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 Adlai Nortye Biopharma Co., Ltd. ("Adlai Nortye" or "the Company"), a biopharmaceutical company dedicated to discovering and commercializing new drugs in the field of oncology/immuno-oncology, announced today that it has entered into a Global License Agreement ("the Agreement") with Novartis Pharma AG, a global pharmaceutical company (Press release, Adlai Nortye Biopharma, JUL 10, 2018, View Source [SID1234556283]). Under the terms of the Agreement, except for certain rights maintained by Novartis Pharma AG, Adlai Nortye will have exclusive development and commercialization rights to buparlisib worldwide for all the therapeutic, prophylactic and/or diagnostic uses in humans.

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Buparlisib (BKM120) is an oral pan-PI3K inhibitor that targets all class 1 PI3K isoforms and is active in both hematologic malignancies and solid tumors. It has shown promising efficacy in combination with paclitaxel in head and neck squamous cell carcinoma (HNSCC) and has received a Fast-Track designation from the FDA.

"Combination of buparlisib and paclitaxel demonstrated improved clinical efficacy with a manageable safety profile in patients with HNSCC compared to paclitaxel alone," said Dr. Lars Birgerson, Chief Development Officer of Adlai Nortye and President & CEO of Adlai Nortye USA Inc. "We believe that buparlisib will be another key component in furthering development of our oncology pipeline, and it has great potential for future application in cancer treatment."

"Buparlisib has been extensively profiled in breast cancer and other tumor types. Buparlisib when combined with other therapies has shown impressive anti-cancer efficacy in HNSCC," said Carsten Lu, CEO of Adlai Nortye, "It has very good market prospects when combined with paclitaxel, and we are planning to carry out clinical trials of combination of buparlisib and immune check point inhibitor treatment."

On July 9, 2018 VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that the company will participate in the Oppenheimer Boston Oncology Insight Summit July 10 – 11, 2018 (Press release, VBI Vaccines, JUL 9, 2018, View Source [SID1234527621]). The two-day summit will feature a series of discussions with primary investigators at the Whitehead Institute in Cambridge, Massachusetts, followed by one-on-one meetings with institutional investors at the Four Seasons Hotel in Boston, MA.

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Event Details
Event: Oppenheimer Boston Oncology Insight Summit
Dates: July 10 – 11, 2018
Location: Boston, MA
Event Website: View Source

On July 9, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, reported that ClinicalTrials.gov has updated its website to now include OncBioMune’s Phase 2 clinical trial evaluating ProscaVax as the first ever therapeutic vaccine for prostate cancer patients in the active surveillance group (Press release, Oncbiomune, JUL 9, 2018, View Source [SID1234527803]). The trial is being hosted at Beth Israel Deaconess Medical Center, a teaching hospital of Harvard University Medical School in Boston, MA, and includes the Dana-Farber Cancer Institute.

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ProscaVax is OncBioMune’s lead immunotherapy platform candidate consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).

The study will evaluate the safety and efficacy of ProscaVax in patients with localized prostate cancer. The goal of the study is to determine if ProscaVax administration results in a change in the rate of prostate cancer progression when compared to a no-treatment control group of active surveillance patients. Active surveillance is a disease management option for patients with localized prostate cancer that elect to work with their doctor to monitor the disease for progression before taking more drastic intervention measures, such as surgery or radiotherapy.

Details on the trials can be viewed at: View Source

"The initiation of this study represents a milestone moment for our company, shareholders and the more than 160,000 men that will learn they have prostate cancer this year," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "For the first time ever, prostate cancer patients in the trial will have a therapeutic vaccine as an option rather than waiting for disease progression or jumping into more invasive treatments options that frequently are accompanied by very unpleasant side effects, such as urinary incontinence and impotence. We look forward to the commencement of enrollment and to the future where we will learn more about the efficacy of ProscaVax as a front-line treatment for prostate cancer."

Sign up for OncBioMune email alerts at: View Source

About Prostate Cancer

According to the American Cancer Society (ACS), prostate cancer is the most common type of cancer in men other than skin cancer, with about 1 in 9 men diagnosed during their lifetime. ACS estimates that about 164,690 new cases of prostate cancer will be diagnosed during 2018 and approximately 29,430 men will die from the disease this year. Prostate cancer is the second leading cause of cancer death in men, trailing only lung cancer. Approximately 2.9 million men are living with prostate cancer today. The average age of diagnosis is 66, with the disease considered rare in men under the age of 40.

On July 9, 2018 Veracyte, Inc. (Nasdaq: VCYT) reported that it will report its second quarter 2018 financial results after the close of market on Monday, July 23, 2018 (Press release, Veracyte, JUL 9, 2018, View Source/news-releases/news-release-details/veracyte-host-conference-call-and-webcast-discuss-second-2 [SID1234527622]). Following the announcement, Veracyte will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The call may be accessed as follows:

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Veracyte Second Quarter 2018 Conference Call, July 23, 2018 at 4:30 p.m. ET

Website: View Source

Dial-in number (U.S.): (855) 541-0980

International number: (970) 315-0440
Conference ID: 7784825

The webcast replay will be available on the company’s website approximately two hours following completion of the call and archived on the company’s website.