On 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:1234514926]). 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. Schedule your 30 min Free 1stOncology Demo! "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."
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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.
LeadArtis leads the cancer immunotherapy with bispecific costimulatory antibodies (IBIMAB) project
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.
CEL-SCI Reports Monthly Patient Enrollment in August for Its Phase 3 Head and Neck Cancer Trial
On September 2, 2016 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported that during the month of August it has enrolled 28 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer (Press release, Cel-Sci, SEP 2, 2016, View Source [SID:1234514890]). Total patient enrollment for the trial is now 905 as of August 31, 2016.
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The Multikine Phase 3 study is enrolling patients with advanced primary (not yet treated) squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only.
About Multikine
Multikine is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line (before any other, right after diagnosis) treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.
Multikine is also being tested in a Phase 1 study at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. Dr. Joel Palefsky, a world-renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, is the Principal Investigator at UCSF.
International Journal of Cancer Publishes Data Showing Tumor Treating Fields in Combination with Paclitaxel is Therapeutically Effective against Ovarian Cancer Cells in Vitro and in Vivo
On September 1, 2016 Novocure (NASDAQ: NVCR) reported that data showing Tumor Treating Fields (TTFields) in combination with paclitaxel is therapeutically effective against ovarian cancer cells in vitro and in vivo has been published by the International Journal of Cancer (Press release, NovoCure, SEP 1, 2016, View Source [SID:1234514873]). This Novocure preclinical research is the first to demonstrate that TTFields in combination with paclitaxel may be a potentially effective strategy for the treatment of ovarian cancer.
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In vitro application of TTFields alone to human ovarian cancer cell lines led to significant reductions in cell counts compared to untreated cells. TTFields treatment combined with paclitaxel resulted in additive and even synergistic efficacy depending on the ovarian cell line treated. In vivo, TTFields plus paclitaxel led to a significantly larger anti-tumor effect than either treatment alone.
Novocure also examined the feasibility of local delivery of TTFields to the human abdomen using finite element mesh simulations, a commonly used technique for calculating electric field distribution in complex geometries like the human body. These simulations demonstrated that electric fields intensities inside and in the vicinity of the ovaries are within the range of intensities required for effective treatment with TTFields.
"Treatment with TTFields is broadly applicable and has shown a consistent antimitotic effect in our preclinical and clinical research over the last 16 years," said Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. "Novocure is committed to increasing the understanding of the mechanisms of action and potential clinical utility of TTFields in multiple solid tumors through the presentation and peer-reviewed publication of high quality data."
Based on these preclinical results, Novocure initiated the INNOVATE trial, an open-label, phase 2 pilot study of TTFields in combination with weekly paclitaxel for the treatment of recurrent ovarian cancer. The INNOVATE trial is fully enrolled, and Novocure expects to share data at its research and development day on Monday, Dec. 12, 2016.
About Ovarian Cancer
Ovarian cancer is the fifth most common cause of cancer death in women in the United States. The National Cancer Institute estimated that in 2015, there were approximately 21,000 new cases of ovarian cancer diagnosed and approximately 14,000 deaths in the United States. Ovarian cancer incidence increases with age, and the median age at time of diagnosis is 63 years old. The five-year survival rate is 44 percent, and the majority of patients present at advanced stage with 60 percent having metastatic disease. TTFields therapy is not approved for the treatment of ovarian cancer by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields therapy for ovarian cancer has not been established.
PharmaCyte Biotech Reports on Progress in Its Medical Cannabis Program
On September 1, 2016 PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported an update on its program for developing treatments for serious brain cancers that involve constituents of the Cannabis plant. These Cannabis-based cancer therapies, like PharmaCyte’s pancreatic cancer therapy, will involve the use of its Cell-in-a-Box technology. The cancer "prodrug" that will be activated (converted to their cancer-killing forms) by the cells inside the Cell-in-a-Box capsules are constituents of the Cannabis plant known as cannabinoids. PharmaCyte has contracted with the University of Northern Colorado (UNCO), led by Dr. Richard M. Hyslop, to conduct the research related to PharmaCyte’s medical Cannabis program. UNCO has obtained all of the necessary approvals and has now received research Cannabis to enable it to advance PharmaCyte’s program.
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The Chief Executive Officer of PharmaCyte, Kenneth L. Waggoner, commented on the progress being made by UNCO, "Obtaining permission to perform Cannabis-related research has been a rigorous and time-consuming process. First, a detailed research plan had to be submitted to, and approved by, the U.S. Drug Enforcement Agency (DEA) before a Schedule 1 license could be issued. Then the research plan and a request for Cannabis plant material had to be submitted to the National Institute on Drug Abuse (NIDA), the only federally approved source of Cannabis, which is grown at a facility at the University of Mississippi. Only after NIDA approved the research plan was Cannabis for research issued to UNCO. Now that all of these governmental approvals have been obtained and UNCO has received the research Cannabis, we are finally able to build upon the firm foundation that had been laid in our quest to develop targeted cannabinoid cancer chemotherapies that utilize the Cell-in-a-Box technology."
The process being used to develop cannabinoid-based treatments involves three basic steps. First, suitable cannabinoid prodrugs or their precursors that are safe and possess few, if any, side effects must be identified. Second, a unique human cell line that manufactures an enzyme that "activates" the cannabinoid prodrug must be developed. This involves identification of the specific gene that encodes for the production of the enzyme and then "transfecting" or inserting the gene into human cells as was done for PharmaCyte’s pancreatic cancer therapy. Third, the engineered cells must be encapsulated utilizing the Cell-in-a-Box technology. The product will then be ready for testing in various cancer cell lines, animal models and ultimately humans.
UNCO researchers have developed and standardized systems and protocols for isolating and utilizing "model" cannabinoid compounds. Further, various types of cells have been cultured and then screened for the appropriate prodrug-activating enzymatic activity, some "target" genes have been amplified, and preliminary dosing and pharmacokinetic studies have been performed. Current and future research is focused on: (i) the synthesis and amplification of specific genes that produce the cannabinoid prodrug-activating enzymes; (ii) transfection of human cells with these genes; and (iii) testing of the ability of these transfected cells to activate cannabinoid prodrugs. Candidates for cannabinoid prodrugs to be studied include the "acidic" forms of the cannabinoids cannabidiol (CBDA) and tetrahydrocannabinol (THCA).