Ark Animal Health is a wholly owned subsidiary of Sorrento. Ark was formed in 2014 to bring to the companion animal market innovative solutions issued from Sorrento’s human research and development activities. It is being organized to become a fully independent and self-sufficient organization once it reaches commercial stage (products ready to receive FDA approval).
Ark’s lead development program (ARK-001) is a single dose resiniferatoxin (RTX) sterile injectable solution. ARK-001 has received FDA CVM (Center for Veterinary Medicine) MUMS (minor use/minor species) designation for the control of bone cancer pain in dogs. Other projects include additional indications for RTX in areas such as chronic articular pain in companion animals, neuropathic pain in horses, and idiopathic cystitis in cats, as well as exploring development opportunities in the area of infectious diseases or cancer treatment.
SmartPharm Therapeutics, Inc. (“SmartPharm”), a wholly owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE), is a development stage biopharmaceutical company focused on next-generation, non-viral gene therapies for the treatment of serious or rare diseases with the vision of creating “biologics from within.” SmartPharm is currently developing a novel, DNA-encoded monoclonal antibody to prevent infection with SARS-CoV-2, the virus that causes COVID-19 under a contract with the Defense Advanced Research Projects Agency of the U.S. Department of Defense. SmartPharm commenced operations in 2018 and is headquartered in Cambridge, MA, USA.
In 2008, Concortis Biosystems was established with the goal to better serve the scientific and pharmaceutical community with high quality antibody drug conjugate (ADC) reagents and services. In 2013, Sorrento acquired Concortis, creating a top tier ADC company. The combination of G-MAB™ (fully human antibody library) with Concortis proprietary toxins, linkers, and conjugation methods has the potential to generate industry-leading, 3rd generation ADCs.
Concortis is currently exploring over 20 different ADC options (pre-clinical) with applications in oncology and beyond. On October 19, 2015, Sorrento announced the creation of Levena Biopharma as an independent entity to offer the market a broad range of ADC services from the initiation of an ADC project through cGMP manufacturing of ADCs to phase I/II clinical studies. For detailed information, please visit www.levenabiopharma.com
Bioserv, located in San Diego, California is a wholly owned subsidiary of Sorrento. Founded in 1988, the organization is a leading cGMP contract manufacturing service provider with over 35,000 square feet of facilities whose core competencies are centered in aseptic and non-aseptic bulk formulation; filtration; filling; stoppering; lyophilization services; labeling; finished goods assembly; kitting and packaging; as well as controlled temperature storage and distribution services to support Pre-Clinical, Phase I and II Clinical Trial drug products, medical device reagents, medical diagnostic reagents and kits, and life science reagents.
SCILEX HOLDING COMPANY (“Scilex”) , a majority-owned subsidiary of Sorrento, is dedicated to the development and commercialization of pain management products. The company’s lead product ZTlido® (lidocaine topical system 1.8%), is a branded prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with Post-Herpetic Neuralgia (PHN), which is a form of post-shingles nerve pain.
Scilex’s SP-102 (10 mg dexamethasone sodium phosphate gel), or SEMDEXA™, for the treatment of Lumbar Radicular Pain is in the process of completing a Phase III clinical trial. The company expects SP-102 to be the first FDA approved non-opioid epidural injection to treat lumbosacral radicular pain, or sciatica, with the potential to replace 10 to 11 million off-label epidural steroid injections administered each year in the US.
ACEA Therapeutics, located in San Diego, California is a wholly owned subsidiary of Sorrento. ACEA Therapeutics is committed to developing and delivering innovative treatments to improve the lives of patients with life-threatening diseases.
Our lead compound, Abivertinib, a small molecule kinase inhibitor, is currently under review by the China Food and Drug Administration (CFDA) for the treatment of patients with non-small cell lung cancer (NSCLC) containing the EGFR T790M mutation. It is also in clinical trials to treat hospitalized patients with Covid-19 in Brazil and US led by Sorrento Therapeutics. A second small molecule kinase inhibitor of ACEA, AC0058, has entered Phase 1B development in the US for the treatment of systemic lupus erythematosus (SLE).
Alongside a robust R&D organization, ACEA has established drug manufacturing and commercial capabilities in China to support our long-term growth. This infrastructure provides us greater control over our supply chain to make sure products are delivered to patients on-time.