Rockville, MD and Beijing, China (Press Release) – CASI Pharma­ceu­ticals, Inc. (Nasdaq: CASI), a U.S. bio­pharma­ceu­tical com­pany focused on devel­op­ing and com­mer­cializing inno­va­tive thera­peutics and pharma­ceu­tical prod­ucts, to­day an­nounced that it sub­mitted a Clinical Trial Appli­ca­tion (CTA) (IND) with the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) for CID-103, its novel anti-CD38 mono­clonal anti­body for the treat­ment of mul­ti­ple myeloma and other hema­to­logical malig­nan­cies.

Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer, commented, "Submitting this CTA is an im­por­tant step in the clin­i­cal de­vel­op­ment of this promising ther­apy in our he­ma­tol­ogy on­col­ogy fran­chise. CID-103 dem­onstrated en­cour­ag­ing ef­fi­cacy in pre­clin­i­cal models and we be­lieve it has the poten­tial to be best in class and can offer meaningful clin­i­cal ben­e­fits over the standard of care for patients with CD38 malig­nan­cies, in­clud­ing mul­ti­ple myeloma."

Alexander Zukiwski, M.D., CASI's Chief Medical Officer commented, "We look for­ward to launching our study for this novel bio­logical entity as a poten­tial treat­ment for patients with hema­to­logical malig­nan­cies. We will con­tinue to monitor the COVID-19 re­lated cir­cum­stances in the UK and are work­ing on administrative ac­­tiv­i­ties in sup­port of this trial. Based on the cur­rent en­viron­ment and timetable of our clin­i­cal sites, we are targeting the study initiation in late 2020 or early 2021."

About CID-103 (Anti-CD38 Mab)

CID-103 (f/k/a TSK011010) is a novel anti-CD38 mono­clonal anti­body pro­gram. CASI licensed the global rights to CID-103, from Tusk Thera­peutics, Ltd in April 2019. Pre­clin­i­cal data dem­onstrate CID-103 possesses en­hanced ac­­tiv­ity against a broad array of malig­nan­cies expressing CD38, and poten­tially en­hance safety and ef­fi­cacy ben­e­fits when com­pared to other CD38 mono­clonal anti­bodies. CASI main­tains ex­clu­sive global rights to CID-103.

About CASI Pharma­ceu­ticals

CASI Pharma­ceu­ticals is a U.S. bio­pharma­ceu­tical com­pany focused on devel­op­ing and com­mer­cializing inno­va­tive thera­peutics and pharma­ceu­tical prod­ucts, with a prod­uct port­folio that in­cludes approved and inves­ti­ga­tional assets. In August 2019, the Com­pany launched its first com­mer­cial prod­uct, EVOMELA® (Melphalan for Injection), in China that is approved for use as a con­di­tioning treat­ment prior to stem cell trans­plan­ta­tion in the mul­ti­ple myeloma setting. The Com­pany's other core he­ma­tol­ogy/oncology assets in its pipe­line in­clude (i) an au­tol­o­gous CD19 CAR-T investigative prod­uct (CNCT19) being devel­oped as a treat­ment for patients with B-ALL and B-NHL; (ii) CID-103, an anti-CD38 mono­clonal anti­body being devel­oped for the treat­ment of patients with mul­ti­ple myeloma; and (iii) ZEVALIN® (Ibritumomab Tiuxetan), a CD20-directed radiotherapeutic anti­body that is approved in the U.S. to treat patients with NHL, and being devel­oped for China. The Com­pany's on­col­ogy assets also in­clude China rights to (i) octreotide long acting injectable (LAI) microsphere for­mu­la­tion in­di­cated for the treat­ment of cer­tain symp­toms asso­ci­ated with par­tic­u­lar neuroendocrine cancers and acro­meg­aly, and (ii) a novel for­mu­la­tion of thiotepa, which has mul­ti­ple in­di­ca­tions and a long history of estab­lished use in the he­ma­tol­ogy/oncology setting, both of which are being devel­oped for import reg­is­tra­tion and mar­ket ap­prov­al in China. 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 ability to design and implement a de­vel­op­ment plan for our ANDAs; the de­vel­op­ment of major pub­lic health con­cerns, in­clud­ing the coro­na­virus or other pan­dem­ics arising in China or elsewhere; 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 CNCT19, CID-103, and our other early-stage prod­ucts under de­vel­op­ment; risks that re­­sult 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; our ability to pro­tect our in­tel­lec­tual property rights; 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® and ZEVALIN® are pro­pri­e­tary to Acrotech Bio­pharma LLC and its affiliates.

Source: CASI Pharma­ceu­ticals.