Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2178 |
| INN | Talacotuzumab |
| Status | Terminated |
| Drug code(s) | JNJ-56022473, CSL362 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1/2 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CD123 |
| Indications of clinical studies | Acute Myeloid Leukemia, Myelodysplastic Syndromes |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Terminated at Phase 2/3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | July 15, 2012 |
| Start of Phase 2 | August 15, 2015 |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | CSLÂ Limited |
| Licensee/Partner | Janssen Research & Development, LLC |
| Comments about company or candidate | June 2018. Efficacy and adverse events data from the phase II SAMBA trial in Acute myeloid leukaemia and Myelodysplastic syndromes presented at the 23rd Congress of the European Haematology Association (EHA-2018) Conclusion of SAMBA study: Even though ADCC-mediated targeting of CD123 seems to be a promising treatment option, patients with advanced MDS/AML displayed significant alterations in their immune cell repertoire which may have contributed to the moderate clinical benefit with single agent TAL treatment. Oct 2017: Phase 2 study in MD still recruiting, but J&J announced that the Phase 3 clinical trial for talacotuzumab, an investigational compound being studied in patients with acute myeloid leukemia, has been discontinued. NCT02472145 is a Phase 2/3 study (started as Phase 2 in June 2015 and converted to Phase 3 in Nov 2015). Under the terms of the agreement with Janssen, CSL will receive a license fee and be entitled to development, regulatory and sales based milestone payments, as well as royalties on sales. CSL will be responsible for the completion of the Phase I clinical trial in AML and Janssen will be responsible for all further development and commercialisation in AML and other indications. Under the terms of an agreement signed in February 2009, Xencor granted CSL Limited a non-exclusive license to Xencor Cytotoxic Fc Domains for use in CSL programs, including CSL362. Xencor is also eligible to receive additional milestone payments and royalties on sales. In 2013, CSL Limited licensed CSL362 to Janssen Biotech Inc. |
| Full address of company | Melbourne, Australia Australia Australia https://www.csl.com/ |
CSL362 is variant of humanized and affinity matured anti-CD123 mAb 168-26; Fc modified for higher affinity to Fc gamma RIIIa 0ptimised for enhanced activation of ADCC via natural killer cells (Xencor Fc-engineering technology). Targets the alpha chain of the interleukin 3 receptor; IND filed in April 2012.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |