On April 10, 2017 FORMA Therapeutics announced today that it has successfully completed two additional objectives under its strategic collaboration agreement with Celgene Corporation, triggering two undisclosed payments from Celgene (Press release, Forma Therapeutics, APR 10, 2017, View Source [SID1234518517]). Previously, FORMA and Celgene entered a collaboration in the promising area of protein homeostasis to discover, develop and commercialize innovative drug candidates. This collaboration enables Celgene to evaluate select therapeutic candidates and programs in protein homeostasis during preclinical development. Schedule your 30 min Free 1stOncology Demo! John Hohneker, M.D., Executive Vice President and Head of Research and Development at FORMA Therapeutics said, "FORMA’s integrated approach to drug discovery, bringing together distinctly novel and proprietary compound collections with clinically-meaningful biological assays across protein families, continues to deliver a promising pipeline. We have successfully identified several additional candidate compounds from our protein homeostasis programs, each with a compelling mechanism of action and potential to represent first in class therapeutic options for patients."
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About Protein Homeostasis
Protein homeostasis, which is important in oncology, neurodegenerative and other disorders, involves a tightly regulated network of pathways controlling the biogenesis, folding, transport and degradation of proteins. Exploring the maintenance and regulation of such competing, yet integrated, biological pathways using a chemical biology approach, should directly contribute to the understanding of diseases associated with excessive protein misfolding, aggregation and degradation.
Author: [email protected]
Chugai’s Alecensa® Met Its Primary Endpoint in the ALEX Study – Following the Japanese P3 Study, Alecensa Demonstrated Statistically Significant Improvement in PFS in a Global P3 Head to Head Study with Crizotinib –
On April 10, 2017 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that Alecensa as an initial (first-line) treatment showed that patients lived significantly longer without disease worsening (progression-free survival, PFS) compared to crizotinib in the ALEX Study, a global phase III study targeting ALK fusion gene positive non-small cell lung cancer (NSCLC), conducted by F. Hoffmann-La Roche Ltd (Press release, Chugai, APR 10, 2017, View Source [SID1234518514]). The safety profile of Alecensa was consistent with that observed in previous studies, with no new or unexpected adverse events. Schedule your 30 min Free 1stOncology Demo! "Following the Japanese phase III J-ALEX study, the ALEX study, the head to head trial with crizotinib, Alecensa demonstrated a significant prolongation of PFS compared to crizotinib. This finding greatly encourages the patients suffering from ALK fusion gene positive NSCLC," said Dr. Yasushi Ito, Senior Vice President, Head of Project & Lifecycle Management Unit. "We believe that Alecensa will also contribute to improving the outcomes for overseas patients from first line therapy in the future."
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The ALEX study was an open-label, randomized global phase III study that compares the efficacy and safety between both monotherapy of Alecensa and crizotinib. The ALEX study enrolled treatment-naïve 303 patients with ALK fusion gene positive NSCLC. The subjects were allocated to either the Alecensa arm or the crizotinib arm in a one to one ratio. The primary endpoint of the ALEX study was PFS as assessed by the investigator. The secondary endpoints included Independent Review Committee-assessed PFS, overall survival, objective response rate, duration of response, safety, and other endpoints. The full data of the ALEX study will be presented at a future medical meeting and submitted to global health authorities, including the United States Food and Drug Administration.
Alecensa is a highly selective oral ALK inhibitor created by Chugai. It has been reported that approximately five percent of patients with NSCLC express a chromosomal rearrangement which leads to fusion of the ALK gene with another gene.1) ALK kinase signalling is constantly active in cells with such fusion genes, resulting in uncontrolled growth of tumour cells and transforming the cells into tumour cells.2, 3) Alecensa exerts its anti-tumour effect by selectively inhibiting ALK kinase activity to inhibit tumour cell proliferation and induce cell death.4) In addition, Alecensa is not recognized by the active efflux system in the blood brain barrier which actively pumps molecules out of the brain. Thus, Alecensa is able to remain active in the central nervous system and has proven activity against brain metastases.
Alecensa is currently approved in the United States, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, the EU, Australia and Taiwan for the treatment of adult patients with ALK-positive, metastatic (advanced) NSCLC who have progressed on or those intolerant to crizotinib." In Japan, "Alecensa capsule 150mg" is available to patients with "ALK fusion gene positive unresectable, recurrent/advanced NSCLC" and is marketed by Chugai.
1) Biomarker committee of The Japan Lung Cancer Society, Guidelines for ALK gene tests in lung cancer patients
2) Soda et al., Nature. 448: 561-566 (2007)
3) Takeuchi et al., Clin Cancer Res. 15: 3143-3149 (2009)
4) Sakamoto et al., Cancer Cell. 19: 679-690 (2011)
Note: The description of Japanese package insert
– Dosage and administration for Japanese patients: "the usual adult dosage is 300mg alectinib administered orally twice daily."
– In the current Japanese package insert, it is described that "2. efficacy and safety of ALECENSA in chemotherapy-naïve patients have not been established.
MediciNova Announces MN-166 (ibudilast) Glioblastoma Abstract Selected for Presentation at the 2017 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois
On April 9, 2017 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that an abstract regarding a mouse model study that examined the potential clinical efficacy of MN-166 for glioblastoma (GBM) has been accepted for presentation at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held June 2-6, 2017 in Chicago, Illinois (Press release, MediciNova, APR 9, 2017, View Source [SID1234518515]). Schedule your 30 min Free 1stOncology Demo! The presentation entitled "Treating glioblastoma with a cytokine inhibitor, ibudilast in combination with temozolomide extends survival in a patient derived xenograft model," will be presented by Associate Professor Kerrie McDonald, Head of the Cure Brain Cancer Foundation Biomarkers and Translational Research Group at the Lowy Cancer Research Centre, University of New South Wales. In this presentation, Dr. McDonald will present detailed information about the effectiveness of MN-166 and temozolomide combination treatment in the GBM model.
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Presentation details are as follows:
Session Date and Time: Monday, June 5, 2017
Session: Central Nervous System Tumors
Location: McCormick Place, 2301 S. Lake Shore Drive, Chicago, Illinois
MediciNova is currently preparing to initiate a Phase 2 clinical trial for the treatment of recurrent Grade IV glioblastoma.
About Glioblastoma
Malignant primary brain tumors represent the most frequent cause of cancer death in children and young adults and account for more deaths than melanoma. According to the American Association of Neurological Surgeons, glioblastoma (GBM) is an aggressive, extremely lethal form of brain malignancy that develops from glial cells (astrocytes and oligodendrocytes) and rapidly grows and commonly spreads into nearby brain tissue. GBM is classified as Grade IV, the highest grade, in the World Health Organization (WHO) brain tumor grading system. The American Brain Tumor Association reports that GBM represents 15% of all brain tumors and 55% of all gliomas and has the highest number of cases of all malignant tumors, with an estimated 12,390 new cases predicted for 2017. Despite decades of advancements in neuroimaging, neurosurgery, chemotherapy, and radiation therapy, only modest improvements have been achieved and the prognosis has not improved for individuals diagnosed with GBM. Median survival is 14.6 months and only approximately 5% of GBM patients survive longer than 36 months.
About MN-166 (ibudilast)
MN-166 (ibudilast) has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova is developing MN-166 for progressive MS and other neurological conditions such as ALS and drug use disorders. MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. It attenuates activated glia cells, which play a major role in certain neurological conditions. Ibudilast’s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical study results and provide the rationale for its therapeutic utility in neurodegenerative diseases (e.g., progressive MS and amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, substance abuse/addiction and chronic neuropathic pain.
REGiMMUNE Completes $6 Million Series E Financing
On April 7, 2017 REGiMMUNE Corporation reported the closing of a Series E financing on April 7th (Press release, REGimmune, APR 7, 2017, View Source [SID1234642231]). The company raised 6 million US in this new round, which was led by SMBC Venture Capital Co., Ltd., the VC arm of Sumitomo Mitsui Banking Corporation(SMBC) and Japan Asia Investment Corporation (JAIC). Additional investors participating in this round are new investors Miyako Capital,Iyo-Gin Capital, Oita Venture Capital, Kyoritsu Captal,Hiroshima Venture Capital and several individual investors. Existing investors, and Mitsubishi UFJ Bank Capital also invested in this financing. Proceeds from this funding will be used clinical study in US.
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REGiMMUNE successfully completed a Phase I/2a study of RGI-2001 for Graft versus Host Disease (GvHD) . Data from the Phase I/2a study showed no safety concerns up to the highest dose and some preliminary signs of efficacy were observed.
Kenzo Kosuda, President and Chief Executive Officer, said "We now have positive human clinical data that validates the usefulness of our immune-regulating technology platform. The financing announced today will allow us to start an addinotal clinical study to gain the more human data."
Pipeline Review Check
1 * Modalities in use across pipeline and marketed products. Modality refers to the structural template of a therapeutic agent. ‡ Amgen has an additional three biosimilar programs in development which are undisclosed at this time. **Tradename provisionally approved by the United States Food and Drug Administration, This information reflects public disclosures cu rrent as of April 7, 2017. Amgen’s product pipeline will change over time as molecules move through the drug development process, including progressing to market or failing in clinical trials, due to the nature of the development process. This description contains forward-looking statements that involve significant risks and uncertainties, including those discussed in Amgen’s most recent Form 10-K and in Amgen’s periodic reports on Form 10-Q and Form 8-K, and actual results may vary materially. Amgen is pro viding this information as of the date above and does not undertake any obligation to update any forward-looking statements contained in this table as a result of new information, future events or otherwise. © 201 7 Amgen Inc. All rights reserved. 33 pre clinical and clinical targets with STRONG GENETIC SUPPORT The industry’s largest toolkit with 13 MODALITIES* A mix of INNOVATIVE MOLECULES, NEW INDICATIONS, AND BIO SIMILARS A robust and differentiated pipeline, leveraging state-of-the-art science to create medicines for serious illness. Amgen is focused on high-quality candidates that demonstrate large, clinically-relevant effects. Human genetic validation is used whenever possible to enhance the likelihood of success. BIOSIMILARS ‡ ABP 215 (biosimilar bevacizumab) Hematology/ Oncology ABP 494 (biosimilar cetuximab) Hematology/ Oncology ABP 710 (biosimilar infliximab) Inflammation ABP 798 (biosimilar rituximab) Hematology/ Oncology & Inflammation ABP 959 (biosimilar eculizumab) Hematology /Oncology ABP 980 (biosimilar trastuzumab) Hematology/ Oncology PHASE ONE PHASE TWO PHASE THREE AMG 176 Hematology/ Oncology AMG 211 Hematology/ Oncology AMG 224 Hematology/ Oncology AMG 899 Cardiovascular BLINCYTO (blinatumomab) Hematology/ Oncology Erenumab Neuroscience AMG 520 Neuroscience Aranesp (darbepoetin alfa) Hematology/ Oncology BLINCYTO (blinatumomab) Hematology/ Oncology AMG 301 Neuroscience AMG 330 Hematology/ Oncology AMG 420 Hematology/ Oncology Tezepelumab Inflammation Enbrel (etanercept) Inflammation Erenumab Neuroscience **EVENITY TM (romosozumab) Bone Health AMG 557 Inflammation AMG 570 Inflammation AMG 592 Inflammation IMLYGIC (talimogene laherparepvec) Hematology/ Oncology KYPROLIS (carfilzomib) Hematology/ Oncology Omecamtiv mecarbil Cardiovascular AMG 820 Hematology/ Oncology AMG 986 Cardiovascular IMLYGIC (talimogene laherparepvec) Hematology/ Oncology Prolia (denosumab) Bone Health Repatha (evolocumab) Cardiovascular Vectibix (panitumumab) Hematolog y/ Oncology KYPROLIS (carfilzomib) Hematology/ Oncology Oprozomib Hematology/ Oncology XGEVA (denosumab) Hematology/ Oncology 2 * Modalities in use across pipeline and marketed products. Modality refers to the structural template of a therapeutic agent. ‡ Amgen has an additional three biosimilar programs in development which are undisclosed at this time. This information reflects public disclosures current as of April 7, 2017. Amgen’s product pipeline will change over time as molecules move through the drug development process, including progressing to market or failing in clinical trials, due to the nature of the development process. This description contains forward-looking statements that involve significant risks and uncertainties, including those discussed in Amgen’s most re cent Form 10-K and in Amgen’s periodic reports on Form 10-Q and Form 8-K, and actual results may vary materially. Amgen is providing this information as of the date above and does not undertake any obligation to update any forward-looking statements contai ned in this table as a result of new information, future events or otherwise. © 201 7 Amgen Inc. All rights reserved. PHASE ONE Phase 1 clinical trials investigate safety and proper dose ranges of a product candidate in a small number of human subjects. MOLECULE NAME & PRONUNCIATION MODALITY THERAPEUTIC AREA DESCRIPTION AMG 176 Small Molecule Hematology/ Oncology AMG 176 is a small molecule being investigated as a treatment for multiple myeloma. AMG 211 BiTE A ntibody Hematology/ Oncology AMG 211 is an anti-CEA x anti-CD3 (BiTE ) bispecific antibody construct. It is being investigated as a treatment for various cancer types. AMG 211 is being jointly developed in collaboration with MedImmune. AMG 224 Antibody Drug Conjugate Hematology/ Oncology AMG 224 is an antibody drug conjugate being investigated for the treatment of multiple myeloma. AMG 301 Monoclonal Antibody Neuroscience AMG 301 is a human monoclonal antibody that inhibits the type 1 receptor of the pituitary adenylate cyclase-activating polypeptide (PAC1). It is being investigated for migraine prevention. AMG 301 is being jointly developed in collaboration with Novartis. AMG 330 BiTE Antibody Hematology/ Oncology AMG 330 is an anti-CD33 x anti-CD3 (BiTE ) bispecific antibody construct. It is being investigated as a treatment for acute myeloid leukemia. AMG 420 BiTE Antibody Hematology/ Oncology AMG 420 is an anti-BCMA x anti-CD3 (BiTE ) bispecific antibody construct. It is being investigated as a treatment for multiple myeloma. AMG 557 Monoclonal Antibody Inflammation AMG 557 is a human monoclonal antibody that inhibits the action of B7 related protein (B7RP-1). It is being investigated as a treatment for systemic lupus erythematosus. AMG 557 is being jointly developed in collaboration with AstraZeneca. AMG 570 Bispecific Antibody Inflammation AMG 570 is a bispecific antibody-peptide conjugate that targets BAFF and ICOSL. It is being investigated as a treatment for systemic lupus erythematosus. AMG 570 is being jointly developed in collaboration with AstraZeneca. AMG 592 Fusion Protein Inflammation AMG 592 is an IL-2 mutein Fc fusion protein. It is being investigated as a treatment for inflammatory diseases. AMG 820 Monoclonal Antibody Hematology/ Oncology AMG 820 is a human monoclonal antibody that inhibits c-fms and decreases tumor-associated macrophage (TAM) function. It is being investigated as a treatment for various cancer types. AMG 986 n/a Cardiovascular AMG 986 is being investigated for the treatment of heart failure. IMLYGIC (t alimogene laherparepvec) tal im’ oh jeen la her" pa rep’ vek Oncolytic Immunotherapy Hematology/ Oncology IMLYGIC is an oncolytic immunotherapy derived from HSV-1. It is being investigated as a combination treatment in patients with mid-to late-stage metastatic melanoma (Phase 1b/3) and in other cancer types (Phase 1).
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