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 28, 2017 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results for the year ended December 31, 2016 (Filing, Q4/Annual, Galectin Therapeutics, 2016, MAR 28, 2017, View Source [SID1234518377]). These results are included in the Company’s Annual Report on Form 10-K, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.
Galectin Therapeutics management will host a conference call at 9:00 a.m. Eastern time March 28, 2017 to discuss this press release.
To access the conference call dial 844-899-6544 and provide the operator with Pin Number 89964111.
Galectin also invites all interested parties to listen to its conference call via webcast at View Source The webcast will also be available on the investor relations portion of the Company’s website at View Source The webcast will be archived on the Company’s website within two hours of the live call. The webcast will be available on the Company’s website at www.galectintherapeutics.com for 90 days.

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Management Commentary
"Galectin Therapeutics achieved a number of significant milestones in the development of our lead compound, GR-MD-02, during 2016," said Peter G. Traber, M.D., president, chief executive officer and chief medical officer of Galectin Therapeutics. "Furthermore, we’ve recently completed equity financings that have generated sufficient funding to cover currently planned expenditures through 2017.
"While non-alcoholic steatohepatitis (NASH) cirrhosis remains GR-MD-02’s primary disease target, a number of additional trials have provided encouraging early results that provide additional insight on the clinical effect of GR-MD-02. In total, what we have seen in our early trials in moderate-to-severe plaque psoriasis and severe atopic dermatitis have consistently shown that GR-MD-02 demonstrates clinically significant, biological activity in humans.
"NASH cirrhosis represents a large unmet medical need with no currently approved therapies, and we are very pleased with our progress in the NASH-CX trial. A drug that can halt progression of, or reverse existing fibrosis, in NASH cirrhosis patients would be a breakthrough therapeutic intervention that may prevent complications, alleviate the need for liver transplant, and even prevent death.
"Our Phase 2b NASH-CX clinical trial enrollment exceeded its target and, to date, 71 patients have completed all 52 weeks of infusions with GR-MD-02, and 155 patients have completed 26 weeks of infusions. More than 3,400 infusions (or 85% of the maximum infusions in the trial) have been administered, with no drug-related serious adverse reactions and a dropout rate that is below the rate included in the trial design. The top-line data readout of the NASH-CX trial remains on track for early December 2017.

"The Providence Cancer Center is continuing two investigator-initiated Phase 1 clinical trials of GR-MD-02 used in combination with approved immunotherapies, Yervoy and Keytruda in patients with advanced melanoma, oral/head and neck cancer (OHN) and non-small cell lung cancer (NSCLC). There have been no safety concerns in either of these studies. Of the five patients with advanced melanoma who underwent combination therapy with GR-MD-02 (2 mg/kg) and Keytruda, one had an impressive partial response, heading towards a complete response, and one had a mixed response.

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"Galectin Therapeutics also announced positive results in studies of GR-MD-02 for patients with serious skin diseases. This an encouraging new indication for GR-MD-02 and one of the previously mentioned demonstrations that the drug is biologically active in humans.

"A Phase 2, exploratory study of GR-MD-02 in patients with severe plaque psoriasis showed all five patients enrolled had significant clinical improvement (mean of 52% improvement) as measured by an objective measurement, the PASI (Psoriasis Area and Severity Index). After receiving 8 mg/kg doses of GR-MD-02 for up to 24 weeks, the fifth patient, who also had the most severe baseline disease, had an 82% PASI improvement approximately one month following the full thirteen infusions (24 weeks).

"In an investigator-initiated protocol, GR-MD-02 was also used to treat three adult patients with severe atopic dermatitis, each of whom had been recalcitrant to multiple therapies over many years. All three patients have had a marked clinical effect with near resolution of pruritus, or itching, and regression of skin lesions. Two patients achieved a 64% and 74% reduction in Eczema Area and Severity Index (EASI), after only 6 weeks and 3 drug infusions. These findings are believed to demonstrate a clinically significant effect of this novel investigational drug in this patient population."

"In summary, we believe that Galectin is in a solid position from clinical, financial and leadership perspectives," Dr. Traber concluded.

Financial Results
For the year ended December 31, 2016, the Company reported a net loss applicable to common stockholders of $22.4 million, or $0.76 per share, compared with a net loss applicable to common stockholders of $21.1 million, or $0.88 per share, for 2015. The increase is largely due to higher research and development expenses primarily related to the Phase 2 clinical program.
Research and development expense for 2016 was $15.3 million, compared with $13.1 million for 2015. The increase primarily relates to costs for the Phase 2 clinical trials begun in 2015, partially offset by lower preclinical costs.
General and administrative expense for 2016 was $6.2 million, compared with $7.0 million for 2015, primarily due to a decrease in stock based compensation.
As of December 31, 2016, the Company had $15.4 million of non-restricted cash and cash equivalents. In January and February 2017, the Company raised a total of $1.5 million in net proceeds from issuance of common stock. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through December 31, 2017.

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 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.

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

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