Rockville, MD (Press Release) – CASI Pharma­ceu­ticals, Inc. (Nasdaq: CASI), a U.S. pharma­ceu­tical com­pany with a plat­form to develop and accelerate the launch of inno­va­tive thera­peutics and pharma­ceu­tical prod­ucts in China, the U.S., and through­out the world, announces the signing of a license agree­ment for exclusive world­wide rights to the inves­ti­ga­tional anti-CD38 mono­clonal anti­body (Mab) TSK011010 pro­gram from Black Belt Therapeutics Limited.

Under the terms of the agree­ment, CASI has obtained global rights to TSK011010 for an up­front pay­ment of 5 million euros and an equity investment of 2 million euros, as well as certain mile­stone and royalty pay­ments. The equity investment will be made in a newly estab­lish­ed com­pany of Black Belt Therapeutics focusing on novel immuno-oncology targets. CASI will be responsible for all devel­op­ment and com­mer­cial­iza­tion activities of the TSK011010 pro­gram.

TSK011010 is at the IND/IMPD sub­mission stage of devel­op­ment, with Phase 1 trials ex­pec­ted to start in late 2019/early 2020. Preclinical data dem­onstrate TSK011010 to have en­hanced activity against a broad array of malig­nan­cies which express CD38 and poten­tially better safety when com­pared to other CD38 Mabs.

Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer, commented, "This license agree­ment for TSK011010 is very exciting because based on pre­clin­i­cal data, we believe this molecule has the poten­tial to be best in class and will hopefully translate into meaningful clin­i­cal benefits for patients with CD38 malig­nan­cies, in­­clud­ing multiple myeloma. The addi­tion of TSK011010 to our portfolio provides CASI the oppor­tu­ni­ty to offer a range of thera­peutic options for the treat­ment of hema­to­logic malig­nan­cies."

Alexander Zukiwski, M.D., CASI's Chief Medical Officer commented, "The pre­clin­i­cal data for TSK011010 targeting multiple myeloma has shown impressive results thus far and seems to outperform other anti-CD38 Mabs. We are enthusiastic and look for­ward to the clin­i­cal devel­op­ment for this novel biological entity as a poten­tial treat­ment for patients with hema­to­logical malig­nan­cies, such as multiple myeloma."

About CD-38 Mab TSK011010

Anti-CD38 Mab TSK011010 is a fully human IgG1 mono­clonal anti­body that recog­nizes a unique epitope on CD38. It has dem­onstrated potent CD38+ cell killing, and was designed to directly activate effector T cells and NK cells. In pre­clin­i­cal studies it has dem­onstrated immune effector mech­a­nisms with strong anti­body-dependent cellular cyto­tox­icity (ADCC), anti­body-dependent cellular phago­cytosis (ADCP) and complement-dependent cyto­tox­icity (CDC) activity. GLP IND-enabling studies have been com­pleted and IND/IMPD sub­missions are planned for 2019.

About CASI Pharma­ceu­ticals

CASI Pharma­ceu­ticals is a U.S. pharma­ceu­tical com­pany with a plat­form to develop and accelerate the launch of pharma­ceu­tical prod­ucts and inno­va­tive thera­peutics in China, the U.S., and through­out the world. CASI's prod­uct pipe­line features (i) TSK011010, an anti-CD38 mono­clonal anti­body being devel­oped for the treat­ment of hema­to­logical cancers; (ii) China regional rights to three U.S. Food and Drug Admin­istra­tion (FDA)-approved drugs (EVOMELA® (melphalan hydrochloride for injection) approved by China's National Medical Products Admin­istra­tion (NMPA) for mar­ket­ing, ZEVALIN® (ibritumomab tiuxetan) and MARQIBO® (vincristine sulfate LIPOSOME injection) approved by NMPA for registration con­firmatory trials in China; and (iii) a portfolio of FDA-approved and pending abbre­vi­ated new drug appli­ca­tions (ANDAs). CASI has offices in Rockville, Maryland and a wholly owned sub­sid­i­ary in Beijing, China through which sub­stan­tially all of our operations are conducted. More in­for­ma­tion on CASI is avail­able at www.casipharmaceuticals.com.

Forward Looking Statements

This news release con­tains for­ward-looking state­ments within the meaning of the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act with respect to the outlook for ex­pec­ta­tions for future financial or business per­for­mance, strategies, ex­pec­ta­tions and goals. Forward-looking state­ments are subject to numerous assump­tions, risks and un­cer­tain­ties, which change over time. Forward-looking state­ments speak only as of the date they are made, and no duty to update for­ward-looking state­ments is assumed. Actual results could differ ma­teri­ally from those cur­rently antic­i­pated due to a number of factors, in­­clud­ing: the dif­fi­culty of executing our business strategy in China; our lack of ex­peri­ence in manu­fac­tur­ing prod­ucts and uncertainty about our resources and capabilities to do so on a clin­i­cal or commercial scale; risks relating to the com­mer­cial­iza­tion, if any, of our prod­ucts and proposed prod­ucts (such as mar­ket­ing, safety, regu­la­tory, patent, prod­uct liability, supply, com­pe­ti­tion and other risks); our in­abil­ity to predict when or if our prod­uct can­di­dates will be approved for mar­ket­ing by the FDA, NMPA, or other regu­la­tory author­i­ties; our in­abil­ity to enter into strategic part­ner­ships for the devel­op­ment, com­mer­cial­iza­tion, manu­fac­tur­ing and distribution of our proposed prod­uct can­di­dates or future can­di­dates; the volatility in the mar­ket price of our common stock; risks relating to the need for addi­tional capital and the uncertainty of securing addi­tional funding on favorable terms; risks asso­ci­ated with TSK011010 and our prod­uct can­di­dates; risks asso­ci­ated with TSK011010 and our other early-stage prod­ucts under devel­op­ment; risks that results in pre­clin­i­cal and early clin­i­cal models are not nec­es­sar­i­ly indicative of later clin­i­cal results; un­cer­tain­ties relating to pre­clin­i­cal and clin­i­cal trials, in­­clud­ing delays to the commencement of such trials; the lack of success in the clin­i­cal devel­op­ment of any of our prod­ucts; and our dependence on third parties. Such factors, among others, could have a ma­teri­al adverse effect upon our business, results of operations and financial con­di­tion. We caution readers not to place undue reliance on any for­ward-looking state­ments, which only speak as of the date made. Additional in­for­ma­tion about the factors and risks that could affect our business, financial con­di­tion and results of operations, are con­tained in our filings with the U.S. Se­cu­ri­ties and Exchange Com­mis­sion, which are avail­able at www.sec.gov.

EVOMELA®, Marqibo® and Zevalin® are pro­pri­e­tary to Acrotech Biopharma LLC and its affiliates.

Source: CASI Pharma­ceu­ticals.