On March 17, 2022 GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, reported the upcoming oral presentation of the discovery and initial clinical utility of a novel signature that identifies patients with head and neck squamous cell carcinoma (HNSCC) that may benefit from treatment beyond typical surgical resection (Press release, GeneCentric Therapeutics, MAR 17, 2022, View Source [SID1234610283]). The presentation will be made at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, one of the world’s largest and long-standing scientific gatherings in the field of cancer research, which is being held in New Orleans, Louisiana, April 8-13, 2022. The results to be presented are from an ongoing collaboration with Jose P. Zevallos, MD, MPH, at the Washington University School of Medicine in St. Louis and Neil Hayes, MD, MPH, at the University of Tennessee Health Science Center’s Center for Cancer Research to discover and develop new prognostic and/or predictive signatures and related tests to aid in the selection of treatments for HNSCC.

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Multiple independent retrospective datasets were utilized as part of the initial signature discovery, including those providing for its initial clinical utility. Oral cavity HNSCC patients with lymph node-negative disease, who are typically treated with surgical resection without additional radiation and/or chemotherapy, were identified as mesenchymal or non-mesenchymal based upon the novel RNA-based signature. For the nearly one-quarter who were mesenchymal, survival was 2.4-fold worse compared to the remaining non-mesenchymal patients. A future diagnostic test, based upon this signature and related clinical findings, potentially may be used to ‘upstage’ patients typically receiving only surgical reduction to become candidates for the addition of radiation and/or chemotherapy.

"I am excited to present our initial findings from this important collaboration with my colleagues at Washington University School of Medicine and GeneCentric evaluating molecular subtypes for head and neck cancer," said Neil Hayes, MD, MPH, GeneCentric co-founder and Director of the University of Tennessee Health Science Center’s Center for Cancer Research. "In this study, our new RNA-based signature identified a significant population of patients who typically only undergo surgical resection based upon their lymph node status but have poor prognosis, making them likely candidates for additional treatment options such as radiation and/or chemotherapy."

Full results from the initial molecular analysis and clinical utility from this study, as well as potential future applications, will be presented at the conference. Further demonstration of clinical utility is ongoing, as well as initial test development discussions with several commercial reference laboratories.

Details regarding the presentation are provided below and will be available following the meeting at View Source

Title: Prognostic and predictive applications from mesenchymal gene expression subtype analysis for early-stage, HPV(-) head and neck squamous cell carcinoma

First Author: Neil Hayes, MD, MPH, Department of Medical Oncology, University of Tennessee Health Science Center’s Center for Cancer Research, Memphis, Tennessee

Abstract Number: 2142

Session: Session MS.CL11.02 – Biomarkers 2

Date: April 11, 2022

Time: 3:20-3:35 PM CST

About Head and Neck Cancer

Head and neck squamous cell carcinoma (HNSCC) is one of the most common cancers worldwide, and in the United States it is estimated that there were approximately 66,000 new cases and 14,00 deaths in 2021. The 5-year overall survival for Stage I-II and III-IV HNSCC is approximately 70-90% and 40-60%, respectively. Oral cavity HNSCC is the most common head and neck cancer, accounting for one-third of cases with a majority HPV-negative and associated with tobacco use. While the treatment of HNSCC depends on multiple tumor and patient-related factors, the three main treatments are surgical resection, radiation therapy and chemotherapy. Patients with early-stage lymph node-negative tumors are generally treated with surgical resection, but treatment for those with more advanced lymph node-positive tumors often includes radiation and/or chemotherapy.

On March 17, 2022 ZAP Surgical Systems, Inc. reported that Unicancer, a leading academic promoter of oncology clinical trials and medical equipment purchasing health cooperation group for 19 French comprehensive cancer centers, has selected the ZAP-X Gyroscopic Radiosurgery platform for cranial stereotactic radiosurgery (Press release, ZAP Surgical Systems, MAR 17, 2022, View Source [SID1234610282]). Carefully chosen by domain experts including neurosurgeons, radiation oncologists, and medical physicists, Unicancer awarded ZAP-X as technology-of-choice for their member institutions.

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Radiosurgery, also commonly referred to as SRS, is well recognized as an alternative to surgery for effectively treating many brain tumors, including brain metastases and functional disease. Unique from surgery however, radiosurgery requires no incision, no pain, and patients often immediately return to normal activities.

"Highly specialized treatments such as SRS require highly specialized tools. ZAP-X’s dedication to treating only cranial indications was critical in our selection process", states Luc Delporte, Director of Purchasing and Access to Innovation at Unicancer. "While multi-purpose radiation delivery systems, commonly used to treat prostate and lung cancers, are readily available, the tailor-made design of ZAP-X for delivering world-class SRS will allow us to optimally protect healthy brain tissue and seek the best patient outcomes available."

Using a distinctive gyroscopic design, the ZAP-X platform delivers hundreds of uniquely angled ionizing beams to precisely sculpt radiation to the unique contours of targeted tumors.

ZAP-X is also recognized for being the first and only dedicated intracranial SRS platform to no longer require hosting volatile radioactive isotopes in the clinical setting. Additionally, ZAP-X is acclaimed for being the first and only vault-free SRS delivery system, thus typically eliminating the need for providers to build costly shielded radiation treatment rooms.

On March 17, 2022 Foundation Medicine, Inc. a pioneer in molecular profiling for cancer, reported it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) EGFR exon 19 deletions or exon 21 (L858R) alterations and are appropriate for treatment with EGFR Tyrosine Kinase Inhibitors (TKI) approved by FDA for this indication (Press release, Foundation Medicine, MAR 17, 2022, View Source [SID1234610281]).

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EGFR mutations are the second most common oncogenic drivers in NSCLC. Deletions in exon 19 and substitutions in exon 21 account for roughly 85 percent of observed EGFR mutations in NSCLC.1 As a companion diagnostic for therapies targeting these mutations in NSCLC, FoundationOneCDx offers oncologists flexibility when selecting the right therapy for their patients and ensures all FDA approved treatment options are considered within this group of therapies.

"Cancer treatment decision-making is growing more complex as we learn more about the mutations that drive cancers to grow and new treatments become available to target those changes," said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. "We believe securing a third group companion diagnostic approval for FoundationOne CDx is another critical step toward simplifying the decision-making process for oncologists and their patients by allowing them to uncover all FDA approved treatment options for this indication through one test."

In addition to driving efficiency in clinical care, this approval is part of an innovative, efficient regulatory approach that simplifies the companion diagnostic approval process for Foundation Medicine’s biopharma partners developing EGFR inhibitor therapeutics targeting EGFR exon 19 deletions or exon 21 alterations in NSCLC while maintaining rigorous quality standards.

About FoundationOne CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit View Source

On March 17, 2022 Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a leading pan-American (ex-USA) specialty pharmaceutical company, reported that it will release its fourth quarter and year end 2021 financial results on Thursday, March 24, 2022 prior to market opening. Following the release, Knight will hold a conference call and audio webcast (Press release, Knight Therapeutics, MAR 17, 2022, View Source;Fourth-Quarter-and-Year-End-2021-Results-Conference-Call-3-17-2022 [SID1234610280]). Knight cordially invites all interested parties to participate in this call.

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This is a listen-only audio webcast. Media Player is required to listen to the broadcast.
Replay: An archived replay will be available for 30 days at www.gud-knight.com.

On March 17, 2022 NexImmune, Inc. (Nasdaq: NEXI) and Zephyr AI (Zephyr) reported a strategic partnership focusing on the discovery and validation of novel targets for new T-cell-mediated therapies in oncology (Press release, NexImmune, MAR 17, 2022, View Source [SID1234610279]). Combining Zephyr’s proprietary artificial intelligence (AI) and algorithmic technology with NexImmune’s Artificial Immune Modulation (AIM) nanoparticle technology, the collaboration will seek to identify and validate optimal antigens and antigen cocktails for the development of potential new therapeutics in solid and hematological cancers.

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Under the terms of the agreement, Zephyr will employ its proprietary AI and machine learning technology to identify targets suitable for activating T-cell-mediated anti-tumor responses. Specifically, Zephyr will evaluate a range of molecular and genetic data through in silico target discovery to uncover known, high potential tumor-associated antigens and neoantigens that map to specific subtypes of cancer. NexImmune will screen and validate these targets using its proprietary AIM platform. The collaboration will focus on selecting multiple cognate peptides derived from known tumor-associated antigens and neoantigens to rapidly develop new product candidates for clinical trials in patients with cancer in need of lifesaving treatments.

"Artificial intelligence is transforming the way the biopharmaceutical industry is approaching target discovery and drug development with the potential to accelerate antigen-specific immunotherapies into the clinic," said Kristi Jones, CEO of NexImmune. "The partnership with Zephyr helps us build a library of novel targets, which can lead to new and more effective cancer therapeutics. We believe that Zephyr’s technology is key to helping us identify disease-specific, shared antigens and neoantigens as targets – which can be combined and delivered using the AIM platform – in addition, it may also increase our knowledge of how cancers evolve with the potential to address immune escape mechanisms."

"NexImmune’s AIM platform has shown itself to be a powerful and novel technology for the activation of cancer-fighting T-cells, and complements Zephyr’s ability to identify optimal targets for the immune system across a range of cancer types. Our partnership with NexImmune will deepen our understanding of the nuances in oncological diseases and immune therapeutic behavior and, most exciting, will be our first opportunity to externally demonstrate the power of Zephyr’s target discovery platform," said David L. Morgan, CEO of Zephyr AI. "Our combined goal is to accelerate drug discovery by identifying antigens to generate targeted, potent, and durable immune responses for patients with cancer, while reducing time and cost in the discovery and clinical process. We believe this collaboration will lead to breakthrough learnings about how cancers develop and progress, and ultimately lead to improved patient outcomes."