and blood cancers, infectious disease pathogens, and other targets in multiple therapeutic areas.

"This financing will enable the next stage in Radiant’s growth and move the company towards the clinic as it continues to demonstrate the superiority of the Multabody platform against therapeutic targets that cannot be treated with traditional antibodies," said Bharat Srinivasa, Ph.D., principal at Amplitude Ventures. "We are investing to accelerate Radiant’s transition to clinical stage and to expand its pipeline in additional therapeutic areas."

Radiant Biotherapeutics was founded in 2020 and is built around foundational science developed at The Hospital for Sick Children (SickKids) in Toronto and the University of Toronto, based on and including work performed at the laboratories of Jean-Philippe Julien, Ph.D., senior scientist at SickKids and associate professor at University of Toronto’s Temerty Faculty of Medicine, and Bebhinn Treanor, Ph.D., a professor at the University of Toronto. The company emerged from stealth mode in 2023 following a seed investment led by Amplitude Ventures, FACIT, TIAP and Alexandria Venture Investments. Radiant maintains offices in Toronto and Philadelphia.