On August 27, 2018 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported it has commenced Stage 2 of the company’s Phase 2 trial of prexigebersen in acute myeloid
leukemia (Press release, Bio-Path Holdings, AUG 27, 2018, View Source [SID1234529151]).

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The open-label Phase 2 study is evaluating the efficacy and safety of prexigebersen in conjunction with LDAC, a therapeutic regimen well established in treatment of AML patients who cannot or elect not to be treated with more intensive chemotherapy. The primary objective of the study is to determine whether the combination of prexigebersen and LDAC provides greater efficacy than would be expected with LDAC alone in this de
novo patient population.

"We are delighted to announce the expansion of our ongoing Phase 2 clinical trial of prexigebersen for the treatment of acute myeloid leukemia using a dosing schedule that administers a greater amount of prexigebersen to the patient prior to commencing LDAC dosing than in the first part of the trial. Based on compelling new data, we are also
including a cohort of patients who will be treated with a combination of prexigebersen and decitabine," said Peter Nielsen, President and Chief Executive Officer of Bio-Path. "Results from the planned interim analysis of the first part of this Phase 2 study were particularly encouraging, with 47% of treated patients demonstrating a response. Consequently, we remain enthusiastic about prexigebersen’s potential and believe these protocol changes
will optimize the drug’s impact in AML cancer patients with high unmet need."

Based on recommendations from the study’s principal investigators, the Company amended the study’s protocol to change the dosing schedule in Stage 2 to that used in the Phase 1b study in relapsed and refractory AML patients as announced in April 2018. In the Phase 1b study, a greater amount of prexigebersen was administered prior to LDAC
treatment starting at day 10 versus LDAC treatment starting on day four as was the case in Stage 1 of the current Phase 2 study. Importantly, Stage 2 of the study includes a cohort of patients treated in combination with decitabine based on relatively new and positive data with this compound. Bio-Path plans to perform an interim analysis of each cohort once approximately 19 evaluable patients are reached in the cohort.

As previously announced, a planned interim analysis of Stage 1 of the study was performed on 17 evaluable patients, with four patients achieving complete responses and four patients achieving stable disease, including one patient achieving a morphologic leukemia free state and one patient who showed significantly reduced bone marrow blasts. In total, 47% of the evaluable patients showed some form of response, including stable disease, to
the combination treatment. The average patient in Stage 1 of the study was 73.5 years of age

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 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 24, 2018 RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases, reported that it will report its second quarter 2018 financial results on Thursday, August 30, 2018 (Press release, RedHill Biopharma, AUG 24, 2018, View Source [SID1234529054]).

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The Company will host a conference call on Thursday, August 30, 2018 at 8:30 a.m. EDT to review the financial results and business highlights.

To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-800-263-0877; International: +1-646-828-8143; and Israel: +972-3-721-9463. The access code for the call is: 9460445.

The conference call will be broadcast live and will be available for replay on the Company’s website, View Source, for 30 days. Please access the Company’s website at least 15 minutes ahead of the conference call to register, download and install any necessary audio software.

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]