Key Developments: Seattle Genetics Inc (SGEN.O)

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Latest Key Developments (Source: Significant Developments)

Seattle Genetics and Genmab Enter into new antibody-drug conjugate collaboration
Wednesday, 10 Sep 2014 08:15am EDT 

Seattle Genetics Inc:Seattle Genetics, Inc. (SGEN) and Genmab A/S(GEN) enters into an additional antibody-drug conjugate (ADC) collaboration.Under new agreement, Genmab will pay an upfront fee of $11 mln for exclusive rights to utilize Seattle Genetics' auristatin-based ADC technology with Genmab'sHuMax(r)-AXL, an antibody targeting AXL which is expressed on multiple types of solid cancers.Seattle Genetics is also entitled to receive more than $200 mln in potential milestone payments and mid-to-high single digit royalties on worldwide net sales of any resulting products.In addition, prior to Genmab's initiation of Phase III study for any resulting products, Seattle Genetics has right to exercise an option toincrease royalties to double digits in exchange for reduction of milestone payments owed by Genmab.Irrespective of any exercise of option, Genmab remains in full control of development and commercialization.  Full Article

Seattle Genetics Inc initiates phase 1 clinical trial of Antibody-Drug Conjugate SGN-CD70A for Non-Hodgkin Lymphoma and Renal Cell Carcinoma
Tuesday, 12 Aug 2014 09:00am EDT 

Seattle Genetics Inc:Initiation of a phase 1 clinical trial evaluating SGN-CD70A for CD70-positive relapsed or refractory non-Hodgkin lymphoma (NHL) and metastatic renal cell carcinoma (RCC).SGN-CD70A is a novel antibody-drug conjugate (ADC) targeted to CD70 utilizing company's newest ADC technology.Phase 1 trial is designed to assess the safety and antitumor activity of SGN-CD70A.New SGN-CD70A study is a phase 1, open-label, multi-center, dose-escalation clinical trial.Primary endpoints are to estimate the maximum tolerated dose and to evaluate the safety of SGN-CD70A.In addition, the trial will evaluate the antitumor activity and pharmacokinetics in patients with CD70-positive metastatic RCC or relapsed or refractory NHL, including mantle cell lymphoma and diffuse large B-cell lymphoma.Study is designed to evaluate SGN-CD70A administered every three weeks and will enroll about 95 patients at multiple centers in the United States.  Full Article

Seattle Genetics Inc highlights ADCETRIS (Brentuximab Vedotin) phase two clinical data in diffuse large B-cell Lymphoma (DLBCL) at ASH 2013
Tuesday, 10 Dec 2013 08:30am EST 

Seattle Genetics Inc:Says updated results from a phase two clinical trial of ADCETRIS (brentuximab vedotin) in diffuse large B-cell lymphoma (DLBCL) and other B-cell non-Hodgkin lymphomas.Says the data, which demonstrated an encouraging activity and tolerability profile in the relapsed and refractory setting, were presented in an oral presentation at the 55th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans, Louisiana, Dec 7-10.Says ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS is currently not approved for the treatment of DLBCL or other B-cell lymphomas.Says d Phase two Study of Brentuximab Vedotin in Patients with Relapsed or Refractory CD30-Positive Non-Hodgkin Lymphomas: Interim Results in Patients with DLBCL and Other B-cell Lymphomas (Abstract #848).Says interim data from an ongoing phase two clinical trial were reported from 50 patients with DLBCL and 18 patients with other B-cell lymphomas.Says among the DLBCL patients, the median age was 63 years, 74 pct were refractory to frontline therapy and 82 pct were refractory to their most recent prior therapy.  Full Article

Seattle Genetics Inc presents data from novel antibody-drug Conjugate (ADC) SGN-CD19A
Saturday, 7 Dec 2013 10:00am EST 

Seattle Genetics Inc:Presents interim phase 1 clinical data from SGN-CD19A, an antibody-drug conjugate (ADC) in development for the treatment of B-cell malignancies, including acute lymphoblastic leukemia (ALL).Says phase 1 trial evaluating SGN-CD19A has demonstrated encouraging early antitumor activity and a generally well-tolerated safety profile among heavily pretreated patients with acute lymphoblastic leukemia and very aggressive types of lymphoma.Says in addition, multiple complete remissions have been observed in a parallel phase 1 study evaluating SGN-CD19A in aggressive non-Hodgkin lymphoma. Dose-escalation is ongoing in both phase 1 clinical trials, and the company plan to report additional data during 2014.  Full Article

Seattle Genetics Inc Initiates Phase 1 Trial of ADC Candidate, SGN-LIV1A, for Patients With LIV-1-Positive Metastatic Breast Cancer
Monday, 21 Oct 2013 09:00am EDT 

Seattle Genetics, Inc announced the initiation of a phase 1 clinical trial evaluating SGN-LIV1A for patients with LIV-1-positive metastatic breast cancer. SGN-LIV1A utilizes Seattle Genetics' antibody-drug conjugate (ADC) technology. The trial is designed to assess the safety and antitumor activity of SGN-LIV1A, an ADC targeted to LIV-1 (SLC39A6), a protein which is expressed in subtypes of metastatic breast cancer.  Full Article

Seattle Genetics Inc Announces Initiation Of Phase 2 Trial of ADCETRIS In Combination With Current Standard Of Care For Frontline Diffuse B-Cell Lymphoma
Thursday, 15 Aug 2013 09:00am EDT 

Seattle Genetics, Inc. announced that the initiation of a phase 2 clinical trial evaluating ADCETRIS (brentuximab vedotin) in combination with RCHOP (A+RCHOP), the current standard frontline therapy, for newly diagnosed patients with diffuse large B-cell lymphoma (DLBCL). The study is intended to evaluate the complete remission rate and safety of the A+RCHOP regimen. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS is currently not approved for the treatment of DLBCL. In this phase 2, open-label clinical trial, approximately 50 frontline high-risk DLBCL patients will receive ADCETRIS in combination with the standard of care consisting of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (A+RCHOP). Patients will be randomized to receive standard dose RCHOP with either 1.2 milligrams per kilogram (mg/kg) or 1.8 mg/kg of ADCETRIS. The trial will enroll patients regardless of CD30 expression level by immunohistochemistry (IHC) to further explore previously reported interim data from an ongoing phase 2 trial for relapsed B-cell lymphomas, including DLBCL, demonstrating objective responses in patients with varying levels of CD30. The primary endpoints are to assess the complete remission rate and safety profile of the combination. Secondary endpoints include objective response rate, progression-free survival and overall survival.  Full Article

Seattle Genetics Inc and Subsidiary of Astellas Pharma Inc Announce Co-Development of an Additional Antibody-Drug Conjugate (ADC) Under Existing Collaboration
Thursday, 27 Jun 2013 08:00pm EDT 

Seattle Genetics, Inc. and Agensys, Inc., a subsidiary Astellas Pharma Inc. announced that Seattle Genetics has exercised an option to co-develop an additional antibody-drug conjugate (ADC) under the companies' existing ADC collaboration agreement. The ADC, called ASG-15ME, targets the tumor antigen SLITRK6, which is known to be expressed on bladder and lung cancer.  Full Article

Bayer AG Strikes Collaboration With Seattle Genetics Inc Of Up To $520 Million-DJ
Tuesday, 25 Jun 2013 07:41am EDT 

Dow Jones reported that Seattle Genetics Inc has struck a new antibody-drug conjugate collaboration with Bayer AG under which Bayer AG will pay up to $520 million in connection with its use of Seattle Genetics' auristatin-based drug technology. Bayer AG will pay up to $20 million in upfront and option-exercise fees for world-wide rights to utilize the technology with antibodies to several oncology targets. Seattle Genetics Inc is also eligible to receive up to about $500 million in potential milestone payments, as well as royalties on world-wide net sales of any resulting products under the multi-target collaboration. Bayer AG is responsible for research, product development, manufacturing and commercialization of all products under the collaboration.  Full Article

Seattle Genetics Inc Announces Data From ASG-5ME Phase I Clinical Trial For Pancreatic Cancer
Friday, 25 Jan 2013 09:00am EST 

Seattle Genetics Inc announced that it presented interim results from a phase I clinical trial evaluating ASG-5ME for the treatment of metastatic pancreatic ductal adenocarcinoma (PDA) at the American Society of Clinical Oncology (ASCO) 2013 Gastrointestinal Cancers Symposium being held January 24-26, 2013 in San Francisco, CA. ASG-5ME is an antibody-drug conjugate (ADC) targeting the SLC44A4 antigen and is being co-developed by Seattle Genetics and Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., for the treatment of solid tumors. The phase I data from the ASG-5ME clinical trial in advanced pancreatic cancer identified the maximum tolerated dose (MTD) for weekly administration, demonstrated tolerability and provided preliminary evidence for antitumor activity. Key findings included: The MTD was identified as 1.2 mg/kg weekly. Of the 35 patients who participated in the trial at the time of analysis, 18 were treated at the MTD. response for the 18 patients treated at 1.2 mg/kg weekly included one patient (6%) who achieved a partial response, six patients (33%) with stable disease and four patients (22%) who had progressive disease. Seven patients (39%) were not evaluable for response. The most common adverse events occurring in patients at the MTD included fatigue (50.0%), vomiting (44.4%), decreased appetite (38.9%), abdominal pain (33.3%) and nausea (33.3%).  Full Article

Seattle Genetics Inc Announces Data from Investigator-Sponsored Trials of ADCETRIS(Brentuximab Vedotin) in Cutaneous T-Cell Lymphoma at ASH Annual Meeting
Monday, 10 Dec 2012 06:15pm EST 

Seattle Genetics Inc announced that results from two ongoing investigator-sponsored phase II clinical trials of ADCETRIS (brentuximab vedotin) in patients with relapsed cutaneous T-cell lymphoma (CTCL) were presented at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS has not been approved for use in the treatment of CTCL. The ongoing phase II clinical trial is enrolling CTCL patients with mycosis fungoides (MF) or Sezary syndrome. Twenty patients have been enrolled to date with a median of six prior systemic therapies. The primary endpoint of the trial is clinical response rate. Secondary endpoints include correlation of clinical response with CD30 expression levels, duration of response and safety. The study was led by principle investigator Dr. Youn H. Kim from Stanford University School of Medicine in Stanford, CA, and was presented in an oral session. Key findings include: Fourteen of 20 patients (70%) achieved an objective response across all stages of disease, including Stage IB, Stage IIB and Stage IVA/B. At the time of analysis, 14 patients had a partial response, one patient had stable disease and four patients had progressive disease. One patient was not evaluable for response.  Full Article

Genmab and Seattle Genetics in antibody drug agreement

COPENHAGEN, Sept 10 - Denmark's Genmab will pay Seattle Genetics $11 million to use its technology with Genmab's AXL antibody and future milestones and royalty payments, as a result of a potential product, could amount to $200 million, the companies said on Tuesday.

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