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TechsoMed Announces Completion of Full Enrollment in Pivotal U.S trial Evaluating its BioTraceIO Software for Liver Ablation Outcomes Assessment in Liver Cancer Patients

On October 24, 2022 TechsoMed, the developer of first of its kind AI Algorithm powered tissue viability imaging technology, reported it has successfully completed patient enrollment in U.S. Pivotal trial designed to demonstrate the safety and effectiveness of its flagship product, BioTraceIO, in providing valuable visualization and quantitative insights on procedure outcome in liver cancer patients undergoing ultrasound guided percutaneous ablation procedures (Press release, TechsoMed, OCT 24, 2022, View Source [SID1234622328]).

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With its algorithm powered technology, the BioTraceIO software system is the first to provide visualization of the ablated area based on standard real-time ultrasound imaging intended to support interventional radiologists performing tumor ablation with valuable procedure outcomes assessment.

"Intraprocedural limited visibility of the area being treated is a true challenge we are facing when performing percutaneous ablation procedures. I believe this hinders the adoption of thermal ablation for treating liver tumors, and I am pleased that new technologies are addressing this challenge," said Dr. Sadeer Alzubaidi, an interventional radiologist from Mayo Clinic Arizona, principal investigator at the trial. "The BioTraceIO enables us, the interventional radiologists, to utilize a standard ultrasound for an added layer of accurate visual and quantitative information of the ablation process. This, no doubt, can increase accuracy and contribute to better care for our patients".

"Ultrasound imaging is critical imaging modality in providing real-time insights during ablation procedures," adds Dr. Nami Azar, Professor of radiology and principal investigator at University Hospitals Cleveland Medical Center. "I am happy to participate in this study to introduce innovative ultrasound monitoring capabilities to the field of tumor ablation. The BioTraceIO solution has the potential to help to see more during the ablation process and to achieve improved procedure outcomes".

The pivotal trial primarily intended to demonstrate that the BioTraceIO Ablation Map generated based on ultrasound imaging during the procedure is effective at estimating the ablation zone as measured 24-hours post-procedure by CT scan, representing the true ablation area. The trial has enrolled 50 patients across 6 leading clinical sites in the U.S. including Mayo Clinic in Arizona and Minnesota, Stanford, Mass General Hospital, UH Cleveland and Houston Methodist Hospital.

"The completion of our first BioTraceIO pivotal trial is a great accomplishment that reflects a milestone in executing our vision of transforming Thermal Ablation from guess-work into precise, real-time feedback dependent treatment", said Yossi Abu, TechsoMed’s CEO. "The collaboration with such leading medical centers and physicians indicates the deep recognition of the interventional-radiology community in BioTrcaeIO potential to provide a much-needed clinical value in the liver ablation space".

Upon the study completion, TechsoMed plans to expand its clinical validation program in the U.S to validate its extended end-to-end BioTraceIO360 software solution designed to equip interventional radiologists with advanced patient-specific procedure modeling, planning capabilities and 3D post-procedure assessment.

Enosi Therapeutics to Present at the ENA 2022 Symposium on Molecular Targets and Cancer Therapeutics in Barcelona

On October 24, 2022 Enosi Therapeutics, a drug research and development company focused on providing industry-leading therapeutics for cancer and autoimmune diseases, reported that Enosi CEO and CSO, Dr. H. Michael Shepard, will be presenting the company’s preclinical work in a presentation titled "High affinity ligand traps derived from the EGFR and HER3 are efficacious in murine models of cancer and autoimmune disease" at the ENA 2022 Symposium being held in Barcelona October 26-28, 2022 (Press release, Enosi Therapeutics, OCT 24, 2022, View Source [SID1234622327]). ENA is a joint program of the National Cancer Institute, the American Association of Cancer Research and the European Organization for Research and Treatment of Cancer.

ENA 2022 is a drug development and translational research meeting, focusing on presentations and discussions regarding preclinical and phase I studies, drawing some of the foremost experts in the field from around the world. The symposium enables in-depth scientific discussions on the latest drug developments and attracts academics, scientists, and pharmaceutical industry executives to discuss the latest innovations in drug research and development.

EN-2642 is an affinity matured EGFR-Fc: HER3:Fc ligand trap and binds 9 of the 11 growth factors which activate the HER family. These growth factors participate in the progression of many diseases, including solid cancers and rheumatoid arthritis, which are characterized by hyperproliferative cells, hypoxia, angiogenesis, and inflammation.

"This therapeutic strategy is unique because it does not depend upon antibodies binding the cell surface, resulting in total signaling blockade or antibody-mediated cellular toxicity, but rather on starving diseased cells which are dependent upon an excess of free growth factors. The problem with earlier "Pan-HER" approaches has been that in most cases the targeted receptors are not overexpressed and thus toxicity results to non-diseased tissues," said Dr. Shepard.

Enosi’s poster will be presented on the opening day of the conference, "Molecular Targeted Agents 1" on Wednesday, October 26, 2022.

Transcenta To Present First-In-Class TST003 Antibody Program at the 10th TEMTIA Meeting

On October 24, 2022 Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported that Transcenta is invited to participate the 10th TEMTIA meeting in Paris, France, November 7 to 10 and present preclinical data of TST003, Transcenta’s first-in-class, high affinity humanized monoclonal antibody targeting Gremlin1 (Press release, Transcenta, OCT 24, 2022, View Source [SID1234622326]).

Details of the speech are as follows:

Topic：TST003, a first-in-class anti-Gremlin1 monoclonal antibody, blocks EMT and displays potent single agent anti-tumor activities in PDX models of multiple difficult-to-treat solid tumors
Date & Time: 9 November 2022, 3:30 pm-3:45 pm (Paris time)
Speaker: Dr. Xueming Qian, CEO, Transcenta

TEMTIA is an international meeting dedicated to the study of epithelial to mesenchymal transition (EMT). EMT process is triggered when epithelial cells loosen cohesiveness and adopt an individualized motile phenotype in link with the progressive loss of epithelial features. EMT was originally defined in the context of developmental stages and contributes to cancer progression and metastasis. EMT has shown to be an important mechanism for resistance to cancer therapies including checkpoint inhibitor immunotherapy.

About TST003

TST003 is a high affinity monoclonal antibody targeting Gremlin1, a member of TGFb superfamily. Gremlin1 protein is a highly conserved secreted protein and has shown to play important roles during development. Gremlin1 is highly upregulated in multiple solid tumors. Gremlin1 protein promotes epithelial mesenchymal transition. TST003 has shown promising single agent activities in patient-derived xenograft tumor models of multiple difficult-to-treat solid tumors resistant to checkpoint inhibitor including castration resistant prostate cancer and microsatellite stable colorectal cancer. TST003 also enhanced the anti-tumor activity of checkpoint inhibitor in syngeneic tumor model. TST003 has received FDA clearance for entering clinical testing in September, 2022.

ViewRay Announces Primary Endpoint Outcome from First Prospective, Multi-Institutional Study to Deliver Ablative Doses of Radiation to Pancreatic Cancer Patients

On October 24, 2022 ViewRay, Inc. (NASDAQ: VRAY) reported that the findings from the first Phase II prospective international multi-institutional study to deliver ablative doses of radiation to pancreatic cancer patients will be presented at the 64th Annual Meeting of the American Society for Radiation Oncology (ASTRO), being held October 23-26, 2022, at the Henry B. Gonzalez Convention Center in San Antonio (Press release, ViewRay, OCT 24, 2022, View Source [SID1234622325]). The results will be featured as part of the Special Session of Late-Breaking Abstracts and will take place on Tuesday, October 25, at 3:00 p.m. Central Time. The data will be presented by Parag Parikh, M.D., study’s principal investigator and Director of GI Radiation Oncology and MR-Guided Radiation Therapy at the Henry Ford Cancer Institute in Detroit.

The trial, titled "Stereotactic MRI-Guided On-table Adaptive Radiation Therapy (SMART) for Locally Advanced Pancreatic Cancer" – and known as SMART Pancreas (NCT 03621644) – was launched in 2019 in response to compelling retrospective data that suggested the potential for ablative dose radiation to improve overall survival relative to patients receiving lower radiation doses without increasing the rate of severe gastrointestinal toxicity.

In the SMART Pancreas study, 136 patients were treated at 13 international centers with ablative MRIdian SMART, 50Gy over 5 fractions. The study’s primary outcome measured grade 3 or higher gastrointestinal toxicity in the first 90 days after treatment. The study’s primary safety objective was met, with zero incidences of acute grade 3+ GI toxicity definitely-related to SMART treatment.

Secondary measures of the study include overall survival, local control, distant progression-free survival, and changes in patient-reported quality of life. While study patients are still early in the follow-up period, 16.4 months from diagnosis and 8.8 months from SMART treatment, the ASTRO presentation will highlight preliminary clinical outcomes data of 1-year local control and distant progression-free survival were 82.9% and 50.6% respectively. One-year overall survival from diagnosis was 93.9%.

"We are pleased to see this prospective study confirmed our experience using MRIdian for pancreas cancer. Ablative SMART for locally advanced and borderline resectable pancreatic cancer is safe; and is promising to improve patient outcomes in this devastating disease," said Dr. Parikh. This study supports further studies looking at overall survival, such as the LAP-ABLATE randomized study that was recently opened."

The MRIdian system provides oncologists outstanding anatomical visualization through diagnostic-quality MR images and the ability to adapt a radiation therapy plan to the targeted cancer with the patient on the table. This combination allows physicians to define tight treatment margins to avoid unnecessary radiation exposure of vulnerable organs-at-risk and healthy tissue and allows the delivery of ablative radiation doses in five or fewer treatment sessions, without relying on implanted markers. By providing real-time continuous tracking of the target and organs-at-risk, MRIdian enables automatic gating of the radiation beam if the target moves outside the user-defined margins. This allows for delivery of the prescribed dose to the target while sparing surrounding healthy tissue and critical structures, which results in minimizing toxicities typically associated with conventional radiation therapy.

To date, nearly 27,000 patients have been treated with MRIdian. Currently, 54 MRIdian systems are installed at hospitals around the world where they are used to treat a wide variety of solid tumors and are the focus of numerous ongoing research efforts. MRIdian has been the subject of hundreds of peer-reviewed publications, scientific meeting abstracts, and presentations. For a list of treatment centers, please visit: View Source

Conflicts of interest: Parag Parikh, M.D. discloses research funding and consulting from ViewRay, Inc, and research funding from Galera Therapeutics, Inc. He also discloses stock ownership from Nuvaira, Inc.

Biotheryx to Present Preclinical Findings on Protein Degrader Programs at 5th Annual Targeted Protein Degradation Summit

On October 24, 2022 Biotheryx, Inc., a clinical stage company discovering and developing a portfolio of innovative small molecule targeted protein degraders (TPDs) in areas of high unmet medical need, reported that it will present preclinical data from its targeted protein degrader programs at the 5th Annual Targeted Protein Degradation Summit, being held October 25-28, 2022, in Boston, Massachusetts (Press release, BioTheryX, OCT 24, 2022, View Source [SID1234622324]).

Leah Fung, Ph.D., Chief Scientific Officer of Biotheryx, will present as a Keynote Plenary Speaker in a session, "Highlighting Key Discoveries of Bifunctional Degraders to New Targets," to highlight novel small molecule bifunctional degraders of son of sevenless homolog 1 (SOS1), potent inhibitors of Kirsten rat sarcoma (KRAS) mutant cancers. Aparajita Chourasia, Ph.D., Vice President of Biology of Biotheryx will also present the latest preclinical data in support of the Company’s BTX-1188 molecular glue program targeting GSPT1 and IKZF1/3.

"We are looking forward to sharing findings at the TPD Summit that highlight the potential of our innovative PRODEGY platform to develop new and exciting cancer therapies," said Dr. Fung. "The data Biotheryx are presenting are evidence of our team’s commitment to the discovery and design of first-in-class protein degraders."