Ankyra Therapeutics Announces Research Collaboration with the College of Veterinary Medicine at the University of Illinois at Urbana-Champaign

On June 3, 2022 Ankyra Therapeutics reported that it has entered into a formal research collaboration with the College of Veterinary Medicine at the University of Illinois Urbana-Champaign (Press release, Ankyra Therapeutics, JUN 3, 2022, View Source [SID1234615529]). Ankyra is developing a novel anchored immunotherapy platform that allows retention of immune-oncology drugs in the tumor microenvironment for several weeks. This promotes local immune-mediated tumor regression while limiting systemic toxicity. Ankyra has developed a canine IL-12 drug designated cANK-101. The collaboration with the U. of I. will evaluate the safety and effectiveness of cANK-101 in dogs with oral malignant melanoma. Dr. Timothy Fan, DVM, PhD, a veterinary oncologist, Professor of Veterinary Clinical Medicine at the U. of I. and program leader for the Cancer Center at Illinois, will lead the project. Dr. Fan’s lab will also conduct biomarker research designed to better understand the mechanism of action of cANK-101 in dogs with melanoma.

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"I am excited to work with Ankyra on their cANK-101 agent that brings a new immune-oncology drug to dogs with melanoma who have few other effective options. Importantly, by including pet dogs with naturally-occuring melanoma, tremendous opportunity exists to evaluate and advance Ankyra’s biologic technologies in a highly relevant and immune competent patient population", stated Dr. Timothy Fan. "We are excited to partner with Dr. Fan and the U. of I. to further advance the therapeutic development of our anchored immunotherapy platform", stated Dr. Howard L. Kaufman, President and Chief Executive Officer of Ankyra Therapeutics. Kaufman added " Our collaboration with Dr. Fan will support further development of a companion animal drug program at Ankyra, and will also inform our human ANK-101 clinical trial for human patients with cancer scheduled to enter the clinic next year."

GE Healthcare Advances the Future of Precision Medicine in Oncology with New Technology Partners at #ASCO22

On June 3, 2022 GE Healthcare’s innovative suite of diagnostic and treatment technologies reported that are designed to help improve detection, clinical efficiency, operational efficiency, and outcomes for cancer patients (Press release, GE Healthcare, JUN 3, 2022, View Source [SID1234615545]).

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"GE Healthcare is collaborating with health systems to bring innovation in oncology to deliver better and more effective patient care and outcomes," said Catherine Estrampes, President & CEO, U.S. and Canada at GE Healthcare. "Oncology treatments are rapidly evolving, making it difficult for clinical teams to adapt. Whether it’s the thousands of active clinical trials or the accelerating number of approved immunotherapies, clinical care providers need solutions that combine patient data from EMRs, imaging, biomarkers and other diagnostics with molecular profiling to enable the most informed care decisions."

Precision imaging is fundamental to determining the size, shape and characteristics of tumors and differentiating between healthy tissues. As a global leader in medical imaging solutions, GE Healthcare continues to demonstrate its commitment to advancing precision medicine through collaborations with technology partners around the world.

At this year’s ASCO (Free ASCO Whitepaper) 2022 annual meeting, GE Healthcare will demonstrate how a collection of strategic partnerships and collaborations announced over the past year will help advance cancer care and offer medical practitioners the solutions, imaging tools and support they need to improve patient-centered care and advance the practice of precision medicine.

"GE Healthcare’s innovative suite of predictive, prescriptive and precision oncology solutions helps support the delivery of more efficient, precise and personalized care across the cancer care continuum. Through our collaboration with other technology leaders, we can continue to elevate oncology innovation and help improve clinical, operational, and patient outcomes at every state and at every step of the care pathway," said Ben Newton, MD, General Manager for GE Healthcare Oncology Solutions.

Below are highlights from oncology announcements over the past year:

RaySearch: GE Healthcare has announced its agreement with RaySearch Laboratories AB (publ), a leading radiation oncology software provider, to develop a new radiation therapy simulation and treatment planning workflow solution, designed to simplify how radiation will be targeted to shrink a tumor. Together the companies aim to combine Stockholm-based RaySearch’s advanced treatment planning systems with GE Healthcare’s leading multi-modality (CT/MR/molecular imaging) simulator systems to make cancer treatment faster and more precise. RaySearch’s software is used by over 800 clinics in more than 40 countries.1

Elekta: GE Healthcare and Elekta (EKTA-B.ST) have signed a global commercial collaboration agreement in the field of radiation oncology that enables the two companies to provide hospitals a comprehensive offering across imaging and treatment for cancer patients requiring radiation therapy. As many as 50–60 percent of all cancer patients require radiation therapy2 which requires high quality imaging and sophisticated delivery equipment and software to precisely target tumors while sparing healthy tissue. Combining GE Healthcare’s imaging solutions with Elekta’s radiation therapy solutions will result in an even more compelling offering for hospitals, and ultimately their patients across both developed and developing markets.

Minerva: GE Healthcare and Minerva Imaging have signed a strategic partnership to accelerate precision medicine and targeted radionuclide therapy (Theranostics). Radionuclide therapy is a form of precision medicine where a radioactive substance is administered through the bloodstream to specifically target cancer cells and irradiate them with the aim of helping to reduce potential side effects compared to traditional cancer therapies. The partnership is designed to facilitate the success of Minerva Imaging’s growth plans by establishing capabilities for in-house production of isotopes and CDMO services for radiopharmaceuticals. Minerva Imaging will be using cutting-edge technology from GE Healthcare to optimize new radiopharmaceuticals, including a cyclotron – a type of particle accelerator used to produce isotopes.

University of Cambridge: The University of Cambridge, Cambridge University Hospitals – including Addenbrooke’s Hospital, and GE Healthcare have agreed to collaborate on developing an application aiming to improve cancer care, with Cambridge providing clinical expertise and data to support GE Healthcare’s development and evaluation of an AI-enhanced application that will integrate cancer patient data from multiple sources into a single interface. The collaboration also supports the further development and integration of AI/Machine Learning pipelines that are already in development at the University of Cambridge. Building on research supported by The Mark Foundation for Cancer Research and Cancer Research UK, the collaboration aims to address the problems of fragmented or siloed data and disconnected patient information, which is challenging for clinicians to manage effectively and can prevent cancer patients receiving optimal treatment.

Optellum: GE Healthcare and Optellum are working together to address one of the largest challenges in the diagnosis of lung cancer – helping providers determine the malignancy of a lung nodule, a suspicious lesion that may be benign or cancerous. Optellum is a leader in AI decision support for the early diagnosis and optimal treatment of lung cancer, and their Virtual Nodule Clinic can help clinicians identify at-risk patients and assess the likelihood of malignancy in a lung nodule through a radiomics score – which is key to determining whether biopsy is necessary and accelerating overall diagnosis. Virtual Nodule Clinic is the only FDA-cleared AI-assisted diagnosis software for early-stage lung cancer3 – enabling clinicians to make optimal management decisions for patients with lung nodules.

Vysioneer VBrain: GE Healthcare is collaborating with Vysioneer to utilize artificial intelligence (AI) towards cancer care. Vysioneer’s FDA-cleared VBrain solution is an auto-contouring system that applies auto-contouring to the three most common types of brain tumors: brain metastasis, meningioma and acoustic neuroma. VBrain allows for greater precision for radiotherapy treatment planning and is vendor-neutral – integrating with different treatment planning systems by supporting data routing to and from DICOM nodes within a hospital network.

Spectronic Medical Synthetic CT, MR[4] auto-segmentation: GE Healthcare announced plans to integrate Spectronic Medical AB’s AI-based software to support more precise cancer treatment planning, providing an alternative to standard CT images in radiotherapy treatment planning. This AI solution and GE Healthcare’s advanced AIR Recon DL technology both offer deep learning solutions for the radiation therapy workflow. GE Healthcare’s AIR Recon DL is a deep learning image reconstruction technology that leverages raw data from the MR scanner to reduce image noise, enhance image quality and resolution, and shorten scan times, to provide high quality diagnostic images. Spectronic Medical’s AI-based solution is designed to convert standard MR images acquired by the GE scanner into synthetic CT images, providing clinicians with the CT images required for treatment planning, while also having the MR soft tissue details to accurately target lesions and help improve patient outcomes.[5]

Mirada RTx: As a part of their strategic collaboration to improve outcomes for patients, GE Healthcare and Mirada Medical are focusing on advancing automation and Artificial Intelligence (AI) technologies to enable faster, more consistent and more precise cancer radiotherapy treatment. To do so, the Mirada Medical RTx product has been integrated into the GE Healthcare AW Workstation and AW Server to enable enhanced cancer visualization and diagnostic capabilities. These integrations can result in increased automation to deliver improvements in care workflows and help drive efficiency and time savings.

SOPHiA GENETICS: GE Healthcare and SOPHiA GENETICS will be collaborating on opportunities in the healthcare market, including various initiatives and projects in the fields of digital oncology and radiogenomic analysis. The companies will initially work together on the creation of infrastructure to integrate data between GE’s Edison platform and the SOPHiA DDM platform, as well as co-marketing and pilot site recruitment across oncology and radiogenomics.

One-Stop Breast Clinic: Momentum continues around this rapid diagnostic breast cancer center model – with the first site in the United States now underway at St. Luke’s University Health Network in Pennsylvania, as well as new sites extending across the world in Colombia, Egypt, and France. GE’s One-Stop Clinic breast care model, originated from the pioneering Gustave Roussy Cancer Center in France, has been shown to improve clinical outcomes and dramatically speed up breast cancer diagnosis and treatment planning. This value-based, multi-modality care approach is designed to provide patients with a tightly coordinated journey from the initial appointment through diagnosis and treatment plan in one location and with one team – all in a significantly shorter timeframe. Since piloting the workflow in 2021, St. Luke’s has implemented the model and been able to reduce the time from screening to diagnosis and treatment to 36 hours or fewer.[6] In Colombia, One-Stop Clinic has dramatically transformed breast cancer care for women by reducing time to treatment by roughly 93%.[7]

Through these and a variety of additional solutions, GE Healthcare aims to further reinforce its role as a core partner in multidisciplinary cancer care and provide increasingly accessible, more precise, and high-value radiation therapy.

GE Healthcare will be exhibiting at ASCO (Free ASCO Whitepaper) 2022 Innovation Hubs – IH14 & IH16 from June 3 – June 7.

Registration for the GE Healthcare – SOPHiA GENETICS Innovation Symposium ‘Unlocking the Promise of Data-Driven Medicine in Cancer Care, Together’ with speakers from Vanderbilt-Ingram Cancer, GE Healthcare and SOPHiA GENETICS can be found here. GE Healthcare and Vanderbilt University Medical Center announced their partnership to enable safer and more precise cancer immunotherapies in 2019 and the symposium will share early progress and findings achieved to date. SOPHiA GENETICS will present the latest developments in their DEEP-Lung-IV Multimodal Clinical Study.

Decibel Therapeutics to Present at the Jefferies Global Healthcare Conference

On June 3, 2022 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported that John Lee, chief development officer, and Lis Leiderman, M.D., MBA, chief financial officer, will participate in a fireside chat at the Jefferies Global Healthcare Conference on Friday, June 10, 2022 at 9:00 a.m. ET (Press release, Decibel Therapeutics, JUN 3, 2022, View Source [SID1234615514]).

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A live webcast of the fireside chat may be accessed by visiting the Investors section of the Decibel Therapeutics website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the fireside chat.

Novocure and Zai Lab Announce EF-31 Phase 2 Pilot Study Evaluating Tumor Treating Fields Together with Standard-of-Care Chemotherapy Meets Primary Endpoint for First-Line Treatment of Gastric Cancer

On June 3, 2022 Novocure (NASDAQ: NVCR), a global oncology company working to extend survival in some of the most aggressive forms of cancer, and Zai Lab (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, reported that the EF-31 phase 2 pilot study, testing the safety and efficacy of Tumor Treating Fields (TTFields) together with standard-of-care (chemotherapy alone or in combination with trastuzumab for HER2-positive patients) as a first-line treatment in patients with gastric adenocarcinoma, met its primary endpoint of objective response rate with supportive signals across secondary endpoints (Press release, NovoCure, JUN 3, 2022, View Source [SID1234615530]). TTFields therapy was well tolerated, with no increase in the systemic toxicity of the XELOX chemotherapy regimen or the combination regimen, and no high-grade skin toxicities were reported.

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Initial analysis was conducted with a median follow-up period of 8.6 months. The primary endpoint, confirmed objective response rate, was 50%. Median progression-free survival was 7.8 months. Duration of response was 10.3 months. Median overall survival has not yet been reached with a one-year survival rate of 72%.

"The EF-31 outcomes are encouraging in a historically difficult to treat cancer," said Dr. Jin Li, Head of Department of Oncology, Shanghai East Hospital, Tongji University School of Medicine. "The addition of Tumor Treating Fields to standard-of-care chemotherapy could lead to impactful changes in the treatment of gastric cancer patients and I look forward to confirming these data in additional clinical studies."

The EF-31 clinical study, which is a prospective, single arm, phase 2 pilot study conducted in China, included 26 patients with unresectable, locally advanced or metastatic gastroesophageal junction or gastric adenocarcinoma who were previously untreated with systemic therapy. Patients received continuous treatment with TTFields together with the XELOX chemotherapy regimen (combination of oxaliplatin and capecitabine). Trastuzumab was allowed for HER2-positive patients.

"TTFields therapy is a highly versatile modality with potential for broad applicability across solid tumor types and lines of therapy," said Asaf Danziger, Novocure’s Chief Executive Officer. "We would like to thank our patients, study investigators, and our partners at Zai Lab. The EF-31 results suggest that the addition of TTFields to standard therapies may offer better patient outcomes in gastric cancer and we are eager to continue exploring these potential benefits as we look ahead to a randomized phase 3 clinical study."

"Each year, more than one million new gastric cancer cases are diagnosed worldwide, with approximately half of all gastric cancer cases occurring in China. There is an urgent need to improve therapeutic options," said Alan Sandler, M.D., President and Head of Global Development, Oncology at Zai Lab. "EF-31, conducted in China, represents an important milestone as Novocure and Zai work together to expand TTFields into new disease areas. We look forward to working with Novocure in future global clinical studies across multiple solid tumor indications."

About Gastric Cancer

Gastric cancer is the third leading cause of cancer deaths worldwide and the third leading cause of cancer deaths in China. The incidence of gastric cancer is approximately 478,500 new cases annually in China, and approximately 26,000 new cases annually in the U.S.

Current therapies include surgery, chemotherapy, radiotherapy, targeted therapy and recently, immunotherapy. One of the most commonly used chemotherapy regimens for treating gastric cancer is XELOX, a combination of oxaliplatin and capecitabine. In the recent phase 3 trial (CheckMate 649, NCT-02872116, Lancet 2021) studying gastric cancer, the standard-of-care chemotherapy regimens showed an objective response rate range of 41% – 45%, median progression-free survival of 6.9 months, duration of response of 6.9 months, and overall survival of 11.6 months. One-year survival was 48%.

Gastric cancer is the third most-frequent cancer in China. Currently, the five-year survival rate of locally advanced or metastatic gastric cancer ranges from 5% to 20%, and the median overall survival is approximately one year.

About Tumor Treating Fields

Tumor Treating Fields NovoTTF-100L(P) is an investigational device for the treatment of gastric cancer. Safety and efficacy have not been established. Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. Fundamental scientific research extends across more than two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. TTFields therapy is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields therapy has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 24,000 patients have been treated with TTFields therapy.

Tempus to Launch Largest Clinically Available Liquid Biopsy Panel, xF+

On June 3, 2022 Tempus, a leader in artificial intelligence and precision medicine, reported the expansion of its comprehensive genomic profiling offerings with xF+, a new non-invasive, liquid biopsy panel of 523 genes, focused on pathogenic mutations in cell-free DNA (cfDNA) (Press release, Tempus, JUN 3, 2022, View Source [SID1234615546]). The test will originally be available on a limited basis alongside xF, Tempus’ 105-gene liquid biopsy assay, with a broader launch slated for later this year.

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Tempus expects that the xF+ panel will be the largest clinically available liquid biopsy panel on the market, covering more genes with single nucleotide variants and indels reported in all genes, plus expanded coverage of translocations/gene rearrangements, and copy number variants. It can also measure blood-based tumor mutational burden (bTMB) and microsatellite instability (MSI), predictive biomarkers for response to various cancer immunotherapies. Liquid biopsies can be useful for parallel testing with tumor tissue to provide a more comprehensive detection of actionable alterations than tissue or liquid biopsy testing alone. Additionally, follow-up liquid biopsy testing can uncover new gene alterations and resistance mechanisms (clonal evolution), sample tumor DNA shed from metastatic sites, and can be used to longitudinally monitor disease burden and response to treatment.

"xF+ further strengthens Tempus’ range of genomic profiling capabilities, offering physicians a broad-panel liquid biopsy option for patients in which a comprehensive, non-invasive test is appropriate," said Nike Beaubier, MD, Vice President of Translational Medicine at Tempus. "We are excited to introduce what we believe is the largest clinically available liquid biopsy panel to provide even more insights on pathogenic mutations in cfDNA."

xF+ is the latest addition to Tempus’ library of assays, which includes xF; xT, an assay that analyzes 648 genes in solid tumor and hematologic malignancies; xG, a 52-gene panel that specifically identifies genetic variants associated with hereditary cancer syndromes and inherited risk of cancer; xG+, a 88-gene multi-cancer panel that covers genes associated with both common and rare hereditary cancer syndromes; and xE, an assay that analyzes the whole exome. All panels are run in Tempus’ CAP-accredited, CLIA-certified robotic sequencing labs.