On March 28, 2017 GeneQuantum Healthcare (Suzhou) Co., Ltd., a high-tech company focused on the research and development of innovative Bio-therapeutics, reported the completion of a RMB40 million (equal to approximately $5.8 million) Series A financing (Press release, GeneQuantum Healthcare, MAR 28, 2017, View Source [SID1234553995]). The lead investor is Oriza Seed Venture Capital ("Oriza Seed"), joined by TF Capital.

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GeneQuantum was founded in August 2013 at Suzhou Industrial Park, and has built-up a world-class bio-conjugation technology platform, focusing on developing series of next generation anti-tumor Antibody-Drug-Conjugates (ADCs) with best-in-class potential. Securing this round of financing will significantly promote the development of current ADC candidates towards IND filling in both US and China, meanwhile further expanding the company’s product pipeline.

"GeneQuantum’s innovative Ligase Dependent Conjugation (LDC) technology, combined with IP protected Automatic On-line Monitoring Conjugation System and Linker Screening & Optimization Facility, provide a holistic solution for the R&D of next generation ADCs," said Dr. Gang Qin, Founder and CEO of GeneQuantum. "In comparison with ADCs produced via conventional technologies, drug candidates generated from the unique LDC platform have shown a drastically enlarged therapeutic window. We believe this will ensure GeneQuantum’s leading role in the field of bio-conjugation therapeutics development. It is our honor to have the acknowledgement and support from Oriza Seed and TF Capital, senior biopharmaceutical investment agencies. This will not only provide us with the financial support needed for IND application, but also bring a wealth of resources. Anchored to our mission ‘Dedication to Innovation, Responsibility for Health’, we will stick to innovation and remain committed to continuously providing global cancer patients with better and safer therapeutics."

"Oriza Seed has been focusing on investing early stage pharmaceutical companies, for us, the most important features are the technology innovation capability of the core team and market potential of the products," said Eric Zhao, Partner of Oriza Seed. "We highly recognize the value of GeneQuantum’s innovative and unique bio-conjugation platform, and would like to facilitate bringing candidate drugs to clinical trials as soon as possible, eventually benefiting patients."

"Since the establishment of TF Capital, we have been dedicated to looking for pharmaceutical companies holding key technologies and a high competition barrier," said Kevin Chiang, CEO of TF Capital. "We are very positive on GeneQuantum’s innovative bio-conjugation technology and the core team’s drug development strategy. The highly effectiveness and persistence of the executive team deeply impressed us. We hope our industry resources will help to accelerate the product development process of GeneQuantum."

On March 27, 2017 Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") reported that the top-line results of a Japanese Phase 3 study of ARQ 197 (generic name: tivantinib) did not meet its primary endpoint (Press release, Kyowa Hakko Kirin, MAR 27, 2017, View Source [SID1234518280]).

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JET-HCC is a randomized, double-blind placebo-controlled study in Japan, to evaluate the efficacy and safety of tivantinib in the patients with c-Met diagnostic-high inoperable hepatocellular carcinoma with a history of prior sorafenib therapy.

The primary endpoint is progression-free survival (PFS), and the top-line results did not show a significant difference in PFS, between the tivantinib group and the placebo group. In terms of safety, the results showed that the safety profiles were similar as previously observed, and a novel safety issue was not found.

The details of the study results will be presented at upcoming scientific congresses and/or in scientific journals.

"I sincerely thank all of the patients, their families, and all of the personnel who contributed to completing this Japanese study of tivantinib." said Mitsuo Satoh, Executive Officer, Vice President, Head of R&D Division of Kyowa Hakko Kirin. "The result was disappointing, but Kyowa Hakko Kirin has gained great experiences in oncology fields through this study."

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

＜Outline of the study design＞ Target disease Patients with c-Met diagnostic-high inoperable hepatocellular carcinoma with a history of prior sorafenib therapy,
Design Multi-center, randomized, double-blind, placebo-controlled study
Dose One tablet of the study drug (tivantinib 120 mg, or placebo) is daily administered to the subjects of each group twice in a day
Subject Number approximately 190
Primary endpoint Progression-free survival
Study Location Japan

About ARQ197 (tivantinib)
Tivantinib, an oral agent whose molecular target is c-MET, was discovered by ArQule, Inc. (NASDAQ: ARQL). Kyowa Hakko Kirin signed a license agreement with ArQule for the exclusive rights to the development and sales of tivantinib in Japan and some parts of Asia (China, Korea, and Taiwan) on April 27th, 2007. News Release

About c-Met
c-Met is receptor tyrosine kinase. When abnormally activated, the c-Met receptor tyrosine kinase plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis.

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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