Vektor Pharma TF GmbH and its team have been leaders in the design, testing, and manufacture of thin film drug formulations.
Vektor Pharma TF GmbH is a German narcotics manufacturer, developer, and researcher located in the district of Biberach, Baden-Württemberg, Germany. It is a wholly-owned subsidiary of XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT), which is a bioscience accelerator focused on next-generation drug delivery, diagnostic, and new active pharmaceutical ingredient investment opportunities.
For over a decade, Vektor and its team have been leaders in the design, testing and manufacture of thin film drug formulations, particularly transdermal patches and sub-lingual (oral) strips for the delivery of active pharmaceutical ingredients (“API”) for the treatment of pain and neurological conditions.
The highlights of the company’s drug formulation strategy for 2021 are:
- Construction of commercial drug manufacturing facility in Germany
- Four clinical studies in neurological indications in 2021
- Development of oral biosensor and contract development and manufacturing
- Psychedelic transdermal and sublingual drug formulation development
These initiatives are discussed in greater detail below.
Commercial manufacturing facility
In anticipation of Vektor’s drug product commercialisation schedule, and due to significant interest in contract manufacturing, Vektor is planning to build a new commercial drug manufacturing facility in Germany in 2021. Vektor has secured a property in the district of Biberach, near its current laboratory, and is currently in the due diligence process to ensure suitability of the land for construction and use as a commercial drug manufacturing and laboratory site.
The estimated maximum capacity of laboratory and manufacturing space that could be constructed on the property is 3,000 m2 (32,000 ft2). The Company is reviewing scalable construction options to synchronise manufacturing capacity and demand with the Company’s projected growth and timelines.
As a vertically integrated drug formulation research, development, and commercial production company, Vektor is well positioned to maximise the value of its physical and intellectual assets by way of:
1) development, manufacture, and distribution of XPhyto products
2) contract development and/or manufacture of products for third parties. The addition of in-house, scalable commercial drug manufacturing capability is expected to add significant value and optionality to XPhyto’s drug formulation business.
XPhyto’s drug formulation business is focused on neurological indications with strong market demand and the potential for improved patient outcomes. In 2020, XPhyto reported significant advancements in four drug formulation development programmes. In 2021, the Company is planning to complete one clinical pilot study in each quarter as follows:
- Rotigotine – transdermal patch in Parkinson’s disease
- CBD – oral/sublingual strip in treatment resistant epilepsy
- THC – oral/sublingual strip in anorexia/nausea
- CBD:THC (1:1) – oral/sublingual strip in Multiple Sclerosis associated spasticity
Each study is planned to be carried out over an approximately two-week period as an open label, randomised, crossover, two-period, two-sequence, single dose pilot study to assess the relative bioavailability of each product. Pending positive results, the company plans to advance the products toward a final pivotal study and application for regulatory approval.
The company is also currently in discussions with multiple potential commercial partners, licensors, and distributors and will be reviewing monetisation opportunities on a continued basis. In-house commercial manufacturing is expected to provide additional value to potential purchasers, partners, and licensors, and ultimately to XPhyto.
Development of oral biosensors and contract development and manufacturing
XPhyto’s diagnostic portfolio includes several novel peptide-based oral screening tests, under licence from 3a-diagnostics GmbH, for the detection of infectious diseases including influenza A, and oral health indications such as peri-implantitis. In 2020, XPhyto confirmed successful activation of its peptide-based biosensor program when delivered using Vektor’s sublingual drug delivery platform. In 2021, XPhyto plans to continue development and validation of its biosensor products and bring at least one biosensor product to market in Europe by the end of the year. In-house commercial manufacturing capacity, as set out above, is expected to maximise profitability of the biosensor commercialisation.
Since its inception, Vektor has worked for major and emerging drug companies to develop new dosage formulations based on its sublingual and transdermal drug delivery platforms. Vektor has produced generic drug formulations of Fentanyl, Rivastigmine, and Clonidine, as well as novel formulation of drugs in Parkinson’s disease, restless leg syndrome, incontinence, local pain, and abuse-resistant pain medications. Further, Vektor is currently engaged in the development of a sublingual drug formulation for a major European generic drug company.
Vektor provides its clients with a versatile and rapidly adjustable sublingual and transdermal dosage platform to create new delivery options for generic and novel APIs. With the addition of in-house commercial manufacturing capacity, Vektor is building a vertically integrated thin film company to significantly grow its contract development and manufacturing business.
Psychedelic transdermal and sublingual drug formulations
Psychedelic compounds are a promising new class of API with potential for the treatment of mental health conditions such as depression, anxiety, addiction, and trauma-related stress disorder. Psychedelics could provide a major improvement over currently available therapeutics for a global market with unmet medical need.
Vektor will begin planning and development work for the incorporation of various psychedelic compounds into its drug formulations. This is facilitated by Vektor’s drug delivery platforms in combination with XPhyto’s agreements for the development of industrial scale biotechnology processes for the production of psilocybin in Germany, and for the research and development of a broad range of psychedelic compounds, including psilocybin, mescaline, LSD, MDMA, and DMT, in Canada.
XPhyto believes that the development of standardised drug formulations with precise, predictable, and efficient API delivery for clinical study and therapeutic use is critical to advancing the field of psychedelic medicine.
The company will provide further information and updates for each of the business initiatives set out above via XPhyto’s news releases at www.xphyto.com.