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

Killing cancer by altering tumor environment Company's DOS47 technology is first-in-class and has many applications Company has plans to uplist onto NASDAQ exchange What Helix BioPharma does:  Helix BioPharma Corp (TSE:HBP) (OTCMKTS:HBPCF) is a Toronto-based clinical-stage biopharmaceutical firm focused on developing cancer drugs through immuno-oncology. For the uninitiated, immuno-oncology is among the big themes of 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. But 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. It 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 preclinical development for the potential treatment of breast cancer. How is it doing: Currently, the group's lead candidate L-DOS47 is in two active clinical trials for the treatment of non-small cell lung cancer (NSCLC) and pancreatic cancer. A Phase 2b trial in Ukraine and Poland is evaluating the therapy in combination with vinorelbine/cisplatin in patients with metastatic lung adenocarcinoma. The study is ongoing, dose-escalation cohort is at the last stage. Another, phase 1b/2 combination study is using L-DOS47 with doxorubicin in patients with previously treated advanced pancreatic cancer. This trial is ongoing. In May last year, the group, which closed a C$6 million placing in March, reported positive results from the Phase I L-DOS47 dose-escalation study on 14 patients in combination with pemetrexed and carboplatin in non-small cell lung cancer. Of 12 patients evaluated for efficacy, five patients (41.7%) had a partial response, four patients (33.3%) experienced stable disease and three patients (25%) had progressive disease. Helix noted that L-DOS47 appeared to be well tolerated with promising anti-tumor activity. Then in August, 2020 the firm revealed it had extended its collaboration with Florida-based Moffitt cancer centre for a further year, building on the pair's progress so far. The pair have developed a new pancreatic cancer mouse model suitable for testing Helix's lead L-DOS47 drug alone or in combination with immunotherapies. And on December 16 last year, the group issued its first-quarter to October 31 - a period, which saw it reduce the net loss and spend C$1.084 million on research and development (R&D). For the three months, the company reported a net loss of C$222,000, reduced from a loss of C$2.21 million in the same period in 2019. This was due to a gain from its loss of control of its Polish subsidiary Helix Immuno-Oncology. R&D expenses in the first quarter were C$1.084 million, down from C$1.446 million in 1Q, 2019. Post period-end, the company, which continues to work towards a Nasdaq listing, closed a private placing of 2.2 million units at C$0.50 per unit, for total gross proceeds of C$1.1 million. The same month, the company confirmed it had closed the previously announced transaction with CAIAC Fund Management AG (CAIAC) to divest its remaining holdings in its Polish subsidiary, for gross proceeds of PLN 6.7 million (C$2.308 million). Inflection points: More clinical trial data More collaborations and deals Financing to allow for uplisting What the broker says: Broker Noble Capital in January, 2021 repeated an 'Outperform' rating on Helix Biopharma shares, with a target price of C$2.50 (current price: C$0.50). "In our opinion, the company is positioned well with multiple large market opportunities in cancer indications. We believe the current share price does not reflect the potential of Helix's pipeline. We foresee more visibility and value expansion in the next 12-months," it wrote in a note. In the near term, Noble analysts believe that data updates from two clinical trials in pancreatic cancer and non-small cell lung cancer will be major value generators, while the company also intends to raise capital and up-list on the Nasdaq stock exchange. Noble has chosen a group of comparable biotech firms with a candidate in Phase II clinical trials to treat NSCLC and/or pancreatic cancer, noting that the average enterprise value (EV) of this group is C$193 million. The  broker notes that, based on comparable analysis, Helix Biopharma's current EV represents an 34% discount to this peer group. What the boss says: Following news of the Florida-based Moffitt Cancer Center collaboration extension last summer, Helix chief executive Heman Chao told Proactive: "In this collaboration we believe now we have an animal model that we're improving on that will help us to study how our drug L-DOS47 will help the immune system. Eventually, in the third year, we hope to expand that to a clinical application." Chao said previous preliminary data had shown that the firm's drug, in combination with an immunotherapy drug, had shown potential improvement of the outcome of treatment, at least in mouse models. Contact the author at giles@proactiveinvestors.com