On October 01, 2015 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, reported that interim results of an ongoing Phase 1 dose escalation study of MGA271 will be presented by the Company in the late-breaking abstract session at the 2015 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, MD (Press release, MacroGenics, OCT 1, 2015, View Source [SID:1234507629]). The 30th Anniversary Annual Meeting is being held November 4-8, 2015 at the Gaylord National Hotel & Convention Center. Presentation details include:

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Title: Interim Results of an Ongoing Phase 1, Dose Escalation Study of MGA271 (Fc-optimized Humanized Anti-B7-H3 Monoclonal Antibody) in Patients with Refractory B7-H3-Expressing Neoplasms or Neoplasms Whose Vasculature Expresses B7-H3

Session: Late-Breaking Abstract Session

Time: Saturday, November 7, 2015, from 12:00 pm – 12:15 pm ET

Presented by: MacroGenics, Inc.

Background on MGA271

MGA271 is a humanized, Fc-optimized monoclonal antibody that targets B7-H3, a member of the B7 family of molecules that are involved in immune regulation. B7-H3 is over-expressed by a wide variety of solid tumor cells as well as cancer stem-like cells and the supporting tumor vasculature. MGA271 is currently undergoing Phase 1 testing both as monotherapy and in combination with checkpoint inhibitors including ipilimumab and pembrolizumab across a wide range of solid tumors.

On September 30, 2015 Fierce Biotech disclosed the 15 selected companies for the Fierce 15 Award. No less than nine of these have solid ties to drug development in oncology (Press release, Fierce Biotech, SEP 30, 2015, View Source [SID:1234507611]). In fact Fierce Biotech has by this choice of companies highlighted the importance of gene editing and cellular therapy in the field of immunotherapy for developing future cures in cancer.

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List of Oncology Associated Companies Among this Year Recipients of the Fierce 15 Award:
Arvinas (USA)
Cell Medica (UK)
CRISPR Therapeutics (Switzerland)
Intellia Therapeutics (USA)
NGM Biopharmaceuticals (USA)
SQZ Biotech (USA)
Surface Oncology (USA)
Syros Pharmaceuticals (USA)
Unum Therapeutics (USA)

On September 30, 2015 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that the 120th patient has been enrolled in DYNAMO, a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma (iNHL) evaluating the safety and efficacy of duvelisib an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma (Press release, Infinity Pharmaceuticals, SEP 30, 2015, View Source;p=RssLanding&cat=news&id=2091831 [SID:1234507617]). This enrollment achievement triggers a $130 million milestone payment from AbbVie Inc. , Infinity’s global development and commercialization partner for duvelisib in oncology. Infinity expects to report topline data from DYNAMO in the third quarter of 2016.

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"The completion of patient enrollment in DYNAMO represents a significant milestone for Infinity," said Julian Adams, Ph.D., president, research and development at Infinity. "We are grateful for the support of the DYNAMO investigators, and most importantly the patients and their families, for their participation in this study. In addition, we would like to thank the Infinity and AbbVie teams for their hard work in ensuring completion of enrollment in this trial. We look forward to sharing topline DYNAMO data next year."

"The duvelisib development program underscores our commitment to developing innovative treatment options for patients with hematologic malignancies, and completing patient enrollment in DYNAMO represents an important step toward advancing the duvelisib program," stated Adelene Perkins, Infinity’s president and chief executive officer. "Additionally, the milestone payment provides Infinity with important financial resources as we continue to execute on our strategic development plans as we work with AbbVie to bring duvelisib to patients. Very few therapeutic options exist for patients with relapsed/refractory indolent non-Hodgkin lymphoma, and more oral therapies are needed."

DYNAMO is a global, Phase 2 open-label, single-arm, monotherapy study of duvelisib (25 mg BID) in 120 patients with iNHL whose disease is refractory to rituximab and to either chemotherapy or radioimmunotherapy. The primary endpoint is overall response rate.

About the AbbVie Collaboration
Under the terms of the agreement announced in September 2014 , Infinity received an upfront payment of $275 million from AbbVie Inc. and will receive a $130 million associated with the completion of patient enrollment for DYNAMO. Additionally, Infinity is eligible additional payments for the achievement of regulatory and commercial milestones. In the U.S., the companies will jointly commercialize duvelisib and will share equally in any potential profits. Outside the U.S., AbbVie will be responsible for the conduct and funding of commercialization of duvelisib, and Infinity is eligible to receive tiered double-digit royalties on net product sales.

About Duvelisib
Duvelisib is an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins with predominantly non-overlapping roles known to support the growth and survival of malignant B-cells.[i] Preclinical data suggest that PI3K-delta signaling can lead to the proliferation of malignant B-cells, and both PI3K-gamma and PI3K-delta play a role in the formation and maintenance of the supportive tumor microenvironment.[ii] Duvelisib is the only investigational PI3K-delta,gamma inhibitor in Phase 3 clinical development and has the potential to be a first-in-class treatment for certain types of hematologic malignancies, or blood cancers. AbbVie and Infinity Pharmaceuticals, Inc. are jointly developing duvelisib in oncology.

Duvelisib is being evaluated in registration-focused studies, including DYNAMO, a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma, DYNAMO+R, a Phase 3 study in patients with previously treated follicular lymphoma, and DUO, a Phase 3 study in patients with relapsed/refractory chronic lymphocytic leukemia. Duvelisib is an investigational compound and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On September 30, 2015 Pfizer Inc., in partnership with five leading breast cancer advocacy organizations, reported the next chapter of the Breast Cancer: A Story Half Told initiative, launched in 2014 to identify public misperceptions and gaps in knowledge surrounding metastatic breast cancer (MBC), the most advanced form of breast cancer (Press release, Pfizer, SEP 30, 2015, View Source [SID:1234507620]). Research conducted as part of this initiative revealed that the majority of Americans (60%) reported they know little to nothing about MBC.1The new chapter aims to address this lack of understanding through the perspectives of women living with MBC, as chronicled by prominent photographers.

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"The findings from our Story Half Told research underscored the need to bring metastatic breast cancer into the public dialogue in a meaningful way. Through this program, we are aiming to do that not only by communicating the facts about metastatic breast cancer, but by sharing the stories of women who are living with it," said Liz Barrett, president and general manager, Pfizer Oncology. "Pfizer is proud to be working with our advocacy partners and Story Half Told participants to dispel misperceptions, combat stigma and foster a more inclusive breast cancer conversation going forward."

MBC affects 150,000-250,000 women in the U.S. alone.2 As part of this initiative, five photographers with a significant Instagram presence have joined with Pfizer to capture the daily lives of five women living with MBC. This photography-based initiative is featured on the @StoryHalfTold Instagram account, as well as on www.StoryHalfTold.com (link is external) and the program Facebook and Twitter accounts. Through this program, Pfizer invites others with MBC and all those who support them, to join in and share their own photos and messages of hope using the hashtag #StoryHalfTold.

"Story Half Told continues my dream as a lifer to help educate the nation about metastatic breast cancer," said Holley Kitchen, who participated in the program. "Through photography, this program depicts the unique challenges we face daily – and expresses that our lives continue as normally as possible despite our disease."

"The Story Half Told program strives to create an environment where people across the country can become more knowledgeable about metastatic breast cancer," said Shirley Mertz, president, Metastatic Breast Cancer Network. "At the same time, they can join an initiative to support women living with the disease who often feel alone. When people truly understand what a group of women are facing, human compassion, improved communications and support naturally follow."

On September 29, 2015 Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle") reported that the United States Patent and Trademark Office (USPTO) has granted U.S. Patent No. 9,144,568, which pertains to the use of the bendamustine hydrochloride (HCl) formulation administered in a 50mL bag within ten minutes (the "rapid infusion" product) (Press release, Eagle Pharmaceuticals, SEP 29, 2015, View Source [SID:1234507608]). The patent issued today expires on March 15, 2033. This new patent, along with three previously issued Patents (Nos. 8,609,707, 9,000,021, and 9,034,908), further expands and protects Eagle’s bendamustine HCI intellectual property estate.

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"Today’s patent issuance further strengthens our intellectual property for the bendamustine rapid infusion product, for which a New Drug Application (NDA) is currently under review by the U.S. Food and Drug Administration (FDA)," said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. "We believe that approval of and subsequent launch by Teva of this important product, along with royalty payments earned on sales and the potential for additional milestone payments, will expedite Eagle’s ability to deliver long term, sustainable growth."

The Prescription Drug User Fee Act (PDUFA) goal date for a decision on the NDA by the FDA is December 2015. The NDA requests FDA approval of the rapid infusion bendamustine HCl product for the treatment of patients with chronic lymphocytic leukemia (CLL) and patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. The NDA for Eagle’s rapid infusion bendamustine product is supported by data from a clinical trial completed in November 2014, which demonstrated that the rapid infusion bendamustine HCl product can be administered in ten minutes in a low- volume, 50 mL admixture.

The rapid infusion product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval.

In February 2015, Eagle and Teva Pharmaceutical Industries Ltd. entered into an exclusive license agreement for the rapid infusion bendamustine product. Teva will be responsible for all U.S. commercial activities for the product including promotion and distribution. Eagle has responsibility for obtaining all regulatory approvals, conducting post-approval clinical studies, if required, and initially supplying drug product to Teva.