On October 17, 2017 Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, reported that its license partner, Janssen Biotech, Inc., presented a poster with initial data from an ongoing first-in-human Phase 1 dose finding trial to evaluate JNJ-64041757 (also known as ADU-214 ), a live, attenuated double-deleted Listeria monocytogenes (LADD)-based immunotherapy in development for the treatment of advanced or metastatic non-small cell lung cancer (Press release, Aduro Biotech, OCT 17, 2017, View Source [SID1234520976]). The data were presented at the International Association for the Study of Lung Cancer’s World Conference being held in Yokohama, Japan.

The Phase 1 first-in-human, open label dose-finding trial included nine patients with advanced stage relapsed or refractory non-small cell lung cancer. Patients were administered either 1×108 or 1×109 colony-forming units infused intravenously over one hour every 21 days. Of the nine patients treated with JNJ-64041757 monotherapy, five experienced a best response of stable disease. The maximum number of cycles administered to a single patient was 25 cycles at the time of the clinical data cut off. Additionally, biomarker data showed evidence of activation of innate immunity with transient cytokine increases in all patients as well as induction of mesothelin-specific T cell immunity in a subset of patients. The immunotherapy was generally well-tolerated with transient mild to moderate adverse events, including headache, nausea, pyrexia and vomiting.

“These are encouraging early data which we believe may support clinical activity of our listeria-based immunotherapy for lung cancer,” said Dirk Brockstedt, executive vice president of research and development at Aduro Biotech. “We look forward to Janssen initiating a combination trial of JNJ-64041757 with other agents, based on synergistic combination data from preclinical mouse tumor models.”

In October 2014, Aduro entered into its second agreement with Janssen Biotech, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, granting an exclusive, worldwide license to JNJ-64041757 and other product candidates engineered for the treatment of lung cancer and certain other cancers based on its novel LADD immunotherapy platform. Under the agreement facilitated by the Johnson & Johnson Innovation center in California, Aduro received a $30 million up-front payment and has received $21 million in milestone payments upon the completion of various development activities. Aduro is eligible to receive future development, regulatory and commercialization milestone payments up to a potential total of $766 million. In addition, Aduro is eligible to receive royalties at a rate ranging from high single-digits to low teens on worldwide net sales upon successful launch and commercialization.

About LADD
LADD is Aduro’s proprietary platform of live-attenuated double-deleted Listeria monocytogenes strains that have been engineered to induce a potent innate immune response and to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity.

On October 17, 2017 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, reported payment of a $6 million milestone to Infinity Pharmaceuticals, Inc., representing the first milestone under the duvelisib license agreement between Verastem and Infinity (Press release, Verastem, OCT 17, 2017, View Source [SID1234520973]). This milestone is based on the achievement of positive top-line results from the Phase 3 DUO study evaluating the efficacy and safety of duvelisib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

In addition, Verastem drew an additional advance of $7.5 million from its existing $25 million loan and security agreement, dated March 21 2017, with Hercules Capital, Inc. (the Term Loan Facility). The proceeds will be used to pay the $6 million milestone payment to Infinity, for ongoing research and development programs, and for general corporate purposes. Verastem has drawn a total of $10 million under the Term Loan Facility, leaving $15 million in available additional advances, subject to certain conditions of funding.

“Payment of this milestone to Infinity reflects the attainment of a critical milestone for the duvelisib development program, positive data from the Phase 3 DUO study in CLL/SLL,” said Julie B. Feder, Chief Financial Officer of Verastem. “We have elected to employ the non-dilutive option of drawing a second tranche of funding under our Term Loan Facility. We believe this approach is a prudent use of the strategic financial tools that we have at hand as we advance the program towards a potential NDA filing in H1 2018.”

In September 2017, Verastem reported that the Phase 3 DUO study met its primary endpoint with oral duvelisib monotherapy demonstrating superiority over ofatumumab for progression free survival (PFS) in patients with CLL/SLL. In this study, duvelisib achieved a statistically significant improvement in median PFS of 13.3 months, compared to 9.9 months for ofatumumab with a hazard ratio (HR) of 0.52 (p<0.0001), representing a 48% reduction in the risk of progression or death. Verastem plans to share these clinical data with the U.S. Food and Drug Administration (FDA) during Q4 2017 with the goal of filing a New Drug Application (NDA) with the FDA during the first half of 2018. The duvelisib NDA submission will also be supported by favorable results from the Phase 2 DYNAMO study in indolent non-Hodgkin’s lymphoma (iNHL), which also achieved its primary endpoint with an ORR of 46% (p<0.0001).

On October 17, 2017 AstraZeneca and MedImmune, its global biologics research and development arm, reported that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) for the treatment of patients with locally advanced (Stage III) unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy (Press release, AstraZeneca
, OCT 17, 2017, View Source [SID1234520970]). The FDA has granted Imfinzi Priority Review status.

The US FDA sBLA submission acceptance is an important milestone for Imfinzi in a disease state where patients need better treatment options and outcomes. Currently, the standard of care for patients with this earlier stage of lung disease is active monitoring following concurrent chemoradiation.

The sBLA submission is based on positive progression-free survival (PFS) data from the Phase III PACIFIC trial. The trial continues to evaluate overall survival (OS), its other primary endpoint. Detailed results of the PACIFIC trial, including additional safety information, were published online in the New England Journal of Medicine.

On 28 September 2017, the US NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) were updated to include Imfinzi for the treatment of patients with locally-advanced unresectable NSCLC with no disease progression after two or more cycles of definitive chemoradiation, based on the data from the PACIFIC Phase III trial. This indication is not yet FDA-approved.

NOTES TO EDITORS

About Locally Advanced (Stage III) NSCLC

Locally advanced (Stage III) lung cancer is commonly divided into two stages (IIIA and IIIB), which are defined by how much the cancer has spread locally and the possibility of surgery. This differentiates it from Stage IV disease, when the cancer has spread (metastasised) to distant organs.

Stage III lung cancer represents approximately one-third of NSCLC incidence and was estimated to affect around 105,000 patients in the top-7 countries in 20161. More than 70% of these patients have tumours that are unresectable. The current standard of care is chemotherapy and radiation followed by active surveillance to monitor for progression. The prognosis remains poor and long-term survival rates are low.

1. France, Germany, Italy, Japan, Spain, United Kingdom, United States

About PACIFIC

The PACIFIC trial is a randomised, double-blinded, placebo-controlled, multi-centre trial of Imfinzi as treatment in unselected patients with locally-advanced, unresectable (Stage III) NSCLC who have not progressed following platinum-based chemotherapy concurrent with radiation therapy.

The trial is being conducted in 235 centres across 26 countries involving approximately 700 patients. The primary endpoints of the trial are progression-free survival (PFS) and overall survival (OS), and secondary endpoints include landmark PFS and OS, objective response rate (ORR) and duration of response.

About Imfinzi

Imfinzi (durvalumab), a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumour’s immune-evading tactics and inducing an immune response.

Imfinzi has already received accelerated approval in the US for the treatment of patients with locally advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.

As part of a broad development programme, Imfinzi is also being investigated for the adjuvant treatment of patients with NSCLC in the CCTG (Canadian Cancer Trials Group) trial ADJUVANT (BR31). In the MYSTIC, NEPTUNE, and PEARL Phase III trials, Imfinzi is being studied for 1st-line treatment as monotherapy and/or in combination with tremelimumab, an anti-CTLA-4 monoclonal antibody, for the treatment of metastatic NSCLC. The POSEIDON trial is investigating Imfinzi with and without tremelimumab in combination with chemotherapy in the same population.

About AstraZeneca in Lung Cancer

AstraZeneca is committed to developing medicines to help every patient with lung cancer. We have two approved medicines and a growing pipeline that targets genetic changes in tumour cells and boosts the power of the immune response against cancer. Our unrelenting pursuit of science aims to deliver more breakthrough therapies with the goal of extending and improving the lives of patients across all stages of disease and lines of therapy.

About AstraZeneca’s Approach to Immuno-Oncology (IO)

Immuno-Oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. At AstraZeneca and MedImmune, our biologics research and development arm, our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies will offer the potential for life-changing cancer treatments for the vast majority of patients.

We are pursuing a comprehensive clinical trial programme that includes Imfinzi (anti-PD-L1) monotherapy and in combination with tremelimumab (anti-CTLA-4) in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small, targeted molecules from across our oncology pipeline, and with those of our research partners, may provide new treatment options across a broad range of tumours.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms–Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates–and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

On October 17, 2017 Johnson & Johnson (NYSE: JNJ) reported sales of $19.7 billion for the third quarter of 2017, an increase of 10.3% as compared to the third quarter of 2016 (Press release, Johnson & Johnson, OCT 17, 2017, View Source [SID1234520972]).

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Operational sales results increased 9.5% and the positive impact of currency was 0.8%. Domestic sales increased 9.7%. International sales increased 10.9%, reflecting operational growth of 9.3% and a positive currency impact of 1.6%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide, domestic and international sales each increased 3.8%.*

Net earnings and diluted earnings per share for the third quarter of 2017 were $3.8 billion and $1.37, respectively. Third-quarter 2017 net earnings included after-tax intangible amortization expense of approximately $0.9 billion and a charge for after-tax special items of approximately $0.5 billion. 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. Excluding after-tax intangible amortization expense and special items, adjusted net earnings for the current quarter were $5.2 billion and adjusted diluted earnings per share were $1.90, representing increases of 11.2% and 13.1%, respectively, as compared to the same period in 2016. * On an operational basis, adjusted diluted earnings per share also increased 10.1%.* A reconciliation of non-GAAP financial measures is included as an accompanying schedule.

“Johnson & Johnson accelerated growth in the third quarter. This is driven by the strong performance of our Pharmaceutical business, and augmented by Actelion and other recent acquisitions across the enterprise that will continue to fuel growth,” said Alex Gorsky, Chairman and Chief Executive Officer. “Our dedicated colleagues continue to focus on advancing our pipelines to bring innovative solutions to patients and consumers around the globe.”

The Company increased its sales guidance for the full-year 2017 to a range of $76.1 billion to $76.5 billion. Additionally, the Company increased its adjusted earnings guidance for full-year 2017 to $7.25 – $7.30 per share.*

Worldwide Consumer sales of $3.4 billion for the third quarter 2017 represented an increase of 2.9% versus the prior year, consisting of an operational increase of 1.6% and a positive impact from currency of 1.3%. Domestic sales decreased 0.5%, international sales increased 5.1%, which reflected an operational increase of 3.0% and a positive currency impact of 2.1%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 1.1%, domestic sales decreased 0.7% and international sales increased 2.3%*.

Worldwide operational results, excluding the net impact of acquisitions and divestitures, were driven by over-the-counter products primarily TYLENOL analgesic products and international smoking cessation aids; as well as OGX and NEUTROGENA beauty products partially offset by the negative impact of domestic baby care products.

During the quarter, the divestiture of COMPEED to HRA Pharma was completed.

Worldwide Pharmaceutical sales of $9.7 billion for the third quarter 2017 represented an increase of 15.4% versus the prior year with an operational increase of 14.6% and a positive impact from currency of 0.8%. Domestic sales increased 15.4%; international sales increased 15.5%, which reflected an operational increase of 13.5% and a positive currency impact of 2.0%. Sales included the impact of the first full quarter of the acquisition of Actelion Ltd. which contributed 7.9%, to worldwide operational sales growth. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 6.7%, domestic sales increased 7.7% and international sales increased 5.1%.*

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, XARELTO (rivaroxaban), an oral anticoagulant, ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer 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 an additional indication for IMBRUVICA (ibrutinib) for the treatment of adult patients with chronic graft-versus-host-disease after failure of one or more lines of systemic therapy. The European Commission granted approval for SYMTUZA (darunavir/cobicistat/ emtricitabine/tenofovir alafenamide) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients aged 12 years and older.

New Drug Applications were submitted to the FDA for apalutamide, an oral androgen receptor inhibitor for men with non-metastatic castration-resistant prostate cancer and also for darunavir/cobicistat/emtricitabine/tenofovir alafenamide for the treatment of HIV-1 infection in adults and pediatric patients aged 12 years and older. In addition, a supplemental New Drug Application (sNDA) was submitted to the FDA to expand the indication for ZYTIGA (abiraterone acetate), in combination with prednisone and ADT to include treatment of patients with high-risk metastatic hormone naïve prostate cancer or newly diagnosed, high-risk metastatic hormone sensitive prostate cancer.

The Company has made a decision not to pursue global approvals of sirukumab for the treatment of moderately to severely active rheumatoid arthritis. In addition, the clinical trial for talacotuzumab, an investigational compound being studied in patients with acute myeloid leukemia, has been discontinued.

Worldwide Medical Devices sales of $6.6 billion for the third quarter 2017 represented an increase of 7.1% versus the prior year consisting of an operational increase of 6.6% and a positive currency impact of 0.5%. Domestic sales increased 4.6%; international sales increased 9.6%, which reflected an operational increase of 8.6% and a positive currency impact of 1.0%. Sales included the impact of the acquisition of Abbott Medical Optics which contributed 5.2%, to worldwide operational sales growth. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 1.2%, domestic sales decreased 0.8% and international sales increased 3.2%.*

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 wound closure products in the General Surgery business, partially offset by declines in the Diabetes Care business.

During the quarter, the acquisitions of TearScience, Inc., a manufacturer of products dedicated to treating meibomian gland dysfunction and Sightbox, Inc., an e-commerce company that provides subscription vision care services connecting consumers with eye care professionals for their contact lens needs, were completed.

Subsequent to the quarter, the Company announced the completion of the divestiture of its Codman Neurosurgery business to Integra LifeSciences Holding Corporation.

On October 17, 2017 Mylan N.V. (NASDAQ, TASE: MYL) reported that it will host a conference call and live webcast, on Monday, Nov. 6, 2017, at 10:30 a.m. ET, to review the company’s financial results for the third quarter ended Sept. 30, 2017. Mylan will release its financial results on Nov. 6, before the open of the U.S. financial markets (Press release, Mylan, OCT 17, 2017, View Source [SID1234520982]).

Mylan (PRNewsfoto/Mylan N.V.)

The briefing can be accessed live by calling 800.514.4861 or 678.809.2405 for international callers (ID#: 99489678) or at the following address on the company’s website: investor.mylan.com. A replay of the webcast also will be available on the website.