CASI Pharmaceuticals Announces Submission Of Clinical Trial Application (IND) To Conduct Phase 1 Study For Anti-38 Monoclonal Antibody Program

ROCKVILLE, Md. and BEIJING, June 8, 2020 /PRNewswire/ -- 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.

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SOURCE CASI Pharmaceuticals, Inc.

Company Codes: NASDAQ-SMALL:CASI