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 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 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) ("BioVaxys" or the "Company") reported that it has closed the third tranche (the "Third Tranche") of its previously announced non-brokered private placement (the "Private Placement") with the issuance of 6,100,000 units (the "Units") of the Company at a price of $0.05 per Unit for aggregate gross proceeds of $305,000.00 (Press release, BioVaxys Technology, SEP 11, 2024, View Source [SID1234646521]).

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Each Unit consists of one common share in the capital of the Company (each, a "Share") and one whole common share purchase warrant (each, a "Warrant"), whereby each Warrant is convertible into one additional Share at an exercise price of $0.15 until September 11, 2026, being the date that is 24 months from the date of issue.

The Company intends to use the proceeds of the Private Placement for general working capital purposes, including enabling the Company to fund and advance its business plans in regard to its successful recent acquisition of the entire portfolio of discovery, preclinical and clinical development stage assets in oncology, infectious disease, antigen desensitization, and other immunological fields based on the DPX immune educating platform technology, developed by the former Canadian biotechnology company, IMV Inc., Immunovaccine Technologies Inc., which was purchased from IMV USA ("IMV") on February 16, 2024.

No finder’s fees were paid in connection with the Third Tranche of the Private Placement. All securities issued pursuant to the Third Tranche are subject to a statutory hold period under applicable Canadian securities laws expiring January 12, 2025, being the date that is four months and one day from the date of closing of the Third Tranche.

James Passin, Chief Executive Officer and Director of the Company, participated in the Third Tranche of the Private Placement by purchasing 6,000,000 Units for $300,000. The participation by Mr. Passin, as an insider of the Company, constitutes a "related party transaction" as defined under Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The Company is relying on the exemptions from the valuation and minority shareholder approval requirements of MI 61-101 contained in sections 5.5(a) and 5.7(1)(a) of MI 61-101, as neither the fair market value of the Units purchased by Mr. Passin, nor the consideration for the Units paid by Mr. Passin, exceeded 25% of the Company’s market capitalization. The Company did not file a material change report in respect of the related party transaction at least 21 days before the closing of the Third Tranche of the Private Placement, which the Company deems reasonable in the circumstances in order to complete the Third Tranche in an expeditious manner.

The securities described herein have not been, and will not be, registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or any state securities laws, and may not be offered or sold within the United States except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities laws or pursuant to available exemptions therefrom. This news release does not constitute an offer to sell or a solicitation of an offer to buy of any securities in the United States.

On September 11, 2024 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported its participation at the 2024 Cantor Global Healthcare Conference (Press release, Tyra Biosciences, SEP 11, 2024, View Source [SID1234646520]).

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Todd Harris, CEO of TYRA, will participate in a fireside chat on Tuesday, September 17, 2024, at 9:45 am ET. TYRA management will also participate in one-on-one meetings with investors during the conference.

A live and archived webcast of the fireside chat will be available via the For Investors page on the Investor section of the TYRA website.

On September 11, 2024 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported positive overall survival data of its Phase 2 clinical study of Bria-IMT in combination with an immune check point inhibitor (CPI) in late stage metastatic breast cancer (Press release, BriaCell Therapeutics, SEP 11, 2024, View Source [SID1234646519]).

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Median overall survival of 15.6 months is reported in BriaCell’s most recent patients (treated since 2022) vs. 6.7-9.3 months for similar patients reported in the literature (see table below). These patients are being treated with the same Bria-IMT formulation currently being used in BriaCell’s ongoing Phase 3 pivotal study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612) and represent patients enrolled post-COVID when full study activities resumed.

This represents a substantial improvement over BriaCell’s 13.4 months median overall survival previously reported in December 2023.

"Overall survival in patients with heavily pre-treated metastatic breast cancer is very poor," stated Sara A. Hurvitz, MD, Professor of Medicine, Fred Hutch Cancer Center and University of Washington and BriaCell medical advisory board member. "The BriaCell early data is quite encouraging from both efficacy and tolerability standpoints."

"We wanted to look at the Phase 2 data of those patients who most closely resemble the patients being treated in our ongoing phase 3 study and compare them to similar patients in the literature," stated Dr. William V. Williams, BriaCell’s President and CEO. "The nearly two-fold overall survival benefit we are seeing with the Bria-IMT regimen, together with the similar previously reported approximate doubling of progression free survival, compared with literature controls, strongly support our belief that Bria-IMT could have a meaningful impact in the lives of heavily pre-treated metastatic breast cancer patients. We look forward to further clinical development of Bria-IMT with the goal of establishing it as a new standard of care for patients with metastatic breast cancer."

"The Bria-IMT regimen is the only investigational drug we have seen to show these impressive survival numbers in heavily pre-treated metastatic breast cancer patients who have failed numerous prior treatments including immune check point inhibitors and antibody drug conjugates," stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "These survival and clinical benefit data support BriaCell’s hypothesis of additive and/or synergistic effects of immune check point inhibitors with Bria-IMT and drive the ongoing pivotal study of our combination regimen in the treatment of metastatic breast cancer."

The Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients (average number of prior treatments = 6) who were treated with the Bria-IMT regimen and an immune checkpoint inhibitor. Of these 54 patients, 37 were treated with the Phase 3 formulation and 25 of these were treated post-COVID when full study activities resumed. This data represents an additional six months of follow-up of the survival data presented at the San Antonio Breast Cancer Symposium in December 2023.