Following the recent completion of preliminary studies of its NR2F6 small molecule modulators, Regen BioPharma will now move to understand the mechanisms of action and optimize its compounds for the treatment of autoimmune diseases such as psoriasis and cancer.
To secure its research and development efforts, the company recently filed a composition of matter patent application covering these NR2F6 small molecule modulators.
Regen’s recent experiments have demonstrated that the administration of its proprietary gene silencing compounds RG-NA01, RG-NI01, and RG-NI02 prevented cells of the immune system from producing quantities of inflammatory growth factors such as interleukin-17a and interleukin-2. These factors play a critical role in autoimmune diseases.
The positive results from these experiments are another step forward in the company’s goal to develop small molecules that target NR2F6 and either inhibit production of these factors or, in other cases, stimulate their production. NR2F6 is a molecular switch which controls genes associated with the immune response.
“We are currently at a point of concentrating on the aspects of these compounds that make them more powerful in treating autoimmune diseases and cancer,” Harry M. Lander, PhD, president and chief scientific officer of Regen, said in a press release. “Also, we are looking for a high level of predictability in treatment outcomes. Once we have achieved these goals, we will focus on moving forward towards clinical trials.”
“Our data are solid, but we need to move it to the next stages of development to be sure we have compounds that will be able to move forward into the clinic,” Lander said. “This includes answering some basic questions such as specificity (do our molecules only bind to NR2F6 or do they also bind to other proteins?), mechanisms of action (how exactly do these molecules turn NR2F6 on and off?) and other similar questions. This is a matter of following a well-known set of procedures to do these tests as all small molecule drugs must have these questions answered.”
Regen plans to develop compounds that can modulate the immune system up or down, which would mean the compounds would be able to treat certain conditions. Like turning a light switch on or off, the compounds may be used to treat cancer (turning a light switch off), or diseases such as psoriasis and arthritis (turning a light switch on).
“In lay terminology, the company is looking to compile more supporting data as it conducts more experiments. This is similar to fine-tuning a race car engine before the race,” said David Koos, Regen’s CEO and chairman of the board. “We need to understand the various aspects that lead to the best performance.”
Koos said Regen BioPharma’s management team believes in the social and financial value of its small molecule program involving NR2F6.
“Since January 2015, we have raised more than $3.2 million to move things forward,” he said. “This money has come from high net worth individuals that believe in the merits of the company’s research. Looking ahead, we anticipate a combination of continued investment by high net worth individuals, transitioning to partnering arrangements with one or more larger pharmaceutical companies to assist us with clearing clinical trials.”