Shuttle Pharmaceuticals will open the laboratory space in Gaithersburg, US, which is located within the Maryland Biotech Corridor. The state is home to approximately 3,000 biotech companies, as well as being the location of Shuttle’s headquarters.
A form 8-K agreement states that the laboratory and office space will cover 2,109-square-feet, and the lease has a term of just over five years, with an option to extend this for a further three years.
The company will not move into the space immediately, but is instead set to move in during June 2023.
Predictive biomarkers
According to Shuttle, the decision was taken to expand its space in the state to complement the development of the company’s lead candidate and accelerate broader diagnostic capabilities on predictive biomarkers.
The company is focused on developing radiation sensitizer agents, with its lead product candidate being ropidoxuridine. The potential treatment is able to sensitize cancer cells and select histone deacetylase inhibitors to sensitize cancer cells and stimulate the immune system.
Ropidoxuridine has been tested in phase 1 trials for the treatment of brain tumors and sarcomas, with the next development milestone expected to be the initiation of phase 2 clinical testing.
In terms of the specific indication being aimed at, Shuttle outlined that it is planning to advance its phase 2 clinical trial of ropidoxuridine in brain cancer patients undergoing radiation therapy for glioblastoma.
Theradex Oncology
In November 2022, the company engaged Theradex Oncology, a clinical research organization (CRO), to aid in the creation of the phase 2 study. At the time, Shuttle stated that it anticipates filing an investigational new drug (IND) application submission to the US Food and Drug Administration (FDA) in the second quarter of 2023.
Anatoly Dritschilo, CEO of Shuttle, said, “Radiation therapy is a proven modality for cancer treatment. However, by developing radiation sensitizers, we aim to increase cancer cure rates, prolong patient survival and improve quality of life when radiation is used as a primary treatment or in combination with surgery, chemotherapy and immunotherapy.”
Prior to securing CRO support for the phase 2 trial, Shuttle had entered into a manufacturing agreement with TCG GreenChem for the manufacture of ropidoxuridine in September 2022.
Alongside manufacturing duties, TCG GreenChem will also be involved in performing process research, development, and optimization work for the drug candidate. The work will also involve creating working standards of starting materials and intermediates to support the qualitative and quantitative analysis of the drug reaction progress, determination of impurities, total mass balance and assay yields of the reactions.
