OncoResponse to Present at BioCentury Future Leaders Conference

On April 4, 2017 OncoResponse, an immuno-oncology antibody discovery company, reported that Chief Executive Officer Clifford J. Stocks will present an update on the Company and the status of its discovery and development pipeline at the 24th annual Future Leaders in the Biotech Industry conference hosted by BioCentury (Press release, OncoResponse, APR 4, 2017, View Source [SID1234522896]). The presentation will take place at 11:00am ET on April 7, 2017 at the Millennium Broadway hotel in New York City, NY.

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OncoResponse utilizes a clinically validated platform technology to rapidly screen antibodies made by the human immune system and identify those antibodies with exceptional activity to cancer from elite responders following immunotherapy. The Company has a strategic alliance with the MD Anderson Cancer Center, which provides broad access to patient samples across multiple cancer indications and to oncology and translational medicine expertise including clinical and regulatory advice.

OncoResponse recently closed a $22.5 million Series A financing with a syndicate of blue chip venture capital and strategic investors including MD Anderson Cancer Center, ARCH Venture Partners, GreatPoint Ventures, Helsinn Investment Fund, Shire, Canaan Partners, HT Family Office (of China), Alexandria Real Estate Equities and William Marsh Rice University.

20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

(Filing, Annual, Celyad, 2016, APR 4, 2017, View Source [SID1234518464])

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SignalRx to Present at the AACR Annual Meeting on its First-In-Class Triple PI3K/CDK4-6/BRD4 Inhibitor SRX3177 for Treating Cancer

On April 3, 2017 SignalRx Pharmaceuticals Inc., focused on developing novel small-molecule cancer therapeutics targeting key orthogonal and synergistic oncotargets, reported the upcoming presentation of scientific data on the company’s triple PI3K/CDK4-6/BRD4 inhibitor program and first-in-class triple inhibitor SRX3177 (Press release, SignalRx, APR 3, 2017, http://www.ireachcontent.com/news-releases/signalrx-to-present-at-the-aacr-annual-meeting-on-its-first-in-class-triple-pi3kcdk4-6brd4-inhibitor-srx3177-for-treating-cancer-617971313.html [SID1234527324]). The poster presentation by Dr. Donald L. Durden, MD, PhD, senior scientific advisor for SignalRx, will be poster #LB-298 at the April 5th late breaking poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Washington, DC.

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SRX3177 is developed on the rationale that concurrent PI3K inhibition can prevent resistance to CDK4/6 inhibition, and combined CDK4/6 and PI3K inhibition leads to synthetic lethality reported in a number of cancer types, including breast cancer and mantle cell lymphoma, and blocking the chromatin reader protein BRD4 downregulates MYC and cyclin D1 transcription, further promoting cell cycle arrest in G1.

The presentation will describe the discovery and early development of the molecularly designed small-molecule triple inhibitor SRX3177. Key highlights to be presented include:

SRX3177’s potent in vitro enzymatic inhibition profile (IC50: CDK4 = 2.54 nM, CDK6 = 3.26 nM; PI3Kα = 79.3 nM, PI3Kδ = 83.4 nM; BRD4-BD1 = 32.9 nM, BRD4-BD2 = 88.8 nM).
SRX3177 rational design based on thieno-pyranone scaffold and target modeling.
Up to 82-fold more potent than palbociclib in a panel of mantle cell lymphoma, neuroblastoma, and hepatocellular carcinoma cell lines.
5-Fold more potent in cancer cells than combination of BKM120 (PI3K inhibitor) + palbociclib (CDK4/6 inhibitor) + JQ1 (BRD4 inhibitor).
40-Fold less toxic to normal epithelial cells than combination of BKM120 + palbociclib + JQ1.
Cell cycle arrest and apoptosis induction with proven mode of action (p-AKT, p-Rb, chromatin release).
SignalRx is also announcing that it is seeking partnering opportunities to accelerate the development of this program and its PI3K-BRD4 program to advance novel small molecules into first-in-man clinical trials based on the promising profile of its inhibitors shown so far. Since these are single molecules with a single PK/PD and toxicity profile, there is a great opportunity to develop them as single therapeutics and streamline their development in combination therapies focused on companion diagnostics built around synthetic lethality discoveries in human cancers.

Xenetic Biosciences Reports 2016 Year End Financial Results and Provides Business Update

On April 3, 2017 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported its financial results for the year ended December 31, 2016 (Press release, Xenetic Biosciences, APR 3, 2017, View Source [SID1234537802]). The Company’s management team will host a quarterly update conference call with a live webcast on Tuesday, April 4, 2017 at 8:30 AM ET for investors, analysts and other interested parties (details below).

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Xenetic also provided an update on its license deal with Shire plc (LSE: SHP, NASDAQ: SHPG), a significant stockholder of the Company, along with the clinical status of the product candidate SHP656, or PSA-Recombinant Factor VIII ("rFVIII") being developed as a long-acting therapeutic for the treatment of hemophilia utilizing Xenetic’s proprietary PolyXen platform technology. The stated goal of Shire is to introduce an innovative, modified FVIII protein with a significantly prolonged circulating half-life, with the objective of providing a once weekly treatment or reaching higher trough activity levels for greater efficacy. SHP656 is currently in a Phase 1/2 clinical study. Shire expects to report topline data from this Phase 1/2 study in the second quarter of 2017 and, if the outcome of the trial is successful, Xenetic expects Shire to launch a Phase 3 trial in 2017. Xenetic has the potential to receive from Shire up to $100 million in cash milestones plus royalties linked to sales.

Additionally, Xenetic provided an update to its corporate progress as well as clinical and regulatory status and anticipated milestones for the Company’s lead product candidate, XBIO-101 (sodium cridanimod), a small-molecule immunomodulator and interferon inducer which, in preliminary studies, has been shown to increase progesterone receptor ("PrR") expression in endometrial tumor tissue. The Company is currently preparing to commence patient recruitment in the second quarter of 2017 for a Phase 2 clinical study of XBIO-101 in conjunction with progestin therapy for the treatment of progestin resistant endometrial cancer. Xenetic also recently filed a protocol under its existing investigational new drug application ("IND") for a biomarker study of XBIO-101 in triple negative breast cancer ("TNBC").

Recent Corporate Highlights

Uplisted to the Nasdaq Capital Market;
Received a $3 million milestone payment from Shire plc related to Shire’s advancing the Phase 1/2 clinical study for SHP656 being developed as a long-acting therapeutic for the treatment of hemophilia;
Filed a protocol under its existing IND for a biomarker study of XBIO-101 for the treatment of TNBC;
Expanded its patent portfolio geographically into key markets including areas of Europe, Asia and North America and strengthened the patent portfolio in the US providing robust protection of its platform technology;
Appointed Jeffrey Eisenberg as Chief Operating Officer;
Appointed Curtis A. Lockshin, Ph.D. as Chief Scientific Officer; and
Appointed Edward J. Benz, Jr., M.D., former CEO of the Dana-Farber Cancer Institute, to its Board of Directors.
"Over the course of 2016 and the beginning of 2017, we have worked diligently to lay a solid foundation for the Company and as such, have positioned ourselves for what we believe will be a transformational year. The corporate achievements we’ve made, including our uplist to Nasdaq, the bolstering of both our management team with two C-level appointments as well as our board of directors and notable progress with our clinical and regulatory strategies, have enabled us to build momentum which we believe has the potential to propel Xenetic to its next stage of growth," stated M. Scott Maguire, Xenetic’s CEO.

Expected Near-Term Milestones

Commence patient recruitment in Q2 2017 for a Phase 2 clinical study of XBIO-101 in conjunction with progestin therapy for the treatment of endometrial cancer in women with recurrent or persistent disease who have failed progestin monotherapy;
Announce topline data from the Shire Phase 1/2 study of SHP656 in Q2 2017;
Receive milestone payment from Shire if endpoints are achieved in Phase 1/2 study of SHP656; and
Leverage Shire SHP656 program to enter into more industry collaborations involving the PolyXen technology.
"Moving forward, we are excited for the year ahead and remain committed to executing our strategy. We believe that our expected near term corporate and clinical advancements will unlock significant shareholder value, in both the short-term and long-term," concluded Mr. Maguire.

Summary of Financial Results for Fiscal Year 2016

Net loss for the three months ended December 31, 2016, was $0.4 million, or a net loss applicable to common stockholders of $4.4 million after accretion of beneficial conversion feature on convertible preferred stock of $4.0 million, compared to a net loss of approximately $3.6 million for the same period in 2015. The decrease in net loss was primarily related to $3.0 million of milestone revenue earned in December 2016.

Net loss for the year ended December 31, 2016, was $54.2 million, or a net loss applicable to common stockholders of $58.2 million after accretion of beneficial conversion feature on convertible preferred stock of $4.0 million, resulting in a loss per share applicable to common stockholders of $7.84, compared to a net loss of $12.5 million resulting in a loss per share applicable to common stockholders of $2.96 for the year ended December 31, 2015. The increase in net loss was primarily related to the immediate expensing of in-process research and development acquired in 2016.

The Company ended the year with approximately $4.0 million of cash.

Conference Call and Webcast Information

Xenetic management will host a conference call for investors, analysts and other interested parties on Tuesday, April 4, 2017 at 8:30 a.m. ET. The conference call and live webcast will be accompanied by presentation slides.

To participate in the call, please dial (877) 407-6914 (domestic) or (201) 493-6709 (international). The live webcast and accompanying slides will be available by accessing the IR Calendar in the Investors section of Xenetic’s website (www.xeneticbio.com). A replay of the webcast will be available for 90 days, starting approximately two hours after the presentation ends.

Bristol-Myers Squibb Announces Results from CheckMate -143, a Phase 3 Study of Opdivo (nivolumab) in Patients with Glioblastoma Multiforme

On April 3, 2016-Bristol-Myers Squibb Company (NYSE:BMY) reported that CheckMate -143, a randomized Phase 3 clinical trial evaluating the efficacy and safety of Opdivo in patients with first recurrence of glioblastoma multiforme (GBM), did not meet its primary endpoint of improved overall survival over bevacizumab monotherapy (Press release, Bristol-Myers Squibb, APR 3, 2017, View Source [SID1234518425]). These data will be presented on May 7, 2017 at the World Federation of Neuro-Oncology Societies (WFNOS) meeting in Zurich, Switzerland.

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"GBM is a historically difficult disease to treat and conventional treatment options have demonstrated limited responses," said Fouad Namouni, M.D., head of Oncology Development and head of Medical, Bristol-Myers Squibb. "We remain steadfast in our pursuit of treatments for diseases with the highest unmet need and continue our work to determine how our Immuno-Oncology agents can potentially improve outcomes for these patients."

CheckMate -143 was the first randomized clinical trial in GBM with a PD-1 checkpoint inhibitor. BMS has two first-line GBM clinical trials, CheckMate -498 and CheckMate -548, evaluating the combination of Opdivo with radiation therapy with or without temozolomide in O6-methylguanine-DNA methyltransferase (MGMT)-unmethylated and methylated patients. These trials are moving forward as planned.

Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines that will raise survival expectations in hard-to-treat cancers and will change the way patients live with cancer.

We are leading the scientific understanding of I-O through our extensive portfolio of investigational and approved agents, including the first combination of two I-O agents in metastatic melanoma, and our differentiated clinical development program, which is studying broad patient populations across more than 35 types of cancers with 13 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs uniquely position us to advance the science of combinations across multiple tumors and potentially deliver the next wave of I-O combination regimens with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and inform which patients will benefit most from I-O therapies.

We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.