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Helix BioPharma Corp. Provides Clinical Development and Strategic Corporate Update

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.

Kiadis Pharma to participate in a panel at Innovation for Health 2019

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])

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.

Abeona Therapeutics Appoints João Siffert, M.D. Chief Executive Officer

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.

"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.

Recombinetics announces new CEO

On February 11, 2019 Recombinetics reported that named Mark Platt the organization’s Chief Executive Officer (Press release, Recombinetics, FEB 11, 2019, View Source [SID1234533249]).

"Recombinetics is at the forefront of innovative research and development to address issues of global significance, like feeding the hungry, improving population health and the humane treatment of animals," Platt says. "I’m joining at this transformational time to ensure the organization and its strategic investors thrive, with all aligned to positively impact people, places and animals at home and abroad."

"Our organization will benefit greatly from Mark’s leadership experience," says Peter Hajas, chairman of the Board, Recombinetics. "Mark brings an excitement for the possibilities of our innovative work and is the right person to guide our corporate culture and nurture relationships with key stakeholders to achieve goals of improving human lives, feeding the world’s growing population, and reducing animal suffering."

Platt’s experience includes his time as President and CEO of Multistack, LLC, in Sparta, Wis., where he provided strategic long-term direction of the company and was directly involved in emerging technology, research and development. From 2002 to 2012, Mark led the company through its highest period of growth, with total revenue increasing by more than 1,000 percent.

Most recently Executive Sales Leader at the Trane, Inc. Midwest sales office, Platt played a role in doubling the organization’s market share in less than two years. He was also Senior Vice President of Business Services for Gundersen Health System from November 2013 to April 2017. In this role, Platt oversaw business development and marketing, government relations, supply chain, facility operations and community wellness initiatives. He has also served on the Gundersen Board of Trustees.

Platt received his bachelor’s degree in electrical engineering from Vanderbilt University, Nashville, Tenn. He was also a commissioned officer in the U.S. Air Force with 17 years of service and held the rank of captain in the U.S. Air Force Reserve.

Tammy Lee, who served as President and CEO of Recombinetics since August 2017, is taking a leave of absence from the company. Recombinetics thanks Lee for her leadership, which included securing $34 million for the company’s Series A financing round.

Progenics Acquires AZEDRA® (iobenguane I 131) Radiopharmaceutical Manufacturing Facility

On February 11, 2019 Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer, reported that it has acquired the Somerset, NJ manufacturing facility for AZEDRA (iobenguane I 131) for cash consideration of $8.0 million (Press release, Progenics Pharmaceuticals, FEB 11, 2019, View Source [SID1234533235]). AZEDRA is the first and only FDA-approved radiopharmaceutical indicated for the treatment of pheochromocytoma and paraganglioma, ultra-rare cancers.

This Somerset site serves as the launch facility for AZEDRA and will also provide manufacturing support for the Company’s development stage radiopharmaceuticals, including 1095. The production of AZEDRA uses a proprietary Ultratrace process which concentrates the MIBG targeted radiolytic activity by eliminating non-therapeutic "cold" MIBG molecules, giving AZEDRA a uniquely high specific activity.

Progenics has also secured the long-term supply of iodine necessary for the production of both AZEDRA and 1095.

"This strategic transaction extends our leadership position in radiopharmaceuticals, establishing the infrastructure and manufacturing capabilities to label multiple types of isotopes, including iodine-131," stated Mark Baker, CEO of Progenics. "With this transaction, we are building the capabilities to ensure the supply of AZEDRA."