PIPELINES TARGET
INDICATION
AREA PRE-
CLINICAL
CLINIAL STUDY NDA APPROVAL
/LAUNCH
PROGRESS PARTNER
PHASE 1 PHASE 2 PHASE 3

SP-02

Peripheral T-Cell Lymphoma (PTCL) Japan
Submitted NDA

Nippon Kayaku:
Japan


HB Human BioScience:
Latin America

South Korea, Taiwan, Hong Kong
Pivotal PII study completion, preparation for NDA filing
China
Phase II/III, preparation
US
Phase IIA, completion
EU
Pre-clinical, completion

SP-02

Solasia acquired the rights to darinaparsin (SP-02) from ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) for worldwide rights.

Darinaparsin, an organoarsenic compound with anticancer activity, is a novel mitochondrial-targeted agent being developed for the treatment of various hematologic and solid tumors. The proposed mechanism of action of the drug involves the disruption of mitochondrial function, increased production of reactive oxygen species, and modulation of intracellular signal transduction pathways. Darinaparsin is believed to exert anticancer effect by inducing cell cycle arrest and apoptosis. Darinaparsin has been granted orphan drug designation in the U.S. and Europe as a treatment of peripheral T-cell lymphoma (PTCL).

In June 2020, darinaparsin achieved the primary endpoint (antitumor effect) in the Asian multinational phase 2 clinical study in patients with relapsed or refractory PTCL in Japan, South Korea, Taiwan, and Hong Kong.

In June 2021, Solasia submitted a New Drug Application (NDA) for darinaparsin as a treatment for relapsed or refractory peripheral T-cell lymphoma to the Ministry of Health, Labour and Welfare (MHLW) in Japan.

Development Strategy: Submitted NDA (Japan),  Preparation for NDA filing (South Korea, Taiwan, Hong Kong)

Expected Target Indications

Peripheral T-Cell Lymphoma (PTCL)

PTCL is a type of malignant lymphoma. Malignant lymphoma is largely classified into Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL), and non-Hodgkin lymphoma is further divided into two main categories of B-cell lymphoma and T-cell lymphoma. PTCL is a subtype of T-cell lymphoma with a relatively high incidence rate among other subtypes of T-cell lymphoma. No standard treatment has been established for PTCL, and the National Comprehensive Cancer Network guidelines recommend as front-line treatment participation in clinical trials or multidrug chemotherapy such as CHOP therapy. For relapsed or refractory PTCL patients, in addition to participation in clinical trials, multidrug chemotherapy or recently approved drugs are recommended. However, as with the newly diagnosed cases, no standard therapy has been established. As prognosis for PTCL may be poor and its treatment difficult, it is one of the diseases with high unmet medical needs for which the development and introduction of new therapies and drugs are much anticipated.

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