On January 31, 2018 Incyte Corporation (Nasdaq:INCY) reported an update to the conference call and webcast time for its fourth quarter and year end 2017 financial results to 8:00 a.m. ET on Thursday, February 15, 2018 (Press release, Incyte, JAN 31, 2018, View Source;p=RssLanding&cat=news&id=2329565 [SID1234523711]).

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The updated schedule for the press release and conference call/webcast is as follows:

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Q4 & YE 2017 Press Release: February 15, 2018 at 7:00 a.m. ET
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Q4 & YE 2017 Conference Call: February 15, 2018 at 8:00 a.m. ET
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Domestic Dial-In Number: 877-407-3042
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International Dial-In Number: 201-389-0864
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Conference ID Number: 13675376

If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference ID number 13675376.

The live webcast with slides can be accessed at www.incyte.com under For Investors, Events and Presentations and will be available for replay for 30 days.

On January 31, 2018 Starpharma (ASX: SPL, OTCQX: SPHRY) reported that it has received regulatory and ethics approvals to commence its phase 1/2 clinical trial for DEP cabazitaxel (Press release, Starpharma, JAN 31, 2018, View Source [SID1234523642]). The objectives of the trial are to evaluate the safety, tolerability and pharmacokinetics of DEP cabazitaxel, to define a recommended phase 2 dose (RP2D), and then to determine anti-tumour efficacy of the product in select tumour types.

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The trial will be conducted at multiple sites, with Guy’s Hospital London and University College London Hospital (UCLH) in the UK being the first sites to open for recruitment. Further sites will open and commence recruitment as dose escalation progresses and the phase 2 part of the trial gets underway. Approximately 35 patients will be enrolled across the phase 1/2 trial.

DEP cabazitaxel is Starpharma’s detergent-free version of cancer drug, Jevtana, which is marketed by Sanofi Aventis to treat advanced prostate cancer, and is also under clinical development for a range of other cancer types, including testicular, ovarian, breast, bladder, and head and neck. Jevtana sales are estimated to reach approximately US$500 million this year.

DEP cabazitaxel is the second product from Starpharma’s DEP platform to enter the clinic, and follows DEP docetaxel, which delivered positive phase 1 clinical results in 2017 and recently progressed to phase 2. The reproducible benefits observed for DEP docetaxel and DEP cabazitaxel in preclinical models include decreased bone marrow toxicity and enhanced efficacy, and in both cases DEP has also allowed for a detergent-free formulation resulting in significant additional benefits for patients.

In parallel, AstraZeneca’s first DEP product, AZD0466, has been developed under licence with Starpharma and has also demonstrated preclinical improvements consistent with findings for DEP docetaxel and DEP cabazitaxel.

The phase 1/2 study for DEP cabazitaxel will enrol patients with advanced solid tumours and is an open-label study. In phase 1, DEP cabazitaxel will be administered once every three weeks at escalating doses to determine if there are any Dose Limiting Toxicities (DLTs) and to establish the Maximum Tolerated Dose (MTD). The characterisation of the safety, tolerability and PK profile of DEP cabazitaxel will help establish and characterise the RP2D.

In phase 2, the study will initially enrol up to 20 patients at the RP2D to determine the anti-tumour efficacy of DEP cabazitaxel in specific tumour types, and to further characterise the safety, tolerability and PK of the product.

The adaptive trial design employed enables Starpharma to move seamlessly from phase 1 to phase 2 and to explore efficacy as early as possible. As the trial progresses, decisions will be made as to which tumour types to focus on and any additional patients required to further characterise efficacy in specific tumour types.

Dr Jackie Fairley, Starpharma CEO, commented: "We are delighted to advance DEP cabazitaxel – our second DEP product from our internal portfolio to the clinic. DEP cabazitaxel has already delivered exciting preclinical results showing sustained efficacy and survival benefits, as well as eliminating neutropenia, which is a significant dose-limiting side effect of many anti-cancer drugs, including Jevtana.

"These benefits for DEP cabazitaxel are consistent with the recent positive phase 1 results for our lead internal DEP product, DEP docetaxel and findings in partnered DEP programs. The growing body of data from our DEP products illustrates the broad applicability of the DEP platform and the compelling commercial advantages of enhancing drug performance and reducing toxicity for patients, while extending patent life", concluded Dr Fairley.

About DEP cabazitaxel

Starpharma’s DEP platform was utilised to create DEP cabazitaxel, a detergent free version of cancer drug Jevtana. Jevtana is a leading oncology agency which is used to treat advanced prostate cancer and also under development for other cancers including breast cancer, bladder cancer and head and neck cancer. The current (non-dendrimer) formulation product has US Food and Drug Administration (FDA)-mandated ‘black box’ warnings in relation to neutropenia, which is a major dose limiting side effect, and sever hypersensitivity (e.g. anaphylaxis) resulting from the polysorbate 80 detergent used in its formulation.

DEP cabazitaxel significantly outperformed Jevtana in a human breast cancer model with respect to both level and duration of anti-cancer activity and survival, whilst protecting against the development of neutropenia, which is a serious side effect for Jevtana.

On January 31, 2018 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported that the first patient was dosed in a global Phase 3 clinical trial of tislelizumab, an investigational anti-PD-1 antibody, as a potential second-line treatment in patients with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC) (Press release, BeiGene, JAN 31, 2018, View Source;p=RssLanding&cat=news&id=2329344 [SID1234523649]). Tislelizumab is also being studied in global Phase 3 trials in non-small cell lung cancer and hepatocellular carcinoma and two pivotal Phase 2 trials in China in relapsed/refractory classical Hodgkin lymphoma and urothelial cancer.

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"We are pleased to be leading the third global Phase 3 study of tislelizumab under our strategic collaboration with Celgene. These studies are designed to support regulatory filings both in China and globally, and take advantage of our unique global clinical development organization as well as the recent regulatory reforms in China. In 2018, we look forward to further expanding the development program for tislelizumab and to accomplishing key milestones including a planned NDA submission in China," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene.

"Patients with advanced unresectable or metastatic esophageal carcinomas face poor prognosis, especially those with squamous histology, due to the extremely aggressive nature of the disease. We are hopeful that this Phase 3 trial will establish safety and efficacy of tislelizumab as an important treatment option for these patients," commented Amy Peterson, M.D., Chief Medical Officer, Immuno-Oncology, at BeiGene.

The Phase 3, open-label, multi-center, randomized trial is designed to compare the efficacy and safety of tislelizumab compared to investigator-chosen chemotherapy as a second-line treatment in patients with advanced unresectable or metastatic ESCC. Approximately 450 patients are planned to be enrolled in Greater China, Japan, Korea, Belgium, France, Germany, Italy, Spain, the United Kingdom and the United States. Patients will be randomized to receive either tislelizumab at 200 mg every three weeks or one of three single-agent chemotherapies, paclitaxel, docetaxel, or irinotecan, as determined by the investigator.

The trial’s primary endpoint is overall survival, and secondary endpoints include progression-free survival, objective response rate, duration of response, health-related quality of life, safety, and tolerability.

"Treatment options for esophageal squamous cell carcinoma have been limited to chemotherapy. Tislelizumab has shown promising anti-tumor activity and has been generally well-tolerated in clinical trials to date in patients with a variety of cancers, including esophageal cancer, and we are hopeful that data from this Phase 3 trial will lead to a new treatment option where it is so greatly needed," said Professor Lin Shen, M.D., Vice President at the Beijing Cancer Hospital, Beijing, China, and lead investigator of the trial.

For more information about the trial, patients and physicians should email BeiGene at [email protected].

About Esophageal Squamous Cell Carcinoma

Esophageal cancer, which includes squamous cell carcinoma, is considered a serious malignancy with respect to prognosis and a fatal outcome in the great majority of cases. Esophageal carcinoma affects more than 450,000 people worldwide.i Esophageal cancer is the eighth most common cancer worldwide and the sixth most common cause of death from cancer.ii

Esophageal squamous cell carcinoma occurs at a rate 20 to 30 times higher in China than in the United States.i An esophageal "cancer belt," primarily squamous cell cancers, extends from northeast China to the Middle East.i Advanced esophageal cancer is a rapidly fatal disease. More than two-thirds of patients diagnosed with esophageal cancer will have advanced or metastatic disease, with a median survival of 8-10 months and an expected five-year survival rate of less than five percent.iii These data, combined with the relative lack of highly effective treatment, are indicative of the large unmet medical need in patients diagnosed with esophageal cancer.

About Tislelizumab (BGB-A317)

Tislelizumab is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for tislelizumab for solid tumors outside of Asia (except Japan).

On January 31, 2018 Seattle Genetics, Inc. (Nasdaq:SGEN) and Cascadian Therapeutics, Inc. (Nasdaq:CASC) reported the signing of a definitive merger agreement under which Seattle Genetics has agreed to acquire Cascadian Therapeutics (Press release, Cascadian Therapeutics, JAN 31, 2018, View Source [SID1234523651]). Under the terms of the agreement, Seattle Genetics will pay $10.00 per share in cash, or approximately $614 million. The transaction was unanimously approved by the Boards of Directors of both companies.

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Cascadian Therapeutics’ most advanced program is tucatinib, an investigational oral, small molecule tyrosine kinase inhibitor (TKI) that is highly selective for HER2, a growth factor receptor that is overexpressed in multiple cancers, including breast, colorectal, ovarian and gastric. Tucatinib is currently being evaluated in a randomized global pivotal trial called HER2CLIMB for patients with HER2-positive (HER2+) metastatic breast cancer, including patients with or without brain metastases. Tucatinib has been evaluated as a single agent and in combination with both chemotherapy and other HER2-directed agents including Herceptin (trastuzumab) and Kadcyla (trastuzumab emtansine). Results from phase 1b trials showed that the combination of tucatinib, capecitabine and trastuzumab was generally well-tolerated and demonstrated clinical activity in patients with and without brain metastases. The data support the ongoing pivotal trial and the potential role of tucatinib in earlier lines of metastatic breast cancer.

"This acquisition would enhance our late-stage clinical pipeline with a potentially best-in-class, orally available and highly selective TKI for patients with HER2-positive metastatic breast cancer," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Tucatinib would complement our existing pipeline of targeted cancer therapies, provide a third late-stage opportunity for a commercial product in solid tumors and expand our global efforts in breast cancer. It also leverages our broad expertise and resources to advance and expand the tucatinib program for patients. Beyond breast cancer, we believe there may be opportunities for tucatinib in other tumor types, such as HER2-positive metastatic colorectal cancer. Cascadian’s pipeline also includes a preclinical immuno-oncology agent. We look forward to welcoming the team at Cascadian Therapeutics and continuing the momentum of the tucatinib development program."

"This agreement represents a very positive outcome for patients with HER2-expressing cancers, our employees and for our stockholders," said Scott D. Myers, President and Chief Executive Officer of Cascadian Therapeutics. "Seattle Genetics has the development and commercial capabilities and the resources needed to more fully realize the potential of tucatinib as a new best-in-class treatment option for metastatic breast cancer, colorectal cancer and potentially for other indications."

Terms of the Transaction

Under the terms of the definitive merger agreement, Seattle Genetics will commence a tender offer on or about February 8, 2018 to acquire all of the outstanding shares of common stock of Cascadian Therapeutics for $10 per share in cash. This represents a 69 percent premium to the closing price of Cascadian Therapeutics’ common stock on Tuesday, January 30, 2018, and a 139 percent premium to its 30-day volume weighted average stock price. The tender offer is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of Cascadian Therapeutics common stock (on a fully diluted basis) and the expiration or early termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Following the closing of the tender offer, a wholly-owned subsidiary of Seattle Genetics will merge with and into Cascadian Therapeutics, with each share of Cascadian Therapeutics common stock that has not been tendered being converted into the right to receive the same $10 per share in cash offered in the tender offer. The transaction is anticipated to close in the first quarter of 2018.

In connection with the transaction, Seattle Genetics has secured a financing commitment in the amount of $400 million from Barclays and JPMorgan-Chase Bank. The balance of the consideration will be provided from cash on hand.

Leerink Partners LLC is acting as lead financial advisor to Seattle Genetics. Barclays and J.P. Morgan Securities LLC are also acting as financial advisors on the transaction. Perella Weinberg Partners LP is acting as financial advisor to Cascadian Therapeutics. Legal counsel for Seattle Genetics is Sullivan & Cromwell LLP and legal counsel for Cascadian Therapeutics is Reed Smith LLP. Goodwin Procter LLP acted as special counsel for the Cascadian Therapeutics Board of Directors and Board transaction committee.

Seattle Genetics Preliminary Financial Results

In conjunction with today’s announcement, Seattle Genetics separately reported preliminary unaudited consolidated financial results as of and for the quarter and year ended December 31, 2017 as follows:

Three Months Ended December 31, 2017 Year Ended December 31, 2017
Total revenues $128 million to $130 million $481 million to $483 million

ADCETRIS net product sales in the U.S. and Canada $82 million to $84 million $306 million to $308 million

Total revenues increased from the comparable periods in 2016 primarily as a result of increased ADCETRIS net product sales. ADCETRIS net product sales increased from the comparable periods in 2016 primarily due to an increase in sales volume and, to a lesser extent, price increases. The increases in sales volumes in both periods were driven primarily by increased use of ADCETRIS across multiple lines of therapy in Hodgkin lymphoma and for the treatment of other malignancies.

In addition, as of December 31, 2017, Seattle Genetics had approximately $413 million in cash and cash equivalents and short-term investments.

Conference Call Details

Seattle Genetics’ management will host a conference call and webcast to discuss the transaction today at 5:30 a.m. Pacific Time (PT); 8:30 a.m. Eastern Time (ET). The live event will be available from the Seattle Genetics website at www.seattlegenetics.com, under the Investors section, or by calling 800-281-7973 (domestic) or 323-794-2093 (international). The conference ID is 7936538. A replay of the discussion will be available beginning at approximately 8:30 a.m. PT today from the Seattle Genetics website or by calling 888-203-1112 (domestic) or 719-457-0820 (international), using conference ID 7936538. The telephone replay will be available until 5:00 p.m. PT on Friday, February 2, 2018.

On January 31, 2018 Johnson & Johnson (NYSE: JNJ) will participate in the Leerink Partners 7th Annual Global Healthcare Conference on Wednesday, Feb. 14, at Lotte New York Palace, NY (Press release, Johnson & Johnson, JAN 31, 2018, View Source [SID1234523686]). Dominic Caruso, Executive Vice President, Chief Financial Officer will represent the Company in a session scheduled at 9:30 a.m. (Eastern Time).

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This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

A webcast and podcast replay will be available approximately two hours after the live webcast.