28 June 2021

Apollon Formulations Kill Triple-Negative Breast Cancer (TNBC) Cells

Apollon Formularies plc (AQSE: APOL) ("Apollon" or the "Company"), a UK based international pharmaceutical company trading on Aquis Stock Exchange, is pleased to announce that its proprietary medical cannabis formulations were successful in killing triple-negative breast cancer (TNBC) cells in 3D cell cultures in third party independent laboratory testing. This finding is in addition to the results recently announced on May 18, 2021, that Apollon formulations were successful in killing HER2+ breast cancer cells. This testing was performed under a joint testing agreement with Aion Therapeutic Inc. (CSE: AION) ("Aion"), a BC based international pharmaceutical company trading on the Canadian Securities Exchange. 

Metastatic triple-negative breast cancer is an aggressive form of breast cancer with limited treatment options.¹ With TNBC, the three most common types of receptors known to fuel most breast cancer growth-estrogen, progesterone, and the HER-2/neu gene, are not present in the cancer.²  According to Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research, has stated "There is intense interest in finding new medications to help treat metastatic triple-negative breast cancer."³ 

Triple-negative breast cancer comprises about 10-20% of diagnosed breast cancers and is more likely to affect younger people, those of African descent, Hispanics, and/or people with a BRCA1 gene mutation.⁴ ⁵ TNBC accounts for approximately 200,000 cases each year globally.⁵ TNBC is associated with worse prognosis, early relapse after standard chemotherapy, a high frequency of metastasis to lung, bones, liver and brain, and a low overall survival compared to other breast cancer subtypes.⁶

The testing was performed by BIOENSIS, an independent, pre-clinical predictive pharmaceutical testing laboratory. The medical cannabis formulations were developed by Apollon Formularies Jamaica Limited ("Apollon Jamaica").

The testing results showed that Apollon Jamaica's medical cannabis formulations were effective in killing living triple-negative cancer cells directly (direct cytotoxicity). The Apollon medical cannabis formulations killed nearly 100% of the triple negative breast cancer cells in 3D cell cultures. ⁷

Stephen D. Barnhill, M.D., CEO of Apollon, commented, "Cannabinoids have been seen to exert 'antitumor' effects by a number of different means, including killing cancer cells directly as well as inhibiting transformed cell growth and tumor metastasis.⁸ Apollon Jamaica, using results from its proprietary artificial intelligence-based analysis on strain genetics, has cultivated and processed certain of its proprietary medical cannabis products with cancer treatment expressly in mind. We are excited that our formulations have been validated via independent laboratory testing to kill both HER2+ and triple-negative breast cancer cells in 3D cell cultures through direct cytotoxicity."

Dr. Herbert A. Fritsche, Chief Science Officer of Apollon and former Professor and Director of Clinical Chemistry at the University of Texas, MD Anderson Cancer Center, stated, "These remarkable results demonstrating the ability of Apollon formulations to directly kill nearly 100% of triple-negative breast cancer cells in 3D culture provide us independent scientific evidence of the success of these products in pre-clinical testing. Pursuant to the Research & Development and the Retail-Therapeutic medical cannabis licences issued to Apollon Jamaica by the Jamaican Cannabis Licensing Authority (CLA), we intend to make these formulations immediately available to licensed Jamaican physicians experienced in prescribing Apollon products, allowing them to begin immediately treating patients who have triple-negative breast cancer in Jamaica where the company's formulations are available by physician prescription. This will allow us to supplement these impressive laboratory results with clinical data from the treatment of human patients."

Commented Mr. Paul Burke, Chairman and CEO of Apollon Jamaica, "These Apollon formulation test results on TNBC and the plan to immediately begin treatments in Jamaica are extremely exciting developments for Jamaican women, in part,  because Women of African Ancestry (WAA) are disproportionately affected by triple-negative breast cancer (TNBC)⁹,Traditional chemotherapy, radiation and surgery cancer treatment protocols are expensive and require a great deal of infrastructure. As a result, many women in Jamaica and worldwide have gone without treatment or with only limited treatment." The Apollon Jamaica Chairman went on to say, "The Apollon medical cannabis formulations are expected to be comparatively much less expensive, providing an opportunity for more women to have their triple -negative breast cancer treated. I look forward to  bringing these formulations to market as quickly as possible and in a manner that allows Jamaican women with triple-negative  breast cancer, as well as women traveling from international locations to Jamaica as medical tourists for our treatment, to have access to high quality complementary and alternative medical care."  

Apollon and Aion expect to negotiate a joint licence agreement whereby Aion's subsidiary AI Pharmaceuticals Jamaica Limited  (AI Pharma) may exclusively license and use Apollon Jamaica's medical cannabis proprietary and intellectual property protected formulations to manufacture  products for sale in the US and Canada where legally allowed. This intellectual property licence would allow Apollon to benefit from Aion's sales in the US and Canada, where Apollon Jamaica is unable to sell medical cannabis products under current US and UK law. In both instances, medical care will be provided by physicians authorized to prescribe and/or recommend medical cannabis medications and treat patients in their jurisdictions.

The Directors of the Company take responsibility for this announcement.

Stephen D. Barnhill, CEO of Apollon, is also the Executive Chair of the Board of Aion Therapeutic Inc.

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For additional information, please visit www.apollon.org.uk or contact:

Apollon Formularies                                                     

Tel:                                         +44 207 907 9314

Stene Jacobs                      stene@apollon.org.uk 

Peterhouse Capital Limited (Corporate Adviser)             

Tel:                                         +44 207 220 9795

Guy Miller                           gm@peterhousecapital.com

Blytheweigh (Financial PR/IR-London)                 

Tel:                                         +44 207 138 3204

Tim Blythe                           tim.blythe@blytheweigh.com

Megan Ray                         megan.ray@blytheweigh.com 

About Apollon Formularies plc

Apollon Formularies plc is an international medical cannabis company headquartered in the United Kingdom. Apollon Formularies Jamaica Limited is a pharmaceutical company incorporated and operating in the Commonwealth of Jamaica and a contractual affiliate of Apollon.  Apollon Jamaica is licensed by the Jamaican government's Cannabis Licensing Authority (CLA) to purchase cannabis under tripartite agreements from licensed cultivators, process, perform research and development, and sell medical cannabis therapeutic products that include legal medical cannabis in order to treat various illnesses under medical supervision.

About Aion Therapeutic Inc.

Aion Therapeutic Inc. is an international pharmaceutical, nutraceutical and cosmeceuticals business headquartered in Canada. AI Pharma is a wholly owned subsidiary of Aion that is in the business of research and development of formulations and products that utilize mushrooms (functional and ones including psilocybin), fungi, and other natural formulations from medicinal plants in a legal environment that permits such work and discoveries. AI Pharma is focused upon the development of medicinal antiviral, antimicrobial, anti-inflammatory, anti-hyperglycemic, and anti-cancer compounds for use with the treatment of various diseases and ailments as well as general health promotion.

About BIOENSIS

BIOENSIS is the solution of choice of predictive pharmacology needs led by a scientific team with more than 40 years of combined experience in preclinical pharmacology. BIOENSIS is the premiere innovator of 3D pharmacology technologies that more accurately recapitulate the microenvironment of human tissues and tumors. Their cutting-edge technology has been validated and optimized in more than 130 cell lines and primary tissues, and their flexible technology enables assay customization and optimization for additional cell lines and organ tissues. They have a demonstrated track record of unparalleled commitment to and collaboration with customers to achieve their predictive pharmacology objectives.

Stephen D. Barnhill, M.D.

Dr. Barnhill is a physician, fellowship trained in Laboratory Medicine and an expert in Artificial Intelligence (AI), an inventor on more than 40 patents globally and a pharmaceutical and biotech executive with experience as a CEO in both private and public companies in the United States and internationally. Dr. Barnhill is the Chairman and CEO of Apollon and the President and a 49% shareholder of Apollon Jamaica, which shares he holds for the benefit of Apollon. Dr. Barnhill is also the Executive Chairman of Aion and serves as a director and executive officer of AI Pharma.

Disclaimer & Reader Advisory

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