On February 11, 2019 Foresee Pharmaceutical reported an exclusive license agreement for the commercialisation of (6576.TWO) novel FP-001 program (leuprorelin depot), Leuprolide Mesylate Injectable Suspension (LMIS) ready-to-use subcutaneous depot formulations has been granted to Accord Healthcare (Press release, Foresee Pharmaceuticals, FEB 11, 2019, View Source [SID1234554013]).

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Under the terms of this partnership, Foresee, a Taiwan and US-based biopharmaceutical company, will receive a combination of upfront, regulatory milestones and sales milestones payments totalling up to 86 million US dollars in addition to a significant share of the product revenue in the territory. Accord Healthcare, a global biopharmaceutical company, will cover all costs of commercialisation in the territory.

The license agreement will cover the global market with the exception of the USA, mainland China, Japan, Taiwan and previously partnered territories, Israel, Turkey and certain Middle East countries.

Dr. Ben Chien, Founder and Executive Chairman of Foresee commented: "We are very pleased to have established this collaboration with Accord, whose established track record of successful registrations and launches of complex oncology and specialty products makes us confident that they will make our FP-001 portfolio a major success in their market. Accord has a remarkable commercial team and infrastructure in place and we are highly confident in their ability to successfully leverage their commercial platform."

James Burt, Executive Vice President, Europe said: "Accord is very committed to bringing complex, added value medicines to market, improving the standard of care and ultimately the lives of patients. This agreement will contribute another key therapy to our already extensive oncology franchise and our comprehensive footprint will ensure that patients and healthcare providers can access this differentiated cancer therapy. We look forward to a mutually beneficial, successful collaboration with Foresee."

On February 11, 2019 3SBio Inc. ("3SBio") (HKEX:1530) and Verseau Therapeutics, Inc. ("Verseau") reported a partnership agreement focused on the development and commercialization of novel monoclonal antibodies in the field of immuno-oncology for a broad range of cancers (Press release, Verseau Therapeutics, FEB 11, 2019, View Source [SID1234542367]). Verseau’s proprietary drug discovery platform generates first-in-class macrophage checkpoint modulators (MCMs) to benefit patients with cancer, immune and inflammatory diseases.

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Under the terms of the agreement, 3SBio will receive an exclusive license to develop and commercialize a select number of MCM antibodies for all human oncology indications in Greater China, including mainland China, Taiwan, Hong Kong and Macau ("Territory"). Verseau will be responsible for discovery and optimization of MCM antibodies for each program. 3SBio will fund and conduct antibody development, GMP manufacturing, and commercialization in the Territory. Verseau and 3SBio will be eligible to receive certain milestone payments and royalties on product sales both in the Territory and globally. 3SBio will also purchase $15 million of Verseau Series B preferred stock. Additional financial terms were not disclosed.

"Recent advances in immuno-oncology have produced unprecedented benefit to patients; however, many people with cancer still require more effective treatment options," said Dr. Jing Lou, Chief Executive Officer of 3SBio. "Our collaboration with Verseau provides 3SBio with access to novel and differentiated immune-modulating antibodies that will complement our growing innovative oncology portfolio. We look forward to partnering with the Verseau team."

"3SBio is an ideal partner for Verseau to rapidly advance our novel, first-in-class macrophage checkpoint modulators in immuno-oncology," said Dr. Christine Bunt, Chief Executive Officer and Chairman of the Board of Verseau. "3SBio is a pioneer in China’s biotechnology industry with a fully-integrated R&D, manufacturing and commercial platform."

About Macrophage Checkpoint Modulators

Verseau is broadening the therapeutic potential of immunotherapy by developing macrophage checkpoint modulators (MCMs) that regulate the functional shift to make macrophages more inflammatory or more tolerogenic depending on the disease context. While PD-1 inhibitors have provided great clinical successes, they are only effective in 10-15% of cancer patients. Macrophages demonstrate one of the highest infiltration rates in human tumors (~75%). MCMs cause tumors to turn highly inflammatory and stimulate multiple immune cell types, including T cells. Verseau’s therapies have the potential to significantly expand the number of patients benefitting from immunotherapy, including those unresponsive to PD-1 inhibitor therapies. Through its proprietary all-human translational system Verseau has validated more than two dozen targets amenable to different therapeutic modalities, including monoclonal antibodies (mAbs).

On February 11, 2019 Helix BioPharma Corp. (TSX: HBP), (FSE: HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer reported an update on the Company’s strategic plans (Press release, Helix BioPharma, FEB 11, 2019, View Source [SID1234533784]).

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Pre-clinical Development

The Company extended its collaboration with the Moffitt Cancer Center as a result of preliminary studies that show L-DOS47 may increase the activity of a PD-1/PD-L1 inhibitor in treating pancreatic cancer. Helix’s plan is to increase the clinical application of L-DOS47 with various combination treatments, including immunotherapies with checkpoint inhibitors.

Clinical Development

As previously announced on November 13, 2018, the Company’s L-DOS47 clinical development program is focused solely on combination therapies in patients with non-small cell lung cancer ("NSCLC").

The Company currently has two L-DOS47 clinical studies underway. The first is a US Phase I program (LDOS001) in combination with pemetrexed and carboplatin which is near completion and has only two more cohorts to complete the study. The second is a European Phase 2b program (LDOS003) in combination with cisplatin and vinorelbine which is ready to enroll patients.

The Company is actively working on an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for an L-DOS47 pancreatic cancer study in combination with doxorubicin ("LDOS006"). The company expects to file the IND application in March.

The Company is also considering a new L-DOS47 combination study with pemetrexed, cisplatin and immunotherapy, such as Keytruda ("LDOS007").

These clinical programs form part of the Company’s overall strategic plan which includes demonstrating L-DOS47’s broad utility as a drug in combination with leading treatments for lung and pancreatic cancer.

Licensing / Partnerships

The Company continues to work with Deloitte Corporate Finance Inc. The Company has engaged in dialogue with several targeted groups of potential qualified partners with the goal of negotiating on a prospective partnership, alliance or licensing transaction.

Divestiture of Polish subsidiary

The Company has been in discussions with a group that includes ACM Alpha Consulting Management AG ("ACMag") to divest a majority stake in the Company’s wholly owned subsidiary Helix Immuno-Oncology S.A. which the Company is working towards putting it to a vote for shareholder approval at its annual general and special meeting which is to take place no later than April 18, 2019.

Corporate Development

The Company has also been in discussions with several U.S. based financial advisory firms. These discussions include the raising of working capital to finance the Company’s drug development programs as well as exploring possible merger and acquisition opportunities and exploring U.S. listing alternatives, such as Nasdaq.

Conference

Dr. Heman Chao, Helix’s Chief Executive Officer will be the attending BIO CEO Conference in New York on February 11th and 12th and has scheduled several meetings with potential licensing partners and U.S. financial advisory firms.

On February 11, 2019 Kiadis Pharma N.V. ("Kiadis Pharma" or the "Company") (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company, reported that it is scheduled to participate in a panel at the Innovation for Health 2019 Conference and Global Investor Forum on Thursday, February 14, 2019 (Press release, Kiadis, FEB 11, 2019, View Source [SID1234533321])

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Innovation for Health
February 14, 2019, World Trade Center Rotterdam, Beursplein 37, Rotterdam, The Netherlands
Arthur Lahr, Chief Executive Officer, will participate in a panel discussion related to "Building a Winning Team for Innovation" held from 13:30 – 14:30 CET.

Innovation for Health is one of the premier events for Health & Life Sciences in the Netherlands and Belgium. It brings together key players in health and care, from bench to boardroom, start-up to multinational and from life sciences to medtech. Held in conjunction with Global Investor Forum, Innovation for Health brings together over 800 delegates and 60 influential speakers from across industry, academia, government, finance and patient-organisations with the purpose to contribute to a sustainable future of healthcare.

On February 11, 2019 Abeona Therapeutics Inc. (Nasdaq: ABEO), a leading clinical-stage biopharmaceutical company developing novel cell and gene therapies for serious diseases, reported the appointment of João Siffert, M.D. as Chief Executive Officer (CEO), effective immediately (Press release, Abeona Therapeutics, FEB 11, 2019, View Source [SID1234533293]). Dr. Siffert joined Abeona as Head of Reasearch & Development (R&D) and Chief Medical Officer (CMO) in 2018, and has served as interim CEO since November of last year. Dr. Siffert will retain his responsibilities as Head of R&D and CMO until a clinical development lead is identified.

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"The Board is confident that João has the right mix of character, leadership, and knowledge to focus Abeona on achieving near-term goals that will pave the way to long-term value for the company," said Steven H. Rouhandeh, Chairman of the Board and Executive Chairman. "His track record of leading successful therapeutic development programs and his experience at the Board level in gene therapy are well-suited to the opportunities that lie ahead for Abeona."

"I am honored to assume the role of CEO and thankful for the Board’s confidence in me. I look forward to leading and standing alongside a dedicated team of employees who are committed to bringing transformative treatments for patients in need," said Dr. Siffert. "The combination of important clinical milestones on the near term horizon, a world-class cell and gene therapy manufacturing facility, and the therapeutic potential of the next-generation AIM vector platform make this an exciting time to take the helm."

Dr. Siffert has successfully led multiple drug development programs from pre-clinical to regulatory approvals and commercial launches in the U.S. and Europe, and has held several scientific leadership positions in biotech and pharma, including programs in gene therapy. In 2017, Dr. Siffert was appointed to the Board of Directors of gene therapy developer AveXis, which was subsequently acquired by Novartis. He served as Chief Medical Officer for Ceregene from 2007 to 2011, where he was responsible for clinical development of adeno-associated viral (AAV2)-based gene therapies for Parkinson’s and Alzheimer’s diseases. Dr. Siffert also led the R&D and medical organizations at Avanir Pharmaceuticals and Avera Pharmaceuticals before most recently guiding translational research, clinical development, regulatory, and medical affairs and health economics as Chief Scientific and Medical Officer for Nestle Health Science. Before joining industry, Dr. Siffert spent seven years in academic practice as a neuro-oncologist. He holds an M.D. from the University of São Paulo and an MBA from Columbia Business School.