ATLANTA--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today announced results from a phase I clinical trial of ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the treatment of newly diagnosed advanced stage Hodgkin lymphoma (HL) patients. The data 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, a defining marker of classical HL. ADCETRIS is currently not approved for use in the front-line treatment of HL.

In the phase I trial, newly diagnosed patients received ADCETRIS concomitantly with either ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) or AVD, which removes bleomycin from the regimen. At the end of front-line therapy, 24 of 25 patients (96 percent) treated with ADCETRIS plus AVD and 21 of 22 (95 percent) patients treated with ADCETRIS plus ABVD had a complete remission. None of the patients treated in the ADCETRIS plus AVD cohort experienced pulmonary toxicity, compared with an expected rate of pulmonary toxicity caused by ABVD alone of 10-25 percent. The trial was designed to establish the safety profile and maximum tolerated dose when adding ADCETRIS to ABVD or AVD. Antitumor activity was assessed as a secondary endpoint.

"For over 30 years, the standard of care for front-line HL has been a chemotherapy regimen called ABVD that has demonstrated a complete remission rate of 70 to 80 percent and is associated with considerable life-threatening toxicities. There is a significant need to identify better treatment options for patients in the front-line HL setting, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Our goal is to redefine front-line treatment of HL with the addition of ADCETRIS, and the encouraging results of this phase I trial clearly support this goal and provide rationale for the ongoing ADCETRIS phase III trial in this setting."

Front-line Therapy with Brentuximab Vedotin Combined with ABVD or AVD in Patients with Newly Diagnosed Advanced Stage Hodgkin Lymphoma (Abstract #798)

In this open-label, multicenter trial, cohorts of patients received an escalating dose of ADCETRIS (0.6 milligrams per kilogram (mg/kg), 0.9 mg/kg, 1.2 mg/kg) every two weeks concomitantly with ABVD or a dose of 1.2 mg/kg every two weeks concomitantly with AVD.

Fifty-one patients were enrolled in the phase I study and 47 were evaluable for response at trial completion. The 47 evaluable patients included 25 in the ADCETRIS plus AVD cohort and 22 in the ADCETRIS plus ABVD cohorts. All patients were previously untreated and 45 percent had Stage IV HL. The median age of patients across all cohorts of the trial was 33 years. Key findings, which were highlighted in an oral presentation by Dr. Stephen Ansell, Professor of Medicine, Division of Hematology, from the Mayo Clinic, included:

For decades researchers have strived to improve our front-line HL treatment strategy by enhancing the activity of traditional chemotherapy regimens while reducing the significant toxicities and long-term side effects of such regimens, said Stephen Ansell,M.D., Ph.D., Professor of Medicine, Division of Hematology, Mayo Clinic. There is a significant need to identify better treatment options for patients in the front-line setting. With a complete response rate of 96 percent and a manageable safety profile, data from this trial support further evaluation of ADCETRIS administered concomitantly with AVD in previously untreated HL patients to potentially improve the current standard of care.

Seattle Genetics and Millennium: The Takeda Oncology Company have initiated a phase III clinical trial in advanced stage front-line HL patients. The randomized trial is comparing progression-free survival in patients receiving ADCETRIS in combination with AVD to patients receiving ABVD alone. For more information about the trial visit http://www.seattlegenetics.com or http://www.clinicaltrials.gov.

About ADCETRIS

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Seattle Genetics Reports Data from Phase I Trial of ADCETRIS® (Brentuximab Vedotin) in Front-line Hodgkin Lymphoma at ...

ATLANTA--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today 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.

Brentuximab Vedotin Demonstrates Significant Clinical Activity in Relapsed or Refractory Mycosis Fungoides with Variable CD30 Expression (Abstract #797)

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:

Results of a Phase II Trial of Brentuximab Vedotin (SGN-35) for CD30+ Cutaneous T-Cell Lymphomas and Lymphoproliferative Disorders (Abstract #3688)

Data were presented from a phase II investigator-sponsored trial evaluating the use of ADCETRIS in CD30-positive CTCL patients, including lymphomatoid papulosis (LyP), primary cutaneous anaplastic large cell lymphoma (pcALCL) or MF. The ongoing study is being conducted by Dr. Madeleine Duvic from The University of Texas MD Anderson Cancer Center in Houston, TX. Among 54 patients enrolled to date, 46 patients were evaluable at the time of analysis. The primary endpoint of the trial is to evaluate the safety and efficacy of ADCETRIS in CD30-positive CTCL. The key findings include:

Seattle Genetics and Millennium: The Takeda Oncology Company have initiated the ALCANZA trial, a randomized phase III clinical trial of ADCETRIS for relapsed CD30-positive CTCL patients. The trial is assessing ADCETRIS versus investigators choice of methotrexate or bexarotene in patients with CD30-positive CTCL, including those with pcALCL or MF. The primary endpoint of the study is overall response rate lasting at least four months. Approximately 124 patients will be enrolled in the pivotal trial. The ALCANZA trial is being conducted under a Special Protocol Assessment agreement from the U.S. Food and Drug Administration (FDA). The study also received European Medicines Agency scientific advice.

About CTCL

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Cutaneous lymphomas are a category of non-Hodgkin lymphomas that primarily involve the skin. According to the Cutaneous Lymphoma Foundation, CTCL is the most common type of cutaneous lymphoma and typically presents with red, scaly patches or thickened plaques of skin that often mimic eczema or chronic dermatitis. Progression from limited skin involvement is variable and may be accompanied by tumor formation, ulceration and exfoliation, complicated by itching and infections. Advanced stages are defined by involvement of lymph nodes, peripheral blood and internal organs. According to published literature, up to 50 percent of CTCL patients lesions express CD30.

About ADCETRIS

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Seattle Genetics Announces Data from Investigator-Sponsored Trials of ADCETRIS® (Brentuximab Vedotin) in Cutaneous T ...

AMES, Iowa, Dec. 13, 2012 /PRNewswire/ --NewLink Genetics Corporation (NLNK) today announced that the results of a Phase 1 dose escalation study with its proprietary HyperAcute Prostate Cancer Immunotherapy were published in the Journal of Immunotherapy. The article, entitled "Cellular Immunotherapy Study of Prostate Cancer Patients and Resulting IgG Responses to Peptide Epitopes Predicted From Prostate Tumor-associated Autoantigens," is featured in the current edition of the Journal.

The study was conducted at the University of Nebraska Medical Center and included eight patients. Patients were scheduled to receive a priming dose on day one, followed by eleven boost doses every two weeks and patients received up to 12 intradermal vaccinations at doses ranging from 30 million to 500 million cells per injection. Patients were tested for safety, immunological and clinical responses arising after immunotherapy.

The study demonstrated that the immunotherapy was safe, and that the first immunization differentially increased the anti-alphaGal IgG response in all patients compared with baseline levels. These data indicated that administration of HyperAcute-Prostate immunotherapy increases the immune response against alphaGal epitopes, demonstrating the immunogenicity of the vaccine in prostate cancer patients.

The patients that received the highest dose of immunotherapy developed antibody responses against prostate tumor-associated antigens that were not seen in a control group of untreated volunteers. Data demonstrated that 37.5 percent (3/8) of patients responded with Prostate Specific Antigen (PSA) level stabilization for more than 100 days.

The adverse events data reported in this publication confirm the safety of this immunotherapy, consistent with previous studies on the safety of alpha-Gal-expressing allogeneic vaccines (HyperAcute immunotherapy) in the treatment of lung, melanoma and pancreatic cancers. Median overall survival for the study was 25.1 months with one patient with bone metastases surviving for more than 70 months.

"The favorable safety profile of this agent combined with evidence of vaccine induced immunologic responses in patients clearly suggests this therapy should be studied in a large controlled trial," said Dr. George P. Hemstreet, III, University of Nebraska Medical Center, the Principal Investigator for the study.

NewLink Genetics is currently evaluating its lead immunotherapy product candidate algenpantucel-L (HyperAcute-Pancreas) in a Phase 3 clinical trial in surgically-resected pancreatic cancer patients.

About HyperAcute Prostate Cancer Immunotherapy

NewLink's HyperAcute Prostate Cancer immunotherapy product candidate consists of two allogeneic prostate cancer tumor cell lines modified to express alpha-Gal. These cell lines were chosen to provide a broad coverage of prostate cancer antigens. Each of the modified cell lines is grown in large cultures, harvested, packaged and irradiated. Each of the two vaccine components was administered separately.

About Prostate Cancer

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Clinical Data from NewLink Genetics' HyperAcute Prostate Cancer Immunotherapy Published in Journal of Immunotherapy

ATLANTA--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today presented preclinical data from SGN-CD33A, an antibody-drug conjugate (ADC) in development for the treatment of acute myeloid leukemia (AML), at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. SGN-CD33A is a novel CD33-directed ADC utilizing Seattle Genetics next generation technology. The CD33 antibody is attached to a highly potent cytotoxic agent called a pyrrolobenzodiazepine (PBD) dimer via a proprietary site-specific conjugate technology to a monoclonal antibody with engineered cysteines (EC-mAb). Seattle Genetics expects to advance SGN-CD33A into a phase I clinical trial in 2013.

Our SGN-CD33A program showcases our next generation ADC technology, including our latest highly potent cell-killing agent and our new engineered antibody technology, said Jonathan Drachman, M.D., Senior Vice President, Research and Translational Medicine at Seattle Genetics. Of approximately 30 ADCs in development, more than 50 percent utilize Seattle Genetics technology. Through our continued innovation we are leading the development of novel ADCs, and believe that ADCs can transform the way cancer is treated.

ADCs are monoclonal antibodies that are designed to selectively deliver cytotoxic agents to tumor cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity.

PBDs are a class of DNA-crosslinking agents that are significantly more potent than systemic chemotherapeutic drugs. Seattle Genetics has been working with PBDs since 2008 under an exclusive licensing arrangement with Spirogen Ltd. Over the past four years, Seattle Genetics has selected and optimized specific PBD molecules combined with novel linkers for use in ADCs, and has conducted process development and scale-up activities to create robust synthetic GMP manufacturing processes for these PBD drug-linkers.

SGN-CD33A: A Novel CD33-Directed Antibody-Drug Conjugate, Utilizing Pyrrolobenzodiazepine Dimers, Demonstrates Preclinical Antitumor Activity Against Multi-Drug Resistant Human AML (Abstract #3589)

Key findings from the preclinical evaluation of SGN-CD33A included:

About Seattle Genetics

Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer. The U.S. Food and Drug Administration granted accelerated approval of ADCETRIS in August 2011 for two indications. ADCETRIS is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has three other clinical-stage ADC programs: SGN-75, ASG-5ME and ASG-22ME. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Agensys (an affiliate of Astellas), Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys and Genmab. More information can be found at http://www.seattlegenetics.com.

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the initiation of future clinical trials with SGN-CD33A. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the inability to generate the appropriate data and information to support an investigational new drug submission to the FDA. More information about the risks and uncertainties faced by Seattle Genetics is contained in the companys 10-Q for the quarter ended September 30, 2012 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Seattle Genetics Highlights Next Generation Antibody-Drug Conjugate SGN-CD33A at ASH Annual Meeting

ATLANTA--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today highlighted clinical data from two antibody-drug conjugate (ADC) programs in development by Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) that utilize Seattle Genetics technology. The data were presented at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. Phase I data from both ADCs, an anti-CD22 ADC (DCDT2980S, RG7593) and an anti-CD79b ADC (DCDS4501A, RG7596), demonstrated antitumor activity in relapsed or refractory B-cell non-Hodgkin lymphoma (NHL) patients at generally well-tolerated doses. These ADC programs are currently being evaluated in a phase II clinical trial for patients with relapsed or refractory B-cell NHL.

Genentechs phase I data and their advancement of these two ADCs into phase II clinical development, as well as their utilization of our technology in six other clinical-stage programs,illustrates their commitment to ADCs as an innovative, targeted approach to treat cancer,saidEric Dobmeier, ChiefOperatingOfficer of Seattle Genetics. Across our ADC collaborations, there is broad potential for our industry-leading technologyto address thesignificant needformore effective and better tolerated treatment options.

Anti-CD22-MMAE and anti-CD79b-MMAE are ADCs designed to deliver potent cytotoxic treatment to targeted cells with improved tolerability. With over a decade of experience and knowledge in ADC innovation, Seattle Genetics has developed proprietary technology employing synthetic cytotoxic agents, such as monomethyl auristatin E (MMAE), and stable linker systems that attach these cytotoxic agents to the antibody. Seattle Genetics linker systems are designed to be stable in the bloodstream and release the potent cell-killing agent once inside targeted cancer cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity. ADCETRIS (brentuximab vedotin) is the first drug approved utilizing Seattle Genetics ADC technology.

A Phase I Study of the Anti-CD79b Antibody-Drug Conjugate (ADC) DCDS4501A Targeting CD79b in Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma (Abstract #56)

A phase I clinical trial is being conducted to evaluate the safety and activity of DCDS4501A in patients with relapsed or refractory B-cell NHL. DCDS4501A is an ADC consisting of an anti-CD79b monoclonal antibody conjugated to the cytotoxic agent MMAE using Seattle Genetics ADC technology. In this analysis, 47 patients were evaluable for safety and 32 were evaluable for efficacy.

Key findings included:

A Phase I Study of DCDT2980S, an Antibody-Drug Conjugate (ADC) Targeting CD22, in Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma (Abstract #59)

A phase I clinical trial is being conducted to evaluate the safety and activity of DCDT2980S in patients with relapsed or refractory B-cell NHL. DCDT2980S is an ADC candidate consisting of an anti-CD22 monoclonal antibody conjugated to the cytotoxic agent MMAE using Seattle Genetics ADC technology. In this analysis, 43 patients were evaluable for safety and 33 were evaluable for efficacy.

Key findings included:

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Seattle Genetics Highlights Data Presentations from Genentech ADC Collaborator Programs at ASH Annual Meeting