On March 28, 2017 GeneQuantum Healthcare (Suzhou) Co., Ltd., a high-tech company focused on the research and development of innovative Bio-therapeutics, reported the completion of a RMB40 million (equal to approximately $5.8 million) Series A financing (Press release, GeneQuantum Healthcare, MAR 28, 2017, View Source [SID1234553995]). The lead investor is Oriza Seed Venture Capital ("Oriza Seed"), joined by TF Capital.

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GeneQuantum was founded in August 2013 at Suzhou Industrial Park, and has built-up a world-class bio-conjugation technology platform, focusing on developing series of next generation anti-tumor Antibody-Drug-Conjugates (ADCs) with best-in-class potential. Securing this round of financing will significantly promote the development of current ADC candidates towards IND filling in both US and China, meanwhile further expanding the company’s product pipeline.

"GeneQuantum’s innovative Ligase Dependent Conjugation (LDC) technology, combined with IP protected Automatic On-line Monitoring Conjugation System and Linker Screening & Optimization Facility, provide a holistic solution for the R&D of next generation ADCs," said Dr. Gang Qin, Founder and CEO of GeneQuantum. "In comparison with ADCs produced via conventional technologies, drug candidates generated from the unique LDC platform have shown a drastically enlarged therapeutic window. We believe this will ensure GeneQuantum’s leading role in the field of bio-conjugation therapeutics development. It is our honor to have the acknowledgement and support from Oriza Seed and TF Capital, senior biopharmaceutical investment agencies. This will not only provide us with the financial support needed for IND application, but also bring a wealth of resources. Anchored to our mission ‘Dedication to Innovation, Responsibility for Health’, we will stick to innovation and remain committed to continuously providing global cancer patients with better and safer therapeutics."

"Oriza Seed has been focusing on investing early stage pharmaceutical companies, for us, the most important features are the technology innovation capability of the core team and market potential of the products," said Eric Zhao, Partner of Oriza Seed. "We highly recognize the value of GeneQuantum’s innovative and unique bio-conjugation platform, and would like to facilitate bringing candidate drugs to clinical trials as soon as possible, eventually benefiting patients."

"Since the establishment of TF Capital, we have been dedicated to looking for pharmaceutical companies holding key technologies and a high competition barrier," said Kevin Chiang, CEO of TF Capital. "We are very positive on GeneQuantum’s innovative bio-conjugation technology and the core team’s drug development strategy. The highly effectiveness and persistence of the executive team deeply impressed us. We hope our industry resources will help to accelerate the product development process of GeneQuantum."

On March 28, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported that it has achieved pharmacokinetic and pharmacodynamic goals for CB-1158 which, under its agreement with Incyte Corporation, entitles the Company to receive a $12 million payment from Incyte (Press release, Calithera Biosciences, MAR 28, 2017, View Source [SID1234535253]).

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"We are very excited to achieve this early milestone under our collaboration with Incyte as CB-1158 has demonstrated the desired pharmacologic activity in humans, with a corresponding elevation in plasma arginine levels to those achieved with efficacious doses in preclinical models of cancer. Through our collaboration with Incyte, we will continue to evaluate the role of arginase inhibition in the immuno-oncology setting with CB-1158 and we expect to present additional clinical data mid-2017," said Susan Molineaux, President and Chief Executive Officer of Calithera Biosciences.

In January, 2017, Calithera and Incyte established a global collaboration and license agreement for the research, development and commercialization of Calithera’s first-in-class, small molecule arginase inhibitor CB-1158 in hematology and oncology. CB-1158 is currently being studied in a monotherapy dose escalation clinical trial and also in combination with anti-PD-1 therapy. Additional studies are expected to evaluate CB-1158 in combination with other immuno-oncology agents. About Arginase Arginase is an enzyme produced by immunosuppressive myeloid cells, including myeloid-derived suppressor cells (MDSCs) and neutrophils, which prevents T-cell and natural killer (NK) cell activation in tumors. Arginase exerts its immunosuppressive effect by depleting the amino acid arginine in the tumor microenvironment which subsequently prevents activation and proliferation of the immune system’s cytotoxic T-cells and NK-cells. Inhibition of arginase activity reverses this immunosuppressive block and restores T-cell function. In preclinical models, arginase inhibition has been shown to enhance anti-tumor immunity and inhibit tumor growth.

On March 27, 2017 Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") reported that the top-line results of a Japanese Phase 3 study of ARQ 197 (generic name: tivantinib) did not meet its primary endpoint (Press release, Kyowa Hakko Kirin, MAR 27, 2017, View Source [SID1234518280]).

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JET-HCC is a randomized, double-blind placebo-controlled study in Japan, to evaluate the efficacy and safety of tivantinib in the patients with c-Met diagnostic-high inoperable hepatocellular carcinoma with a history of prior sorafenib therapy.

The primary endpoint is progression-free survival (PFS), and the top-line results did not show a significant difference in PFS, between the tivantinib group and the placebo group. In terms of safety, the results showed that the safety profiles were similar as previously observed, and a novel safety issue was not found.

The details of the study results will be presented at upcoming scientific congresses and/or in scientific journals.

"I sincerely thank all of the patients, their families, and all of the personnel who contributed to completing this Japanese study of tivantinib." said Mitsuo Satoh, Executive Officer, Vice President, Head of R&D Division of Kyowa Hakko Kirin. "The result was disappointing, but Kyowa Hakko Kirin has gained great experiences in oncology fields through this study."

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

＜Outline of the study design＞ Target disease Patients with c-Met diagnostic-high inoperable hepatocellular carcinoma with a history of prior sorafenib therapy,
Design Multi-center, randomized, double-blind, placebo-controlled study
Dose One tablet of the study drug (tivantinib 120 mg, or placebo) is daily administered to the subjects of each group twice in a day
Subject Number approximately 190
Primary endpoint Progression-free survival
Study Location Japan

About ARQ197 (tivantinib)
Tivantinib, an oral agent whose molecular target is c-MET, was discovered by ArQule, Inc. (NASDAQ: ARQL). Kyowa Hakko Kirin signed a license agreement with ArQule for the exclusive rights to the development and sales of tivantinib in Japan and some parts of Asia (China, Korea, and Taiwan) on April 27th, 2007. News Release

About c-Met
c-Met is receptor tyrosine kinase. When abnormally activated, the c-Met receptor tyrosine kinase plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis.

On March 27, 2017 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported an update to the progress of its patent portfolio development (Press release, Xenetic Biosciences, MAR 27, 2017, View Source [SID1234537803]).

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Since 2014, the Company has broadened its patent portfolio geographically, into key markets including areas of Europe, Asia and North America, including the United States. Current patents include the manufacturing and conjugation chemistry of Xenetic’s PolyXen platform technology for creating proprietary, next-generation protein therapeutics by attaching polysialic acid ("PSA"), a biodegradable polymer found in living systems, to existing protein or peptide therapeutics, which can improve their pharmacological properties. Xenetic has also successfully obtained patent coverage for its proprietary polysialated protein therapeutics in the United States and globally.

M Scott Maguire, Xenetic’s Chief Executive Officer, stated, "Our focus remains on delivering shareholder value by leveraging our PolyXen platform technology with additional collaborations like our deal with Shire PLC on their SHP656 program, and advancing our lead product in clinical development, XBIO-101, for the treatment of endometrial cancer and triple negative breast cancer. We have worked diligently to continue to build our robust patent estate which includes 200 issued patents in order to provide substantial coverage for potentially safe and well tolerated therapy options for patients across a variety of indications."

Xenetic’s IP for its PolyXen technology platform provides protection on average into 2027 – 2029.

About PolyXen

PolyXen is a patent-protected platform technology for creating proprietary, next-generation protein therapeutics by attaching polysialic acid ("PSA"), a biodegradable polymer found in living systems, to existing protein or peptide therapeutics, which can improve their pharmacological properties.

Attachment of PSA ("polysialylation") to a therapeutic increases its apparent size, which reduces systemic clearance rates, while shielding the protein from other degradation pathways. The PolyXen platform permits optimization of a target therapeutic’s pharmacological properties, by controlling the amount, size, and sites of attachment of the PSA polymers.

In clinical and preclinical settings, therapeutic proteins polysialylated with the PolyXen platform have been shown to have extended circulating half-life, improved thermodynamic stability and resistance to proteases, while retaining pharmacological activity. Numerous human clinical trials to date have shown no evidence of PSA- induced immunogenicity.

Selecta Biosciences has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Selecta Biosciences, 2018, MAR 27, 2017, View Source [SID1234524635]).

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