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Genmab Announces Daratumumab and Ofatumumab Data to Be Included in 18 Presentations at American Society of Hematology Annual Meeting (ASH)

On November 3, 2016 Genmab A/S (Nasdaq Copenhagen: GEN) reported that 17 daratumumab abstracts have been accepted for presentation at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place December 3-6 in San Diego, California (Press release, Genmab, NOV 3, 2016, View Source [SID1234516215]). The daratumumab abstracts are sponsored by our collaboration partner Janssen Biotech, Inc., with the exception of one that was based on an investigator-sponsored study, and one that used commercial daratumumab. One abstract on a study with ofatumumab has also been scheduled for a poster presentation at the meeting. All abstracts are available on the ASH (Free ASH Whitepaper) website at www.hematology.org. A list of the key daratumumab abstracts is included below.

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"A number of presentations will highlight additional analyses and details from the daratumumab Phase III POLLUX and CASTOR studies that formed the basis of regulatory filings earlier this year. Additional presentations include the Phase I study of the subcutaneous formulation of daratumumab, data on the immuno-modulatory properties of daratumumab, and novel ‘real life’ clinical practice data on daratumumab plus pomalidomide retreatment of refractory multiple myeloma patients. We are excited that daratumumab will be featured in so many presentations at this key hematology conference," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Key Daratumumab Abstracts
Efficacy of Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Relapsed or Refractory Myeloma Based on Prior Lines of Therapy: Updated Analysis of CASTOR – Oral presentation
Efficacy of Daratumumab, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients with 1 to 3 Prior Lines of Therapy: Updated Analysis of POLLUX – Oral presentation
Efficacy of Daratumumab, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone Alone for Relapsed or Refractory Multiple Myeloma Among Patients with 1 to 3 Prior Lines of Therapy Based on Previous Treatment Exposure: Updated Analysis of POLLUX – Oral presentation
Evaluation of Minimal Residual Disease (MRD) in Relapsed/Refractory Multiple Myeloma (RRMM) Patients Treated with Daratumumab in Combination with Lenalidomide Plus Dexamethasone or Bortezomib Plus Dexamethasone – Oral presentation
Open-Label, Multicenter, Dose Escalation Phase 1b Study to Assess the Subcutaneous Delivery of Daratumumab in Patients (pts) with Relapsed or Refractory Multiple Myeloma (PAVO) – Oral presentation
Clinical Efficacy of Daratumumab, Pomalidomide and Dexamethasone in Relapsed, Refractory Myeloma Patients: Utility of Retreatment with Daratumumab Among Refractory Patients — Oral presentation
This is an independent study, not sponsored by Janssen.
Daratumumab, Bortezomib and Dexamethasone Versus Bortezomib and Dexamethasone Alone for Relapsed or Refractory Multiple Myeloma Based on Prior Treatment Exposure: Updated Efficacy Analysis of CASTOR – Poster presentation
Daratumumab in Combination with Lenalidomide Plus Dexamethasone Induces Clonality Increase and T-Cell Expansion: Results from a Phase 3 Randomized Study (POLLUX) – Poster presentation
High-parameter Mass Cytometry (CyTOF) Evaluation of Relapsed/Refractory Multiple Myeloma (MM) Pts (Pts) Treated with Daratumumab Supports Immune Modulation as a Novel Mechanism of Action – Poster presentation

Roche showcases new clinical data across a variety of blood diseases at American Society of Hematology 2016 Annual Meeting

On November 3, 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that more than 60 abstracts featuring nine of its approved or investigational medicines will be presented during the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from December 3-6 in San Diego (Press release, Hoffmann-La Roche , NOV 3, 2016, View Source [SID1234516214]). The abstracts include more than 20 oral presentations across a broad range of medicines and combinations.

"The breadth of data we are presenting at ASH (Free ASH Whitepaper) this year reflects our deep commitment to people with blood diseases," said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. "We are excited to share the results of the pivotal GALLIUM study in previously untreated follicular lymphoma, which showed that people treated with Gazyva/Gazyvaro plus chemotherapy lived significantly longer without their disease worsening than those treated with Rituxan/MabThera plus chemotherapy."

The results from the phase III GALLIUM study have been selected for presentation during the Plenary Scientific Session, which honours the top six abstracts submitted to the meeting, as determined by the ASH (Free ASH Whitepaper) Program Committee. Results from other studies of Gazyva/Gazyvaro1 will also be presented at the meeting, including an overall survival update from the phase III GADOLIN study in Rituxan/MabThera2 -refractory indolent (slow-growing) non-Hodgkin lymphoma (NHL) and the first results from the phase III GOYA study in previously untreated diffuse large B-cell lymphoma (DLBCL).

Updated results from the phase III SABRINA study comparing subcutaneous and intravenous Rituxan/MabThera in previously untreated follicular lymphoma will be presented. The US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for the subcutaneous formulation of Rituxan, with an action date of June 26, 2017.

Early results will be shared for combinations of Venclexta/Venclyxto with either Gazyva/Gazyvaro or Rituxan/MabThera in chronic lymphocytic leukaemia and certain types of non-Hodgkin lymphoma. Further follow-up from early studies in multiple myeloma and acute myeloid leukaemia that support further investigation of Venclexta/Venclyxto in these diseases will also be presented. Venclexta/Venclyxto is being co-developed by AbbVie and Roche.

The first cohort from a non-interventional study of people with haemophilia will be presented, including real world safety and efficacy data from patients with inhibitors to factor VIII replacement therapy treated with current standard of care according to routine clinical practice. Separately, there are currently three pivotal studies underway to explore the safety and efficacy of emicizumab3 in the treatment of haemophilia A: a phase III study in people 12 years of age or older with haemophilia A with factor VIII inhibitors investigating weekly dosing; a phase III study in people younger than 12 years of age with factor VIII inhibitors investigating weekly dosing; and a phase III study in people 12 years of age or older without factor VIII inhibitors investigating weekly and every other week dosing.

Key abstracts featuring Roche medicines that will be presented at ASH (Free ASH Whitepaper) can be found in the table below.
Follow Roche on Twitter via @Roche and keep up to date with ASH (Free ASH Whitepaper) Annual Meeting news and updates by using the hashtag #ASH16.
Overview of key presentations featuring Roche medicines at ASH (Free ASH Whitepaper) 2016
Medicine Abstract title Abstract number/Presentation details
Gazyva/Gazyvaro
(investigational use) Obinutuzumab-Based Induction and Maintenance Prolongs Progression-Free Survival in Patients with Previously Untreated Follicular Lymphoma: Primary Results of the Randomized Phase 3 GALLIUM Study
#6 (Plenary Scientific Session)
04 Dec 2016
2.00–4.00pm PT
Minimal Residual Disease Assessment in Patients with Follicular Lymphoma Treated with Obinutuzumab or Rituximab as First-Line Induction Immunochemotherapy in the Phase III GALLIUM Study
#613 (Oral presentation)
05 Dec 2016
7.00am PT
(7.00–8.30am PT)
Obinutuzumab or Rituximab Plus CHOP in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma: Final Results From an Open Label, Randomized Phase 3 Study (GOYA)
#470 (Oral presentation)
04 Dec 2016
4.45pm PT
(4.30–6.00pm PT)
Gazyva/Gazyvaro
(approved use, updated study results) Obinutuzumab Plus Bendamustine Followed By Obinutuzumab Maintenance Prolongs Overall Survival Compared With Bendamustine Alone in Patients with Rituximab-Refractory Indolent Non-Hodgkin Lymphoma: Updated Results of the GADOLIN Study
#615 (Oral presentation)
05 Dec 2016
7.30am PT
(7.00–8.30am PT)
Rituxan/MabThera (subcutaneous formulation)
Longer Term Efficacy and Safety of Subcutaneous Compared with Intravenous Rituximab: Updated Results of The Phase III SABRINA Study
#1103 (Oral presentation)
05 Dec 2016
5.30pm PT
(4.30–6.00pm PT)
Venclexta/Venclyxto
(investigational use) Safety and Efficacy of Venetoclax and Obinutuzumab in Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL) And Coexisting Medical Conditions: Final Results of The Run-In Phase of the Randomized CLL14 Trial
#2054 (Poster)
03 Dec 2016
5.30-7.30pm PT
Results of a Phase Ib Study of Venetoclax Plus R- or G-CHOP in Patients with B-cell Non-Hodgkin Lymphoma (CAVALLI)
#3032 (Poster)
04 Dec 2016
6.00-8.00pm PT
Phase 2 Study of Venetoclax plus Rituximab or Randomized Venetoclax plus Bendamustine+Rituximab (BR) versus BR in Patients with Relapsed/Refractory Follicular Lymphoma: Interim Data (CONTRALTO)
#617 (Oral presentation)
05 Dec 2016
8.00am PT
(7.00-8.30am PT)
Safety and Efficacy of Venetoclax Plus Low-Dose Cytarabine in Treatment-Naive Patients Aged ≥65 Years with Acute Myeloid Leukemia (M14-387)
#2843 (Oral presentation)
03 Dec. 2016
10:45am PT
(9.30- 11.00am PT)
Emicizumab
(investigational) Bleeding Events and Safety Outcomes in Patients with Hemophilia A with Inhibitors: A Prospective, Multicenter, Non-Interventional Study
#3800 (Poster)
05 Dec 2016
6.00-8.00pm PT

Curis Reports Third Quarter 2016 Financial Results

On November 3, 2016 Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of human cancers, reported its financial results for the third quarter ended September 30, 2016 (Press release, Curis, NOV 3, 2016, View Source [SID1234516211]).

"We are pleased with our progress this quarter, and remain focused on patient enrollment within our two clinical programs. CA-170’s Phase 1 trial is progressing rapidly through the dose escalation stage with no limiting adverse safety effects," said Ali Fattaey, Ph.D., Curis’s CEO. "Additionally, we continue to enroll at multiple centers in the Phase 2 trial of CUDC-907 in patients with relapsed/refractory DLBCL. Our goal is to assess CUDC-907’s efficacy in patients with MYC-altered DLBCL and we expect to use this information for discussion with the FDA in 2017."

Dr. Fattaey continued, "Our collaboration with Aurigene continues to progress well. In September, we completed a $24.5M financing with Aurigene. In October, we licensed a second immuno-oncology program, designating CA-327 as an oral small molecule development candidate targeting PDL1 and TIM3. We expect to file an IND for CA-327 in 2017."

Third Quarter 2016 Financial Results

Curis reported a net loss of $28.3 million, or $(0.21) per share on both a basic and diluted basis for the third quarter of 2016, as compared to a net loss of $5.5 million, or $(0.04) per share on both a basic and diluted basis for the same period in 2015. Curis reported a net loss of $49.1 million or $(0.38) per share on both basic and diluted basis for the nine months ended September 30, 2016, as compared to a net loss of $45.5 million, or $(0.37) per share on both basic and diluted basis for the same period in 2015. The net loss for the three and nine months ended September 30, 2016 includes a non-cash in-process research and development charge of $18.0 million related to the amendment of Curis’s license agreement with Aurigene. The net loss for the nine months ended September 30, 2015 includes a non-cash in-process research and development charge of $24.3 million related to Curis’s license agreement with Aurigene.

Revenues for the third quarter of 2016 were $1.8 million, as compared to $2.0 million for the same period in 2015. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge. Revenues for the nine months ended September 30, 2016 were $5.2 million, as compared to $5.8 million for the same period in 2015.

Operating expenses were $29.5 million for the third quarter of 2016, as compared to $6.9 million for the same period in 2015.

Operating expenses for the nine months ended September 30, 2016 were $52.4 million, as compared to $49.0 million for the same period in 2015, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.1 million for both the third quarter of 2016 and 2015. Cost of royalty revenues for the nine months ended September 30, 2016 and 2015 were $0.3 million for both periods.

In-Process Research and Development Expense. In-process research and development expense was $18.0 million for the third quarter of 2016, as compared to $24.3 million for the same period in 2015. These charges are associated with the stock issuances of 10,208,333 and 17,120,131 shares of Curis common stock to Aurigene, respectively. These shares were issued as consideration for the rights granted under the terms of the September 2016 amendment to the collaboration agreement and partial consideration for the rights granted under the terms of the January 2015 collaboration agreement, respectively.

Research and Development Expenses. Research and development expenses were $6.8 million for the third quarter of 2016, as compared to $4.0 million for the same period in 2015. The increase was primarily due to increased direct spending related to clinical activities of CUDC-907 and programs under the Aurigene collaboration over the prior year period. Employee-related expenses increased over the prior year period primarily due to additional headcount to support the multiple programs. Research and development expenses were $22.4 million for the nine months ended September 30, 2016 as compared to $14.7 million for the same period in 2015.

General and Administrative Expenses. General and administrative expenses were $4.7 million for the third quarter of 2016 as compared to $2.8 million for the same period in 2015. The increase in general and administrative expenses was driven primarily by higher personnel costs and stock-based compensation expense due to increased headcount and an increase in legal service costs. General and administrative expenses were $11.7 million for the nine months ended September 30, 2016, as compared to $9.7 million for the same period in prior 2015.

Other expense, net was $0.6 million for the third quarter of 2016, as compared to $0.7 million for the same period in 2015. Other expense, net primarily consisted of interest expense related to the loan made by BioPharma-II (an investment fund managed by Pharmakon Advisors) to Curis Royalty (a wholly owned subsidiary of Curis). Other expense, net was $1.8 million and $2.3 million for the nine months ended September 30, 2016 and 2015, respectively.

As of September 30, 2016, Curis’s cash, cash equivalents, marketable securities and investments totaled $53.4 million and there were approximately 140.0 million shares of common stock outstanding.

Recent Operational Highlights

Curis – Aurigene collaboration:

In October, 2016 Curis licensed the second oral small molecule immuno-oncology development candidate under the collaboration. This program is focused on the development of oral, small molecule antagonists that target two distinct checkpoint pathways: the programmed death-1 (PD1) and T-cell immunoglobulin and mucin domain containing protein-3 (TIM3) pathways. Curis has designated CA-327 that targets programmed death ligand-1 (PDL1) and TIM3 as the development candidate.

In September, 2016 Curis’s collaboration Aurigene Discovery Technologies Ltd. invested in Curis at a premium by acquiring 10.2 million shares of Curis’s common stock in lieu of receiving up to $24.5 million of milestone and other payments from Curis that may become due under the companies’ 2015 collaboration agreement.
Upcoming Activities

Curis expects that it will make presentations at the following conferences through December 2016:

Presentation of preclinical results from CA-170 and CA-327 at the SITC (Free SITC Whitepaper) conference
Presentation of preclinical results from combination of CUDC-907 with other treatments at the ASH (Free ASH Whitepaper) annual conference

Advancements in ArQule’s Proprietary Pipeline to be Highlighted at the 2016 American Society of Hematology Annual Meeting

On November 3, 2016 ArQule, Inc. (Nasdaq: ARQL) reported that preclinical data will be presented on two molecules from its proprietary pipeline at the 2016 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, California, December 3 – 6, 2016 (Press release, ArQule, NOV 3, 2016, View Source [SID1234516206]).

A poster presentation summarizing preclinical studies of ARQ 531 in Chronic Lymphocytic Leukemia (CLL) will be presented by The Ohio State University investigators. ARQ 531 is an investigational, orally bioavailable, potent and reversible Bruton’s tyrosine kinase (BTK) inhibitor.

An oral presentation of preclinical studies with ARQ 092 in Sickle Cell Disease will be presented by ArQule’s collaborator, the University of Illinois College of Medicine. ARQ 092 is an orally available, selective pan-AKT inhibitor.

The data reinforce the strength and depth of ArQule’s proprietary pipeline while warranting further exploration of both molecules in their respective indications. The company remains on track to submit an Investigational New Drug (IND) application for ARQ 531 in early 2017. ARQ 092 is currently being tested in a phase 1b trial for AKT driven oncology malignancies and in a phase 1 trial in the ultra-rare Proteus syndrome indication in collaboration with the National Institutes of Health (NIH).

Details, including times and locations, of the ASH (Free ASH Whitepaper) Annual Meeting presentations can be found below. Abstracts are available online at View Source

ARQ 092 in Sickle Cell Disease
Title: Specific inhibition of AKT with ARQ 092, an orally-available selective allosteric AKT inhibitor, attenuates acute vaso-occlusive events in sickle cell disease
Presenter: Dr. Jaehyung Cho, University of Illinois College of Medicine
Session Date: Saturday, December 3, 2016
Oral Session Name: Hemoglobinopathies, Excluding Thalassemia – Basic and
Translational Science: Mechanisms of Vaso-Occlusion
Session Time: 2:00 PM – 3:30 p.m. PT
Oral Presentation Time: 2:45 p.m. PT
Location: San Diego Convention Center, Room 7AB

ARQ 531 in Chronic Lymphocytic Leukemia
Title: The Bruton’s Tyrosine Kinase (BTK) Inhibitor ARQ 531 Effectively Inhibits Wild Type and C481S Mutant BTK and Is Superior to Ibrutinib in a Mouse Model of Chronic Lymphocytic Leukemia
Presenter: Sean Reiff, The Ohio State University
Session: Date: Sunday, December 4, 2016
Poster Session Name: CLL: Therapy, excluding Transplantation: Poster II
Poster Viewing Time: 9:00 a.m. – 8:00 p.m. PT
Poster Presentation Time: 6:00 p.m. – 8:00 p.m. PT
Location: San Diego Convention Center, Hall GH

About the AKT Pathway and ARQ 092

ARQ 092 is an orally bioavailable, selective small molecule inhibitor of the AKT kinases. The AKT pathway when abnormally activated is implicated in multiple oncogenic processes such as cell proliferation and apoptosis. This pathway has emerged as a target of potential therapeutic relevance for compounds that inhibit its activity, which has been linked to a variety of cancers as well as to select non-oncology indications.

ARQ 092, the lead compound in ArQule’s AKT program, has completed phase 1a clinical testing and has fully enrolled a phase 1b trial including cohorts of patients with endometrial cancer, lymphomas and tumors harboring either AKT or PI3K mutations. It is also in a phase 1 trial being conducted by the NIH for Proteus syndrome, a rare over-growth disease from the PROS family. Collaborators are exploring, in preclinical testing, other indications for ARQ 092 including Sickle Cell Disease. In mid-2016 the company initiated a phase 1 clinical trial with ARQ 751, a next generation AKT inhibitor, in cancers with AKT mutations.

About BTK and ARQ 531

ARQ 531 is an investigational, orally bioavailable, potent and reversible Bruton’s tyrosine kinase (BTK) inhibitor. Biochemical and cellular studies have shown that ARQ 531inhibits both the wild type and C481S-mutant forms of BTK. The C481S mutation is a known emerging resistance mechanism for first generation irreversible BTK inhibitors. ARQ 531 has high oral bioavailability as well as good ADME, pharmacokinetic and metabolic properties. The company plans to file an IND for ARQ 531 in early 2017. BTK is a therapeutic target that has been clinically proven to inhibit B-cell receptor signaling in hematological cancers.

Argos Therapeutics Announces Publication of a Case Report on Long-term Survival of Kidney Cancer Patients Treated with AGS-003 Individualized Immunotherapy Featured in the Kidney Cancer Journal

On November 3, 2016 Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis technology platform, reported the publication of a Case Report in the Kidney Cancer Journal which details the clinical outcomes of two patients with intermediate risk metastatic renal cell carcinoma who had participated in a Phase 2 clinical trial of the company’s investigational immunotherapy AGS-003 in combination with sunitinib (Press release, Argos Therapeutics, NOV 3, 2016, View Source [SID1234516205]). These patients have obtained long-term control of metastatic disease that is ongoing seven years after initiation of treatment.

"Our report discusses truly remarkable cases from a Phase 2 study, where two intermediate risk mRCC patients have sustained an immune response to their disease for many years," said lead author Gautam Jha, MD, medical oncologist at the University of Minnesota. "Perhaps most importantly, we have observed an increase in the number of effector memory T-cells associated with improved Overall Survival (OS) in 14 patients who received at least 5 doses of AGS-003. Considering AGS-003 is well-tolerated without significant additional side effects over single agent sunitinib, this investigational therapy remains promising for patients with advanced kidney cancer."

In the open-label Phase 2 clinical trial, 21 patients with newly-diagnosed, intermediate and poor risk mRCC were treated with AGS-003 plus sunitinib as a first-line therapy. Results demonstrated a median Progression Free Survival (PFS) of 11.2 months and median OS of 30.2 months for all patients. Five patients in the trial survived for more than five years, and two patients have maintained durable immune responses for seven years. According to the International mRCC Database Consortium, similar unfavorable risk mRCC patients have an expected OS of only 14.7 months. In addition, follow-up analysis of these Phase 2 data, approximately two years after database lock, demonstrated a median OS of 61.9 months for the intermediate risk patients in the study compared with 20.7 months for similar patients in the International mRCC Database Consortium.

Argos designed AGS-003 to capture the mutated and variant antigens that are unique to each patient’s tumor to induce a robust targeted immune response. This individualized immunotherapy is created using a small tumor sample and the patient’s own dendritic cells collected in a leukapheresis procedure. RNA is isolated from the tumor sample and used to program dendritic cells to target disease-specific antigens. Activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma, and administered via intradermal injection as an individualized immunotherapy.

"By capturing the array of known, unknown, and mutated antigens present in an individual patient’s specific cancer, AGS-003 appears to elicit a broad, individualized anti-tumor immune response," said Lee F. Allen, MD, PhD, chief medical officer of Argos. "We remain focused on aggressively advancing our development program through late-stage clinical research, and continue to be encouraged by the long-term outcomes from the Phase 2 study."

Argos is currently evaluating AGS-003 in combination with standard-of-care targeted therapy in the pivotal ADAPT Phase 3 clinical trial for the treatment of mRCC. Enrollment in this 462-patient study was initiated in February 2013 and completed in July 2015. The Independent Data Monitoring Committee (IDMC) for this study most recently recommended continuation of the study following a meeting in June 2016, with the next IDMC meeting planned for February 2017. In addition, AGS-003 is being studied in Phase 2 investigator-initiated clinical trials as neoadjuvant therapy for RCC and for the treatment of non-small cell lung cancer (NSCLC).

To read the full report in the Kidney Cancer Journal, visit View Source

About the Arcelis Technology Platform
Arcelis is a precision immunotherapy technology that captures both mutated and variant antigens that are specific to each patient’s individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of a wide range of different cancers and infectious diseases, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies. The Arcelis process uses only a small disease sample or biopsy as the source of disease-specific antigens, and the patient’s own dendritic cells, which are optimized from cells collected by a leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease-specific antigens. These activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma, and administered via intradermal injection as an individualized immunotherapy.