On September 6, 2016 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 the National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) has awarded three grants to investigators to support research of bavituximab in combination with other therapeutics for the treatment of glioblastoma, head and neck cancer, and hepatocellular carcinoma (Press release, Peregrine Pharmaceuticals, SEP 6, 2016, View Source [SID:1234514951]).

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NCCN, a not-for-profit alliance of 27 of the world’s leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Funding for the three investigator-initiated clinical studies will take place through a $2 million research grant made by Peregrine to NCCN’s ORP. NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant. It is expected that the selected trials will be initiated in early 2017.
"NCCN is excited to initiate three studies by accomplished investigators at NCCN Member Institutions that will explore the effect of this novel immunotherapy in three different cancers with significant unmet need," said Robert C. Young, MD, Interim Vice President, NCCN ORP.
The following NCCN-affiliated researchers were recipients of the grant awards:
Jessica Frakes, MD, Moffitt Cancer Center, "A Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy (SBRT) for Unresectable Hepatitis C Associated Hepatocellular Carcinoma"

Elizabeth Gerstner, MD, Massachusetts General Hospital Cancer Center, "Phase I/II Clinical Trial of Bavituximab with Radiation and Temozolomide for Patients with Newly Diagnosed Glioblastoma"

Ranee Mehra, MD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, "Phase II Study of Pembrolizumab and Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck"
"Our collaboration with NCCN provides the unique opportunity to support the group’s highly-regarded research institutions and advance our understanding of the potential role of bavituximab in the treatment of various cancers. With this in mind, we were very pleased by the level of interest shown in bavituximab from the NCCN community and are grateful to all those who submitted their projects for rigorous evaluation by the ORP scientific review committee," said Joseph Shan, MPH, vice president, clinical and regulatory affairs of Peregrine. "We’d like to extend our congratulations to the three investigators who were selected for their unique and innovative concepts. These studies align with our development strategy for bavituximab which is currently focused on small, early stage clinical trials evaluating the drug in combination with other cancer treatments. Collaborators such as NCCN play a central role in this strategy and we look forward to integrating the valuable clinical data generated by these investigators to expand our knowledge regarding bavituximab-focused cancer treatment combinations."
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (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. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses.

O September 5, 2016 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported that the first patient has been dosed in the safety evaluation phase of a phase 2/3 combination trial of MOR208 with bendamustine (Press release, MorphoSys, SEP 5, 2016, View Source [SID:1234514927]). The B-MIND trial (Bendamustine-MOR208 IN DLBCL) will evaluate the safety and efficacy of MOR208 combined with the chemotherapeutic agent bendamustine in comparison to rituximab plus bendamustine. The randomized international study will enroll adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation. DLBCL is the most common form of non-Hodgkin’s lymphoma (NHL). Following the phase 2 safety evaluation part, the study is expected to be transitioned into a pivotal phase 3 part in 2017. The investigational drug MOR208 is an Fc-enhanced monoclonal antibody targeting CD19, and is being developed for the treatment of patients with B cell malignancies.

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"We are truly excited to begin the phase 2/3 B-MIND trial with MOR208 in DLBCL, which we aim to transition into MorphoSys’s first pivotal study with an antibody from our proprietary pipeline next year. CD19 is a potential target in B cell malignancies and, coupled with MOR208’s proprietary antibody design, we aim at developing MOR208 as a new treatment option for patients with a high unmet medical need," said Dr. Arndt Schottelius, Chief Development Officer of MorphoSys. "With the start of the B-MIND clinical trial, we now have two combination studies ongoing with MOR208 in relapsed/refractory DLBCL. We are encouraged by the results we have seen so far in patients treated with MOR208 as a single agent in our earlier clinical trials and we look forward to more data coming from our combination trials."

The randomized, double-arm, open-label, multicenter phase 2/3 B-MIND study is expected to enroll approximately 330 patients in about 180 centers in Europe, Asia Pacific (APAC) and the USA. At the time of study entry, patients must present with relapsed or refractory DLBCL, which has previously been treated with at least one and not more than three prior lines of therapy, including one anti-CD20 targeting therapy (e.g. rituximab). Patients must not be eligible for high-dose chemotherapy and autologous stem cell transplantation.

The phase 2 safety evaluation part of the study will assess the safety and tolerability of MOR208 plus bendamustine vs. the rituximab plus bendamustine combination, enrolling approximately 10 patients in each treatment arm.

Following the safety evaluation part, the trial is intended to be transitioned into the pivotal phase 3 part, expected to start in 2017. The primary endpoint of the study is progression-free survival (PFS). Secondary outcome measures will include objective response rate (ORR), duration of response (DoR), overall survival (OS), disease control rate (DCR), time to progression (TTP) as well as an evaluation of patients’ quality of life (QoL).

Detailed information on the trial can be found at clinicaltrials.gov.

About CD19
CD19 is broadly and homogeneously expressed across different B cell malignancies including DLBCL and CLL. CD19 enhances B cell receptor (BCR) signaling, which is important for B cell survival, making CD19 a potential target in B cell malignancies.

About MOR208
MOR208 (previously Xmab5574) is an Fc-enhanced monoclonal antibody targeting CD19. Fc-modification of MOR208 is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus possibly improving a key mechanism of tumor cell killing. Furthermore, MOR208 induces direct apoptosis by binding to CD19, which is a crucial component for B cell receptor (BCR) signaling.
MorphoSys AG is investigating MOR208 as an immunotherapeutic option in B cell malignancies.
Updated data, presented at the 2016 annual meetings of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper), presented the safety and efficacy results of an open-label study of MOR208 as monotherapy in 92 heavily pre-treated NHL patients (non-Hodgkin’s lymphoma). The overall response rate (ORR) in evaluable patients was 36% in the diffuse large B cell lymphoma (DLBCL) and 33% in indolent NHL (iNHL) patients. At the time of the analysis, the median duration of response (DoR) (Kaplan-Meier estimates) in DLBCL was 20 months with three ongoing responses. Median DoR was not reached in iNHL patients with 72% of responders without disease progression at 16 months. The 12-months PFS rate in DLBCL was 40% with similar PFS in both rituximab-sensitive and -refractory patients. The incidence of grade 3 or higher hematologic treatment-emergent adverse events was 26% in DLBCL and 9% in iNHL. Infusion-related reactions were seen in 9% of patients with DLBCL and iNHL, respectively. No treatment-related deaths were reported.

On September 5, 2016 Fresenius Helios reported that it has acquired IDC Salud Holding S.L.U. ("Quirónsalud"), Spain’s largest private hospital operator, for a purchase price of €5.76 billion2. Quirónsalud’s network is comprised of 43 hospitals, 39 outpatient centers and around 300 Occupational Risk Prevention ("ORP") centers located in all economically important areas in Spain (Press release, Fresenius, SEP 5, 2016, View Source [SID:1234514925]). The company has about 35,000 employees and offers the full spectrum of inpatient and outpatient care. Quirónsalud was created by the merger of IDC Salud ("IDC") and Grupo Hospitalario Quirón ("GHQ") in 2014.

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Quirónsalud has posted organic sales growth of more than 5% p.a. in recent years. Growth is driven by an above-market increase of patient admissions due to excellent quality of care combined with consistently short waiting times.

Quirónsalud is also a pioneer in public-private partnership ("PPP") models, operating five hospitals (four in Madrid and one in Barcelona) that are integrated within the public healthcare network. Under the PPP agreements, Quirónsalud is assigned responsibility for the publicly insured inhabitants of certain coverage areas and receives remuneration based on capitation or activity performed.

Greenfield hospital projects and acquisitions have also contributed to Quirónsalud’s overall strong sales growth. Going forward, cross-selling between the recently acquired ORPs and Quirónsalud’s hospitals are expected to be yet another growth driver.
For 2016, Quirónsalud expects sales of approximately €2.5 billion and EBITDA of €460 to €480 million. In 2017, EBITDA is expected to be in the range of €520 to €550 million. The purchase price corresponds to approximately 10.8x at the mid-point of the 2017 EBITDA range.

Key drivers of the anticipated EBITDA growth are already implemented synergy projects related to the 2014 merger of IDC and GHQ, recent acquisitions, well-advanced efficiency projects as well as operating leverage. Neither greenfield projects, further acquisitions nor synergies with HELIOS are included in the 2017 projections. In the medium-term, the merger of HELIOS and Quirónsalud is expected to lead to incremental pre-tax synergies of approximately €50 million p.a. without meaningful implementation expenses.

Stephan Sturm, CEO of Fresenius, said: "This acquisition combines two leaders in terms of quality and size. Our patients will benefit from the exchange of knowledge and ideas. For Fresenius, this acquisition is another strategic step towards offering quality and yet affordable care for patients worldwide."

Francesco De Meo, CEO of Fresenius Helios, said: "We are acquiring the largest private hospital operator in Spain, Europe’s number four. Quirónsalud has shown an impressive development and stands for best-in-class quality in patient care. Quirónsalud and HELIOS perfectly fit together as we can leverage on each other’s experience and knowledge. The new group will preserve both brands, Quirónsalud in Spain and Helios in Germany. I am particularly delighted that Víctor Madera will, beyond his ongoing role as CEO of Quirónsalud, play a very active role in our combined group. We aim to achieve the best for our patients in Germany and Spain, and, together with our Spanish partners, intend to leave a mark in the European health care system."

Víctor Madera, founder and CEO of Quirónsalud, said: "I am extremely pleased to join such a splendid organization as HELIOS and very much look forward to a fruitful cooperation with Francesco De Meo. I am firmly convinced that HELIOS and Quirónsalud are ideal partners to achieve the best care for our patients in both Germany and Spain."

Fresenius Helios acquires 100% of the share capital in Quirónsalud. Sellers are the private equity group CVC Capital Partners, Víctor Madera and other members of Quirónsalud’s management board.

Fresenius will issue 6,108,176 shares valued at €400 million to Víctor Madera who has agreed to a two year lock-up period. The balance of the purchase price will be debt-financed.

Group net debt/EBITDA will temporarily increase to approximately 3.1. Already in mid-2017, the leverage ratio is expected to return to the 2.5 to 3.0 target range.

The transaction is subject to regulatory approval by the relevant antitrust authorities and is expected to close in Q4/2016 or Q1/2017.

The transaction is expected to be highly accretive to Group net income3 and EPS3 already in 2017.

Given the expected meaningful accretion to Group sales and earnings, Fresenius will publish new mid-term targets as part of its full-year 2016 reporting.

On September 2, 2016 LeadArtis reported its participation as coordinator of the IBIMAB project (Cancer immunotherapy with bispecific costimulatory antibodies) funded by the Spanish Ministry of Economy and Competitiveness (MINECO) under the RETOS 2016 Collaboration program (Press release, LeadArtis, SEP 2, 2016, View Source [SID:SID1234515139]). IBIMAB counts with collaborators such as the internationally regarded research institutions: Centro de Investigación Médica Aplicada-CIMA (Pamplona, Spain), Hospital Universitario Puerta de Hierro-HUPH (Madrid, Spain) and Instituto de investigaciones biomédicas Alberto Sols-IIBm-CSIC (Madrid, Spain). The MINECO’s funding demonstrates the support of LeadArtis technology and main objectives.

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Some of the most effective cancer immunotherapy strategies are based on the modulation of molecular interactions dubbed immune check-points using monoclonal antibodies (mAbs). LeadArtis generates bispecific hexavalent trimerbodies (BHTs) exploiting the expression of two cell surface antigens, one a costimulatory molecule on the T cells and the other a tumor-associated antigen (TAA) on the tumor cells. The anti-TAA specificity allows efficient location of the BHT into the tumor deposits, providing a more efficient interaction with the costimulatory antigen expressed on the surface of tumor infiltrating T lymphocytes. Our company focuses on two clinically validated mechanisms of action synergistic when combining individual mAbs (IgG type). LeadArtis will use its proprietary trimerbody technology to generate a fully human bispecific hexavalent antibody as candidate for development.

LeadArtis is the leading company aiming to bring to the market cancer immunotherapeutic trimerbodies. Despite recent advances in the field, most of the current initiatives are early stage and exploratory. Currently, most of current immune-checkpoint blockers in development are conventional monoclonal antibodies (mAbs); comparatively, recombinant antibody technologies are strongly positioned and shortly will become preferred for clinically validated mechanisms of action. The trimerbody added value is multivalence and multispecificity, small size & ease of manufacturing to generate more effective compounds.