On March 7, 2018 Seattle Genetics, Inc. (NASDAQ: SGEN) reported dosing of the first patient in a phase 1 clinical trial evaluating the safety and tolerability of SGN-CD48A for patients with relapsed or refractory multiple myeloma (MM) (Press release, Seattle Genetics, MAR 7, 2018, View Source;p=RssLanding&cat=news&id=2336726 [SID1234524488]). SGN-CD48A is an investigational ADC targeted to the protein CD48, which is highly expressed on MM cells. SGN-CD48A uses the company’s latest ADC technology advancement, a PEGylated glucuronide linker that improves stability, reduces off-target uptake, and enables conjugation of more molecules of the microtubule-disrupting cytotoxic agent monomethyl auristatin E (MMAE) per antibody. With this novel linker, SGN-CD48A has demonstrated promising antitumor activity in preclinical studies.
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"Multiple myeloma is the second most common blood cancer in the US and remains an incurable disease despite recent medical advances. Patients are in need of new targeted treatment options that increase durable remissions," said Robert Lechleider, M.D., Senior Vice President, Clinical Development at Seattle Genetics. "SGN-CD48A uses our latest ADC technology, and the initiation of this phase 1 trial in relapsed or refractory multiple myeloma highlights our continued leadership in ADCs as we address this challenging disease."
The phase 1 study is a multicenter open-label dose-escalation trial designed to enroll approximately 75 patients with relapsed or refractory MM. SGN-CD48A will be administered at an initial dosing interval of every three weeks. The primary objectives of the trial are to evaluate the safety and tolerability of SGN-CD48A and to identify the maximum tolerated dose (MTD). Key secondary objectives include assessing the antitumor activity and identifying the recommended single-agent dose and schedule.
For more information about the phase 1 clinical trial (NCT03379584), please visit www.clinicaltrials.gov.
About Multiple Myeloma
Multiple myeloma (MM) is a rare and aggressive cancer that forms in white blood cells called plasma cells. Cancerous plasma cells can crowd out healthy blood cells, impair bone strength and weaken the immune system. MM is the second most common blood cancer in the US. According to the American Cancer Society, more than 30,000 new cases of MM were expected in the US in 2017, with over 12,500 deaths. Despite recent medical advances, MM still remains an incurable disease. It is managed with sequential lines of treatment that typically yield shorter durations of disease control with each subsequent relapse, and some patients receive more than four lines of treatment over the course of their disease.
About SGN-CD48A
SGN-CD48A is a novel investigational ADC targeted to CD48, a cell surface protein highly expressed in multiple myeloma. The ADC uses Seattle Genetics’ latest technology innovation, a next generation PEGylated glucuronide linker that enables conjugation of eight molecules of the microtubule-disrupting cytotoxic agent monomethyl auristatin E (MMAE) to a CD48-targeted monoclonal antibody. SGN-CD48A is designed to be highly stable in circulation and release an increased amount of MMAE upon internalization into CD48-expressing cells, producing greater antitumor activity in preclinical studies.