On August 6, 2018 BioLineRx Ltd. (NASDAQ, TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported it will release its unaudited financial results for the quarter ended June 30, 2018 on Monday, August 13, 2018, before the US markets open (Press release, BioLineRx, AUG 6, 2018, View Source;itemid=619 [SID1234528445]).

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The Company will host a conference call on Monday, August 13, 2018 at 10:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

To dial into the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0664 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until August 16, 2018; please dial +1-877-456-0009 from the U.S. or +972-3-925-5937 internationally.

On August 3, 2018 Zenyaku Kogyo Co., Ltd. (Japanese-only website) and Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that Zenyaku filed an application for approval with the Ministry of Health, Labour and Welfare for the anti-CD20 monoclonal antibody RITUXAN injection 100 mg and 500 mg [generic name: rituximab (genetical recombination)] for the treatment of "CD20-positive chronic lymphocytic leukemia (CLL) (Press release, Chugai, AUG 3, 2018, View Source [SID1234528993]). RITUXIAN is co-marketed by the two companies in Japan.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Zenyaku received a request from the MHLW to develop RITUXAN for the treatment of CD20-positive CLL issued on April 6, 2012, as a result of the evaluation by the "11th Review Committee on Unapproved Drugs and Indications with High Medical Needs" held on March 23, 2012, and has been preparing to file for the addition of this indication. On March 20, 2018, the orphan drug designation was granted for RITUXAN for CD20-positive CLL as the estimated number of newly diagnosed CLL patient per year is about 400.

CLL is a disease in which small mature B lymphocytes proliferate monoclonally and proliferate in peripheral blood, bone marrow, lymph nodes and spleen, many of which progress slowly. This rare disease is mostly prevalent in elderly people, and considered as difficult to cure with current treatments while many patients often experience recurrence and progression repeatedly. The number of patients in Japan is small, reportedly about 0.3 to 100,000 people per year. The age of onset is typically over 50 years, and rarely seen in people under 30 years of age. In patients with CLL, the ratio of females to males is higher at about 1.5 or 2 to 1*.

Zenyaku and Chugai will continue to work for the early approval of the product to provide RITUXAN for CLL patients and medical professionals who are waiting for a new treatment option.

* Center for Cancer Control and Information Services. Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma View Source (Japanese only)

On August 3, 2018 IMPACT Therapeutics, Inc. (IMPACT), a China-based clinical-stage biopharmaceutical company dedicated to the discovery and development of "best-in-class" medicine for the treatment of cancer and other life-threatening diseases, reported the completion of $30 million in series C financing (Press release, Impact Therapeutics, AUG 3, 2018, View Source [SID1234528890]). The series C round was led by Decheng Capital (Decheng), with participation from existing investor Lilly Asian Ventures (LAV). Proceeds from the series will be used for the clinical development of IMP4297, a potential best-in-class PARP inhibitor, and to advance IMPACT’s integrated programs targeting DNA Damage Response (DDR).

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PARP inhibitors are targeted therapies for cancer patients with defects in DNA repair mechanisms, such as with BRCA1 and BRCA2 mutations. Three PARP inhibitors, which have been shown to be tolerable and effective in clinical studies, have already been approved for marketing outside of China. IMP4297 has demonstrated an excellent safety profile and good preliminary efficacy in phase I clinical trials in Australia and China, which is consistent with the high potency and large therapeutic window found in pre-clinical studies.

"We are grateful for the faith our new and existing investors have shown in us, and for sharing our vision of developing the best potential treatments for cancer patients with DNA repair defects," commented Dr. Ye Edward Tian, CEO of IMPACT. "Decheng and LAV are renowned global VC firms in the biomedical industry. With the capital and resources provided by Decheng and LAV, we will be able to advance the clinical development of IMP4297 and enrich our pipeline."

"IMPACT is committed to the discovery and development of best-in-class therapeutics to treat cancer and other life-threatening diseases. Our data indicates that IMP4297 could be more efficacious and/or less toxic than other PARP inhibitors currently in the market, making it a potential best-in-class drug," added Dr. Sui Xiong Cai, SVP and CTO of IMPACT. "With this series C financing, we are well-positioned to achieve key data milestones as we accelerate the clinical development of IMP4297, in the hope of bringing it to market and patients soon."

"IMP4297 has shown potential to be a best-in-class drug in both pre-clinical studies and clinical trials. IMPACT is an excellent Chinese company with products that can compete globally," said Dr. Xiangmin Cui, Founder and Managing Director of Decheng. "We are very happy to collaborate with the IMPACT team and to support IMPACT’s growth."

"IMPACT is advancing its IMP4297 program steadily," said Dr. Fei Chen, Managing Partner of LAV. "We have seen excellent results from the clinical trials of IMP4297. As an existing investor from the previous two rounds of financing, LAV will continue to support IMPACT with capital and resources."

About Decheng Capital

Founded in 2012, Decheng is a leading VC firm investing in the biomedical and healthcare sectors. With more than $1 billion in capital under management, Decheng provides financial and strategic support to entrepreneurs, innovators and startup companies to take advantage of opportunities in China’s fast-growing healthcare, biomedical and pharmaceutical industries. Well placed to capitalize on revolutionary breakthroughs in life-science innovation worldwide, Decheng has offices in Shanghai and Silicon Valley.

About Lilly Asia Ventures

Founded in 2008 and headquartered in Shanghai, LAV is a leading VC firm investing in the biomedical, pharmaceutical and medical devices/diagnostics industries. LAV provides early-to-growth-stage companies with capital, professional expertise and valuable resources. LAV has offices in northern California, Shanghai and Hong Kong.

On August 3, 2018 Oncolytics Biotech Inc. (Nasdaq: ONCY) (TSX: ONC), currently developing REOLYSIN (pelareorep), an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported financial results and operational highlights for the quarter ended June 30, 2018 (Press release, Oncolytics Biotech, AUG 3, 2018, View Source [SID1234528878]). All dollar amounts are Canadian unless otherwise noted.

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"The second quarter began with clinical updates at three scientific conferences and an agreement with the FDA for our Special Protocol Assessment, followed by the announcements of two combination studies with Merck’s Keytruda and culminated in the company’s relisting on Nasdaq," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "The immuno-oncology data we have presented at recent conferences, as well as the data we expect from recently announced studies supports the potential for combination with checkpoint inhibitors and other immunotherapy and anticancer agents as we broaden our pipeline to demonstrate the ultimate value of pelareorep. Our Nasdaq listing has already raised our profile with institutional investors focusing on biotech and we hope to see additional analyst coverage out of the U.S."

Selected highlights since April 1, 2018

Clinical Updates

Reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints and statistical analysis approach for the company’s phase 3 study evaluating pelareorep for the treatment of metastatic breast cancer.

Announced two combination studies with Merck’s Keytruda:

Investigating pelareorep in combination with Keytruda to treat second line pancreatic cancer patients. The study, run by Dr. Devalingham Mahalingam, will plan to enroll approximately 40 patients with advanced pancreatic cancer and will be conducted at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

Investigating pelareorep in combination with Keytruda, Velcade and dexamethasone to treat multiple myeloma patients. The study, facilitated by Dr. Kevin Kelly, Associate Professor of Clinical Medicine, will be conducted at the USC Norris Comprehensive Cancer Center.

Presented poster highlights from pelareorep studies at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting. The presentation demonstrated that pelareorep promotes the expression of gene signatures predictive of a response to immunotherapy in breast cancer and hepatocellular carcinoma and that the tumor inflammation promoting effects in breast cancer models provide a compelling explanation for the significant overall survival benefit in hormone receptor positive metastatic breast cancer patients in the phase 2, IND 213, study.

Presented posters highlighting data from pelareorep studies at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018. The presentations showed preclinical models demonstrating pelareorep increased PD-L1 expression in microsatellite stable (MSS) colorectal cancer cells (CRC) and demonstrated efficacy for pelareorep and anti-PD1 agent combination.

Presented positive pelareorep data in combination with Keytruda and anti-CD73 at the International Oncolytic Virus Conference 2018. The poster highlighted the effectiveness of pelareorep in combination with Keytruda and/or an anti-CD73 immunotherapy in prostate cancer cell lines.

Corporate Updates

Announced a share consolidation on the basis of 1 new common share for every 9.5 outstanding common shares.

Announced the listing of the company’s shares of common stock on the Nasdaq Capital Market and commenced trading on June 1, 2018, under the symbol "ONCY".

Closed an underwritten public share offering of 1,532,278 common shares at a purchase price of USD $5.83 for gross proceeds of approximately USD $8.9 million.

Expanded the clinical development team in San Diego, including Senior Medical Personnel.

Anticipated Milestones

Initiate a phase 2 window of opportunity study of pelareorep in combination with a checkpoint inhibitor and/or the standard of care in the neoadjuvant breast cancer setting in 2H 2018.

Initiate a phase 2 study in combination with Merck’s Keytruda in multiple myeloma in 2H 2018.

Initiate a phase 2 study in combination with Merck’s Keytruda in advanced pancreatic cancer in 2H 2018.

Data from window of opportunity study in mBC in 1H 2019.

Data from Keytruda combination study in multiple myeloma in 2H 2019.

Preliminary data from Keytruda combination study in advanced pancreatic cancer in 1H 2020.

Financial

At June 30, 2018, the company reported $18.7 million in cash and cash equivalents.

As at August 2, 2018, the company had an unlimited number of authorized common shares with 16,531,956 common shares issued and outstanding, 16,443,500 warrants exercisable into 1,730,894 common shares with a $9.025 strike price and 1,153,080 options and share units.

About REOLYSIN/Pelareorep
REOLYSIN, also known as pelareorep, is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.

On August 3, 2018 Zenyaku Kogyo Co., Ltd. (Japanese-only website) and Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that Zenyaku filed an application for approval with the Ministry of Health, Labour and Welfare for the anti-CD20 monoclonal antibody RITUXAN injection 100 mg and 500 mg [generic name: rituximab (genetical recombination)] for the treatment of "CD20-positive chronic lymphocytic leukemia (CLL) (Press release, Chugai, AUG 3, 2018, View Source [SID1234528819]). RITUXIAN is co-marketed by the two companies in Japan.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Zenyaku received a request from the MHLW to develop RITUXAN for the treatment of CD20-positive CLL issued on April 6, 2012, as a result of the evaluation by the "11th Review Committee on Unapproved Drugs and Indications with High Medical Needs" held on March 23, 2012, and has been preparing to file for the addition of this indication. On March 20, 2018, the orphan drug designation was granted for RITUXAN for CD20-positive CLL as the estimated number of newly diagnosed CLL patient per year is about 400.

CLL is a disease in which small mature B lymphocytes proliferate monoclonally and proliferate in peripheral blood, bone marrow, lymph nodes and spleen, many of which progress slowly. This rare disease is mostly prevalent in elderly people, and considered as difficult to cure with current treatments while many patients often experience recurrence and progression repeatedly. The number of patients in Japan is small, reportedly about 0.3 to 100,000 people per year. The age of onset is typically over 50 years, and rarely seen in people under 30 years of age. In patients with CLL, the ratio of females to males is higher at about 1.5 or 2 to 1*.

Zenyaku and Chugai will continue to work for the early approval of the product to provide RITUXAN for CLL patients and medical professionals who are waiting for a new treatment option.