CHICAGO, IL, USA I January 17, 2022 I With a mission of “Bolstering human immunity by utilizing empowered antibody therapies”, the SparX Group is rapidly becoming a significant player in the field of discovering unique therapeutic target combinations and development of novel bispecific antibody constructs. Today, SparX announced that the FDA has approved their IND application for its organically developed anti-claudin18.2 antibody, SPX-101. The first patient is set to receive their initial dose in March of 2022.

Dr. Gui-Dong Zhu, the President, CEO and founder of the company stated, “This is a significant milestone for SparX. The FDAs approval validates the effectiveness of SparX’s SAILINGTM antibody discovery platform. This platform is composed of seven proprietary modules, encompassing the entire process for antibody-based drug discovery and production. Few start-up biotech companies are able to identify unique targets, discover and optimize antibody therapeutics, produce the drug substance, and prepare the IND submission package, all in-house without the help of a CDMO or CRO. Our scientists felt we could accomplish this mission. It is gratifying that the FDA approval of our IND has substantiated SparX’s capabilities to do so.”

SPX-101 is a highly selective anti-claudin18.2 monoclonal antibody. The antibody was discovered, then biologically and biophysically improved, using a customized optimization funnel, taking advantage of the acidity in the tumor microenvironment and Fc-mediated immune effects. “Claudin18.2 is a highly specific tumor antigen, but optimizing therapeutic targeting could still benefit from a more sophisticated molecular design and selection algorithms in order to maximize the therapeutic window. We are aware of the fierce competition in the field, but we believe SPX-101 is a uniquely designed and carefully selected compound that has the potential to be a best-in-class molecule coupled with task specific formulation. Our sophisticated basket trial design, along with a first-in-class companion diagnostic, will help us to stand out during the development stage,” said Dr. Zhu.

SparX Group has built a well-equipped pilot plant at its Mount Prospect, IL location. This facility encompasses process development through cGMP production, including QC laboratories, supplying the deliverables required for IND filing and early-stage clinical development. By the end of 2022, the company’s Yangzhou facility will launch and be able to supply material needs for later stages of development, and ultimately commercial production. “We are committed to quality”, added Dr. Zhu. “The “0” information request from the FDA over the CMC package demonstrates our dedication to the quality of manufacturing”.

About SparX Group
Headquartered in the Cayman Islands, the SparX Group has a mission of “restoring and bolstering human immune system using empowered antibody therapeutics”. The group of companies consists of four entities, each focusing on different phases of pharmaceutical development. Delaware-based SparX Biopharmaceutical serves as the engine and powerhouse for the discovery of novel biologic therapies. Their process utilizes a sophisticated AI-based target mining algorithm, which is combined with an integrated multi-component SAILING™ antibody optimization platform to yield novel target/therapeutic combinations. This subsidiary also possesses a cGMP-audited pilot plant facility for antibody drug manufacturing and characterization. Yangzhou-based SparX (Jiangsu) provides manufacturing capabilities sufficient for five commercial launches in parallel and the CMC needs for more than twelve programs in clinical trials at various stages of development. SparX Group will be evolving into a full-scale biopharmaceutical covering all phases of biologics drug development and commercialization.

SOURCE: SparX Group