What was the context that prompted the foundation of Hillstream Biopharma in the oncology arena?
Our driving mission is to improve and transform the lives of patients with drug resistant and devastating rare cancers through our new, cutting-edge platform and mechanisms. This is more than a corporate mission, as in my case it is also personal: when I was the CEO of another publicly traded company, we acquired the Quatramer technology from a Dana-Farber Cancer Institute spin out company. Around this time, my brother Todd was diagnosed with multiple myeloma. We started Hillstream precisely to advance this technology in oncology, with the purpose to capitalize upon the unique advantages of the Quatramer technology.
What is the Quatramer tumor-targeted platform, and what is its capacity to deliver drug and biologic combinations?
Quatramer is a tumor-targeted platform with capacity to deliver drug and biologic combinations. It allows us to leverage and exploit key tumor targets and novel emerging pathways such as Iron Mediated Cell Death to facilitate the delivery of potent drugs directly to the Tumor MicoEnvironment (TME), while sparing healthy tissue. By efficiently extending the circulation half-life, as well as targeting delivery to the tumor site, Quatramer traps drugs into the TME. This alleviates off-target toxicities. We are building a robust portfolio of long-acting, potent anti-cancer drug candidates using our Quatramer platform.
Our product pipeline includes DNA-based contents which hijack the tumor’s genetic code and kill the tumor from within by generating an array of cancer-killing cytokines, such as TNF-alpha and potentially others. The platform’s tunability stems from the fact that the system can be modified and adjusted to deliver single or multiple ratios of payloads in order to optimize synergistic mechanisms of action in lower doses in order to eradicate rare cancers and treatment resistant tumors with minimal or no treatment options. In addition, Quatrabody™ conjugates Quatramers with novel biologics developed against proprietary undruggable epitopes of PD-1 and other validated immuno-oncology targets with greater binding affinity than approved therapies.
What is HSB-121 and what potential impact can it have on the treatment of cancer?
Our most advanced candidate , HSB-1216, works by a new mechanism called ferroptosis, which is an iron mediated cell death modulator. We know that tumors require iron for their growth, and hence this drug acts by mopping up the iron within the tumor and denying these cancer cells of their needed iron. Without iron the cancer cells fail to multiply and die - what scientists call ferroptosis. There have been over 10,000 papers written on this mechanism over the past two years, whereas there were only a couple of hundred several years prior.
The active drug in HSB-1216 is unique and is a front runner in the ferroptosis area. This novel drug has already been tested in humans and has already shown an effect. The active was found to be efficacious in a clinical pilot study in Germany in devastating cancers, including triple negative breast cancer and epithelial carcinomas. We have found a way to make it more effective, safer and commercially viable, and we capitalize on this novel mechanism by using our unique Quatramer technology.
In our Phase 1 study we intend to test HSB-1216 in a variety of solid tumors. Although we have received orphan drug designation (ODD) in small cell lung cancer and uveal melanoma for HSB-1216’s active drug, we may pursue the Orphan Drug Designation in multiple indications. The drug has the potential to be used in cancer patients who have failed standard-of-care therapies.
What Impact do you think the Inflation Reduction Act (IRA) might have on innovation in the life sciences?
The drug-pricing-control legislation will definitely have very negative consequences. I think it is important to remember that prescription drug prices climbed more slowly than overall healthcare costs according to the most recent health sector economic indicators from Altarum. In addition, although healthcare costs are continuing to expand, they are growing at a slower pace than overall inflation.
I believe we should adopt legislation and policies that will help improve patient access and deliver savings to the healthcare system. Policies such as capping patient out-of-pocket costs, using negotiated rebates to provide savings to patients, implementing the existing state pricing transparency site and PBM reverse auctions will provide system wide savings while reducing patient costs for necessary prescription treatments.
Efforts to control drug prices through the IRA are flawed and will inevitably harm innovation and limit patient access to the most innovative life saving therapies.
There are other measures – such as step therapy guidelines, patient out-of-pocket cost caps and PBM reverse auctions – that could better address lowering patient costs while maintaining biopharmaceutical innovation which is critical in developing life saving medicines.
What are the main objectives for Hillstream in the coming years?
Firstly, we will initiate IND discussions with the FDA in the first half of 2023 for HSB-1216. Secondly, we will focus on the clinical development and positive clinical trials for HSB-1216. Thirdly, we want to demonstrate that HSB-1940 can be used to treat other cancer indications. As a fourth point, we will focus on building our products, helping patients, and hiring the right people. At the end of the day, there is only one thing that really matters in this business — helping patients get better.
