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Medivation and Astellas Announce Enrollment of the First Patients in Advanced Prostate Cancer Outcomes Registry

On June 17, 2015 Medivation and Astellas reported that the first patients have been enrolled in TRUMPET (Treatment Registry for Outcomes in CRPC Patie nts), a prospective observational patient registry designed to better understand the unique needs and treatment patterns for patients with castration-resistant prostate cancer (CRPC) (Press release, Medivation, JUN 17, 2015, View Source [SID:1234505447]). The registry will enroll and evaluate 2,000 patients diagnosed with CRPC from urology and oncology sites across the United States. The study will also collect data from the primary caregivers of patients, including spouses, family members and/or friends.

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"While there have been many treatment advances in prostate cancer over the past few years, there is still a great deal for us to learn. The insights from TRUMPET can directly impact our research and increase our understanding of important treatment considerations," said Jeffrey Bloss, M.D., senior vice president, Astellas Pharma Global Development, Inc. "This registry provides an important building block to support our commitment to providing effective, evidence-based cancer care for patients and their caregivers."

TRUMPET will follow patients with CRPC and participating caregivers for up to six years to gather information about the management of the disease, including patterns of care, treatment decisions and settings, and physician referral patterns. The registry will also track information about patient health-related quality of life outcomes, work productivity and treatment satisfaction, as well as caregiver health-related quality of life outcomes associated with managing a patient with CRPC.

"As a direct result of advances in therapies available to treat patients with CRPC, treatment decisions have become more complex than ever," said David F. Penson, M.D., M.P.H., chair, department of urologic surgery, Vanderbilt University Medical Center. "TRUMPET will expand our scientific understanding of CRPC to help healthcare professionals, patients and their loved ones make more informed decisions about their care."

TRUMPET is currently enrolling eligible patients and their caregivers; the study will be completed in 2020.

Lilly and Dana-Farber Cancer Institute Announce Research Collaboration

On June 17, 2015 Eli Lilly and Dana-Farber Cancer Institute reported a multiyear collaboration to research new medicines under development to fight cancer (Press release, Eli Lilly, JUN 17, 2015, View Source [SID:1234505444]).

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"Working together is the most powerful approach in fighting cancer," said Richard Gaynor, M.D., senior vice president, product development and medical affairs, Lilly Oncology. "Lilly’s partnership with Dana-Farber demonstrates an open, collaborative research approach—uniting the expertise of the pharmaceutical industry with that of a leading academic cancer research institution."

Per the agreement, over the course of three years Dana-Farber will provide research and development expertise for a number of early-stage Lilly oncology compounds. Dana-Farber researchers and Lilly scientists will work collaboratively on preclinical and clinical studies, molecular studies of patient samples and the design and conduct of clinical trials, which may result in important advances in the science of cancer care. The agreement also allows Dana-Farber scientists to conduct independent studies on select Lilly compounds. Following research conducted at Dana-Farber, the evaluated compounds will still be fully owned by Lilly. Financial terms of the agreement are not being disclosed.

"This is a new kind of collaboration between a comprehensive cancer center and a large pharmaceutical company," said Barrett Rollins, M.D., Ph.D., chief scientific officer of Dana-Farber. "Under this agreement, Lilly can access the expertise within Dana-Farber to help it develop multiple preclinical and clinical compounds. Together, we can bring compounds to clinical trials and to FDA approval quickly and efficiently, and thus benefit our patient population."

AbCheck and Pierre Fabre Pharmaceuticals Enter Into Strategic Research Partnership

On June 17, 2015 AbCheck s.r.o, a wholly owned subsidiary of Affimed N.V., Heidelberg, Germany, and Pierre Fabre Pharmaceuticals reported that they have expanded their ongoing collaboration into a strategic research partnership in the field of human antibody discovery and optimization (Press release, Pierre Fabre, JUN 17, 2015, View Source [SID:1234505451]).

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AbCheck is recognized for its expertise in human antibody discovery and optimization throughout the US and Europe. Pierre Fabre, the third largest French pharmaceutical company, has a long-standing commitment to oncology and immunology. The Pierre Fabre Immunology Centre (CIPF) in Saint-Julien-en-Genevois, France, is dedicated to the identification, development and manufacturing of therapeutic monoclonal antibodies in focused therapeutic areas.

Under the expanded agreement, AbCheck will use its proprietary human antibody discovery and optimization platform technologies, AbSieve and AbAccel, to deliver antibodies against two or more targets provided by Pierre Fabre per year over a period of three years. This period can be extended to up to five years. Pierre Fabre has secured full rights to all antibodies selected in exchange for discovery fees and milestone payments to AbCheck. Additional deal terms as well as financial details were not disclosed.

"We are extremely pleased that our technology platform, performance and business attitude has encouraged Pierre Fabre to select AbCheck as its main provider for therapeutic antibodies," said Dr. Volker Lang, Managing Director of AbCheck. "This validation once more proves our ability to efficiently address the needs of our partners, which is instrumental to AbCheck’s future development."

"At Pierre Fabre Immunology Center, we are working on a wide range of new promising targets and are always looking to reinforce our capabilities through collaborations with world-class platforms. This strategic partnership with AbCheck will support and accelerate our antibody discovery," said Dr. Nathalie Corvaïa, Managing Director of the Pierre Fabre Immunology Center.

"Pierre Fabre is deeply committed to bringing targeted therapies to patients that need them as quickly as possible. This partnership with AbCheck coupled with our internal capabilities provides us with a platform to achieve this objective," added Prof. Laurent Audoly, Head of R&D, Pierre Fabre Pharmaceuticals.

ImmunoGen’s IMGN529 for B-Cell Malignancies Demonstrates Synergistic Activity with Rituximab in Preclinical Models of Non-Hodgkin Lymphoma

On June 17, 2015 ImmunoGen reported the first presentation of findings with the Company’s CD37-targeting ADC, IMGN529, in combination with the CD20-targeting antibody, rituximab (Rituxan), in preclinical assessments (Press release, ImmunoGen, JUN 17, 2015, View Source [SID:1234505446]). These data are being presented in a poster at the 13th International Conference on Malignant Lymphoma taking place in Lugano, Switzerland (abstract #P-274).

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Among the findings being presented are:

IMGN529 exhibits strong synergy with rituximab and other CD20-targeting antibodies in cell lines representative of an array of non-Hodgkin lymphoma (NHL) subtypes, including both GCB and ABC diffuse large B-cell lymphoma (DLBCL);

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Consistent with the in vitro findings, the combination of IMGN529 and rituximab was highly active against DLBCL models in vivo;

Synergy also was seen in vitro in a model representative of "double hit" lymphoma, a particularly difficult-to-treat type of DLBCL characterized by deregulation of two different genes, BCL2 (or BCL6) and MYC; and

Both IMGN529’s antibody component and its DM1 payload contributed to its synergistic activity with rituximab.

"Rituximab is a standard of care in the treatment of B-cell malignancies, and thus it is highly exciting that IMGN529 and rituximab demonstrate synergistic activity in combination in these models," commented Dr. Charles Morris, EVP and Chief Development Officer of ImmunoGen. "We plan to initiate clinical testing of IMGN529 in combination with rituximab later this year to assess the potential benefit of such a regimen for patients with DLBCL."

IMGN529 is currently in Phase I clinical testing for the treatment of NHL, used as a single agent in patients with heavily pre-treated disease. It has demonstrated encouraging evidence of activity, particularly for patients with relapsed/refractory DLBCL.1 Later this year, ImmunoGen plans to begin assessing IMGN529 used in combination with rituximab for the treatment of relapsed/refractory DLBCL in addition to assessing it as a single agent in DLBCL and chronic lymphocytic leukemia disease-specific patient populations.

About IMGN529

IMGN529 is a CD37-targeting ADC created by ImmunoGen for the treatment of B-cell malignancies. It consists of a CD37-binding antibody with one of the Company’s potent cancer cell-killing agents, DM1, attached. The antibody serves to deliver the DM1 specifically to B cells to kill them and, based on preclinical research, also contributes anticancer activity.

About Diffuse Large B-cell Lymphoma (DLBCL)

More than 70,000 people will be diagnosed with non-Hodgkin lymphoma (NHL) in the US in 2014.2 DLBCL is an aggressive lymphoma that represents approximately one third of the new NHL cases diagnosed annually.2 GCB, or Germinal Center B-cell like, and ABC, or Activated B-cell like, are prevalent sub-types of DLBCL which can differ markedly in their responses to treatment.

Eli Lilly and Company Enters Into Strategic Partnership with Sarah Cannon Research Institute to Develop Investigational Oncology Therapy

On June 17, 2015 Eli Lilly and Sarah Cannon Research Institute reported a strategic partnership to co-develop an investigational oncology compound, LY3023414, a PI3K/mTOR dual inhibitor (Press release, Eli Lilly, JUN 17, 2015, View Source [SID:1234505445]). Under the agreement, SCRI will collaborate with Lilly to provide clinical development expertise and program design, as well as medical oversight and trial management. Patient enrollment for the initial Phase II clinical trial is underway.

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"Lilly has a long history of leading innovation in cancer therapy with the goal to offer patients improved treatment outcomes," said Christopher A. Slapak, M.D., vice president, early phase clinical research for Lilly. "This strategic partnership is an exciting step to foster further collaboration with SCRI in advancing the field of cancer research."

The partnership supports the development of this novel targeted cancer therapy, including flexible and efficient program design and implementation, as well as more rapid patient enrollment to clinical trials by accessing SCRI’s large network of patients.

"Our clinical trial management capabilities and scientific leadership, combined with Lilly’s leading drug development expertise, furthers our mission to advance therapies for patients seeking novel cancer medicines," said Dee Anna Smith, CEO of SCRI. "Through partnerships like this one, we can accelerate the time it takes to bring clinical trials into communities for those fighting cancer."