IN THE WAR OF BEATING CANCER, STARPAX BIOPHARMA BRINGS A DISRUPTIVE TECHNOLOGY TO SOLVE A PROBLEM THAT HAS PERSISTED FOR OVER A CENTURY
Over the years magnificent and ingenious drug solutions to cure cancer were brought to the market by pharma companies. Today new discoveries still provide small steady incremental improvements in cancer treatments, but the overall response to cytotoxic chemotherapy seems to be unable to move higher than an average of 40%, with results for solid tumors ranging from 14% to 60% depending of the type of cancer (Maldonado, Parsons, Chen). Many immunotherapy studies show that approximately half of all human would not respond to target immunotherapy solutions. Because chemotherapy and immunotherapy appear to show resistance to efficacy, an important question needs to be addressed: Do these treatments reach their target? Traditional chemotherapy, still the standard of care, only allows 0.001% to 0.01% of systemic dose to be delivered to a tumor. Recently published studies report that a median of only 0.7% of administered doses of new types of drugs(e.g., precision medicine, precision target drugs, nanocarriers, antibody-drug conjugates, etc) can reach tumors. But reaching a tumor is only the first step. A meta-analysis of 117 studies has shown that 90% of the tumor volume receives little or no drug at all during systemic administration of anticancer therapeutic agents. This is because tumoral blood vessels become chaotic and dysfunctional, and this deterioration restricts drug diffusion. Furthermore, the pressure in interstitial tumoral tissues becomes higher than that in capillaries limiting the diffusion of drugs outside capillaries and preventing them from being distributed throughout the entire tumor volume.
So, how can drugs be made to reach all cancer cells? Drugs don’t swim, they cannot travel through tumors without blood vessels, and they cannot be controlled precisely to move in specific directions so they can fill the entire tumor volume. A company that has taken a great leap in this regard is Starpax Biopharma (www.StarpaxBiopharma.com). Starpax has developped living Magnetodrones™ to address this important challenge. A Starpax Magnetodrone consists of a proprietary self-propelled bacterium created in laboratory after 800 mutations, on the surface of which are attached liposomes loaded with an approved drug. It is non-pathogenic, sensitive to magnetic fields, and aerotactic (can detect levels of oxygen). Starpax Magnetodrones are injected directly into the tumor. These Magnetodrones are so small they can swim through the interstitial spaces of tumoral tissues without needing blood vessels. Their path in the tumor is controlled by the Starpax PolarTrak into which the patient is positioned. The PolarTrak generates special monopole magnetic vectors that keep the Magnetodrones captive inside the tumor and take control of their movements in 3-D with millimetric precision (turning left, right, up, and down). This is all made possible by artificial intelligence creating algorithms that are based on the data transferred from magnetic resonance imaging system (MRI) of the patient’s tumor taken days before. Once injected into a tumor, Magnetodrones gradually release their drug along their path that aim to attack cancer cells throughout the volume of the tumor. Magnetodrones can even reach deep into hypoxic areas that contain stem cells, which are known to be important drivers of metastatic spread. Being aerotactic, they will accumulate in tumoral hypoxic areas because the low level of oxygen there is the same as that of their culture medium. In addition, Magnetodrones do not reproduce in humans. They will die within 60 minutes after injection because the temperature of the human body is too high for them to survive any longer. Independent preclinical trials on 120 animals demonstrated a 100% response rate. There were no observed side effects, and the drug was shown to spread throughout the tumor volume, even penetrating and accumulating in hypoxic zones. Calculations shown that an intratumoral injection of Magnetodrones instead of traditional systemic chemotherapy, the drug concentration is 3,500 times higher in tumors with 800 times fewer toxic molecules in the patient’s body. Independent analysis shown that Magnetodrones triggered an immune response with T cell, NK cell, and macrophage recruitment inside tumors. Furthermore, tests done with injections of Magnetodrones alone without their drug complement were able to demonstrate significant tumor regression. The company doesn’t expect this immune response would eradicate tumors on its own, but with this high number of T cells returning to the body and reproducing, we might expect they would attack floating cancer cells and metastases, all this without any drug circulating in the bloodstream. In conclusion, Starpax seems to provide three therapeutic effects in the same treatment: local chemotherapy, hypoxic zones therapy, and immunotherapy, all with no side effects.
Starpax has just completed the construction of three laboratories as well as its GMP Magnetodrones manufacturing plant. A PolarTrak has already been installed for clinical trials in a top-tier research hospital. The technology is not yet approved by the FDA but in 2023 Starpax plans to initiate its first human phase trials I/II (Bayesian protocol, adaptative design, basket trial) including six Unmet Medical Needs indications: pancreas, prostate, breast recurrence, head & neck, colorectal and vulva cancers.