On August 2, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform, reported that the European Patent Office (EPO) and Japan Patent Office (JPO) have granted patents for the Company’s novel self-delivering RNAi (sd-rxRNA) therapeutic platform (Press release, RXi Pharmaceuticals, AUG 2, 2018, View Source [SID1234528839]). The EPO Patent #: 2949752 B1 and JPO Patent #: 620309 cover composition of matter, specifically structural and chemical attributes of sd-rxRNA. These patents will be set to expire in 2029.

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"We are pleased that both the European and Japan Patent offices have recognized our novel therapeutic platform with the granting of these patents," said Dr. James Cardia, Vice President of Business Operations at RXi Pharmaceuticals. He further added, "The Company recently reported the successful outcomes from both our dermatology and ophthalmology clinical trials where our lead candidate RXI-109, an sd-rxRNA therapeutic compound targeting connective tissue growth factor (CTGF), is being evaluated. We announced earlier this year that we would exclusively focus on developing the next generation of immuno-oncology therapeutics based on our self-delivering RNAi therapeutic platform. As such, we are actively seeking to partner or out-license both the Dermatology and Ophthalmology Franchises. The granting of these patents further provides for multiple commercial and development opportunities with RXI-109 and RXi’s sd-rxRNA technology platform, each broadly protected in the United States and International regions."

On August 2, 2018 Genprex, Inc. (NASDAQ:GNPX), a clinical stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, reported that it has amended its agreement with The University of Texas MD Anderson Cancer Center to resume patient enrollment in its Phase I/II clinical trial evaluating the combination of the company’s investigational drug Oncoprex and erlotinib (Tarceva) for the treatment of Stage IV non-small cell lung cancer (NSCLC) (Press release, Genprex, AUG 2, 2018, View Source [SID1234529159]).

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Oncoprex is a TUSC2 gene encapsulated in a positively charged nanovesicle made from lipid molecules and injected intravenously, which can specifically target cancer cells and insert wild-type TUSC2 into cellular DNA, effectively increasing expression of the TUSC2 protein and promoting tumor cell death.

Previously announced interim data from nine patients from the Phase II portion of this Phase I/II clinical trial showed a disease control rate of 78%, with seven out of nine patients achieving stable disease or better, including one complete response. In a previous Phase I clinical trial at MD Anderson evaluating Oncoprex as a monotherapy, five of 23 patients with late-stage NSCLC achieved stable disease or better, with one durable metabolic response.

"We look forward to completing the Oncoprex/erlotinib trial and expanding the study of Oncoprex in combination with other targeted and immunotherapies in the future," said Rodney Varner, Chairman and Chief Executive Officer of Genprex. "We believe the data from the more than 50 late-stage NSCLC patients treated to date provide persuasive evidence of Oncoprex’s anti-tumor effects and favorable safety profile."

A subset of NSCLC patients (approximately 10% of NSCLC patients of North American and European descent and approximately 30% to 50% of NSCLC patients of Asian descent) carry an EGFR mutation that makes their tumors sensitive to tyrosine kinase inhibitors, or TKIs, such as erlotinib. However, even for these patients, tumor resistance to TKIs frequently develops within two years, resulting in eventual disease progression. While next generation TKIs show promise in targeting resistant EGFR positive tumors that carry a mutation known as T790M, only about one-half of EGFR positive patients (5% to 7.5% of all NSCLC patients of North American and European descent and 15% to 25% of NSCLC patients of Asian descent) carry the T790M mutation. This leaves a significant majority of NSCLC patients—those who are EGFR negative and those who are EGFR positive but have become resistant to erlotinib and do not have the T790M mutation—without a targeted therapy for their cancer.

Combination therapies targeting multiple anti-cancer pathways represent a promising approach to achieving greater response rates, and may also allow the expanded use of targeted therapies and immunotherapies in a larger population of cancer patients who are not currently candidates for these treatments.

About Lung Cancer

According to the World Health Organization, lung cancer is the leading cause of cancer deaths worldwide, and is the second most common type of cancer. Each year, there are over 1.8 million new lung cancer cases and 1.6 million deaths from lung cancer worldwide, and in the United States there are over 225,000 new cases and more than 150,000 deaths from lung cancer per year. NSCLC represents 80% of all lung cancers. According to a 2016 American Cancer Society report, the five-year survival rate for Stage IV (metastatic) NSCLC is about 1%, and overall survival for lung cancer has not improved appreciably in the last 25 years.

On August 2, 2018 Xspray Pharma reported that the first clinical trial material from NerPharMa S.r.l., Xspray’s strategic pharmaceutical manufacturing partner in Milan, has been delivered to the HyNap-Dasa clinical trial, the results of which are expected in Q3 2018 (Press release, Xspray, AUG 2, 2018, View Source [SID1234650103]). HyNap-Dasa is one of three product candidates that Xspray currently has in development. The company’s goal is to launch HyNap-Dasa on the US market in 2021.
Xspray has contracted NerPharMa to produce materials for Xspray’s clinical program and finished products for future commercial sale. The material delivered to the HyNap-Dasa study is the first resulting from this collaboration.

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Xspray is developing HyNap-Dasa both as a fully equivalent version of Sprycel to be registered in the US under an Abbreviated New Drug Application (ANDA), or as an improved product under the 505(b)(2) regulatory procedure. NerPharMa is a pharmaceutical contract manufacturer and subsidiary of Nerviano Medical Sciences S.r.l. of Milan, Italy.

NerPharMa’s GMP manufacturing facility has been approved by the Italian Medicines Agency (AIFA), Italy’s national authority responsible for drug regulation, and the US Food and Drug Administration (FDA).

The clinical HyNap-Dasa trial is a pilot study, testing two formulations in healthy volunteers. Study results are expected in the third quarter and will be the base of the planned pivotal study, scheduled to start in 2019.

"Technology transfer in the pharmaceutical industry is complex, but our partnership with Nerpharma over the past half-year has gone very well, and we were able to deliver clinical trial material according to plan," commented Per Andersson, CEO of Xspray Pharma.

"We’ve now proved that we can deliver GMP materials in an FDA-approved manufacturing facility, both clinical. This is critical, partly for our ongoing clinical program, but first and foremost, for our future commercial sales in the US."

"We’re delighted that the transfer of Xspray’s technology has gone well, and that we now have functional equipment at NerPharMa. I’m convinced that we’ll see more widespread uptake of Xspray’s very useful technology soon," responded Angelo Colombo, CEO of NerPharMa.

On August 2, 2018 Avelas Biosciences, Inc., a clinical stage oncology-focused company that is developing products to advance a new standard-of-care for cancer surgery and therapeutic intervention, reported that the first patient has been dosed in Period 2 of its Phase 2 clinical trial of AVB-620 in women with primary, nonrecurrent breast cancer undergoing surgery (Press release, Avelas Biosciences, AUG 2, 2018, View Source [SID1234528310]).

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"We are excited to have initiated the second period of our Phase 2 study of AVB-620 in women with breast cancer undergoing surgery," said Carmine Stengone, President and Chief Executive Officer of Avelas Biosciences. "This second portion of our Phase 2 study should enable us to further demonstrate the accuracy of AVB-620 in distinguishing between malignant and nonmalignant tissues."

"A technology like AVB-620 has the potential to revolutionize cancer surgery by enabling surgeons to visualize cancer while still in the operating room, and make informed, real-time decisions to improve surgical treatment," said Steven Chen, M.D., Chief Medical Officer of Avelas Biosciences. "We believe that AVB-620 has the potential to significantly reduce the number of breast cancer re-operations, which would result in better outcomes for patients and substantial cost savings for healthcare payers."

About the Phase 2 Study

The Phase 2 study of AVB-620 is a multi-center, open-label, single-arm study designed to evaluate patients during two separate trial periods. Period 1, which was completed in December 2017, enrolled 31 patients to evaluate optimal conditions to achieve differentiation between malignant and nonmalignant tissue using fluorescent signals. Period 2 of the Phase 2 study will enroll approximately 108 additional patients to assess the ability of AVB-620 to identify malignant tissue at or close to the surface of excised tissue and of tissue that would otherwise have been left behind. Additional information about this clinical trial is available at www.clinicaltrials.gov using the identifier: NCT03113825.

On August 2, 2018 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that it will report its second quarter 2018 financial results on Thursday August 9, 2018, and will host a conference call and webcast on Friday, August 10, 2018, at 8:30 a.m. ET (Press release, GlycoMimetics, AUG 2, 2018, View Source [SID1234528375]).

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The dial-in number for the conference call is (844) 413-7154 (U.S. and Canada) or (216) 562-0466 (international) with passcode 3876308. To access the live audio webcast, or the subsequent archived recording, visit the "Investors – Events & Presentations" section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the call.