Daiichi Sankyo Unveils New Research Across Industry-Leading ADC Portfolio in Multiple Cancers at WCLC and ESMO

On September 4, 2024 Daiichi Sankyo (TSE: 4568) reported that it will present new clinical research across its antibody drug conjugate (ADC) portfolio with more than 25 abstracts across multiple types of cancer at the IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC24) and the 2024 European Society for Medical Oncology (#ESMO24) (Press release, Daiichi Sankyo, SEP 4, 2024, https://www.businesswire.com/news/home/20240903292956/en/Daiichi-Sankyo-Unveils-New-Research-Across-Industry-Leading-ADC-Portfolio-in-Multiple-Cancers-at-WCLC-and-ESMO [SID1234646360]).

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Data at WCLC and ESMO (Free ESMO Whitepaper) showcasing Daiichi Sankyo’s progress towards its goal of creating new standards of care for patients with cancer will include six late-breaking presentations, including two back-to-back presentations during Presidential Symposium 1 featuring datopotamab deruxtecan (Dato-DXd) data at WCLC, and the first presentation of clinical data of DS-9606, a CLDN6 directed modified pyrrolobenzodiazepine (PBD) ADC from Daiichi Sankyo’s second ADC platform, at ESMO (Free ESMO Whitepaper).

"New data in lung, breast, gastric, ovarian, endometrial and other cancers from several of our DXd antibody drug conjugates demonstrates how we are making substantial progress toward creating new standards of care for patients with cancer," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "We look forward to presenting initial clinical data from our second antibody drug conjugate platform at ESMO (Free ESMO Whitepaper), which underscores how Daiichi Sankyo is applying our expertise in this technology to craft new innovation for patients."

Progress in Lung Cancer at WCLC and ESMO (Free ESMO Whitepaper)
Late-breaking data at WCLC to be reported during back-to-back presentations at Presidential Symposium 1 will highlight the first interim results from the NeoCOAST-2 phase 2 platform trial evaluating novel perioperative treatment combinations including one arm studying datopotamab deruxtecan with durvalumab and chemotherapy as neoadjuvant treatment followed by adjuvant treatment with durvalumab in patients with resectable early-stage (IIA to IIIB) non-small cell lung cancer (NSCLC).

The second Presidential Symposium 1 presentation will feature results from the application of quantitative continuous scoring (QCS), AstraZeneca’s proprietary computational pathology platform, to measure TROP2 in tissue samples collected in the TROPION-Lung01 phase 3 trial that evaluated datopotamab deruxtecan versus docetaxel in patients with locally advanced or metastatic NSCLC treated with at least one prior line of therapy. Overall survival results from TROPION-Lung01 also will be presented as a late-breaking oral presentation.

Other data at WCLC include two oral presentations featuring the interim results from the dose optimization part of the IDeate-Lung01 phase 2 trial of ifinatamab deruxtecan (I-DXd) in patients with pretreated extensive-stage small cell lung cancer and results from the ENHERTU (trastuzumab deruxtecan) monotherapy arm of the DESTINY-Lung03 phase 1b trial in patients with previously treated HER2 overexpressing unresectable, locally advanced or metastatic NSCLC. A trial-in-progress poster from the NSCLC cohort of a phase 1b trial evaluating the combination of datopotamab deruxtecan and valemetostat, a dual inhibitor of EZH1 and EZH2, in previously treated locally advanced, unresectable or metastatic nonsquamous NSCLC with or without actionable genomic alterations also will be highlighted.

At ESMO (Free ESMO Whitepaper), additional data in lung cancer being reported include poster presentations featuring a post-hoc analysis of patients with nonsquamous NSCLC by baseline brain metastases status in the TROPION-Lung01 phase 3 trial of datopotamab deruxtecan and intracranial responses seen in the IDeate-Lung01 phase 2 trial of ifinatamab deruxtecan, as well as a trial-in-progress poster featuring the design of the IDeate-Lung03 phase 1b/2 trial of ifinatamab deruxtecan in combination with atezolizumab with or without carboplatin as first-line induction or maintenance therapy in patients with extensive-stage small cell lung cancer.

Continued Innovation in Breast Cancer at ESMO (Free ESMO Whitepaper)
Late-breaking presentations in breast cancer at ESMO (Free ESMO Whitepaper) will include a proffered paper session featuring the primary results of the DESTINY-Breast12 phase 3b/4 trial evaluating ENHERTU in patients with HER2 positive advanced or metastatic breast cancer with or without brain metastases, and two mini oral sessions highlighting patient reported outcomes and determination of the HER2 low and HER2 ultralow status of tumors from the DESTINY-Breast06 phase 3 trial in patients with HR positive, HER2 low and HER2 ultralow metastatic breast cancer.

Two proffered paper sessions will highlight results from the ICARUS-BREAST01 phase 2 study of patritumab deruxtecan (HER3-DXd) in patients with HR positive, HER2 negative advanced breast cancer with disease progression following two or more treatments and the investigator-initiated ERICA phase 2 trial evaluating olanzapine-based triplet antiemetic therapy for prevention of nausea and vomiting in combination with ENHERTU in patients with metastatic breast cancer. A mini oral session will feature a supplementary biomarker analysis from the DAISY phase 2 trial evaluating ENHERTU in three cohorts of patients with HER2 expressing metastatic breast cancer and a poster presentation will report on an exploratory biomarker analysis of ENHERTU in patients with HR positive, HER2 low metastatic breast cancer from the DESTINY-Breast04 phase 3 trial. A poster reporting on exposure-adjusted incidence rates of adverse events from the TROPION-Breast01 phase 3 trial of datopotamab deruxtecan versus chemotherapy in patients with previously treated HR positive, HER2 negative metastatic breast cancer also will be featured.

Data from Daiichi Sankyo’s Second ADC Platform and DXd ADC Data in Multiple Additional Cancers at ESMO (Free ESMO Whitepaper)
At ESMO (Free ESMO Whitepaper), a proffered paper session will highlight preliminary results from a phase 1 trial of DS-9606, a CLDN6 directed modified PBD ADC from Daiichi Sankyo’s second ADC platform, in patients with solid tumors known to express CLDN6. Results from the DESTINY-Gastric03 phase 1b/2 trial evaluating ENHERTU monotherapy or ENHERTU combinations with chemotherapy and/or immunotherapy in patients with HER2 expressing advanced/metastatic gastric or gastroesophageal junction carcinoma also will be presented at a proffered paper session.

A mini oral session will feature results from the TROPION-PanTumor03 phase 2 trial of datopotamab deruxtecan in patients with previously treated recurrent endometrial or ovarian cancer. Trial-in-progress poster presentations will highlight the HERTHENA-PanTumor01 phase 2 trial evaluating patritumab deruxtecan in patients with a broad range of solid tumors including bladder, cervical, endometrial, esophageal, gastric, head and neck, melanoma, ovarian, pancreatic and prostate and a phase 1 trial of DS-1471, a CD147 monoclonal antibody, in patients with locally advanced or metastatic solid cancers.

Investor Conference Call Following ESMO (Free ESMO Whitepaper)
Daiichi Sankyo will hold a virtual conference call for investors on Tuesday, September 17, 2024 from 8:00 to 9:30 am EDT / 9:00 to 10:30 pm JST. Executives from Daiichi Sankyo will provide an overview of the WCLC and ESMO (Free ESMO Whitepaper) research data and address questions.

WCLC and ESMO (Free ESMO Whitepaper) Data Highlights
Highlights of data from Daiichi Sankyo’s ADC portfolio at WCLC 2024 include:

Presentation Title

Author

Abstract

Presentation (PDT)

NSCLC

NeoCOAST-2: efficacy and safety of neoadjuvant durvalumab (D) + novel anticancer agents + CT and adjuvant D ± novel agents in resectable NSCLC

T. Cascone

PL02.07

Presidential Symposium 1
Sunday, September 8
8:30 – 10:00 am

Normalized membrane ratio of TROP2 by quantitative continuous scoring is predictive of clinical outcomes in TROPION-Lung01

M.C. Garassino

PL02.11

Presidential Symposium 1
Sunday, September 8
8:30 – 10:00 am

Datopotamab deruxtecan vs docetaxel in patients with non-small cell lung cancer: final overall survival from TROPION-Lung01

J. Sands

OA08.03

Oral Presentation
Monday, September 9
10:45 – 12:00 pm

Trastuzumab deruxtecan monotherapy in pretreated HER2 overexpressing nonsquamous non-small cell lung cancer: DESTINY-Lung03 part 1

D. Planchard

OA16.05

Oral Presentation
Tuesday, September 10
1:30 – 2:45 pm

Valemetostat and datopotamab deruxtecan in previously treated, advanced, unresectable, or metastatic non-squamous NSCLC

A. Spira

P2.10A.04

Poster Session

Sunday, September 8

6:15 – 7:45 pm

SCLC

Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer (ES-SCLC): interim analysis of IDeate-Lung01

C. Rudin

OA04.03

Oral Presentation
Sunday, September 8
2:00 – 3:15 pm

Exposure-response analyses to support phase 3 dose selection for I-DXd (ifinatamab deruxtecan) in extensive stage SCLC patients

N. Midde

P1.13A.12

Poster Session
Sunday, September 8
12:00 – 2:00 pm

Highlights of data from Daiichi Sankyo’s ADC portfolio at ESMO (Free ESMO Whitepaper) 2024 include:

Presentation Title

Author

Abstract

Presentation (CEST)

NSCLC

Datopotamab deruxtecan (Dato-DXd) vs docetaxel in patients with advanced nonsquamous non-small cell lung cancer with brain metastases: results from TROPION-Lung01

E. Pons-Tostivint

1312P

Poster Session
Saturday, September 14

SCLC

Intracranial response in patients with baseline brain metastases and extensive-stage small cell lung cancer treated with ifinatamab deruxtecan (I-DXd) in the IDeate-Lung01 study

M. Johnson

1787P

Poster Session
Saturday, September 14

IDeate-Lung03: a phase 1b/2 study of ifinatamab deruxtecan (I-DXd) plus atezolizumab with or without carboplatin as first line induction or maintenance in patients with extensive stage small cell lung cancer

C. Rudin

1812TiP

Poster Session
Saturday, September 14

BREAST

Trastuzumab deruxtecan (T-DXd) in patients with HER2+ advanced/metastatic breast cancer with or without brain metastases: primary results from DESTINY-Breast12

N. Lin

LBA18

Proffered Paper Session
Friday, September 13
4:00 – 5:30 pm

HER2 low and HER2 ultralow status determination in tumors of patients with HR+ mBC in DESTINY-Breast06

G. Viale

LBA 21

Mini Oral Session
Sunday, September 15
8:30 – 10:00 am

Effects of trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice on patient-reported outcomes in hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2) low/ultralow metastatic breast cancer: results from DESTINY-Breast06

X. Hu

LBA22

Mini Oral Session
Sunday, September 15
8:30 – 10:00 am

Efficacy, safety and biomarker analysis of ICARUS-BREAST01: a phase 2 study of patritumab deruxtecan (HER3-DXd) in patients with HR+/HER2- advanced breast cancer

B. Pistilli

340O

Proffered Paper Session
Friday, September 13
4:00 – 5:30 pm

A multicenter, randomized, double-blind, placebo-controlled study of olanzapine-based triplet antiemetic therapy for prevention of delayed and persistent nausea and vomiting induced by trastuzumab deruxtecan in patients with metastatic breast cancer: ERICA study

H. Sakai

1816O

Proffered Paper Session
Saturday, September 14
2:45 – 4:25 pm

Unraveling the mechanisms of action and resistance to trastuzumab deruxtecan (T-DXd): supplementary biomarker analyses from DAISY trial

F. Mosele

343MO

Mini Oral Session
Sunday, September 15
8:30 – 10:00 am

Exploratory biomarker analysis of trastuzumab deruxtecan versus treatment of physician’s choice in HER2-low, hormone receptor-positive metastatic breast cancer in DESTINY-Breast04

N. Ueno

432P

Poster Session
Monday, September 16

Exposure-adjusted incidence rates of adverse events from the TROPION-Breast01 study of datopotamab deruxtecan (Dato-DXd) vs investigator’s choice of chemotherapy in patients with pretreated, inoperable/ metastatic HR+/HER2- breast cancer

H. Rugo

431P

Poster Session
Monday, September 16

Treatment patterns and outcomes in HER2 low, HR+ metastatic breast cancer patients previously treated with endocrine therapy in the United States

S. Modi

399P

Poster Session
Monday, September 16

OTHER SOLID TUMORS

Preliminary results from a phase 1, first-in-human study of DS-9606a, a Claudin 6 (CLDN6) directed antibody drug conjugate, in patients with tumor types known to express CLDN6

M. Patel

610O

Proffered Paper Session
Sunday, September 15
2:45 – 4:15 pm

Trastuzumab deruxtecan (T-DXd) monotherapy and combinations in patients with advanced/metastatic HER2 positive esophageal, gastric or gastroesophageal junction adenocarcinoma: DESTINY-Gastric03

Y. Janjigian

1401O

Proffered Paper Session
Saturday, September 14
8:30 – 10:00 am

Datopotamab deruxtecan (Dato-DXd) monotherapy in patients with endometrial or ovarian cancer: results from the phase 2 TROPION-PanTumor03 study

A.

Oaknin

714MO

Mini Oral Session
Sunday, September 15
2:45 – 4:15 pm

HERTHENA-PanTumor01: A global phase 2 trial of HER3-DXd in metastatic solid tumors

T. Powles

690TiP

Poster Session
Saturday, September 14

A phase 1, first-in-human study of DS-1471 in patients with advanced/metastatic solid tumors

S. Koganemaru

682TiP

Poster Session
Saturday, September 14

Claudin-6 expression in primary and recurrent epithelial ovarian cancer: a potential therapeutic target for high-grade serous ovarian cancer

D. Shintani

771P

Poster Session
Saturday, September 14

About the ADC Portfolio of Daiichi Sankyo
The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo.

The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo.

The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified PBD payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform.

Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

ArsenalBio Announces $325 Million Financing to Advance Programmable Cell Therapy Programs Through Clinical Development

On September 4, 2024 Arsenal Biosciences, Inc. (ArsenalBio), a clinical stage programmable cell therapy company focused on engineering advanced CAR T-cell therapies for solid tumors, reported the close of an oversubscribed $325 million Series C financing round (Press release, ArsenalBio, SEP 4, 2024, View Source [SID1234646359]). The funding round included new investors ARCH Venture Partners, Milky Way Investments Group, Regeneron Ventures, NVentures (NVIDIA’s venture capital arm), Luma Group, funds and accounts advised by T. Rowe Price Associates, Inc., Rock Springs Capital, among others, with ongoing support from existing investors the Parker Institute for Cancer Immunotherapy (PICI), SoftBank Vision Fund 2, Bristol-Myers Squibb Company, Westlake Village BioPartners, Kleiner Perkins, Byers Capital, and Hitachi Ventures.

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Proceeds from the financing will be used to advance ArsenalBio’s lead programs through development as the company continues to build its pipeline of therapeutic candidates for solid tumor cancers based on its proprietary T cell engineering technology, including logic gating. The funds will also drive further innovation in developing tools and processes for identifying new candidate cell therapies, helping ArsenalBio remain at the forefront of the rapidly evolving field of cell therapy, and bringing it closer to its goal of addressing unmet needs across the oncology category.

"Our initial clinical trials and preclinical studies have shown the promise of our T cell engineering approach and have given us the confidence to broaden the application of our technology to address additional cancer types," said Ken Drazan, M.D., ArsenalBio’s co-founder, CEO and Chairman. "This new investment enables us to continue our development roadmap, scale up our manufacturing capabilities, and invest in new avenues for innovation in T cell medicine."

ArsenalBio’s robust pipeline includes potential therapies in development for ovarian, kidney, and prostate cancers, as well as other solid tumors being co-developed through a collaboration with Bristol-Myers Squibb Company. The fundraising follows ArsenalBio’s recent entry into clinic with its second T cell product candidate, AB-2100, being studied in a Phase 1/2 clinical trial for clear-cell renal cell carcinoma (ccRCC). The candidate has been granted Fast Track designation by the U.S. Food and Drug Administration.

Tempus Announces Real World Data Collaboration with BioNTech

On September 4, 2024 Tempus AI, Inc. (NASDAQ: TEM, "Tempus"), a technology company leading the adoption of AI to advance precision medicine and patient care, reported a multi-year collaboration with BioNTech SE (Nasdaq: BNTX, "BioNTech"), a global next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases (Press release, Tempus, SEP 4, 2024, View Source [SID1234646358]). This collaboration leverages Tempus’ robust multimodal datasets in support of BioNTech’s next-generation oncology pipeline.

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Under this collaboration, Tempus is providing analytical support and computational biology expertise to BioNTech across its comprehensive research and development oncology pipeline. BioNTech will work collaboratively with Tempus to leverage Tempus’ real-world multimodal database to generate novel insights into the biological mechanisms supporting the discovery of new therapies and aiming to enhance the development of BioNTech’s clinical oncology pipeline.

"We are looking forward to collaborating with BioNTech to combine our real-world multimodal data and cutting-edge computational technology to help advance their differentiated oncology pipeline," said Ryan Fukushima, Chief Operating Officer of Tempus. "By applying Tempus’ extensive real-world multimodal data to BioNTech’s AI capabilities and multi-platform discovery engine, we believe we can generate a real impact by working to bring novel therapies to those cancer patients who could potentially benefit the most."

BostonGene and Mount Sinai to Collaborate on a Prospective Precision Medicine Study of Patients with Multiple Myeloma

On September 4, 2024 BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, reported they will collaborate with the Icahn School of Medicine at Mount Sinai on a precision medicine clinical study in multiple myeloma (MM) (Press release, BostonGene, SEP 4, 2024, View Source [SID1234646357]). The study aims to evaluate and improve cancer sequencing for the characterization of tumor molecular vulnerabilities and the identification of novel therapeutics, paving the way for developing targeted therapies and personalized treatment approaches for MM patients.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Samir Parekh, MBBS, Professor of Medicine at the Icahn School of Medicine at Mount Sinai, and fellow researchers at Mount Sinai will utilize BostonGene’s CLIA-certified, CAP-accredited and NY State-approved next-generation sequencing technologies, including whole exome and whole transcriptome sequencing, to support clinical care and discovery efforts for patients with MM.

"Collaborating with BostonGene enables us to leverage their advanced next-generation sequencing to gain deeper insights into the molecular and immune characteristics of multiple myeloma," said Cesar Rodriguez, MD, Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai. "This partnership will help us identify novel therapeutic targets and develop more effective, personalized treatment strategies for our patients. By recognizing the unique features a patient and their disease have, we may be able to select optimal regimens that may translate to better outcomes."

BostonGene’s cloud-based solutions, bioinformatics capabilities and analytical tools offer a robust platform for integrated analysis of the patient and their tumor. This comprehensive approach delivers data-driven results, transforming patient care and revolutionizing precision medicine practices.

"We are excited to partner with Mount Sinai on this study," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Our AI-powered solutions and comprehensive analytical tools provide unparalleled insights into the molecular underpinnings of cancer and we are committed to advancing precision medicine to improve outcomes for multiple myeloma patients."

Median Technologies to share positive pivotal data for eyonis™ LCS diagnostic software as medical device at the IASLC 2024 World Conference on Lung Cancer

On September 4, 2024 Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, "Median" or "The Company") reported that the Company will be sharing information on its proprietary AI/ML-powered SaMD, eyonis LCS, including recently announced data from the pivotal REALITY study, at Booth #2601 during the 2024 World Conference on Lung Cancer (WCLC), being held in San Diego, CA, USA, from September 7-10, 2024 (Press release, MEDIAN Technologies, SEP 4, 2024, View Source [SID1234646356]). The WCLC, the premier world conference on lung cancer, is organized by the International Association for the Study of Lung Cancer (IASLC), a global multidisciplinary association dedicated to eradication of all forms of lung cancers.

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eyonis LCS is designed to improving the detection and diagnostic accuracy of LDCT in lung cancer screening procedures. LDCT imaging is the standard of diagnostic care globally and is currently the only approved lung cancer screening modality in U.S. and Europe. The average five-year survival rate for all lung cancer patients is 18.6 percent because only 16 percent of lung cancers are diagnosed at an early stage2. Conversely, Stage 1 lung cancer can be cured when detected, with an 80% survival rate after 20 years, where many die from other causes. For Stage 1A cancers that measure 10 mm or less, the 20-year survival rate has been shown to be 92%.

The Company released in August the definitive results from the first of the two pivotal eyonis LCS clinical studies, REALITY (Clinicaltrials.gov identifier: NCT0657623) evaluating the standalone performance of the medical device in characterizing cancerous vs non-cancerous patients (i.e. "performance at patient level"), and in detecting and characterizing suspicious versus malignant nodules. Despite the inclusion of many challenging LDCT images, the eyonis LCS SaMD achieved exceptional results and met all study primary and secondary endpoints with statistical significance and achieved an area under the curve (AUC) value of 0.904 at patient level versus an AUC of 0.80 – the minimum value set as the primary endpoint for REALITY.

REALITY analyses were conducted on data from a cohort of 1,147 patients from five major cancer centers and hospitals in the US and Europe and two clinical data providers. Importantly, 80% of the cancers in the analyzed cohort of REALITY were difficult-to-diagnose Stage 1 cancers. Moreover, the REALITY cohort was enriched compared to real life with small non-spiculated cancers, and large spiculated benign nodules, both of which are challenging for radiologists to diagnose.

The second pivotal trial, RELIVE, is a Multi-Reader Multi-Case (MRMC) study that will offer clinical validation of eyonis LCS to complement the analytical validation already achieved with REALITY. RELIVE is ongoing and scheduled for completion in the coming months, with an anticipated data read-out in Q1 2025. Median Technologies expects eyonis LCS regulatory filings in the US for FDA 510(k) clearance and in Europe for CE marking in H1 2025.

With eyonis LCS, Median Technologies is working to provide the U.S. and European lung cancer medical communities with a unique breakthrough software as medical device to help medical professionals expedite lung cancer screening programs. Increased accuracy with eyonis LCS can help save lives and reduce the distress and costs associated with unnecessary procedures.

About eyonis LCS: eyonis Lung Cancer Screening (LCS) is an artificial intelligence (AI) powered diagnostic device that uses machine learning to help analyze imaging data generated with low dose computed tomography (LDCT) to diagnose lung 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) and RELIVE (ongoing). Filing applications including these pivotal data are scheduled to be submitted for FDA 510(k) premarket clearance and CE marking in 2025. Separately, Median’s AI technology is being sold and deployed across cancer indications, via Median’s iCRO business unit, to companies performing clinical trials of experimental therapeutics, including the world’s leading pharmaceutical companies in cancer.

About IASLC 2024 World Conference on Lung Cancer: The International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC) is an immersive scientific meeting where over 5,000 leading experts, researchers, and oncologists gather to showcase cutting-edge advancements in lung cancer research, treatment modalities, and personalized therapies, fostering collaboration towards a world free from the burden of lung cancer. For more information about 2024 WCLC, visit View Source