Seattle Genetics Announces Multiple ADCETRIS® (Brentuximab Vedotin) Data Presentations at the International Conference on Malignant Lymphoma

On June 17, 2015 Seattle Genetics reported several ADCETRIS (brentuximab vedotin) data presentations at the 13th International Conference on Malignant Lymphoma (ICML) being held June 17 to 19, 2015, in Lugano, Switzerland (Press release, Seattle Genetics, JUN 17, 2015, View Source;p=RssLanding&cat=news&id=2060135 [SID:1234505449]). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in classical Hodgkin lymphoma (HL), systemic anaplastic large cell lymphoma (sALCL) and several other types of non-Hodgkin lymphoma (NHL). Seven oral presentations and one poster at ICML demonstrate the breadth of the clinical development program for ADCETRIS. Data include an additional analysis of the phase 3 AETHERA clinical trial showing that up to 16 cycles (approximately one year) of ADCETRIS consolidation therapy following autologous stem cell transplant (ASCT) significantly extended progression-free survival (PFS) versus placebo for those patients with primary-refractory HL. In addition, data from several corporate and investigator-sponsored trials with ADCETRIS showed activity in a variety of HL and NHL treatment settings. ADCETRIS is currently approved by the U.S. Food and Drug Administration (FDA) for relapsed HL and sALCL and was granted conditional marketing authorization by the European Commission for relapsed or refractory HL and sALCL.

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"Since the initial FDA approval of ADCETRIS in 2011 for the treatment of relapsed HL and sALCL, it has been approved in more than 55 countries, and our clinical development program has expanded to include more than 30 corporate and investigator-sponsored clinical trials in CD30-expressing malignancies," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "The ADCETRIS data presented at ICML support our broad development plans for ADCETRIS. In the near-term, we anticipate an FDA decision on its use in the AETHERA setting as a post-transplant consolidation therapy, and, ultimately, our goal is to move even earlier into the treatment paradigm and redefine frontline treatment of HL with the addition of ADCETRIS."

Analysis of primary-refractory Hodgkin lymphoma patients in a randomized, placebo-controlled study of brentuximab vedotin consolidation after autologous stem cell transplant (Seattle Genetics and Takeda; Abstract #120, oral presentation Friday, June 19, 2015, at 11:50 a.m. CEST)

Data were reported from an additional analysis of the phase 3 AETHERA clinical trial evaluating PFS by investigator in patients who were refractory to frontline treatment. Previously published data suggest primary-refractory HL patients have poor outcomes following ASCT, as demonstrated by the historical two-year PFS and three-year overall survival rates of less than 40 percent and 50 percent, respectively. Of the 329 patients enrolled in the AETHERA trial, 60 percent (196 patients) were primary-refractory to frontline treatment.

Results of the analysis demonstrated:

Two-year PFS rates per investigator among primary-refractory patients on the ADCETRIS and placebo arms were 60 percent and 42 percent, respectively, consistent with the primary analysis in the full intent-to-treat population.

Subgroup analyses of patients by disease characteristics as well as number of risk factors showed that PFS was improved broadly across subgroups, including patients with B-symptoms, extranodal involvement and those who received more than two systemic anticancer treatments pre-ASCT.

Adverse events in primary-refractory patients who received ADCETRIS were consistent with the known safety profile.

Additional AETHERA data were included in a poster presentation reporting the frequency of healthcare resource utilization (HRU) among patients on the two treatment arms of the trial. Preliminary reports suggest a trend toward lower HRU in patients treated with ADCETRIS compared with placebo.

ADCETRIS is currently not approved for use in the AETHERA treatment setting. Based on the positive results from the AETHERA trial, a supplemental Biologics License Application (BLA) for ADCETRIS in the post-ASCT consolidation treatment of HL patients at high risk of relapse or progression was accepted for filing by the FDA. The FDA granted Priority Review for the application and the Prescription Drug User Fee Act (PDUFA) target action date is August 18, 2015.

Additional ADCETRIS corporate and investigator presentations are included below and full abstracts can be found in the ICML Educational and Abstract Book accessed on the ICML website at www.lymphcon.ch.

Wednesday, June 17, 2015

Healthcare utilization in the AETHERA trial: phase 3 study of brentuximab vedotin in patients at increased risk of residual Hodgkin lymphoma post ASCT (Seattle Genetics and Takeda; Abstract #177, poster presentation)

Thursday, June 18, 2015

Brentuximab vedotin plus AVD for non-bulky limited stage classical Hodgkin lymphoma: A phase 2 trial (Investigator-sponsored; Abstract #087, oral presentation at 5:15 p.m. CEST)

Preliminary efficacy and safety of brentuximab vedotin and AVD chemotherapy followed by involved-site radiotherapy in early stage, unfavorable risk Hodgkin lymphoma (Investigator-sponsored; Abstract #088, oral presentation at 5:25 p.m. CEST)

Sequential brentuximab vedotin and AVD for older Hodgkin lymphoma patients: Initial results from a phase 2 multicenter study (Investigator-sponsored; Abstract #089, oral presentation at 5:35 p.m. CEST)

A phase 1 study of brentuximab vedotin (Bv) and bendamustine (B) in patients with relapsed or refractory Hodgkin lymphoma (HL) and anaplastic large T-Cell lymphoma (ALCL) (Investigator-sponsored; Abstract #090, oral presentation at 5:45 p.m. CEST)

Brentuximab vedotin demonstrates antitumor activity in CD30+ DLBCL (Seattle Genetics; Abstract #091, oral presentation at 5:55 p.m. CEST)

Updated results of a phase 2 trial of brentuximab vedotin combined with RCHOP in frontline treatment of pts with high-intermediate/high-risk DLBCL (Seattle Genetics; Abstract #092, oral presentation at 6:05 p.m. CEST)

ADCETRIS is not currently approved for use in frontline HL, in combination with bendamustine for relapsed or refractory HL and sALCL, or in DLBCL.

About ADCETRIS

ADCETRIS is being evaluated broadly in more than 30 ongoing clinical trials, including four phase 3 studies, in earlier lines of its approved HL and sALCL indications as well as in many additional types of CD30-positive malignancies, including cutaneous T-cell lymphoma, B-cell lymphomas and mature T-cell lymphomas.

ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS for intravenous injection received accelerated approval from the FDA and approval with conditions from Health Canada for two indications: (1) the treatment of patients with HL after failure of ASCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen. The indications for ADCETRIS are approved under accelerated approval based on overall response rate. An improvement in patient-reported outcomes or survival has not been established. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive HL following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. ADCETRIS has received marketing authorization by regulatory authorities in more than 55 countries. See important safety information below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda will be solely responsible for development costs.

BioInvent progresses collaboration with leading U.S. biotechnology company

On June 17, 2015 BioInvent International (OMXS: BINV) announces that its partnership with a leading U.S. biotechnology company advances to next phase (Press release, BioInvent, JUN 17, 2015, http://www.bioinvent.com/media-centre/press-releases/release/?ReleaseID=838A03317B4A0E87 [SID:1234506546]). The collaboration aims to discover novel therapeutic antibodies to be incorporated into the U.S. company’s CAR-T programs.

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The unnamed biotech company signed earlier this year a license to get access to BioInvent’s unique ability to discover antibodies with the antibody library n-CoDeR. The first of up to three targets covered by the agreement has now been identified and the work to develop appropriate antibodies can thus be initiated.

Under the license agreement BioInvent may receive revenue in the form of potential clinical milestone payments and royalties on future sales of any product developed as a result of the collaboration. In addition, BioInvent is in the early phase of the collaboration entitled to limited compensation for the work to identify antibodies against the first target.

"We are excited to start the identification of appropriate antibodies using our unique technology platform. We are delighted to be partnering with one of the world’s most innovative biotechnology companies on a project of such potential significance." stated Michael Oredsson, CEO of BioInvent.

This kind of agreement allow us to further strengthen BioInvent’s prominent position within the immuno-oncology field and to use our n-CoDeR library in new clinical applications. At the same time it contributes to offset costs relating to our internal development of innovative antibody-based cancer drugs", concluded Michael Oredsson.

CAR-Ts are T cells that have been removed from the body and attached through genetic engineering to an antibody fragment that recognizes a specific tumor protein. The result is a cancer immunotherapy drug with the killing power of a greatly enhanced T cell, combined with the tumor-targeting ability of an antibody.

8-K – Current report

On June 16, 2015 Provectus Biopharmaceuticals reported that the Society of Surgical Oncology (SSO) has published an abstract describing preliminary research into use of the Company’s investigational agent, PV-10, in murine models of colon cancer (Filing, 8-K, Provectus Pharmaceuticals, JUN 16, 2015, View Source [SID:1234505440]). A poster based on the published abstract was presented at the SSO’s 68th Annual Cancer Symposium.
Titled, "Intralesional Injection of Rose Bengal Induces an Anti-tumor Immune Response and Potent Tumor Regressions in a Murine Model of Colon Cancer," the abstract detailed research by K. Pardiwala, G. Qiao, J. Sundararajan, B. Prabhakar, and A.V. Maker at the University of Illinois at Chicago, Chicago, IL.
Based on their findings, the researchers concluded, "Rose Bengal induced potent cell death in human and murine colon cancer cells in vitro. Intralesional injection in established tumors induced an anti-tumor immune response and significant tumor regressions in vivo. These studies establish that intralesional PV-10 therapy warrants further study as a potential immunotherapeutic agent in colorectal cancer and metastases."
The SSO has made available all the abstracts from the Symposium in an electronic supplement to Annals of Surgical Oncology, its house journal. The abstract on PV-10 can be found on page S86 of the book, View Source

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Nymox Announces $850,000 Financing

On June 16, 2015 Nymox Pharmaceutical reported that it has recently completed financing for a total of $850,000 at prices of $1.25-$1.66 (Press release, Nymox, JUN 16, 2015, View Source;fvtc=4&fvtv=6907 [SID:1234505443]). The financing consisted of a private placement of 400,000 shares with a European investor at $1.25 per share and an equity line drawdown from the Company’s existing facility consisting of 217,122 shares priced at $1.66 per share. There were no warrants attached to the transactions.

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The Company’s lead product NX-1207 is in Phase 3 development for benign prostatic hyperplasia (BPH). Nymox recently announced that the Company is conducting Phase 3 NX-1207 BPH pivotal studies long-term follow-up extension data capture that is expected to be completed and results reported in late Q2 or early Q3 2015.

Nymox has also recently reported a successful Phase 2 long-term outcome study in 147 men of NX-1207 at higher dosage for low grade localized prostate cancer.

BPH is one of the most commonly diagnosed diseases in middle aged and older men. The condition has negative impacts on men’s health and quality of life and often leads to need for surgery. It is estimated that 50% of men in their 50’s have pathological signs of prostatic hyperplasia and one quarter to one half of men over 40 suffer from moderate to severe urinary symptoms associated with BPH.

The American Cancer Society estimates that in 2012 more than 240,000 men in the United States will be newly diagnosed with prostate cancer and more than 28,000 men will die from the disease. Most cases are detected via prostate-specific antigen (PSA) screening and usually found to have localized tumors. Surgical removal of the prostate (radical prostatectomy) and radiation therapy with or without androgen deprivation therapy are the most common active treatment options for localized prostate cancer but have significant short and long-term adverse effects, including impotence, urinary dysfunction, and other complications.

– See more at: View Source;fvtc=4&fvtv=6907#sthash.gnhqulFg.dpuf

Taiho Pharmaceutical Co., Ltd. and Servier Enter Into License Agreement for Development and Commercialization of Oral Anticancer Drug TAS-102 in Europe

On June 15, 2015 Taiho Pharmaceutical Co., Ltd. (Japan) and Servier (France) reported on June 15 that they have entered into an exclusive license agreement on June 12, 2015 for the development and commercialization of TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride) in Europe and other countries (Press release, Servier, JUN 15, 2015, View Source [SID1234529066]). Taiho Pharmaceutical Co., Ltd. retains the right to develop and commercialize TAS-102 in the United States, Canada, Mexico and Japan/Asia and to manufacture and supply the product. TAS-102 is an oral combination anticancer drug initially developed by Taiho Pharmaceutical Co., Ltd. for use in the treatment of refractory metastatic colorectal cancer (mCRC).

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Under this agreement, Taiho Pharmaceutical Co., Ltd. will receive a total of US$ 130 million in an upfront payment and for MAA approval in the EU. In addition, Taiho will receive further regulatory and sales event milestone payments and royalties based on net sales. Taiho and Servier will also collaborate on the further global development of TAS-102 sharing effort and cost on an equal basis.

TAS-102 is currently under review by Health Authorities in Europe and the United States and in 2014 was approved for marketing in Japan. In the United States, Taiho Oncology Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd., will market TAS-102.

"We are very pleased to enter into this agreement for TAS-102 with Servier who has a strong presence around the world especially in Europe as a research-based pharmaceutical company and has made a long term commitment to oncology," said Masayuki Kobayashi, President and Representative Director of Taiho Pharmaceutical Co., Ltd. "Taiho and Servier will work vigorously in close cooperation to accelerate development and commercialization of TAS-102 and make it available to patients globally."

"This partnership with Taiho will hopefully allow us to rapidly bring a new therapeutic option to patients suffering from refractory metastatic colorectal cancer in Europe and other countries," said Olivier Laureau, President of Servier. "We respect and value Taiho’s well-known expertise in the development of oral cancer drugs and hence this collaboration will contribute to develop Servier’s capabilities in oncology. Such a landmark agreement confirms Servier’s strong ambition in oncology and our willingness to bring to cancer patients new therapeutic solutions through Servier’s extensive portfolio of innovative treatments currently in clinical development. This is in line with our commitment to therapeutic progress for the benefit of patients."

Taiho Pharmaceutical Co., Ltd. and Servier anticipate that TAS-102, as a new treatment option, will make an even greater contribution to cancer patients in Europe and other countries through their partnership.

About TAS-102

TAS-102 is an oral combination anticancer drug of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is an antineoplastic nucleoside analog, which is incorporated directly into DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme, thymidine phosphorylase. TAS-102 is commercially available in Japan and is under regulatory review in the United States of America and the European Union for the treatment of refractory metastatic colorectal cancer.

About Refractory Metastatic Colorectal Cancer

There are no definitive data on the number of patients who are refractory to standard metastatic colorectal cancer treatments; however, colorectal cancer is one of the most common cancers in the European Union (i) and the third most common cancer worldwide (ii). In 2013, a study published in the European Journal of Cancer revealed that an estimated 447,000 patients (242,000 men and 205,000 women) were diagnosed with and 215,000 patients died of colorectal cancer in Europe in 2012 (i). In addition, the American Cancer Society estimated that 136,830 patients (71,830 men and 65,000 women) were diagnosed with and 50,310 patients died of cancer of the colon and rectum in the United States in 2014 (iii).

Notes:

(i) Ferlay, J. et. al. Cancer incidence and mortality patterns in Europe:
Estimates for 40 countries in 2012.European Journal of Cancer. (2013)
49; 1374-1403

(ii) World Cancer Research Fund International. Worldwide Data. 2013.
View Source
Accessed February 2015.
GLOBOCAN 2012 Estimated Cancer Incidence, Mortality and Prevalence
Worldwide in 2012.

(iii) Cancer facts & figures 2014. American Cancer Society.