- Unique therapies in the field of immuno-oncology, based on proprietary DOS47 platform
- Experienced management team
- Plans to uplist onto NASDAQ exchange
What Helix BioPharma Corp 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 modify the tumor microenvironment to become hostile for fighting immune system cells.
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 second candidate, V-DOS47, is in preclinical development for the potential treatment of breast cancer.
How is it doing:
In May, Helix BioPharma reported results from the Phase One L-DOS47 dose-escalation study on 14 patients in combination with pemetrexed and carboplatin in non-small cell lung cancer. Top line data will be published at the American Society for Clinical Oncology (ASCO) 2020 annual conference at the end of the month.
Of the 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 pointed out that the objective response rate was 41.7% and the clinical benefit rate 75%, noting that L-DOS47 appeared to be well tolerated with promising anti-tumor activity.
Meanwhile, the US Phase1b/II pancreatic study of L-DOS47 in combination with doxorubicin (LDOS006) continues to enroll patients and has dosed two patients. But the coronavirus (COVID-19) crisis is expected to affect patient enrollment.
The company said it is working closely with the clinical trial site and the hospital to ensure the best care is being provided to patients while ensuring Helix complies with the hospital's COVID-19 protocols.
On April 2, the group said it was taking protective measures and maintaining business continuity amid the coronavirus (COVID-19) pandemic.
It said the US Phase I L-DOS47 lung cancer study in combination with pemetrexed and carboplatin (LDOS001) had completed patient recruitment. Study reports are being compiled and an abstract has been submitted to a conference.
The European Phase II L-DOS47 lung cancer study in Poland and Ukraine (LDOS003) no longer requires patient enrollment and the firm indicated that the first stage of the study related to dose escalation would be concluded and progression to the second stage of the study would only proceed if a third-party was willing to partner with it and upon a confirmatory medical review.
Helix BioPharma revealed in March that it had closed a C$6 million placing to be used for working capital and research and development. The company spent around C$1.6 million on research and development (R&D) costs during its fiscal second quarter ended January 3, 2020.
The firm is also in the process of divesting its remaining 49% stake in a Polish subsidiary, which it hopes to complete before the end of fiscal 2020. Proceeds will fund clinical development programs and Helic will retain licensing agreements for future royalties and milestone payments.
What the broker says:
Following the L-DOS47 dose-escalation study results, Noble Capital Markets repeated an 'Outperform' rating and US$1.78 ($2.50) price target on the Helix BioPharma shares.
The broker's analysts said: "We view the efficacy results as promising, especially given that 75% clinical benefit rate is rare in this patient population. However, the study is designed as an open label trial, and as such, it is difficult to draw definite conclusions without a control patient group.
"Helix Biopharma plans to confirm the results in a larger trial using the treatment in combination with immunotherapy (Merck's Keytruda)."
The analysts said they believe results from ongoing clinical trials on the use of lead drug L-DOS47 will be positive, which could potentially act as a catalyst for the shares.
Noble's analysts pointed out that they had looked at a group of comparable biotechnology companies with a candidate medicine in Phase II clinical trials for the treatment of NSCLC and/or pancreatic cancer.
"The average EV of this group is $193 mm. Based on comparable analysis, Helix Biopharma's current EV represents an 34% discount to the peer group. Based on our valuation model, we calculate a risk-adjusted equity value of $240 mm and a twelve-month target price of $2.50. Based on our target, the potential implied return is 84%," they said.
What the boss says:
Helix BioPharma's CEO Dr Heman Chao said, when announcing that topline data from the recent L-DOS47 dose-escalation study in combination with pemetrexed and carboplatin in non-squamous non-small cell lung cancer will be published at the ASCO 2020 annual conference: “We are very optimistic with L-DOS47’s demonstrated excellent safety profile and encouraging efficacy data.”