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Combined Apollon and Aion Formulations Kill Breast Cancer Cells Through Multiple Pathways

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LONDON and TORONTO, May 18, 2021 /CNW/ - Apollon Formularies plc (AQSE: APOL) ("Apollon" or the "Company"), a UK based international pharmaceutical company trading on the Aquis Stock Exchange, and Aion Therapeutic Inc. (CSE: AION) ("Aion"), a BC based international pharmaceutical company trading on the Canadian Securities Exchange, are pleased to announce that joint testing has revealed their combined formulations to be effective in killing HER2+ breast cancer cells grown in 3D cell culture via three separate mechanisms: direct cell cytotoxicity, immune stimulated T-cell cytotoxicity, and macrophage induced phagocytosis. HER2-positive constitutes approximately 20% of all breast cancers.

Aion Therapeutic Inc. (CSE: AION) - Logo (CNW Group/Aion Therapeutic Inc.)
Aion Therapeutic Inc. (CSE: AION) - Logo (CNW Group/Aion Therapeutic Inc.)

The testing was performed by BIOENSIS, an independent, pre-clinical predictive pharmaceutical testing laboratory. The medical cannabis formulations were developed by Apollon's affiliate, Apollon Formularies Jamaica Limited ("Apollon Jamaica"), and the medicinal mushroom formulations were developed by AI Pharmaceuticals Jamaica Limited ("AI Pharma"), a subsidiary of Aion.

The testing results showed that Apollon Jamaica's medical cannabis formulations were particularly effective in killing living HER2+ cancer cells directly (direct cytotoxicity), while Aion's medicinal mushroom formulations were most effective in stimulating the immune system's T-cell production to attack and kill HER2+ cancer cells and through macrophage induced phagocytosis. When the two formulations were combined, nearly 100% of HER2+ breast cancer cells in 3D cell cultures were killed through the three different pathways.

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. 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 HER2+ breast cancer cells in 3D cell culture through direct cytotoxicity."

Dr. Herbert A. Fritsche, Chief Science Officer of Aion and former Professor and Director of Clinical Chemistry at the University of Texas, MD Anderson Cancer Center, stated, "Our recent medicinal mushroom formulation testing demonstrated that two formulations, AION F7 and AION F8, when used together, showed high efficacy in killing HER2+ breast cancer cells via immune stimulated cytotoxicity by T-cells and macrophages. This result suggests that these Aion medicinal mushroom formulations have a similar effectiveness as Trastuzumab (Herceptin, Roche), a monoclonal antibody treatment." [See PRNEWSWIRE, Wed, April 21, 2021: Aion Therapeutics' Proprietary Mushroom Preparations Shown Effective in Killing Breast Cancer Cells.]

Added Dr. Barnhill, "It is our theory that use of a combination of anticancer therapies, especially ones involving separate treatment pathways, may have advantages over single-agent-based strategies as they may allow simultaneous or serial targeting of tumor growth, progression, and/or spreading at different levels with efforts to kill cancer cells. As a part of the independent laboratory testing, we have demonstrated that, when Apollon's medical cannabis formulations are used together with Aion's medicinal mushroom formulations, nearly 100% of HER2+ breast cancer cells in 3D cell culture are killed through multiple different pathways. Pursuant to the Research & Development and the Retail -Therapeutic licences issued to Apollon, we intend to have Jamaican physicians begin treating patients who have HER2+ breast cancer in Jamaica where each company's formulations can be available by physician prescription. This will allow us to corroborate these exciting laboratory results by observing the results of treatment in human patients."

Worldwide, breast cancer is the most common cancer in women and accounts for the most cancer related deaths. In 2019, the breast cancer market totalled over US$20 billion, with 68% of therapies sold targeting HER2 or CDK4/6. [See: Nature. Vol 20, 340. (May, 2021). The breast cancer drug market.] Market research analysts Paul Wilcock and Rachel M. Webster of Decision Resources Group (part of Clarivate, London, UK) have predicted that the breast cancer market will grow 9% annually and be over US$47 billion by 2029.

Commented Mr. Paul Burke, Chairman and CEO of Apollon Jamaica, "These test results and the plan to begin treatments in Jamaica are very exciting developments. 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, or with only limited, treatment." The Apollon Jamaica Chairman went on to say, "The combined formulations of Apollon and Aion are expected to be comparatively inexpensive, providing an opportunity for all women to have their breast cancer treated. I look forward to collaborating with Aion with regard to our shared vision to bring these formulations to market as quickly as possible and in a manner that allows all Jamaican women with HER2+ breast cancer, as well as, women traveling from international locations to Jamaica as medical tourists for our treatment, to have access to quality care."

The testing occurred as a part of a Joint Testing Agreement between the parties and was authorized in accordance with Apollon Jamaica's Research & Development licence issued by the Jamaican government's Cannabis Licensing Authority (CLA). In the performance of services under the Joint Testing Agreement, each party confined its activities to those permitted by applicable law, with CLA licensed Apollon Jamaica performing medical cannabis activities and AI Pharma performing services involving functional medicinal mushrooms. Mushroom formulations containing psilocybin or psilocin, which comes from psychedelic mushrooms, were not included as a part of the joint testing.

AI Pharma currently has an agreement with Apollon Jamaica to license equipment and an agreement with Doc's Place International, Inc. to sublease space in order that AI Pharma can perform cultivation, research and development, processing and treatment services in Jamaica with regard to its medicinal mushrooms formulations. The companies next expect to negotiate a joint license agreement involving their formulations and intellectual property whereby AI Pharma may exclusively use Apollon Jamaica's medical cannabis formulations in their combined product lines in the US and Canada, and Apollon may exclusively use certain of Aion's medicinal (non-psilocybin) mushroom products in their combined product lines in Europe and Jamaica, where legal. This structure would allow Apollon to benefit from Aion's sales in the US and Canada, where Apollon Jamaica is unable to sell medical cannabis under current US and UK law. In both instances, medical care will be done by physicians and psychiatrists authorized to prescribe medications and treat patients.

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 Pharmaceuticals Jamaica Limited 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
Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or future performance. The use of any of the words "could", "intend", "expect", "believe", "will", "may", "projected", "estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company's current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, this release contains forward-looking information relating to the business of the Company. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to the parties. The material factors and assumptions include regulatory and other third-party approvals; licensing and other risks. The forward-looking information contained in this release is made as of the date hereof and the parties are not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Because of the risks, uncertainties and assumptions contained herein, investors should not place undue reliance on forward-looking information. The foregoing statements expressly qualify any forward-looking information contained herein.

* Endnotes

1.

Wilcock, Paul and Webster, Rachel M. The breast cancer drug market. Nature - online. 20, 339-340. (2021).

2.

Trefis Team and Great Speculations. Can Roche's Blockbuster Drug Herceptin's Sales Grow? Forbes – online. (Fri., 28 August 2019)

3.

Bowles, D.W., O'Bryant, C.L., Camidge, R. & Jimeno, A. The intersection between cannabis and cancer in the United States. Crit. Rev. Oncol. Hematol. 83, 1–10 (2012).

4.

De Petrocellis, L. et al. The endogenous cannabinoid anandamide inhibits human breast cancer cell proliferation. Proc. Natl. Acad. Sci. U. S. A. 95, 8375–8380 (1998).

5.

Hart, S.; Fischer, O.M.; Ullrich, A. Cannabinoids Induce Cancer Cell Proliferation via Tumor Necrosis Factor-Converting Enzyme (TACE/ADAM17)-Mediated Transactivation of the Epidermal Growth Factor Receptor. Cancer Res. 2004, 64, 1943–1950. [CrossRef]McAllister, S.D. et al. Cannabinoids selectively inhibit proliferation and induce death of cultured glioblastoma multiforme cells. J. Neurooncol. 74, 31–40 (2005).

6.

Patsos, H.A., Hicks, D.J., Greenhough, A., Williams, A.C. & Paraskeva, C. Cannabinoids and cancer: potential for colorectal cancer therapy. Biochem. Soc. Trans. 33, 712–714 (2005).

7.

Pertwee, R.G. (ed). Handbook of Cannabis (Oxford University Press, Oxford, UK, 2014).

8.

Sarfaraz, S., Afaq, F., Adhami, V.M. & Mukhtar, H. Cannabinoid receptor as a novel target for the treatment of prostate cancer. Cancer Res. 65, 1635–1641 (2005).

9.

Schwarz, R.; Ramer, R.; Hinz, B. Targeting the endocannabinoid system as a potential anticancer approach. Drug Metab. Rev. 2018, 50, 26–53. [CrossRef] [PubMed]

Cision
Cision

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SOURCE Aion Therapeutic Inc.

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Cision

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