On July 10, 2018 CSPC Pharmaceutical Group Limited (the "Company") is reported that the Company has entered into a product co-development and strategic collaboration agreement (the "Agreement") with Shanghai Junshi Biosciences Co., Ltd. ("Junshi") in relation to the clinical development, registration and commercialization of PD-1 (the anti-PD-1 monoclonal antibody exclusively supplied by Junshi) in combination with albumin-bound paclitaxel for the treatment of breast cancer (the "Product") (Press release, CSPC Pharmaceutical, JUL 10, 2018, View Source [SID1234532266]).

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Pursuant to the Agreement, the Company and Junshi shall form a joint research committee to (1) formulate clinical strategy for the development of the Product; (2) establish and monitor the clinical trials timeline and progress; (3) ensure the full access of clinical data by both parties; (4) discuss and make decision on combination studies of PD-1 with albumin-bound paclitaxel and other chemotherapeutic agents; and (5) resolve any issues that arise during the process of the development and registration of the Product.

The Company shall be responsible for (1) designing and executing clinical trials for the Product; (2) supplying albumin-bound paclitaxel to conduct clinical trials of the Product in the People’s Republic of China (including Hong Kong, Taiwan and Macau) (the "Territory"); (3) applying and securing approval of the Product in the Territory; and (4) commercialization of the Product in the Territory.

Junshi shall be responsible for (1) securing approval of PD-1 single entity in the Territory; (2) supplying PD-1 for the Company to conduct clinical trials for the Product in the Territory; (3) supplying PD-1 to the Company for sales of the Product in the Territory according to a supply agreement to be mutually agreed between the parties.

Junshi grants to the Company a royalty-bearing exclusive license to commercialize the Product in the Territory for a term commencing from the date of the Agreement until 20 years from the receipt of the relevant regulatory approval in the Territory (the "Term"), which allows the Company during the Term to (1) perform clinical and non-clinical studies of the Product; (2) apply for and obtain approvals of the Products in the Territory; and (3) market and sell the Product in the Territory.

Junshi and its affiliates shall not grant any right or license of its PD-1 to any third party for the purpose of development and commercialization of the Product in the Territory. The Company and its affiliates shall only collaborate with Junshi to develop and commercialize the Product.

The Company agrees to pay to Junshi a milestone payment of RMB30,000,000 at each of the five milestone events (i.e. up to an aggregate of RMB150,000,000) leading to the product approval and issuance of product licence by the China Drug Administration for the Product.

All intellectual property rights related to the Product, to the extent solely discovered, invented or developed under the Agreement, shall be jointly owned by the Company and Junshi.

On July 10, 2018 Aravive Biologics, Inc. reported that the company has completed both the single ascending dose and repeat dose portions of its Phase 1 study of AVB-S6-500 in healthy volunteers (Press release, Aravive Biologics, JUL 10, 2018, View Source [SID1234528276]).

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The study met the safety and tolerability endpoints for the trial. As previously announced, the study also demonstrated clinical proof-of-mechanism for AVB-S6-500 in neutralizing GAS6, based on analysis of the single ascending dose portion of the study which demonstrated a dose-dependent decrease in measurable, circulating free GAS6 in serum. Aravive plans to submit full results of the study for potential presentation at a major medical meeting later in 2018. Also during the second half of 2018, the company expects to initiate the Phase 1b portion of a Phase 1b/Phase 2 trial combining AVB-S6-500 with standard-of care-therapies in patients with platinum-resistant ovarian cancer.

Elevated GAS6 levels have been associated with poor prognosis in cancer. As a decoy molecule, AVB-S6-500 has been shown to neutralize GAS6 activity by binding to that molecule with very high affinity. In doing so, AVB-S6-500 selectively inhibits triggering of the GAS6-AXL signaling pathway. In preclinical studies, GAS6-AXL inhibition has shown activity, whether achieved by a single agent (including AVB-S6-500) or through combinations of a variety of anticancer therapies including radiation therapy, immuno-oncology agents, and drugs that affect DNA replication and repair. Inhibition of the GAS6-AXL pathway has also shown potential as a strategy for the treatment of certain fibrotic diseases.

"We are pleased with the positive outcome of this first study of AVB-S6-500 in humans. The results not only demonstrated initial safety and tolerability for this therapeutic candidate but clearly showed a dose-related reduction of circulating free GAS6, a measurement that we anticipate will be highly useful as a biomarker of drug activity in future clinical studies," said Gail McIntyre Ph.D., DABT, Senior Vice President of R&D at Aravive. "We look forward to our anticipated initiation of the Phase 1b portion of our planned Phase 1b/Phase 2 studies in ovarian cancer during the second half of this year, which are designed to evaluate the anti-cancer effects of lowering of GAS6 in patients with ovarian cancer."

On July 10, 2018 Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of genes, reported that it will host a key opinion leader (KOL) breakfast symposium focused on the unmet need, treatment landscape and opportunity for new combination approaches in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) from 8:30-10:30 a.m. ET on Tuesday, July 17, 2018 in New York City (Press release, Syros Pharmaceuticals, JUL 10, 2018, View Source [SID1234527702]). Syros is currently evaluating SY-1425, its first-in-class, selective retinoic acid receptor alpha (RARα) agonist, in a Phase 2 clinical trial in combination with standard-of-care and targeted therapies in genomically defined subsets of AML and MDS patients.

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The event will feature presentations from Rachel J. Cook, M.D., M.S., Assistant Professor of Medicine and Site Director for Acute Leukemia at the Knight Cancer Institute, Oregon Health and Science University and Eytan M. Stein, M.D., Assistant Professor of Medicine; Leukemia Service, Department of Medicine at Memorial Sloan Kettering Cancer Center. Additionally, members of Syros’ management will provide an overview of SY-1425 and review preclinical and clinical data supporting its combination strategy with SY-1425.

A live webcast of the event will be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following each presentation.

On July 10, 2018 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ:APTO) (TSX:APS), reported that the Japan Patent Office has issued Japanese Patent No. 6325573 for CG-806 (Press release, Aptose Biosciences, JUL 10, 2018, View Source;p=RssLanding&cat=news&id=2357553 [SID1234527629]). The granted patent claims various compounds, including the CG-806 compound, pharmaceutical compositions comprising the CG-806 compound, and uses for the treatment of various diseases, such as cancer. The patent is expected to provide protection until the end of 2033.

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"This newly issued patent extends the CG-806 patent protection into an important market and is a welcome addition to the US patent that was issued last year," stated Dr. William G. Rice, Chairman, President and Chief Executive Officer of Aptose. "As noted previously, we plan to continue expansion of the patent portfolio through additional findings and applications."

About CG-806

CG-806 is an oral, first-in-class pan-FLT3/pan-BTK multi-kinase inhibitor. This small molecule demonstrates potent inhibition of wild type and mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), eliminates acute myeloid leukemia (AML) tumors in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with AML. Likewise, CG-806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser mutant forms of the BTK enzyme, as well as other oncogenic kinase pathways operative in B cell malignancies, suggesting CG-806 may be developed for various B cell malignancy patients (including CLL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent BTK inhibitors.

On July 10, 2018 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies against cancers and infectious diseases, signed a series of agreements with Tasly Biopharmaceuticals Co., Ltd. ("Tasly Biopharmaceuticals") involving T601 and T101, two immunotherapeutics developed by the Transgene-Tasly joint venture in China (Press release, Transgene, JUL 10, 2018, View Source [SID1234527652]). These products incorporate Transgene’s TG6002 and TG1050 technologies, respectively. As a result of these agreements Transgene will receive shares in Tasly Biopharmaceuticals valued at $48 million. These agreements are designed to further deliver the potential of Transgene’s virus-based technologies in China.

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Philippe Archinard, Chairman and Chief Executive Officer of Transgene, added: "We are delighted to have signed these strategic agreements that create value for Transgene through our share ownership in Tasly Biopharmaceuticals and demonstrate the significant potential of the oncolytic virus T601 and therapeutic vaccine T101 in China. As a long-standing partner of the Tasly group, Transgene will remain involved in the further development of these products in China. We look forward to the first readout of the ongoing Phase 1 trial evaluating T101 against chronic hepatitis B, which is expected early 2019. In addition, a Phase 1 trial with the oncolytic virus T601 in China is actively being prepared."

Kaijin Yan, Holding Group Executive Chairman of the Board of Tasly Pharmaceuticals, commented: "Our mission is to become a world-leading biotechnology company, dedicated to continuously offer high-quality and affordable drugs to patients. These new strategic agreements with Transgene provide us with the full development and commercial rights to T601 (through 100% ownership of the joint venture) and T101 in Greater China and will allow us to build a broad innovative product portfolio. We are very happy to welcome Transgene as a key supportive shareholder of Tasly Biopharmaceuticals."

Structure of the transactions
Transgene is transferring its 50% share of the current Transgene-Tasly joint venture (Transgene Tasly (Tianjin) BioPharmaceutical Co., Ltd.) to Tasly Biopharmaceuticals, making it the 100% owner of the joint venture entity and the greater China patent rights to T601.
In parallel, Transgene is assigning the T101 patent rights in Greater China, to which the joint venture held an option, directly to Tasly Biopharmaceuticals.
As a result of these transactions, which are subject to customary closing conditions including completion of the administrative transfer of the assets contributed by Transgene to Tasly Biopharmaceuticals, Tasly Biopharmaceuticals will control all research, development and commercial rights to T601 and T101 in Greater China. In return, Transgene is receiving an aggregate of $48 million in newly created Tasly Biopharmaceuticals shares, representing 2.53% of the Tasly Biopharmaceuticals capital post completion of the Tasly Biopharmaceuticals’s pre-IPO investment round which priced simultaneously with Transgene’s transactions. Tasly Biopharmaceuticals has announced its intention to list its shares on the Hong Kong Stock Exchange.

Lazard and the Adamas law firm advised Transgene on the transaction.

A conference call in English is scheduled on July 10th at 4:00 p.m. CET.