On May 19, 2016 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported the publication of three abstracts which were accepted for the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from June 3 to June 7 in Chicago, Illinois, USA (Press release, MorphoSys, MAY 19, 2016, View Source [SID:1234512586]). The abstracts include updated clinical data on the Company’s proprietary drug candidate MOR202 from a phase 1/2a study in patients with multiple myeloma as well as a patient subgroup analysis from the phase 2 study of MOR208 in non-Hodgkin’s lymphoma (NHL). The MOR202 abstract has also been selected by the conference organizers for discussion in a separate session. In addition, partners of MorphoSys will present data on several HuCAL antibodies that are currently in clinical development.

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"We are delighted to publish a new package of clinical data at the preeminent conference on clinical oncology. The data set provides additional insight into the progress of our lead cancer compounds MOR208 and MOR202," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "For MOR202, we are in particular looking forward to presenting additional efficacy data from the dose escalation Phase 1/2a study in multiple myeloma in combination with lenalidomide and with pomalidomide."

List of abstracts relating to MorphoSys’s proprietary programs

Abstract #8012

MOR202 alone and in combination with pomalidomide or lenalidomide in relapsed or refractory multiple myeloma: Data from clinically relevant cohorts from a phase 1/2a study.

The poster presentation will include safety results and, in particular, efficacy from additional patient cohorts receiving the anti CD38 antibody MOR202 alone and in combination with pomalidomide or lenalidomide from the ongoing trial. The poster presentation will take place on Monday, June 6, 8:00 am – 11:30 am CDT, as part of the Hematologic Malignancies – Plasma Cell Dyscrasia track. The findings will be discussed at the poster discussion session on Monday, June 6, 2016, 3:00 PM – 4:15 PM CDT, at E354b.

Abstract #7545

Subgroup analyses of diffuse large B-cell lymphoma (DLBCL) and indolent lymphoma cohorts from a phase 2a study of single-agent MOR208 in patients with relapsed or refractory non-Hodgkin’s lymphoma (R-R NHL).

The poster presentation will include a subgroup analysis of an open-label, multicenter, phase 2a study of the anti-CD19 antibody MOR208 in R-R NHL patients progressing after at least one prior rituximab-containing therapy, as described in the abstract. The poster presentation will take place on June 6, 8:00 am – 11:30 am CDT, as part of the Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia track.

Abstract #TPS7572

A phase 2 study of MOR208 plus idelalisib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously treated with a Bruton’s tyrosine kinase inhibitor

The poster presentation will include the trial design of an intended phase 2 study (COSMOS), which was originally planned to evaluate MOR208 in combination with idelalisib in CLL and SLL, in particular ibrutinib-refractory CLL, as described in the abstract. After the discontinuation of several combination trials of idelalisib with other compounds and clinical holds by the regulatory authorities in Europe and the U.S., this planned trial is currently under review and discussions with regulatory authorities are ongoing. The poster presentation will take place on June 6, 8:00 am – 11:30 am CDT, as part of the Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia track.

List of abstracts for programs from MorphoSys’s partnered discovery business

Additionally, MorphoSys’s partners will present data for several HuCAL antibodies, which are currently in clinical development:

Abstract #TPS8576

A pivotal randomized phase 2 study of anetumab ravtansine or vinorelbine in patients with advanced or metastatic pleural mesothelioma after progression on platinum/pemetrexed-based chemotherapy (NCT02610140).

Abstract #8564

Updated results of phase 1b study of tarextumab (TRXT, anti-Notch2/3) in combination with etoposide and platinum (EP) in patients (pts) with untreated extensive-stage small-cell lung cancer (ED-SCLC).

Abstract #530

Phase 1b/2 trial of BI 836845, an insulin-like growth factor (IGF) ligand-neutralizing antibody, combined with exemestane (Ex) and everolimus (Ev) in hormone receptor-positive (HR+) locally advanced or metastatic breast cancer (BC): primary phase 1b results.

Abstract #3002

Phase 1b study of PF-05082566 in combination with pembrolizumab in patients with advanced solid tumors.

Abstract #2516

Phase 1b study of WNT inhibitor vantictumab (VAN, human monoclonal antibody) with Paclitaxel (P) in patients (pts) with 1st- to 3rd-line metastatic HER2-negative breast cancer (BC).

Abstract #2509

Phase I study of anti-mesothelin antibody drug conjugate anetumab ravtansine (AR).

The full abstracts can be accessed online at View Source

On May 19, 2016 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that new data will be presented for duvelisib, an investigational, oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, at the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place from June 9 – 12, 2016, in Copenhagen (Press release, Infinity Pharmaceuticals, MAY 19, 2016, View Source;p=RssLanding&cat=news&id=2169736 [SID:1234512585]). At the meeting, preliminary data from CONTEMPO, a Phase 1b/2 study evaluating duvelisib in combination with rituximab or obinutuzmab in treatment-naïve follicular lymphoma patients, will be presented in a poster session. Duvelisib is the only dual inhibitor of PI3K-delta,gamma in Phase 3 clinical development and is in registration-focused studies in patients with relapsed/refractory indolent non-Hodgkin lymphoma (iNHL) and relapsed/refractory chronic lymphocytic leukemia (CLL). Infinity and AbbVie are jointly developing duvelisib in oncology.

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Additionally, posters reviewing ongoing clinical studies of duvelisib and IPI-549, Infinity’s investigational immuno-oncology development candidate that selectively inhibits PI3K-gamma, will be presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago from June 3 – 7, 2016.

Presentations and publications are listed below. All abstracts are available on the conference websites.

EHA 2016
Friday, June 10, 2016, 11:15 a.m. ET – 12:45 p.m. ET (5:15 p.m. – 6:45 p.m. CEST) (poster presentation)
Title: Preliminary Safety, Pharmacokinetics, and Pharmacodynamics of Duvelisib Plus Rituximab or Obinutuzumab in Patients with Previously Untreated CD20+ Follicular Lymphoma
Abstract Number: P319
Lead Author: Carla Casulo, M.D., James P. Wilmont Cancer Center Strong Memorial Hospital, University of Rochester
Location: Hall H

ASCO 2016
Sunday, June 5, 2016, 9:00 a.m. – 12:30 p.m. ET (8:00 a.m. – 11:30 a.m. CT) (poster session)
Title: IPI-549-01-A phase 1/1b First-in-Human Study of IPI-549, a PI3K-Gamma Inhibitor, as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
Abstract Number: TPS3111
Lead Author: Anthony W. Tolcher, M.D, Director of Clinical Research, South Texas Accelerated Research Therapeutics (START)
Location: Hall A

Monday, June 6, 2016, 9:00 a.m. – 12:30 p.m. ET (8:00 a.m. – 11:30 a.m. CT) (poster session)
Title: FRESCO: A Phase 2, Randomized Study of Duvelisib Plus Rituximab vs R-CHOP in Patients with Relapsed/Refractory Follicular Lymphoma Who Have Progressed within 24 Months of Receiving an Alkylator-Based Chemotherapy Regimen.
Abstract Number: TPS7578
Lead Author: Nathan Fowler, M.D., Associate Professor at the Department of Lymphoma/Myeloma, University of Texas, MD Anderson Cancer Center
Location: Hall A

ASCO Publication Only
Title: Preliminary Safety, Pharmacokinetics, and Pharmacodynamics of Duvelisib Plus Rituximab or Obinutuzumab in Patients with Previously Untreated CD20+ Follicular Lymphoma
Abstract Number: #e19052
Lead Author: Carla Casulo, M.D., James P. Wilmont Cancer Center Strong Memorial Hospital, University of Rochester

About Duvelisib
Duvelisib is an investigational dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins that are known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment. 1-3AbbVie and Infinity Pharmaceuticals, Inc. are jointly researching and developing duvelisib in various cancer types.

Duvelisib is being evaluated in several studies, including a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma4, a Phase 3 study in combination with other agents in patients with previously treated follicular lymphoma5 and a Phase 3 study in patients with relapsed/refractory chronic lymphocytic leukemia6. Duvelisib is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.

About IPI-549
IPI-549 is an orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 inhibits immune-suppressive macrophages within the tumor microenvironment, whereas other immunotherapies such as checkpoint modulators more directly target immune effector cell function. As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

These are investigational drugs being studied for indications that have not been approved by Regulatory Agencies. Safety and efficacy have not been established in unapproved indications.

May 19, 2016 Varian Medical Systems (NYSE: VAR) reported that it has been selected by the Apollo Hospitals Group to supply 12 advanced medical linear accelerators and five brachytherapy systems as India’s largest private hospital chain rolls out a program to replace ageing cancer treatment machines (Press release, InfiMed, MAY 19, 2016, View Source [SID:1234512584]). Based on an order placed in March, Varian will supply 11 TrueBeam systems, one Edge Radiosurgery system, and five GammaMed brachytherapy systems for the Apollo network over the next two years.

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The Edge Radiosurgery system, which will be installed in one of Apollo’s tertiary care centers, is a precise, non-invasive alternative to conventional surgery. With enhanced precision and speed, the Edge system offers state of the art radiosurgery and can treat a wide range of conditions across an ever increasing number of clinical indications. Varian’s flagship TrueBeam family of linear accelerators, to be installed at hospitals throughout the Apollo chain, incorporates numerous technical innovations that dynamically synchronize imaging, patient positioning, motion management, and treatment delivery during a radiotherapy or radiosurgery procedure.

As well as advanced treatment equipment, Apollo is ordering a full suite of Varian software tools including the Eclipse treatment planning system and ARIA oncology information management system, along with specific modules such as RapidPlan to enhance the speed and quality of treatment plans, and the InSightive Analytics real-time dashboard to maximize workflow in a clinic.

"We are pleased that Apollo has selected our technology-leading hardware and software to offer their cancer patients fast and precise treatments," says Ashok Kakkar, senior managing director of Varian India. "India is severely under-equipped when it comes to radiotherapy treatment machines and more than two million new cancer cases are detected each year in the country. Programs such as this help to make a big difference in the treatment of cancer patients in India."

Commenting on the collaboration, Dr. Preetha Reddy, executive vice chairperson of Apollo Hospitals Enterprise Limited said, "Healthcare has evolved by leaps and bounds in the past few years and technology has played a critical role in improving clinical outcomes for patients. Providing high quality healthcare on a par with global standards is our prime objective and we are glad to partner with Varian in this endeavor. Already enriched with highly skilled doctors, technicians and physicians, cutting edge technology will further enhance India’s positioning as a global healthcare destination."

Last year, Varian and Apollo announced a collaboration on the first radiotherapy educational co-operation of its kind between industry and a care provider in India. In this collaboration, Varian and Apollo will work together to bring greater access to training in modern radiotherapy by leveraging the existing Apollo Knowledge network that comprises several educational entities in the healthcare space in India. This collaboration with Apollo is a furtherance of Varian’s Access to Care program, which seeks to bridge the gap between the growing need for modern radiotherapy treatment machines in developing countries and the lack of trained personnel to operate them.

On May 19, 2016 Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, reported the upcoming presentation of its final results from the Phase 1 study of its drug candidate, necuparanib, in patients with metastatic pancreatic cancer (Press release, Momenta Pharmaceuticals, MAY 19, 2016, View Source [SID:1234512582]). The poster will be presented at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting.

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Poster Presentation Details

Abstract #4117 / Poster #109: Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of Necuparanib Combined with nab-Paclitaxel and Gemcitabine in Patients with Metastatic Pancreatic Cancer: Updated Phase 1 Results
Presentation Date/Time: Saturday, June 4, 2016; 8:00 a.m. -11:30 a.m. CDT
Presenter: Eileen Mary O’Reilly, MD of David M. Rubenstein Center for Pancreatic Cancer Research, Memorial Sloan Kettering Cancer Center

About Necuparanib
Necuparanib is a novel oncology drug candidate engineered to have a broad range of effects on tumor cells. The use of heparins to treat venous thrombosis in cancer patients has generated numerous reports of antitumor activity; however, the dose of these products has been limited by their anticoagulant activity. Leveraging its experience in deciphering the structure-function relationships of complex therapeutics, Momenta engineered necuparanib from unfractionated heparin to have significantly reduced anticoagulant activity while preserving relevant antitumor properties associated with heparins. A Phase 2 randomized, double-blind, controlled study to evaluate the antitumor activity of necuparanib in combination with nab-paclitaxel (Abraxane) plus gemcitabine, versus nab-paclitaxel plus gemcitabine alone, in pancreatic cancer is currently underway. Necuparanib has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.

On May 19, 2016 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage immuno-oncology drug development company, reported that Paul Maffuid, PhD, Executive Vice President of Research and Development, will discuss MabVax’s unique approach to the discovery of fully human antibodies to cancer antigens and the resulting lead HuMab-5B1 clinical projects in a presentation at America’s Antibody Congress in San Diego on May 19-20, 2016 (Press release, MabVax, MAY 19, 2016, View Source [SID:1234512575]).

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Dr. Maffuid will outline the unique approach that MabVax has taken to the discovery of novel fully human antibodies from cancer patients vaccinated against their cancers. The discovery platform surveys the immune response of many patients by interrogating single B-cells from these patients who are producing antibodies against the intended target. These antibodies are then cloned, retaining the natively paired heavy and light chains of the antibody, and produced recombinantly. To date, MabVax has identified multiple antibodies with the selectivity, affinity, and cytotoxicity necessary to make them clinical development candidates. MVT-5873 is the company’s lead clinical development product and currently in a Phase I clinical trial in patients with metastatic pancreatic cancer. MVT-5873 (HuMab-5B1) is currently being evaluated at three centers in an open-label, multicenter, dose-escalation Phase I clinical trial as a single agent and in combination with gemcitabine/nab-paclitaxel in patients with metastatic pancreatic cancer. MVT-2163 (89Zr-DFO-HuMab-5B) is the company’s lead immuno-PET imaging agent that utilizes the targeting specificity of MVT-5873. MVT-2163 will open as an open-label, multicenter, dose-escalation Phase I clinical trial early in June. MVT-1075 (177Lu-DTPA-HuMab-5B) is the company’s radioimmunotherapy agent and third clinical program from this platform. The radioimmunotherapy product is planned for introduction into the clinic early in 2017.

The MVT-5873 Phase I trial is designed to evaluate the safety, tolerability and pharmacokinetics of MVT-5873 as a single agent or in combination with the current standard of care chemotherapy regimen in subjects with metastatic pancreatic cancer. The first cohort of patients is being enrolled in a traditional dose escalation regimen to assess safety and determine the optimal dose of the antibody. A second patient cohort will establish the safety and optimized dose of the antibody when administered with standard of care chemotherapy and a third patient cohort will be administered the optimized dose of antibody as a single agent for the treatment of patients with advanced cancer.

Dr. Maffuid will also present information regarding a second Phase I trial scheduled to begin in the next few weeks. This trial will evaluate MVT-2163, also based on HuMab-5B1 antibody, as a next-generation PET imaging agent for the diagnosis and management of patients with pancreatic cancer. When the antibody is combined with a radio-label as a novel PET imaging agent, the 89Zr-HuMab-5B1 product has demonstrated high-image resolution of tumors in established xenograft animal models, making it attractive diagnostic agent for detection of metastatic pancreatic cancer and for use in combination with the HuMab-5B1 therapeutic product.

The company is currently completing preclinical development activities to support filing an Investigative New Drug Application (IND) for MVT-1075 with the FDA later this year. A summary of preclinical data will be presented which demonstrated effectiveness in established xenograft animal models demonstrating potential as an therapeutic agent.

MabVax anticipates discussing preliminary results from both Phase I trials during the third quarter of this year.