Yisheng Biopharma and Tavotek Biotherapeutics Announce Strategic Research Alliance for Development of YS-ON-001/002 and Tavo-301/303 Combination Therapy for Cancer Treatment

On January 6, 2020 Yisheng Biopharma Co., Ltd. ("Yisheng Biopharma"), a biopharmaceutical company focusing on research, development, manufacturing, sales and marketing of immunological biologics and vaccines, and Tavotek Biotherapeutics, a biotech company focusing on novel multi-specific antibodies in immuno-oncology and autoimmune diseases, reported that the companies have entered into a strategic research alliance and collaborate in the development involving their lead assets in oncology (Press release, Yisheng US Biopharma, JAN 6, 2020, View Source [SID1234552768]). The objective of the alliance is to co-develop a combination therapy of YS-ON-001/002 and Tavo-301/303 for cancer treatment. The two companies are also in discussions regarding additional research and development collaborations beyond oncology.

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"We are excited to collaborate with Tavotek, which has a rich pipeline of multi-specific antibodies and advanced technology platforms in oncology and other therapeutic areas," commented Dr. David Shao, President and Chief Executive Officer of Yisheng Biopharma. "As potent agonists of TLR3, MDA5 and RIG-I pathways, YS-ON-001 and YS-ON-002 have demonstrated promising effects in activating the innate and adaptive immune systems and modulating the tumor microenvironment, and YS-ON-001 has shown an excellent safety profile with clinical data to date. By combining YS-ON-001/002 with multi-specific antibodies directed against tumors, we are well positioned in developing a first-in-class immunotherapy with potentially higher response rates. We look forward to working with the Tavotek team to explore the potential synergy of YS-ON-001/002 and Tavo-301/303."

"The collaboration with Yisheng aligns with Tavotek’s mission to develop life-changing therapies for patients with significant unmet medical need," said Dr. Mann Fung, Chief Executive Officer of Tavotek. "Current immuno-oncology approaches such as PD1/PDL1 antibody achieve only approximately 20 to 30 percent response rates in clinical settings. A majority of cancer patients still are not seeing a benefit from current therapies. We believe a combination regimen of YS-ON-001/002 with multi-specific IO antibodies, such as Tavo-301/303, will have beneficial impact on cancer care."

YS-ON-001 and YS-ON-002 are immunotherapeutic products based on the TLR3/RIG-I/MDA-5 signaling pathways of PIKA immunomodulating technology. They are capable of both reducing the immunosuppressive effect of tumor microenvironment and enhancing the anti-tumor function of the immune system to tumor cells. YS-ON-001 is currently in clinical development in China and Singapore, and has received orphan drug designations from the U.S. FDA for treatment of pancreatic and liver cancers. The product has been approved in Cambodia for the treatment of advanced solid tumors. YS-ON-002 is a clinical candidate ready for IND submission. YS-ON-001/002 can be an integral immunotherapy component with standard of oncology care, such as chemotherapies, targeted therapies and checkpoint inhibitors or with emerging immunotherapies for additive or synergistic treatment benefits.

Tavo-301/303 is a series of novel multi-specific antibody-based Immuno-Oncology assets that was developed using Tavotek’s proprietary TavoSelect Platform. Novel protein engineering employing TavoSelect technology generates multi-specific biologics with optimal molecular profiles for targeting multiple relevant epitopes simultaneously to manage difficult-to-treat solid tumors. These biologics modulate the immunosuppressive pathway by multiple mechanisms of action to promote anti-tumor response and efficacy. The TavoSelec technology also provides biologic molecules with favorable pharmacokinetic profiles and stable formats for ease of development and manufacturing.

Announcement of Joint Development Agreement with Sapporo Medical University

On January 6, 2020 Gene Techno Science (Kidswell Bio) reported a joint development agreement with Sapporo Medical University for a development of an anticancer drug using antibodies with an ability of entering cancer cell (Press release, Kidswell Bio, JAN 6, 2020, View Source [SID1234625474]).

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1. Purpose and background for concluding this agreement
This agreement aims to develop new anticancer drugs for rare and refractory cancers as a new pipeline in the new biologic business, which is the future growth driver for our company. In recent years, cancer treatment has dramatically improved due to the emergence of drugs that selectively inhibit abnormal proliferation signals of cancer cells or antibody drugs that selectively recognize only cancer cells. On the other hand, the therapeutic effect achieved only with single antibody drug is limited, so in clinical practice, the combination treatment of other existing anticancer drugs and antibody drugs is a common treatment. Recently, development of antibody-drug conjugates combining cytotoxic small molecules to an antibody that recognizes cancer cells, has been actively conducted. In Japan, two antibody-drug conjugates have been launched in the market and show a great therapeutic effect.

Assistant professor Miki Yamaguchi of Research Institute of Frontier Medicine, Sapporo Medical University School of Medicine, possesses antibodies by immunizing mice, which bind to molecules expressed only on the surface of cancer cells with an ability to enter cancer cells. GTS will sort out antibodies with superior ability in a recognition specificity and entering to cancer cells, and combine them to antibodydrug conjugates combining small molecule drugs or immunotoxin combining cytotoxic protein. GTS aims to develop anti-cancer drugs that show excellent therapeutic effects even by the single administration.

GTS will conduct this research and development based on the expertise of handling proteins accumulated in the past developments of biosimilar products and append this drug as a new pipeline in the new biologic business to secure new revenue sources in the future. Through the contribution to society by developing new anticancer drugs for rare and refractory cancers, we will accelerate to raise our enterprise value and aim to achieve GTS3.0 at an early stage.

2. Contents of this agreement
Joint development agreement for an anticancer drug using antibodies with an ability of entering cancer cells which Sapporo Medical University possesses.

3. Outline of counterparties to this agreement
1. Name Sapporo Medical University
2. Location South-1, West-17, Cyuo-ku, Sapporo, Japan
3. Chairperson and President Taiji Tsukamoto
4. Department Department of Molecular Medicine, Research Institute
for Frontier Medicine, Sapporo University School of
Medicine

4. Future outlook
The impact on the business results for the fiscal year ending March 2020 is expected to be minimal.

Astellas Announces Status of Acquisition of Own Shares

On January 6, 2020 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. "the Company") reported the status of acquisition of its own shares as stated below (Press release, Astellas, JAN 6, 2020, View Source [SID1234552693]). The acquisition was implemented pursuant to the provision of its Articles of Incorporation in accordance with Article 459, paragraph 1 of the Companies Act.

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Particulars

1. Class of shares acquired: Common stock of the Company

2 Total number of shares acquired: 7,360,600 shares

3 Total amount of acquisition cost: 13,738,364,050 yen

4 Period of acquisition: From December 1, 2019 to December 23, 2019

5 Method of acquisition: Purchased on the Tokyo Stock Exchange

(Reference)

1. Details of the resolution at the meeting of the Board of Directors (announced on October 31, 2019)
-Class of shares to be acquired: Common stock of the Company

-Total number of shares to be acquired: Up to 32 million shares (Ratio to the total number of shares outstanding [excluding treasury stock]: 1.70%)

-Total amount of acquisition cost: Up to 50 billion yen

-Period of acquisition: From November 1, 2019 to January 31, 2020

2. Accumulated Company’s own shares acquired through December 31, 2019, pursuant to the above board resolution

-Total number of shares acquired: 20,026,200 shares

-Total amount of acquisition cost: 36,866,306,500 yen

Genmab to Present at the 38th Annual J.P. Morgan Healthcare Conference

On January 6, 2020 Genmab A/S (Nasdaq: GMAB) reported that its CEO, Jan van de Winkel, Ph.D., will present a company update at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco at 3:30 PM PST on January 15, 2020 (12:30 AM CET, January 16) (Press release, Genmab, JAN 6, 2020, View Source [SID1234552719]). The live and archived webcast of the presentation will be available on Genmab’s website at View Source

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Moderna to Provide Business and Pipeline Updates at the 2020 J.P. Morgan Healthcare Conference

On January 6, 2019 Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported that CEO Stéphane Bancel will present an update on the Company and its pipeline of mRNA development programs at this year’s 38th annual J.P. Morgan Healthcare Conference (Press release, Moderna Therapeutics, JAN 6, 2020, View Source [SID1234552736]).

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Mr. Bancel’s presentation will take place on Monday, January 13, 2020 at 4:30 p.m. PT in the Colonial Room at The Westin St. Francis Hotel in San Francisco. The presentation will be followed by a question and answer session. A live webcast of both the presentation and question and answer session will be available under "Events & Presentations" in the investors section of Moderna’s website at View Source A replay of the webcast will be archived on Moderna’s website for 30 days following the presentation.