SGN-LIV1A to be Investigated in Combination with Atezolizumab as Part of Initiative for the Development of Novel Cancer Immunotherapy Combinations
BOTHELL, WA, USA I July 24, 2017 I Seattle Genetics, Inc. (Nasdaq: SGEN), a global biotechnology company, today announced a clinical collaboration agreement with Genentech, a member of the Roche Group, for the evaluation of its investigational antibody-drug conjugate (ADC) SGN-LIV1A in combination with atezolizumab (TECENTRIQ®) in patients with metastatic triple-negative breast cancer (TNBC). SGN-LIV1A, one of four clinical-stage treatments under development by Seattle Genetics for solid tumors, consists of a LIV-1 targeted monoclonal antibody linked to the potent cell-killing agent monomethyl auristatin E (MMAE). Breast cancer is the most common cancer among women worldwide, with an estimated 1.7 million new cases per year. About 15 to 20 percent of breast cancers are triple negative, which means they lack expression of three breast cancer-associated proteins that serve as key therapeutic targets.
“A key challenge in triple-negative breast cancer, or TNBC, is the lack of available novel targeted treatments. People with this disease generally have poor prognoses. Moreover, current therapies are not curative and only delay disease progression,” said Robert Lechleider, M.D., Senior Vice President, Clinical Development of Seattle Genetics. “We have phase 1 data showing that SGN-LIV1A is active as monotherapy in patients with heavily pretreated, metastatic TNBC. Now, under this new collaboration, we will evaluate the potential to expand therapeutic benefit to these patients through combination therapy with atezolizumab.”
SGN-LIV1A administered in combination with atezolizumab will be evaluated in a phase 1b/2 clinical study as second-line therapy in patients with metastatic TNBC who have not been previously treated with immunotherapy. This randomized, controlled study is anticipated to enroll up to 45 patients in the treatment arm. Seattle Genetics and Genentech will test the experimental combination in MORPHEUS, Roche’s Novel Cancer Immunotherapy Development Platform. MORPHEUS is a phase 1b/2 adaptive platform to develop combinations of cancer immunotherapies rapidly and efficiently.
Under the terms of the collaboration agreement, Genentech will manage the study operations for the phase 1b/2 trial. Seattle Genetics will retain global development and commercialization rights to SGN-LIV1A.
About SGN-LIV1A
SGN-LIV1A is a novel investigational ADC targeted to LIV-1 protein utilizing Seattle Genetics’ proprietary ADC technology. LIV-1 is expressed by most metastatic breast cancers. It has also been detected in a number of other cancers, including melanoma, prostate, ovarian, and cervical cancer. SGN-LIV1A consists of a LIV-1-targeted monoclonal antibody linked to a potent microtubule-disrupting agent, monomethyl auristatin E (MMAE) by a protease-cleavable linker, using the same technology as ADCETRIS (brentuximab vedotin). It is designed to bind to LIV-1 on cancer cells and release the cell-killing agent into target cells upon internalization. SGN-LIV1A may also cause antitumor activity through other mechanisms, including activation of an immune response.
TECENTRIQ® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
About Seattle Genetics
Seattle Genetics is an innovative biotechnology company that develops and commercializes novel antibody-based therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. ADCETRIS® (brentuximab vedotin), the company’s lead product, in collaboration with Takeda Pharmaceutical Company Limited, is the first in a new class of ADCs commercially available globally in 67 countries for relapsed classical Hodgkin lymphoma and relapsed systemic anaplastic large cell lymphoma (sALCL). Seattle Genetics is also advancing enfortumab vedotin, an ADC for metastatic urothelial cancer, in a planned pivotal trial in collaboration with Astellas. Headquartered in Bothell, Washington, Seattle Genetics has a strong pipeline of innovative therapies for blood-related cancers and solid tumors designed to address significant unmet medical needs and improve treatment outcomes for patients. The company has collaborations for its proprietary ADC technology with a number of companies including AbbVie, Astellas, Bayer, Celldex, Genentech, GlaxoSmithKline and Pfizer. More information can be found at www.seattlegenetics.com
SOURCE: Seattle Genetics
Post Views: 103
SGN-LIV1A to be Investigated in Combination with Atezolizumab as Part of Initiative for the Development of Novel Cancer Immunotherapy Combinations
BOTHELL, WA, USA I July 24, 2017 I Seattle Genetics, Inc. (Nasdaq: SGEN), a global biotechnology company, today announced a clinical collaboration agreement with Genentech, a member of the Roche Group, for the evaluation of its investigational antibody-drug conjugate (ADC) SGN-LIV1A in combination with atezolizumab (TECENTRIQ®) in patients with metastatic triple-negative breast cancer (TNBC). SGN-LIV1A, one of four clinical-stage treatments under development by Seattle Genetics for solid tumors, consists of a LIV-1 targeted monoclonal antibody linked to the potent cell-killing agent monomethyl auristatin E (MMAE). Breast cancer is the most common cancer among women worldwide, with an estimated 1.7 million new cases per year. About 15 to 20 percent of breast cancers are triple negative, which means they lack expression of three breast cancer-associated proteins that serve as key therapeutic targets.
“A key challenge in triple-negative breast cancer, or TNBC, is the lack of available novel targeted treatments. People with this disease generally have poor prognoses. Moreover, current therapies are not curative and only delay disease progression,” said Robert Lechleider, M.D., Senior Vice President, Clinical Development of Seattle Genetics. “We have phase 1 data showing that SGN-LIV1A is active as monotherapy in patients with heavily pretreated, metastatic TNBC. Now, under this new collaboration, we will evaluate the potential to expand therapeutic benefit to these patients through combination therapy with atezolizumab.”
SGN-LIV1A administered in combination with atezolizumab will be evaluated in a phase 1b/2 clinical study as second-line therapy in patients with metastatic TNBC who have not been previously treated with immunotherapy. This randomized, controlled study is anticipated to enroll up to 45 patients in the treatment arm. Seattle Genetics and Genentech will test the experimental combination in MORPHEUS, Roche’s Novel Cancer Immunotherapy Development Platform. MORPHEUS is a phase 1b/2 adaptive platform to develop combinations of cancer immunotherapies rapidly and efficiently.
Under the terms of the collaboration agreement, Genentech will manage the study operations for the phase 1b/2 trial. Seattle Genetics will retain global development and commercialization rights to SGN-LIV1A.
About SGN-LIV1A
SGN-LIV1A is a novel investigational ADC targeted to LIV-1 protein utilizing Seattle Genetics’ proprietary ADC technology. LIV-1 is expressed by most metastatic breast cancers. It has also been detected in a number of other cancers, including melanoma, prostate, ovarian, and cervical cancer. SGN-LIV1A consists of a LIV-1-targeted monoclonal antibody linked to a potent microtubule-disrupting agent, monomethyl auristatin E (MMAE) by a protease-cleavable linker, using the same technology as ADCETRIS (brentuximab vedotin). It is designed to bind to LIV-1 on cancer cells and release the cell-killing agent into target cells upon internalization. SGN-LIV1A may also cause antitumor activity through other mechanisms, including activation of an immune response.
TECENTRIQ® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
About Seattle Genetics
Seattle Genetics is an innovative biotechnology company that develops and commercializes novel antibody-based therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. ADCETRIS® (brentuximab vedotin), the company’s lead product, in collaboration with Takeda Pharmaceutical Company Limited, is the first in a new class of ADCs commercially available globally in 67 countries for relapsed classical Hodgkin lymphoma and relapsed systemic anaplastic large cell lymphoma (sALCL). Seattle Genetics is also advancing enfortumab vedotin, an ADC for metastatic urothelial cancer, in a planned pivotal trial in collaboration with Astellas. Headquartered in Bothell, Washington, Seattle Genetics has a strong pipeline of innovative therapies for blood-related cancers and solid tumors designed to address significant unmet medical needs and improve treatment outcomes for patients. The company has collaborations for its proprietary ADC technology with a number of companies including AbbVie, Astellas, Bayer, Celldex, Genentech, GlaxoSmithKline and Pfizer. More information can be found at www.seattlegenetics.com
SOURCE: Seattle Genetics
Post Views: 103
