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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.

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"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.

PRIMA BIOMED ANNOUNCES SECOND MILESTONE PAYMENT FOR IMP701 PROGRAM

On July 17, 2017 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) ("Prima" or the "Company") reported it will receive a second undisclosed significant clinical milestone payment from Novartis, based on the collaboration and licensing agreement between the companies, relating to Prima’s IMP701 LAG-3 antibody (also referred to as LAG525) (Press release, Prima Biomed, JUL 17, 2017, View Source [SID1234519818]).

The LAG525 antibody is currently being evaluated in clinical trials together with Novartis’ PD1 inhibitor PDR001 for the treatment of cancer. Novartis has full responsibility for the continued development of the antibody program and Prima is eligible to receive further potential development-based milestone payments and royalties on sales following commercialisation of the products.

Mr. Marc Voigt, CEO of Prima, commented "We are very pleased by the progression of the LAG525 program. It is wonderful to see our commercial partners continuing to progress the development of LAG-3 products. This announcement, together with the other clinical and non-clinical data published regarding other LAG-3 directed drug development programs over the past twelve months is very encouraging."

About IMP701
IMP701 is a therapeutic antibody originally developed by Immutep S.A.S to target LAG-3. This antagonist antibody plays a role in controlling the signalling pathways in both effector T cells and regulatory T cells (Treg). The antibody works to both activate effector T cells (by blocking inhibitory signals that would otherwise switch them off) and at the same time inhibit Treg function that normally prevent T cells from responding to antigen stimulation. The antibody therefore removes two brakes that prevent the immune system from responding to and killing cancer cells. In contrast, some other checkpoint antibodies in development target only the effector T cell pathway and don’t address the Treg pathway.

IMP701 was licensed to CoStim Pharmaceuticals in 2012 which was subsequently acquired by Novartis in 2014.

Ligand Enters Into Commercial License and Supply Agreement with Amgen for Rights to Use Captisol in the Formulation of AMG 330

On July 17, 2017 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that it has entered into a commercial license and supply agreement with Amgen, granting rights to use Ligand’s Captisol technology in the formulation of AMG 330 (Press release, Ligand, JUL 17, 2017, View Source [SID1234519812]). Captisol is a patent protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. AMG 330 is an anti-CD33 x anti-CD3 (BiTE) bispecific antibody construct. It is being investigated as a treatment for acute myeloid leukemia by Amgen.

This license agreement replaces the prior research agreement which allowed Amgen to evaluate AMG 330 with Captisol in preclinical and early clinical studies. Under this new commercial license agreement, Amgen receives exclusive worldwide rights to combine Captisol with AMG 330 for use in humans for a wide variety of therapeutic indications. In addition to an upfront payment, Ligand is entitled to potential milestone payments, royalties and revenue from future sales of AMG 330 formulated using Captisol.

"This agreement expands our license relationship with Amgen on AMG 330," said John Higgins, Chief Executive Officer of Ligand Pharmaceuticals. "Ligand’s portfolio of fully-funded shots on goal continues to grow and contains a large number of Captisol-enabled drugs targeted to a number of serious diseases with unmet medical needs."

About AMG 330
AMG 330 is an anti-CD33 x anti-CD3 (BiTE) bispecific antibody construct. It is being investigated as a treatment for acute myeloid leukemia by Amgen.