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CStone Pharmaceuticals’ PD-L1 monoclonal antibody IND has been formally accepted by the CFDA

On October 18, 2016 CStone Pharmaceuticals announced reported that, following the successful site inspection by the Jiangsu FDA for its recombinant anti PD-L1 monoclonal antibody (WBP3155), the CFDA has recently accepted the submission of WBP3155’s IND (acceptance number CXSL1600075) (Press release, CStone Pharmaceauticals, OCT 18, 2016, View Source [SID1234517821]). Wholly owned and independently developed by CStone Pharmaceuticals, WBP3155 is China’s first innovative, fully humanized, full length original format IgG (most similar to human’s naturally produced IgG) monoclonal antibody drug candidate. WBP3155 is also the world’s first OMT platform produced antibody, which could mean safer and less immunogenic. WBP3155 has hopes of becoming one of the first China developed PD-L1 therapies.

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The inhibition of key checkpoints, such as PD-1/PD-L1, is currently the major development focus for immuno-oncology both in China and abroad. These drugs are designed to use our own immune system to treat cancer and have shown significant effects in the treatment of melanoma, lung cancer, renal cell carcinoma, bladder cancer, as well as other tumors. There are a number of related monoclonal antibody drugs approved internationally, and a few domestic companies also have related drug candidates in both pre-clinical and clinical trial phases. The acceptance of WBP3155’s IND by the CFDA signifies that the CStone has made significant progress with the development of this molecule.

Dr. Frank Jiang, CEO of CStone Pharmaceuticals, stated that China has the highest number of newly diagnosed cancer patients and deaths from cancer in the world. As such, CStone is committed to meeting this pressing need by developing innovative, effective, and safe therapies for Chinese patients.

Positive Phase III Clinical Trial Results for Ribociclib (LEE011), an Investigational Compound for Advanced Breast Cancer in Development by Major Pharmaceutical Company under a Research Collaboration with Otsuka’s Subsidiary Astex Pharmaceuticals

On October 18, 2016 Otsuka Pharmaceutical Co., Ltd., which is active in the discovery of new medicines in the fields of cancer and central nervous system diseases reported positive phase III trials results for a drug compound in development by Novartis related to its subsidiary Astex Pharmaceuticals (Press release, Otsuka, OCT 18, 2016, View Source [SID1234515912]).

Positive clinical trial results on ribociclib (LEE011) plus letrozole as first-line treatment for advanced or metastatic breast cancer, compared to letrozole alone, were presented by Novartis at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016. (The contents of this press release were announced earlier by Novartis in an October 8 press release. See the press release on the trial results including full safety and efficacy data here.)

In the trial (MONALEESA-2 study), patients with HR+ (hormone receptor positive)/HER2- (human epidermal growth factor receptor 2-negative), advanced or metastatic breast cancer were assigned to treatment with ribociclib (LEE011) and letrozole or to the standard of care: letrozole alone. Progression-free survival (the length of time during which cancer does not progress) was significantly extended in the experimental group treated with ribociclib plus letrozole. Trial results were published simultaneously in an online article in The New England Journal of Medicine.

Ribociclib (LEE011) was developed by the Novartis Institutes for BioMedical Research under a research collaboration with Astex Pharmaceuticals.
Otsuka’s subsidiary Astex undertakes drug discovery in the U.K. directed at unmet medical needs in the field of oncology and diseases of the CNS, thereby contributing to the lives of patients and their families.

Actinium Pharmaceuticals Granted Orphan Designation from the European Medicines Agency for Iomab-B

On October 18, 2016 Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, reported that the Company’s lead asset, Iomab-B, has been granted orphan designation in the European Union (EU) by the European Medicines Agency (EMA) (Press release, Actinium Pharmaceuticals, OCT 18, 2016, View Source [SID1234515904]). Iomab-B is intended to be used, upon approval, in preparing patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are over the age of 55 for a bone marrow transplant (BMT), often referred to as a hematopoietic stem cell transplant (HSCT). Iomab-B is currently in a 150 patient multicenter, pivotal Phase 3 trial that is being conducted in the United States.

"We are excited to have been granted orphan designation in the EU for Iomab-B, which comes in addition to the SME status Actinium was granted and orphan designation for Iomab-B in the U.S.," stated Sandesh Seth, Executive Chairman of Actinium Pharmaceuticals. "We believe Iomab-B represents a potentially revolutionary therapy for relapsed or refractory AML patients who are over the age of 55 who could benefit from a bone marrow transplant, which is a drastically underserved patient population. With additional regulatory support for Iomab-B in the EU through orphan designation and SME status we hope to one day bring Iomab-B to the patients of the EU."

The EMA grants orphan designation to rare diseases that are defined as life-threatening or chronically debilitating conditions that affect no more than 5 in 10,000 people in the EU. With an estimated 30 million people living in the EU this equates to approximately 250,000 people or less for each rare disease.

About Iomab-B

Iomab-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. BC8 has been developed by the Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues.

Adaptimmune Announces Initiation of Triple Tumor Study to Evaluate its SPEAR® T-Cell Therapy Targeting MAGE-A10

On October 18, 2016 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it has initiated a Phase I triple tumor study using its wholly owned MAGE-A10 SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell therapy in patients with inoperable or metastatic urothelial cancer (transitional cell cancer of the bladder, ureter, or renal pelvis), melanoma, or squamous cell carcinoma of the head and neck (Press release, Adaptimmune, OCT 18, 2016, View Source [SID1234515899]).

This is the first collaborative study under the recently announced multi-year strategic alliance between Adaptimmune and The University of Texas MD Anderson Cancer Center, designed to expedite the development of novel adoptive T-cell therapies for multiple types of cancer. The two teams are collaborating in a number of areas including preclinical and clinical development of Adaptimmune’s first and second generation SPEAR T-cell therapies across a number of cancers.

"We are excited to initiate this triple tumor study with our partners at MD Anderson," said Dr. Rafael Amado, Adaptimmune’s Chief Medical Officer. "While important advances are being made with immune therapies in inoperable or metastatic tumors of the urothelium, and in melanoma and head and neck cancers, there remains a significant unmet medical need for more effective therapies for patients suffering with these cancers. It is our hope that this study will prove to be a positive first step towards the development of this SPEAR T-cell therapy in patients who are HLA-A2 positive and have advanced solid tumors expressing MAGE-A10."

This is a Phase I, open-label, modified 3+3 dose escalation study of autologous T-cells genetically engineered with an affinity optimized MAGE-A10 T-cell receptor in HLAA*0201 and HLA-A*0206 positive patients with inoperable or metastatic urothelial cancer (transitional cell cancer of the bladder, ureter or renal pelvis), melanoma, or squamous cell carcinoma of the head and neck expressing the MAGE-A10 antigen.

The study is part of a multi-center study intended to enroll up to 12 patients in leading clinical centers in the United States, with MD Anderson Cancer Center being the first site initiated, and will assess the safety and tolerability of Adaptimmune’s affinity enhanced T-cell therapy targeting MAGE-A10. Secondary objectives will include the assessment of clinical efficacy, measurements of durability of persistence of MAGE-A10 T-cells in the blood, and exploratory tumor biomarker studies and evaluations of the phenotype and functionality of MAGE-A10 T-cells.

About Urothelial, Melanoma, or Head and Neck Tumors
Urothelial Cancer
Ninety percent of urothelial cancers originate in the bladder, while 8 percent originate in the renal pelvis and two percent in the ureter or urethra. Non-muscle invasive urothelial bladder cancer comprises 70 percent of newly diagnosed bladder cancers. The American Cancer Society’s estimates for bladder cancer in the United States for 2016 are about 76,960 new cases of bladder cancer (about 58,950 in men and 18,010 in women), and about 16,390 deaths from bladder cancer (about 11,820 in men and 4,570 in women). Bladder cancer accounts for about 5 percent of all new cancers in the United States. It is the fourth most common cancer in men. The average survival for metastatic urothelial bladder cancer is 12 to 15 months.

Melanoma
Melanoma is a cancer that begins in specific skin cells called melanocytes. Because most of these cells still make melanin, melanoma tumors are often brown or black, though this is not always the case. The American Cancer Society estimates that approximately 76,380 new melanomas will be diagnosed (about 46,870 in men and 29,510 in women), and about 10,130 people are expected to die of melanoma (about 6,750 men and 3,380 women) in the United States in 2016. The rates of melanoma have been rising for the last 30 years. Five-year survival for Stage 3 melanoma (lymphatic involvement) ranges from about 40 to 75 percent and for Stage 4 (metastatic) is approximately 15 to 20 percent in the United States. Patients with Stage 4 melanoma suffer an especially poor prognosis with a median survival of six to 10 months.

Squamous Cell Carcinoma of the Head and Neck
Cancers that are known collectively as head and neck cancers usually begin in the squamous cells that line the mucosal surfaces inside the head and neck (for example, inside the mouth, the nose, and the throat). These squamous cell cancers are often referred to as squamous cell carcinomas of the head and neck. There are two possible developmental paths for most head and neck cancers: environmental factors such as alcohol and tobacco, and HPV infection. Over the past 30 years, there has been a significant rise in the incidence of head and neck cancers caused by HPV. The majority of patients with head and neck cancer present with locally advanced disease. For those patients with stage III/IV locally advanced cancer, the prognosis is quite poor; 40 to 60 percent of patients relapse, and approximately 30 to 50 percent of patients live for 3 years after treatment with surgery and radiotherapy.

Johnson & Johnson Reports 2016 Third-Quarter Results:

On October 18, 2016 Johnson & Johnson (NYSE: JNJ) reported sales of $17.8 billion for the third quarter of 2016, an increase of 4.2% as compared to the third quarter of 2015 (Press release, Johnson & Johnson, OCT 18, 2016, View Source [SID1234515896]).

Operational sales results increased 4.3% and the negative impact of currency was 0.1%. Domestic sales increased 6.7%. International sales increased 1.5%, reflecting operational growth of 1.7% and a negative currency impact of 0.2%. Excluding the net impact of acquisitions, divestitures and hepatitis C sales, on an operational basis, worldwide sales increased 5.9%, domestic sales increased 7.3% and international sales increased 4.2%.* Operations in Venezuela negatively impacted worldwide operational sales growth by 30 basis points, and international sales growth by 70 basis points.

Net earnings and diluted earnings per share for the third quarter of 2016 were $4.3 billion and $1.53, respectively. Third quarter 2016 net earnings included after-tax intangible amortization expense of approximately $0.2 billion and a charge for after-tax special items of approximately $0.2 billion. Third quarter 2015 net earnings included after-tax intangible amortization expense of approximately $0.4 billion and a charge for after-tax special items of approximately $0.4 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $4.7 billion and adjusted diluted earnings per share were $1.68, representing increases of 12.2% and 12.8%, respectively, as compared to the same period in 2015. * On an operational basis, adjusted diluted earnings per share also increased 12.8%.* A reconciliation of non-GAAP financial measures is included as an accompanying schedule.

"Our third-quarter results reflect the success of our new product launches and the strength of our core businesses, driven by strong growth in our Pharmaceuticals business. With a number of regulatory approvals, several new drug application submissions and new breakthrough therapy designations from the FDA, we are increasingly confident in our pipeline expectation of filing 10 new pharmaceutical products between 2015 and 2019, each with revenue potential over $1 billion," said Alex Gorsky, Chairman and Chief Executive Officer. "Our broad-based business model, strategic investments and talented colleagues position us well for continued leadership in health care."

The Company maintained its sales guidance for the full-year 2016 of $71.5 billion to $72.2 billion. Additionally, the Company increased its adjusted earnings guidance for full-year 2016 to $6.68 – $6.73 per share.*

Worldwide Consumer sales of $3.3 billion for the third quarter 2016 represented a decrease of 1.6% versus the prior year, consisting of an operational increase of 0.1% and a negative impact from currency of 1.7%. Domestic sales increased 1.1%; international sales decreased 3.3%, which reflected an operational decrease of 0.6% and a negative currency impact of 2.7%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales decreased 0.4%, domestic sales decreased 1.5% and international sales increased 0.3%*. Operations in Venezuela negatively impacted worldwide Consumer operational sales growth by 110 basis points and international sales growth by 180 basis points.

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were negatively impacted by lower trade inventory levels, primarily in the U.S. Positive contributors to Consumer operational sales results included LISTERINE oral care products; AVEENO skin care products and digestive health products and international smoking aids in over-the-counter products.

Worldwide Pharmaceutical sales of $8.4 billion for the third quarter 2016 represented an increase of 9.2% versus the prior year with an operational increase of 9.0% and a positive impact from currency of 0.2%. Domestic sales increased 11.8%; international sales increased 5.4%, which reflected an operational increase of 5.0% and a positive currency impact of 0.4%. Excluding the net impact of acquisitions, divestitures and hepatitis C sales, on an operational basis, worldwide sales increased 10.7%, domestic sales increased 13.0% and international sales increased 7.0%.*

Worldwide operational results, excluding the net impact of acquisitions, divestitures and hepatitis C sales, were driven by new products and the strength of core products. Strong growth in new products include IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer; DARZALEX (daratumumab), for the treatment of patients with multiple myeloma; and XARELTO (rivaroxaban), an oral anticoagulant.

Additional contributors to operational sales growth included STELARA (ustekinumab), REMICADE (infliximab) and SIMPONI/SIMPONI ARIA (golimumab), biologics approved for the treatment of a number of immune-mediated inflammatory diseases; and INVEGA SUSTENNA/XEPLION/TRINZA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults.

During the quarter, the U.S. Food and Drug Administration (FDA) approved INVOKAMET XR (canagliflozin/metformin HCl extended-release) for first-line treatment of adults with type 2 diabetes, and STELARA (ustekinumab) for the treatment of adults with moderately to severely active Crohn’s disease. The Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of STELARA for the treatment of adults with moderately to severely active Crohn’s disease.

Additionally, regulatory applications for approval were submitted to the FDA and European Medicines Agency (EMA) for DARZALEX in combination with standard-of-care regimens for patients with multiple myeloma who have received at least one prior therapy. DARZALEX also received Breakthrough Therapy Designation from the FDA for this pending indication. The FDA also granted Breakthrough Therapy Designation to esketamine for major depressive disorder with imminent risk for suicide. Regulatory applications for approval were also submitted to the FDA for sirukumab in rheumatoid arthritis, and to EMA for a darunavir-based single tablet regimen for the treatment of HIV-1.

Worldwide Medical Devices sales of $6.2 billion for the third quarter 2016 represented an increase of 1.1% versus the prior year consisting of an operational increase of 0.7% and a positive currency impact of 0.4%. Domestic sales increased 1.4%; international sales increased 0.7%, which reflected an operational decline of 0.2% and a positive currency impact of 0.9%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 3.1%, domestic sales increased 2.3% and international sales increased 3.9%.*

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by electrophysiology products in the Cardiovascular business; endocutters and energy in the Advanced Surgery business; ACUVUE contact lenses in the Vision Care business; and joint reconstruction and trauma products in the Orthopaedics business.

During the quarter, a definitive agreement was announced to acquire Abbott Medical Optics, a wholly-owned subsidiary of Abbott Laboratories, for $4.325 billion in cash. Acclarent announced the U.S. launch of ACCLARENT AERA, the first balloon dilation intervention approved by the FDA for Eustachian Tube Dysfunction.