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Xenetic Biosciences Announces FDA Acceptance of Investigational New Drug Application to Initiate Phase 2 Clinical Trial of Virexxa® in Endometrial Cancer

On August 19, 2016 Xenetic Biosciences, Inc. (OTCQB: XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company developing next-generation biologic drugs and novel orphan oncology therapeutics, reported that an Investigational New Drug (IND) application for the Company’s product candidate, Virexxa (sodium cridanimod), has been allowed to proceed by the U.S. Food and Drug Administration (FDA) (Press release, Xenetic Biosciences, AUG 19, 2016, View Source [SID:1234514655]). This enables Xenetic to initiate a Phase 2 clinical study of Virexxa in conjunction with progestin therapy for the treatment of endometrial cancer in women with recurrent or persistent disease who have failed progestin monotherapy. The primary objective of the study is to assess the anti-tumor activity of Virexxa. Secondary objectives include assessment of additional efficacy, pharmacokinetic and safety/tolerability parameters. Further translational objectives are to observe the effect of Virexxa in combination with progestins, on the levels of progesterone receptor (PrR) and activated progesterone receptors (APrR) in tumor tissues.

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"This IND clearance enables us to proceed with our Phase 2 study in endometrial cancer and represents a major step forward in our clinical development of Virexxa," stated Scott Maguire, CEO. "We believe Virexxa to be a next-generation therapeutic that has the potential to provide women with no additional treatment options a novel and effective therapy."

Endometrial cancer is the most common malignancy of the female genital tract and represents a major health concern, as overall five-year survival rates have not improved over the past three decades. Annually in the United States, an estimated 60,050 patients are diagnosed with endometrial cancer and 10,470 deaths occur from this disease, representing 1.8% of all cancer deaths in the US. The incidence of endometrial cancer is on the rise with a lifetime risk of approximately 3% while the disease-specific mortality of endometrial carcinoma has been rising in the last 25 years. Endometrial cancer patients whose tumors no longer express progesterone receptors are not candidates for progestin-based therapy. Patients who fail monotherapy with progestins have no additional treatment options. Virexxa may improve sensitivity to progestin therapy in subjects with advanced or recurrent PrR-negative tumors.

About Virexxa
Virexxa is a small-molecule immunomodulator and interferon inducer which, in preliminary studies, has been shown to increase progesterone receptor (PrR) expression in endometrial tissue. Restoration of PrR expression may re-sensitize endometrial tumor tissue to progestin therapy in previously unresponsive tumors.

Virexxa is currently being studied in an ongoing Phase 2 multi-national study enrolling 58 subjects with documented evidence of progesterone receptor negative (PrR-negative) endometrial cancer as determined by tumor biopsy. This study is being conducted in conjunction with Pharmsynthez PJSC (St. Petersburg Russia) and its subsidiary AS Kevelt (Tallinn, Estonia). For more information on this Phase 2 study of Virexxa for the treatment of PrR-negative endometrial cancer, please visit www.clinicaltrials.gov and reference Identifier NCT02064725.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Immunomedics 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, Immunomedics, AUG 18, 2016, View Source [SID1234514636]).

Virogin Biotech Ltd. Joining Forces with Guangdong University of Technology, Establishing Joint Research Lab on Virotherapy

On August 18, 2016 Virogin Biotech Ltd. ("Virogin") reported its strategic collaboration with Guangdong University of Technology (GDUT) in China (Press release, Virogin Biotech, AUG 18, 2016, View Source [SID1234518864]).

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The first step of such collaboration is the Joint Research Lab on Virotherapy, which will be located in Institute of Biomedical and Pharmaceutical Sciences at GDUT. The Institute is a newly established faculty at GDUT equipped with brand new laboratories for translational research. The lab will focus primarily on oncolytic virology and cancer immunology, and is expected to be fully functional by October 2016.
Guangdong University of Technology is a key provincial university in Guangzhou, Guangdong, China. The university offers a wide range of courses in engineering, science, technology, management, liberal arts and law; and it has the privilege to confer Doctor’s, Master’s, and Bachelor’s degrees. It has played an active role in international scientific research and cultural cooperation and exchanges.
Guangdong University of Technology
The objectives of Virogin’s strategic collaboration with GDUT are 1) to facilitate and bridge the gap between academic research and industrial application; 2) to establish a platform for technical exchange and resource pooling; and 3) to further academic research and development by combining Virogin’s experience and expertise in the field with GDUT’s strong research capabilities and cutting-edge infrastructure.
Dr. Wen Tan, Dean of Institute of Biomedical and Pharmaceutical Sciences at GDUT, expressed his excitement and vision for the future of the joint lab, "Oncolytic virology and cancer immunology are the emerging trends in the biomedical world. As the Dean, it is my responsibilities to provide our students with the most up-to-date knowledge and exposure. As for our partner, Virogin Biotech is a very promising company in this field with a strong R&D team and an experienced management team. Its CSO Dr. William Jia is not only one of the pioneers in the field of oncolytic virology with over 20 years of research experience, but also the ideal person to facilitate such collaboration, because as a professor at UBC he would be able to better understand and bring together academia and industry. Ultimately through our collaboration with Virogin Biotech, we wish to establish a world-class research facility in virotherapy."
Virogin Biotech’s Co-founders – CSO Dr. William Jia and CEO Mr. Chris Huang also indicated their high expectation for the collaboration, "Guangdong University of Technology is a well-known and well-respected university in China that also actively involves in international scientific research collaboration. The Institute of Biomedical and Pharmaceutical Sciences, despite being new, has very strong research capabilities with state-of-the-art research facilities and infrastructure. With our company’s active involvement, we expect to pool resources together, while sharing our years of experience and expertise in oncology and virotherapy. We’ve already recruited several talented PhDs globally to carry out post-doctoral studies in the field at this lab. We believe by combining our strengths, we will be able to achieve mutually beneficial outcomes; and ultimately, reaching significant scientific breakthroughs that would benefit the world."
Virogin‘s Co-founders Dr. William Jia and Mr. Chris Huang, accompanying Dr. Wen Tan, Dean of GDUT’s Institute of Biomedical and Pharmaceutical Sciences, at Dr. Jia‘s research lab at UBC.

Zymeworks Receives FDA Acceptance of IND Application for ZW25, a Novel Bi-Specific Antibody, for the Treatment of HER2-Expressing Cancers

On August 18, 2016 Zymeworks Inc., a biopharmaceutical company discovering and developing innovative multi-functional protein-based therapeutics, including bi-specific antibodies and drug conjugates, for the treatment of cancer, reported that the United States Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application for ZW25 for the treatment of certain HER2-expressing cancers (Press release, Zymeworks, AUG 18, 2016, View Source [SID:1234514640]). The Phase 1 clinical trial for ZW25 is anticipated to begin in late August of this year.

ZW25 is Zymeworks’ lead therapeutics program. It is a novel bi-specific antibody, developed using the Company’s industry-leading Azymetric platform, to target two different epitopes (bi-paratopic targeting) of the human epidermal growth factor receptor 2 (HER2) protein, which is over-expressed on the surface of many tumor types, including certain breast, gastric, lung, and ovarian cancers. ZW25 will be evaluated in the clinic for safety as well as efficacy in patients with tumors with low to moderate levels of HER2 expression. There are significant unmet medical needs for these patients as the current standard of care treatment approaches do not include HER2-targeted immunotherapies such as ZW25.

"We are proud and excited to advance ZW25 into clinical trials. We strongly believe ZW25 will address the needs of many HER2-expressing cancer patients, especially those who do not qualify for targeted HER2 therapies and other biologics," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "We remain committed to the research and development of protein based therapeutics to address unmet medical needs and that we believe will result in patients returning home to their loved ones, cancer free."

"We’re pleased the FDA has cleared ZW25 for this first Phase 1 study in patients with locally advanced and/or metastatic HER2-expressing cancers and we look forward to initiating this clinical program in late August," said Diana Hausman, M.D., Zymeworks’ Chief Medical Officer. "This is a significant milestone for Zymeworks and for the development of ZW25, and we are excited about its therapeutic potential in HER2-expressing cancers."

Previously, the FDA granted Orphan Drug Designation to Zymeworks’ ZW25 for the treatment of ovarian cancer. Orphan designation qualifies Zymeworks for a number of development incentives, including tax credits for clinical testing and marketing exclusivity for a period of seven years if ZW25 is approved for this indication.

About ZW25

ZW25 is Zymeworks’ lead therapeutics program based on the Azymetric platform. It is an engineered bi-specific antibody that targets two different epitopes (bi-paratopic targeting) of the HER2 protein and confers its efficacy via multiple mechanisms of action, including: (i) enhanced antibody-mediated effector function resulting from the increased decoration of the tumor cell surface; (ii) increased blockade of the HER2 cellular growth signal by the dual engagement of HER2 epitopes; and (iii) increased removal of surface-expressed HER2 protein due to enhanced HER2 internalization upon antibody engagement. ZW25 as a best-in-class HER2-targeting antibody for a variety of tumors characterized by HER2 overexpression, including breast, gastric, ovarian, colorectal and non-small cell lung cancers.

About Azymetric Platform

Bi-specific antibodies developed using the Azymetric platform resemble conventional mono-specific antibodies while being able to simultaneously bind to two different targets resulting in additive or synergistic therapeutic responses. Azymetric antibodies spontaneously assemble into a single molecule with two different Fab domains comprising of unique heavy and light chain pairings. Azymetric antibodies are manufactured using conventional monoclonal antibody processes and can be easily adapted to rapidly screen target and sequence combinations for bi-specific activity in the final therapeutic format, thereby significantly reducing drug development timelines.

Immune Pharmaceuticals Provides Business and R&D Update and Announces Second Quarter 2016 Financial Results

On August 16, 2016 Immune Pharmaceuticals Inc. (NASDAQ:IMNP) ("Immune" or the "Company") reported financial results for the second quarter and six months ended June 30, 2016 as well as provided pipeline highlights and a business update (Press release, Immune Pharmaceuticals, AUG 18, 2016, View Source [SID:1234514638]).

"Immune has continued to make significant R&D and operational progress, while we seek to unlock the potential value of our pipeline through institutional financing and corporate transaction opportunities," said Dr. Daniel Teper, CEO of Immune Pharmaceuticals Inc.

Pipeline Highlights
Immuno-inflammation
· Bertilimumab continues to accrue patients in its two phase 2a clinical trials in bullous pemphigoid (BP) and ulcerative colitis (UC). The BP trial is expanding to six US centers in addition to the two Israeli centers. The first US center was initiated in August 2016 and started to screen patients with others to follow shortly. The UC trial is expanding to Eastern Europe with site initiations to be completed in the fourth quarter of 2016. An additional phase 2a trial in Atopic Dermatitis (AD) is in final planning stages in Canada.
· In the second quarter of 2016, new pre-clinical data was generated in AD and a new provisional patent was filed in partnership with Hadasit, the technology transfer of Hadassah hospital, for oral use of anti-eotaxin antibodies in Non-Alcoholic Steato-Hepatitis (NASH).
· Immune also advanced process development for its new cell line for the production of bertilimumab. Immune expects to bridge to the new cell line starting in mid-2017. Immune is assessing options for development of a sub-cutaneous formulation of bertilimumab.
· Immune advanced the development of NanoCyclo, a topical formulation of cyclosporine A for the potential treatment of AD and psoriasis. We are currently focused on the GMP manufacturing process and pre-clinical regulatory studies toward filing of an Investigational New Drug application in 2017.

Immuno-oncology
We are continuing to advance our plans to focus on our two clinical stage assets in oncology, Ceplene and Azixa and have made significant progress in the past quarter with both of these assets.
· Ceplene is approved in Europe for remission maintenance and prevention of relapse in adults with Acute Myeloid Leukemia (AML), an orphan indication with poor survival prognosis, for which no effective therapy is available to patients.
· Presented new positive biomarker driven clinical data from the European Phase IV study at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual meeting in New Orleans in April 2016. The phase IV RE:MISSION trial was designed to assess the immuno-modulatory properties of Ceplene/IL-2, and to correlate potential biomarkers with clinical outcome. Results indicated that outcomes were strongly predicted with a specific T-cell biomarker including leukemia-free survival (LFS) (HR 0.25, P=0.001) and overall survival (OS) (HR 0.24, P=0.009).
· Reported new data showing that Ceplene enhanced response to PD-1 and PD-L1 checkpoint inhibitors in lymphoma and solid tumor models. This data is supporting the provisional patent application filed in the first quarter of 2016 for use of Ceplene in combination with check point inhibitors.
· Presented new data at the Conference "Regulatory Myeloid Suppressor Cells: From Basic Discovery to Therapeutic Application" held in Philadelphia, PA providing further mechanistic evidence to explain the promising efficacy of Ceplene in combination with low dose IL-2 observed clinically in the myelomonocytic M4 and M5 AML subtypes in both Phase III and the recently completed Phase IV clinical trials.

· Immune now plans to leverage recent Ceplene/IL-2 data on predictive bio-markers and recent phase IV data results to design and reach an agreement with the FDA for a pivotal study in AML supporting a new drug application in the U.S.

· Azixa is a novel microtubule destabilizer that has a dual mode of action, acting as a vascular disrupting agent (VDA) and a potent cytotoxin with a unique ability to penetrate the blood brain barrier and reach high concentrations in the brain.
· Generated and reported new data demonstrating that the combination of Azixa and immune checkpoint inhibitors such as anti-CTLA-4 antibody resulted in enhanced activity compared to the activity elicited by the single agents alone.
· Filed a provisional patent application with the USPTO relating to the combination of Azixa and immune checkpoint inhibitors such as an anti-CTLA-4 antibody and anti-PD1 monoclonal antibodies in the treatment of cancer.

Business Update
On July 18, 2016, the Company signed an amendment to the May 15, 2016 Option Agreement with Novel Pain Therapeutics, LLC (NPT), a syndicate of experienced healthcare investors. Immune agreed to designate a subsidiary that will hold all of the Intellectual Property for Immune’s pain assets (Amiket, Amiket Nano and LidoPain). Under the terms of the Amended Option Agreement, the parties have agreed to a pre-money valuation of $15 million for Immune’s equity stake in the pain subsidiary with a target closing date of September 15, 2016 for the first tranche of dedicated financing by NPT and other investors. In addition, subject to the exercise of the Option Agreement and the execution of the definitive License Agreement, as well as the ultimate development, sale and/or licensing of the products, Immune will be eligible to receive up to $145 million in milestone payments as well as sublicensing fees and royalties.

Second Quarter and Six Months Ended June 30, 2016 Financial Discussion
Immune reported a loss attributable to common stockholders of $5.7 million, or $0.13 per share, for the quarter ended June 30, 2016, compared to a loss attributable to common stockholders of $2.9 million, or $0.12 per share, for the quarter ended June 30, 2015. For the six months ended June 30, 2016, Immune reported a loss attributable to common stockholders of $11.7 million, or $0.30 per share, compared to a loss attributable to common stockholders of $8.2 million, or $0.34 per share, for the six months ended June 30, 2015.

Research and Development ("R&D") expenses increased by $0.8 million during the quarter ended June 30, 2016 to $1.9 million compared with $1.1 million during the quarter ended June 30, 2015. For the six months ended June 30, 2016 R&D expenses increased by $1.7 million to $4.0 million from $2.3 million. The increase in R&D expenses for the quarter and six months ended June 30, 2016 was primarily driven by higher salaries, employee benefits and share-based compensation as a result of higher R&D headcount. In addition, the increase in R&D expenses was driven by higher clinical trial expenses as the Company continues to ramp up its clinical trials related to bertilimumab in both BP and UC.

General and Administrative ("G&A") expenses decreased $0.8 million during the quarter ended June 30, 2016 to $0.9 million compared with $1.7 million during the quarter ended June 30, 2015, due to lower share based compensation expense and lower consulting and business development expenses. For the six months ended June 30, 2016 G&A expenses decreased by $0.6 million to $3.4 million from $4.0 million during the six months ended June 30, 2015 primarily due to lower share based compensation expense and lower legal fees.

Non-operating expense was $0.7 million during the three months ended June 30, 2016 compared with non-operating expense of $0.1 million during the three months ended June 30, 2015. For the six months ended June 30, 2016, non-operating expense was $1.4 million compared with $0.2 million for the six months ended June 30, 2015. Non-operating expense increased for the three and six months ended June 30, 2016 primarily relating to cash interest expense and amortization of debt issuance costs for the Company’s loan agreement and the loss on the change in fair value of derivative liability instrument.