On June 1, 2015 Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM) (Nasdaq:PPHMP), provided a corporate update on its immuno-oncology pipeline, its wholly-owned contract manufacturing business, Avid Bioservices, as well as anticipated upcoming milestones. This update outlines the expansion of the bavituximab clinical pipeline with a focus on exploring expanded indications and combinations in lung and breast cancers (Press release, Peregrine Pharmaceuticals, JUN 1, 2015, View Source [SID:1234505178]). These new trials build on recently published clinical data of bavituximab in combination with paclitaxel in HER2 negative breast cancer and clinical translational and preclinical data presented at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting that support the potential combination of bavituximab with the anti-PD-1 checkpoint inhibitor, nivolumab (marketed as Opdivo). These clinical trials are expected to begin enrollment later this year.

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"With many exciting near-term opportunities for Peregrine and Avid, we are pleased to share several strategic decisions aimed at expanding the potential clinical indications for bavituximab. These new trials represent large market opportunities for the bavituximab clinical program that can add significant value," said Steven King, president and chief executive officer of Peregrine. "As we near completion of enrollment in the SUNRISE pivotal Phase III trial by year-end, we are looking to expand bavituximab’s market potential and market position in key indications that are supported by strong clinical, translational, and preclinical data. Taken together with the research collaboration we announced last week, we believe we are setting the stage for many significant value driving events throughout 2015 and into 2016."

SUNRISE Phase III Pivotal Trial

The company’s Phase III SUNRISE (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study) is an approximately 600 patient trial that continues to enroll at over 150 sites worldwide. Completion of enrollment is anticipated by calendar year-end. This Phase III, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety, tolerability and efficacy of bavituximab as a second-line treatment in patients with non-squamous, non-small cell lung cancer (NSCLC). Enrollment is proceeding according to plan with two planned interim efficacy analyses which will be reviewed by the trial’s Independent Data Monitoring Committee (IDMC). The first interim analysis, which will be conducted when 33% of the targeted overall survival events are reached, is for futility and the second interim analysis, for futility or superiority, will be conducted at 50% of events. As these analyses are event driven, the exact timing of each is unknown, however the company plans to provide updates as these events are reached. For additional information about the SUNRISE trial, please visit www.sunrisetrial.com or ClinicalTrials.gov using the Identifier NCT01999673.

Beyond SUNRISE: Exploring Checkpoint Inhibitor Combinations in Lung Cancer

Joe Shan said: "Following recent encouraging preclinical data supporting the combination of bavituximab with immune checkpoint inhibitors, today we are supplementing our strategy in lung cancer with the second clinical trial to emerge from our Immuno-Oncology Development Program, a combination trial of bavituximab with nivolumab, an immune checkpoint inhibitor of PD-1. Specifically, recent preclinical data show that the addition of bavituximab could result in turning patients that do not respond to monotherapy into patient responders. This supports our long held knowledge of the synergistic properties of the combination of bavituximab and chemotherapies, thus making this new trial the next logical step."

The company plans to initiate an open-label multi-center, randomized Phase II trial of the anti-PD-1 monoclonal antibody nivolumab (marketed as Opdivo) versus nivolumab plus bavituximab in patients with previously treated locally advanced or metastatic NSCLC. Enrollment will include patients with squamous and non-squamous NSCLC who have not received a prior PD-L1 or PD-1 inhibitor. The primary endpoint of this trial will be overall response rate (ORR) with secondary endpoints including tumor response and duration, progression free survival, overall survival (OS) and safety. The trial is in the final stages of design and the details of which will be made available once details are completed. Trial initiation is anticipated in the second half of 2015.

Leveraging Positive Data in Breast Cancer

"Today we are pleased to be detailing our strategy in breast cancer which is built upon very promising data which were recently published in the peer-reviewed journal Cancer Medicine," said Joseph Shan, vice president of clinical and regulatory affairs at Peregrine Pharmaceuticals. "The clinical development pathway that we are outlining today is based upon the strong clinical experience that supports synergies between bavituximab and docetaxel and paclitaxel, our deep and consistently positive clinical experience in breast cancer to date, as well as the support of leading breast cancer physicians."

The company plans to initiate a Phase II/III open-label trial of physician’s choice of either docetaxel or paclitaxel with or without bavituximab in patients with locally advanced or metastatic HER2 negative breast cancer. The primary endpoint for the Phase II trial will be ORR. Results from this trial are expected to inform decisions on future studies in breast cancer and add value to the overall program. The initiation of this trial is anticipated in the second half of 2015.

Fiscal Year End Cash Position

Peregrine today reported $68 million in cash and cash equivalents, as of fiscal year ended April 30, 2015. The company will review full financial results for the fourth quarter and fiscal year 2015 during its quarterly call on Tuesday, July 14, 2015 after the close of markets, details of which will be included in a forthcoming press release.

Avid Bioservices’ Expansion on Track and Strongly Positioned to Meet Increased Client Demand

In December 2014, the company announced the expansion of Avid’s Current Good Manufacturing Practice (cGMP) current manufacturing capacity with a build out that is utilizing an existing 40,000 square foot facility located adjacent to the company’s current campus. Designed to more than double Avid’s current manufacturing capacity, this state-of-the-art biotechnology facility will employ an innovative and flexible modular clean room design and the latest in single-use technologies to meet the growing needs of Avid’s existing and future clients as well as the planned commercialization of bavituximab. Avid’s new facility is anticipated to be ready for cGMP production of biotechnology products in July 2015.

Added Steve King: "We are very pleased with the rapid progress by which this expansion is advancing as this is a key component to further demonstrating Avid as a leading provider of high quality biotechnology contract manufacturing services. The design and the features that we have employed in this expansion will truly be an integral part to the future growth of this unique part of our business. We look forward to sharing specific details on the expansion upon its formal unveiling later this year."

On June 1, 2015 Baxter Ventures, the Mayo Clinic and Velocity Pharmaceutical Development reported the formation of Vitesse Biologics, LLC, ("Vitesse") (Press release, Baxter International, JUN 1, 2015, View Source [SID:1234505234]). Vitesse is a unique collaboration model initiated by Baxter Ventures to focus on the development of antibody and protein-based therapeutics in the areas of immunology, hematology, and oncology. Following the spin-off of Baxter BioScience as Baxalta Incorporated, anticipated to take place by mid-2015, the Vitesse relationship will be managed by the planned venture arm, Baxalta Ventures, for the new company.

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The collaboration model, which represents a new method of drug development, was designed to incent each partner to advance promising therapies quickly through the development process. Each partner will provide its recognized expertise to enhance the target selection, target optimization, expression and product development process. Baxter BioScience will provide global commercialization, antibody and protein development and manufacturing capabilities; Mayo Clinic researchers will execute the Phase I clinical trials; VPD will be responsible for target identification, selection of early stage drug candidates and will lead the design and execution of pre-clinical and clinical protocols.

"Delivering innovative treatments to address unmet patient needs is at the very core of everything we do and drives our ongoing R&D focus," said Ludwig N. Hantson, Ph.D., president of Baxter BioScience. "By creating Vitesse, our business is executing on a new concept in early stage R&D by leveraging the expertise of industry-leading partners to accelerate the identification and development of novel biologic treatments that could eventually contribute to unmet patient needs while enhancing the Baxalta commercial portfolio."

Vitesse will develop treatments in the fields of hematology, oncology and immunology, which aligns strongly with Baxter BioScience’s therapeutic focus. This innovative model enables Baxter to serve as a hands-on partner in the pursuit of innovative treatments, as Baxter BioScience will be involved in the early-stages of development for all products identified by Vitesse and has an exclusive option to acquire each such product following the completion of the applicable Phase I trials.

"We are excited about the possibilities for this new collaboration, and particularly for this new model for early stage drug development," said Greg Gores, M.D., executive dean for research at Mayo Clinic. "Our goal is to identify new, useful therapeutics to address the unmet needs of our patients."

David Collier, M.D., CEO of VPD, said, "We are fortunate to have world-class partners in this project. We believe that the combination of the development and manufacturing expertise offered by Baxter BioScience and the clinical capabilities of the Mayo Clinic, working in conjunction with our team at VPD, will produce a series of very promising new therapeutics developed in a more rapid and cost-efficient manner."

With research as a key priority of the Destination Medical Center (DMC) initiative, Mayo Clinic is building upon the clinical and research infrastructure further accelerating Mayo Clinic’s ability to conduct some of the most important medical research, eventually to translate these discoveries into therapies for patients from across the globe.

On June 1, 2015 BioInvent International (OMXS: BINV) reported a three-year research collaboration with the University of Southampton (UoS), one of the world’s leading antibody research groups, under the direction of Professor Mark Cragg, BSc, PhD, Professor of Experimental Cancer Research and Director of the Cancer Pathway Integrated Postgraduate Programme (Press release, BioInvent, JUN 1, 2015, http://www.bioinvent.com/media-centre/press-releases/release/?ReleaseID=0E5DCBBC28836A0F [SID:1234506557]).

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The collaboration, also involving Professor Martin Glennie and Dr Stephen Beers is aimed at developing new immunotherapy treatments for cancer by targeting regulatory T cells (T regs). The program builds on the clinical successes of antibodies to so called T cell checkpoint inhibitors. The collaboration aims to develop novel antibodies and targets that are more specific for the cancer-associated T regs.

This collaboration is separate from two existing research programs in place between the University of Southampton and BioInvent.

Terms of the collaboration are not disclosed, noting that BioInvent will have the option to license any promising results for further development and commercialization. Under the agreement, both parties will contribute to intellectual property generation.

BioInvent has the capacity, through the F.I.R.S.T. platform, to generate a large number of T cell depleting antibodies. UoS has unique capabilities to test and evaluate potential lead candidates in several advanced in vitro and in vivo models. The collaboration between BioInvent and UoS around n-CoDeR antibodies targeting human T regs for cancer therapy utilizes the strengths from both groups.

Professor Cragg commented, "We look forward to building on the strength of our collaborative relationship with BioInvent, which should allow us to remain at the cutting edge of antibody immunotherapy for the benefit of cancer patients worldwide. Both clinical and preclinical data suggests that depletion of T regs can result in efficient anti-tumor T cell responses and tumor eradication. However, current T cell targeting therapeutic antibodies and checkpoint inhibitors were developed based on their abilities to block inhibitory signals. Novel, as yet unidentified targets with broad expression on regulatory T cells in different cancers, such as melanoma, lung cancer etc. and antibody formats with superior T reg depleting activity may have greater activity. We look forward to working with BioInvent’s extensive antibody library and its novel targeting platform to establish several lead candidates for clinical development in this very important area of cancer research."

"We are especially pleased to be undertaking this additional research collaboration with the team at the University of Southampton. This esteemed research center and its renowned clinicians are experts in the fields of immunology and oncology and are at the forefront of unlocking the potential of therapeutic antibodies," said Björn Frendéus, PhD, Chief Scientific Officer of BioInvent and honorary Professor at the University of Southampton. "BioInvent’s phenotypic target and mAb discovery platform, F.I.R.S.T., are ideally suited to identify a great diversity of human mAb with cancer T reg depleting or modulating activity. In collaboration with our colleagues in Southampton, we aim to generate more efficacious and safer immune modulatory antibodies for cancer treatments."

On June 1, 2015 Baxter Ventures, the venture arm of Baxter International Inc. (NYSE:BAX), the Mayo Clinic and Velocity Pharmaceutical Development, LLC ("VPD") reported the formation of Vitesse Biologics, LLC, ("Vitesse") (Press release, Velocity Pharmaceutical Development, JUN 1, 2015, View Source [SID:1234506532]). Vitesse is a unique collaboration model initiated by Baxter Ventures to focus on the development of antibody and protein-based therapeutics in the areas of immunology, hematology, and oncology. Following the spin-off of Baxter BioScience as Baxalta Incorporated, anticipated to take place by mid-2015, the Vitesse relationship will be managed by the planned venture arm, Baxalta Ventures, for the new company.

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The collaboration model, which represents a new method of drug development, was designed to incent each partner to advance promising therapies quickly through the development process. Each partner will provide its recognized expertise to enhance the target selection, target optimization, expression and product development process. Baxter BioScience will provide global commercialization, antibody and protein development and manufacturing capabilities; Mayo Clinic researchers will execute the Phase I clinical trials; VPD will be responsible for target identification, selection of early stage drug candidates and will lead the design and execution of pre-clinical and clinical protocols.

"Delivering innovative treatments to address unmet patient needs is at the very core of everything we do and drives our ongoing R&D focus," said Ludwig N. Hantson, Ph.D., president of Baxter BioScience. "By creating Vitesse, our business is executing on a new concept in early stage R&D by leveraging the expertise of industry-leading partners to accelerate the identification and development of novel biologic treatments that could eventually contribute to unmet patient needs while enhancing the Baxalta commercial portfolio."

Vitesse will develop treatments in the fields of hematology, oncology and immunology, which aligns strongly with Baxter BioScience’s therapeutic focus. This innovative model enables Baxter to serve as a hands-on partner in the pursuit of innovative treatments, as Baxter BioScience will be involved in the early-stages of development for all products identified by Vitesse and has an exclusive option to acquire each such product following the completion of the applicable Phase I trials.

"We are excited about the possibilities for this new collaboration, and particularly for this new model for early stage drug development," said Greg Gores, M.D., executive dean for research at Mayo Clinic. "Our goal is to identify new, useful therapeutics to address the unmet needs of our patients."

David Collier, M.D., CEO of VPD, said, "We are fortunate to have world-class partners in this project. We believe that the combination of the development and manufacturing expertise offered by Baxter BioScience and the clinical capabilities of the Mayo Clinic, working in conjunction with our team at VPD, will produce a series of very promising new therapeutics developed in a more rapid and cost-efficient manner."

With research as a key priority of the Destination Medical Center (DMC) initiative, Mayo Clinic is building upon the clinical and research infrastructure further accelerating Mayo Clinic’s ability to conduct some of the most important medical research, eventually to translate these discoveries into therapies for patients from across the globe.

ABOUT VITESSE BIOLOGICS, LLC Vitesse Biologics, LLC, a Delaware Corporation based in South San Francisco, CA, develops antibody and protein-based therapeutics in the areas of immunology, hematology, and oncology.

On June 1, 2015 Janssen Research & Development reported data from the Phase 3 multicenter study SAR3007, which demonstrated a significant improvement in progression-free survival (PFS) with trabectedin (YONDELIS) compared to dacarbazine in patients with advanced liposarcoma (LPS) or leiomyosarcoma (LMS) previously treated with an anthracycline and at least one additional chemotherapy regimen (Press release, Johnson & Johnson, JUN 1, 2015, View Source [SID:1234505209]). SAR3007 is the largest randomized Phase 3 study ever conducted in this patient population. These data were presented today in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL.

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Soft tissue sarcoma (STS) is a type of cancer originating in the soft tissues that connect, support and surround other body structures, such as muscle, fat, blood vessels, nerves, tendons and the lining of joints.[1],[2] LPS and LMS are among the most common types of STS in adults and represent approximately 40-50% of all STS cases.[3],[4]

"Advanced soft tissue sarcomas represent a complex set of rare diseases which, when advanced, are life threatening. Our patients need new treatment options that are effective and reasonably well tolerated, as the treatment landscape has been relatively stagnant for decades," said George Demetri, M.D., Director, Center for Sarcoma and Bone Oncology at the Dana-Farber Cancer Institute and Professor at Harvard Medical School. "In soft tissue sarcomas, disease stabilization is an important metric for evaluating treatment success in patients with advanced disease. The safety data from this trial were consistent with the well-defined adverse events observed in previous clinical trials of trabectedin and in clinical use outside the United States where trabectedin has been approved to treat these aggressive diseases."

Trabectedin is approved in 77 countries in North America, Europe, South America and Asia under the trade name YONDELIS for the treatment of advanced STS as a single agent. Janssen submitted a New Drug Application for YONDELISto the U.S. Food and Drug Administration on November 24, 2014, which was granted Priority Review on February 3, 2015.

"The data presented at ASCO (Free ASCO Whitepaper) underscore the value of trabectedin as a potentially important treatment option for patients with LPS and LMS subtypes of soft tissue sarcoma," said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Oncology, Janssen. "This latest research underlines our long-standing commitment to patients with advanced soft tissue sarcoma. To date, more than 50,000 patients worldwide have been treated with YONDELIS, including approximately 3,000 patients in our Expanded Access Program in the United States."

In this randomized, active-controlled Phase 3 study in patients with advanced LPS or LMS, trabectedin significantly reduced the risk of disease progression or death by 45% compared with those who received dacarbazine (hazard ratio [HR] = 0.550; P< 0.0001; median [M] 4.2 vs. 1.5 months, respectively), with results validated through an audit by independent radiologists. The improved PFS benefit with trabectedin treatment was consistently observed across all clinically relevant subgroups and was further supported by an increased objective response rate (ORR), a longer duration of response (DOR), and a higher clinical benefit response rate as compared to dacarbazine. At the interim analysis for overall survival (OS), the trial had not met the primary endpoint of OS. The study is ongoing to determine the final OS results, which will be presented at a future meeting. The results for the secondary efficacy endpoints are mature.

Safety findings were consistent with the well-characterized safety profiles of both agents, with the most common Grade 3-4 toxicities in the trabectedin versus the dacarbazine groups being decreased absolute neutrophil count (40% vs. 25%), decreased platelets (19% vs. 20%), and transient increases in liver transaminases, including alanine transaminase (ALT) (29% vs. 1%). Drug-related deaths occurred in 2.1% of patients in the trabectedin group versus 0% of patients in the dacarbazine group.

About SAR3007

The Phase 3 multicenter study SAR3007 compared trabectedin with dacarbazine in patients with advanced LPS or LMS previously treated with an anthracycline and at least one additional chemotherapy regimen. The primary endpoint is OS and secondary endpoints included PFS, time to progression (TTP), ORR, DOR, symptom severity and safety. Both treatments were administered via an IV infusion every three weeks with the trabectedin dose of 1.5 mg/m2 given over 24 hours versus dacarbazine dose of 1 g/m2 given over 20-120 minutes. Ninety-four percent of study participants were in the United States.

About Soft Tissue Sarcoma

Soft tissue sarcoma is a type of cancer originating in the soft tissues that connect, support and surround other body structures, such as muscle, fat, blood vessels, nerves, tendons and the lining of joints.1,2 In the United States, nearly 12,000 people will be diagnosed and approximately 4,870 are expected to die of soft tissue sarcomas in 2015.[5] Leiomyosarcoma is an aggressive type of soft tissue sarcoma that occurs in smooth muscles, such as those in the uterus, gastrointestinal tract or lining of blood vessels.[6] Liposarcoma originates in fat cells and most commonly occurs in the thigh and abdominal cavity, though it can occur in fat cells in any part of the body.[7],[8]

About YONDELIS (trabectedin)
YONDELIS (trabectedin) is a novel, multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The anti-cancer medicine works by preventing the tumor cells from multiplying and is approved in 77 countries in North America, Europe, South America and Asia for the treatment of advanced soft tissue sarcoma as a single agent, and in 70 countries for relapsed ovarian cancer in combination with DOXIL/CAELYX (doxorubicin HCl liposome injection).

Under a licensing agreement with PharmaMar, a wholly owned member of the Zeltia Group, Janssen Products, LP has the rights to develop and sell YONDELIS globally except in Europe, where PharmaMar SA holds the rights, and in Japan, where PharmaMar has granted a license to Taiho Pharmaceuticals Co., Ltd. If approved in the United States, YONDELIS would be commercialized by Janssen Biotech, Inc.