TORONTO, ON--(Marketwired - Dec 23, 2016) - Helix BioPharma Corp. ("Helix" or the "Company") (TSX: HBP) (FRANKFURT: HBP), a clinical-stage, immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, announces today it has signed an exclusive out-license agreement with Xisle Pharma Ventures Trust ("Xisle") for the Company's late-stage, Biphasix™ technology platform, including the lead product candidate, interferon alpha. Xisle will be responsible for the continued clinical development and subsequent commercialization of the product for the treatment of HPV-induced, low-grade, cervical intraepithelial lesions. As part of its asset development strategy, Xisle has initiated collaboration with senior pharmaceutical executives at Altum Pharmaceuticals Inc., who possess extensive regulatory, clinical, and product development expertise.
Under the terms of the agreement, Xisle has paid an up-front fee and agreed to subsequent milestone payments as they advance the technology to registration and market approvals. Helix has retained marketing rights for certain territories. EVOLUTION Life Science Partners LLC, a division of Gordian Investments, LLC acted as advisor to Helix BioPharma Corp.
"This is an important milestone for Helix as it represents our ability to take a novel immunotherapy asset from discovery to out license," said Dr. Sven Rohmann, Chief Executive Officer for Helix. Dr. Rohmann added that, "We can now fully concentrate our financial and development efforts on advancing our clinical stage Tumor Defense Breaker and newest CAR-T program aimed at solid tumors."
About The Biphasix™ Topical Formulation System
The Biphasix™ Topical Formulation System is a platform technology for microencapsulating therapeutic compounds in multilayered, lipid-based microvesicles. These microvesicles have complex structures that include a variety of compartments into which drug molecules can be integrated. The principal application of the technology is in the preparation of topical dosage forms for the dermal (into the skin) or mucosal (into the mucosal tissues) delivery of large molecular weight drug compounds.
About Topical Interferon Alpha-2b
Topical Interferon Alpha-2b incorporates Helix's patented Biphasix™ drug delivery technology. It is a topical preparation that is intended to be easily self-applied to HPV-infected tissues, to deliver interferon alpha-2b into the skin and mucosal tissues.
L-DOS47 is Helix's first immunoconjugate-based drug candidate in development is based on Helix's novel DOS47 technology platform which the Company believes alters the tumor microenvironment from acidic to alkaline. The Company believes L-DOS47 represents an innovative approach in modifying the microenvironmental conditions of cancer cells which the Company also believes serves as a general defense against cancer drugs and immunotherapies. Breaking the tumor defense by changing the tumor micro environment from acidic to alkaline represents one of the forgotten hallmarks of cancer. L-DOS47 is intended to offer an innovative approach to the first-line treatment of inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer ("NSCLC"). L-DOS47 is currently being evaluated in two clinical studies, one in the United States ("LDOS001") and the other in Poland ("LDOS002").
The Company is leveraging its know-how in manipulating the tumor microenvironment, and its expertise in developing unique single domain antibody therapeutics to develop Chimeric Antigen Receptors ("CAR") for engineered T cell based treatment ("CAR-T"). CAR-T is a novel cell based treatment that uniquely leverages the patient's immune system to treat cancer. In one application, the patient's T cells are isolated and then transformed with specific CAR that recognize the cancer. The transformed T cells or CAR-Ts are infused back into the patient to affect the treatment. The Company has selected CEACAM6 and VEGFR2 specific CARs for treatment of solid tumors in several unmet medical indications. In addition, the Company's research program has selected CD19 and CD22 targets for hematological cancers.
About Helix BioPharma Corp.
Helix BioPharma Corp. is an immuno-oncology company specializing in the field of cancer therapy. The company is actively developing innovative products for the prevention and treatment of cancer and is positioning its core technology in the field of immuno-oncology as a unique Tumour Defence Breaker. Helix's product development initiatives include its novel L-DOS47 new drug candidate. Helix is currently listed on the TSX and FSE under the symbol "HBP."
About Xisle Pharma Ventures Trust
Xisle Pharma Ventures Trust ("Xisle") is an asset-based investor and developer of late-stage biotechnology assets. Xisle seeks to combine capital with proven drug and device management and undervalued, biotechnology intellectual property.
About Evolution Life Science Partners (EVOLUTION)
EVOLUTION is an investment bank focused on the needs of life sciences and healthcare companies through Gordian Investments, LLC, (member: FINRA/SIPC). EVOLUTION assists companies throughout their life cycle, including capital raising, licensing/partnering, and M&A. The senior bankers at EVOLUTION have an average of 25 years of investment banking and industry experience, executing hundreds of M&A, partnering and capital raising engagements, with an aggregate deal value of more than $125 Billion. EVOLUTION is based in San Francisco, CA and New York, NY. Gordian Investments is a registered broker-dealer with the U.S. Securities and Exchange Commission (SEC) and the Financial Industry Regulatory Authority (FINRA). http://evolutionlsp.com
Forward-Looking Statements and Risks and Uncertainties
This news release contains certain forward-looking statements and information (collectively, "forward-looking statements") within the meaning of applicable Canadian securities laws, without limitation, those relating to unique Tumour Defense Breaker™, which may be identified by words including, without limitation, "unique", "believes" "will", "may", "anticipated", "intended", "build". "effective", "continuing progress" and other similar expressions, are intended to provide information about management's current plans and expectations.
Although Helix believes that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties that may cause actual results or events to differ materially from those anticipated and no assurance can be given that these expectations will be realized, and undue reliance should not be placed on such statements. Risk factors that could cause actual results or events to differ materially from the forward-looking statements include those described in Helix's most recent Annual Report, including under the headings "Forward-Looking Statements" and "Risk Factors", filed under Helix's profile on SEDAR at www.sedar.com (together, the "Helix Risk Factors"). Certain material factors or assumptions are applied in making the forward-looking statements, including, without limitation, that the Helix Risk Factors will not cause Helix's actual results or events to differ materially from the forward-looking statements. These cautionary statements qualify all such forward-looking statements.
Forward-looking statements and information are based on the beliefs, assumptions and expectations of Helix's management on the date of this news release, and Helix does not assume any obligation to update any forward-looking statement or information should those beliefs, assumptions or expectations, or other circumstances change, except as required by law.