Helix BioPharma Corp. L-DOS47 Phase I Lung Cancer Trial Data to be released at ASCO 2020

RICHMOND HILL, Ontario, May 14, 2020 (GLOBE NEWSWIRE) — Helix BioPharma Corp. (TSX: HBP) (“Helix” or the “Company”), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, announces that topline data of the recently completed L-DOS47 dose escalation study in combination with pemetrexed and carboplatin in recurrent or metastatic non-squamous non-small cell lung cancer (“LDOS001”) will be published at the ASCO 2020 Annual Conference.

The ASCO publication details are:

Abstract: e21680

Title: Phase I dose escalation study of immunoconjugate L-DOS47 in combination with pemetrexed/carboplatin in non-squamous non-small cell lung cancer (“NSCLC”) patients.

Authors: Afshin Dowlati, Chandra Prakash Belani, George R. Simon, Heman Chao, Sarina Anne Piha-Paul; University Hospitals Case Medical Center, Cleveland, OH; Penn State Cancer Institute, Hershey, PA; Department of Thoracic and Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; Helix BioPharma Corp, Aurora, ON; Department of Investigational Cancer Therapeutics (Phase I Program), The University of Texas MD Anderson Cancer Center, Houston, TX.

NCT Registration number: NCT02309892

Results: Fourteen (14) patients were enrolled across 6 dosing cohorts in the study. No dose limiting toxicities were observed. Of the twelve (12) patients evaluated for efficacy, 5 patients (41.7%) had a partial response (“PR”), 4 patients (33.3%) experienced stable disease (“SD”) and 3 patients (25.0%) had progressive disease (“PD”). The objective response rate is 41.7%. The clinical benefit rate is 75.0%. L-DOS47, in combination with pemetrexed/carboplatin, appears to be well tolerated with promising anti-tumor activity against non-squamous NSCLC.

“I would like to thank the patients and their families who participated in our clinical study, as well as the principle investigators and associates who helped conduct the study,” said Dr. Heman Chao, Helix’s Chief Executive Officer. “We are very optimistic with L-DOS47’s demonstrated excellent safety profile and encouraging efficacy data.”

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 based on its proprietary technologies. Helix’s product development initiatives include its novel L-DOS47 new drug candidate and Chimeric Antigen Receptor (“CAR”) based cell therapies. Helix is currently listed on the TSX under the symbol “HBP”.

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Cautionary Statements
This news release may contain forward-looking statements with respect to Helix, its operations, strategy, financial performance and condition, including its activities relating to its drug development program, any anticipated timelines for the commencement or completion of certain activities such as raising sufficient capital, merger and acquisition activity, listing on a U.S. exchange and other information in future periods. These statements generally can be identified by use of forward-looking words such as “aims”, “transform”, “should”, “may”, “will”, “expect”, “estimate”, “anticipate”, “intends”, “believe” or “continue” or the negative thereof or similar variations. The actual results and performance of discussed herein could differ materially from those expressed or implied by such statements. Such statements are qualified in their entirety by the inherent risks and uncertainties surrounding future expectations, including: (i) Helix’s ability to operate as a going concern being dependent mainly on securing sufficient additional financing in order to fund its ongoing research and development and other operating activities; (ii) the generally inherent uncertainty involved in scientific research and drug development and those specific to Helix’s pre-clinical and clinical development programs (DOS47, L-DOS47, V-DOS47 and CAR-T); (iii) that any transactions contemplated herein are completed; and (iv) those risks and uncertainties affecting Helix as more fully described in Helix’s most recent Annual Information Form, which is available at www.sedar.com (together, the “Helix Risk Factors”). Certain material factors and assumptions are applied in making the forward-looking statements, including, without limitation, that sufficient financing will be obtained in a timely manner to allow Helix to continue operations and implement its clinical trials in the manner and on the timelines anticipated and 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, opinions, plans and expectations of Helix’s management on the date of this news release, and the Company does not assume any obligation to update any forward-looking statement or information should those beliefs, assumptions, opinions, plans or expectations, or other circumstances change, except as required by law.