On March 27, 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 an update to the progress of its patent portfolio development (Press release, Xenetic Biosciences, MAR 27, 2017, View Source [SID1234537803]).

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Since 2014, the Company has broadened its patent portfolio geographically, into key markets including areas of Europe, Asia and North America, including the United States. Current patents include the manufacturing and conjugation chemistry of Xenetic’s PolyXen platform technology for creating proprietary, next-generation protein therapeutics by attaching polysialic acid ("PSA"), a biodegradable polymer found in living systems, to existing protein or peptide therapeutics, which can improve their pharmacological properties. Xenetic has also successfully obtained patent coverage for its proprietary polysialated protein therapeutics in the United States and globally.

M Scott Maguire, Xenetic’s Chief Executive Officer, stated, "Our focus remains on delivering shareholder value by leveraging our PolyXen platform technology with additional collaborations like our deal with Shire PLC on their SHP656 program, and advancing our lead product in clinical development, XBIO-101, for the treatment of endometrial cancer and triple negative breast cancer. We have worked diligently to continue to build our robust patent estate which includes 200 issued patents in order to provide substantial coverage for potentially safe and well tolerated therapy options for patients across a variety of indications."

Xenetic’s IP for its PolyXen technology platform provides protection on average into 2027 – 2029.

About PolyXen

PolyXen is a patent-protected platform technology for creating proprietary, next-generation protein therapeutics by attaching polysialic acid ("PSA"), a biodegradable polymer found in living systems, to existing protein or peptide therapeutics, which can improve their pharmacological properties.

Attachment of PSA ("polysialylation") to a therapeutic increases its apparent size, which reduces systemic clearance rates, while shielding the protein from other degradation pathways. The PolyXen platform permits optimization of a target therapeutic’s pharmacological properties, by controlling the amount, size, and sites of attachment of the PSA polymers.

In clinical and preclinical settings, therapeutic proteins polysialylated with the PolyXen platform have been shown to have extended circulating half-life, improved thermodynamic stability and resistance to proteases, while retaining pharmacological activity. Numerous human clinical trials to date have shown no evidence of PSA- induced immunogenicity.

Selecta Biosciences has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Selecta Biosciences, 2018, MAR 27, 2017, View Source [SID1234524635]).

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On March 27, 2017 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with a primary focus on Myelodysplastic Syndromes, reported a corporate update and reported financial results for the year ended December 31, 2016 (Press release, Onconova, MAR 27, 2017, View Source [SID1234518287]).

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"We are pleased to report that our lead clinical candidate, rigosertib, is positioned for multiple key milestones, following the advancement of our late stage trials for patients with myelodysplastic syndromes (MDS). Enrollment for the targeted INSPIRE pivotal trial for patients with second-line higher-risk (HR) MDS is on track, with trial sites currently active across 17 countries on four continents. The trial eligibility criteria are highly selective and require extensive search to identify appropriate patients meeting the stringent entry criteria. We intend to maintain current momentum, with interim analysis expected in the second half of the year and full enrollment by the first quarter of 2018," said Dr. Ramesh Kumar, President and Chief Executive Officer.

"Development of oral rigosertib in combination with azacitidine for first line HR MDS patients is advancing as planned, with the protocol for a pivotal Phase 3 trial expected to be ready for submission to FDA for a Special Protocol Assessment during the second or third quarter of this year. MDS represents a growing and underserved market, with more than 10,000 patients diagnosed with HR-MDS annually in the U.S. No new therapy has been approved in over ten years and none has ever been approved for patients after the failure of hypomethylating agents."

"We will continue to focus on our lead programs and will look for partnering or other opportunities for our other pipeline and clinical programs. We will be presenting non-clinical data on pipeline compounds at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) conference," added Dr. Kumar.

Recent Business Highlights:

Enrollment on Track for INSPIRE Pivotal Trial of IV Rigosertib in 2nd line HR-MDS

The global Phase 3 INSPIRE trial of IV rigosertib in patients who have failed to respond to or progressed following hypomethylating agent (HMA) therapy is active in sites across four continents in 16 countries, which is in line with the Company’s plan. Our partner, SymBio Pharmaceuticals, has opened an additional 33 sites in Japan in collaboration on the INSPIRE protocol. The trial is expected to be active in all 19 countries in the second quarter of 2017 following the activation of sites in Switzerland and the Netherlands.
Pre-planned interim analysis for the global INSPIRE trial is currently on track and will be conducted after 88 death events have occurred.
Progress on Oral Rigosertib Combination with Azacitidine for 1st-line HR-MDS

Following a productive end of Phase 2 meeting with the Food and Drug Administration (FDA) in the third quarter of 2016, a protocol for a pivotal Phase 3 trial is being developed. The Company expects to submit this protocol for review by regulatory agencies in the US and Europe in the second or third quarter of 2017.
The pivotal trial will be designed as a 1:1 randomized placebo controlled trial of oral rigosertib plus azacitidine, compared to azacitidine plus placebo. The Company plans to use a full dose of azacitidine, as defined in the product insert. The patient population studied on this trial will be HMA naïve HR MDS patients. The primary endpoint for assessment of efficacy will be Response Rate of complete remission (CR) + partial remission (PR,) as per the International Working Group (IWG) 2006 Response criteria.
Formal FDA review will be sought via the Special Protocol Assessment (SPA) mechanism.
Further details, including sample size and other criteria will be available post regulatory review, anticipated in the second half of 2017. While the pivotal trial is being designed, we plan to expand the trial cohort with the view of further dose optimization for the planned pivotal Phase 3 Trial.
Upcoming Events and Conferences

Sachs Cancer Bio Partnering & Investor Forum, New York City: March 28, 2017
American Association for Cancer Research (AACR) (Free AACR Whitepaper), Washington, D.C.: April 1-5, 2017
2016 Financial Results

Cash and cash equivalents as of December 31, 2016, totaled $21.4 million, compared to $19.8 million as of December 31, 2015. Onconova believes that its current cash and cash equivalents will be sufficient to fund its ongoing trials and operations into the fourth quarter of 2017.
Net loss was $19.7 million for the year ended December 31, 2016, compared to $24.0 million for the year ended December 31, 2015, primarily due to the change in fair value of warrant liability in the 2016 period related to warrants issued in the July 2016 rights offering.
Research and development expenses were $20.1 million for the year ended December 31, 2016, compared to $25.9 million for the year ended December 31, 2015.
General and administrative expenses were $9.2 million for the year ended December 31, 2016, compared to $9.5 million for the year ended December 31, 2015.
"During 2016, we sharpened our focus and were able to reduce costs while making progress on our lead programs. We are encouraged with the interest from potential partners and importantly, look forward to advancing our clinical programs," concluded Dr. Kumar.

(Filing, Annual, Oncolytics Biotech, 2017, MAR 27, 2017, View Source [SID1234518299])

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On March 28, 2016 Kitov Pharmaceuticals (NASDAQ and TASE: KTOV), reported that TyrNovo Ltd., a company majority-owned by Kitov, will present preclinical data on TyrNovo’s anti-tumor resistance drug candidate NT219 in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017, to be held April 1-5, at the Walter E. Washington Convention Center in Washington, D.C (Press release, Kitov Pharmaceuticals , MAR 27, 2017, View Source [SID1234518293]).

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Dr. Hadas Reuveni, TyrNovo’s founder and chief technology officer, will discuss recent promising results demonstrating NT219’s efficacy in patient-derived xenograft models (PDX) in mice.

NT219 is a small molecule that blocks two feedback pathways highly involved in drug resistance, IRS and STAT3. Combined treatment of NT219 with drugs targeting EGFR, such as Tagrisso and Erbitux, overcame acquired resistance of colon, lung, and head-and-neck cancers in PDX models.

Details on the poster presentations are as follows:

Title: Comprehensive high-throughput screen for combination therapies to block acquired resistance to targeted drugs

Session: PO.ET04.05 – Reversal of Drug Resistance

Location: Section 6

When: Monday, Apr 3, 2017, 8:00 AM – 12:00 PM ET

Poster Board Number: 1190 / 5

About TyrNovo

TyrNovo Ltd. is developer of novel small molecules in the oncology therapeutic field which is majority owned by Kitov Pharmaceuticals (NASDAQ/TASE: KTOV). TyrNovo is developing NT219, a potential oncology combination product. NT219 is a small molecule that presents a new concept in cancer therapy. In combination with various approved oncology drugs, NT219 demonstrated potent anti-tumor effects and increased survival in various cancer models, including sarcoma, melanoma, pancreatic, lung, ovarian, head & neck, prostate and colon cancers. Its mechanism of action is through the prevention of acquired resistance in tumors and by regression of resistant tumors. For more information on TyrNovo please visit View Source