Theralase® Discovers New Anti-Cancer Vaccine

Toronto, Ontario – November 20, 2017

Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a leading biotech company focused on the commercialization of medical lasers to eliminate pain and the development of Photo Dynamic Compounds (“PDCs”) to destroy cancer has announced the discovery of a new anti-cancer vaccine.

This new anti-cancer vaccine was created by exposing Rat Glioma (RG2) cancer cells, representative of GlioBlastoma Multiforme (“GBM”), a deadly form of human brain cancer, to proprietary and patented stressors extracorporeally (outside the body) and then injecting this anti-cancer vaccine into rats to delay the progression of brain gliomas, utilizing a well-established animal model of GBM.

The data obtained in this model by Theralase researchers demonstrated a significant increase of 35% in the survival of animals versus control (no vaccination).

In previous research, Theralase reported that Rutherrin® (TLD-1433 + transferrin) injected intravenously (“IV”) into an animal diagnosed with GBM was able to effectively cross the Blood Brain Barrier (“BBB”) and localize preferentially to GBM tumors. Once localized, the drug is able to be activated by laser light, and / or potentially X-ray, to safely and effectively destroy the GBM tumours.

In light of the new discovery, Theralase is currently developing a comprehensive, multi-pronged Photo Dynamic Therapy (“PDT”) clinical procedure; whereby, a patient diagnosed with GBM would:

1)  receive an IV injection of Rutherrin®.

2)  receive laser light activation (via surgically inserted optical fiber and/or using conventional trans-cranial X-ray treatment, at levels at or below standard of care), at a specified number of hours post-injection (allowing Rutherrin® to cross the BBB and selectively be absorbed into their GBM cancer cells) to activate the drug.

3)  be provided a precise treatment to safely and effectively destroy their GBM cancer, with minimum side effects.

4)  receive repeat PDT treatments to induce an immune-mediated response.

5)  receive the new anti-cancer vaccine, created from their own tumour cells (or alternatively cancer cells from another patient, which tumour(s) have a similar genetic profile), to stimulate the body’s immune cells to hunt, recognise and destroy residual GBM cancer cells.

Malignant gliomas are not uncommon in patients, with an estimated 24,000 new cases and more than 14,000 deaths in the US, annually. In the majority of cases, they recur following initial treatment, especially for GBM, the most common and most lethal form of brain cancer.

Most patients do not survive beyond 2 years, post diagnosis.

For GBM patients treated with the current standard of care (i.e.: surgical removal of brain tissue, radiation and chemotherapy (temozolomide), the National Cancer Institute of Canada’s randomized clinical study reported that the five year Progression Free Survival (“PFS”) rate was determined to be 4%, with less than 10% of patients surviving more than five years, post diagnosis.

In Theralase conducted research, it was demonstrated that the anti-cancer vaccine, increases well-established biomarkers of the immunological destruction of GBM cancer cells, such as Adenosine TriPhosphate (“ATP”) and calreticulin.

Extracellular ATP quantification:

Cell surface expression of calreticulin was increased 85% over control:

Proinflammatory genes: IL-1b (key regulatory cytokine), Heat Shock Protein 70 (“HSP 70”) (important cellular stressor proven to enhance Antigen Presenting Cells (“APCs”)), Interferon-α (“IFN-α”) (cytokine important for inducing protective anti-tumour responses) and Granulocyte Macrophage Colony-Stimulated Factor (“GMC-SF”) (essential cytokine for processing and presenting tumor antigens for the priming of anti-tumour cytotoxic T lymphocytes) all play a major role in the immunological response of the body to cancer cells.

The Theralase conducted research has demonstrated that the new anti-cancer vaccine increases expression of:

1)  IL-1b by 10 times

2)  HSP 70 by 10 times

3)  IFN-α by 2 times

4)  GMC-SF by 3 times

To evaluate the new anti-cancer vaccine in animals, rats were vaccinated and then subjected to GBM induction. Vaccinated rats were able to survive 35% longer on average than non-vaccinated rats.

Post mortem evaluation detected a 700% increase in anti-cancer CD8+ T cells (“cancer-killer” cells) in the anti-cancer vaccine GBM tissue samples.

Based upon the collected data, Theralase researchers have established that the new anti-cancer vaccine, in a GBM RG2 cancer model is able to:

1)  demonstrate a source of tumor antigens for an immunologic, tumour specific, anti-cancer response

2)  potentially target micro-metastases of GBM in the brain unable to be removed by surgical intervention

3)  restore the body’s own complex immune and defense mechanisms to recognize and destroy GBM cancer cells.

Next steps planned by the Company to commercialize this technology include: optimization of the pre-clinical animal models, followed by a Phase Ib clinical study in a patient population presenting with GBM disease and pre-existing tolerance mechanisms, which are actively retarding the immune recognition and destruction of tumours in these cancer patients.

Manjunatha Ankathatti Munegowda, Ph.D., DVM, Research Scientist, Theralase, stated that, “In order to be effective, an anti-cancer vaccine must have an ample supply of antigens and be able to provide secondary responses required to stimulate the body to elicit an effective immune response. The Theralase anti-cancer vaccine has both, possessing multiple tumour antigens and adjuvants such as: TNFa and IL-1b. This anti-cancer vaccine could be used along with current debulking strategies, to help eliminate any residual disease. It is also able to serve as a protective vaccine to target and eliminate any possible relapses.”

Mark Roufaiel, Ph.D., Research Scientist, Theralase stated, “The data supports that the anti-cancer vaccine induces immunogenic changes in the highly aggressive GBM RG2 model. Our results demonstrate that the anti-cancer vaccine treated GBM RG2 cancer cells may be a source of tumor related antigens for induction of an immunologic, tumour specific, anti-cancer, therapeutic response. This advanced vaccination approach induces a potent anti-tumour effect with significant delay in tumour progression, and significant increase in animal survival; therefore, this new anti-cancer vaccine may be an ideal treatment to improve the clinical outcomes of standard of care treatments of various cancers; including, highly recurrent and/or treatment resistant tumours.”

Arkady Mandel M.D., Ph.D., D.Sc., Chief Scientific Officer, Theralase and the originator of Theralase’s vaccine technology stated, “As tumour cells frequently undergo high rates of mutation, resulting in the loss of single or multiple antigens, it would be ideal to choose a source of an antigen that can elicit a broad tumour-specific response. Theralase’s anti-cancer vaccine was designed to offer this distinct advantage, allowing APCs to process and present numerous patient specific tumour antigens to stimulate a strong T cell immunological response to prevent tumour escape. The stimulated CD4+ Th cells could also provide assistance to CD8+ T cells to generate a more direct and robust anti-tumour immunity and long-term memory. Moreover, the Theralase anti-cancer vaccine has been created to be suitable for all cancer patients, regardless of their diagnosis and / or human leukocyte antigen type. The Theralase anti-cancer vaccine based immunotherapy offers an exciting opportunity to target specific cancers, by becoming the “master regulator of immune responses” via activation of the most potent APC population for priming and activating naïve T cells to recognize and combat tumours.

Roger Dumoulin-White, P.Eng., President and CEO of Theralase stated that, “In the international scientific and medical community, it has long been understood that the immune system is the key to conquering cancer. We’re now at a point in the Company’s research and development phase, where this knowledge can be effectively translated into treatment solutions, such as this new anti-cancer vaccine, used in conjunction with our existing anti-cancer technology, to help cancer patients combat and defeat this deadly disease.”

About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF) in its Therapeutic Laser Technology (“TLT”) Division designs, manufactures, markets and distributes patented super-pulsed laser technology indicated for the treatment of chronic knee pain, and in off-label use, the elimination of pain, reduction of inflammation and dramatic acceleration of tissue healing for numerous nerve, muscle and joint conditions. Theralase’s Photo Dynamic Therapy (“PDT”) Division researches and develops specially designed molecules called Photo Dynamic Compounds (“PDCs”), which have demonstrated an ability to localize to cancer cells and then when laser light activated, effectively destroy them.

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For More Information:
Roger Dumoulin-White
President & CEO
1.866.THE.LASE (843-5273) ext. 225
416.699.LASE (5273) ext. 225