Innovation1 Biotech Profile
Innovation1 Biotech Inc. operates as a pharmaceutical company.
The company focuses on the discovery and clinical development of novel synthetic analogs of botanical Schedule 1 molecules addressing major unmet medical needs. The company takes already validated technologies and identifies opportunities to refine and reengineer them, eliminating deficiencies and creating products with more desirable performance attributes. The candidate molecules in the company’s portfolio have their genesis in natural product botanical chemistry but have been subsequently modified via synthetic chemistry to endow them with more favorable pharmaceutical characteristics.
On November 9, 2021, the company completed its acquisition of all of the assets, including intellectual property assets, relating to Mioxal, a nutraceutical complex composed of essential amino acids, natural coenzymes and minerals, held by ST Biosciences, Ltd., a company organized under the laws of England and Wales (STB).
On November 7, 2022, the company completed the disposition of all of the intellectual property assets and associated liabilities relating to Mioxal.
Pipeline
The company is delivering innovative change in the psychedelic and cannabinoid space through the development of a portfolio that addresses five independent clinical indications with fully synthetic prodrugs, wherein the current therapeutic armamentarium is inadequate or non-existent.
The first agent is a novel prodrug of psilocin, a molecule naturally found in certain mushroom species that has been shown to interact with hydroxytryptamine receptors in the limbic system of the central nervous system. Preclinical and human data support its use as a long-effecting agent for reduction of clinical depression. The company’s prodrug allows for a smooth pharmacokinetic profile, and avoids peak toxicologic side-effects, by blunting the maximal peak concentration.
The second agent is a novel prodrug of synthetic tetrahydrocannobivarin, a molecule naturally found in Cannabis that modulates the two principal cannabinoid receptors: CBR1 and CBR2. Preclinical data support its use in the treatment of drug addiction. The company’s prodrug, which is manufactured chemically without any connection to the Cannabis plant, allows for improved bioavailability and hence more stable and reliable concentrations of the drug in the central nervous system.
The third agent is a novel prodrug of synthetic cannabidophorol, a molecule naturally found in Cannabis, closely related to cannabidiol (CBD), that desensitizes several membrane-bound receptors in the brain (TRPV1, TRPA1, and GPR55) that impact neuronal excitability and seizures. The FDA (the U.S. Food and Drug Administration) has already approved Epidiolex (CBD) for the treatment of a childhood seizure disorder (Dravet syndrome). The company’s prodrug, which is manufactured chemically without any connection to the Cannabis plant, is expected to have improved bioavailability in comparison to CBD and its payload, cannabidophorol, is anticipated to be more potent than CBD in suppressing seizures due to its greater affinity for its biological targets.
The fourth agent is a second novel prodrug of a highly selective CB2R agonist payload, synthetic HU-308, which is structurally similar to tetrahydrocannabinol but without its psychotropic properties. HU-308 prodrug is manufactured chemically, without any connection to the Cannabis plant. Preclinical data support the use of this payload in the treatment of wounds, based on its role in blocking inflammatory injury and in triggering stem cell proliferation and angiogenesis required for prompt wound closure. The company intends to advance its HU-308 for the treatment of burn wound injury.
The fifth agent is a second water-soluble prodrug of HU-308, formulated as an eye drop for topical ophthalmic care. Preclinical data support the use of this payload in the treatment of uveal inflammation and corneal injury, based on its role in suppressing pro-inflammatory cytokine and chemokine expression and via stimulation of growth factors necessitated for the repair of damaged epithelium. The company’s prodrug allows for improved bioavailability and facile administration as an eye drop.
Research and Clinical Development Strategy
The company is in the pre-clinical development stage for its five pharmaceutical candidates. The company’s intention is to become a leader in the development of modified Schedule 1 molecules of botanical origin where there is the opportunity to effect breakthrough advances in diseases of unmet medical need.
Product Development
The company has engaged with Salzman Group, a U.S.-Israeli pharmaceutical firm that according to Salzman Group has designed and developed of novel small molecules for a number of clinical applications. The company has acquired five proprietary preclinical prodrugs, all fully synthetic without connection to botanical sourcing: a psychedelic molecule for the treatment of post-traumatic stress disorder and depression, a novel cannabinoid and tree bark derived psychedelic for the treatment of addiction, and three additional novel cannabinoid prodrugs addressing clinical indications of refractory pediatric epilepsy, hypertrophic scarring after burn wound injury, and ocular inflammation of the cornea and anterior uvea.
Intellectual Property
The company filed provisional patent applications protecting composition of matter and method of use of all the technologies described below. All of these applications are assigned to the company. The company will have the option to convert its provisional applications to full published patent applications in 2023. Within 30-31 months of the publication of the full patent applications, the company will have the opportunity to file national phase applications in up to 154 countries.
The company has the following approved trademark application with the U.S. Patent & Trademark Office (USPTO):
INNOVATION1 BIOTECH – U.S. Trademark SN 97195093
The company is reliant on its domain name, www.innovation1bio.com, to market its products.
Research and Development
The company’s research and development expenses were $201,165 for the year ended August 31, 2022.
History
The company was founded in 2014. It was formerly known as Gridiron BioNutrients, Inc. and changed its name to Innovation1 Biotech Inc. in April 2022.
