Q1 F2021: Business Update

Q3 F2020 Earnings: More Value to Add in 2020

Phase I Results at ASCO Bode Well for Lead Drug’s Prospects

Pioneer in Cancer Therapy Targeting Tumor Microenvironment (TME)

Virtual & In-person Roadshows / Conferences

Channelchek Premium. Access more at no cost. 

The site "channelcheck" is opened on the phone

Join the Channelchek Investor Community. Your name, email, zip, and investor type is all it takes to open the door to research reports, favorites tracking, and virtual and in-person roadshows / conferences. Even exclusive investment opps.

Take it to the next level. It doesn’t cost a penny.

Click “Log In” to agree to Channelchek.com <a href="#">Terms of Use</a> and acknowledge that Channelchek.com <a href="#">Privacy Policy</a> applies to you.

Welcome to the Channelchek Investor Community

Informed investors make more money. And it’s all about timing. Get it when it happens.

Inbox Intel from Channelchek.

Healthcare

Biotechnology

Helix BioPharma Corp.

Investment Appraisal
Helix Biopharma&#8217;s lead candidate medicine, L-DOS47, is a anti-cancer therapeutic designed to exploit the acidic tumor extracellular environment. L-DOS47 consists of two domains: 1) urease enzyme conjugated to 2) an anti-CEACAM6 camelid monoclonal antibody. The antibody serves as a targeting agent to deliver the enzyme urease to tumor sites (Exhibit 1). Urease is a plant enzyme, which does not exist in humans, but his enzymatic target or substrate, urea, is very abundant in the human body. When L-DOS47 is administered to patients, the plant urease enzyme converts natural urea into ammonia and generates a local pH increase. Cancer cells create a very acidic environment, low pH (concentration of hydrogen ions), in the tumor microenvironment (TME). Cancer cells thrive in this acidic tumor microenvironment (TME). In contrast, T lymphocytes or killer T cells struggle to defend the human body against cancer cells in the acidic TME. Helix Biopharma believes that L-DOS47 could potential revert this process. By increasing pH of TME, L-DOS47 might induce cell death, increasing the potency of chemotherapeutic drugs such as pemetrexed/carboplatin (PC). 
Exhibit 1 &#8211; L-DOS47 candidate medicine (&#8220;CEACAM6-Urease&#8221;) consists of the conjugation of the enzyme urease (green) to an antibody (yellow). The urease portion of the conjugate functions to increase the pH (less acidity) in the tumor microenvironment, whereas the antibody portion of the conjugate is responsible for tumor specificity as it recognizes and binds to tumor antigen CEACAM6 on the surface of cancer cells, but not on the surface of normal cells (cancer cells overexpressed abnormally high amounts of CEACAM6 on their surfaces). The urease enzyme converts urea into ammonia in the tumor microenvironment, which raises pH restoring function of immune system cells.
<img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/Snip20200514_23.png" style="width: 275px;height: 228px;float: none" /> 

Source &#8211; Helix Biopharma, Corp.
Data published by ASCO demonstrates a clinical benefit in 75% of patients treated with L-DOS47
Helix BioPharma yesterday announced results from a recently completed Phase I dose escalation clinical trial on the use of L-DOS47, in combination with pemetrexed and carboplatin, for the treatment of a type of lung cancer. The results were published by ASCO, Abstract e21680, titled &#8220;Phase I dose escalation study of immunoconjugate L-DOS47 in combination with pemetrexed/carboplatin in non-squamous non-call cell lung cancer (&#8220;NSCLC&#8221;) patients&#8221;. In the trial, 75% of treated patients showed a clinical benefit. 
Study design &#8211; In the study, fourteen patients with Stage IV histologically confirmed non-squamous NSCLC were enrolled in six cohorts receiving escalating treatment doses (consisting of four cycles of L-DOS47 in combination with standard of care doses of pemetrexed/carboplatin). L-DOS47 was administered weekly over 21 days in each treatment cycle. Six dosing cohorts (0.59, 0.78, 1.5, 3.0, 6.0, 9.0 micrograms per kg of body weight) were performed. 
Safety results &#8211; The maximum tolerated dose (MTD) could not be determined as no dose limiting toxicities (DLTs) were observed in the trial. The treatment was safe and well tolerated, with approximately 50.0% of patients experiencing at least one treatment emergent adverse event (TEAE) assessed as study drug-related, with 14.3% of patients experiencing at least one grade 3/4 drug-related toxicity. 
Efficacy results &#8211; Of the twelve patients evaluable for efficacy, 5 patients (42%) had a partial response (PR), 4 patients (33%) showed stable disease (SD) and three patients (25%) had progressive disease (PD). In the trial, the objective response rate or ORR (complete responses (CR) plus partial responses (PR)) was 42% and the clinical benefit rate (CR plus PR plus SD) was 75%. We view the efficacy results as promissing, 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 as there is no control group. 
The results from Helix Biopharma&#8217;s Phase I clinical trial on the use of L-DOS47 in combination with pemetrexed/carboplatin (PC) for the treatment of NSCLC confirm previous observations using experimental models. Using a NSCLC cell line known as A549, treatment with L-DOS47 increased the effectiveness of pemetrexed/carboplatin (PC) chemotherapies (Exhibit 2). A549 cell line consists of human adenocarcinoma alveolar basal epithelial cells, which was first developed from an extract of cancerous lung tissue from a 58-year old Caucasian male (J Natl Cancer Inst 1973, 51(5) p1417-1423). According to Helix&#8217;s medical hypothesis, the reduction in acidity (increase in pH) augment the efficacy of PC chemotherapy. &nbsp;
Exhibit 2 &#8211; In preclinical cancer models, the addition of L-DOS47 to chemotherapeutic drugs pemetrexed/carboplatin (PC) increased the effectiveness of these anti-cancer drugs (red columns) compared to the use of PC alone (blue columns). These preclinical results support Helix Biopharma&#8217;s efforts in human clinical trials to develop L-DOS47 as an anti-cancer drug to be used in combination with chemotherapy.
<img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/Snip20200514_21.png" style="width: 457px;height: 187px;float: none" /> 

Source &#8211; Helix Biopharma, Corp.
Historical comparison to previous clinical results
Merck &amp; Co. and collaborators conducted a human clinical trial known as KEYNOTE-021 evaluating pembrolizumab (Keytruda) in combination with pemetrexed/carboplatin (PC) for the first-line treatment of advanced non-squamous NSCLC. The study included a group of 63-patients, who were treated with pemetrexed/carboplatin (PC) alone. The overall response rate (ORR) to treatment in PC group was 30.2% (Journal of Thoracic Oncology 2019, 14(1) p124-129). Although the open label &#8220;Helix Biopharma study&#8221; included only 12 evaluable NSCLC patients, much smaller than the PC group of KEYNOTE-021 trial, the ORR of the Helix study was 42% versus 30.2% for Merck&#8217;s study. Historical data comparisons have many limitations, and are deemed less valuable than data from controlled human clinical trials. Without a head-to-head, controlled comparator trial designed with two group of patients: one group receiving L-DOS47 plus PC, and the control group receiving PC alone, it is difficult to assess the true efficacy of L-DOS47/PC drug combination. However, we believe the results from Helix&#8217;s Phase I trial indicate the need to evaluate L-DOS47 in a larger, controlled human clinical trial. This is a positive development for the Company as the L-DOS47 clinical programs can move ahead. 
Helix Biopharma has designed several studies to test L-DOS47 potential as an anti-cancer drug (Exhibit 3). In our view, a critical clinical trial in Helix&#8217;s overall clinical program is the evaluation of immunotherapy (Merck&#8217;s Keytruda) in combination with pemetrexed/carboplatin (PC) for the treatment of NSCLC. The KEYNOTE-021 clinical trial demonstrated a 56% ORR in patients treated with Keytruda plus PC. We believe the addition to L-DOS47 will increase the effectiveness of this drug combination as the reduction in TME&#8217;s acidity (increase in pH) will improve functions of T infiltrating lymphocytes and augment efficacy of chemotherapy.
Exhibit 3 &#8211; Helix Biopharma&#8217;s product pipeline shows several clinical programs on the use of L-DOS47 for the treatment of non-small cell lung cancer (NSCLC) and pancreatic cancer.
<img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/Snip20200514_22.png" style="width: 430px;height: 195px;float: none" /> 

Source &#8211; Helix Biopharma, Corp. 
Reiterating Outperform Rating
We value Helix Biopharma using a risk-adjusted discounted cash flow (DCF) model based on a WACC of 12%. The DCF model is risk-adjusted for probability of success of L-DOS47 in clinical development. We used a probability estimate to account for financial, clinical and regulatory risks. This probability model is based on data compiled by previous industry studies (Clinical Development Success Rates 2006-2015 by Biotechnology Innovation Organization, BioMedTracker and Amplion). Based on analysis of available preclinical and clinical data, we 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. We are reiterating our Outperform rating and $2.50 target price on the stock.

Helix BioPharma Corp. (HBP:CA)

Phase I Results at ASCO Bode Well for Lead Drug’s Prospects

Fundamental Analysis:

Rating: Log in to view

Q1 F2021: Business Update (HBP:CA)

Q3 F2020 Earnings: More Value to Add in 2020 (HBP:CA)

Phase I Results at ASCO Bode Well for Lead Drug’s Prospects (HBP:CA)

Pioneer in Cancer Therapy Targeting Tumor Microenvironment (TME) (HBP:CA)

Inbox Intel from Channelchek.