On March 23, 2017 Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies, and advancing its proprietary R&D pipeline, reported that four preclinical abstracts and one clinical abstract have been accepted for presentation at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), to be held April 1 – 5, 2017 in Washington, D.C (Press release, Peregrine Pharmaceuticals, MAR 23, 2017, View Source [SID1234518245]).

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Peregrine scientists and collaborators will present positive findings from multiple studies of the company’s phosphatidylserine (PS)-targeting antibodies in combination with other anti-tumor agents, including results from two Memorial Sloan Kettering Cancer Center studies that evaluate the use of a bavituximab equivalent in combination with immune stimulating therapies. The following abstracts will be presented:
Abstract Number: 574
Session: PO.IM02.02 – Checkpoints 1
Presentation Title: Phosphatidylserine targeting antibody in combination with tumor radiation and immune checkpoint blockade promotes anti-tumor activity in mouse B16 melanoma
Presentation Day/Time: Sunday, April 2, 2017, 1:00 – 5:00 PM Eastern
Location: Section 25
Poster Board Number: 8
Author Institutions: Memorial Sloan Kettering Cancer Center, New York, NY; Peregrine Pharmaceuticals, Inc., Tustin, CA
Abstract Number: 1651
Session: PO.IM02.08 – Tumor Microenvironment and Checkpoints
Presentation Title: Targeting phosphatidylserine in combination with adoptive T cell transfer eliminates advanced tumors without off-target toxicities in a melanoma preclinical model
Presentation Day/Time: Monday, April 3, 2017, 8:00 – 12:00 PM Eastern
Location: Section 27
Poster Board Number: 29
Author Institutions: Memorial Sloan Kettering Cancer Center, New York, NY; Peregrine Pharmaceuticals, Inc., Tustin, CA
Abstract Number: CT159
Session: PO.CT02 – Phase III Clinical Trials and Phase II/III Clinical Trials in Progress
Presentation Title: IFN-γ analysis in blood and tissue as a potential prognostic and/or predictive biomarker
Presentation Day/Time: Monday, Apr 3, 2017 1:00 – 5:00 PM Eastern
Location: Section 33
Poster Board Number: 25
Author Institution: Peregrine Pharmaceuticals, Tustin, CA
Abstract Number: 3652
Session: PO.IM02.05 – BITES Bispecifics and Checkpoints
Presentation Title: Combinational activity of LAG3 and PD-1 targeted therapies is significantly enhanced by the addition of phosphatidylserine targeting antibodies and establishes an anti-tumor memory response in murine triple negative breast cancer
Presentation Day/Time: Tuesday, April 4, 2017, 8:00 – 12:00 PM Eastern
Location: Section 26
Poster Board Number: 25
Author Institution: Peregrine Pharmaceuticals, Tustin, CA
Abstract Number: 3657
Session: PO.IM02.05 – BITES Bispecifics and Checkpoints
Presentation Title: Phosphatidylserine-targeting antibodies enhance anti-tumor activity of a tumor vaccine in a HPV-induced tumor model
Presentation Day/Time: Tuesday, April 4, 2017, 8:00 – 12:00 PM Eastern
Location: Section 26
Poster Board Number: 30
Author Institutions: Immunovaccine, Inc., Halifax, NS, Canada; Peregrine Pharmaceuticals, Inc., Tustin, CA
Bavituximab is an investigational monoclonal antibody that targets PS. Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab is believed to override PS mediated immunosuppressive signaling by blocking the engagement of PS with its receptors as well as by sending an alternate immune activating signal. Previous studies demonstrated PS-targeting antibodies shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor responses.
Peregrine’s clinical development strategy for bavituximab currently focuses on small, early-stage, proof-of-concept trials evaluating the drug in combination with other cancer treatments. As part of this approach the National Comprehensive Cancer Network (NCCN) has awarded grants to support three different clinical trials of bavituximab treatment combinations. These trials will evaluate novel bavituximab combinations in glioblastoma, head and neck cancer, and hepatocellular carcinoma including an immunotherapy combination. Additionally, Peregrine continues to advance its pre-clinical collaboration with Memorial Sloan Kettering Cancer Center with the goal of evaluating combinations of bavituximab with other checkpoint inhibitors and immune stimulatory agents. The intent behind this strategy is to focus our research and development spending to further validate bavituximab’s combination potential as we seek to advance the program though a pharmaceutical or biotechnology partner.

On March 23, 2017 Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK) reported the enrollment of its first patient in a Phase 1 study of MM-310 in solid tumors (Press release, Merrimack, MAR 23, 2017, View Source [SID1234518244]). MM-310 is an antibody-directed nanotherapeutic (ADN) that encapsulates a novel taxane and targets the EphA2 receptor, a protein which surveys suggest is overexpressed in 50-100% of many major tumor types, including prostate, ovarian, bladder, gastric, pancreatic and lung cancers.

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"The initiation of this study is an important step in evaluating MM-310’s safety and preliminary activity in patients diagnosed with solid tumors," said Vasileios Askoxylakis, MD, PhD, Medical Director and MM-310 Project Leader at Merrimack. "MM-310 was designed to maximize targeted delivery and local activation of a newly engineered and proprietary prodrug of docetaxel, a broadly-used potent chemotherapy that is often associated with significant drug-related toxicities, with a goal of minimizing exposure to healthy tissue. In several preclinical models, MM-310 not only demonstrated superior antitumor activity when compared to free docetaxel, but also fewer hematologic toxicities. We look forward to continuing MM-310’s development via this study."

The Phase 1 open-label study will assess the safety, pharmacology and preliminary activity of MM-310 in three parts. In part one, MM-310 will be assessed as a monotherapy until a maximum tolerated dose (MTD) is established. After the MTD of MM-310 is established, the study will include two further concurrent parts consisting of an expansion cohort as a single agent and a dose-finding phase in combination with other therapies. Merrimack expects to report data from part one of the study in 2018.

Five sites are currently expected to participate in this study. The first patient was dosed at Honor Health in Scottsdale, AZ.

About MM-310

MM-310 is an antibody-directed nanotherapeutic (ADN) that encapsulates a novel prodrug of the highly potent chemotherapy docetaxel in an ephrin receptor A2 (EphA2)-targeted liposome. EphA2 receptors are shown to be overexpressed in several solid tumors, including prostate, ovarian, bladder, gastric, pancreatic and lung cancers. Moreover, EphA2 receptors are associated with poor outcomes in certain indications. Preclinical data on MM-310 were presented in an oral presentation and three poster sessions at the 2016 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and further data will be presented at the 2017 AACR (Free AACR Whitepaper) Annual Meeting in April. For more information on the Phase 1 study in solid tumors, please visit www.clinicaltrials.gov (Identifier: NCT03076372).

On March 23, 2017 Advaxis, Inc. (NASDAQ:ADXS), a biotechnology company developing cancer immunotherapies, reported the European Medicines Agency (EMA) issued an advanced therapy medicinal product certificate for manufacturing quality and non-clinical data (Press release, Advaxis, MAR 23, 2017, View Source [SID1234518243]).

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The certification procedure involved a thorough scientific evaluation over several months of the quality (CMC) data and non-clinical data by the EMA’s Committee for Advanced Therapies (CAT). After a positive opinion from CAT, EMA issued a certificate confirming that the CMC and non-clinical data comply with the standards that apply for evaluating the Marketing Authorization Application (MAA) of axalimogene filolisbac for the treatment of metastatic cervical cancer. Advaxis is now positioned to file the complete MAA in the second half of 2017.

"EMA’s issuance of this certification is a major milestone for Advaxis," said Daniel J. O’Connor, President and CEO. "With a significant portion of the MAA now reviewed and certified, we are preparing to file the complete MAA as we work to bring this innovative immunotherapy to patients with metastatic cervical cancer who have limited treatment options."

About Axalimogene Filolisbac

Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based immunotherapy that attacks HPV-associated cancers by altering a live strain of Lm bacteria to generate cancer-fighting T cells against cancer antigens while neutralizing the tumor’s natural protections that guard the tumor microenvironment from immunologic attack. In a phase 2 trial evaluating axalimogene filolisbac for the treatment of persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC), the drug candidate showed a 12-month overall survival rate of 38 percent observed in 50 patients in the trial. This is a 52 percent improvement over the 12-month overall survival rate that was expected in the trial’s patient population based on prognostic factors.

Axalimogene filolisbac has received Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients. The immunotherapy has also received orphan drug designation in three clinical indications.

On March 23, 2017 Otsuka Pharmaceutical Co., Ltd ("Otsuka") is pleased to reported that the U.S. FDA has granted regulatory approval to Novartis for ribociclib (compound number: LEE011), on which Otsuka’s Cambridge-U.K. based subsidiary Astex and Novartis Institutes for BioMedical Research (NIBR) scientists jointly developed and optimised the chemical structure of ribociclib, which was then progressed through clinical trials by Novartis (Press release, Otsuka, MAR 23, 2017, View Source [SID1234518241]). Manufacturing and marketing approval was granted to Novartis for use of the drug as a first-line treatment in combination with an aromatase inhibitor for patients with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.

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Novartis, which developed ribociclib, will market it in the U.S. as Kisqali.

(Novartis announced the contents of this news release on March 13, 2017.)

Astex will receive from Novartis a regulatory approval milestone payment and future royalty payments based on product sales in accordance with their agreement made in 2005.

Ribociclib is a cyclin-dependent kinase inhibitor developed by Novartis Institutes for Biomedical Research in a research collaboration with Astex. This drug helps slow tumor proliferation by inhibiting two proteins (CDK4 & CDK6) which, when over-activated, can enable cancer cells to grow and divide quickly. Novartis received the regulatory approval under the US FDA Breakthrough Therapy designation and Priority Review programs.

In a clinical trial, a group treated with letrozole alone, a standard therapeutic treatment, was compared to a group treated with a combination of ribociclib and letrozole. The primary endpoint of progression-free survival (the period during which cancer does not progress and is in a stable state) was extended significantly in the group treated with the combination of ribociclib and letrozole.