What is the critical gap in cancer treatment that you are addressing?
Cancer researchers, biotech innovators and pharmaceutical companies have been searching for the “cure” over the past five decades. While a silver bullet cancer cure has not been identified, many candidate treatments for various cancers have entered the market ranging from chemo to immune based therapies.
The currently marketed cancer drugs work by sabotaging a particular protein or “target” that is essential for cancer cell survival. Unfortunately, the approach of targeting one component of a cell system is a fundamental flaw in how we develop drugs because the cancer cell will almost certainly find an opportunity for a work-around. For this reason, current cancer drugs lose their killing powers allowing tumors to return in a more aggressive and malignant response.
Singh Biotechnology is designing cancer drugs differently so that cancer cells cannot escape their drug’s killing effects. Singh’s approach is to create drugs that shut down the “master switch” of cancer cell growth, similar to shutting off the master switch of an electric circuit breaker box. Once the master switch is in the off position, all cellular pathways for growth are shut down, leaving cancer cells no ability to work around.
Importantly, Singh’s drugs are small, so small that they can in fact permeate all cells, including those in the brain and eyes, while leaving normal cells unharmed. These organs have been traditionally difficult to treat because existing drugs are too big to cross the cell membrane, the blood brain barrier and the blood retina membrane.
Singh’s lead drug candidate is called SBT-100 and has already shown preliminary success in animal models for various cancers, including hard to treat cancers such as pancreatic.
What is the key product development milestone you seek to fund?
Singh Biotechnology has already received Orphan Drug designations from the U.S. Food and Drug Administration (FDA) for pancreatic cancer and osteosarcoma. Therefore pancreatic cancer and osteosarcoma (which are considered rare cancers) will be the first cancer we test with our novel drug.
Singh has also obtained a favorable FDA review for a “pre-IND” briefing packet, which included preclinical data in triple negative breast cancer (TNBC), details about the manufacturing process for, and a proposal for toxicology studies in two species.
We are now raising funds to complete the required toxicology studies and move into phase one clinical trials for triple negative breast cancer.
How will funds be used?
The raised funds will be used for:
- 2 animal toxicology, safety, and efficacy studies
- Determining the best Liquid Chromatography-Mass Spectrometry (LCMS) bio-analytical method for drug analysis
- CMC (Chemistry, Manufacturing, and Controls) to scale-up to produce SBT-100 under good manufacturing practice conditions for investigational new drug (IND) enabling studies
- Investigational New Drug application fees
- Entry into Phase 1 clinical trials and ancillary expenses
What key resources have/will you acquire to facilitate the accomplishment of the above product development milestone?
Singh Biotechnology is a virtual company therefore all studies are being performed by independent contractors or scientific collaborators. We have already identified a contract manufacturing organization (CMO) and contract research organization (CRO) to aid us in conducting the toxicology studies and enter phase 1 clinical trials.
Funds raised on the Music Beats Cancer platform would solely be used for the advancement of our lead asset, SBT-100, by conducting the studies outlined above.
If your Technology were to disappear in the “Valley of Death” funding bottleneck how might this impact society?
There is a public misconception that cancer has not been cured because the “cure” has not been found. The truth is there have been hundreds of cancer treatments that have entered the market since 1971, when then President Nixon declared war on cancer. Many of these drugs unfortunately lose their potency because cancer cells figure out how to avoid the drug’s killing effects.
Singh Biotechnology’s SBT-100 however has the potential to maintain its drug killing effects by completely shutting down the cell’s ability to grow and divide. Therefore SBT-100 is positioned to revolutionize cancer treatment and significantly ease both the physical and economic burdens endured by society. If this technology fails to get funding, it would be a tremendous setback for science, medicine and most importantly for patients in need of treatment options.