Joint research on personalized cancer immunotherapy using regenerated T cells
derived from iPS cells

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.

Aravive to Participate in Fireside Chat at H.C. Wainwright 23rd Annual Global Investment Conference

On September 1, 2021 Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing innovative therapeutics to treat life-threatening diseases, reported that Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive, and Reshma Rangwala, M.D., Ph.D., Chief Medical Officer of Aravive, will participate in a virtual fireside chat at the H.C. Wainwright 23rd Annual Global Investment Conference taking place September 13-15, 2021 (Press release, Aravive, SEP 1, 2021, View Source [SID1234594063]). The Company’s presentation will be available for viewing on September 13, 2021 at 7:00 AM ET. Aravive will also participate in one-on-one meetings at the conference.

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This meeting is being held virtually, and a live webcast will be accessible on the Events & Presentations page of www.aravive.com. An archived replay of the webcast will be available for 90 days following the webcast.

Ayala Pharmaceuticals to Present Clinical Data from Ongoing Phase 2 ACCURACY Trial and New Preclinical Results from Combination Study of AL101 at the European Society for Medical Oncology (ESMO) Virtual Congress 2021

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.

Shattuck Labs Announces Participation in Upcoming September Conferences

On September 1, 2021 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, reported that company management will participate in three virtual investor conferences in September 2021 (Press release, Shattuck Labs, SEP 1, 2021, View Source [SID1234591768]).

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Presentation Details

Conference: Citi 16th Annual BioPharma Virtual Conference
Format: Panel Discussion, "Framing the Tip of the Spear for Novel Antibodies and Protein Therapeutics"
Presenter: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer
Date: September 9, 2021
Time: 1:25 p.m. EST

Conference: H.C. Wainwright 23rd Annual Global Investment Conference
Format: Corporate Presentation
Presenter: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer
Date: September 13, 2021
Time: 7:00 a.m. EST

Conference: Morgan Stanley 19th Annual Global Healthcare Conference
Format: Fireside Chat
Presenters: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer and Andrew Neill, M.B.A., Shattuck’s Chief Financial Officer
Date: September 15, 2021
Time: 11:45 a.m. EST

A live webcast of the panel discussion, corporate presentation, and fireside chat will be available on the Events & Presentations section of the Company’s website. A replay of the webcasts will be archived for up to 90 days following the presentation date.

Phynova are delighted to announce a partnership agreement with Bioriginal to promote Reducose in the North American market.

On September 1, 2021 PHYNOVA Group Ltd ("Phynova") and Bioriginal Food & Science Corp ("Bioriginal") reported a partnership on Reducose, Phynova’s patented and clinically researched White Mulberry Leaf extract that supports significant lowering of post-meal blood sugar and insulin response (Press release, Phynova, SEP 1, 2021, View Source [SID1234587256]).

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The partnership will encompass both distribution to North American customers as well as joint promotion of the health benefits of Reducose. Bioriginal will serve customers with Reducose as a stand-alone ingredient or as a hero-ingredient in turn-key solutions.

Stephane Ducroux, CEO at Phynova, said: "We are excited to embark on our go-to-market partnership with Bioriginal in the North American market. Phynova’s strategy is to partner with market focused experts such as Bioriginal, who have a proven track record of building deep customer relationships, fast prototyping and turn-key solutions using ingredients with a strong science pedigree like Reducose.

Phynova produces Reducose 5%, a patented premium white mulberry leaf extract that can reduce the blood sugar and insulin response after a meal by up to 40%. Reducose is vegetarian, natural, allergen free and is backed by 6 human clinical studies. Most recently Phynova published the positive clinical trial results on Reducose in the peer-reviewed journal ‘Nutrition & Metabolism’. The full paper can be accessed here: View Source

"We are excited to partner with Phynova by bringing a unique ingredient into Bioriginal’s highly selective nutraceutical ingredient line", said Matt Phillips, Vice President of Sales at Bioriginal. "Phynova’s sustainable, unique and clinically researched white mulberry leaf extract perfectly complements our innovative ingredients portfolio and strengthens our offerings to the nutraceutical and food industries. We look forward to collaborating with Phynova and utilizing Reducose to formulate turnkey concepts – that our customers can quickly take to market – addressing consumer demands for a multitude of benefits."