On May 17, 2018 MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX; Nasdaq: MOR; OTC: MPSYY) reported the publication of two abstracts on its proprietary hemato-oncological drug candidates MOR208 and MOR202 submitted to the 23rd European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, to be held in Stockholm/Sweden from June 14-17, 2018 (Press release, MorphoSys, MAY 17, 2018, View Source [SID1234526772]).

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!

In a poster presentation, first clinical data from the exploratory phase 2 COSMOS trial with the Fc-engineered CD19 antibody MOR208 in combination with idelalisib in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), after discontinuation of an ibrutinib therapy, will be presented. In an oral presentation, updated maturing data from a phase 1/2a study with the CD38 antibody MOR202 alone and in combination with pomalidomide or lenalidomide in relapsed/refractory multiple myeloma will be presented.

"We are pleased that clinical data from trials investigating our proprietary antibody programs MOR208 and MOR202 in indications with high medical need were selected for presentation at the upcoming EHA (Free EHA Whitepaper) conference," commented Dr. Malte Peters, Chief Development Officer of MorphoSys AG.

Details about the abstracts from MorphoSys’s proprietary programs MOR208 and MOR202 accepted for presentation at EHA (Free EHA Whitepaper) 2018:

Abstract Code: PF350

Two-cohort, phase II study in R/R CLL (COSMOS): First preliminary safety and efficacy results of MOR208 treatment in combination with idelalisib in patients who discontinued prior ibrutinib therapy

The poster presentation will include clinical results from the phase 2 study COSMOS with MOR208 in combination with idelalisib (cohort A) in adult patients with relapsed/refractory CLL who failed prior treatment with Bruton’s Tyrosine Kinase inhibitor (BTKi) ibrutinib.

The poster will be presented during the session "Chronic lymphocytic leukemia and related disorders – Clinical" on Friday, June 15, 2018 5:30-7:00 pm CEST (11:30am-1:00pm EDT), in the poster area at the Stockholmsmässan in Stockholm.

In addition, the abstract will be on display on the E-poster screens at the conference from Friday, June 15, 2018, 9:30 am CEST (3:30 am EDT) to Sunday, June 17, 2018 1:00 pm CEST (7:00 am EDT).

Abstract Code: S848

MOR202 with low-dose dexamethasone (DEX) or pomalidomide/DEX or lenalidomide/DEX in relapsed or refractory multiple myeloma (r/r MM): A phase I/IIa, multicenter, dose-escalation study

The oral presentation will include updated clinical data from the phase 1/2a study with MOR202 alone or in combination with the immunomodulatory drugs lenalidomide or pomalidomide, plus low-dose dexamethasone (DEX). The trial is being conducted in pre-treated patients with relapsed/refractory multiple myeloma.

The oral presentation will be given during the session "New therapeutic strategies to improve the outcome of relapse/refractory plasma cell disorders" on Saturday, June 16, 2018, from 4:15-4:30pm MEST (10:15-10:30am EDT), in Room A1 at the Stockholmsmässan in Stockholm.

Additional information can be found at www.ehaweb.org, including the abstracts.

On May 17, 2018 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage biotechnology company with a fully human antibody discovery platform focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer, reported that the Company has been issued Patent No. 9,856,324 by the United States Patent and Trademark Office (USPTO) for a patent titled, "HUMAN MONOCLONAL ANTIBODIES TO GANGLIOSIDE GD2 (Press release, MabVax, MAY 17, 2018, View Source [SID1234526770])."

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!

This is the second patent issued in the antibody portfolio created through MabVax’s unique discovery platform, which uses blood samples from patients vaccinated with selected tumor associated carbohydrate antigens. The recovery of human antibodies directly from vaccinated cancer patients makes the antibodies discovered by MabVax highly unique and potentially useful while reducing the kinds of toxicities induced by non-human antibodies. Similar to the Company’s sialyl lewis A (sLea) and Thomsen-nouveau (Tn) antigen targeting antibodies, the ganglioside GD2 targeting antibodies have the potential to be developed as therapeutic and diagnostic products. Additional disease targets for anti-GD2 antibodies include sarcoma, melanoma, and neuroblastoma.

"The issuance of this patent represents another valuable intellectual property asset brought forward by MabVax and is an important component of our unique discovery strategy and expands our robust patent estate. Importantly, this filing is timely as we evaluate additional product candidates that have the potential to address significant unmet needs in the treatment of cancers to fuel our pipeline and expand our partnering discussions," stated David Hansen, MabVax’s President and Chief Executive Officer.

The Company has already made substantial progress required to translate the GD2 preclinical development program into clinical development. In collaboration with St. Jude Children’s Research Hospital, data from the preclinical development program were presented as a poster at the World Molecular Imaging Conference last year. The results of the study demonstrated the anti-GD2 antibodies had high specificity and antibody drug conjugates based on these antibodies were readily internalized and cytotoxic. Immuno-PET agents developed with these antibodies showed good accumulation on osteosarcoma tumors and demonstrated potential utility as a diagnostic imaging agent.

On May 17, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that three posters highlighting clinical data from the ongoing Phase 1b/2 STOMP study will be presented at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) 2018 Annual Meeting taking place June 14-17, 2018 in Stockholm, Sweden (Press release, Karyopharm, MAY 17, 2018, View Source [SID1234526769]). These three poster presentations will feature updated data from the STOMP arms evaluating selinexor, the Company’s lead, novel, oral SINE compound, and dexamethasone in combination with standard approved therapies, Velcade, Pomalyst or Darzalex in patients with heavily pretreated multiple myeloma.

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!

"Following our positive results for selinexor in the STORM study in patients with penta-refractory multiple myeloma, we are pleased to be presenting updated results of selinexor combinations in earlier lines of myeloma treatment," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "In the previously reported Phase 1b/2 STOMP study results, selinexor has shown robust anti-myeloma activity and a manageable safety profile in patients with relapsed or refractory myeloma after at least one prior therapy. The STOMP results not only provide the underlying clinical rationale for the ongoing pivotal Phase 3 BOSTON study evaluating selinexor in combination with once weekly Velcade, but also provide supportive data for selinexor as a potential new backbone therapy in combination with approved myeloma therapies, often with synergistic activity. We look forward to sharing these updated STOMP results from the Velcade, Pomalyst and Darzalex arms with the medical community at EHA (Free EHA Whitepaper) this year."

Details for the EHA (Free EHA Whitepaper) 2018 presentations are as follows:

Title: Selinexor combined with pomalidomide and low dose dexamethasone (SPd) in a relapsed/refractory multiple myeloma patient population
Presenter:Christine Chen, University of Toronto, Princess Margaret Cancer Center
Final Abstract Code: PF586
Topic/Session Title: Myeloma and other monoclonal gammopathies – Clinical
Date and Time:Friday, June 15, 2018; 17:30 – 19:00 CEST
Location: Poster area

Title: Selinexor combined with low dose bortezomib and dexamethasone (SVd) induces a high response rate in patients with relapsed or refractory multiple myeloma (MM)
Lead author: Nizar Bahlis, Southern Alberta Cancer Research Institute
Final Abstract Code: PS1322
Topic/Session Title: Myeloma and other monoclonal gammopathies – Clinical
Date and Time: Saturday, June 16, 2018; 17:30 – 19:00 CEST
Location: Poster area

Title: A Phase 1b study using the combination of selinexor, daratumumab, and dexamethasone in multiple myeloma patients previously exposed to proteasome inhibitors and immunomodulatory drugs
Lead author:Cristina Gasparetto, Duke University
Final Abstract Code: PS1329
Topic/Session Title: Myeloma and other monoclonal gammopathies – Clinical
Date and Time: Saturday, June 16, 2018; 17:30 – 19:00 CEST
Location: Poster area

About Selinexor

Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,400 patients have been treated with selinexor. In April 2018, Karyopharm reported positive top-line data from the Phase 2b STORM study evaluating selinexor in combination with low-dose dexamethasone in patients with penta-refractory multiple myeloma. Selinexor has been granted Orphan Drug Designation in multiple myeloma and Fast Track designation for the patient population evaluated in the STORM study. Karyopharm plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) during the second half of 2018, with a request for accelerated approval for oral selinexor as a new treatment for patients with penta-refractory multiple myeloma. The Company also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2019 with a request for conditional approval. Selinexor is also being evaluated in several other mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON) and as a potential backbone therapy in combination with approved therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), liposarcoma (SEAL), and an investigator-sponsored study in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with one or more approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

On May 17, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that one abstract on Genmab’s DuoBody-CD3xCD20 and six industry sponsored abstracts on daratumumab will be presented at the 23rd European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress 2018 in Stockholm, Sweden, June 14-17 (Press release, Genmab, MAY 17, 2018, View Source [SID1234526767]). An abstract containing a pre-clinical evaluation of Genmab’s proprietary DuoBody-CD3xCD20 will be presented as a poster. The daratumumab abstracts, submitted by Janssen Research & Development, LLC, include an oral presentation on ALCYONE (MMY3007), the Phase III trial of daratumumab plus bortezomib, melphalan and prednisone in newly diagnosed multiple myeloma that was the basis for the recent U.S. Food and Drug Administration approval. There will also be an oral presentation regarding the Phase II CENTAURUS (SMM2001) study of daratumumab in smoldering multiple myeloma. The abstracts have been published on the EHA (Free EHA Whitepaper) website, and may be accessed via www.ehaweb.org.

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!

"In addition to the multiple presentations of daratumumab clinical data in multiple myeloma or amyloidosis, we are very pleased that a pre-clinical evaluation of our proprietary DuoBody-CD3xCD20 product will be presented to the attendees at this year’s EHA (Free EHA Whitepaper) congress," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

List of Industry Sponsored Abstracts

DuoBody-CD3xCD20
CD3 Bispecific Antibody Screen Identifies CD20 as the Most Efficient Target for Elimination of B Cell Malignancies; Pre-clinical Evaluation of DuoBody-CD3xCD20 — Poster presentation, Friday, June 15, 5:30 PM — 7:00 PM CEST

Daratumumab
Daratumumab Plus Bortezomib-Melphalan-Prednisone (VMP) in Elderly (≥75 Years of age) Patients with Newly Diagnosed Multiple Myeloma Ineligible for Transplantation (ALCYONE) — Oral presentation, Friday, June 15, 12:00 PM — 12:15 PM CEST

Effects of Daratumumab on the Composition and Activation Status of Immune-Cell Populations in CENTAURUS, a Phase 2 Randomized Study of Smoldering Multiple Myeloma (SMM) Patients — Oral presentation, Sunday, June 17, 8:30 AM — 8:45 AM CEST

Subcutaneous Daratumumab (DARA SC) + Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) in Patients with Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis: Safety Run-in Results of ANDROMEDA — Poster presentation, Saturday, June 16, 5:30 PM — 7:00 PM CEST

Daratumumab, Carfilzomib and Dexamethasone (D-Kd) in Lenalidomide-refractory Patients with Relapsed Multiple Myeloma (MM): Subgroup Analysis of MMY1001 — Poster presentation, Friday, June 15, 5:30 PM — 7:00 PM CEST

Subcutaneous Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: Part 2 Update of the Open-label, Multicenter, Dose Escalation Phase 1b Study (PAVO) — Poster presentation, Friday, June 15, 5:30 PM — 7:00 PM CEST

Impact of Baseline Renal Function on Efficacy and Safety of Daratumumab Plus Bortezomib-Melphalan-Prednisone (VMP) in Newly Diagnosed Multiple Myeloma Patients Ineligible for Transplantation (ALCYONE) — Poster presentation, Friday, June 15, 5:30 PM — 7:00 PM CEST

On May 17, 2018 Seattle Genetics, Inc. (Nasdaq: SGEN) reported the appointment of Roger D. Dansey, M.D., as Chief Medical Officer (Press release, Seattle Genetics, MAY 17, 2018, View Source;p=RssLanding&cat=news&id=2349629 [SID1234526766]). Dr. Dansey brings extensive experience in cancer drug development, most recently from Merck Inc. where he was Therapeutic Area Head for Late Stage Oncology, responsible for the ongoing registration efforts for KEYTRUDA (pembrolizumab) across multiple tumor types.

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!

"Roger’s appointment reflects the growing importance of late-stage clinical drug development at Seattle Genetics as we transition to a global, multi-product oncology company," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Roger’s drug development and approval experience at industry leaders, including Merck, Gilead and Amgen, his deep oncology background and proven ability to collaborate and lead teams, make him an ideal fit for Seattle Genetics as we strive to bring transformative therapies to people with cancer."

Dr. Dansey stated, "This is an exciting time at Seattle Genetics with both a growing, approved drug in ADCETRIS as well as a product pipeline with important new opportunities, including three solid tumor programs in ongoing or planned pivotal trials. I look forward to working with the many talented individuals at Seattle Genetics to bring these new therapies to patients."

Roger D. Dansey was Senior Vice President at Merck Inc. from January 2015 to April 2018, where he led the company’s late-stage oncology development efforts including the approved PD-1 inhibitor, KEYTRUDA. Prior to joining Merck, Dr. Dansey was Vice President, Oncology Clinical Research at Gilead Sciences. He initially joined the industry at Amgen working in roles of increasing responsibility in Amgen’s oncology and hematology therapeutic area, including as Global Development Leader for XGEVA. He received his Medical Degrees from the University of Witwatersrand, Johannesburg, South Africa.

Dr. Dansey succeeds Jonathan Drachman, M.D., who will remain with Seattle Genetics as a strategic advisor for innovation. Dr. Siegall added, "Jonathan has been a key contributor and leader at Seattle Genetics since joining the company nearly 14 years ago. He has been instrumental in the development of ADCETRIS, the expansion of Research and Development and advancement of our robust pipeline of both antibody-drug conjugates and novel immuno-oncology programs. I look forward to working with Jonathan on innovation initiatives that can ultimately benefit cancer patients."