PsyBio Therapeutics Corp., a biotechnology company developing a portfolio of psychoactive compounds aimed at the treatment of mental health disorders, told shareholders that it has filed “six additional provisional manufacturing patent applications” to expand its intellectual property portfolio.
The Oxford, Ohio-based biotech said it had filed the applications with the United States Patent and Trademark Office (USPTO) and they cover a “broad range of approaches to PsyBio's biologic methodology.”
PsyBio said that it remains interested in developing the intellectual property landscape within the psycho-targeted development drug arena.
READ: PsyBio Therapeutics is pioneering the next generation of targeted psychoactive medications
"Adding these new patent applications to our existing intellectual property portfolio demonstrates PsyBio's commitment to being a leader in developing psycho-targeted therapeutic candidates," PsyBio CEO Evan Levine earlier said in a statement.
Meanwhile, in clinical milestones, the company told shareholders that PsyBio has “successfully demonstrated the ability to manufacture PsyBio-11040, one of its first promising therapeutic candidates, at commercial scale.”
Scale up to full production was achieved utilizing a commercially available, stainless-steel bioreactor with integrated continuous readout probes as well as ongoing sample analysis to gather real-time data on the process. The company said it is expected that similar scale-up procedures and outcomes will be replicated across its therapeutic candidate strains as additional promising target candidates undergo tech transfer to commercial manufacturing. It expects to commence manufacturing on a commercial scale in the first quarter of 2022.
Significantly, the company highlighted that it has submitted its first pre-Investigational New Drug (IND) application meeting request to the US Food and Drug Administration (FDA) as part of the regulatory submission process. The pre-IND meeting request for discussions with the FDA was submitted in anticipation of filing the first of several clinical IND packages, said the company.
Meanwhile, in a corporate finance update, the company said it “filed and obtained receipts” for a final base shelf prospectus dated October 28, 2021, which is “expected to help facilitate institutional investor access to the company's securities.”
In other milestones, the company touted its inclusion in AdvisorShares Psychedelics Exchange Traded Fund, which is listed on the NYSE Arca under the ticker symbol (NYSE:PSIL). The fund was formed to actively manage investments in the emerging psychedelic drugs sector, noted the company.
PsyBio Therapeutics has a collaboration with Miami University, in Ohio where they have filed intellectual property for biosynthesized psilocybin, its intermediates, and other molecules. They have retained the global exclusive rights to a proprietary platform technology that biologically synthesizes psilocybin and other targeted next-generation psychoactive compounds that are produced naturally in fungi and plants.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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