- Killing cancer by altering tumor environment
- Company's DOS47 technology is first-in-class and has many applications
- 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 only clinical program enrolling patients is Helix's US Phase Ib/II, so-called LDOS006 study (which is L-DOS47 in combination with chemotherapy drug doxorubicin) to treat metastatic pancreatic cancer The coronavirus (COVID-19) pandemic has affected enrolment so Helix is now adding two additional clinical trial sites in the US.
Patient enrollment has been completed in small cell lung cancer patients for the US Phase I LDOS001 study (L-DOS47 in combination with pemetrexed and carboplatin) and the European Phase II LDOS003 study (L-DOS47 in combination with vinorelbine and cisplatin).
In the LDOS001 study, Helix is now completing the anti-drug antibody assays, which have been delayed by the pandemic. Once that analysis is complete, the aim is to finalize the clinical study report by April, next year, the firm has said.
In May this 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.
In August, 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.
In another move, on November 10, the group said it had finalized the divestment of its remaining 49% stake in a Polish subsidiary. inking a definitive share purchase agreement with CAIAC Fund Management AG, as designed trustee of HIO Fund to purchase Helix's remaining holdings in the subsidiary, Helix Immuno-Oncology, for gross proceeds of PLN 6.7 million.
In its fiscal 2020 results to end-July, the firm reported total research and development (R&D) expenses for the 12 months of $5.86 million, up from $4.94 million in 2019.
It noted that during the fiscal year, it had held talks with various capital market firms in the US and Canada, over raising sufficient capital of between $15 million and $20 million to qualify for a NASDAQ listing and further advance its clinical programs. In keeping with a firm at this stage of development, the net loss from continuing operations was around $9.1 million for the year, versus a loss of around $7.5 million in 2019.
- More clinical trial activity and data
- More collaborations and deals
- Financing to allow for uplisting
What the analyst says:
Following the third quarter results and the divestment of its Polish subsidiary, Zacks Investment Research analyst John Vandermosten confirmed his valuation of the Helix Biopharma stock at C$2, which is significantly higher than the current share price of C$0.32.
This is based on a 15% probability of ultimate approval and commercialization for L-DOS47 in non-small-cell lung cancer (NSCLC) and pancreatic cancer, he noted. The model includes contributions from the US and Europe.
The analyst added that he expects pivotal trials to generate registrational data in 2025 for both indications and work with a partner will advance the candidate outside North America.
"Our 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."
Vandermosten said Helix had now streamlined its operations with the successful divestiture of the Polish asset and is expected to receive around C$2 million net "in short order".
"The company is also planning a capital raise in the near term that will allow an uplisting to the NASDAQ. With the additional capital and the two new sites planned for the LDOS006 trial, we see an acceleration in enrollment by 1H:21 and continued advancement of the pancreatic indication," he said.
"The opportunity for L-DOS47 extends beyond the US and Europe and the company has other programs in development that may ultimately generate value," the analyst added.
What the boss says:
Following news of the Florida-based Moffitt Cancer Center collaboration extension, 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.
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