1stOncology™: Cancer Intelligence Service – Page 6480 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

CDx Diagnostics’ WATS3D Participates in Highmark, Inc. Health Plans in Delaware, Pennsylvania, and West Virginia

On May 19, 2022 CDx Diagnostics reported WATS3D, an AI-powered diagnostic platform to empower physicians to reliably detect Barrett’s esophagus (BE) and esophageal dysplasia to help prevent esophageal cancer, was designated as medically necessary by Highmark, Inc. health plans in Delaware, Pennsylvania, and West Virginia in Q4 2021 (Press release, CDx Diagnostics, MAY 19, 2022, View Source [SID1234614881]). CDx Diagnostics is pleased to share, that effective immediately, WATS3D is now considered an in-network procedure as CDx Diagnostics participates in the Commercial and Medicare networks of these Highmark, Inc. plans.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

Clinically proven to significantly increase the detection rate of BE, pre-cancer, and cancerous cells in the esophagus compared to the traditional screening methods, WATS3D is now a covered benefit for more than 3.6 million Highmark members. The computer-assisted procedure, which is intended as an adjunct to standard four-quadrant biopsies for screening, diagnosis, or surveillance of cancerous or precancerous esophageal lesions, may be considered medically necessary for the surveillance of both Barrett’s Esophagus and chronic gastroesophageal reflux disease (GERD).

"Using artificial intelligence to reliably detect precancerous cells is truly remarkable science. Empowering physicians to preempt esophageal cancer and improve patient lives is what drives us. We are therefore delighted to announce Highmark’s decision to issue a positive medical policy for WATS3D because it means a total of 36 million contracted health plan members now have access to our life-saving technology," said Bill Huffnagle, CEO of CDx Diagnostics.

WATS3D technology helps clinicians to overcome the limitations associated with traditional upper endoscopy screening and surveillance methods, by combining a specially designed tissue acquisition instrument, unique 3D imaging with artificial intelligence powered analysis, and a team of trained expert GI pathologists. In large multicenter clinical studies, WATS3D has been found to significantly increase the detection rate of BE and esophageal dysplasia, both treatable precursors to esophageal cancer, one of the fastest growing and most fatal cancers in the United States.

WATS3D testing meets the five pillars of evidence-based medicine typically required by insurance payors: analytic validity, clinical validity, clinical utility, cost-effectiveness, and recommendations by major medical societies. The American Society for Gastrointestinal Endoscopy (ASGE), the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), and the American Foregut Society (AFS) each currently include WATS3D testing in their recommendations.

Since 2019, the ASGE has included WATS3D in its Standards of Practice Committee’s guideline for the screening and surveillance of BE. In 2020, the technology was deemed a safe and effective adjunct to forceps biopsies in the evaluation of BE, low-grade dysplasia, and high-grade dysplasia by SAGES and its Technology and Value Assessment Committee (TAVAC).

Melanoma Research Alliance Announces $13 Million in Grants to Advance Melanoma Prevention, Detection & Treatment

On May 19, 2022 Coinciding with Melanoma Awareness Month, the Melanoma Research Alliance (MRA), the largest non-profit funder of melanoma research, reported funding for 27 research grants totaling $13,046,774 to support new research aimed at advancing melanoma prevention, diagnosis and treatment (Press release, Melanoma Research Alliance, MAY 19, 2022, View Source [SID1234614880]). Melanoma is the deadliest form of skin cancer and the fifth most common cancer in the United States.

The grants will support 11 Team Science Awards, 10 Young Investigator Awards, and 6 Pilot Awards. MRA grant awards back development of innovative ideas that offer the promise of rapidly improving outcomes for melanoma patients.

This year’s grant awards focus on a variety of approaches, including the use of novel cellular barcodes to identify causes – and possible treatments – of resistant disease; research focused on rare melanoma subtypes ways to improve response to existing checkpoint immunotherapies; and two pilot awards co-funded with the Michael J. Fox Foundation to study the connection between melanoma and Parkinson’s Disease.

"These scientific proposals selected this year for funding by MRA’s expert Grant Review Committee are exceptional," said MRA Chief Executive Officer Marc Hurlbert, PhD. "We are at a pivotable moment in the fight against melanoma. We are thrilled to support this critical work with the hope of benefiting all patients and families dealing with melanoma, and preventing countless more from having to do so."

2022 Melanoma Research Alliance Grant Awards

Team Science Awards

Targeting Oncogenic Gaq in Uveal Melanoma
MRA Team Science Award
Boris Bastian, MD, The University of California, San Francisco

Identification & Validation of Novel Druggable Targets in Mucosal Melanoma
MRA Team Science Award
Genevieve Boland MD, PhD, Massachusetts General Hospital

Targeting Epigenetics to Enhance Anti-Melanoma Immunity
Leveraged Finance Fights Melanoma – MRA Team Science Award
Marcus Bosenberg MD, PhD, Yale University

Targeting RNA Processing to Enhance Mucosal Melanoma Immunotherapy
MRA Team Science Award
Rotem Karni PhD, Hebrew University of Jerusalem

Harnessing B Cell Checkpoints in Melanoma
MRA Team Science Award, collaboratively funded by Brigham and Women’s Hospital and The University of Texas MD Anderson Cancer Center
Vijay Kuchroo DVM, PhD, Brigham and Women’s Hospital, Inc.

Targeting Chromothripsis to Suppress Metastasis and Therapy Resistance
MRA Team Science Award
Roger Lo MD, PhD, The University of California, Los Angeles

Cellular Barcoding to Define Melanoma Drug Resistance and Cell of Origin
MRA Team Science Award for Women in Melanoma Research
Elizabeth E. Patton PhD, University of Edinburgh

Identifying Public Neoantigens, their TCRs and their Rules of Engagement
MRA Team Science Award
Yardena Samuels PhD, Weizmann Institute of Science

Improving Immunological Memory During Anti-PD-1 Immunotherapy
MRA Team Science Award, collaboratively funded by Harvard Medical School and Dana-Farber Cancer Institute
Arlene Sharpe MD, PhD, Harvard Medical School

Noninvasive Prediction of Severe Toxicity from Immune Checkpoint Blockade
MRA Team Science Award, collaboratively funded by Yale University, Washington University, and Stanford University
Mario Sznol MD, Yale University

Team Science Academic-Industry Partnership Award

Analytical and Clinical Validation of a Multiplex IF Biomarker for Anti-PD1
MRA Team Science Academic-Industry Partnership Award
Janis Taube MD, Johns Hopkins University School of Medicine

Young Investigator Awards

New Genetic Tools to Understand the Role of M6A in Melanomagenesis
MRA Young Investigator Award
Claudio Alarcon PhD, Yale University, School of Medicine

Decipher the Epigenetic Code Regulating Cellular Dynamics in Acral Melanoma
MRA Young Investigator Award
Junyue Cao PhD, The Rockefeller University

Targeting Anti-Tumor Immunity in Anatomically Distinct Mucosal Melanomas
MRA Young Investigator Award for Women in Melanoma Research
Kasey Couts PhD, University of Colorado Denver

Investigating Lipid Kinase Pip4k2c in Regulating Anti-Tumor Immunity
Bristol Myers Squibb – MRA Young Investigator Award
Karen Dixon PhD, Brigham and Women’s Hospital

Mechanisms and Relevance of Treg Expansion after PD-1 Blockade in Melanoma
Bristol Myers Squibb – MRA Young Investigator Award
Francesco Marangoni PhD, The University of California, Irvine

Interfering with Early Cell State Transitions to Prevent Drug Tolerance
The Wayne Stinchcomb Big Orange Melanoma Foundation – MRA Young Investigator Award
Florian Rambow PhD, Essen University Hospital

Interrogating Epigenetic Regulation of PD1 in Melanoma-Infiltrating T Cells
Leveraged Finance Fights Melanoma – MRA Young Investigator Award in memory of Michael Konigsberg
Debattama Sen PhD, Massachusetts General Hospital

Tumor-Stroma Metabolic Crosstalk in Melanoma Brain Metastases
Tara Miller Melanoma Foundation – MRA Young Investigator Award
Inna Smalley PhD, H. Lee Moffitt Cancer Center & Research Institute

Investigating the role of FGL1/LAG-3 Axis in Melanoma Immunity
Bristol Myers Squibb – MRA Young Investigator Award
Jun Wang PhD, New York University School of Medicine

mRNA-Based Re-Programming of Terminally Differentiated TILs
MRA Young Investigator Award
Yochai Wolf PhD, The Sheba Fund for Health Service and Research

Pilot Awards

A Strategy to Identify the Basis of Melanoma and Parkinson’s Comorbidity
The Michael J. Fox Foundation – MRA Pilot Award
Deanna L. Benson PhD, Icahn School of Medicine at Mount Sinai

Investigating ARID2 as a Suppressor of Melanoma Metastasis
MRA Pilot Award for Women in Melanoma Research
Emily Bernstein PhD, Icahn School of Medicine at Mount Sinai

Combined Intrathecal Immunotherapeutic Strategies for Melanoma LMD
MRA Pilot Award
Sherise Ferguson MD, University of Texas MD Anderson Cancer Center

Novel Mouse Models of Uveal Melanoma
MRA Pilot Award
Florian Karreth PhD, H. Lee Moffitt Cancer Center & Research Institute, Inc

The Role of APC Mutations in Melanoma Brain Metastasis
Leveraged Finance Fights Melanoma – MRA Pilot Award
James Robinson PhD, The University of Minnesota, Twin Cities

Alpha-Synuclein’s Role in Melanoma Formation and Metastasis
The Michael J. Fox Foundation – MRA Pilot Award
Vivek Unni MD, PhD, Oregon Health & Science University

UZ Brussel First to Treat Breast Cancer Patients with New Brainlab Deep Inspiration Breath Hold with Instant X-Ray Confirmation

On May 19, 2022 Brainlab reported that clinicians at UZ Brussel are the first to treat patients with the company’s new Deep Inspiration Breath Hold (DIBH)* technology designed to streamline image guided and surface guided radiation therapy (IGRT and SGRT) and deliver the highest quality of care for breast cancer patients (Press release, Brainlab, MAY 19, 2022, View Source [SID1234614879]). UZ Brussel is a university hospital at the Vrije Universiteit Brussel with 721 hospital beds and almost 4,000 employees. UZ Brussel successfully validated the technology and presented research at the Novalis Circle Symposium at ESTRO on May 8, 2022. The research demonstrates that Brainlab ExacTrac Dynamic DIBH streamlines the process and increases positioning confidence through "on-the-fly" X-Ray confirmation. Internal anatomy verification at the breath hold level may increase confidence in dose sparing of critical structures like the heart.

Deep Inspiration Breath Hold is a well-established technique and standard of care in treating breast cancer with radiation therapy. When a patient takes a deep breath, the distance between the heart and the chest cavity is increased, reducing the risk of cardiac toxicity during breast cancer treatment. The new Brainlab technology takes traditional surface tracking methodology and augments it with a thermal signature, delivering a fourth dimension to reduce ambiguities otherwise associated with surface tracking systems. Adding synchronized X-ray images to the workflow increases accuracy and clinician confidence by incorporating insights derived from internal bony anatomy. Brainlab DIBH workflow is CE marked and FDA cleared.

"The incorporation of ‘on-the-fly’ X-Ray confirmation streamlines the process and delivers the confidence that the heart is outside of the treatment beam," said Stefan Vilsmeier, President and CEO, Brainlab. "This solution delivers correlation between internal and external anatomy in one shot, revealing any misalignment that would otherwise remain undetected and could result in delivering excess dose to the heart. Partnering with UZ Brussel on new technologies demonstrates our combined interest in expanding personalized digital treatment innovation to other indications requiring high precision radiotherapy."

"This is next generation technology and UZ Brussel is proud to work in close collaboration with our long-time partner Brainlab to validate and present our findings showing the superior speed, innovative postural patient positioning and seamless integration into our therapeutic radiation program," said Prof. Mark de Ridder, Head of the Radiotherapy Department at UZ Brussel. "We’re excited to be the first to use this game changing positioning and breath hold control in breast cancer patients without skin marks. The positive effect on reducing cardiotoxicity on population level is significant. This becomes even more important with the increasing incorporation of neo-adjuvant chemotherapy and new HER2-directed monoclonal antibodies in the treatment strategy."

In 2020, Brainlab installed new ExacTrac Dynamic Patient Positioning and Monitoring systems at UZ Brussel. The system’s deep integration with most linear accelerators enables thermal-surface triggered beam gating and repositioning. ExacTrac IGRT has always been the gold standard in frameless cranial, and high-precision spine stereotactic radiosurgery, enabling ablative treatments with minimal target margins.

With the introduction of the DIBH workflow, Brainlab is delivering the power of integrated IGRT to radiation therapy treatments for breast cancer patients. "We implemented this new workflow over the course of a few days," explained Prof. Thierry Gevaert, Coordinator of the Medical Physics Radiotherapy Department at UZ Brussel. "The use of surface guided technology generates a more stable breathing curve compared to traditional surrogate marker technology. And the system’s X-Ray imaging allows for fast and low-dose internal anatomy verification at breath hold. The accurate triggering and correlation of anatomical verification with ExacTrac kV imaging will be the key differentiator to further margin reduction in breast radiotherapy."

Please access the Dr. de Ridder presentation here and the Dr. Gevaert presentation here.

*Not yet commercially available in all countries. Please contact your sales representative.

Be Bio and Resilience Announce Strategic Collaboration to Manufacture Engineered B Cells, a New Class of Cellular Medicines

On May 19, 2022 Be Biopharma, Inc. ("Be Bio") and National Resilience, Inc. (Resilience) reported a strategic collaboration to advance initial programs in Be Bio’s rare disease pipeline. Be Bio’s proprietary engineered B Cell Medicines (BeCM) platform is harnessing the power of the human B cell to create a new class of autologous and allogeneic cellular medicines that durably and redosably produce therapeutic proteins in vivo without toxic pre-conditioning (Press release, Be Biopharma, MAY 19, 2022, View Source [SID1234614878]).

The two companies are investing to drive innovation and reliability in cell therapy manufacturing, a critical success factor for broad and meaningful patient impact. As part of this unique partnership, Resilience will dedicate personnel solely to produce and supply Good Manufacturing Practices (GMP)-grade viral vector and cell therapy drug product for the initial programs in Be Bio’s rare disease pipeline. Through a creative cost and risk-sharing model, Resilience will be responsible for manufacturing costs and receive potential future milestones and royalties.

"Over the past year, Be Bio has built a strong foundation with our BeCM platform, pipeline, team, and recent $130 million financing. Manufacturing is critical to rapidly progress our BeCMs to the clinic and we have built non-GMP manufacturing capabilities in our Cambridge facility. This deal allows us to drive GMP manufacturing with an outstanding partner, and in a capital efficient manner," said Joanne Smith-Farrell, Ph.D., Chief Executive Officer at Be Bio. "Resilience’s broad manufacturing capabilities, strong collaborative spirit and dedicated resources to our platform, make them an ideal partner for our BeCM programs."

Resilience will lead clinical GMP manufacturing of both the viral vector and the cell therapy drug product for Be Bio’s initial rare disease programs to support first-in-human clinical trials. Resilience will apply its pioneering bioprocessing solutions and network of cell therapy sites, including facilities in Research Triangle Park, NC, Philadelphia, PA, Waltham, MA and Marlborough, MA to conduct the work.

"This collaboration shows our excitement for the promising science of Be Bio’s proprietary BeCM platforms, and our confidence in their expertise to deliver transformative cell therapies," said Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience. "By working alongside Be Bio early in the drug development process, we aim to accelerate the development of their B cell medicines with the potential to unlock a pipeline of product candidates across a variety of serious diseases."

About B Cells – A New Class of Cellular Medicines

Imagine what could "Be?" In nature, a single B cell engrafts in the bone marrow and can produce thousands of proteins per second at constant levels over decades. B cells are nature’s exquisite medicine factories, manufacturing proteins to fight disease and maintain health. Unleashing the power of B cells is driving a new class of cellular medicines – Engineered B Cell Medicines (BeCM). BeCMs have the potential to be durable, allogeneic, redosable and administered without toxic conditioning. The promise of BeCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas.

Alchemab Announces Publication of AntiBERTa, an Antibody-Specific Machine Learning Model with Multiple Applications

On May 19, 2022 Alchemab Therapeutics, a biotechnology company focused on the discovery and development of naturally-occurring protective antibodies and immune repertoire-based patient stratification tools, reported the publication of research demonstrating the potential of AntiBERTa (Antibody-specific Bi-directional Encoder Representation and Transformers), a transformer neural network that reads the components of an antibody amino acid sequence, to deeply understand the structure and function of antibody sequences (Press release, Alchemab Therapeutics, MAY 19, 2022, View Source [SID1234614877]). The article, titled "Deciphering the language of antibodies using self-supervised learning" has been published online in the journal Patterns. AntiBERTa is a 12-layer transformer model that provides a contextualized numeric representation of antibody sequences and learns biologically relevant information.

"AntiBERTa forms the basis of Alchemab’s machine learning platform, providing a pre-trained model which is primed for multiple downstream tasks relevant to antibody drug discovery," said Jake Galson, Ph.D., Head of Technology at Alchemab. "We have already demonstrated the utility of AntiBERTa for binding-site prediction, and this is helping us to better identify convergent antibodies associated with disease resilience. We are excited to further progress our research and leverage our expertise to develop pioneering ways of treating diseases in the field of immunotherapy."

The study found that the B cell receptor (BCR) sequence representations separate according to mutational load and the underlying BCR V gene segments used. Importantly, there is distinct partitioning of BCRs derived from naïve versus memory B cells, suggesting that functionally important information is captured by the model. Finally, the model recognized pairs of positions within the BCR sequence that form contacts in three-dimensional space. These data demonstrate that AntiBERTa learns various characteristics of the BCRs, such as B cell origin, activation level, immunogenicity, and structure.

Dr. Jane Osbourn, PhD, Co-founder and Chief Scientific Officer of Alchemab, commented: "Our AntiBERTa technology has the potential to transform our ability to understand antibody structure and function and will inform our understanding of antibody paratopes, or the amino acid sequences comprising the site at which antibodies bind to antigens. It will also enable Alchemab to continue to build its unbiased platform to identify novel oncology and neurodegenerative targets. Alchemab’s novel approach learns from nature and naturally optimized antibodies and works backwards to uncover the most important targets and pathways involved in disease modulation. This approach has been very successful, leading to the identification of several novel oncology and neurodegenerative disease drug targets."