On September 1, 2021 Pillar Biosciences, an innovative next-generation sequencing (NGS) solutions in-vitro diagnostics (IVD) company, reported the appointment of Randy Pritchard as Chief Executive Officer (Press release, Pillar Biosciences, SEP 1, 2021, View Source [SID1234587119]). The company’s founder, industry veteran and renowned scientific innovator, Gang Song, Ph.D., will transition to the role of Chairman of the Board, where he will be responsible for leading the Board, ensuring governance standard and focusing on all strategic matters for Pillar Biosciences. In his new role as CEO, Mr. Pritchard will look to accelerate the company’s efforts to make precision oncology accessible for all patients throughout the patient journey.

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Mr. Pritchard brings to Pillar Biosciences more than 24 years of healthcare experience, as a diagnostics executive who has deep experience in corporate and commercial strategy, sales and marketing, driving growth through innovation. He has held positions of increasing responsibilities, including SVP of US Diagnostics marketing, SVP & Lifecycle Leader at the divisions of POC Diagnostic & Core Reagents, and VP of Marketing at Centralized Diagnostics at Roche Diagnostics.

"On behalf of the Board, I am excited to welcome Randy to lead Pillar Biosciences in its next stage of growth. He brings invaluable experience, as we accelerate our growth with the launch of our oncoReveal Dx Lung and Colon Cancer Assay, which received FDA Premarket Approval recently," said Gang Song, Ph.D., Co-Founder and Chairman of the Board, Pillar Biosciences. "Pillar Biosciences was founded with a mission to make precision medicine accessible for all, by simplifying clinical next-generation sequencing (NGS) and bringing testing closer to the patient."

"The Board was impressed by Randy’s depth of understanding of the diagnostics space and what drives growth, as well as his leadership experience," said Simone Song, Founder, ORI Capital who has led repeated investments in Pillar Biosciences since its Series A financing. "His ability to quickly analyze a business, develop and execute on the growth strategy was truly remarkable. I am fully confident that Randy will be an outstanding leader for Pillar at this next stage of growth."

"I look forward to working with Gang and the Pillar Biosciences team to accelerate the adoption of oncoReveal Dx and bring more innovative NGS cancer testing products to patients, in particular in the area of liquid biopsy," said Randy Pritchard, CEO, Pillar Biosciences. "Pillar has grown to over 150 dedicated team members in the US and China, and I look forward to leading the company in its next stage of growth to become a global clinical cancer NGS diagnostics company."

On September 1, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported that the Company will present at the H.C. Wainwright 23rd Annual Global Investment Conference being held virtually September 13-15, 2021 (Press release, Lipocine, SEP 1, 2021, https://www.prnewswire.com/news-releases/lipocine-to-present-at-the-hc-wainwright-23rd-annual-global-investment-conference-301366743.html [SID1234587138]).

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H.C. Wainwright 23rd Annual Global Investment Conference September 13-15, 2021

Presentation time: September 13, 2021 starting at 7:00 a.m. EST
Webcast link: View Source

A webcast of Lipocine’s presentation will be available on-demand as of 7:00 am ET, Monday, September 13, 2021, thorough the H.C. Wainwright conference portal, on Lipocine’s website under "Events & Presentations" in the Investors section or using the webcast link above. The webcast will be available on the Lipocine’s website for 90 days.

On September 1, 2021 The Center for iPS Cell Research and Application, Kyoto University ("CiRA"; Headquarters: Sakyo-ku, Kyoto, Japan; Director: Shinya Yamanaka), KOTAI Biotechnologies, Inc. ("KOTAI"; Headquarters: Suita, Osaka, Japan; CEO, Kazuo Yamashita) and Thyas Co. Ltd. ("Thyas"; Headquarters: Sakyo-ku, Kyoto, Japan; CEO, Yasumichi Hitoshi) jointly reported that Thyas has joined joint research initiated by CiRA and KOTAI on personalized cancer immunotherapy using regenerated T cells1 derived from induced pluripotent stem (iPS) cells2 (Press release, Thyas , SEP 1, 2021, View Source [SID1234629214]).

The laboratory of Professor Shin Kaneko, CiRA,Department of Cell Growth and Differentiation, is conducting research on therapeutic regenerative T cells using iPS cells for cancer immune cell therapies. In these therapies, cytotoxic T cells3 that can attack cancer cells are isolated from cancer patients and reprogrammed into iPS cells. These patientsderived iPS cells (or allogeneic iPS cells transduced with these patients-derived TCR genes) are then used to produce large numbers of rejuvenated T cells with high anti-cancer function (see figure below). CiRA and KOTAI started the joint research in October, 2020 to establish more efficacious personalized cancer immune cell therapies using a surface antigens4 specifically expressed on anti-cancer cytotoxic T cells and immuno-informatics technologies possessed by KOTAI.

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Thyas is developing robust and standardized manufacturing methods to produce regenerated T cells for industrial use using the research achievements by Professor Kaneko. It has also been manufacturing the clinical-grade batches of regenerated T cell products for clinical studies. The inclusion of Thyas, well-experienced in the production of regenerated T cells, is expected to accelerate the clinical application of the joint research outcomes.

In this joint research, CiRA will isolate T cells from cancer tissue and conduct iPS cell induction, T cell redifferentiation, and functional evaluation, while KOTAI will provides information on the surface antigen for the T cell isolation and performs genetic analysis of the cells. Thyas will optimize the production of regenerated T cells for clinical trials. The first trials are scheduled to begin by 2025 and will be the world’s first iPSC-derived therapeutic cells equipped with personalized TCRs5.

By conducting this joint research, CiRA, KOTAI, and Thyas aim to establish personalized cancer immunotherapy using regenerated T cells and contribute to the further development and popularization of cancer immune cell therapy through the efforts toward clinical trials.

The Center for iPS Cell Research and Application (CiRA), Kyoto University : View Source
KOTAI Biotechnologies, Inc. : View Source
Thyas Co. Ltd.: View Source

(Note 1) T cells: A type of lymphocyte that acts in immunity by recognizing and eliminating infected cells and cancer cells. Each T cell responds to a specific antigen. There are various types of T cells, such as cytotoxic T cells, helper T cells and others.

(Note 2) iPS cells: Somatic cells, such as skin or blood cells are reprogrammed into the pluripotent state by introducing a few genes. iPS cells are a type of stem cell with almost indefinite capacity to multiply and can differentiate into almost any kind of cell in the body.

(Note 3) Cytotoxic T cells: A type of T cell. When antigen information is received from other immune cells, cytotoxic T cells attack the cells corresponding to the antigen.

(Note 4) Surface antigen: A substance on a cell surface recognized by an antibody.

(Note5) Thyas’ Regenerated T Cell Products
Thyas aims to start clinical trials of allogeneic iPS cell-derived regenerated T cell therapy targeting common antigens in 2023 as its first pipeline. Development of this personalized T cell therapy will be its second pipeline.

On September 1, 2021 Ayala Pharmaceuticals, Inc. (NASDAQ: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, reported upcoming ePoster presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2021, being held September 16-September 21, 2021 (Press release, Ayala Pharmaceuticals, SEP 1, 2021, View Source [SID1234593997]). Ayala will present preliminary data from the 6mg cohort of the ongoing Phase 2 ACCURACY clinical trial of AL101 for the treatment of recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) harbouring Notch-activating mutations in addition to preclinical results from Ayala’s new study of AL101 in combination with other drugs for dual targeting of Notch dysregulated tumors.

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ePoster details:

Title: ACCURACY: a phase 2 trial of AL101, a selective gamma secretase inhibitor, in subjects with recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) harboring NOTCH-activating mutations (NOTCHmut): results of 6-mg cohort
Presentation Number: 904P
Presenter: Alan L. Ho, M.D., Ph.D., Memorial Sloan Kettering Cancer Center

Title: The gamma secretase inhibitor AL101 combined with other drugs for dual targeting of Notch dysregulated tumor
Presentation Number: 1789P
Presenter: Renata Ferrarotto, M.D., MD Anderson Cancer Center

The two ePosters will be available to registrants of the ESMO (Free ESMO Whitepaper) Virtual Congress 2021 starting at 8:30 AM CEST (2:30 AM ET) on Thursday, September 16, 2021.

About AL101

AL101 is an investigational small molecule Gamma Secretase Inhibitor (GSI) that is designed to potently and selectively inhibit Notch 1, 2, 3 and 4, and is currently being evaluated in two Phase 2 clinical studies, ACCURACY and TENACITY, in patients with adenoid cystic carcinoma (ACC) and in patients with triple negative breast cancer (TNBC), respectively. AL101 is designed to inhibit the expression of Notch gene targets by blocking the final cleavage step by the gamma secretase required for Notch activation. Ayala obtained an exclusive, worldwide license to develop and commercialize AL101 from Bristol-Myers Squibb Company in November 2017. AL101 was granted U.S. FDA Fast Track Designation and Orphan Drug Designation for the treatment of ACC.

On September 1, 2021 The Upstate Foundation reported that it has invested in brain cancer research at Upstate Medical University with an award of $50,000 to a project led by Mariano Viapiano, PhD, associate professor of neuroscience and neurosurgery and director of the Brain Tumor Laboratory and Biorepository (Press release, SUNY Upstate, SEP 1, 2021, View Source [SID1234587100]). The award is the result of a competitive application and evaluation process overseen by David Amberg, PhD, vice president for research at Upstate.

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Viapiano currently directs a research program to develop novel treatments for patients with malignant gliomas, the most aggressive form of brain cancer. In his latest project, he and his team plan to target a rare change in tumor cells that makes these cells able to avoid the immune system. For the past two decades, the Viapiano Lab has studied how tumor cells change the proteins that coat the cell surface and how those mutated proteins promote tumor growth.

In the past two years the team has identified a type of protein alteration that tumor cells use to avoid immune surveillance, but that has remained entirely ignored in the field of brain cancer. Their project will identify which proteins carry this alteration in brain cancer cells and will use small fragments of those proteins to force the immune system to recognize and attack the tumor cells.

This project, which has received a university research award, is already in its initial phase and has identified a number of potential protein candidates that can be used to boost the immune system against brain cancer. The team’s overarching goal is to identify the mutated proteins in each patient’s tumor biopsy and formulate a personalized "immuno-boosting" cocktail for each patient. To this end, the project includes not only the resources of the Brain Tumor Lab but also the expertise of collaborators in neuroscience, immunology and biochemistry at Upstate Medical University. This funding will support a wide range of investigators and technological development at the University.

"We are so pleased to support this important project," said Eileen Pezzi, vice president for development at Upstate. "This investment will help Upstate advance new treatments that are desperately needed by patients with brain cancer."

Established in the early 1990s, the Brain Tumor Laboratory and Biorepository is the flagship resource of the University for research and diagnosis of patients with brain cancer. Viapiano has led the Brain Tumor Lab since his arrival at Upstate in 2006, after directing the Harvey Cushing Neuro-Oncology Laboratories at Brigham and Women’s Hospital and Harvard Medical School.

To learn more about this research project, contact Mariano Viapiano at [email protected]

Caption: Lab director and principal investigator Mariano Viapiano, PhD, second from right, with the team of the Upstate Brain Tumor Laboratory and Biorepository. From left, Leah Longo, research aide; Joan Chou, medical student; Sharon Longo, laboratory manager; John Longo, research specialist; Somanath Kundu, postdoctoral scientist; and Roshini Arivazhagan, postdoctoral scientist. Photo taken pre-pandemic.