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Seattle Genetics Reports Third Quarter 2016 Financial Results

On October 27, 2016 Seattle Genetics, Inc. (NASDAQ: SGEN) reported financial results for the third quarter and nine months ended September 30, 2016 (Press release, Seattle Genetics, OCT 27, 2016, View Source [SID1234516058]).

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The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development accomplishments, vadastuximab talirine (SGN-CD33A) activities and progress with its pipeline of antibody-drug conjugates (ADCs) and other proprietary programs.

"Seattle Genetics is transitioning into a global, multi-product oncology company, demonstrated by our substantial progress with ADCETRIS both commercially and clinically, our advancing vadastuximab talirine phase 3 CASCADE pivotal trial and the promising data recently presented on enfortumab vedotin for urothelial cancer," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Looking forward, key upcoming activities include a strong presence at the ASH (Free ASH Whitepaper) Annual Meeting in December, reporting top-line data in 2017 from the ECHELON-1 phase 3 trial of ADCETRIS in frontline Hodgkin lymphoma and initiating discussions with regulatory agencies about advancing enfortumab vedotin. In addition, we are generating data from multiple other phase 1 programs and anticipate moving several novel programs into the clinic within the next year."

ADCETRIS Program Updates

ALCANZA Phase 3 Trial: Seattle Genetics and its collaborator Takeda reported top-line data in August 2016 from the phase 3 ALCANZA clinical trial in 131 patients with CD30-expressing cutaneous T-cell lymphoma (CTCL). The trial met its primary endpoint demonstrating that treatment with ADCETRIS resulted in a highly statistically significant improvement in the rate of objective response lasting at least four months (ORR4) versus the control arm as assessed by an independent review committee (p-value <0.0001). Full data from the ALCANZA clinical trial will be featured in an oral presentation at the ASH (Free ASH Whitepaper) Annual Meeting in December 2016, and Seattle Genetics plans to submit a supplemental Biologics License Application in the U.S. for label expansion in CTCL during the first half of 2017.
ECHELON-1 Phase 3 Trial: Top-line data from the ECHELON-1 phase 3 trial in frontline classical Hodgkin lymphoma are anticipated during 2017 (previously expected in the 2017 to mid-2018 timeframe). ECHELON-1 is designed to redefine the way newly diagnosed patients with advanced Hodgkin lymphoma are treated.
ECHELON-2 Phase 3 Trial: Enrollment of 450 patients is ongoing in the phase 3 ECHELON-2 clinical trial in patients with frontline CD30-expressing mature T-cell lymphoma (MTCL). Seattle Genetics and Takeda anticipate completing enrollment during 2016 with top-line data expected in the 2017 to 2018 timeframe.
Leadership in Hodgkin Lymphoma: ADCETRIS was recently highlighted in several data presentations at the 10th International Symposium on Hodgkin Lymphoma (ISHL) in October 2016. The data included an update from the phase 3 AETHERA trial showing a sustained progression-free survival (PFS) benefit approximately four years after the last patient was enrolled.
Collaboration with Bristol-Myers Squibb: Seattle Genetics and Bristol-Myers Squibb recently expanded the companies’ clinical development collaboration to add cohorts to ongoing trials evaluating ADCETRIS combined with Opdivo (nivolumab). In addition to the current trials in second-line Hodgkin lymphoma and relapsed/refractory non-Hodgkin lymphoma, the companies will evaluate the combination of the two agents as frontline treatment for older Hodgkin lymphoma patients, as well as in relapsed/refractory primary mediastinal B-cell lymphoma and mediastinal gray zone lymphoma.
Upcoming ASH (Free ASH Whitepaper) Presentations: In addition to the ALCANZA oral presentation, more than 10 abstracts on ADCETRIS will be featured at the ASH (Free ASH Whitepaper) Annual Meeting. These include preliminary results from a phase 1 trial evaluating ADCETRIS in combination with Opdivo in second-line Hodgkin lymphoma, four-year follow-up from a phase 1 trial in frontline MTCL and five-year follow-up from a pivotal trial in systemic ALCL.
ADCETRIS is not currently approved for use in CTCL, frontline Hodgkin lymphoma, frontline MTCL or in combination with nivolumab.

Vadastuximab Talirine (SGN-CD33A) Program Updates

CASCADE Phase 3 Trial: Seattle Genetics is continuing enrollment in the 500-patient, global, randomized pivotal phase 3 CASCADE clinical trial evaluating vadastuximab talirine in combination with hypomethylating agents (HMAs) in older patients with newly diagnosed acute myeloid leukemia (AML).
Upcoming ASH (Free ASH Whitepaper) Presentations: Data from several ongoing phase 1 trials of vadastuximab talirine will be featured in four oral presentations at the ASH (Free ASH Whitepaper) Annual Meeting. Included are data from a phase 1b trial of vadastuximab talirine in combination with cytarabine and daunorubicin ("7+3") for frontline, younger AML patients as well as follow-up data from a phase 1 trial of vadastuximab talirine plus HMAs in older AML patients.
More information about vadastuximab talirine and ongoing clinical trials can be found at www.ADC-CD33.com.

Pipeline Updates

Enfortumab Vedotin (ASG-22ME) and ASG-15ME: Seattle Genetics and its collaborator Agensys, an affiliate of Astellas, reported data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October 2016 from phase 1 trials of enfortumab vedotin and ASG-15ME in patients with previously treated metastatic urothelial cancer, including those who had received prior checkpoint inhibitors. At the recommended phase 2 dose, enfortumab vedotin demonstrated a 59 percent objective response rate. While both phase 1 studies will continue to enroll patients, Seattle Genetics is working closely with its partner Astellas to define next steps for enfortumab vedotin, including potential later-stage trials and discussions with regulatory agencies.
Denintuzumab Mafodotin (SGN-CD19A): Seattle Genetics recently initiated a phase 2 trial of denintuzumab mafodotin in frontline diffuse large B-cell lymphoma (DLBCL). The trial will assess the activity and tolerability of adding denintuzumab mafodotin to the standard frontline regimen, R-CHOP, as well as a modified regimen, R-CHP. Denintuzumab mafodotin is also being evaluated in an ongoing phase 2 trial in relapsed DLBCL.
SGN-LIV1A: Data from a phase 1 trial of SGN-LIV1A will be presented at the San Antonio Breast Cancer Symposium taking place in December 2016. SGN-LIV1A is in development for metastatic breast cancer, with a focus on triple negative disease.
SEA-CD40: The first clinical data from an ongoing phase 1 trial of SEA-CD40 will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2016 Annual Meeting in November. SEA-CD40 is a novel immuno-oncology agent targeted to CD40 utilizing Seattle Genetics’ proprietary sugar-engineered antibody (SEA) technology to produce a non-fucosylated antibody.
SGN-CD123A: The first patient was treated in a multicenter phase 1 clinical trial of SGN-CD123A for relapsed/refractory AML. SGN-CD123A is an ADC, comprising an engineered cysteine antibody (EC-mAb) stably linked to a highly potent DNA binding agent called a pyrrolobenzodiazepine (PBD) dimer. CD123 is expressed across AML subtypes and is particularly prominent on leukemic stem cells.
SGN-CD70A: Based on a portfolio review and evaluation of phase 1 clinical data of SGN-CD70A in renal cell carcinoma and CD70-positive non-Hodgkin lymphoma, Seattle Genetics is discontinuing further clinical development of the program.
Lead Preclinical Programs:
SGN-CD352A is a novel ADC targeting CD352 that utilizes the company’s PBD dimer and EC-mAb technologies. Seattle Genetics plans to initiate a phase 1 clinical trial of SGN-CD352A for multiple myeloma by early 2017.
SGN-2FF is a small molecule immuno-oncology agent that is expected to advance into a phase 1 trial for solid tumors during 2017. Preclinical data from SGN-2FF will be presented in a poster presentation at the SITC (Free SITC Whitepaper) 2016 Annual Meeting.
SGN-CD48A is a novel ADC utilizing Seattle Genetics’ latest technology advances. Preclinical data will be described in a poster presentation at the ASH (Free ASH Whitepaper) Annual Meeting and the company plans to submit an investigational new drug (IND) application during 2017 for a phase 1 clinical trial in multiple myeloma.
ADC Collaborations: Seattle Genetics generated fees and milestones under its ongoing ADC collaboration with AbbVie based on AbbVie’s progress with programs utilizing Seattle Genetics technology.
Third Quarter and Nine Months 2016 Financial Results

Total revenues in the quarter and nine month periods ended September 30, 2016 increased to $106.3 million and $312.9 million, respectively, compared to $84.1 million and $243.3 million from the same periods in 2015. Revenues included:

ADCETRIS net sales in the third quarter were $70.1 million, a 19 percent increase from net sales of $59.1 million in the third quarter of 2015. For the year-to-date, ADCETRIS sales were $195.0 million, compared to $163.0 million for the year-to-date period in 2015, a 20 percent increase.
Royalty revenues in the third quarter of 2016 were $12.2 million, compared to $9.7 million in the third quarter of 2015. For the year-to-date in 2016, royalty revenues were $53.7 million, compared to $28.4 million for the first nine months of 2015. Royalty revenues are primarily driven by international sales of ADCETRIS by Takeda. Royalty revenues for the year-to-date in 2016 also included a $20.0 million sales milestone payment from Takeda earned in the first quarter of 2016.
Amounts earned under the company’s ADCETRIS and ADC collaborations totaled $24.0 million in the third quarter and $64.1 million for the first nine months of 2016, compared to $15.3 million and $51.9 million for the same periods in 2015.
Total costs and expenses for the third quarter of 2016 were $138.7 million, compared to $110.6 million for the third quarter of 2015. For the first nine months of 2016, total costs and expenses were $399.7 million, compared to $339.1 million in the first nine months of 2015. The increase in 2016 costs and expenses was primarily driven by investment in vadastuximab talirine, ADCETRIS collaboration activities for product supply to Takeda, and the company’s pipeline programs.

Non-cash, share-based compensation cost for the first nine months of 2016 was $37.0 million, compared to $28.7 million for the same period in 2015.

Net loss for the third quarter of 2016 was $31.8 million, or $0.23 per share, compared to a net loss of $26.4 million, or $0.21 per share, for the third quarter of 2015. For the nine months ended September 30, 2016, net loss was $85.0 million, or $0.61 per share, compared to a net loss of $95.6 million, or $0.76 per share, for the same period in 2015.

As of September 30, 2016, Seattle Genetics had $631.9 million in cash, cash equivalents and investments.

2016 Financial Outlook

Seattle Genetics tightened its 2016 financial outlook within previously provided ranges as follows:

ADCETRIS net product sales in the U.S. and Canada are expected to be in the range of $260 million to $270 million.
Research and development expenses are expected to be in the range of $370 million to $390 million.

Dong-A ST and Beactica announce licence and collaboration agreement to develop new cancer treatments

On October 26, 2016 Dong-A ST Co., Ltd. (170900: Korea SE), the Korean pharmaceutical company, and Beactica AB, the Swedish fragment-based drug discovery company, reported a new multi-year research and drug discovery collaboration and licensing agreement (Press release, Dong-A ST, OCT 26, 2016, View Source [SID1234535725]). Beactica and Dong-A ST will jointly develop novel anti-cancer drugs against certain disease-related oncology targets.

Under the terms of the agreement, Dong-A ST will gain exclusive global rights for the further development and commercialization of Beactica’s small molecule inhibitors against multiple members of a family of epigenetic enzymes. The partnership will pool existing compound series from both companies and combine Beactica’s unique early-stage lead generation capabilities with DONG-A ST’s strengths in downstream pre-clinical and clinical development of new therapeutic agents.

Beactica will receive an undisclosed upfront payment and is eligible to receive research funding as well as potential milestone payments for certain research, preclinical, clinical and regulatory milestones. In addition, Beactica is eligible to receive royalties on commercial sales of the products resulting from the partnership. Beactica is also entitled to a revenue share from any related future licensing activities by Dong-A. Full financial details remain undisclosed.

"This global research collaboration between Dong-A ST and Beactica which specializes in developing novel drug targets marks a big step forward in development of next generation anti-cancer therapeutics" said Dr Soo-Hyoung Kang, President and CEO of Dong-A ST. "This collaboration and licensing of Beactica’s small molecule inhibitors will greatly strengthen Dong-A ST’s current oncology pipeline and will further enhance Dong-A ST’s global competitiveness in the pharmaceutical industry."

"We’ve been impressed by Dong-A’s commitment to benefiting cancer patients through therapeutics that modulate epigenetic pathways and are excited to initiate this collaboration." said Dr Per Källblad, CEO of Beactica. "This is a ground-breaking partnership in terms of structure, scope and the potential clinical impact of therapeutics created through our complementary capabilities."

Epigenetics is the study of physiological changes caused by altered gene expressions originating from inherited changes other than the DNA sequence itself. Cancer epigenetics is a rapidly emerging research area with potential to provide new treatments for patients by modifying DNA and chromatin, both of which play important roles in tumour development.

X-Rx and Mercachem Provide Update on Two Discovery-Stage Oncology Programs

On October 26, 2016 X-Rx, Inc, a biotechnology company focused on the creation of small molecule drug candidates, and Mercachem BV, a leading chemistry CRO with expertise in medicinal and process chemistry, reported progress with two discovery-stage oncology programs from the portfolio of X-Rx (Press release, X-Rx, OCT 26, 2016, View Source [SID1234527704]). The programs target Mcl1, an anti-apoptotic target that is over-expressed in many liquid and solid tumor types, and TAK1, a member of the mitogen-activated protein kinase family.

Under the service agreement with X-Rx, Mercachem is responsible for hit-to-lead and lead optimization campaigns targeting Mcl1 and TAK1. Mcl1-targeting agents could lead to inducing tumor cell death via apoptosis and via modulation of the tumor micro-environment, drive sensitivity to chemotherapy and other immunotherapy approaches. Blocking TAK1, a kinase that when over-expressed in many cell types can drive tumor onset and progression, fibrosis and autoimmune diseases, will have numerous clinical applications.

"In 2015, we successfully partnered two of our therapeutic programs with leading pharma organizations in major markets. We are committed to building on this initial success and bringing additional candidates towards a stage where significant value has been generated to partner them on favorable terms," said Dr. Lee Babiss, CEO of X-Rx. "With today’s news we are taking the next step in the discovery and development of our Mcl1 and TAK1 programs together with Mercachem."

"We are pleased that X-Rx has chosen Mercachem as their collaboration partner as they further explore the therapeutic potential of their two promising oncology targets using our competence and expertise with kinases and PPI targets," commented Dr. Gerhard Müller, SVP Medicinal Chemistry of Mercachem.

Active Biotech and NeoTX enter into a partnership for the development and commercialization of ANYARA for immuno-oncology

On October 26, 2016 Active Biotech AB (NASDAQ OMX NORDIC: ACTI) and NeoTX Therapeutics Ltd. reported that they have entered into a licensing agreementfor Active Biotech’s investigational compound Naptomumab estafenatox ("ANYARA") for cancer immunotherapy (Press release, Active Biotech, OCT 26, 2016, View Source [SID1234523671]). NeoTX will be responsible for the worldwide clinical development and commercialization of the drug.This partnership is a key milestone in NeoTX’s strategy to bring tumor recognition enhancing therapeutics to the market.

"We are very enthusiastic about our collaboration with Active Biotech. At NeoTX, we are strongly committed to developing innovative immunotherapies for unmet medical needs. "Active Biotech brings to our collaboration outstanding scientific and intellectual capital, and a powerful commitment to positively impact the treatment of cancer," said Asher Nathan, Chief Executive Officer of NeoTX.

Dr. Marcel Rozencweig, Chief Medical Officer of NeoTX and former Head of Global Clinical Oncology Research at BMS said "We are looking forward to developing ANYARA for immuno-oncology applications. We believe that the ANYARA technology is well suited to increase tumor recognition by the immune system and has demonstrated synergistic activity in combination with checkpoint inhibitors in animal models. As such, ANYARA would be attractive in combination with checkpoint inhibitors whose efficacy can be limited by poor tumor recognition".

"We are excited about the partnership with NeoTX, who we consider as an ideal partner for ANYARA. This partnership constitutes the next step in the clinical development, as well as the commercialization strategy, for the project." said Tomas Leanderson, President & CEO of Active Biotech.

About the agreement
Under the terms of the agreement, Active Biotech grants NeoTX exclusive rights to develop and commercialize ANYARA worldwide in cancer indications. The total deal value amounts to $71 million and is contingent upon achievement of clinical, regulatory and commercial milestones whereof Active Biotech will receive $250 000 as an initial payment upon signing. In addition, NeoTX will pay Active Biotech progressive, double-digit royalties on its net sales.

About ANYARA
ANYARA is a TTS (Tumor Targeting Superantigen) compound that increases the ability of the immune system to recognize the tumor. Synergy has been reported in vivo with a combination of ANYARA and a checkpoint inhibitor in an experimental tumor model. Clinically, the development of ANYARA has primarily been focused on cancer indications with a high unmet medical need. Positive data was reported from clinical Phase I trials in lung cancer, renal cell cancer and pancreatic cancer, where ANYARA was studied both as a single agent (monotherapy) and in combination with an established tumor therapy – docetaxel (Taxotere) – in patients with advanced cancer. The results showed that ANYARA was well tolerated both as monotherapy and in combination with docetaxel, and increased tumor recognition by T cells.

A Phase 2/3 trial of ANYARA in combination with interferon alpha in renal cell cancer demonstrated acceptable safety but did not meet its primary efficacy endpoint in the ITT population. The upcoming clinical trial will be done in combination with drugs that inhibit checkpoint dampening of the immune system, a combination strategy in line with the mode of action of ANYARA and supported by preclinical data.

Varian and McKesson Specialty Health Announce Strategic Agreement for Advanced Radiotherapy Equipment and Software

On October 26, 2016 Varian Medical Systems (NYSE: VAR) and McKesson Specialty Health reported a strategic agreement for the deployment and servicing of Varian advanced radiotherapy equipment and software over a three-year period across The US Oncology Network and Vantage Oncology affiliated sites of care (Press release, Varian Medical Systems, OCT 26, 2016, View Source [SID1234516101]). This multiyear agreement delivers significant value to oncology providers in The US Oncology Network, which now operates the largest system of radiotherapy facilities in the U.S. following the acquisition of Vantage Oncology earlier this year.

Over the next two years, seven Varian TrueBeam and five VitalBeam medical linear accelerators will be installed in The US Oncology Network and Vantage Oncology affiliated cancer centers across the U.S. In addition, McKesson and Varian will collaborate to establish interoperability between McKesson Specialty Health’s iKnowMedSM electronic health record (EHR) system and Varian’s ARIA oncology information system. The interoperability aims to deliver direct value to all physicians using these information systems in managing patient care.

"McKesson Specialty Health and The US Oncology Network offer robust, comprehensive practice management capabilities, value-based care expertise, and state-of-the-art technology solutions to its affiliated practices, providing support as they navigate today’s challenging healthcare landscape," said Kirk Kaminsky, president of The US Oncology Network and Practice Management for McKesson Specialty Health. "Combined, Vantage Oncology and The US Oncology Network support more than 1,300 affiliated physicians and approximately 400 affiliated sites of care. Bringing them together earlier this year and now executing this strategic agreement with Varian will help our affiliated practices simultaneously enhance clinical capabilities, workflow for physicians, and the quality of patient care while improving the cost-effectiveness of their operations. The specialized hardware, service offerings and roadmap for interoperability with iKnowMed gives clinicians greater efficiency and increased quality of patient care benefits."

"We are honored by the long-term commitment McKesson Specialty Health is making in Varian equipment and technology as part of this agreement," said Kolleen Kennedy, president of Varian’s Oncology Systems business. "Our companies share a common goal to develop and deliver the highest level of care. Through this strategic agreement, we are increasing the ability of patients to access the most advanced treatments in their fight against cancer."