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Myriad Genetics and BeiGene Sign Agreement to Develop Companion Diagnostics for Use with BeiGene’s Novel PARP Inhibitor, BGB-290

On April 6, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that it has entered into a companion diagnostic development collaboration with BeiGene, a clinical-stage biopharmaceutical company developing molecularly-targeted and immuno-oncology drugs for the treatment of cancer, to accelerate precision medicine in oncology (Press release, Myriad Genetics, APR 6, 2017, View Source [SID1234518501]).

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Under the agreement, BeiGene will use Myriad’s myChoice HRD and BRACAnalysis CDx companion diagnostic tests to support the clinical development of its novel PARP inhibitor, BGB-290. Specific terms of the deal were not disclosed.

"We are excited to collaborate with BeiGene to help identify patients who stand to benefit the most from treatment with BGB-290," said Mark C. Capone, president and CEO, Myriad Genetics. "As the pioneer in companion diagnostics for PARP inhibitors, we recognize that precision medicine only can be achieved by molecularly matching patients to the right therapy. Together with BeiGene, we are in a unique position to integrate advanced genetic information into clinical practice and achieve better patient outcomes."

About BRACAnalysis CDx
BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens.

About myChoice HRD
Myriad’s myChoice HRD is the first homologous recombination deficiency test that can detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. It is estimated that 1.8 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents.

Kite Wins ‘Clinical Trial Result of the Year’ for its Pivotal CAR-T Trial of Axicabtagene Ciloleucel in Patients with Aggressive Non-Hodgkin Lymphoma at the 2017 Clinical and Research Excellence Awards

On April 6, 2017 Kite Pharma, Inc., (Nasdaq:KITE) reported that it won the Clinical Trial Result of the Year award for ZUMA-1, its pivotal CAR-T trial of axicabtagene ciloleucel, in patients with refractory aggressive B-cell non-Hodgkin lymphoma (NHL) at the Clinical and Research Excellence (CARE) Awards (Press release, Kite Pharma, APR 6, 2017, View Source [SID1234518500]). The award recognizes clinical achievements in the pharmaceutical industry and contribution to the advancement of therapies for unmet medical needs.

"This award is an important acknowledgement of the ZUMA-1 trial, the first multicenter CAR-T therapy trial in aggressive NHL, and the potential of CAR-T therapy to significantly transform the treatment of cancer," said Arie Belldegrun, M.D., FACS, Chairman, President and Chief Executive Officer of Kite. "We thank the Kite research and development team for their dedication and congratulate them on this well-deserved recognition for their central role in advancing the development of this potentially paradigm changing treatment."

The study met the primary endpoint of objective response rate (ORR) recorded after a single infusion of axicabtagene ciloleucel with 82 percent (p < 0.0001). At a median follow-up of 8.7 months, 44 percent of patients were in ongoing response, which included 39 percent of patients in complete response (CR). These results from 101 patients demonstrate the treatment effect of axicabtagene ciloleucel in diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL), which are types of aggressive NHL.

The most common grade 3 or higher adverse events included anemia (43 percent), neutropenia (39 percent), decreased neutrophil count (32 percent), febrile neutropenia (31 percent), decreased white blood cell count (29 percent), thrombocytopenia (24 percent), encephalopathy (21 percent) and decreased lymphocyte count (20 percent). As compared to the interim analysis, grade 3 or higher cytokine release syndrome (CRS) decreased from 18 percent to 13 percent and neurologic events decreased from 34 percent to 28 percent. There were three deaths throughout the course of the trial not due to disease progression, of which two events, were deemed related to axicabtagene ciloleucel. There were no cases of cerebral edema.

Full data from the primary analysis of ZUMA-1 were most recently presented at the 2017 American Association of Cancer Research Annual Meeting in Washington, D.C. in April. In December 2015, axicabtagene ciloleucel received Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for DLBCL, TFL, and PMBCL. Kite completed its submission of a Biologics License Application (BLA) for axicabtagene ciloleucel with the FDA in March 2017 and, if approved, plans to commercially launch axicabtagene ciloleucel in 2017.

The awards, presented by Informa’s Pharma Intelligence, were announced at a ceremony in Boston on April 5, 2017.

ZUMA-1 is supported in part by funding from The Leukemia & Lymphoma Society (LLS) Therapy Acceleration Program.

About axicabtagene ciloleucel

Kite’s lead product candidate, axicabtagene ciloleucel, is an investigational therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. Axicabtagene ciloleucel has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.

Acceleron Announces Clinical Presentations on Luspatercept at the 14th International Symposium on Myelodysplastic Syndromes

On Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics to treat serious and rare diseases, reported that two abstracts on luspatercept have been accepted for presentation at the 14th International Symposium on Myelodysplastic Syndromes (MDS) in Valencia, Spain on May 3-6, 2017 (Press release, Acceleron Pharma, APR 6, 2017, View Source [SID1234518497]).

The oral presentation will include data from a Phase 2 study with luspatercept in lower-risk MDS populations, including first-line ring sideroblast-negative and -positive subpopulations. Luspatercept is being developed under a global partnership with Celgene.

Oral presentation

Title:
Luspatercept Response in New Subpopulations of Patients with Lower-Risk Myelodysplastic Syndromes (MDS): Update of the PACE Study (Abstract #17-0245)
Session: Oral Session 3 (Valencia Conference Center, Auditorium 1)
Date: Saturday, May 6th
Time:
9:15 a.m. CEST
Poster presentation

Title:
Pharmacokinetics and Exposure-Response Relationship of Luspatercept in Patients with Anemia Due to Lower-Risk MDS: Preliminary Results from Phase 2 Studies (Abstract #17-0112)
Session: 637. Myelodysplastic Syndromes – Clinical Studies: Poster I (Valencia Conference Center)
Date: Thursday, May 4th to Saturday, May 6th
The luspatercept clinical poster and slides from the oral presentation will be available immediately following the presentations at the conference in the "Science" section on Acceleron’s website, www.acceleronpharma.com.

About Luspatercept

Luspatercept is a modified activin receptor type IIB fusion protein that acts as a ligand trap for members in the Transforming Growth Factor-Beta (TGF-beta) superfamily involved in the late stages of erythropoiesis (red blood cell production). Luspatercept regulates late-stage erythrocyte (red blood cell) precursor cell differentiation and maturation. This mechanism of action is distinct from that of erythropoietin (EPO), which stimulates the proliferation of early-stage erythrocyte precursor cells. Acceleron and Celgene are jointly developing luspatercept as part of a global collaboration. Phase 3 clinical trials are underway to evaluate the safety and efficacy of luspatercept in patients with myelodysplastic syndromes (the "MEDALIST" study) and in patients with beta-thalassemia (the "BELIEVE" study). For more information, please visit www.clinicaltrials.gov.

Indian FDA Approves the First Autologous Dendritic Cell-based Immuno-oncology Product, APCEDEN®

On April 5, 2017 APAC Biotech, reported that it was granted with a commercial license by Indian FDA (CDSCO – Central Drugs Standard Control Organization) to market product, APCEDEN, a Dendritic cell-based autologous Immuno-oncology product for four cancer indication namely Prostate, Ovarian, Colo-rectal and Non Small Cell Lung carcinoma (Press release, APAC Biotech, APR 5, 2017, View Source [SID1234562370]).

The Indian Food and Drug Administration authorities, after their stringent review of the application, have issued the commercial license (Form 46) to conduct a post marketing surveillance on statistically significant number of patients for each indication.

Other products namely STEMPEUCEL, an allogeneic-cultured mesenchymal cells from Stempeutics and OSSORON, an autologous-cultured adult osteoblast and CHONDRON, an autologous-cultured adult chondrocyte from Regenerative Medical Services, Mumbai, also received the marketing license at the same time.

"The past decades have seen revolutionary progress in the development and application of cell and genetic engineering in an effort to personalize the treatment of cancer. We are now confident that it is possible to treat cancer patients using this approach as observed during clinical trials across India. The results are encouraging and mark a potential new paradigm in treating these solid tumors that do not respond to standard therapies," said a leading oncologist, Dr. Ashok Vaid.

APCEDEN, an autologous monocyte-derived mature Dendritic cell when loaded with tumor antigen have the ability to generate an effective immune response against the tumor. In the year 2011, an ATTEST trial was conducted where refractory solid tumor with multiple chemo failure patients were enrolled and administered with APCEDEN. The results were published in International Journal of Cytotherapy in the year 2014. ATTEST study included a stringent logistics management and was uniquely, effectively, conducted under the leadership of Principal investigator, Medical oncologist, Dr. P P Bapsy.

The trial was designed to understand the potential benefits and risk of the therapy. In the trial 28.9% of cases showed stability of disease with good quality of life. A retrospective study was also conducted on the advice of CBBTDEC (Cell Biology Based Therapeutic Drug Evaluation Committee), ICMR (Indian Council of Medical Research) where more than 200 days’ of survival benefit was observed as compared to the retrospective control group.

Alligator presents at DNB Small and Medium Enterprises (SME) Conference in Oslo

On April 5, 2017 Alligator presented at DNB Small and Medium Enterprises (SME) Conference in Oslo (Presentation, Alligator Bioscience, APR 5, 2017, View Source [SID1234538701]).