Helix BioPharma advancing efforts to combat killer cancers with unique immuno-oncology therapies

Killing cancer by altering tumor environment DOS47 technology is first-in-class and has many applications Experienced management What Helix BioPharma does:  Helix BioPharma Corp (TSE:HBP) (OTCMKTS:HBPCF) is a clinical-stage biopharmaceutical firm focused on developing cancer drugs through immuno-oncology. For the uninitiated, immuno-oncology has been a big theme in cancer treatment in recent years. It is based around the idea that the human immune system is constantly searching for and getting rid of foreign particles from the body. But sometimes rogue cells slip past the body's defense system to become cancers. The idea behind the therapy is to provide the immune system with the tools to both unmask tumors and strengthen the body's ability to attack harmful cells. Helix BioPharma is developing an immune-oncology drug platform (DOS47) for the treatment of cancer that is designed to turn the tumor's environment to alkaline from acid, which, in turn, corrects an impaired immune system. The company says it is the only therapeutic in advanced development based on a unique mechanism of action and can be combined with chemotherapy, biologics and other novel treatments. The company's lead drug, L-DOS47, is in Phase II clinical trials for the treatment of non-small cell lung cancer and pancreatic cancer. It is also developing a number of Tumor Attackers, CAR-T, that are potential treatments for haematological and solid tumors. The company’s candidate, V-DOS47, is in pre-clinical development for the potential treatment of breast cancer. How is it doing: Helix posted its fiscal third-quarter results on June 15, 2021, reporting it had spent around C$1.9 million on research and development (R&D) costs in the period to April 30. R&D costs for the three months to April 30 were C$1.933 million, up from C$1.523 million in the same period a year earlier, the company said, as it reported three and nine-month figures. On the clinical side, the company said that for the LDOS001 study (a US Phase I L-DOS47 in combination with pemetrexed and carboplatin for lung cancer), it was aiming for a final clinical study report to be completed in September, this year. Elsewhere, a Phase II combination therapy study in lung cancer (LDOS003) will not be advancing without third-party partner funding, and so far, no third-party partner has been identified, the firm added. For the company's L-DOS47 immunotherapy chemo combination study in lung cancer, Helix said it was engaging key opinion leaders on the feasibility and design of the trial, and depending on this, among other factors, plans to submit an Investigational New Drug (IND) application by December, 2021. On the corporate side and after the period under review, Helix noted that in May, it had closed a C$3.5 million first tranche financing after a convertible security financing agreement with Lind Global Macro Fund LP. A C$6.5 million second tranche financing is also available provided both parties agree to close the second tranche. Helix also noted it was deferring plans for a Nasdaq listing to prioritize having its shares trade on the OTC Markets. The net loss for the three months to April 30 was C$2.554 million, compared to a loss of C$2.594 million loss it posted in the third quarter of fiscal 2020. In February, 2021, Helix announced the appointment of Dr Frank Gary Renshaw to its scientific advisory board, noting he is a healthcare industry executive and Oncologist-Hematologist drug developer with several decades of oncology drug development experience. He has provided medical and scientific expertise ranging from early-stage pre-clinical drug development to presiding over dozens of successful US. investigational new drug applications and European Medical Agency new drug submissions of which some have resulted in successful new drug applications. Dr Renshaw is currently the chief medical officer of Zhejiang DTRM Biopharma Co. Ltd. Previous roles included Medical Oncology Director at Eisai; Global Executive Director Level II, Oncology and Hematology R&D at Celgene Corporate; Executive Director at Celsion Corporation and Global Clinical Lead; and Clinical Pharm Lead at Bayer Health Care Corporation. He also participates in a number of oncology industry committees and task forces. Inflection points: Submission of Investigational New Drug (IND) application for L-DOS47 immunotherapy chemo combination study Clinical study report for LDOS001 Third party funding in LDOS003 study What the broker says: In a note on June 18, 2021,, following Helix BioPharma’s fiscal 3Q results, Zacks Small-Cap Research put a valuation on the stock of C$1.70 a share, almost double the current price of C$0.90. That valuation assumes a 2026 approval and launch of L-DOS47 in select markets including the US and Europe, the latter of which will be achieved through the efforts of partners, the Zack analysts noted. "Lead candidate L-DOS47 is in Ph2 clinical trials for pancreatic cancer in combination with chemotherapy. We expect pivotal trials to generate registrational data in 2026 and work with a partner will advance the candidate outside North America," they added. What the boss says: Following February's appointment news, Dr Heman Chao, Helix's chief executive and science officer said in a statement: "We are very excited to welcome Dr Renshaw to the Company's Scientific Advisory Board. Dr Renshaw brings a wealth of experience in oncology drug development and medical expertise to Helix. I look forward to working with the Scientific Advisory Board in continuing the advancement of L-DOS47 in the clinic." Contact the author at giles@proactiveinvestors.com