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

On September 4, 2024 TippingPoint Biosciences, a therapeutic company focused on innovative drug discovery targeting the aberrant DNA in cancer cells, reported pre-seed investment from the Pediatric Brain Tumor Foundation, Sontag Foundation, Yuvaan Tiwari Foundation, and BrightEdge, the impact investment and venture capital arm of the American Cancer Society (Press release, TippingPoint Biosciences, SEP 4, 2024, View Source [SID1234646355]).

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The investments will support TippingPoint’s breakthrough work to target Diffuse Intrinsic Pontine Glioma (DIPG), a rare pediatric brainstem tumor that is untreatable and terminal, usually within months of diagnosis. TippingPoint’s novel drug discovery platform is the first to target disease-specific interfaces in DNA packaging networks in cancer cells, also known as chromatin states, without affecting healthy states. Current approaches to address DNA packaging dysfunction target single chromatin factors that have broad functions across both disease and healthy cells, which leads to unwanted toxicities. Because TippingPoint’s platform is able to specifically target the unique chromatin interactions in disease, they have successfully applied their technology to target DIPG cancer cells in the laboratory, which cancer researchers regard as a significant breakthrough.

"We are committed to accelerating breakthrough treatments for DIPG and other fatal pediatric brain tumors," said Parvati Tiwari, President and Co-Founder of the Yuvaan Tiwari Foundation. "TippingPoint’s innovative approach to targeting complex chromatin interactions offers real hope for new therapies. We’re proud to back their efforts to transform the future of DIPG treatment."

"We are proud to support the work being done by Tipping Point to further the American Cancer Society’s mission to end cancer as we know it for everyone, said Alice Pomponio, VP, Innovation & Impact Investing / Managing Director, BrightEdge. It has been a privilege to support their journey from the beginning to where they are today, and we look forward to seeing a DIPG treatment benefit people with cancer in the future."

"There will be no cure for DIPG without collaboration, and we’re proud to come alongside other investors to back TippingPoint’s novel search for new treatment pathways," said Pediatric Brain Tumor Foundation President and CEO Courtney Davies. "We believe their research focus promises to be transformative."

The Sontag Innovation Fund, building on the reputation of the Sontag Foundation as one of the largest private funders of brain tumor research in North America, is thrilled with being part of TippingPoint’s efforts. "We are excited to help support TippingPoint and their effort to use an innovative screening platform to identify new potential therapeutic options for DIPG and other diseases" said Scott Davis, Managing Director of the Sontag Innovation Fund.

TippingPoint Bioscience’s founder, Dr. Laura Hsieh, formerly a post-doctoral researcher in Dr. Geeta Narlikar’s lab at the University of California San Francisco (UCSF), left the university to launch TippingPoint and accelerate the development of cancer therapeutics. TippingPoint raised its first investments in 2023, from early stage ventures like Mission BioCapital, ACS BrightEdge and SOSV’s IndieBio, and won four golden or platinum ticket awards in pitch competitions sponsored by major pharmaceutical companies including ONO Pharma, Astellas, and Abbvie.

Dr. Hsieh and the TippingPoint Biosciences team are currently conducting hit-to-lead studies to develop a new class of molecules for DIPG that are highly specific to the disease. They are diligently working to increase the potency and selectivity of their molecules so they can test them in mouse models in the near term with an eye on reaching first-in-human studies for DIPG patients in 4 years.

"We are honored to receive these investments to further our drug development efforts for such a devastating disease like DIPG. In order to make significant breakthroughs in complex diseases like DIPG and really make a difference in patient lives, big bets need to be made on paradigm-shifting technologies like ours. The support in capital, expertise and networks with patient advocates and world-class researchers goes a long way for TippingPoint to continue development of much-needed therapeutics for DIPG and other complex diseases," said Dr. Laura Hsieh, CEO and Founder of TippingPoint Biosciences.

On September 4, 2024 Caris Life Sciences (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, reported that the company and collaborators from the biopharma industry and leading cancer centers, including those within the Caris Precision Oncology Alliance (POA), will collectively present seven studies across a wide range of tumor types at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain from September 13-17, 2024 (Booth #608) (Press release, Caris Life Sciences, SEP 4, 2024, View Source [SID1234646354]). The findings demonstrate the power of Caris’ comprehensive multi-modal database to enable novel insights into cancer that could have profound effects on a patient’s diagnosis, prognosis, care plan and response to treatment.

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"The research being presented at this year’s ESMO (Free ESMO Whitepaper) Congress is a testament to Caris’ continued commitment to data-driven molecular innovation and the power of our ever-expanding network of collaborators to answer some of today’s pressing questions in precision oncology," said Caris EVP and Chief Medical Officer George W. Sledge, Jr., MD. "The findings underscore the critical role of comprehensive profiling in cancer care and the power of large clinico-genomic datasets to enable the identification of new biomarkers with clinical implications across diverse tumor types. Through extensive sequencing and data analysis efforts, we are unlocking new avenues for tailored therapies to revolutionize cancer treatment."

"Our comprehensive molecular profiling coupled with rich clinical data is enabling Caris to help clinicians make the best treatment choices, researchers to discover novel cancer biology, and the biopharmaceutical industry to develop the next breakthrough medicines," said Caris President David Spetzler, MS, PhD, MBA. "Our vast real-world evidence from over 689,000 cases, including over 550,000 with matched molecular data and outcomes, enables our team and research collaborators to better understand the biological hallmarks of cancers and how they impact clinical outcomes, paving the way for personalized therapies and improved patient outcomes."

Mini oral presentations include:

Metastatic hormone receptor-positive breast cancer outcomes in 628 patients with BRCA1, BRCA2, or PALB2 pathogenic variants: Real world data analysis of genomics and targeted therapy sequencing. (Abstract Number: 342MO)
September 15, 2024

Atlas of tertiary lymphoid structures in solid tumors: Genomic features and prediction of response to immunotherapy. (Abstract Number: 75MO)
September 16, 2024
Poster presentations include:

Impact of TLS Status on outcomes in patients with high TMB or MSI-high status treated with immune checkpoint inhibitors. (Abstract Number: 1051P)
September 14, 2024

Comparison of breast and gastric HER2 immunohistochemistry (IHC) scoring criteria in the assessment of endometrial endometrioid adenocarcinoma (EEA). (Abstract Number: 739P)
September 14, 2024

METPRO: Evaluating prognostic value of c-Met protein overexpression and concurrent biomarker presence. (Abstract Number: 1303P)
September 14, 2024

Genomic landscape & prognostic impact of HER2 low-expressing tumors. (Abstract Number: 126P)
September 15, 2024

Molecular and immunologic correlates of high PSMA/FOLH1 mRNA expression in prostate cancer (PC). (Abstract Number: 1653P)
September 15, 2024
Poster and abstract summaries highlighting the Caris research presented at ESMO (Free ESMO Whitepaper) 2024 will be available onsite at Caris’ Booth #608. The full abstracts will be available on the Caris website at the event’s conclusion.

The Caris POA includes 95 cancer centers, academic institutions, research consortia and healthcare systems, including 46 NCI-designated cancer centers, collaborating to advance precision oncology and biomarker-driven research. Caris and POA members work together to establish and optimize standards of care for molecular testing through innovative research focused on predictive and prognostic markers that improve the clinical outcomes for cancer patients.

On September 4, 2024 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or the Company") reported that it has been invited to present "A Novel Delivery System for Personalized Peptide & mRNA Vaccines for More Targeted Therapies" at The Personalized Cancer Vaccine Summit (formerly known as the mRNA Cancer Vaccine Summit) to be held December 3-5, 2024, in Boston, MA (Press release, BioVaxys Technology, SEP 4, 2024, View Source [SID1234646353]).

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The 3-day program brings together top industry players developing individualized approaches in mRNA, DNA, peptide, viral, dendritic cells, and optimizing personalized cancer vaccine approaches with immune-checkpoint inhibitor combinations to combat multiple tumor specific pathways and minimize off-target effects. In addition to BioVaxys, other companies and organizations invited to present include BioNTec, CureVac, ImVax, The Mayo Clinic, and NEC Biotherapeutics.

BioVaxys Chief Medical Officer David Berd, MD, will present new data from recent in vivo studies of DPX conducted by Pramrod K. Srivastava, Ph.D., M.D., Professor, Department of Immunology, Director, Center for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) and Infectious Diseases and the Carole and Ray Neag Comprehensive Cancer Center at UConn Health, University of Connecticut, and Hakimeh Ebrahimi-Nik, DVM, Ph.D., Assistant Professor, Medical Oncology, The Ohio State University Comprehensive Cancer Center.

BioVaxys President and Chief Operating Officer Kenneth Kovan stated, "We will be withholding detailed disclosure on potential new therapeutic roles for DPX and neoepitopes until the conference, but suffice to say, the data suggests DPX has a significant role in the delivery of tumor neoepitope vaccines that induce tumor rejection, and DPX on its own appears to have an anti-tumor capacity."

BioVaxys is advancing additional studies with Dr. Nik and her research team on DPX delivering tumor neoepitope vaccines that induce tumor rejection, and DPX anti-tumor capacity.

On September 4, 2024 CASI Pharmaceuticals, Inc. (Nasdaq: CASI) ("CASI" or the "Company"), a Cayman incorporated biopharmaceutical company specializing in the development and commercialization of innovative therapeutics and pharmaceutical products, reported its participation in the H.C. Wainwright 26th Annual Global Investment Conference taking place September 9-11, 2024, at the Lotte New York Palace in New York City (Press release, CASI Pharmaceuticals, SEP 4, 2024, https://www.prnewswire.com/news-releases/casi-pharmaceuticals-to-participate-in-the-2024-hc-wainwright-global-investment-conference-302237656.html [SID1234646352]). Members of the CASI management team, including Chief Financial Officer Daniel Lang, MD, and Chief Medical Officer Alexander Zukiwski, MD, will host 1×1 investor meetings at the conference.

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A pre-recorded corporate presentation will be available for conference participants to view in "Virtual Room 1" at 7 a.m. Eastern Time on September 9th. Thereafter, the presentation will be available on the Investors page of the CASI corporate website at View Source