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Glenmark announces Strategic Development and Global Licensing Agreement with Particle Sciences,
Inc., a Lubrizol Company, for generic ABRAXANE®

On September 19, 2016 Glenmark Pharmaceuticals, Inc., USA (Glenmark) reported that it has entered into a strategic Development, License and Commercialization Agreement with Particle Sciences, Inc. to develop and market a generic version of Celgene’s ABRAXANE product – paclitaxel protein (albumin)-bound particles for injectable suspension (Press release, Glenmark, SEP 19, 2016, View Source [SID:SID1234515301]).

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As per the terms of the agreement, Glenmark has obtained Global Exclusive Marketing and Distribution rights of the product upon commercialization. Particle Sciences will develop this product exclusively for Glenmark, and shall receive certain milestone payments during various stages of the product’s development from Glenmark, including royalties on sales. Development of the product has been initiated for the USA market and Glenmark intends to file the ANDA in FY19. The product will be subsequently filed in other key markets across the globe.

"The partnership is a significant development in Glenmark’s complex generics strategy and we are pleased to collaborate with Particle Sciences given their strong technical capabilities and understanding of particulate injection products. This is a challenging product to develop and we expect it to remain a limited competition opportunity." said Robert Matsuk, President – North America and Global API, Glenmark Pharmaceuticals Limited.

ABRAXANE marketed globally by Celgene has reported sales of USD 967 million world-wide and USD 654 million in the USA in the calendar year 2015. As per IMS MAT December 2015, ABRAXANE has registered sales of USD 990 million world-wide and USD 669 million in the USA.

ABRAXANE is paclitaxel protein (albumin)-bound particles for injectable suspension indicated for the treatment of:
Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated

Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy

Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine

CNS Oncology Publishes Tumor Treating Fields Treatment Planning and Patient Follow-up Guidelines in Glioblastoma

On September 19, 2016 Novocure (NASDAQ:NVCR) reported that CNS Oncology published Tumor Treating Fields (TTFields) treatment planning and patient follow-up guidelines, providing a standardized resource for the use of the NovoTAL System to optimize TTFields intensity in Optune patients with newly diagnosed and recurrent glioblastoma (GBM) (Press release, NovoCure, SEP 19, 2016, View Source [SID:SID1234515225]). Treatment planning with the NovoTAL System is an essential component of treatment with TTFields. The guidelines present a framework for utilizing the NovoTAL treatment planning software to start patients, monitor patient response and evaluate when TTFields treatment should be re-planned.

"Transducer array placement and TTFields intensity are important factors in the success of treatment with Optune," said Dr. Eilon Kirson, Chief Science Officer and Head of Research and Development at Novocure. "We are pleased that CNS Oncology published treatment planning guidelines and believe the guidelines will advance Optune as a standard treatment option in GBM."

All glioblastoma patients starting Optune should receive treatment planning with the NovoTAL System. In simulation studies, personalized treatment planning with the NovoTAL system resulted in near doubling of TTFields intensity delivered to the tumor compared with TTFields delivered using a default symmetric array layout.

The guidelines explain that there may be a benefit to certified physicians conducting TTFields treatment planning because they have comprehensive information regarding the patients’ medical history, current medical status and knowledge of sequential imaging changes.

"The publication of TTFields treatment planning guidelines in CNS Oncology will increase physicians’ confidence when planning patients’ therapy with TTFields," said Dr. John Trusheim, lead author of the guidelines, Assistant Clinical Professor at the University of Minnesota Medical School and Medical Director of Neuro-oncology at the Virginia Piper Cancer Institute in Minneapolis. "This tool will help inform physicians on how to incorporate Optune into glioblastoma patients’ treatment, potentially resulting in better treatment outcomes."

Novocure’s EF-14 phase 3 pivotal trial data published in The Journal of the American Medical Association in December 2015 demonstrated that adding TTFields to maintenance temozolomide significantly extended progression free and overall survival in newly diagnosed GBM patients versus maintenance temozolomide alone.

About Glioblastoma Glioblastoma, also called glioblastoma multiforme, or GBM, is a type of primary brain cancer. This means that GBM tumors begin in the brain, rather than traveling to the brain from other parts of the body, such as the lungs or breasts. GBM is the most common type of primary brain cancer in adults. It is more likely to appear in adults than children and to affect men than women.

Approved Indications
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).

Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.

In the United States, for the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

Delcath Sponsors Ocular Melanoma Foundation Patient Retreat

On September 19, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on treatments for primary and metastatic liver cancers, reported that the company provided a grant to the Ocular Melanoma Foundation (OMF) in support of the organization’s 6th Annual Eye Am Not Alone (EANA) patient education retreat, held in Miami, Florida at the Bascom Palmer Eye Institute on September 9-11, 2016 (Press release, Delcath Systems, SEP 19, 2016, View Source;p=RssLanding&cat=news&id=2204432 [SID:SID1234515223]). Delcath supported a lecture by Jonathan Zager, M.D., FACS, Professor of Surgery in the Cutaneous Oncology and Sarcoma Departments and a Senior Member at Moffitt Cancer Center, and principal investigator for the Company’s FOCUS Phase 3 Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the FOCUS Trial).

The EANA is an annual conference and patient education seminar organized by the OMF and hosted by some of the leading research institutions working on treatments for ocular melanoma. The EANA retreat offers patients and caregivers opportunities to learn about treatment options, clinical trials and other resources available to them as they contend with this difficult to treat cancer.

"Patient advocacy organizations like the OMF are vital sources of support for patients facing an ocular melanoma diagnosis," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. "We were pleased to sponsor this important conference, and look forward to supporting the mission of the OMF and other patient advocacy organizations working on ocular melanoma in the future."

Corvus Pharmaceuticals to Present Data on Lead Oral Checkpoint Inhibitor CPI-444 at Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference

On September 19, 2016 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology therapies, reported that it will present preclinical data, and preliminary biomarker data from its ongoing Phase 1/1b study of CPI-444 as a single agent, and in combination with Genentech’s TECENTRIQ (atezolizumab)‎, in both oral and poster presentations at the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper): Translating Science into Survival, which is taking place from September 25-28 in New York (Press release, Corvus Pharmaceuticals, SEP 19, 2016, View Source;p=RssLanding&cat=news&id=2204373 [SID:SID1234515202]).

Following are details of the oral and poster presentations.

ABSTRACT TITLE: CPI-444: A potent and selective inhibitor of A2AR induces antitumor responses alone and in combination with anti-PD-L1 in preclinical and clinical studies
PRESENTER: Stephen Willingham, Ph.D., senior scientist, Corvus
ORAL SESSION: Plenary Session 2: New Checkpoints
ORAL SESSION DATE, TIME AND LOCATION: Sunday, September 25, 1:30-4:40 p.m. ET, Sheraton Metropolitan Ballroom, Sheraton New York Times Square Hotel
POSTER SESSION: Poster Session A: New Checkpoints
POSTER NUMBER: A048
POSTER PRESENTATION DATE, TIME AND LOCATION: Sunday, September 25, 5:00-7:30 p.m. ET, Americas Hall I, New York Hilton Midtown

Infinity Announces Publication On PI3K-Gamma In Nature

On September 19, 2016 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported the publication of new findings by research collaborators at University of California San Diego School of Medicine and Moores Cancer Center and Infinity scientists in the September 19 online issue of Nature (Press release, Infinity Pharmaceuticals, SEP 19, 2016, View Source [SID:SID1234515231]). The paper, entitled "PI3K-gamma is a molecular switch that controls immune suppression,"1 describes research showing that targeting macrophage signaling pathways by inhibiting phosphoinositide-3-kinase (PI3K)-gamma may open the possibility to further improving and refining emerging immunotherapies that boost the body’s own abilities to fight a range of diseases, including cancer. Infinity is conducting a Phase 1 clinical study of IPI-549, an orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. IPI-549 is the only PI3K-gamma inhibitor in clinical development.

"Immunotherapies, such as T cell checkpoint inhibitors, are showing great promise in early treatments and trials, but they are not universally effective," said Judith A. Varner, PhD, professor in the departments of Pathology and Medicine at UC San Diego School of Medicine. "We have identified a new method to boost the effectiveness of current immune therapy. Our findings also improve our understanding of key mechanisms that control cancer immune suppression and could lead to the development of more effective immunotherapies."

"The findings published today build upon other work by Infinity and our collaborators, reinforcing the therapeutic potential of Infinity’s selective PI3K-gamma inhibitor, IPI-549, to alter the immune-suppressive microenvironment, promoting an anti-tumor immune response that leads to tumor growth inhibition," stated Jeffery Kutok, M.D., Ph.D., vice president of biology and translational science at Infinity Pharmaceuticals and a co-author of the paper. "Infinity is excited to be at the forefront of advancing PI3K-gamma inhibition as a new immunotherapeutic approach that could potentially enhance existing treatment options, including checkpoint inhibitors."

When confronted by pathogens, injury or disease, the initial response of the body’s immune system comes in the form of macrophages, a type of white blood cell that express pro-inflammatory proteins called cytokines that, in turn, activate T cells, another immune cell, to attack the health threat. The macrophages then switch gears to express other cytokines that dampen T cell activation, stimulating tissue repair. In cancer, highly abundant macrophages express anti-inflammatory cytokines that induce immune suppression, leading to enhanced tumor growth.

In the Nature paper, researchers pinpoint a key, suspected player: an enzyme in macrophages called PI3K-gamma. In mouse studies, they found that macrophage PI3K-gamma signaling promotes immune suppression by inhibiting activation of anti-tumor T cells. Blocking PI3K-gamma activated the immune response and significantly suppressed growth of implanted tumors in animal models. It also boosted sensitivity of some tumors to existing anti-cancer drugs and synergized with existing immune therapy to eradicate tumors. Researchers also identified a molecular signature of immune suppression and response in mice and cancer patients that may be used to track the effectiveness of immune therapy.

Earlier this year, Infinity initiated its first clinical study of IPI-549 designed to explore safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with an anti-PD-1 antibody, a checkpoint inhibitor, in approximately 150 patients with advanced solid tumors, including non-small cell lung cancer and melanoma.2

"Infinity’s first clinical study of IPI-549 is progressing well, and we expect to initiate the first combination therapy cohort this Fall," said Julian Adams, Ph.D., president, research and development at Infinity. "We also look forward to the presentation of early clinical and new preclinical data at an immuno-therapy conference later this month."

Recently, Infinity announced that new preclinical data as well as early clinical data from the ongoing Phase 1 study will be presented for IPI-549 during the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper): Translating Science into Survival taking place September 25-28, 2016, in New York City. The IPI-549 presentations will take place during the poster session being held on Monday, September 26, from 5:15 p.m. – 7:45 p.m. ET (Poster Boards B070 and B032).

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.

IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.