On January 21, 2020 Takeda Pharmaceutical Company Limited (TOKYO:4502/NYSE:TAK) ("Takeda") reported is proud to be named in the Corporate Knights Global 100 Most Sustainable Corporations in the World (Global 100) for the fifth consecutive year (Press release, Takeda, JAN 21, 2020, View Source [SID1234553347]). Corporate Knights assesses more than 7,300 companies against 21 key performance indicators. It uses these indicators to determine the top 1% most sustainable companies in the world, which are announced annually at the World Economic Forum in Davos, Switzerland.

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"Building sustainable value is a fundamental part of the way we do business at Takeda, and we are proud to be recognized as a global leader in sustainability," said Christophe Weber, President and CEO. "This recognition by Corporate Knights is a testament to the strong foundation Takeda has laid and the progress we have already achieved. We remain steadfast in our commitment to realizing Better Health and a Brighter Future for all."

Corporate Knights highlighted Takeda’s performance in the following areas:

Significant year-on-year improvement in energy, water and greenhouse gas productivity scores.
High marks for clean revenue, which measures revenue earned by providing access to medicine for top priority diseases in low- and middle-income countries through equitable pricing strategies.
Three times the average score for female representation among senior executives.
In addition to the Global 100 index, Takeda is recognized by many other environmental, social and governance (ESG) investment valuations. As a long-standing member of the United Nations Global Compact, Takeda’s sustainability efforts are guided by key international targets, such as the Sustainable Development Goals (SDGs).

Name of
Index or Rating

Company/
Organization

Country

History of
Inclusion

Dow Jones Sustainability World Index

Dow Jones

U.S.

1st year

Dow Jones Sustainability Asia Pacific Index

Dow Jones

U.S.

10th year

FTSE4Good Developed Index

FTSE Russell

U.K.

15th consecutive year

MSCI ESG Leaders Index

MSCI

U.S.

10th consecutive year

Ethibel EXCELLENCE Investment Register

Forum Ethibel

BEL

Since July 2017

Prime Status

ISS-Oekom

GER

2nd consecutive year

Industry Mover Sustainability Yearbook Award 2019

RobecoSAM

CHE

Since February 2019

On January 21, 2020 OncoTherapy Science, Inc. (President & CEO: Jae-Hyun Park; hereinafter "OncoTherapy") reported that the first patient has been enrolled for Phase I study of OTSA101 and the treatment initiated (Press release, OncoTherapy Science, JAN 21, 2020, View Source [SID1234553342]). This is a Phase I study to assess the safety of OTSA101 in Japanese patients with refractory, relapsed and/or advanced synovial sarcoma.

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In this study, the safety and pharmacokinetic profiles of radioisotope-conjugated OTSA101 will be evaluated in the synovial sarcoma patients.

OTSA101 is an anti-FZD10 chimeric monoclonal antibody. Frizzled homolog 10 (FZD10) was identified through genome-wide gene expression analysis by Yusuke Nakamura, a former professor in the University of Tokyo. FZD10 is a transmembrane protein which is highly expressed in synovial sarcoma but not in human normal vital organs. Radioisotope-conjugated OTSA101 was specifically accumulated in tumor tissue and showed strong anti-tumor effect in preclinical study, and it is being developed as a radioimmunotherapy (RIT) for synovial sarcoma. The investigatorinitiated Phase I study in France was completed with the favorable results about the primary objectives of this study, safety and bio-distribution profile. OTSA101 has been designated as an orphan drug against synovial sarcoma by European Medicines Agency (EMA) and Food and Drug Administration (FDA).

On January 20, 2020 Oasmia Pharmaceutical AB reported is launching its product, Apealea 60 mg, in Sweden, Denmark and Finland (Press release, Oasmia, JAN 20, 2020, View Source [SID1234556565]). The first batch of the drug has been shipped to distributors in these countries.

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Apealea is a patented, water-soluble, intravenously injectable formulation of paclitaxel, developed using Oasmia’s proprietary technology platform – XR17 – which facilitates the solubility of paclitaxel. Paclitaxel is a chemotherapy medication used to treat a number of types of cancers. Apealea has been authorized for marketing by the European Commission. Apealea in combination with Carboplatin is approved for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.

"The launch of Apealea in the Nordic countries enables therapeutic potential for patients in need of innovative cancer treatment. This is an important milestone for Oasmia in its transition towards becoming a fully integrated pharmaceutical company. As a second step, we intend to continue our efforts of engaging strategic partners for Apealea in other territories", comments Sven Rohmann, acting CEO of Oasmia.

"Oasmia has fulfilled all the regulatory requirements required for launch of the drug in the EU. The next intended step for us is to prepare for the submission for a regulatory approval from the United States Food and Drug Administration to obtain access to the U.S. market", says Nina Heldring, Chief Medical Officer at Oasmia.

Oasmia will participate as official sponsor of the 41st EORTC-PAMM Winter Meeting in Stockholm between February 13th – 15th 2020. The Winter Meeting is organized under the umbrella of the European Organization for Treatment of Cancer (EORTC) intended to provide opportunities for interdisciplinary and international exchange of knowledge on optimizing cancer treatment.

On January 20, 2020 University of Pennsylvania (Penn) and Applied Cells Inc., a Santa Clara, California based biotechnology company, reported that they have entered into a Collaborative Research Agreement to evaluate Applied Cells new generation cell isolation and sample preparation system, "MARS", in cancer and immunology research at Penn (Press release, University of Pennsylvania, JAN 20, 2020, View Source [SID1234553351]).

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Applied Cells proprietary innovative MARS platform, short named after "Multi-physics Automated Reconfigurable Separation", is ideal for high-throughput, high-efficiency, high-recovery, automated cell separation and sample preparation. Modular design of MARS allows flexible configurations to meet versatile workflows for rare cell analysis, immune cell profiling, and cell therapy, with capabilities including target cell enrichment, cell purification, and cell concentration.

"We are excited by the opportunity to evaluate the MARS instrument from Applied Cells, as if we are successful, it will allow us to identify rare populations for diagnostic markers and potentially isolate new cellular therapeutics," said Jonni Moore, PhD, Professor of Pathology and Laboratory Medicine at the Hospital of the University of Pennsylvania. "Applied Cells MARS system could be a powerful companion to our cell isolation and identification technologies, and we are very excited by this prospect."

"Applied Cells is bringing benefit to our customers by enabling successful isolation of target cells from complex blood and tissue samples for broad downstream analysis platforms," said Yuchen Zhou, Founder and CEO of Applied Cells. "Teaming up with Penn, a world leader in medical research and modern medicine, enables us to bring our leading-edge products into the hands of researchers at the forefront of advanced medicine discoveries, and help them achieve their goals more quickly and bring greater value to our society as whole."

On January 20, 2020 Transcenta Holding Limited ("Transcenta"), a global biotherapeutics company with fully-integrated capabilities in discovery, R&D and manufacturing of antibody-based therapeutics, reported that an investigational new drug (IND) application of its humanized Claudin 18.2 (CLDN18.2) monoclonal antibody (also known as TST001 internally) for the treatment of solid tumors submitted by its Suzhou subsidiary Mabspace Biosciences has been accepted by the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) of China (Press release, Transcenta, JAN 20, 2020, View Source [SID1234553350]). The IND enabling CMC work was done in its Hangzhou subsidiary HJB. TST001 is the first program developed by Transcenta since merger and it took less than 12 months from the identification of preclinical candidate to IND filing.

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TST001 is a humanized mAb targeting CLDN18.2, which is strictly expressed by the differentiated epithelial cells of the gastric mucosa in normal tissues and typically overexpressed in gastroesophageal cancer, pancreatic cancer, and other solid tumors. TST001 mainly kills tumor cells by antibody-dependent cellular cytotoxicity (ADCC). TST001 displayed significantly higher binding affinity to CLDN18.2 relative to a competitor molecule, lower fucose content, binds to a different binding epitope, which resulted in over 100-fold improved ADCC activity in tumor cells with varying CLDN18.2 expression, especially in CLDN18.2 low expressing tumors.

"We are very glad to be able to file the first IND at the anniversary of our merger. The advantage with an integrated platform is fully reflected in this program. TST001 provides us an important opportunity to target not only first line gastric cancer with Claudin18.2 expression, which are highly prevalent in Asia, but also several other globally prevalent tumor types with CLDN18.2 expression. These tumors, usually neither PDL1 positive nor responsive to checkpoint inhibitors, are an area of significant unmet medical needs. The development of TST001 will be guided by a novel companion diagnostic antibody developed by Transcenta which only binds CLDN18.2 but not CLDN18.1, a closely related isoform expressed in normal lung tissue. The US IND filing will be followed shortly. We look forward to expediting the development of TST001 to bring more effective treatment to a large number of cancer patients," said Xueming Qian, Transcenta’s Co-Founder and Chief Executive Officer.