Capabilities
Driving innovation in development, manufacturing, and IP
The use of DNA based technology to address anti-cancer immunotherapies and the development of vaccines requires strategic investment and the ability to scale.
At Imunon, we’ve built a bench of internal talent and key partners across science, research, commercialization, and manufacturing, enabling our non-viral DNA technology to go from sequence to the clinic to approved products in record time.
As a small biotechnology company, we are uniquely equipped to manage the full range of drug development from within our site: from bench discovery, to making the active pharmaceutical ingredient, to formulation, to invitro, invivo and animal testing, and finally to human clinical production and delivery. We have complete control over the entire process, including end-to-end quality control, testing and product release. This affords us enormous advantages in flexibility, speed and cost.
Our integrated inhouse processes also assure that at each stage of the development process, we fully understand the steps that are still to come. We can look ahead and around the corners as we progress candidates towards the clinic, thus avoiding being blindsided by unexpected downstream challenges.
Leadership
Our executive team has 50 combined years of experience in the biotech industry, including at global brands like Lilly, Biogen, Science 37, Valentis, Genemedicine, Novamax and more.
Key Partners
We believe in the power of collaboration and scientific progress – our partners include some of the world’s most respected organizations and institutions.
Formulation Development
IMUNON has developed the inhouse know-how in technology and development to take a scientific insight, turn it into an active ingredient and then formulate it into a drug which may be ultimately available as a commercial therapeutic. We have built our core capabilities around delivery systems, including novel polymers and liposomes that can take a portion of DNA or RNA and migrate it to a cell in the body. We have built impressive skills and a strong intellectual property foundation around our formulation, chemistry and delivery systems, with a particular emphasis on delivering DNA
End-to-end Quality Control
Despite our smaller size, we have the unique capacity to achieve complete inhouse control over development and release of our clinical candidates and products. We control all development from our site, and have the capability and capacity to do all testing and release, including ongoing stability testing. This is advantageous in that we are not forced to depend on outside contract manufacturing and development organizations (CDMO’s) to execute these steps on our behalf. This can help us achieve not only cost savings, but much greater flexibility and speed in our development timelines.
In-House Manufacturing
We recently launched a GMP facility, based in Huntsville, Alabama, which has produced drug product for multiple clinical trials, enabling simple handling an distribution leading to strong product margins at commercial scale.
- Internal capability to produce plasmid DNA and Facilitating Agent to support Phase 1 and Phase 3 Studies.
- 1,000 ft2 of space dedicated to GMP manufacturing
- Supported by adjacent GMP Quality Control Laboratory