Development Pipeline Progress Status (Summary) in Third Quarter of Fiscal Year Ending March 31, 2017 The followings summarize the changes in development status progressed from the announcement of financial results at the 2 nd Quarter of the fiscal year released on November 7, 2016. For details, please refer to pages 12 to 17 of the 3 rd Quarter Flash Report (Filing, 3 mnth, MAR 31, Ono, 2017, MAR 31, 2017, View Source [SID1234519525]). Development status of ONO products excluding ONO-4538/Opdivo (nivolumab) (Japan) Parsabiv  Intravenous Injection for Dialysis (ONO-5163/etelcalcetide hydrochloride), a calcium sensing receptor agonist An application for manufacturing and marketing approval of Parsabiv was approved for the treatment of secondary hyperparathyroidism on hemodialysis on December 19, 2016. The NHI price listing is expected to be this February. Orencia  Subcutaneous Injection (ONO-4164/ BMS-188667), a T-cell activation inhibitor Global Phase III clinical study of Orencia was started for the treatment of primary Sjögren syndrome. ONO-4578, a Prostaglandin E2 receptor (EP4) antagonist Phase I clinical study of ONO-4578 was initiated for solid tumor. (Outside of Japan) ONO-4059, a Bruton’s tyrosine kinase (Btk) inhibitor Phase II clinical study of ONO-4059 was started for the treatment of B cell lymphoma in the US by our licensee, Gilead Sciences, Inc. ONO-7475, an Axl /Mer inhibitor Phase I clinical study of ONO-7475 was initiated for the treatment of acute leukemia in the US. ONO-7579, a Tropomyosin receptor kinase (Trk) inhibitor Phase I clinical study of ONO-7579 was initiated for solid tumor in Europe and the US. ONO-2952, a Translocator protein (TSPO) antagonist ONO-2952 had been developed for potential treatment of diseases caused due to stress by suppressing the production of neuroprotein causing stress. However, the development of ONO-2952 for the treatment of irritable bowel syndrome was discontinued due to the strategic reason considering differentiation among existing products and competing products under development and others comprehensively. ONO-4232, a P rostaglandin E2 receptor (EP4) agonist The development of ONO-4232 for the treatment of acute heart failure was discontinued due to the strategic reason considering future development period, development cost and others comprehensively. Development status of ONO-4538/Opdivo (nivolumab), etc. ONO-4538/Opdivo (Japan, South Korea and Taiwan)-An application of Opdivo for a partial change in approved items of the manufacturing and marketing authorization was approved for additional indication of relapsed or refractory classical Hodgkin lymphoma, a blood cancer, in Japan on December 2, 2016.-An application of O pdivo for a partial change in approved items of the manufacturing and marketing authorization was submitted for the indication of unresectable advanced or recurrent gastric cancer in Japan on December 27, 201 6.-Phase III clinical study was started for the treatment of ovarian cancer in Japan. ONO-4538/ Opdivo (US and Europe)-In the US, a supplemental Biologics License Application (sBLA) of Opdivo was approved for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.-In Europe, Opdivo was approved for additional indication of relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin.-In the US, Phase I clinical study was initiated for the treatment of sepsis. ONO-4686/BMS-986207, an Anti-TIGIT antibody (Japan, South Korea and Taiwan) Phase I/II clinical study was initiated for solid tumors in Japan.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On March 30, 2017 Seattle Genetics, Inc. (Nasdaq: SGEN), a global biotechnology company, reported its broad presence at the upcoming 108th Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) being held April 1 to 5, 2017, in Washington, D.C., including 14 presentations on antibody-drug conjugate (ADC) and immuno-oncology technology advances and development programs (Press release, Seattle Genetics, MAR 30, 2017, View Source;p=RssLanding&cat=news&id=2257546 [SID1234518388]). Data in multiple presentations demonstrate potential improvements in linker technologies for multiple payloads which may enable development of novel ADCs, including the planned clinical program SGN-CD48A for multiple myeloma. The company’s SGN-2FF program was selected for an oral presentation in the New Drugs on the Horizon symposium focusing on the preclinical rationale and phase 1 trial design for this small molecule immuno-oncology agent. Seattle Genetics’ scientific leadership will also be featured in an Educational Session and a Forum focused on advances in ADC research and the value of ADCs over other drug conjugate therapeutics in the cancer treatment landscape.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Over nearly 20 years, Seattle Genetics has continued its tradition of innovation to produce industry-leading ADC and empowered-antibody technologies designed to improve outcomes for patients with cancer," said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development, at Seattle Genetics. "In 14 presentations, including four orals, our new data at the AACR (Free AACR Whitepaper) Annual Meeting will highlight key improvements to linker technologies for cancer cell-killing payloads, including novel auristatins and tubulysins, preclinical combination regimens with checkpoint inhibitors, and progress with our immuno-oncology therapeutic candidates."

ADCs are targeted cancer treatments that harness the specificity of antibodies to deliver cell-killing agents directly to cancer cells. ADCETRIS, Seattle Genetics’ first commercially available product, vadastuximab talirine, a phase 3 candidate in acute myeloid leukemia (AML), and enfortumab vedotin, an advancing clinical-stage bladder cancer candidate, are three of more than 20 ADCs in clinical development using the company’s proprietary technology.

Multiple oral and poster presentations are being featured at AACR (Free AACR Whitepaper) that highlight Seattle Genetics’ ADC and immuno-oncology advances. Abstracts can be found at www.aacr.org and include the following:

Saturday, April 1, 2017

Expanding the payload scope and drug load of ADCs through drug-linker design (Session #ED03, oral presentation at 2:00 p.m. ET)
Sunday, April 2, 2017

Antibody-drug conjugates containing glucuronide-tubulysin payloads display activity in MDR+ and heterogeneous tumor models (Abstract #56, poster presentation)
Reducing toxicity of antibody-drug conjugates through modulation of pharmacokinetics (Abstract #60, poster presentation)
Elucidating the roles of antibody pharmacokinetics and maleimide stability in the toxicology of antibody-drug conjugates (Abstract #70, poster presentation)
Development of homogeneous dual-drug ADCs: Application to the co-delivery of auristatin payloads with complementary antitumor activities (Abstract #982, oral presentation at 4:05 p.m. ET)
SGN-2FF: A Novel Small Molecule Inhibitor of Fucosylation with Preclinical Antitumor Activity through Multiple Immune Mechanisms (Abstract #DDT02-02, oral presentation at 3:24 p.m. ET)
Monday, April 3, 2017

Cysteine Mutant Location Affects Chemotype Lability in Site-Specific Antibody Drug Conjugates (Abstract #LB-066, poster presentation)
Targeted Delivery Using Antibody Drug Conjugates (Session #FO01, oral presentation at 5:00 p.m. ET)
Tuesday, April 4, 2017

Therapeutic activity of effector function-enhanced, non-fucosylated anti-CD40 antibodies in preclinical immune-competent rodent tumor models (Abstract #3647, poster presentation)
Superior T cell activity of a membrane-proximal binding antibody when targeting Glypican-3 with an Antibody-Coupled T cell Receptor (ACTR) armed T cell (Abstract #3762, poster presentation; collaboration with Unum Therapeutics)
Effect of PEG Chain length on Antibody-Drug Conjugate Tumor and Tissue Distribution in Tumor Bearing Xenograft Mice (Abstract #4075, poster presentation)
Efficient targeting of BCMA-positive multiple myeloma cells by Antibody-Coupled T cell Receptor (ACTR) engineered autologous T cells in combination with an anti-BCMA antibody (Abstract #4605, poster presentation; collaboration with Unum Therapeutics)
Assessment of Myeloblast CD33 Receptor Occupancy (RO) by Vadastuximab Talirine in Patients with Acute Myeloid Leukemia (AML) Receiving Monotherapy Treatment (Abstract #CT120, poster presentation)
Wednesday, April 5, 2015

Brentuximab vedotin-driven immunogenic cell death enhances antitumor immune responses, and is potentiated by PD1 inhibition in vivo (Abstract #5588, poster presentation)

Affimed has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, Annual, Affimed, 2016, MAR 30, 2017, View Source [SID1234518326]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On March 30, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) reported that its collaboration partner for daratumumab, Janssen Biotech, Inc., has decided not to initiate stage 2 of the Phase II study (CARINA, LYM2001) of daratumumab in three types of relapsed or refractory non-Hodgkin’s lymphoma (NHL) (Press release, Genmab, MAR 30, 2017, View Source [SID1234518322]). The study will not proceed to stage 2 as a data review showed that two cohorts of the study, investigating the use of daratumumab monotherapy in relapsed or refractory patients with follicular lymphoma (FL), and with diffuse large B-cell lymphoma (DLBCL) did not reach the predefined futility thresholds of overall response rates (ORR) of 50%, and 30%, respectively. In the third cohort in the study, patients with mantle cell lymphoma (MCL), ORR was not evaluable due to slow recruitment, driven by the aggressive nature of the disease in its final stages. This has no impact on other ongoing or planned studies with daratumumab.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"While we hoped that daratumumab as a monotherapy could potentially provide a new treatment option in NHL patients with a high unmet medical need, the preliminary activity profile seen was not sufficient for the study to continue. Daratumumab is still being investigated in a number of indications including multiple myeloma and other hematological cancers such as NK/T-cell lymphoma and myelodysplastic syndrome as well as in solid tumors," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About the CARINA LYM2001 study
The Phase II study (NCT02413489) is a three arm (DLBCL, FL, MCL), open-label multicenter study, which planned to enroll up to 210 patients in 2 stages with relapsed or refractory non-Hodgkin’s lymphoma. Stage 1 of the study was designed to provide a preliminary assessment of monotherapy activity, with stage 2 designed to further evaluate safety and efficacy of daratumumab monotherapy. Stage 2 will now not proceed. The primary endpoint of the study was overall response rate. The safety profile of daratumumab in these diseases was also assessed.

About DARZALEX (daratumumab)
DARZALEX (daratumumab) injection for intravenous infusion is indicated in the United States in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe for use as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. For more information, visit www.DARZALEX.com.
Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,2,3,4,5

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. Five Phase III clinical studies with daratumumab in relapsed and frontline multiple myeloma settings are currently ongoing, and additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma, NK/T-cell lymphoma, amyloidosis, myelodysplastic syndromes and solid tumors. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA, for multiple myeloma, as both a monotherapy and in combination with other therapiesa

(Filing, Annual, Can-Fite BioPharma, 2016, MAR 30, 2017, View Source [SID1234518331])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!