CASI Pharmeceuticals

CID-103

17 April 2019

CASI Pharmaceuticals In-Licenses Exclusive Worldwide Rights to Novel Anti-CD38 Monoclonal Antibody Program From Black Belt Therapeutics


About Anti-CD38 Monoclonal Antibodies

Anti-CD38 monoclonal antibodies are targeted antibodies that bind to the CD38 protein which is expressed on a number of hematopoietic malignancies and tissues; as well as, some solid tumors. The level of expression of CD38 on hematopoietic cells varies and is related to the stage of maturation and activation of the cells. CD-38 has been demonstrated to be highly expressed on multiple myeloma cells. When an anti-CD38 mAb binds to the CD38 protein on malignant cells it can cause cell death by a number of different mechanisms including complement dependent cellular cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and/or antibody-dependent cellular phagocytosis (ADCP). Anti-CD38 mAbs can be used to treat patients with multiple myeloma and potentially other malignancies.

About CID-103

CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody that recognizes a unique epitope on CD38. It was engineered to have strong activity against CD38 malignant cells and to reduce certain safety issues observed with existing treatments. CID-103 is currently at the IND/IMPD submission stage of development. Phase 1 trials are expected to start in late 2019 or early 2020.

Preclinical data of CID-103 demonstrates enhanced activity against a broad array of malignancies which express CD38 and demonstrates a better preclinical safety profile when compared to other CD38 mAbs. These attributes offer the potential for accelerated development and regulatory review, including rapid advancement into earlier lines of therapy. CASI believes CID-103 has the potential to be a best in class therapy, which will translate into meaningful clinical benefits for patients with CD38 positive malignancies including multiple myeloma.

About Multiple Myeloma

Multiple myeloma is a malignant hematological disorder that is characterized by abnormal proliferation of clonal plasma cells in the bone marrow and the secretion of monoclonal immunoglobulins that are detectable in the serum or urine. Multiple Myeloma cells express high levels of CD38, while CD38 is expressed at relatively low levels on normal lymphoid and myeloid cells, and in some non-hematopoietic tissues. This expression profile, together with the role of CD38 in adhesion and as ectoenzyme, resulted in the development of CD38 antibodies for the treatment of multiple myeloma (MM)1.

Multiple myeloma is a difficult to treat disease and the worldwide incidence of this disease is on the rise due to an aging population. In fact, in 2013 there were approximately 170,000 documented cases of multiple myeloma worldwide. This number is expected to climb to 240,000 cases worldwide by 2023.

Multiple myeloma is the second most commonly diagnosed blood cancer and accounts for 10-13% of hematological malignancies2,3 and in Western countries, the estimated incidence is 5.6 cases per 100,000 persons3. The estimated incidence of multiple myeloma in China is ~2.0 cases per 100,000 persons4, for an estimated annual incidence of approximately 27,8004.

1. N.W.C.J. van de Donk & S.A. Usmani, Frontiers in Immunology 2018; 9:2134

2. S. Rajkumar, Mayo Clin Proc. 2016 January; 91(1): 101–119

3. A. Palumbo, N Engl J Med, 2011; 364: 1046-60

4. J. Lu, Blood Cancer Journal (2014) 4, e239; doi:10.1038/bcj.2014.55

About Us

CASI is a U.S. NASDAQ-listed biopharmaceutical company with a platform to develop and accelerate the launch of pharmaceutical products and innovative therapeutics in China, U.S., and throughout the world. We have offices in Rockville, Maryland, and a wholly owned subsidiary in Beijing, China through which substantially all of our operations are conducted.

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