On August 26, 2018 Harbour BioMed reported that it has completed a Series B round financing of $85 million to accelerate the growth of its innovative therapeutic pipeline, including both clinical and discovery stage programs (Press release, Harbour BioMed, AUG 26, 2018, View Source [SID1234529067]). GIC Private Limited, Singapore’s sovereign wealth fund, led the financing round, with participation from new investors, including China Life Private Equity Investment Company and Vertex Ventures, and Series A investors AdvanTech and Legend Capital

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"During the one and half years since we established operations, Harbour has successfully expanded its network of collaborations for its core transgenic mouse technologies, rapidly built an innovative pipeline through internal discovery and in-licensed development stage programs in the areas of oncology and immunology, and established an experienced and professional team," said Dr. Jingsong Wang, the Founder, Chairman and CEO of Harbour BioMed. "The financing is a very strong vote of confidence by our new and existing investors in our vision for the company, strategy, progress to date and our team. With their continued support, we will accelerate the growth and advancement of our pipeline through both internal innovation and external collaboration."

Harbour BioMed was established in December 2016 around a Series A round of $50 million and the acquisition of the Netherlands-based fully human transgenic antibody technology company, Harbour Antibodies BV and its subsidiaries. The company has integrated the Harbour Mice technologies into its newly built antibody technology and discovery biology, preclinical and clinical development operations, entered into multiple license and collaboration agreements for its Harbour Mice, and established an innovative therapeutic pipeline based on internal discovery and in licensing activities. In early 2018 Harbour raised an A+ Round from CDH and AdvanTech to support its in-licensed clinical programs for Greater China. Harbour’s development programs include:

An anti-FcRn based antibody against multiple autoimmune diseases, including myasthenia gravis and neuromyelitis optica, and a biologic against inflammatory dry-eye disease, among other potential indications. Harbour, which in-licensed these assets in 2017, is developing them for the Greater China market. Harbour recently filed two INDs for three different indications in China to conduct clinical trials with these assets.
A CD3-based bi-specific antibody therapy against Her-2 overexpressed cancer in clinical development, acquired in August 2018, which Harbour is developing for the Greater China market.
A clinical stage, anti-PD-L1 antibody for the treatment of multiple solid tumors and hematological cancers, acquired in August 2018, that Harbour is developing worldwide outside of China.

On August 26, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported the acceptance by the China Drug Administration (CDA) of a new drug application (NDA) for zanubrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL) (Press release, BeiGene, AUG 26, 2018, View Source;p=irol-newsArticle&ID=2364823 [SID1234529065]). Zanubrutinib was discovered in BeiGene’s research facilities in Beijing, China, and is being developed globally by BeiGene as a monotherapy and in combination with other therapies to treat various hematologic malignancies.

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"We are proud of our team, and are appreciative of the clinical investigators and patients in China who made this first regulatory filing for zanubrutinib possible. This is BeiGene’s first NDA and is a significant milestone for our company. We look forward to additional regulatory submissions with zanubrutinib and with tislelizumab, our investigational anti-PD-1 antibody," commented John Oyler, co-founder, CEO and Chairman of BeiGene.

"We believe zanubrutinib is a potentially differentiated BTK inhibitor based on the depth and durability of responses observed in clinical trials of zanubrutinib to date. We are hopeful that zanubrutinib, if approved, may represent a valuable and important treatment option for patients in China with MCL," said Dr. Xiaobin Wu, General Manager of China and President of BeiGene, Ltd.

"We are excited that the CDA has accepted our new drug application of zanubrutinib for patients with MCL and that it is being reviewed as a Category 1 new drug submission, which is reserved for medicines that are going through their first worldwide regulatory review in China. We look forward to working with the CDA as it completes its thorough assessment of zanubrutinib," added Wendy Yan, Global Head of Regulatory Affairs at BeiGene.

The NDA is supported by an extensive clinical and non-clinical data package, including the results from an 86-patient single-arm pivotal Phase 2 study in Chinese patients with relapsed or refractory MCL treated with zanubrutinib, dosed at 160 mg orally twice daily. An independent review of response data from this study showed overall response rate (ORR) of 84 percent, including 59 percent of patients who achieved a complete response. With 8.3 months median follow-up, the median duration of response has not been reached, as a majority of the responders remain in a response. The safety profile was consistent with previously reported clinical data for zanubrutinib. Full results of the study are planned to be presented at an upcoming medical conference.

Zanubrutinib is being studied in several clinical trials as part of a broad development program and was recently granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Waldenström macroglobulinemia (WM). BeiGene plans to submit an NDA to the FDA for zanubrutinib as a potential treatment for patients with WM in the first half of 2019 based on results from a global Phase 1 study.

In addition to the global Phase 1 trial of zanubrutinib, it is also being evaluated in a fully-enrolled, global Phase 3 clinical trial in patients with WM comparing zanubrutinib to ibrutinib, the currently approved BTK inhibitor for WM. Zanubrutinib is also being studied in a global Phase 3 clinical trial in patients with previously untreated chronic lymphocytic leukemia (CLL) and a pivotal Phase 2 trial in patients with relapsed/refractory follicular lymphoma in combination with GAZYVA (obinutuzumab). In China, BeiGene has completed enrollment in two other pivotal Phase 2 clinical trials of zanubrutinib in patients with CLL and WM, respectively. BeiGene also plans to initiate a Phase 3 trial comparing zanubrutinib to ibrutinib in patients with relapsed/refractory CLL/small lymphocytic lymphoma (SLL). As of August 2018, more than 1,500 patients have been enrolled in the zanubrutinib clinical development program.

About Mantle Cell Lymphoma
Lymphoma is a diverse group of malignancies that originates from B, T or NK cells. Mantle cell lymphoma (MCL) is typically an aggressive form of non-Hodgkin lymphoma (NHL) that arises from B cells originating in the "mantle zone." In 2013, the incidence of lymphoma was 4.2 per 100,000 and the mortality was 2.2 per 100,000 in mainland Chinai, making it the eleventh most common cancer and the tenth leading cause of cancer death.ii Mantle cell lymphoma usually has a poor prognosis, with a median survival of three to four years, although occasional patients may have an indolent course.iii Frequently, mantle cell lymphoma is diagnosed at a later stage of disease.

About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) that is currently being evaluated in a broad pivotal clinical program globally and in China as a monotherapy and in combination with other therapies to treat various B cell malignancies.

On August 24, 2018 Beijing Percans Oncology Co., Ltd. reported that released a blockbuster new product, a new generation of tumor cell culture products based on conditional reprogramming [1] (CR ) technology, aiming to developing customized " In Vitro Detection Kit for i-CR Primary Tumor Cell Culture " for enterprises, hospitals, and scientific research institutions (Press release, Cothera Bioscience, AUG 24, 2018, View Source [SID1234618855]). This new testing product can performdirect tumor cell drug susceptibility testing, and the results are more intuitive and can help discover new effective cancer drugs.

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CR cell culture technology

For a long time, culturing tissue cells in vitro and constructing pre-clinical models have been important methods in biomedical reseearch. Cell models can help scientists not only with better understandings of molecular mechanisms and causes of diseases, but also in drug discovery and the development of new therapies. CR (Conditional Reprogramming) technology is the only proven system in the field that can cultivate normal and diseased cells without restriction, while retaining the genotype and phenotype of thecells.The method can preserve the full characteristics of cancer cells, which is critical for the construction of tumor models.

Breaking through technical barriers – i-CR tumor cell culture system

In the past two years, Percans Oncology has completed two rounds of financing, which has accelerated its development in the field of cancer detection. Improved on CR technology, Percans Oncology’s innovation goes a step further. With the ability to control which type of cells, tumorous or normal, are being cultivated, the technology can effectively eliminate the signal noise generated by normal cells, therefore greatly improving the testing accuracy and efficiency.

After extensive gathering of opinions and suggestions fromnumerous clinicians and medical research experts, and accumulating huge amount of stability test data, Percans Oncology has strived to build an accurate "i-CR primary tumor cell culture" detection system to help with customers’need for efficient and affordable research projects, including construction of primary tumor cell banks,performing accurate pharmacological analysis and efficacy testing for individualized therapies and carrying out novel oncological studies.

"i-CR Tumor Primary Cell Culture Detection Kit" uses standardized laboratory consumables and simplifies the operating procedures (from the preservation of tumor tissues to the preparation, isolation, culture of primary tumor cells, and the final quantitative detection method), which in turn helps to ensure the consistency of test results. In addition, the "i-CR Tumor Primary Cell Culture Detection Kit" will continue to expand the analysis menu and improve detection performance to broadly cover the needs of more cancer types.

On August 24, 2018 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast its management presentation at the Morgan Stanley 16th Annual Global Healthcare Conference at 9:55 a.m. Eastern Time on Wednesday, September 12, 2018 (Press release, Regeneron, AUG 24, 2018, View Source [SID1234529070]).

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The session may be accessed from the "Investors & Media" page of Regeneron’s website at View Source A replay of the webcast will be archived on the Company’s website and will be available for 30 days.

On August 24, 2018 Kiadis Pharma N.V. ("Kiadis Pharma" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing a T-cell immunotherapy product candidate designed to reduce Graft versus Host Disease (GVHD) and relapse after hematopoietic stem cell transplantations (HSCT), reported that it will be announcing Financial Results for the six months ended June 30, 2018 at 7:00am CEST on Friday, August 31, 2018 (Press release, Kiadis, AUG 24, 2018, View Source [SID1234529064]).

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For more information, please contact:

Kiadis Pharma:

Karl Hård, Head of IR & Communications
Tel. +31 611 096 298
[email protected]

Optimum Strategic Communications:

Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 203 714 1787
[email protected]