The Problem: Current Drug Attrition Rates
Much of the cost of a new drug may be accrued in the cost of other drug failures. The attrition rates of cancer medications reaching FDA registration after first in man studies remains poor and the cost of these failures are enormous(1). The overall probability of approval of a drug is close to 9.5% and oncology drugs may fair even worse with only about 5% of compounds reaching FDA registration (2). Delivering a therapeutic compound to the vicinity of a tumor is not at all sufficient. This is like your mailman dropping your mail off at the end of the street. A great challenge in cancer therapy is to deliver efficacious doses of a drug into the right compartment within a tumor cell with minimal systemic toxicity. Our focus is on this journey.
of new cancer drugs fail in clinical trials.
Lack of efficacy and safety issues are the major causes of attrition in the clinic and account for close to 60% of drug failures (2). Many of these drugs may be discarded from further consideration for want of a more focused delivery pathway. While the revival of such compounds is an enormous economic opportunity, the desire to resuscitate such a failed drug can be greatly diminished by the gigantic outlay of resources required to re-tool such a compound. Early consideration of this technology during the conception of a drug is definitely the best approach.
Even if a drug reaches market approval, a patient may be left with challenging questions regarding the cost effectiveness of their therapy verses quality of life issues as they undergo repetitive treatment regimes. Achieving remission is often foiled by the rise of mutations that resist otherwise effective therapies. Addressing these challenges with cost effective and patient centric approaches is the goal of RJS Biologic’s drug development program.
Opportunities for a new drug delivery solution
The addition of integrated targeted delivery built into small molecules will reduce the total drug dose in circulation and we will mitigate dose limiting off-target effects such as delayed cardiotoxicity, bone marrow suppression, peripheral neuropathy and alopecia. The major strength of the RJSBio approach is that it actively drives drugs into defined intracellular compartments within cancer cells by hitchhiking on endogenous proteins rather than relying on simple passive diffusion or endosomal import pathways.
The utility of this approach is reliant on simple small molecule affinity-tethering compounds (MW ~ 300g/mole.). We can cost effectively adapt these delivery agents to deliver other therapeutic payloads and are actively seeking such corporate collaborations. Early access to potential payloads could allow RJS Biologics to assist in ferrying new compounds across the cell membrane and to assist our most precious anticancer agents in reaching their target. The tortuous path required to reach market approval is challenging enough, our job is to make this path a little smoother.
1). Alazraki M. It’s Getting Harder to Come Up With a Successful Drug. In; 2011 My Daily Finance.com
2). Kola I, and Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 2004;3:711