Salarius is a biotech company developing targeted therapies to treat pediatric and other cancers, including advanced solid tumors
Despite the ongoing pandemic, Salarius clinical trials in Ewing sarcoma and advanced solid tumor continue to enroll patients. In an exclusive interview with The Fly, Salarius Pharmaceuticals’ (SLRX) David Arthur discussed how both trials are progressing, talked about the company's new EU patent, the expansion of the Ewing sarcoma trial and some upcoming milestones.
EU PATENT, PRESENTATION AT ODAC: The European Patent Office has recently issued a new patent for seclidemstat. Patent EP2744330 covers composition of matter and methods of use for seclidemstat, a potent reversible inhibitor of the LSD1 enzyme which is currently the subject of a Phase 1/2 clinical trial for Ewing sarcoma, a rare pediatric bone cancer, and a Phase 1/2 trial in advanced solid tumors. Salarius intends to validate this European patent in several important EU countries, ensuring protection of seclidemstat and other compounds in Europe through at least August 2032.
CEO David Arthur explained to The Fly that "the issuance of the European Union patent is yet another piece of the puzzle that build protection for our molecule. We now have 24 patents issued around the world for seclidemstat. There are nine additional patents still working their way through the approval process. This just builds our patent portfolio."
The company has also been asked to present seclidemstat data to the Pediatric Oncology Subcommittee to the Food and Drug Administration's Oncologic Drugs Advisory Committee, or ODAC. "We were one of only four companies that presented. We consider this to be a real honor and a validation of our program because the pediatric oncology subcommittee is focused on identifying potential breakthrough therapies and advising the FDA on working with companies like ours," the executive added.
EWING SARCOMA TRIAL EXPANSION: Salarius has also announced that its Ewing sarcoma clinical trial has been expanded to include Ewing-related sarcomas supported by clinical observations, including observation of seclidemstat activity in a patient with refractory Ewing sarcoma. "The recent month has been a great demonstration of Salarius ongoing implementation of our business plan. But the real highlight of the last few months is the clinical observations, including a patient in the Ewing sarcoma study that we feel showed clear and definitive drug activity in Ewing sarcoma," Arthur told The Fly. "That coupled with pre-clinical data gave us the confidence to expand our Ewing program to include Ewing-related sarcomas. We are very excited. We expanded from 20 patients to a total of 50 patients, from just Ewing to Ewing and three other types of Ewing-related sarcomas."
FUNDING INTO LATE 2021: Earlier this month, the company announced $6.2M gross proceeds in an underwritten public offering that closed August 3. "We also had tremendous interest from investors to put another $6.2M into the company not only to help us fund that trial expansion but also to increase our funding into late 2021," the CEO added.
TRIAL ENROLLMENT ONGOING: Ewing sarcoma Phase 1/2 clinical trial and advanced solid tumor Phase 1/2 clinical trial continue to enroll patients during COVID-19. While the CEO acknowledged that "This COVID-19 situation has affected all of us and every aspect of our personal and business lives and Salarius is not an exception," he also noted that "both clinical trials have continued to be prioritized very highly because these patients have failed all current therapies and these patients are desperately need potential treatment options." "We have continued to enroll patients. COVID, of course, as affected us and we have adapted. We have taken advantage of the FDA's opportunities that they presented to make participation in the trials easier for patients and we are continuing to work with our sites to ensure that we're doing having possible to continue enrollment. We are pleased that, so far, the disruptions that we have observed have been minimal and manageable."
UPCOMING MILESTONES: Looking out over the remainder of the year and early next year, the CEO believes "a lot of information will become available." "We are entering a very milestone rich and data rich 12 to 15 months. We will be enrolling not only in Ewing sarcoma but also in Ewing-related sarcomas and next year, hopefully, we will be able to disclose early patient information from both of those studies. We plan to be receiving another large disbursement of funds from the Cancer Prevention & Research Institute of Texas, which is non-dilutive funding. And we hope to be announcing even more studies that we think represent areas where seclidemstat can help patients," he told The Fly.