On May 25, 2021 Geneoscopy Inc. reported publication of the peer-reviewed article, "Multitarget Stool RNA Test for Noninvasive Detection of Colorectal Neoplasias in a Multicenter, Prospective, and Retrospective Cohort", which presents the results of its multifactor RNA-FIT test in Clinical and Translational Gastroenterology (Press release, Geneoscopy, MAY 25, 2021, View Source [SID1234580574]). The article reports high sensitivity of the company’s noninvasive, at-home diagnostic screening test to successfully detect colorectal neoplasms, including advanced adenomas, in average-risk individuals within the intended use population for colorectal cancer screening. The promising data was previously presented by Dr. Erica Barnell, Geneoscopy’s co-founder and Chief Scientific Officer, at the Association for Molecular Pathology (AMP) 2020 Annual Meeting.

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In comparative analysis versus colonoscopy findings, the RNA-FIT assay demonstrated 95% sensitivity for colorectal cancer, 62% sensitivity for advanced adenomas, and 25% sensitivity for other non-advanced adenomas with an 85% specificity for no findings on a colonoscopy. The prospective study included 1,305 average risk patients and was supplemented with a 22-patient retrospective cohort of patients who were diagnosed with advanced adenomas or colorectal cancer but were sampled prior to treatment or surgical resection. All patients were evaluated with the RNA-FIT assay and an optical colonoscopy.

The RNA-FIT assay was evaluated under a robust study design. Samples were collected from individuals across all 48 contiguous United States and individuals were evaluated at over 600 different endoscopy sites. The study design will be replicated in Geneoscopy’s CRC-PREVENT Clinical Trial, which is currently underway.

"Colorectal cancer can be prevented with early detection of advanced adenomas. Screening compliance is key, and simple, at-home collection kits are emerging as an attractive option. However, it is critical that a diagnostic test has the necessary sensitivity to identify clinically relevant lesions early," commented Dr. Barnell. "We are pleased to share results of this study and look forward to building upon this body of evidence to support the use of Geneoscopy’s RNA-FIT assay as a valuable noninvasive tool to help prevent cancer through routine colorectal cancer screening."

Responsible for over 50,000 deaths annually, colorectal cancer (CRC) is the second leading cause of cancer related death in the United States.1 Disease progression begins with polyps that may or may not develop into cancer over time. Early detection and treatment are crucial to improve survival; however, the majority of newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold-standard for CRC screening in the US, yet this method is frequently met with patient aversion due to its required bowel preparation, sedation, and associated discomfort, which results in low patient compliance. Currently available noninvasive screening methods lack sufficient levels of sensitivity to effectively and reliably detect both early-stage CRC and high-risk precancerous lesions, including advanced adenomas which are a precursor in up to 70% of CRC cases.

The article is currently available online and is scheduled to be published in the May 2021 issue.

On May 25, 2021 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported it has entered into a technology license agreement with Bristol-Myers Squibb Company (NYSE:BMY) under which Bristol Myers Squibb will have non-exclusive access to Xencor’s Xtend Fc technology to extend the half-life of a novel antibody combination therapy that is intended to neutralize the SARS-CoV-2 virus ("SARS-CoV-2 mAb Duo") for treatment or prevention of COVID-19. SARS-CoV-2 mAb Duo was discovered by researchers at The Rockefeller University and was subsequently licensed by Bristol Myers Squibb (Press release, Xencor, MAY 25, 2021, View Source [SID1234580573]). Phase 1 clinical evaluation to assess dosing and safety of the antibody combination is being conducted by investigators at Rockefeller University Hospital, while the initial Phase 2 and 3 studies are being planned as part of the NIH ACTIV-2 trial examining treatment of infected outpatients.

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"Xencor’s Xtend Fc domains have been incorporated into more than a dozen clinical-stage programs or commercialized medicines, including two programs under investigation for the treatment of COVID-19 and five for other infectious diseases," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "This reflects the potential of Xencor’s XmAb protein engineering platforms to enhance the therapeutic performance of novel antibody candidates. By extending half-life, we improve upon a candidate’s product profile and potentially reduce costs – both of which are important features, particularly for an anti-viral therapy intended for pandemic use. We are committed to partnering with industry and the academic community to support the development of potential treatments for COVID-19, as well as other areas of urgent unmet medical need."

Under the terms of the agreement, Bristol Myers Squibb will have sole responsibility for supporting and advancing the research, development, regulatory and commercial activities for SARS-CoV-2 mAb Duo. Xencor is eligible to receive royalties from net sales of products including these antibodies.

About Xtend XmAb Fc Technology

Xencor’s Xtend XmAb Fc domains have been shown to increase circulating half-life by increasing binding affinity to the receptor FcRn. FcRn is present inside lysosomes in endothelial cells lining the blood vessels and functions to rescue antibodies from the degradation that makes most proteins short-lived in circulation. Half-life extension can be exploited to potentially improve therapeutic antibody performance in several ways, such as increasing dosing interval or decreasing drug quantities at the same dosing interval compared to a parent antibody. Xtend technology is currently in multiple clinical-stage programs and one approved therapy, Alexion’s Ultomiris (ravulizumab-cwvz).

Ultomiris is a registered trademark of Alexion Pharmaceuticals, Inc.

On May 25, 2021 -Novocure (NASDAQ: NVCR) reported it has entered into a clinical trial collaboration agreement with GT Medical Technologies, Inc., to develop Tumor Treating Fields (TTFields) together with GT Medical Technologies’ GammaTile Surgically Targeted Radiation Therapy (STaRT) for treatment of recurrent glioblastoma (GBM) (Press release, NovoCure, MAY 25, 2021, View Source [SID1234580572]). Novocure’s TTFields are electric fields that disrupt cancer cell division. GammaTile is an FDA-cleared therapy for the treatment of all types of brain tumors.

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"Our collaboration with GT Medical Technologies is an exciting and important opportunity to test the radio-sensitizing effect of Tumor Treating Fields, which will be applied for at least two weeks prior to resection and GammaTile implantation," said William Doyle, Novocure’s Executive Chairman. "This trial is designed to build additional evidence of the effectiveness of Tumor Treating Fields plus radiation therapy and to explore the potential to further extend survival for recurrent GBM patients."

Novocure and GT Medical Technologies plan to conduct a phase 2 pilot study to test the effectiveness and safety of neo-adjuvant TTFields followed by resection, GammaTile Therapy, and adjuvant TTFields for recurrent GBM. The study is designed to enroll approximately 55 patients in the United States. Progression free survival (PFS) for the intent-to-treat population is the primary endpoint of the study. Secondary endpoints include overall survival, PFS for per protocol patients, time to progression, six-month survival rate, one-year survival rate, PFS at six months, and safety.

"GT Medical Technologies is enthusiastic about the potential of these combined therapies," said Matthew E. Likens, President and CEO of GT Medical Technologies. "This trial is a great opportunity to expand care and therapeutic options for recurrent GBM patients. GammaTile delivers 50 percent of the radiation within 10 days of resection, which we believe maximizes patient outcomes while improving local tumor control and access to care. We are pleased to partner with Novocure in this pursuit."

About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division.

When cancer develops, rapid and uncontrolled division of unhealthy cells occurs. Electrically charged proteins within the cell are critical for cell division, making the rapidly dividing cancer cells vulnerable to electrical interference. All cells are surrounded by a bilipid membrane, which separates the interior of the cell, or cytoplasm, from the space around it. This membrane prevents low frequency electric fields from entering the cell. TTFields, however, have a unique frequency range, between 100 to 500 kHz, enabling the electric fields to penetrate the cancer cell membrane. As healthy cells differ from cancer cells in their division rate, geometry and electric properties, the frequency of TTFields can be tuned to specifically affect the cancer cells while leaving healthy cells mostly unaffected.

Whether cells are healthy or cancerous, cell division, or mitosis, is the same. When mitosis starts, charged proteins within the cell, or microtubules, form the mitotic spindle. The spindle is built on electric interaction between its building blocks. During division, the mitotic spindle segregates the chromosomes, pulling them in opposite directions. As the daughter cells begin to form, electrically polarized molecules migrate towards the midline to make up the mitotic cleavage furrow. The furrow contracts and the two daughter cells separate. TTFields can interfere with these conditions. When TTFields are present in a dividing cancer cell, they cause the electrically charged proteins to align with the directional forces applied by the field, thus preventing the mitotic spindle from forming. Electrical forces also interrupt the migration of key proteins to the cell midline, disrupting the formation of the mitotic cleavage furrow. Interfering with these key processes disrupts mitosis and can lead to cell death.

TTFields 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 has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect.

Fundamental scientific research extends across two decades and, in all preclinical research to date, TTFields has demonstrated a consistent anti-mitotic effect. The TTFields global development program includes a broad range of clinical trials across all phases, included four phase 3 pivotal trials in a variety of tumor types. To date, more than 18,000 patients have been treated with TTFields.

On May 25, 2021 Epizyme, (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that Robert Bazemore, President and Chief Executive Officer, will participate in a fireside chat during the Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 2:30 p.m. ET.

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A live webcast of the fireside chat will be available in the investor section of the Company’s website at www.epizyme.com, and will be archived for 60 days following the call.

On May 25, 2021 Xilio Therapeutics, a biotechnology company developing tumor-selective immuno-oncology therapies for patients with cancer, reported that it has entered into a clinical trial collaboration and supply agreement with Merck, known as MSD outside the United States and Canada, to evaluate XTX101, Xilio’s engineered tumor-selective Fc-enhanced, anti-CTLA-4 monoclonal antibody (mAb) product candidate, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy (Press release, Xilio Therapeutics, MAY 25, 2021, View Source [SID1234580570]). The planned clinical trial will be conducted by Xilio and is designed to evaluate the safety and efficacy of XTX101 as a monotherapy and in combination with KEYTRUDA in patients with solid tumors.

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"We believe tumor-selective immuno-oncology has significant potential to provide meaningful treatments to patients with a number of different cancers. The clinical benefit of targeting CTLA-4 as a treatment for cancer is well-established. However, treatment with the combination of an anti-CTLA-4 mAb and PD-1 checkpoint inhibitor has been associated with challenging toxicities, preventing patients from receiving effective doses of the anti-CTLA-4 antibody," said Marty Huber, M.D., chief medical officer of Xilio Therapeutics. "XTX101 is designed to be tumor-selective and based on data observed in preclinical studies, we believe it could be an ideal CTLA-4-targeting candidate to combine with checkpoint inhibitors like KEYTRUDA. We are pleased to partner with Merck to study this combination in an effort to improve therapeutic options for people with cancer."

XTX101 is a tumor-selective anti-CTLA-4 mAb designed to pinpoint the anti-CTLA-4 effect geographically within the tumor without off-tumor peripheral effects, potentially improving the therapeutic index and overcoming the potency and tolerability limitations of other anti-CTLA-4 antibodies. In preclinical studies, XTX101 has been well-tolerated and achieved robust tumor growth inhibition, including complete responses accompanied by tumor-selective immune activation. Xilio plans to submit an investigational new drug (IND) application for XTX101 to the U.S. Food and Drug Administration (FDA) in the second quarter of 2021. Subject to FDA clearance of the IND application, Xilio expects to promptly initiate a Phase 1 clinical trial evaluating XTX101 as a monotherapy and as a combination therapy with KEYTRUDA for the treatment of solid tumors.