SGEN Starts Phase I Study on SGN-CD33A

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Seattle Genetics Inc. (SGEN) recently announced the commencement of a phase I study on its acute myeloid leukemia (:AML) candidate, SGN-CD33A.

SGN-CD33A uses Seattle Genetics’ latest antibody-drug conjugate (ADC) technology targeted to CD33. The open-label, multi-center, dose-escalation study will assess the safety and anti-leukemia activity of SGN-CD33A. 

Primary endpoints are the maximum tolerated dose estimation and safety evaluation of SGN-CD33A. Additionally, the study will evaluate pharmacokinetics, progression-free survival and overall survival of patients with AML. Patients achieving complete remission in the dose-escalation study are eligible to continue receiving SGN-CD33A at a lower, maintenance dose given every three weeks.

Encouraging preclinical data on SGN-CD33A was presented at the American Society of Hematology (ASH) Annual Meeting in Dec 2012. Preclinical data on SGN-CD33A showed significant antitumor activity in AML models.

The AML market consists of drugs like Mylotarg. Many candidates are being developed for the treatment of AML, like BioLineRx (BLRX) BL-8040. Another candidate, quizartinib, is also being developed for AML.

Seattle Genetics’ sole marketed ADC product is Adcetris. Adcetris is used for the treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (:ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not suitable for ASCT. Adcetris is also approved for the treatment of systemic anaplastic large cell lymphoma (sALCL) after failure of at least one multi-agent chemotherapy regimen. 

ADCs have been attracting a lot of interest of late with major companies entering into collaborations. Seattle Genetics has an alliance with Genentech, a business wing of Roche Holding AG (RHHBY) for the development of ADCs.

Seattle Genetics carries a Zacks Rank #3 (Hold). Currently, Jazz Pharmaceuticals Public Limited Company (JAZZ) looks well positioned with a Zacks Rank #1 (Strong Buy).

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