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.

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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.

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.

On August 16, 2016 Tioma Therapeutics, Inc., a venture-stage biopharmaceutical company developing anti-CD47 antibodies for the treatment of solid and hematologic cancers, reported it has raised $86 million in Series A venture financing (Press release, Tioma Therapeutics, AUG 16, 2016, View Source [SID:1234514627]). Proceeds from this financing will be used to further develop Tioma’s antibody portfolio, including its lead drug candidate – an anti-CD47 immune checkpoint inhibitor – through advanced proof-of-concept in human clinical trials.

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The Series A financing was co-led by RiverVest Venture Partners (including 3×5 RiverVest Fund), Novo Ventures, Roche Venture Fund and S.R. One, Limited (the corporate venture capital arm of GlaxoSmithKline). Pursuant to this financing, John McKearn, PhD, of RiverVest Venture Partners, Peter Moldt, PhD, of Novo Ventures, Carole Nuechterlein of Roche Venture Fund and Jill Carroll of S.R. One will serve on the company’s board of directors, with Dr. McKearn serving as Chairman of the Board.

"We find CD47 to be an extremely interesting target in the evolving cancer immunotherapy landscape," said Peter Moldt, PhD, Partner at Novo Ventures. "We believe Tioma Therapeutics, with its portfolio of diverse, functionally heterogeneous antibodies, is well positioned to test the CD47 hypothesis in the clinic."

The company also announced today that John Donovan will lead the Tioma executive management team as President, Chief Executive Officer and member of the board of directors. John has more than two decades of industry experience, first as an investment banker and then as a member of senior leadership within several biotechnology companies. Most recently, he was a co-founder of Alios BioPharma and served as its Chief Business Officer and Chief Financial Officer through its acquisition by Johnson & Johnson.

"We are delighted to have John’s strong leadership skills, extensive corporate strategy experience and financial expertise to guide Tioma’s management team during this new phase of the company’s development," commented John McKearn, PhD, Managing Partner, RiverVest Venture Partners.

"We’re pleased by the degree of investor interest in this financing and thrilled to have enabled the robust advancement of our therapeutic antibodies well into clinical development," stated John Donovan, President and Chief Executive Officer of Tioma Therapeutics. "We’re particularly excited by the prospect of using these compounds in combination with other therapeutic agents, such as PD-L1/PD-1 inhibitors. We believe we have the ability to meaningfully improve outcomes for patients suffering from a variety of debilitating cancers."

About Immunotherapy and CD47

There are two distinct but interdependent arms of the immune system that work in concert to recognize cancer cells and destroy them. Both the innate and adaptive immune responses are capable of recognizing and destroying cancer cells but tumors evolve mechanisms to evade them.

Immunotherapy is intended to "wake" the immune system so that it can recognize and destroy cancer cells. Currently approved immuno-oncology therapies have been effective in a subset of patients despite harnessing only the adaptive immune response. Anti-CD47 antibodies have the potential to promote coordination by the innate and adaptive immune systems with both acting in concert to attack tumors.

On August17, 2016 Cerulean Pharma Inc. (NASDAQ:CERU), a clinical-stage company developing nanoparticle-drug conjugates (NDCs), reported top-line results from the Company’s Phase 2, randomized, multi-center clinical trial of its lead candidate, CRLX101, in combination with Avastin (bevacizumab) in the treatment of patients with advanced renal cell carcinoma (RCC) (Press release, Cerulean Pharma, AUG 17, 2016, View Source [SID1234514632]).

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The trial was conducted at 43 sites in the US and South Korea, and enrolled 115 patients with RCC who progressed through two or three prior lines of therapy. Patients were randomized to receive CRLX101 in combination with Avastin or investigator’s choice standard of care (SOC) therapy. SOC agents included axitinib, bevacizumab, everolimus, pazopanib, sorafenib, sunitinib, and temsirolimus. The primary endpoint was progression free survival (PFS) in the clear cell population (n=102) assessed by independent radiological review. Secondary endpoints included overall response rate, duration of response and overall survival.

The study demonstrated no statistically significant difference in median PFS and objective response rate for the CRLX101 combination compared to SOC. Median PFS was 3.7 months for the CRLX101 combination compared with a median PFS of 3.9 months for SOC (hazard ratio: 1.25, p=0.822). The 95% confidence interval for PFS for the CRLX101 combination was 2.0 months to 4.3 months and for SOC was 2.2 months to 5.4 months. Objective response rate by independent radiological review for patients who received the CRLX101 combination was 5% (2/42) compared to 14% (6/43) for SOC (p=0.836). The CRLX101 and Avastin combination appeared to be safe and well-tolerated and the safety and tolerability profile of the combination was consistent with that observed in previous studies. The full data set from the trial are expected to be submitted for presentation at an upcoming medical conference.

"We are disappointed with this outcome and will undertake a thorough analysis of the data to understand why CRLX101 plus Avastin underperformed compared to the results we saw in an earlier investigator-sponsored trial," said Christopher D. T. Guiffre, President and Chief Executive Officer of Cerulean. "This outcome did not support our hypothesis that targeting hypoxia inducible factor (HIF) in combination with VEGF inhibitor in RCC, a HIF-overexpressing tumor type, would be beneficial, so we will not pursue HIF as a target going forward. We will continue to focus on the potent topoisomerase 1 inhibition of CRLX101’s payload, camptothecin, in topoisomerase 1-sensitive tumors. Our combinations with weekly paclitaxel and LYNPARZA (olaparib) are examples of ongoing trials that leverage CRLX101’s topoisomerase 1 inhibition in combination with chemotherapies and DNA damage repair agents."

Conference Call Details

Cerulean will host a conference call today at 4:30 pm Eastern Daylight Time to discuss the results and provide an update on the CRLX101 development program. The call can be accessed by dialing (844) 831-3031 or (443) 637-1284 prior to the start of the call and referencing conference ID: 67807137. The conference call will also be webcast live over the Internet and can be accessed on the "Investors" section of the Cerulean website, www.ceruleanrx.com. The webcast will be available on Cerulean’s website for two weeks.

About CRLX101

CRLX101 is a nanoparticle-drug conjugate (NDC) designed to concentrate in tumors and slowly release its anti-cancer payload, camptothecin, inside tumor cells. CRLX101 inhibits topoisomerase 1 (topo 1), which is involved in cellular replication. CRLX101 has shown activity in multiple tumor types, both as monotherapy and in combination with other cancer treatments. CRLX101 is in Phase 2 clinical development and has been dosed in more than 400 patients. The U.S. FDA has granted CRLX101 Orphan Drug designation for the treatment of ovarian cancer, Fast Track designation in combination with paclitaxel for platinum-resistant ovarian carcinoma, fallopian tube or primary peritoneal cancer, and Fast Track designation in combination with Avastin in metastatic renal cell carcinoma.

On August 17, 2017 AskAt reported that it has received a notice of allowance dated August 17, 2016 from State Intellectual Property Office of the P.R.C. (SIPO) in connection with the Application No. 201080017743.X, a use patent of EP4 receptor antagonist for the treatment of Cancer (Press release, AskAt, AUG 17, 2016, View Source [SID1234535065]).

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