On January 31, 2018 Alexion Pharmaceuticals (Nasdaq: ALXN) reported that management will present at the Leerink Partners 7th Annual Global Healthcare Conference in New York City on Wednesday, February 14, 2018 at 11:00 a.m., ET (Press release, Alexion, JAN 31, 2018, View Source [SID1234523659]).

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An audio webcast of the presentation will be available live. You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

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 Oncoceutics, Inc. reported that the first patient has been treated in a clinical trial of ONC201 for pediatric patients with brain tumors that contain a specific mutation called the histone H3 K27M mutation (Press release, Oncoceutics, JAN 31, 2018, View Source [SID1234558373]). The trial, which will treat patients with recurrent high-grade gliomas, including glioblastoma and diffuse intrinsic pontine glioma (DIPG), is led by Sharon Gardner, MD, a pediatric neuro-oncologist at NYU Langone Health’s Stephen D. Hassenfeld Children’s Center for Cancer & Blood Disorders. The study will enroll approximately 45 pediatric patients using ONC201 as a single agent or in combination with radiotherapy for patients with recurrent or newly diagnosed disease, respectively.

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The H3 K27M mutation has been identified as an important prognostic indicator in aggressive midline gliomas that involve specific parts of the brain, including the thalamus, pons, or spinal cord. In 2016, the World Health Organization categorized any midline brain tumor that contains the H3 K27M mutation as the highest grade (IV) because the mutation confers such a poor prognosis. Beyond palliative radiation, no medical therapy has been shown to provide clinical benefit for patients with this mutation in their tumor. Pediatric patients are particularly impacted by this mutation, especially those with DIPG where 70-80% of the patients have the mutation.

As previously announced, the company’s focus on H3 K27M mutual gliomas arose from success with a patient in the first group of its phase II trial for recurrent glioblastoma conducted at Harvard. This patient, a 22-year old woman, had the H3 K27M mutation and has experienced a 96% reduction in tumor size. She remains on therapy today (after 22 months) and has returned to her normal activities. Based on the strong result for this patient, Oncoceutics enrolled additional brain tumor patients with the H3 K27M mutation, and some of these patients have also done well, including a patient whose tumors have completely disappeared. In addition to enrolling more adult patients with the H3 K27M mutation at Harvard (where the trial was limited to adults), we have enrolled a handful of children with brain tumors that have the mutation under compassionate use protocols, special permission from the FDA to enroll patients on a case-by-case when there is no approved clinical trial accessible to the patient. We have also seen signs of efficacy in these children. In total, 14 patients with brain tumors that have the H3 K27M mutation have been treated with single agent ONC201 (7 in formal clinical studies and 7 in compassionate use studies), and five of these patients have demonstrated clinical and/or radiographic benefit from ONC201 therapy. These data will be reported in upcoming scientific conferences and publications. In addition, corroborating preclinical efficacy and mechanistic studies from the lab of Andrew Chi, MD, also at NYU Langone Health, have shown that H3 K27M gliomas cells are extremely sensitive to ONC201.

"The previously reported responses to ONC201 in patients with H3 K27M gliomas, combined with the preclinical results from Dr. Chi’s lab here at NYU, make me excited to offer ONC201 to our patients with this molecularly-defined disease," said Dr. Gardner. "To date, no drugs have proven effective in these tumors, and this patient population is in need of novel therapeutic options.

"We are excited to expand our existing clinical program targeted at patients with the H3 K27M mutation to the pediatric populations," said Lee Schalop, MD, Chief Operating Officer at Oncoceutics. "Based on the results we have seen in patients with the H3 K27M tumor mutation who have received ONC201, as well as the preclinical data generated by Dr. Chi, we believe that ONC201 offers a unique opportunity to eliminate these devastating tumors."