On August 25, 2022 IEEE, the world’s largest technical professional organization dedicated to advancing technology for humanity, and the IEEE Engineering in Medicine and Biology Society (EMBS), reported the publication of a report that demonstrates how a new 3D screening tool can help accelerate the development of cancer treatments through a new testing method that increases the number of tests on solid tumor samples by up to 50 times and potentially facilitates larger-scale testing of innovative immunotherapies (Press release, IEEE, AUG 25, 2022, View Source [SID1234618683]). The report, derived from research led by the University of Strathclyde in Glasgow, Scotland, has been published in IEEE Open Journal of Engineering in Medicine and Biology, and is freely available for open access and full-text viewing by all readers around the world.

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The report, "Assessment of CAR-T Cell-Mediated Cytotoxicity in 3D Microfluidic Cancer Co-Culture Models for Combination Therapy," which also is available in the IEEE Xplore digital library, details a more-than-two-year study of screening 3D tumor models with a miniaturized technology platform to evaluate the toxicity of genetically engineered Chimeric Antigen Receptor T (CAR-T) cells used in immunotherapies. Researchers at the University of Glasgow and the Cancer Research UK Beatson Institute in Glasgow also contributed to the study.

"Our study illustrates the promise of our microfluidic technology platform to accelerate the development of leading-edge therapies by enabling 20 to 50 times more experiments to be performed on a solid tumor sample," said Dr. Michele Zagnoni, a reader in Strathclyde’s Department of Electronic and Electrical Engineering, who led the study along with doctoral student Karla Paterson. "CAR-T cell development is typically very expensive, and our research indicates that the miniaturized 3D modeling we employed, which is not yet widely established in the pharma industry, could facilitate significantly more effective and cost-efficient developmental immunotherapies. We look forward to seeing its life-saving impact in preclinical drug testing and, ultimately, precision medicine in the clinic."

Solid tumors are complex environments including both cancerous and noncancerous cells. The IEEE Open Journal of Engineering in Medicine and Biology report details how the microfluidic technology in the study effectively enabled visualization and quantification of the ability of CAR-T cells to rapidly kill the cancer cells without significantly harming the other cells in a tumor sample. The research also revealed that the efficacy of chemotherapies can be improved when combined with CAR-T cell treatment. The deep look into how CAR-T cells do their work was enabled by the 3D models used in the Strathclyde study, which more closely reproduce the complexity of actual tumor microenvironments in the human body than is possible via legacy 2D modeling.

"This report is of equally keen interest to engineers and scientists in medicine and biology. We look forward to further spurring the conversation with more papers of this type and in this topic area," said Paolo Bonato, editor-in-chief of IEEE Open Journal of Engineering in Medicine and Biology. "IEEE EMBS has a valuable transdisciplinary dimension with substantial interaction among expertise across diverse technology areas, and, so, we publish papers both where the main emphasis is on methodology and technology and where the main emphasis is on science. Bridging these two worlds with an open-access journal is crucial to advancing innovative research into concrete, real-world benefit to society."

On August 25, 2022 Celsius Therapeutics, a biotechnology company pioneering new precision medicines for patients with cancer and autoimmune disease by harnessing the power of single-cell RNA sequencing and human biology at scale, reported the appointment of Sarah Grant, M.D., as chief medical officer (Press release, Celsius Therapeutics, AUG 25, 2022, View Source [SID1234618682]). In this role, Dr. Grant will lead the company’s clinical strategy and development of its pipeline of therapies for autoimmune disease and cancer, including its potential first-in-class TREM1 antibody program for inflammatory bowel disease.

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"I am delighted to welcome Sarah as our first chief medical officer," said Tariq Kassum, M.D., president and CEO of Celsius. "Sarah brings deep translational and clinical medicine expertise to Celsius, with more than two decades of experience working across multiple therapeutic areas and all stages of drug development, which will be instrumental as Celsius transitions into a clinical-stage company. We look forward to her important contributions in advancing our pipeline of precision medicines in autoimmune disease and cancer."

Dr. Grant is an accomplished physician-scientist who brings to Celsius more than 20 years of experience in translational medicine, early and late-stage drug development, and clinical medicine. Prior to Celsius, Dr. Grant spent nine years at Novartis in multiple senior leadership roles, most recently as the chief of staff and strategic assistant for the head of global drug development. Previously at Novartis, she was head of respiratory discovery within translational medicine. She began her career at Novartis leading multiple early-stage clinical programs focused in pulmonary and immunology indications. Prior to Novartis, Dr. Grant was on the faculty at Harvard Medical School and was an attending physician at the Brigham and Women’s Hospital. Dr. Grant completed her internship and residency at the Brigham and Women’s Hospital. She holds an M.D. from Stanford University School of Medicine and an A.B. from Harvard University.

"Through deep analysis of proprietary and meticulously curated datasets from human tissue samples, Celsius has pioneered a new path to understand the cells that drive disease progression for heterogeneous diseases with complex disease biology," said Dr. Grant. "This approach unlocks novel insights into targets and patient subsets, with the potential to deliver the right therapeutics to the right patients. I am so excited to join Celsius at this important time as the company translates these novel insights into its first clinical programs."

On August 25, 2022 AVM Biotechnology reported the award of a third Phase I Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) (Press release, AVM Biotechnology, AUG 25, 2022, View Source [SID1234618681]). This grant will evaluate the ability of the company’s small molecule, AVM0703, in combination with the standard chemotherapy regimen, R-CHOP, to reduce R-CHOP cycles in an aggressive, immune-resistant murine B cell Non-Hodgkin’s Lymphoma (NHL) model.

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AVM0703 is currently the subject of an adaptive design expansion cohort clinical trial treating imminently terminal "no-option" NHL patients (NCT04329728). In the trial, which is nearing completion of the safety portion, patients have experienced mild to moderate side-effects. Although median survival has not been reached, patients have shown a durable response to at least 11 months in multiple forms of NHL. After a single, one-hour outpatient infusion, AVM0703 induces and mobilizes endogenous bispecific gamma delta TCR+ invariant TCR+ Natural Killer T-like cells. It is the only therapeutic known to mobilize these unique immune cells.

While R-CHOP typically administered in six repeat cycles can elicit high response rates in NHL, relapse rates are high and long-term toxicities problematic. This includes secondary cancers caused by the treatment itself, as well as substantial neuro- and cardiac toxicities. An approach that increases complete response rates and lowers relapse rates without significant toxicities continues to be an unmet need for NHL. AVM0703 in combination with NHL standard of care such as R-CHOP could reduce relapse rates and even potentially limit the total number of chemotherapy cycles required for complete response, significantly impacting patient’s short and long-term quality of life.

The company previously received two other SBIR Phase 1 grants from the NCI and National Institute of Diabetes and Digestive Kidney (NIDDK) as well as two Phase 2 grants from the same agencies. The previous NCI grants support the existing clinical trial as well as research utilizing AVM0703 as a preconditioning agent prior to chemotherapy. This brings AVM’s total nondilutive government funding to $4.4 million validating the potential of AVM0703 in both cancer and Type 1 Diabetes.

AVM Biotechnology, a clinical stage company, is developing AVM0703 as a treatment for NHL, solid tumors, and autoimmune disorders. The research funded by this grant will help to further elucidate the use of AVM0703 in combination with chemotherapy while the company is concurrently investigating AVM0703 as a monotherapy in relapsed/refractory "no-option" NHL. Previous preclinical research as well as patient outcomes in an FDA approved Compassionate Use Program indicate AVM0703 has the potential to become an important treatment modality for NHL patients solidifying AVM’s influence in the immunotherapy space.

On August 25, 2022 PathAI, a global leader in AI-powered pathology, reported a multi-year expanded collaboration agreement with Bristol Myers Squibb (Press release, Bristol-Myers Squibb, AUG 25, 2022, View Source [SID1234618680]). The initial work within this extended agreement will focus on key translational research in oncology, fibrosis, and immunology, with an overall goal to continue transitioning this work into clinical trials.

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"We look forward to collaborating with PathAI to expand the potential application of AI in the drug development process to include translational research, clinical trials and diagnostic advancements," said Robert Plenge, M.D., Ph.D., Bristol Myers Squibb Senior Vice President and Head, Immunology, Cardiovascular and Fibrosis Thematic Research Center and Head, Translational Medicine. "We feel that PathAI will be a productive collaborator given digital pathology represents a growing area for BMS, PathAI is a leader in the field, and the fact that we have a long-standing productive relationship with the company."

Bristol Myers Squibb and PathAI will utilize AI pathology models with the potential to de-risk therapeutic development across the Bristol Myers Squibb’s pipeline by better identifying patient populations. In addition, Bristol Myers Squibb and PathAI plan to leverage these models to obtain key insights to help enhance patient segmentation in clinical trials across multiple disease indications. The companies are also collaborating on developing AI-powered diagnostics, most notably measuring CD8 T-cell infiltration across oncology disease areas. This powerful biomarker has demonstrated the potential to predict response to immunotherapy and possibly inform patient treatment decisions.

Today’s announcement builds on the existing relationship between the companies that began in 2016 and has shown results in multiple areas. In June 2020, PathAI and Bristol Myers Squibb presented retrospective exploratory findings from completed clinical trials on AI-powered PD-L1 scoring, which identified more patients as PD-L1 positive compared to manual-based PD-L1 scoring. In November 2021, the companies jointly presented results from PathAI’s CD8 algorithm at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. Most recently in July 2022, the two companies jointly published new exploratory data in the Journal of Modern Pathology, comparing the use of AI-powered algorithms to manual IHC scoring PD-L1 expression in relation to outcomes across multiple cancer types from several clinical trials.

"Given the insights generated from past collaborations, we have entered into a long-term collaboration with Bristol Myers Squibb to expand our use of machine learning models," said Andy Beck, Co-founder, and CEO of PathAI. "We will build on our work using AI-based pathology in translational research and validate the use of this technology through clinical trials and diagnostic development. Our ultimate goal is to improve patient care through AI."

On August 25, 2022 Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) a clinical stage biopharmaceutical company dedicated to meeting unmet medical needs in oncology, autoimmune diseases and infectious diseases, reported that Mr. Darren Lui, CEO and Executive Director of Aptorum Group will present both in-person and virtually at the H.C. Wainwright Global Investment Conference, New York, being held on September 13-16, 2022 (Press release, Aptorum, AUG 25, 2022, View Source [SID1234618679]).

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Aptorum Group management will be available and conducting in-person or online one-on-one meetings with institutional investors through the conference. To register for the conference, please visit: View Source