1stOncology™: Cancer Intelligence Service – Page 15714 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Sunesis Pharmaceuticals Announces First Patient Dosed in Phase 1b/2 Study Evaluating Oral Non-Covalent BTK-inhibitor SNS-062 in Adults with Chronic Lymphocytic Leukemia and other B-Cell Malignancies

On July 18, 2017 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported that the first patient has been dosed at the Dana-Farber Institute in the Phase 1b/2 dose-escalation and cohort-expansion study of its reversible, non-covalent Bruton’s Tyrosine Kinase (BTK)-inhibitor, SNS-062, in adults with chronic lymphocytic leukemia (CLL), small lymphocytic leukemia, Waldenstrom’s macroglobulinemia and mantle cell lymphoma that have progressed after prior therapies (Press release, Sunesis, JUL 18, 2017, View Source [SID1234519830]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"Resistance to ibrutinib, the only FDA approved BTK inhibitor, is a growing area of unmet need in the treatment of relapsed CLL," said Dr. Jennifer Brown, Director of the CLL Center at Dana-Farber Cancer Institute. "SNS-062 is designed to retain its activity in the presence of the C481S mutation, the primary resistance mechanism thus far identified to treatment by covalent-binding BTK inhibitors such as ibrutinib. We look forward to participating in Sunesis’ Phase 1b/2 study to explore the therapeutic potential of SNS-062."

"The start of this Phase 1b/2 study marks a significant milestone for the Company," said Daniel Swisher, Chief Executive Officer of Sunesis. "This study is designed to provide initial proof of concept that SNS-062 can become a new treatment option for patients with relapsed CLL. We look forward to progressing this trial to identify a recommended dose and to characterize the profile of SNS-062 across a range of B-cell malignancies."

The Phase 1b/2 trial is an open-label, sequential-group study that will enroll up to 124 subjects and is being conducted at five leading sites in the United States: Dana-Farber Cancer Institute, MD Anderson Cancer Center, The Ohio State University Comprehensive Cancer Center, U.C. Irvine Medical Center, and Weill Cornell Medicine. The target population comprises adult subjects who have advanced B-cell malignancies that have relapsed/progressed after prior therapy, including a BTK inhibitor. Phase 1b is the dose escalation portion of the study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and antitumor activity of a range of SNS-062 dose levels, to determine the maximum tolerated and/or recommended dose. The Phase 2 portion is the cohort expansion that will further explore the clinical activity and safety of SNS-062 mono-therapy within specific disease cohorts, including relapsed CLL patients with C481S mutations.

About SNS-062

SNS-062 is a selective, oral, reversible, non-covalent inhibitor of Bruton’s tyrosine kinase (BTK). BTK is a validated target for the treatment of B-cell malignancies driven by B-cell receptor signaling. SNS-062 is designed to retain its activity in the presence of a C481S mutation in BTK’s kinase domain, a leading resistance mechanism of ibrutinib for the treatment of chronic lymphocytic leukemia (CLL). In preclinical studies, SNS-062 demonstrated potent activity in both wild-type and C481S mutant BTK. In a Phase 1A randomized, double-blind, placebo-controlled single ascending dose study in healthy volunteers, SNS-062 demonstrated improved pharmacokinetics over ibrutinib, and sustained inhibition of BTK. SNS-062 is now being investigated in a Phase 1B/2 study in patients with relapsed B-cell malignancies, including CLL.

Moleculin Signs Agreement with MD Anderson Cancer Center for Leukemia Drug, Annamycin

On July 18, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported it has signed a new technology license agreement with MD Anderson Cancer Center based on new patent applications it intends to file relating to its drug Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (AML) (Press release, Moleculin, JUL 18, 2017, View Source [SID1234519817]).

"In anticipation of beginning our planned clinical trials for Annamycin," commented Walter Klemp, CEO of Moleculin, "one of our priorities has been to ensure the best possible protection for our intellectual property. Some key patent applications had yet to be filed and signing a new license agreement with MD Anderson clears the way for those patents."

Mr. Klemp continued: "we have benefitted greatly from our collaboration with MD Anderson, and this license helps ensure that collaboration continues."

Kura Oncology Announces Issuance of U.S. Patent for Lead Product Candidate Tipifarnib in Head and Neck Cancer

On July 18, 2017 Kura Oncology, Inc. (NASDAQ:KURA), a clinical stage biopharmaceutical company focused on the development of precision medicines for oncology, reported that the United States Patent and Trademark Office has issued a patent protecting the company’s lead product candidate, tipifarnib, which is currently being studied in multiple Phase 2 clinical trials (Press release, Kura Oncology, JUL 18, 2017, View Source [SID1234519816]). The patent includes multiple claims directed to the use of tipifarnib in patients with HRAS mutant squamous cell carcinoma of the head and neck (SCCHN) and has an expiration date of August 2036, excluding any possible patent term extension.

"Our goal is to identify genetically-defined patient populations in which tipifarnib will demonstrate enhanced therapeutic activity and to pursue patent protection in those indications," said Troy Wilson, Ph.D., President and CEO of Kura Oncology. "The granting of this new patent is a major milestone for Kura, and it illustrates the potential of our broader strategy to generate intellectual property related to tipifarnib and its use in treating human diseases."

U.S. Patent No. 9,707,221, entitled "Methods of Treating Cancer Patients with Farnesyltransferase Inhibitors" is directed to the use of tipifarnib for treating patients with relapsed and/or refractory HRAS SCCHN.

About HRAS Mutant SCCHN

Head and neck cancer is one of the leading causes of cancer-related deaths worldwide, with squamous cell carcinomas accounting for most head and neck cancers. The relapsed and/or refractory SCCHN patient population has an overall survival of approximately 6-8 months and few therapeutic options. New therapies for SCCHN, including immunotherapy, typically show a response rate in the range of 10-20%. HRAS is a proto-oncogene that has been implicated in the development and progression of SCCHN. HRAS mutant SCCHN has an estimated annual incidence of approximately 2,800 to 3,400 patients in the U.S. and represents a significant unmet medical need.

About Tipifarnib

Kura Oncology’s lead program, tipifarnib, is an inhibitor of farnesylation, a key cell signaling process implicated in cancer initiation and development. In extensive clinical trials, tipifarnib has shown a well-established safety profile and compelling and durable anti-cancer activity in certain patient subsets. Preclinical and clinical data suggest that, in the appropriate context, tipifarnib has the potential to provide significant benefit to cancer patients with limited treatment options. Leveraging advances in next-generation sequencing as well as emerging information about cancer genetics and tumor biology, Kura Oncology is seeking to identify patients most likely to benefit from tipifarnib.

Kitov Announces Results of Study Demonstrating NT-219 Enhanced Efficacy of Keytruda® in Immune-Oncology Preclinical Model

On July 18, 2017 Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV) (TASE: KTOV), an innovative biopharmaceutical company, reported results of a pre-clinical study demonstrating that NT-219, the lead drug candidate of its subsidiary TyrNovo Ltd., in combination with Keytruda, converted non-responding tumors to responders and blocked tumor progression in an immune-oncology preclinical model (Press release, Kitov Pharmaceuticals , JUL 18, 2017, View Source [SID1234519813]).

The study, conducted in collaboration with researchers at Bar Ilan University and Rabin Medical Center, assessed NT-219’s ability to overcome cancer drug resistance in a patient-derived xenograft (PDX) model of immune-deficient mice, in which a tumor originated from an esophagus cancer biopsy was implanted. The mice were supplemented with immune cells from the same patient (double autologous). While no response was observed with Keytruda alone or with NT-219 alone, and the tumors aggressively progressed, mice treated concomitantly with a combination of Keytruda and NT-219 demonstrated complete blockage of tumor progression.

"We are excited with these initial results obtained with NT-219 in combination with pembrolizumab (Keytruda)," stated Dr. J. Paul Waymack, Chairman of Kitov’s Board and Chief Medical Officer. "Previous results obtained with NT-219 demonstrated its efficacy in overcoming drug resistance in a variety of cancers and in combination with various pharmacologic cancer therapies. We are focused on advancing this highly promising therapeutic candidate to clinical trials as quickly as possible in order to provide enhanced treatment options to cancer patients."

Johnson & Johnson Reports 2017 Second-Quarter Results:

On July 18, 2017 Johnson & Johnson (NYSE: JNJ) reported sales of $18.8 billion for the second quarter of 2017, an increase of 1.9% as compared to the second quarter of 2016 (Press release, Johnson & Johnson, JUL 18, 2017, View Source [SID1234519815]).

Operational sales results increased 2.9% and the negative impact of currency was 1.0%. Domestic sales increased 1.6%. International sales increased 2.3%, reflecting operational growth of 4.4% and a negative currency impact of 2.1%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 0.5%, domestic sales decreased 1.0% and international sales increased 2.0%.*

Net earnings and diluted earnings per share for the second quarter of 2017 were $3.8 billion and $1.40, respectively. Second-quarter 2017 net earnings included after-tax intangible amortization expense of approximately $0.4 billion and a charge for after-tax special items of approximately $0.8 billion. Second-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 $0.7 billion. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $5.0 billion and adjusted diluted earnings per share were $1.83, representing increases of 3.1% and 5.2%, respectively, as compared to the same period in 2016. * On an operational basis, adjusted diluted earnings per share also increased 6.9%.* A reconciliation of non-GAAP financial measures is included as an accompanying schedule.

"Our second-quarter results reflect strong adjusted earnings growth and we are optimistic that the investments we are making will accelerate our sales growth in the second half of this year. Our pharmaceutical pipeline continued its strong momentum with the approval of TREMFYA as well as the submission and approval of several key line extensions," said Alex Gorsky, Chairman and Chief Executive Officer. "The Actelion acquisition establishes a new therapeutic area as well as another engine for growth and we are pleased to welcome the Actelion colleagues to the Johnson & Johnson Family of Companies. Together with all of our businesses, we will continue to transform the lives of patients around the world."

The Company increased its sales guidance for the full-year 2017 to $75.8 billion to $76.1 billion. Additionally, the Company increased its adjusted earnings guidance for full-year 2017 to $7.12 – $7.22 per share.*

Worldwide Consumer sales of $3.5 billion for the second quarter 2017 represented an increase of 1.7% versus the prior year, consisting of an operational increase of 2.3% and a negative impact from currency of 0.6%. Domestic sales increased 7.4%, international sales decreased 2.2%, which reflected an operational decrease of 1.1% and a negative currency impact of 1.1%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales decreased 0.8%, domestic sales increased 1.2% and international sales decreased 2.3%*.

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were negatively impacted by baby care products, partially offset by domestic over-the-counter products, including upper respiratory products and international anti-smoking aids, and NEUTROGENA beauty products.

Worldwide Pharmaceutical sales of $8.6 billion for the second quarter 2017 represented a decrease of 0.2% versus the prior year with an operational increase of 1.0% and a negative impact from currency of 1.2%. Domestic sales decreased 2.6%; international sales increased 3.3%, which reflected an operational increase of 6.1% and a negative currency impact of 2.8%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 0.5%, domestic sales decreased 2.6% and international sales increased 5.1%.* Worldwide operational sales growth was negatively impacted by approximately 4 points due to a positive adjustment of U.S. rebate accruals in the second quarter of 2016, which did not repeat in the second quarter of 2017.

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by new products and the strength of core products. Strong growth in new products include DARZALEX (daratumumab), for the treatment of patients with multiple myeloma and IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer. Additional contributors to operational sales growth included STELARA (ustekinumab), a biologic 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 Company announced the completion of the acquisition of Actelion Ltd., a leading biopharmaceutical company, for a total purchase price of approximately $30 billion in cash.

Also in the quarter, the U.S. Food and Drug Administration (FDA) approved an additional indication for DARZALEX (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies. The European Commission (EC) granted approval for DARZALEX (daratumumab) for use in combination with lenalidomide and dexamethasone, or bortezomib (VELCADE) and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

In addition, a supplemental New Drug Application was submitted to the FDA to update the prescribing information for XARELTO (rivaroxaban) to add a 10mg dose to reduce patients’ risk of recurrent venous thromboembolism (VTE) after at least six months of standard anticoagulation therapy and regulatory submissions were made to both the European Medicines Agency and the FDA for a single-tablet, two-drug regimen of dolutegravir and rilpivirine for the maintenance treatment of HIV-1 infection.

In July, subsequent to the quarter, the FDA approved TREMFYA (guselkumab) for the treatment of adults living with moderate to severe plaque psoriasis.

Worldwide Medical Devices sales of $6.7 billion for the second quarter 2017 represented an increase of 4.9% versus the prior year consisting of an operational increase of 5.9% and a negative currency impact of 1.0%. Domestic sales increased 6.1%; international sales increased 3.9%, which reflected an operational increase of 5.8% and a negative currency impact of 1.9%. Sales included the impact of the first full quarter of the recently completed acquisition of Abbott Medical Optics which contributed 5.1%, to worldwide operational sales growth. Excluding the net impact of all acquisitions and divestitures, on an operational basis, worldwide sales increased 1.1%, domestic sales increased 0.8% and international sales increased 1.4%.*

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by electrophysiology products in the Cardiovascular business, ACUVUE contact lenses in the Vision Care business, and Advanced Surgery products, partially offset by declines in the Diabetes Care business.

During the quarter, FDA clearance was received for the 30-minute STERRAD VELOCITY Biological Indicator System for low temperature H202 sterilization as well as approval for the SURGICEL Powder Absorbable Hemostat for adjunctive hemostasis during surgery.