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

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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.

On April 4, 2017 Oxis International Inc. (OTCQB: OXIS and Euronext Paris OXI.PA) reported that the Food and Drug Administration has cleared the way for the Company’s wholly owned subsidiary, Oxis Biotech Inc., to begin a FDA Phase 2 clinical trial for its promising cancer treatment OXS-1550 in the treatment of lymphoma and leukemia (Press release, OXIS International, APR 4, 2017, View Source [SID1234539558]).

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Oxis Biotech, a targeted immuno-oncology company focused on novel antibody constructs, owns the worldwide rights to commercialize OXS-1550.

The FDA Phase 2 clinical trial will be conducted with Oxis’ partner, the University of Minnesota’s Masonic Cancer Center. Researchers at the University of Minnesota recently completed a FDA Phase 1 trial of OXS-1550. The Phase 1 portion of the trial completed a safety review to determine the safe and effective dose of the drug.

OXS-1550 uses a proprietary immunoconjugate platform technology, as a treatment for leukemia and other blood-born cancers. What sets OXS-1550 (DT2219ARL) apart from other treatments, such as chemotherapy, is that it is designed to specifically target and kill cancer cells minimizing damage to normal tissues.

"This milestone represents a major step forward for our technology. The product has performed well in its phase 1 studies in blood cancers and we look forward to positive results in Phase 2," said Anthony Cataldo, Chairman and Chief Executive Officer of Oxis. "This next generation drug has the possibility of treating a number of different liquid tumors and, if successful, will drastically change the paradigm now being developed that relies on highly expensive autologous cell therapies such as presented by Kite Pharma, Inc. (KITE), Juno Therapeutics, Inc. (JUNO) and other autologous or semi-autologous and adoptive therapy approaches currently under development."

Dr. Daniel Vallera, director of the section on Molecular Cancer Therapeutics at the University of Minnesota Cancer Center, lead developer of OXS-1550 said, "The FDA’s clearance for Phase 2 is an important step forward for this cancer treatment."

Dr. Vallera has spent 35 years with the University of Minnesota’s cancer center, where he oversees a laboratory specializing in the development of biological recombinant drugs focusing on bispecific antibody therapies that directly deliver toxic signals to cancer cells.

"We are excited to see this new therapy proceed to Phase 2," Dr. Vallera said. "So many of these patients presenting with chemotherapy refractory cancer have few, if any, alternative choices for cancer treatment."

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.

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.