Genmab Announces Updated 2016 Financial Guidance

On February 6, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) reported that it has updated its 2016 Financial Guidance (Press release, Genmab, FEB 6, 2017, View Source [SID1234517639]). Based on preliminary reporting, Genmab is improving its 2016 financial guidance published on December 20, 2016 .

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The table below summarizes our revised and previous guidance.
MDKK Revised Guidance Previous Guidance
Revenue 1,790 — 1,840 1,720 — 1,770
Operating expenses (750) — (800) (800) — (850)
Operating income 1,015 — 1,065 895 — 945
Cash position at end of year* 3,850 — 3,950 3,650 — 3,750
*Cash, cash equivalents, and marketable securities
The revenue range has increased primarily due to higher royalties on net sales of DARZALEX by Janssen and achievement of additional DuoBody milestones. Among other items, the operating expense range has decreased due to timing of clinical and pre-clinical expenses. The operating income range has increased due to the combination of higher revenue and lower expenses. Our cash position has increased mainly due to timing of operating expenses and other working capital adjustments.
As previously announced, the annual report for 2016 will be published on February 22, 2017.

Abbisko Completes Series A Round Financing of $ 28 Million

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.

Abbisko Therapeutics closes $28M in Series A financing

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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Innate Pharma announces top-line results from EffiKIR trial evaluating the efficacy of lirilumab as a single agent in elderly patients with acute myeloid leukemia

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."

Lieutenant Gov. Kathy Hochul Celebrates Launch of Innovative Immunotherapy Biotech Company Based in Buffalo

On February 3, 2017 Tactiva Therapeutics LLC, a new biotech company spun off from Roswell Park Cancer Institute, will create jobs as it develops some of the most promising concepts in the burgeoning field of cancer immunotherapy and accelerates the timeline for getting beneficial therapies to patients (Press release, Roswell Park Cancer Institute, FEB 3, 2017, View Source [SID1234518860]).

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Founded by a trio of Buffalo entrepreneurs, Tactiva will pursue and expand concepts originating from Roswell Park’s Center for Immunotherapy. Located within the New York State Center of Excellence in Bioinformatics and Life Sciences, immediately adjacent to Roswell Park laboratories and research support facilities, the company will create employment opportunities within the life sciences and develop new therapies designed to give cancer patients better, more effective treatment options.

"The new biotech company spun off from Roswell Park Cancer Institute showcases the potential for New York innovation to impact lives around the world," said Lieutenant Governor Hochul during an announcement at Roswell Park today. "Tactiva Therapeutics is a perfect example of how government, business and academia can join forces to accomplish great things, including creating more jobs for Western New York."

Tactiva’s lead platform is a unique approach to adoptive cell transfer (ACT), a form of immunotherapy in which a patient’s own immune cells are drawn from blood, genetically engineered, multiplied and injected back into the patient in order to launch a powerful attack against cancer. Tactiva’s novel therapies use particular types of immune cells and cell reengineering processes that have never been employed before, in a way that may prove beneficial for patients with many different kinds of cancer.

There are two main types of T cells, or T lymphocytes, within the immune system — the so-called "helper" T cells, and the "killer" T cells. Through preclinical studies at Roswell Park, the Tactiva team developed a way to make "helper" CD4 T cells also act as "killer" CD8 T cells that can destroy tumor cells, significantly extending the durability of the antitumor response.

"We’re using fundamental principles of how the immune system works to enhance the body’s own ability to attack and eliminate cancer cells," says Tactiva Co-Founder and Chief Medical Officer Kunle Odunsi, MD, PhD, FRCOG, FACOG, also Deputy Director, Chair of Gynecologic Oncology and Center for Immunotherapy Executive Director at Roswell Park. "We’re making the two main types of immune cells work together in a way that has never been tried before, and which we believe will have long-lasting effects for patients with some of the most persistent, hard-to-treat cancers."

Tactiva plans to initiate a clinical trial within the next year that will make this novel platform available to patients for the first time. Preclinical studies suggest that the Tactiva platform may be an effective approach for treating several different solid and liquid tumors, including some ovarian, pancreatic, prostate, lung, esophageal, melanoma and sarcoma cancers, as well as some forms of multiple myeloma.

"We will take a patient’s own stem cells, hematopoietic stem cells that are the progenitors of all other blood cells, and engineer them to express specialized T-cell receptors that recognize and target cancer cells without damaging healthy cells," adds Richard Koya, MD, PhD, Co-Founder and Chief Scientific Officer for Tactiva as well as Associate Director of the Roswell Park Center for Immunotherapy. "The self-perpetuating nature of the stem cells gives them the ability to provide lifelong protection against cancer, standing on guard like a sentry. While much will depend on our early clinical trials, we believe this may be a highly effective way to deliver a lethal and enduring hit to the tumor cells."

"This is a potent combination of benefits, and our team’s preclinical findings convince us that this is a highly promising approach for treating cancer and keeping it at bay for many years," says Tactiva co-founder and Chief Executive Officer Matthew Colpoys Jr., who has held numerous leadership positions during his three decades working in the pharmaceutical and medical-technology industries.

This strategy is a broadly applicable model that may, if it proves to be effective, be adapted to many different antigens and employed in a variety of different cancers, notes Dr. Odunsi, who is also Professor of Gynecology & Obstetrics in the University at Buffalo’s Jacobs School of Medicine and Biomedical Sciences.

The foundational concepts that Tactiva will develop were established in large part thanks to grants to Dr. Odunsi and his team totaling $25 million from the National Cancer Institute and New York State Stem Cell Science Program (NYSTEM).

"We’ve been excited about immunotherapy for a long time because of its great potential in treating cancer and improving quality of life for cancer patients," says Roswell Park President and CEO Candace Johnson, PhD. "Tactiva has developed a unique approach that shows great promise, advancing one of our key goals: to develop our best ideas and get them quickly to the patients who can benefit most from them."

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About Roswell Park:
The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. Founded in 1898, RPCI is one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email [email protected]. Follow Roswell Park on Facebook and Twitter.

About Tactiva Therapeutics LLC:
Tactiva Therapeutics is an immuno-oncology company specializing in potent cancer immunotherapy using a dual T cell receptor approach. For more information, visit www.tactivatherapeutics.com