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Wednesday, Jul 6, 2022

Dog Drug Theory

Dr. Ilya Rachman has spent thousands of hours with patients since opening his Tarzana internal medicine clinic, Rachman Medical Group, eight years ago. Day in and day out, he has witnessed the perpetual cycle of rise and fall in the health of patients treated for cancer with the longstanding arsenal of chemotherapy and radiation. They may get better, but only for a while – and, too often, only to succumb to the disease when the cancer inevitably evolves. “The issue with the current approach to cancer is that we approach it as a relatively static problem,” Rachman explained. “But cancer doesn’t really care – it evolves, mutates and changes its shape.” That means the drugs that work on cancer at first often stop working when it figures out how to evade them. With that in mind, Rachman founded Immix Biopharma Inc. The L.A.-based startup has an ambitious goal: Cure cancer with drugs that are made faster and more efficiently, without the toxic side effects. To do that, the company has taken an approach to drug development that is more akin to the process of building an iPhone than the traditional means of building a medication: Take the best components from diverse scientific fields, from oncology to nanotechnology, and build a comprehensive product. Canine patient On Aug. 6, Immix announced that its drug Imx-110 had successfully brought a dog named Jerry into remission from late-stage lymphoma. Rachman was approached with the chance to treat Jerry by the pet’s veterinarian. The 10-year-old Vizsla had stage IV lymphoma, with bleeding from his spleen, lung metastases and poor liver function. Even with the standard course of chemotherapy and abdominal surgery, he was unlikely to survive. “He had a very dismal prognosis,” Rachman said. “Because of that, the vet and owner asked us to make Imx-110 available for compassionate use treatment.” Jerry was given a five-day course of once-daily injections of a low dose of the medication. Soon after, he was back to his normal energy levels and eating habits. His bleeding stopped, his liver function normalized and the swelling in his lymph nodes subsided – all signs that the treatment had worked. About five weeks later, the vet thought he detected a minor swelling. Just to be safe, Jerry was given another week of injections. To date, the symptoms have subsided and have not returned. Of course, Jerry is just one dog – Immix needs a larger cohort of canines to determine that the treatment holds true for others as well. Still, it is pushing ahead with studies in humans. It launched its first human trials with the drug earlier this year in collaboration with Dr. Paul de Souza at Western Sydney University School of Medicine in Australia. Meanwhile, the company also has dosed Imx-110 in its first two human patients as part of an ongoing clinical trial in Australia. The company expects to see preliminary data from that study by the end of the year, with more concrete results available in early 2019. Rachman believes his company’s approach to drug development – if it proves successful – could be a paradigm shift in the way the pharma industry creates new products. Unlike other firms in biotechnology, Immix does not license the technology behind its products from a major research institution. Instead, it’s a “virtual biotech” – the drugs in the firm’s pipeline were invented by Rachman, who pieced several existing treatments together into a product. “I decided to take what science already had, the technologies already available, and mold them into clinical products that benefit patients now or at least in the very near future,” Rachman said. Imx-110 was not formulated in a single lab. Instead, the components that make up the drug – a plant-based compound called curcumin, a bit of doxorubicin and a nanoparticle that allows the drug to be delivered effectively into the bloodstream – were molded into a product through collaborations between scientists and manufacturers across state and national borders. It was patched together from pieces ordered through a number of contract labs, shipped from one to another before being sent off to yet another lab for assembly. “It’s the same way that Boeing makes airplanes, or that Toyota assembles their product,” Rachman said. “I thought this was common sense, but not in biotech.” Most companies license technology from laboratories at major research universities, Vice President Ryan Witt explained. But this approach only gives a company assets, not necessarily comprehensive solutions. Immix’s plan is to build effective solutions to clinical problems, he said. “A lot of biotechs are built off of patents first,” Witt said. “Our goal is to build solutions to problems, not to take some sexy science and commercialize it.” The company’s near-term priority is to demonstrate the efficacy of its drug in hard-to-treat cancers, Witt said. If successful, Immix wants to license out the product to larger pharmaceutical companies for manufacturing and distribution, while Rachman and the rest of the team focus their energy on further drug development. Built in L.A. Outsourcing the development of Imx-110 has helped keep the company’s overhead low. From conception to the forecasted completion of a clinical trial of the drug in 15 human patients, the firm will spend just $3.5 million, according to Witt – a fraction of what it usually takes to bring a new drug into clinical trials. And while the prospective regulatory costs associated with bringing the drug to market will be high, the grand total will still likely be much lower than the several billion dollars often cited as necessary for the development of cancer treatments. Part of that can be credited to Rachman’s own frugality; he has not taken a salary in the six years since the company began. There was also a bit of luck involved: Rachman’s initial seed funding came from a highly experienced financial modeling expert who acted as a consultant on building out the firm. The evening after they met, the expert sent Rachman an email offering him an initial investment – even though the company had not yet been formalized. “It was pretty incredible,” Rachman said. “I wasn’t consciously looking for investment at that point, so it came as a pleasant surprise.” The funding was enough for Rachman to get the product out of his head and into a prototype. The concept showed efficacy against six different types of tumor cells, hitting all its key milestones. As the firm prepared to raise more money to scale up, Rachman realized just how lucky he had been to get that initial investment. “When you want to make a product that solves a problem, you run into tremendous issues because of the status quo in the biotech industry,” Rachman said. Potential investors don’t necessarily understand the technology, so they must rely on surrogate markers of validity in the form of Nobel prize winners. “That was not the case with us: There were no Nobel prize winners, I was not a proven executive, we didn’t have a track record of selling millions of dollars’ worth of medical products,” Rachman said. But the company’s good luck was certainly furthered by Rachman’s practical approach to product development. This mindset can be seen among other biotechnology entrepreneurs in Los Angeles, explained Dina Lofesky, executive director of the Los Angeles office of Biocom, a statewide advocacy organization for businesses in the life sciences industry. Laboratory space has not yet scaled up in keeping with the expansion of the region’s biotech cluster, a fact that means startups like Immix must get creative with their development process. “What makes L.A. different – and Ilya and Ryan are a great example of this – is that they’re focused on the end result and how to get there in the simplest, easiest, most effective manner,” Lofesky said. Rachman believes that if he and his company can show that their business model is capable of producing more effective drugs in less time – and at lower cost to boot – others in the industry will follow. Drug development may be a highly complex process, but it held back by financial incentives that reward “sexy” science over functional innovation. “The financial system is completely misaligned to the endpoints that are meaningful to patients,” Rachman said. “If you can connect the means to the ends, I think it’s going to unleash tremendous creativity and will be fantastic for the financial community as well as for the scientific community.”

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