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.

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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.

On August 3, 2018 vTv Therapeutics Inc. (Nasdaq:VTVT) reported financial results for the second quarter that ended June 30, 2018, and provided an update on recent achievements and upcoming events (Press release, vTv Therapeutics, AUG 3, 2018, View Source;p=RssLanding&cat=news&id=2361982 [SID1234528671]).

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"Since our announcement regarding the topline results from Part B of the STEADFAST Study, we have continued to analyze the results from Parts A and B and are encouraged by our findings," said Steve Holcombe, chief executive officer, vTv Therapeutics. "In addition, our other programs, including our glucokinase activator currently in clinical development for type 1 diabetes and our GLP-1R program that is being developed in partnership with Huadong Medicine for type 2 diabetes, continue to make steady progress."

Recent Achievements and Outlook

Azeliragon data analysis continues in order to move development of the therapy forward in consultation with our scientific advisory board and the FDA.
SimplicT-1 Study enrolling patients with type 1 diabetes. The adaptive Phase 1/2 SimplicT-1 Study has begun dosing patients with type 1 diabetes in a 12 week study to evaluate TTP399 as an add-on to insulin therapy. TTP399 has previously demonstrated statistically significant reductions in HbA1c levels in the AGATA Study, a phase 2 study in type 2 diabetes.
Advancing PDE4 program with Newsoara. During the second quarter, vTv licensed rights to its PDE4 program to Newsoara Biopharma Co., Ltd. to further its development and potential commercialization in China and other Pacific Rim countries. Newsoara is developing vTv’s PDE4 compounds as a potential therapeutic for COPD, a chronic illness affecting nearly 100 million people in China.
Additional Investment by MacAndrews & Forbes Incorporated. MacAndrews & Forbes provided vTv an additional $10 million capital line.
Upcoming Events

vTv will participate in the following upcoming investor conferences:

H.C. Wainwright Annual Healthcare Conference, September 4-6, New York.
vTv will also participate in the following upcoming scientific conferences:

11th Clinical Trials on Alzheimer’s Disease (CTAD), October 24-27, Barcelona.
Second Quarter 2018 Financial Results

Cash Position: Cash and cash equivalents as of June 30, 2018, were $1.2 million compared to $6.5 million as of March 31, 2018.
R&D Expenses: Research and development expenses were $8.6 million in the second quarter of 2018, compared to $8.9 million in the first quarter of 2018. The decrease in research and development expenses was primarily driven by the termination of the STEADFAST and open label extension studies during the second quarter of fiscal 2018.
G&A Expenses: General and administrative expenses were $2.7 million and $2.3 million, for the second quarter of 2018 and the first quarter of 2018, respectively. The change in general and administrative cost was driven by lower incentive compensation costs in the first quarter of 2018 related to a reduction in the expected probability of payment of the remaining amount of fiscal 2017 incentive bonuses.
Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $9.6 million for the second quarter of 2018 compared to net loss before non-controlling interest of $10.0 million for the first quarter of 2018.
Net Loss per Share: GAAP net loss per share was $0.31 and $0.30 for the three months ended June 30, 2018 and March 31, 2018, respectively, based on weighted-average shares of 10.0 million and 9.7 million for the three month periods ended June 30, 2018 and March 31, 2018, respectively. Non-GAAP net loss per fully exchanged share was $0.29 and $0.30 for the three months ended June 30, 2018 and March 31, 2018, respectively, based on non-GAAP fully exchanged weighted-average shares of 33.1 million and 32.8 million for the three months ended June 30, 2018 and March 31, 2018, respectively.

On August 3, 2018 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it will release second quarter 2018 and six months ended June 30, 2018 earnings results on August 14, 2018 before the market opens (Press release, Athenex, AUG 3, 2018, View Source;p=RssLanding&cat=news&id=2361991 [SID1234528634]). The Company will host a conference call and live audio webcast on Tuesday, August 14, 2018 at 9:00 a.m. Eastern Time to discuss the financial results and provide a business update.

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To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13682063. A replay of the call will be accessible two hours after its completion through August 21 by dialing 844-512-2921 (in the U.S.) or 412-317-6671 (outside the U.S.) and entering passcode 13682063. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at www.athenex.com.