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.

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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.

Medtronic to announce financial results for its fourth quarter and full fiscal year 2022

On May 19, 2022 Medtronic plc (NYSE:MDT), a global leader in healthcare technology, reported that it will report financial results for its fourth quarter and full fiscal year 2022 on Thursday, May 26, 2022 (Press release, Medtronic, MAY 19, 2022, View Source [SID1234614896]). A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at View Source The news release will include summary financial information for the company’s fourth quarter and full fiscal year 2022, which ended on Friday, April 29, 2022.

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Medtronic will host a video webcast at 7:00 a.m. CDT on Thursday, May 26, 2022, to discuss financial results for its fourth quarter and full fiscal year 2022. The webcast can be accessed at View Source

Within 24 hours of the broadcast, a replay and transcript of the prepared remarks will be available by clicking on the Investor Events link at View Source

Looking ahead, Medtronic plans to report its fiscal year 2023 first, second, third, and fourth quarter results on Tuesday, August 23, 2022, November 22, 2022, February 21, 2023, and Thursday, May 25, 2023, respectively. For these events, confirmation and additional details will be provided closer to the specific event.

BioMoti collaborates with global pharmaceutical company to develop ovarian cancer treatment and appoints Dr John Beadle as chairman

On May 19, 2022 BioMoti Ltd reported an agreement with a global pharmaceutical company to collaborate on the development of its lead ovarian cancer candidate, BMT101, to clinical phase 2a proof-of-concept (Press release, BioMoti, MAY 19, 2022, View Source [SID1234614847]). The collaboration agreement provides access to the partner company’s expertise including its proprietary commercial manufacturing technology and an option for the global pharmaceutical company to licence BMT101 in specific territories.

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BMT101, BioMoti’s lead candidate for the unmet need in ovarian cancer, is a new type of tumour-targeted treatment consisting of CD95-coated long-acting paclitaxel-loaded microparticles. BMT101 has shown very encouraging preclinical proof-of-concept results compared to the clinical standard-of-care, paclitaxel, including over 10-fold increases in drug concentration in tumours, 65-fold reductions in tumour burden, a 4-fold increase in survival and a reduction in toxicity.

BioMoti also announces that Dr John Beadle has joined its Board of Directors as Chairman, replacing Dr Keith Powell who has stepped down. Dr John Beadle, MBBCh, MBA, brings a wealth of experience and knowledge in the development of clinical stage biotech companies. He was previously founding Chief Executive Officer of PsiOxus Therapeutics, founder and Chief Medical Officer of PowderMed, Entrepreneur-in-Residence at Imperial innovations and Vice President of Global Medical Operations at GlaxoSmithKline. To date, he has raised in excess of $150M and realised transaction values in excess of $300M within the biotech industry.

Dr Davidson Ateh, CEO of BioMoti, said: "We are extremely pleased to have secured a strong development partner with commercial manufacturing experience on similar products to BMT101. The company’s expertise includes developing clinical candidates to market launch, offering a unique opportunity for us to address the significant medical need in the treatment of ovarian cancer patients."

He added: "We are very grateful for the contributions of our departing Chairman, Dr Keith Powell, who has stepped down to focus on other duties. He remains a good friend and trusted advisor. We are delighted to welcome Dr John Beadle at this crucial stage of our development. John is a remarkable leader within our industry with an impressive track record and whose impact is already being felt as we move forward with the next stages of clinical development."

Dr John Beadle, Chairman of BioMoti, said: "I am delighted to join BioMoti at this exciting time as we transition the technology from pre-clinical research into a clinical development programme, thus bringing the BioMoti technology one step closer to becoming a treatment for patients with ovarian cancer."

Mersana Therapeutics Announces FDA Grant of Orphan Drug Designation to XMT-2056 for the Treatment of Gastric Cancer

On May 19, 2022 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to XMT-2056, the company’s lead Immunosynthen STING-agonist ADC, for the treatment of gastric cancer (Press release, Mersana Therapeutics, MAY 19, 2022, View Source [SID1234614864]).

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According to the American Cancer Society, gastric cancer (also referred to as stomach cancer) accounts for approximately 1.5 percent of all new cancers diagnosed in the United States each year, with an estimated 26,560 new cases reported in 2021. The FDA grants orphan drug designation to a drug or biologic intended to treat a rare disease or condition impacting fewer than 200,000 individuals in the United States. This designation qualifies Mersana for potential incentives, including tax credits for certain trials, exemption from user fees and the potential for seven years of market exclusivity following approval (if granted).

"The FDA’s decision to grant orphan drug designation to XMT-2056 for the treatment of gastric cancer is an important recognition of its potential in this area of high unmet medical need," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "We are eager to bring XMT-2056 and its unique mechanism of action into the clinic mid-year to investigate its safety, tolerability and anti-tumor activity in gastric and other cancers."

XMT-2056 is designed to offer a differentiated and complementary therapeutic approach to existing and emerging solid tumor treatments. The company developed XMT-2056 leveraging a differentiated antibody that binds to a novel HER2 epitope, providing the opportunity, as demonstrated in preclinical studies, for treatment both as monotherapy and in combination with a variety of agents, including other anti-HER2 therapies. Mersana plans to initiate a Phase 1 trial of XMT-2056 in a range of HER2 expressing tumors, such as breast, gastric and non-small-cell lung cancers, in mid-2022.

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.

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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