Apexigen To Present At Upcoming Investor Conferences

On February 27, 2020 Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, reported that Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer, will present at the following upcoming investor conferences (Press release, Apexigen, FEB 27, 2020, View Source [SID1234554949]):

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Cowen’s 40th Annual Healthcare Conference
Tuesday, March 3, 2020 at 11:30 am ET in Boston, MA

Solebury Trout’s Spring 2020 Private Company Showcase
Thursday, April 2, 2020 in New York, NY

Tessa Therapeutics Announces U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to its CD30 CAR-T Cell Therapy for the Treatment of Relapsed or Refractory CD30-positive Classical Hodgkin Lymphoma

On February 27, 2020 Tessa Therapeutics (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments, reported that the Company’s investigational CD30-directed autologous chimeric antigen receptor T cell (CD30 CAR-T) therapy has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma (cHL) (Press release, Tessa Therapeutics, FEB 27, 2020, View Source [SID1234554948]). Tessa expects to initiate its pivotal Phase II multi-site trial in the fourth quarter of 2020.

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"The RMAT designation speaks to the strength of the data in two independent Phase I/II trials, which show promising efficacy and a strong safety profile of the therapy in Hodgkin lymphoma patients whose disease had failed to respond to other available therapies," said Ivan D. Horak, M.D., President of Research and Development at Tessa Therapeutics. "We look forward to working closely with the FDA as we advance our trial at multiple sites in North America and work to bring this potentially transformative treatment option to patients."

The RMAT designation is supported by clinical data from two independent CD30 CAR-T Phase I/II studies in patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma conducted by Baylor College of Medicine (NCT02917083) and University of North Carolina Lineberger Comprehensive Cancer Center (NCT02690545). Both studies demonstrated objective response rates of more than 70%, with 18 patients achieving complete response out of 27 patients treated with CD 30 CAR-T with lymphodepleting chemotherapy as of November 2019.

Dr Horak added: "As part of our longer-term R&D program, we are also developing an allogeneic CD30-CAR Epstein-Bar Virus-Specific T cell (CD30-CAR EBVST) therapy product that combines the unique properties of VSTs and CD30 CARs, in an effort to develop off-the-shelf cell therapies intended to treat a range of hematologic malignancies and solid tumors."

RMAT designation is designed to facilitate development and expedite review of cell therapies and other qualifying regenerative medicines intended to treat a serious or life-threatening disease or condition; and preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition. Advantages include all the benefits of the FDA’s Fast Track and Breakthrough Therapy Designation programs, such as early interactions with the FDA that may be used to discuss potential surrogate or intermediate endpoints to support accelerated approval and satisfy post-approval requirements.

Ionis Pharmaceuticals to present at upcoming investor conferences

On February 27, 2020 Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), the leader in antisense therapeutics, reported that management will present a company overview at the following investor conferences (Press release, Ionis Pharmaceuticals, FEB 27, 2020, View Source [SID1234554947]):

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Cowen 40th Annual Health Care Conference on Wednesday, March 4, 2020; and
Oppenheimer 30th Annual Healthcare on Wednesday, March 18, 2020.
The above listed dates are subject to change. Details on presentation times or changes to presentation dates can be found on the Company’s website. Please check www.ionispharma.com for the latest information.

A live webcast of the presentations will be available on the Investors & Media section of the Ionis website. The replays will be available within 48 hours and will be archived for a limited time.

RareCyte announces the first blood-to-result PD-L1 Circulating Tumor Cell Assay

On February 27, 2020 RareCyte reported a liquid biopsy blood test for programmed death-ligand 1 (PD-L1), enabling customers to evaluate PD-L1 expression on circulating tumor cells (CTCs) with industry leading sensitivity. PD-L1 is a biomarker that directs checkpoint inhibitor immunotherapy treatment and liquid biopsy offers a noninvasive method to evaluate biomarker expression for treatment selection and patient monitoring in clinical research (Press release, RareCyte, FEB 27, 2020, View Source [SID1234554946]).

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With the RareCyte PD-L1 assay and the AccuCyte-CyteFinder system, blood from a single tube is processed to cells for CTC enumeration and PD-L1 biomarker expression analysis, and to plasma for optional cfDNA analysis. Single CTCs can also be retrieved using the CytePicker Module for sequencing analysis. As a result, the RareCyte assay provides the first comprehensive liquid biopsy solution for PD-L1 analysis.

The PD-L1 Panel Kit was validated based on rigorous requirements set to clinical standards. Tad George, PhD, SVP of Biology R&D at RareCyte noted, "Our approach to assay development and validation is centered on creating globally deployable products that combine the sensitivity, specificity, and precision required for multi-center clinical trials for CTC enumeration and phenotyping. In addition, the RareCyte platform enables cell-free DNA analysis on the same sample, providing a comprehensive assessment of patient status."

Joe Victor, CEO of RareCyte, said "We released this new assay as a response to customer feedback from an earlier generation assay still in use today and we anticipate that this PD-L1 Panel Kit will be utilized in a variety of exploratory clinical research this year." The PD-L1 Panel Kit is now available for purchase. More information on the PD-L1 Panel Kit and the RareCyte platform is available at View Source

RareCyte products are for research use only. Not for use in diagnostic procedures.

Menarini Silicon Biosystems to Announce New Solutions for Advancing Liquid Biopsy in Clinical Research

On February 27, 2020 Menarini Silicon Biosystems, the pioneer of liquid biopsy and rare cell technologies, reported that it is developing several new products that could help advance precision medicine research by expanding the capabilities and applications of its CELLSEARCH and DEPArray technologies, for rare cells isolation and single cell analysis (Press release, Menarini Silicon Biosystems, FEB 27, 2020, View Source [SID1234554945]).

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The new solutions include an assay for the enumeration and molecular characterization of circulating multiple myeloma cells (CMMC) from peripheral blood samples, the DEPArraysystem upgraded to 9 colors and artificial intelligence software.

The company’s technological developments will be highlighted during a presentation by Mark Connelly, PhD, Chief Research and Development Officer at Menarini Silicon Biosystems Inc, as part of the Molecular Medicine Tri-Conference’s Circulating Tumor Cells & Liquid Biopsy track.

"We are continually working to develop additional tools that will facilitate the exploration of new areas of inquiry," said Connelly. "Providing researchers with more information from a wider variety of cell populations and the ability to examine tumor heterogeneity in real-time could help address some critical questions in pharmaceutical and clinical research."

The CMMC assay based on the capabilities of CELLSEARCH to enrich and enumerate rare cells allow researchers to monitor the number of CMMCs in peripheral blood; furthermore when combined with the DEPArray system, will allow to perform molecular analysis at single cell level**. Research suggests that the ability to obtain CMMCs via liquid biopsy may help clinical researchers to better monitor disease state and treatment response, though, not only the cell enumeration but also the real time cell molecular profiling. Menarini Silicon Biosystems currently offers a CMMC assay (Research Use Only) as a service through its Global Laboratory Services. The company plans to release the assay for Research Use Only in the summer of 2020.

The 9-Color DEPArray will offer more fluorescence channels to examine the heterogeneity of markers expression on various rare cells, enabling researchers to simultaneously identify and characterize multiple cell populations. The artificial intelligence software will reduce operator variability by automating cell identification and selection and will help researchers move beyond enumeration to unravel hidden information in the cell image data.

Connelly’s presentation will also feature new research supporting the potential use of CTCs as a response biomarker for prostate cancer treatment. A 2018 study published in the Journal of Clinical Oncology indicates that using CTC counts obtained from liquid biopsy after 13 weeks of treatment can provide an accurate assessment of response to treatment. PSA (prostate-specific antigen) is one of the only markers currently available for the disease but is not considered to be a sufficient indicator of treatment response.

Menarini Silicon Biosystems is working with the FDA to get this application qualified as a response biomarker. This would enable researchers to incorporate CTCs as a response biomarker into clinical trials to expedite the drug development process.

Jennifer Davids, PhD, Director of Field Scientific Support at Menarini Silicon Biosystems Inc, will also be presenting on how the DEPArray technology can overcome the challenges of sample heterogeneity by enabling rare cell sorting with single cell precision.

Presentation Details
Location: Moscone South Convention Center

Monday, March 2 at 1:05 pm
Title: Advancing Liquid Biopsy – presented by Mark Connelly, PhD
Program: Circulating Tumor Cells and Liquid Biopsy
Track: Companion Diagnostics with Liquid Biopsy

Tuesday, March 3 at 11:40 am
Title: Utilizing the Next Generation Single Cell Sorter, DEPArray – presented by Jennifer Davids, PhD
Program: Immuno-Oncology Biomarkers and Companion Diagnostics
Track: Neoantigen Approaches

"These exciting developments demonstrate our continued commitment in advancing the applications of liquid biopsy," said Fabio Piazzalunga, President of Menarini Silicon Biosystems. "Our goal at MSB is to contribute to the advancement of precision medicine through innovative rare cell technologies, and we are actively working with our partners in the research community to provide advanced integrated and automated solutions."

To learn more about the CELLSEARCH and DEPArray Systems, MMTC attendees can visit Menarini Silicon Biosystems at Booth #601.

The 27th International Molecular Medicine Tri-Conference will be held March 1-4, 2020 in San Francisco.