On February 5, 2017 Abbisko Therapeutics Co., Ltd. reported the successful completion of its series A round financing at $28 million (Press release, Abbisko Therapeutics, FEB 5, 2017, View Source;article_id=70 [SID1234556289]). This round was led by Lilly Asia Ventures and followed by Sinopharm Capital, Jianxin Capital, and TF Capital.

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The fund raised in this round will be used to support new drug research of Abbisko Therapeutics Co., Ltd. (hereinafter referred to as Abbisko), including setting up a new drug R&D center, building an innovative drug R&D team and establishing antitumor drug R&D pipelines.

Abbisko is a new innovative biopharmaceutical company established in Zhangjiang of Shanghai. The company’s founding members previously held significant R&D leadership and management positions in several Fortune 500 pharmaceutical companies (Novartis, Johnson & Johnson, Merck, Eli Lilly and AbbVie) and China’s leading pharmaceutical companies (Hengrui and Hansoh). They have extensive project leadership and team management experience in novel drug development and clinical trials. Abbisko will focus on unmet needs of patients especially those of Chinese patients, follow international standards for new drug development, and dedicate itself to the research and development of innovative therapeutics with global intellectual property rights.

Dr. Yao-chang Xu, Abbisko’s founder, board chairman and CEO, commented on this round of financing: "We are gratified that several of the world’s leading investment institutions participated in this very important round of financing. We are a new but highly experienced drug development team. The investors agree with our strategy and philosophy. As a result, our team can set sail quickly and seize the opportunities brought by the rapid development of biotech sector in China. We’ll work hard to bring more revolutionary treatment solutions to suffering patients as soon as possible."

Mr. Aimin Wu, Sinopharm Capital’s president and partner, said: "At present, China’s innovative drug R&D are in a golden age of development. Abbisko has established a top-notch R&D team with a fast growing cutting-edge product pipelines. Sinopharm fully recognize and appreciates Abbisko’s R&D strength and supports its direction. Led by Dr. Yao-chang Xu, Abbisko is capable of becoming a super star company in the biomedical sector. Sinopharm is honored to participate in the establishment and development of Abbisko, helping domestic biomedical companies to compete with international innovative enterprises."

With Abbisko’s successful establishment and completion of this round of investment, an important new force has risen for China’s innovative drug R&D.

On February 5, 2017 Abbisko Therapeutics, a biopharmaceutical company dedicated to discover and develop innovative medicines, reported the completion of a $28 million Series A financing from a leading group of healthcare investors, including Lilly Asia Ventures, Sinopharm Capital, Jianxin Capital, and TF Capital (Press release, Abbisko Therapeutics, FEB 5, 2017, View Source;article_id=43 [SID1234521011]).

The proceeds will be used to support Abbisko Therapeutics’ drug research and development effort, including the creation of a state-of-the-art R&D center and advancing a drug discovery pipeline with multiple programs in oncology and other disease areas.

"We are fortunate to have a number of the world’s premier healthcare investors participated in this round of financing." said Dr. Yao-chang Xu, founder and CEO of Abbisko. "We have a new but highly experienced drug research and development team. Investors agree with our strategy and philosophy, providing strong financing support to enable our quick start. We will seize the opportunities to become a critical force and leading company in the discovery of novel medicines in China and the world. We hope to bring revolutionary therapeutic solutions to patient as soon as possible".

"At present, China’s innovative drug discovery is in a golden period of time with vigorous development and progress. In a very rapid fashion, Abbisko has built up a top notch R&D team and established a strong pipeline." said Ai’min Wu, Partner and President of Sinopharm Capital. "Sinopharm Capital fully recognizes Abbisko’s expertise and strategy and believes in that, under the leadership of Dr. Yao-chang Xu and the management team, Abbisko has a great potential to become one of the leading biopharmaceutical companies in China and in the industry. Sinopharm Capital is pleased to participate the creation and development of Abbisko Therapeutics and will continue to dedicate in helping domestic biomedical companies to be competitive with international leading players.

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On February 6, 2017 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported top-line results from the randomized, double-blind, placebo-controlled Phase II trial testing the efficacy of lirilumab as a single agent maintenance treatment in elderly patients with acute myeloid leukemia (AML) in first complete remission ("EffiKIR" trial) (Press release, Innate Pharma, FEB 4, 2017, View Source [SID1234517640]). The study did not meet its primary efficacy endpoint of leukemia-free survival (LFS).

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Two arms of the trial tested single agent lirilumab at different doses and treatment intervals (0.1 mg/kg q3months or 1 mg/kg q1month) whereas in the third arm, patients received placebo. There was no statistically significant difference between either lirilumab arms and the placebo arm on the LFS nor on other efficacy endpoints. As announced in March 2015, one arm of the trial was discontinued upon DSMB recommendation. This arm has now been identified as the 1 mg/kg q1month arm of the trial. At the time of its decision, the DSMB assessed that the objective of achieving a superior LFS in this arm compared to placebo could not be reached. There was no concern with tolerance.

The adverse events encountered with lirilumab were consistent with the previously reported safety profile of lirilumab.

Data analyses are ongoing and the full trial data will be submitted to a future medical conference and for publication.

Lirilumab is being investigated in six trials sponsored by Bristol-Myers Squibb, across a range of solid and hematological cancer indications in combination with other agents, including nivolumab (see on clinicaltrials.gov).

Pierre Dodion, Chief Medical Officer of Innate Pharma, said: "Although we knew that this setting was challenging, we are disappointed by the results of the EffiKIR study and will investigate further to better understand the data in its entirety. However, Effikir is only one of seven studies currently investigating lirilumab. Lirilumab is tested in a broad and comprehensive combination program in multiple indications and we saw encouraging early efficacy signals of lirilumab in combination with nivolumab at the 2016 SITC (Free SITC Whitepaper) meeting. We are looking forward to the next data sets as well as the next steps for the program in 2017."

On February 2, 2017 Immune Therapeutics, Inc. (OTCQB:IMUN), a global specialty pharmaceutical company dedicated to advancing the science of affordable, non-toxic therapies in Emerging Markets, reported that the Dominican Republic’s Ministry of Health and Social Assistance has issued a Certificate of Pharmaceutical Product (COPP) for Lodonal (Naltrexone) (Press release, Immune Therapeutics, FEB 2, 2017, View Source [SID1234517625]). This certificate grants approval for the manufacturing and export of LodonalTM for the treatment of HIV/AIDS, opportunistic infections, inflammatory disease and cancer in the dosages specified in the filings.

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The approval of Lodonal (Naltrexone) was supported by a vast array of research including dossier, certificate of analysis, stability reports, pharmacology and toxicology reports as well as clinical data from several Phase II multi-center, randomized studies. The results of these studies and documents showed patients treated with LodonalTM reported significant improvements when compared with patients receiving placebo.

"We are thrilled with this certification as we are now only one step away of seeing all of our hard work come to fruition," said Noreen Griffin, CEO of Immune Therapeutics. "Before selling into the Nigerian market, we required three main approvals: We received our Drug Approval last year; our Certificate of Pharmaceutical Product which was announced today; and our final approval which is the Marketing Approval from Nigeria."

"The Certificate of Pharmaceutical Product is not just required for Nigeria," Ms. Griffin continued. "It is the cornerstone for exportation into any of the other countries we are engaged in. This certificate is required to follow the World Health Organization format as it provides quality assurance for the pharmaceutical products (LodonalTM) and the facility (Acromax). As we push forward in Nigeria, we are simultaneously leveraging the successful clinical trial results and NAFDAC approval to expedite the approval and distribution into other nations devastated by HIV/AIDS including Malawi, Equatorial Guinea and Senegal."

On February 2, 2017 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical-stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported its expected 2017 activities and milestones (Press release, Trillium Therapeutics, FEB 2, 2017, View Source [SID1234517631]).

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Phase 1 trials of TTI-621:
During the year, Trillium expects to make progress in the Phase 1b TTI-621-01 study (NCT02663518) of its anti-CD47 checkpoint inhibitor TTI-621 (SIRPaFc), which is designed to evaluate safety, pharmacokinetics and preliminary anti-tumor activity across a broad range of hematologic malignancies. One cohort of lymphoma patients is receiving TTI-621 in combination with rituximab, and the company will consider additional combination cohorts based on emerging preclinical data. Furthermore, given the good safety profile of the agent, further dose intensification is planned with the goal of achieving increased blockade of CD47.

In a second Phase 1 trial, TTI-621-02 (NCT02890368), patients with percutaneously accessible solid tumors are receiving intratumoral injections of TTI-621 with the goal of achieving a high level of localized CD47 blockade. The company expects to complete the dose escalation phase, and potentially begin an expansion phase in 2017. This trial provides a unique opportunity to closely characterize local anti-tumor immune responses and to assess the impact of TTI-621 treatment on the tumor microenvironment. Combination cohorts are also under consideration for this trial.

"We are aggressively advancing the TTI-621 clinical program through multiple efforts. After completing the phase 1a dose escalation trial in patients with lymphoma, where we observed preliminary evidence of anti-tumor activity at well-tolerated doses, we finished the year with robust enrollment in the 10-cohort expansion phase and recruitment continues to progress well. As our data mature, we intend to explore the addition of other cohorts to this trial. The TTI-621-02 solid tumor trial has enrolled its first patient and we expect this study to provide key scientific data for charting the course of our clinical development program, especially as it relates to combination therapies," said Dr. Niclas Stiernholm, Trillium’s Chief Executive Officer. "In TTI-621 we believe that we have a potent CD47-targeting agent, and we aim to identify cancers that depend upon the CD47 ‘do not eat’ signal to evade the immune system."

Trillium intends to provide an update on both ongoing TTI-621 trials by year-end. There may be additional opportunities to report on individual cohorts in both trials throughout the year.

Expanding the CD47 Franchise with TTI-622:
In 2017, Trillium is also planning to advance its second SIRPaFc fusion protein, TTI-622, into clinical testing. TTI-622 contains an IgG4 Fc region and is thus anticipated to have a different pharmacologic profile and enable greater exposures in patients than TTI-621 (IgG1 Fc). Like TTI-621, TTI-622 does not bind erythrocytes, and the company believes that this property could give TTI-622 best-in-class status among IgG4-based CD47 blocking agents currently in development. The company plans to submit an IND by the end of 2017 and begin enrolling patients in early 2018, with the goal of rapidly advancing this agent into combination studies.

"With the introduction of TTI-622, we are specifically targeting opportunities for drug combinations that are complementary to TTI-621. Our two SIRPaFc fusion proteins allow us to block CD47 and achieve different levels of Fc receptor engagement on macrophages, which we believe represents a diversified approach to targeting the CD47 axis in the treatment of cancer," said Dr. Bob Uger, Trillium’s Chief Scientific Officer. "CD47 is in its infancy as a therapeutic cancer target and we have chosen to apply a broad, science-driven investigative approach to maximize our chances of defining patient populations that will derive clinical benefit from TTI-621 or TTI-622 therapy."

Additional Preclinical Data and Small Molecule Pipeline:
In 2017 Trillium intends to continue investigating SIRPaFc in relevant preclinical models, focusing on combination strategies and mechanism of action studies. The company expects to report data at the 2017 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Washington D.C., as well as at other international scientific conferences throughout the year.

The company is actively investigating the competitive advantages and positioning of its orally available small molecule bromodomain and EGFR inhibitor programs and expects to provide guidance on the next steps in the first half of 2017. In addition, Trillium recently launched a discovery program against an undisclosed immuno-oncology target using its proprietary fluorine-based chemistry platform.

Trillium’s cash balance at the end of 2016 was approximately $50 million. A major component of the company’s business strategy continues to be a focus on evaluating potential partnering opportunities across all programs, which may help fund future growth.

The company also announced that its ticker symbol on the Toronto Stock Exchange changed to "TRIL" effective Feb. 1, 2017.