25 June 2019 - - US-based clinical-stage biopharmaceutical company ArTara Therapeutics has initiated development of TARA-002, a toll-like receptor 4 agonist (TLR4a), for the potential treatment of lymphangiomas (Lymphatic Malformations [LMs]), the company said.
This is ArTara's second pipeline program and the first to focus in the immunology and oncology therapeutic area.
TARA-002 is an investigational cellular therapy based on OK-432, an immunostimulant, currently approved in Japan and Taiwan, that has been the standard of care for LMs for over 20 years.
Lymphatic malformations are localized anomalies of the lymphatic vasculature that develop in utero or in infants, most commonly in the head and neck. LMs are estimated to occur in 1 out of 4,000 live births.
The only approved treatment for LMs in the US and Europe is surgical excision, which carries high rates of recurrence and surgical complications.
In partnership with Novex Innovations, a leading biologics CDMO, ArTara will build a US-based manufacturing facility for TARA-002 and initiate regulatory activities in the US to support marketing authorization for TARA-002.
TARA-002 is a cellular therapy based on OK-432, a genetically distinct strain of Streptococcus Pyogenes which is rendered nonvirulent through a proprietary manufacturing process.
This process retains the Streptococcus antigen properties while eliminating the infectious properties of the bacteria.
TARA-002's predecessor treatment, OK-432, has been the standard of care in Japan for LMs for over 25 years and has demonstrated statistical and medical superiority compared to surgery in a multi-center study conducted in the US through the University of Iowa.
In addition to its use in LMs, OK-432's attenuated Streptococcus Pyogenes modality has been approved in Japan as a potent biologic response modifier in adjunctive use with first-line oncology therapies in gastric and lung cancer, and as a direct agent in Thyroid, head and neck tumors and for cancerous pleural effusion and ascites.
ArTara is a rare diseases therapeutics company focused on optimising product candidates for patients suffering from rare diseases where there is a significant unmet need.
ArTara's current development programs focus on rare diseases of structural and connective tissues as well as rare hepatology/gastrointestinal and metabolic disorders with further programmes in immunology, beginning with investigational candidate TARA-002 for the potential treatment of Lymphatic Malformations.