On May 27, 2022 Mercy BioAnalytics, Inc., a pioneer in extracellular vesicle-based liquid biopsies for the early detection of cancer, reported that the Mercy Halo Ovarian Cancer (OC) assay substantially outperformed CA125 when distinguishing patients with early-stage high-grade serious ovarian cancer (HGSOC) from women with benign conditions in a new study to be presented next week at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting (Press release, Mercy BioAnalytics, MAY 27, 2022, View Source [SID1234615203]). The assay uses a novel method of analyzing biomarkers based on individual extracellular vesicles (EVs).

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"These preliminary data suggest this approach may detect all stages of ovarian cancer with high sensitivity at a very high specificity and works equally well in both plasma and serum. Mercy’s assay shows promise in improving on CA125 by distinguishing stage I/II cancer from benign ovarian tumors and could have clinical utility for both early detection and surgical referral recommendation for benign and malignant ovarian tumors," said Christine D. Berg, M.D., retired Chief, Early Detection Research Group, National Institutes of Health.

The study, titled "Extracellular vesicle-based biomarker assay for the detection of early-stage ovarian cancer," will be presented on Saturday, June 4, 2022, at ASCO (Free ASCO Whitepaper) by Daniel Gusenleitner, Ph.D., Head of Computational Biology for Mercy Bioanalytics (Abstract #5542).

The study found that the Mercy Halo OC assay:

Displayed separation of HGSOC from benign adnexal masses and healthy controls that was superior to CA125.
When run against a variety of off-target cancers and inflammatory conditions, in most instances, discriminated them from ovarian cancer.
When run in paired serum and plasma samples, had highly correlated signals with virtually no bias, indicating the assay can be validated further in established blood biorepositories, which offers the potential to accelerate clinical study and development.
HGSOC is the most aggressive of all ovarian cancers and accounts for up to 70 percent of all ovarian cancer cases. Nearly 50 percent of ovarian cancer is detected at stage III or stage IV with poor survival outcomes. Current surveillance methods, including CA125, a current standard of care for ovarian cancer diagnosis, and ultrasound, are not effective enough at detecting early-stage disease. Emerging methods for early cancer detection rely primarily on tumor DNA circulating in blood (ctDNA), which is scarce in early-stage cancers, costly to measure, and not reliably obtained from tumors that are not well vascularized.

The novel Mercy Halo technology enables simultaneous detection of multiple cancer-related biomarkers co-localized on the surface of individual tumor-derived extracellular vesicles, which are abundant in circulation and can be readily measured. The Mercy Halo OC assay is designed to detect stage I/II ovarian cancer and to distinguish cancer from benign conditions.

"Too many women today suffer, and ultimately lose their lives, as a result of the late detection of ovarian cancer. We are encouraged by the data of our most recent study comparing the Mercy Halo Ovarian Cancer assay to CA125 in detecting early-stage ovarian cancer and distinguishing it from benign disease," said Paul Blavin, Chief Executive Officer of Mercy BioAnalytics. "Our unique approach, focused on co-localization to interrogate single extracellular vesicles, has important advantages over current early cancer detection methods, and our work thus far has fueled our passion for relieving suffering and saving lives through the early detection of cancer. We look forward to expanding our studies of the Mercy Halo Ovarian Cancer assay to include average risk, asymptomatic women who might benefit from an improved ovarian cancer screening paradigm."

On May 27, 2022 CEL-SCI Corporation (NYSE American: CVM) reported the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) has published two abstracts related to CEL-SCI’s pivotal Phase 3 Multikine (Leukocyte Interleukin, Inj.)* head and neck cancer clinical trial (Press release, Cel-Sci, MAY 27, 2022, View Source [SID1234615202]). The poster will be presented by CEL-SCI’s Chief Scientific Officer, Eyal Talor, Ph.D., at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting to be held June 3-7, 2022 in Chicago, Illinois.

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Abstract titles and corresponding links are as follows:

"Leukocyte interleukin injection (LI) immunotherapy extends overall survival (OS) in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck: The IT-MATTERS study." Link to abstract: View Source
"Novel algorithm for assigning risk/disease-directed treatment (DDT) choice in locally advanced primary squamous cell carcinoma of the head and neck (SCCHN): Using pretreatment data only." Link to abstract: View Source
ASCO is the largest cancer meeting in the world, bringing together thousands of cancer experts from academia, industry, patient advocacy and policy.

On May 27, 2022 LintonPharm Co., Ltd., a China-based biopharmaceutical company focusing on the development of T cell engaging bispecific antibodies for cancer immunotherapy, reported that preliminary results of Catumaxomab for advanced Gastric Cancer (GC) with peritoneal metastasis is published online at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Lintonpharm, MAY 27, 2022, View Source [SID1234615200]).

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Abstract Number：e16102
Abstract Title：Global multi-center phase I trial of the intraperitoneal infusion of anti-EpCAM x anti-CD3 bispecific antibody catumaxomab for advanced gastric carcinoma with peritoneal metastasis.

The abstract is about the cohort A, stage I of the ongoing global phase Ⅲ trial that evaluating the safety and efficacy of Catumaxomab in advanced GC patients with peritoneal metastasis (clinicaltrials.gov: NCT04222114). Worldwide, GC is one of the most common cancers, contributing to more than 1 million cases per year and 5.6% of all cancer diagnoses [1]. Approximately 50% of the advanced GC patients will develop peritoneal metastasis after radical resection, along with malignant ascites in most cases. Furthermore, peritoneal metastasis is associated with poor prognosis and quality of life compared with metastasis to other organs [2]. Peritoneal metastasis is treated with systemic therapies. The estimated survival period for the patients who fail to respond to third-line therapy is limited to only 2.3-2.4 months according to multiple RCTs.

In our study, 9 GC patients with peritoneal metastasis (33% had failed third-line therapy) were treated with Catumaxomab, the median overall survival was 3.4 months, with remarkable ascites regression. Catumaxomab as an T cell engaging immunotherapy has showed promising early efficacy signals.

About Catumaxomab
Catumaxomab was approved by the European Medicines Agency in 2009 for the treatment of malignant ascites. It is a bispecific antibody that binds to EpCAM (the epithelial cell adhesion molecule) on the tumor cell–and CD3 on the T cell, recruits immune accessory cells through FcγR binding at the same time. Catumaxomab kills tumor cells by engaging T cell and accessory cell mediated cytotoxicity and has the potential to induce long-term vaccinal effects which has been verified in animal models. Currently, Catumaxomab is being evaluated in clinical trials for both advanced gastric cancer (NCT04222114) and non-muscle invasive bladder cancer (NCT04799847).

On May 27, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that the VAL-083 treatment arm in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial for glioblastoma (GBM), titled Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE), has activated its first European site, University Hospital Zurich in Zurich, Switzerland (Press release, Kintara Therapeutics, MAY 27, 2022, View Source [SID1234615199]).

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GBM AGILE is currently active at 44 clinical sites in the United States and Canada as of May 26, 2022.

GBM AGILE is a patient-centered, Phase 2/3 adaptive platform trial evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. Since January 2021, GCAR has accelerated the pace of clinical site activation with increased awareness in the medical community of Kintara’s arm of the study. GCAR plans to enroll 150-200 patients in the Kintara arm of the study at over 40 sites in the U.S. and Canada with potential to increase this total to 65 clinical trial centers worldwide.

"This first European clinical site for the Kintara treatment arm of the GBM AGILE study joins 44 active sites in the U.S. and Canada," stated Timothy Cloughesy, M.D., Global Principal Investigator for the GBM AGILE study and Professor of the Neurology and Molecular and Medical Pharmacology program at the University of California, Los Angeles. "We are pleased with the reception we are receiving internationally, and this milestone provides us with continued confidence in the ability of GCAR’s GBM AGILE platform trial to materially accelerate the clinical development timelines for companies."

"We continue to see an accelerated pace for which our treatment arm is being executed in the study," commented Robert E. Hoffman, Kintara’s President and Chief Executive Officer. "We are also observing GCAR’s exceptional clinical trial execution capabilities, which were among the aspects that drew us to participate in this highly efficient registrational study. This achievement provides continued excitement as this study progresses."

GBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with GBM through response adaptive randomization and a seamless Phase 2/3 design. The trial, conceived by over 130 key opinion leaders, is conducted under a master protocol allowing multiple therapies, or combinations of therapies, from different pharmaceutical partners to be evaluated simultaneously. With its innovative design and efficient operational infrastructure, data from GBM AGILE may be used as the foundation for a new drug application and biologics license application submissions and registrations to the FDA and other health authorities.

On May 27, 2022 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that management will be attending the Jefferies Healthcare Conference at the Marriott Marquis in New York City (Press release, Autolus, MAY 27, 2022, View Source [SID1234615198]). Autolus’ Chief Executive Officer Dr. Christian Itin will participate in a Fireside Chat on Thursday, June 9 at 9.00 – 9.30 am ET (2:00 pm – 2.30 pm BST) and the Company will also be attending one-on-one investor meetings at the event.

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An audio webcast of the Fireside Chat will be on the Events section of the Autolus website. An archived version will also be available through the Company’s website for a limited time following the conference.