Carcinoembryonic Antigen-Related Cell Adhesion Molecule 6 (CEACAM6) is a protein that is over-expressed on the cell surface of a number of prevalent, hard-to-treat cancers and plays a major role in promoting tumour progression.
Helix BioPharma is advancing a proprietary platform of bio-conjugates to score with precision against solid tumours over-expressing CEACAM6.
The acidic tumour microenvironment (TME) is a hallmark of solid tumours and a major defence barrier against anti-cancer immunity, chemotherapy and immunotherapy. TME acidity is associated with cancer proliferation, metastasis, resistance to treatment and poor prognosis.
Our lead candidate, L-DOS47 is a clinical-stage antibody-enzyme conjugate (AEC) that modifies the TME of CEACAM6-expressing solid tumours.
Three Phase I studies of ascending doses of L-DOS47 as monotherapy and in combination with chemotherapy have been completed in NSCLC.
The greatest clinical benefit in recurrent or metastatic NSCLC has been shown in a Phase I, dose-escalation study of L-DOS47 in combination with pemetrexed/carboplatin, where the therapy was shown to be safe and well-tolerated at doses up to 9.0 µg/kg and of the 5/12 patients evaluable, all exhibited partial RECIST response (42%); 4 additional patients exhibited stable disease (33%) and 3 patients (25%) exhibited progressive disease, with an overall clinical benefit rate of 75%.
Helix BioPharma intends to assess the efficacy of L-DOS47 in combination with chemotherapeutics and/or checkpoint inhibitors in Phase II studies in the near future.
A Phase I/II, open-label, non-randomized dose escalation study of immuno-conjugate L-DOS47 as a monotherapy in non-squamous Non-Small Cell Lung Cancer (NSCLC) patients.
Chief Executive Officer
Jacek Antas is a shareholder of the Company, has spent more than 25 years in the financial services industry holding various positions in sales and consulting.
Mr. Antas obtained a master’s degree from the Warsaw School of Economics and has served as a board member of various
companies throughout his career.
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Chief Financial Officer
Mr. Murphy is a certified public accountant with over thirty years of experience in finance and operations management. He is currently a consultant with Danforth Advisors LLC (“Danforth”), a leading provider of outsourced strategic and operational specialists across functions in the life sciences industry. While at Danforth, Mr. Murphy has served over fifteen private and publicly held life sciences companies as CFO and CFO Advisor, helping them secure over USD 0.5 billion in financing and successfully execute pivotal asset transactions. Mr. Murphy functions as a consultant to Helix pursuant to a consulting agreement between the Company and Danforth.
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Medical Adviser
Thomas Mehrling (PhD in Pharmacology and MD) has over 20 years’ experience in multinational Pharma companies developing novel oncology compounds from preclinical research through to registration. Prior to entering the industry, he spent 13 years as an MD at the University Hospital in Frankfurt, working on preclinical and translational projects. He served as Director of European Oncology at Mundipharma International (2003–2013), building the company’s first European oncology business from the ground up out of Cambridge, UK, and completing the clinical development, registration and launch of two major products in Europe, DepoCyte® and Levact® (Ribomustin® and Treanda®). In 2013, he led the establishment of the Mundipharma Group’s start-up, Mundipharma EDO, developing anti-cancer therapeutics for solid tumours out of Basel, Switzerland.
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Chief Business Development Officer
Dr. Christof Boehler is a commercially oriented scientist with a proven track record in building and leading teams that successfully commercialize products and services in the life science industry. His core competencies are in technology transfer, business development and corporate governance with a focus on technology scouting, preclinical and clinical R&D, licensing, sales, capital raising and M&A.
Mr. Boehler is also a strategic advisor to Takeda.
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Director Quality Assurance
Kim is the Director of Quality Assurance at Helix BioPharma Corp. An experienced quality assurance professional with expertise in Canadian, US, and EU regulations, she has been involved in all aspects of Phase I/II biopharmaceutical product development over the years, including regulatory submissions, QC laboratory compliance, tech transfer and third-party oversight of CMC activities, clinical QA, and bioanalytical data analysis. Kim joined Helix in 2000, transitioning into QA in 2003. She holds a B.Sc in Biochemistry and a Ph.D in Veterinary Physiological Sciences, both from the University of Saskatchewan.
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Director Clinical Operations
Brenda is the Clinical Operations Director at Helix Biopharma Corp. A clinical research operations professional with 25 years of experience managing clinical trials, ranging from early Phase I to late Phase IIIb/IV studies, she brings experience in clinical study protocol writing and development, trial start-up and vendor management, and a proven track record in planning and managing clinical trials to quality standards, timelines and budget. Brenda joined Helix Biopharma Corp. in 2018, working to advance the clinical program of L-DOS47. She holds B.Sc and M.Sc. degrees from the University of Toronto, specializing in Nutritional Sciences and Human Biology.
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V.P. Drug Development
Praveen has experience working in the pharmaceutical industry for more than 25 years and has expertise in the development of drug products for small and macro-molecules using various dosage forms. He was involved in projects comprising the formulation development of generic drug products and their production and developed a novel transdermal drug product containing a protein-based drug (interferon alpha 2b) for the treatment of HPV infections.
Presently as a V.P. he manages the CMC-related activities (drug product formulation, technology transfer, quality, stability testing and interaction with regulatory agency) for the development of L-DOS47 drug product, an antibody drug conjugate, for the treatment of various cancers. He has a Ph.D. in Pharmaceutical sciences and he completed his post-doctoral fellowship in gene regulation. He was the author of multiple peer-reviewed published articles, a book chapter, and patents.
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Director
Jerzy Leszczynski is a shareholder of the Company, has spent more than 35 years developing businesses and has served in the capacity of board member of various real estate development companies. Mr. Leszczynski obtained his Master of Science in Chemistry from the Warsaw Institute of Technology.
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Director, Chair of Audit Committee
Janusz (John) Grabski is a lawyer specialized in corporate and real estate law with over twenty years of experience.
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Director
Malgorzata Laube has over 19 years of experience in nuclear medicine. In her last role with Alberta Health Services, she was the Department Supervisor, Nuclear Medicine at Royal Alexandra Hospital. Ms. Laube obtained a MSc degree in Environmental Engineering from the Warsaw University of Technology and is based in Edmonton, Alberta, Canada.
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Chairman of the Board
Jacek Antas is a shareholder of the Company, has spent more than 25 years in the financial services industry holding various positions in sales and consulting.
Mr. Antas obtained a master’s degree from the Warsaw School of Economics and has served as a board member of various
companies throughout his career.
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