Contract with Ki-CONNECT for academic advisory support.

On November 20, 2020 Thyas reported that it has signed an advisory agreement with Kyoto Innovation Center for Next Generation Clinical Trials and iPS Cell Therapy, Kyoto University Hospital ("KiCONNECT"; Sakyo-ku, Kyoto, Director Dr. Manabu Muto) for strategic planning for a clinical trial of autologous iPS cell-derived cytotoxic T cell therapy (Press release, Thyas , NOV 20, 2020, View Source [SID1234629211]).

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Study Shows Biocept’s Assays are Viable and Sensitive for Detecting Tumor Cells and Biomarkers in the Cerebrospinal Fluid of Patients with Breast and Lung Cancer that has Metastasized to the Central Nervous System

On November 20, 2020 Biocept, Inc. (Nasdaq: BIOC), a leading commercial provider of molecular diagnostic assays, products and services designed to provide physicians with clinically actionable information to improve patient outcomes, reported the results of a study analyzing cerebrospinal fluid (CSF) samples in patients with primary lung or breast cancer with either brain or leptomeningeal disease (Press release, Biocept, NOV 20, 2020, View Source [SID1234571492]). The findings indicate that Target Selector CSF assays are a viable and sensitive platform for circulating tumor cell (CTC) detection and molecular analysis compared to the current standard of care, CSF cytology, which is typically used to establish or confirm leptomeningeal disease when imaging findings are suspicious or equivocal. CSF cytology has limited sensitivity and provides no additional information needed for target therapy choice.

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The results were discussed yesterday in a poster presentation by Santosh Kesari, MD, PhD, Chair and Professor, Department of Translational Neurosciences, Director of Neuro-oncology at the Pacific Neuroscience Institute and John Wayne Cancer Institute, at the Society for Neuro-Oncology’s SNO2020 Virtual Conference on November 19, 2020.

"Once a tumor has metastasized to the brain, CTCs and circulating tumor DNA (ctDNA) can be found in the cerebrospinal fluid," said Dr. Kesari. "This prospective study compared the sensitivity of CTC detection and molecular analysis of Biocept’s Target Selector CSF assays to cytology (microscopic examination of conventional CSF cytology slide preps). This study highlights the potential of CSF-based diagnostics for longitudinal monitoring cancers in the central nervous system."

"Our Target Selector testing is a minimally invasive, cost-effective strategy to simultaneously confirm metastasis to the brain, while also assessing cancer biomarkers in order to qualify a patient for potential targeted therapy options," said Michael Nall, President and CEO of Biocept. "Identifying CTCs and actionable biomarkers with Target Selector can help to confirm and monitor central nervous system involvement when clinically suspected, without the risk of complications associated with surgical biopsies, which are often impossible in these cases.

"This the second major scientific conference in less than two months to accept study results from Target Selector testing in cerebrospinal fluid for presentation," added Mr. Nall. "We view neuro-oncology as an area where our technology is uniquely suited to answer questions posed by treating physicians, and we are appreciative of the Society of Neuro-Oncology’s recognition of our Target Selector testing."

About the SNO2020 Virtual Conference

The Society for Neuro-Oncology exists to advance multi-disciplinary brain tumor research, education, and collaboration to drive discovery and improve patient care. Over 2,600 neuro-oncology professionals are expected to register for the SNO2020 Virtual Conference being held November 19-21, 2020. More information can be found at soc-neuro-onc.org.

Seres Therapeutics, Inc. Corporate Slide Presentation as of November 20, 2020

On November 20, 2020 Seres Therapeutics Presented the Corporate Presentation (Press release, Seres Therapeutics, NOV 20, 2020, View Source [SID1234575087]).

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Clovis Oncology to Present at the Piper Sandler 32nd Annual Healthcare Conference

On November 20, 2020 Clovis Oncology, Inc. (Nasdaq: CLVS) reported that a pre-recorded fireside chat with President and Chief Executive Officer Patrick J. Mahaffy will be available next week for replay as part of the Piper Sandler 32nd Annual Healthcare Conference (Press release, Clovis Oncology, NOV 20, 2020, View Source [SID1234571471]). The virtual conference, which takes place November 30 to December 3, 2020, incorporates a library of pre-recorded fireside chat presentations with presenting companies available on Monday, November 23, 2020 at 10:00 a.m. Eastern time.

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This conference is virtual and the pre-recorded presentation can be accessed through the investor relations section of the Company’s website at www.clovisoncology.com. The replay of the webcast will be available on the Company’s website for 30 days. The presentation was recorded on November 18, 2020, and statements made in the presentation speak only as of such date. Clovis Oncology does not undertake to update or revise any statements made therein.

Glycostem initiates phase I/IIa (pivotal) trial to evaluate the safety and efficacy of oNKord® in patients with Acute Myeloid Leukemia (AML)

On November 20, 2020 Glycostem Therapeutics B.V., a leading clinical-stage company focused on the development of therapeutic off-the-shelf Natural Killer (NK) cells, reported the opening of a phase I/IIa trial for its lead product oNKord for the treatment of AML patients (Press release, Glycostem Therapeutics, NOV 20, 2020, View Source [SID1234571493]). The WiNK trial will enroll 33 AML patients at eight clinical sites based in five European countries. oNKord is the company’s first-generation off-the-shelf allogeneic NK cellular immunotherapy product. Glycostem is furthermore developing a range of second (CAR-NK) and third generation (TCR-NK) NK products in-house.

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"During our phase I safety study, in which ten elderly AML patients were treated, we verified our lead product oNKord to be a safe therapeutic agent in the field of cellular immunotherapy. Interestingly, year 1 survival data showed promising efficacy outcome (80%) compared to historical cohort data (40%)," tells Troels Jordansen, CEO at Glycostem. "The opening of this phase I/IIa / pivotal trial is an important step and we are looking forward to the data from this study, which will allow us to draw conclusions regarding oNKord safety and tolerability and most importantly its efficacy for treatment of AML patients."

Professor Doctor Arnold Ganser, MD of Hannover Medical School in Germany and WiNK trial coordinating investigator said: "The preliminary efficacy data obtained with oNKord was very promising and NK-cells have proven to be highly capable of targeting cancer cells. Therefore, I am excited about participating and being able to enroll patients in the WiNK trial." He continues: "Currently there is a risk of relapse for 80% of the successfully treated patients. This new form of cellular treatment can change the lives and future prospects of many patients with AML worldwide who do not proceed to allogeneic hematopoietic stem cell transplantation, in particular elderly patients, who represent the majority of patients with AML."

WiNK is a prospective two-stage, open-label, single arm, multicenter phase I/IIa trial to evaluate the safety and efficacy of oNKord, an off-the-shelf, ex. vivo-cultured allogeneic NK cell preparation, in 33 adults with AML who are in complete morphologic remission with residual measurable disease and with no strong indication for hematopoietic stem cell transplantation.