On August 23, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that the independent Data Safety Monitoring Board (DSMB) of the Phase 3 clinical trial for Patients with Hepatic Dominant Ocular Melanoma (The FOCUS Trial) completed another pre-specified review of safety data for treated patients in the trial (Press release, Delcath Systems, AUG 23, 2018, View Source;p=RssLanding&cat=news&id=2364655 [SID1234529753]). This review was conducted on data collected from the prior randomized protocol for the FOCUS Trial. The DSMB again recommended that no safety related modifications to the treatment protocol be made.

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In July, the Company announced that it has amended the protocol for the FOCUS trial, which will now enroll as a single-arm, multi-center open label study. Safety data to be collected were not modified as a result of the amendment, and safety data from both the randomized and single-arm protocols will be pooled in any analyses submitted to the Food & Drug Administration as part of a New Drug Application. The FOCUS trial, now entitled A Single-arm, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular Melanoma (The FOCUS Trial), will enroll a minimum of 80 patients with ocular melanoma metastatic to the liver. Patients previously enrolled under the prior randomized protocol will continue to be treated and evaluated as part of the amended trial, and periodic DSMB reviews will continue to be conducted.

"The safety data in the Melphalan/HDS arm of the prior randomized protocol of the FOCUS trial has been consistent with that observed in recent research in a non-clinical setting," said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath. "Given that safety concerns with the prior generation product and procedure were the primary issue in the FDA’s previous assessment, we are pleased with the safety profile observed by our therapy in the trial thus far."

On August 23, 2018 MEI Pharma, Inc. (NASDAQ: MEIP) a pharmaceutical company focused on leveraging its extensive development and oncology expertise to identify and advance new therapies for cancer, reported that the Company will release its 2018 fiscal year end financial results after the close of the U.S. financial markets on August 30, 2018 (Press release, MEI Pharma, AUG 23, 2018, View Source [SID1234529047]). The Company will host a conference call and live webcast with the investment community to provide a corporate update the same day at 5:00 p.m. ET.

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Conference Call & Webcast Information
When: August 30, 2018, 5:00 p.m. ET
Dial-in: (866) 939-3921 (United States) or (678) 302-3550 (International)
Conference ID: 47469059

Please join the conference call at least 10 minutes early to register. You can access the live webcast under the investor relations section of MEI’s website at: www.meipharma.com. A replay of the conference call will be archived under events and webcasts for at least 30 days after the call.

On August 23, 2018 Rakuten Aspyrian, a biotechnology company developing precision-targeted cancer therapies based on its proprietary Photoimmunotherapy platform, reported that it has raised $150 million in a Series C financing (Press release, Aspyrian Therapeutics, AUG 23, 2018, View Source [SID1234529072]). This round, as with previous rounds, was led by Hiroshi Mikitani, CEO of Rakuten Inc., a leading global innovation company in e-commerce, communications and fintech, and chairman of Rakuten Aspyrian. The Series C brings the company’s total fundraising to approximately $238 million in equity.

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"Developing treatments for cancer patients is a mission I began to pursue years ago and is the motivation behind my investment in Rakuten Aspyrian," said Mr. Mikitani, chairman of Rakuten Aspyrian. "Rakuten Aspyrian’s approach of combining a biologic with laser-activation to target tumors holds the potential to offer an alternative treatment option to help cancer patients fight their disease. Our company has advanced rapidly in developing this technology and is now poised to start Phase 3 studies. My vision is to develop and commercialize a strong pipeline of treatments based on Photoimmunotherapy to create a new platform for cancer treatments."

"With this financing we will advance our lead compound ASP-1929, a treatment that received Fast Track designation by the FDA, into a global, pivotal Phase 3 trial to evaluate the efficacy and safety to treat recurrent head and neck squamous cell carcinomas," said Miguel Garcia-Guzman, Ph.D., president and CEO of Rakuten Aspyrian. "I congratulate the Rakuten Aspyrian team for their excellence and commitment to rapidly advancing ASP-1929 into a Phase 3 study by the end of this year."

The financing will also support manufacturing scale-up for the commercialization of ASP-1929 and corporate growth including the initial buildup of commercial operations to support the launch of ASP-1929 in the United States, Japan and Europe.

In addition, this funding will support the expansion of R&D efforts to evaluate the safety and efficacy of ASP-1929 and other therapies in a range of cancer types, including the initiation of two additional Phase 2 proof of concept studies of ASP-1929 in other cancer types before the end of 2018.

"We are honored to be working with Hiroshi Mikitani, a visionary leader who supports our long-term corporate mission of conquering cancer," said Dr. Garcia-Guzman. "With this influx of capital, we are well positioned to advance our company to the next phase towards developing a fully integrated R&D and commercial biopharmaceutical corporation advancing first-in-class precision tumor-targeted therapies."

About ASP-1929

ASP-1929, a conjugate of cetuximab and IRDye 700DX, targets epidermal growth factor receptor (EGFR), a cancer antigen expressed in multiple types of solid tumors, including head and neck squamous cell carcinomas, esophagus, lung, colon, pancreas and other cancers. This first-in-class therapy targets cancer cells, after which it is locally activated with red light using a proprietary investigational laser and fiber optics. The local activation of the tumor-selective conjugate targets the tumor but not surrounding normal tissues and structures.

Interim results of the Phase 1/2 trial in patients with head and neck squamous cell carcinoma showed a clinically meaningful improvement in the overall response rate, and potential improvements in progression free survival and overall survival when compared to historical data for the standard of care treatments currently available to this patient population. Top line results of the Phase 1/2 trial are expected later this year.

ASP-1929 is an investigational compound that is not approved for any use in any country.

On August 22, 2018 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported the Company will be participating in the following upcoming investor conferences (Press release, Arcus Biosciences, AUG 22, 2018, View Source [SID1234529028]):

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Citi’s 13th Annual Biotech Conference in Boston on Wednesday, September 5, 2018. At 3:15 pm ET, Terry Rosen, Ph.D., Chief Executive Officer, will participate in a panel discussion entitled, "Targeted Therapies Oncology – Aiming for the Bull’s Eye."

Morgan Stanley 16th Annual Global Healthcare Conference in New York City on Thursday, September 13, 2018. At 4:40 pm ET, Terry Rosen, Ph.D., Chief Executive Officer, and Jennifer Jarrett, Chief Operating Officer and Chief Financial Officer, will participate in a fireside chat. Individuals may access the live audio webcast of the fireside chat by visiting the "Events & Presentations" section of the Company’s website at View Source A replay of the webcast will be available for 30 days following the live event.

On August 22, 2018 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or "the Company") reported that an additional patent has been issued related to BENDEKA by the United States Patent and Trademark Office (USPTO) (Press release, Eagle Pharmaceuticals, AUG 22, 2018, View Source [SID1234529091]). Patent number 10,052,385 will expire March 2033. The USPTO has now issued or allowed a total of 16 patents in the BENDEKA family of patents expiring from 2026 to 2033.

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The newly issued patent will be listed in the U.S. Food and Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) bringing Eagle’s total Orange Book listed patents for BENDEKA to fourteen1. BENDEKA has Orphan Drug Exclusivity (ODE) until December 2022 as a result of the U.S. District Court for the District of Columbia’s decision issued on June 8, 2018.

"The ODE and growing strength of our intellectual property portfolio may protect the BENDEKA franchise well beyond 2022," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

Under a February 2015 exclusive license agreement for BENDEKA, Teva Pharmaceutical Industries, Ltd. is responsible for all U.S. commercial activities for the product including promotion and distribution.