List of Biologics Companies in Utah - 12

Applied Biosensors was established in 2013 to transform the production of life-saving medicines. The company has developed a biosensors and analytics platform for continuous monitoring of critical process parameters designed specifically for the biomanufacturing industry. The platform generates 1000X more process data in real-time compared to current off-line manual systems, and enables predictive analytics and models based on artificial intelligence and machine learning. Importantly, it is adaptable and scalable for any bioreactor: single use, glass or stainless steel, and it can be used in R&D and can scale up for GMP. Applied Biosensors mission is to provide its customers with comprehensive, high-quality solutions that improve productivity and process reliability thus resulting in superior biomanufacturing and life science products. For more information, visit www.appliedbiosensors.com

Clene Inc., a clinical-stage biopharmaceutical company, focuses on the development of various therapeutics for neurodegenerative diseases. The company has a nanotechnology drug platform for the development of orally administered neurotherapeutic drugs. Its lead drug is CNM-Au8, which is being studied in various clinical trials, including a Phase 2 study for the treatment of stable multiple sclerosis; a Phase 2 biomarker study in Parkinson’s; and Phase 2 and Phase 3 trials to investigate the potential for disease modification for neurodegenerative diseases. The company’s products also include CNM-AgZn17, a topical gel polymer suspension of silver and zinc ions that is being developed for the treatment of infectious diseases and to accelerate wound healing; and NM-PtAu7, a gold-platinum CSN therapeutic. Clene Inc. is based in Salt Lake City, Utah.

DiscGenics is a privately held, clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. DiscGenics is harnessing the restorative potential of cells native to the intervertebral disc to develop what we hope will be a profound therapeutic option for millions of patients suffering from the debilitating effects of back pain. DiscGenics’ first product candidate, IDCT, is a homologous, allogeneic, injectable cell therapy for the treatment of patients with mild to moderate degenerative disc disease.

Noorda-COM Pre-Accreditation Status Commission on Osteopathic College Accreditation (COCA) predoc@osteopathic.org Noorda-COM is a private institution situated at the edge of the East Bay Golf Course in Provo, Utah. Our mission at Noorda-COM is to empower our students with essential personal and professional skills needed to be competent, confident, and compassionate osteopathic physicians who are dedicated to meeting the healthcare challenges of the communities in which they serve. Our values align with instilling and fostering cultural awareness and ethical leadership, embracing diversity, and inspiring a servant's heart towards caring for the poor and needy. Noorda-COM offers osteopathic programs endorsed by local universities, Brigham Young and Utah Valley. Over the course of our program, students will expand on their medical experiences through simulation, clinical rotation, clerkship, and research projects. Our local healthcare providers are willingly partnered with us to complete this clinical portion of a medical education. Noorda-COM curriculum utilizes a blended classroom structure. No large classrooms, no regularly scheduled classes. Students will make their own schedule to meet in groups to complete modules and are assessed based on their progress. Module content is continuously being improved, since our staff is able monitor which lessons are effective with students and lessons that are not. Our campus is designed with the intention to create a stress-free environment. In addition to the incredible mountain-range view, our campus will have other attractive amenities including comfortable study areas for single person or group use, student and faculty lounges, fitness and recreation areas including access to the golf course and will be adjacent to campus housing.

Over the course of millions of years, nature evolved to create the world’s most awe-inspiring, life-changing health outcomes. Peel Therapeutics translates these evolutionary outliers to develop medicines for patients with cancer and inflammatory diseases. Using scientific and medical expertise, state-of-the-art technology and drug development knowledge, we redesign what nature offers into medicines for patients by tackling solubility, scalability, and bioavailability. Our clinical stage therapeutic pipeline treats a spectrum of devastating conditions, with a near-term focus on cancer and inflammation. At Peel Therapeutics, we push the limits of biology to develop highly effective and safe medicines for patients that transcend the incremental.

PolarityTE, Inc., headquartered in Salt Lake City, Utah, is a biotechnology company developing regenerative tissue products. PolarityTE's first regenerative tissue product is SkinTE®. PolarityTE has an open investigational new drug application (IND) for SkinTE® with the U.S. Food and Drug Administration (FDA) and is now pursuing the first of two pivotal studies on SkinTE® needed to support a biologics license application (BLA) for a chronic cutaneous ulcer indication. SkinTE® is available for investigational use only. Learn more at www.PolarityTE.com.

Q Therapeutics is a biotechnology company based out of 417 S Wakara Way, Salt Lake City, UT, United States.

Rebel Medicine is developing the next generation of local anesthetics that control pain locally and mitigate the need for opioids after surgery. Opioids after surgery can lead to addiction, respiratory depression, nausea, constipation, and death. These opioid-related adverse events are associated with prolonged hospitalizations and increased cost of care. Rebel’s long-acting local anesthetics will provide significant value to the customer, patient, and society alike by preventing addiction and reducing the cost of care. Headquartered in Salt Lake City, our team draws on firsthand experiences with active lifestyles to understand the real-world need for effective, non-opioid pain management solutions. This perspective drives our commitment to creating innovative solutions that improve patient outcomes.

ScyTek Laboratories, Inc. a Utah, USA corporation involved in the manufacture of diagnostic reagents Special Stains, Antibodies, Hematology, Microbiology, Hematoxlyn

SymbioCellTech (SCT) is an early stage, university spin out, that has developed stem cell-based technology that achieves euglycemia (glucose control) in Type-1 Diabetes, and will soon be adapted for Type-2 Diabetes. The SCT proprietary Neo-Iset therapy, comprising both pancreatic islet and mesenchymal stem cells, can be administered in a simple out-patient procedure resulting in glucose control identical to that of a normal healthy individual. Backed by rigorous NIH, VA and privately funded research and resultant data, SCT has completed pre-clinical trials and is preparing for FDA submission and approval to begin well-designed, controlled, clinical trials treating humans suffering from Type-1 Diabetes. FDA Investigational New Animal Drug (INAD) approval for diabetic companion animals has been approved and canine clinical trials are ongoing with outstanding results and outcomes.

Thunder Biotech, Inc. is an immune-oncology company developing patented MOTO-CAR™ technology - genetically engineered CAR macrophages - that help cancer patients' immune cells recognize and attack solid tumors. Traditional cancer treatments— like surgery, radiation, and chemotherapy—are often ineffective, invasive, and difficult to tolerate. Thunder Biotech is designing MOTO-CAR™s to be a more effective and humane therapy. Thunder Biotech's MOTO-CAR™s re-educate Tumor Associated Macrophages and restore their M1 ability to recognize and eliminate tumor cells. In addition, MOTO-CAR™s are armed with tumor specific receptors that directly adhere to the tumor cell surface allowing them to initiate tumor cell destruction and recruit the natural T cell response engaging them to eliminate the tumor. This T cell response will then provide the body with a memory response preventing tumor recurrence.

TikkunLev Therapeutics is on a mission to revolutionize the treatment of heart failure by targeting the underlying biology of failing heart muscle. Founded on the pioneering research of Professor Robin Shaw M.D., Ph.D., our lead program, TLT-101, is a precision therapy that targets the underlying protein trafficking defects in heart failure. Extensive preclinical data demonstrate an unprecedented efficacy and safety profile with our therapeutic approach. TLT-101 is in IND-enabling development for non-ischemic dilated cardiomyopathy (DCM), a severe and progressive disease that is a leading cause of heart failure. With cardiovascular disease remaining the leading global cause of death and 1 in 4 people expected to develop heart failure, our innovative approach aims to repair the heart and transform lives.