On october 29, 2018 LSK BioPharma (LSKB, Company) reported it has completed patient enrollment in its pivotal Phase 3 trial, ANGEL, which is evaluating the efficacy and safety of rivoceranib plus Best Supportive Care (BSC) compared to placebo plus BSC in patients with advanced or metastatic gastric cancer (Press release, LSK BioPharma, OCT 29, 2018, View Source [SID1234530520]). The ANGEL study is designed to support approval by the U.S Food and Drug Administration (FDA), the European Medicines Agency (EMA), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Korean Ministry of Food and Drug Safety (MFDS) and Taiwan Food and Drug Administration (TFDA).

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"Completion of enrollment in the ANGEL study is an important achievement and a critical milestone for our gastric cancer program and we appreciate all of the support from patients and investigators in accomplishing this global development milestone" said Dr. Sung Chul Kim, LSKB President, "Although rivoceranib has been approved in China, there is still no oral small-molecule angiogenesis inhibitor approved outside of China for gastric cancer. We believe it will be the first such drug for these patients worldwide."

The Company will now focus on follow-up of enrolled patients and preparation of the data for analysis with an expectation that the top-line, unblinded efficacy and safety data will be reported in the second half of 2019. The Company further expects to submit a New Drug Application for rivoceranib with the FDA in late 2019.

About the ANGEL Study

The ANGEL study is a prospective, randomized, double-blinded, placebo-controlled, multinational, multicenter, parallel-group, phase III study to evaluate the efficacy and safety of rivoceranib plus Best Supportive Care (BSC) compared to placebo plus BSC in patients with advanced or metastatic gastric cancer. A total of 459 patients have been randomized in the ANGEL study in 12 countries (in USA, EU, EEC, Japan, Korea and Taiwan). Details of the ANGEL Study can be found at the following link: View Source

About Rivoceranib (Apatinib)
Rivoceranib is the first successful oral small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis. It was approved in China (advanced gastric cancer, Dec 2014) where it is marketed by the Chinese-territory license-holder Jiangsu Hengrui Medicine Co., Ltd. LSK BioPharma holds the global rights (ex-China). The Company is currently conducting a global (12 countries including US, Japan, Korea, Italy, Germany, and Russia) Phase 3 clinical trial of rivoceranib in advanced or metastatic gastric cancer patients. Rivoceranib has been clinically tested in over 1,000 patients worldwide and has demonstrated efficacy in numerous cancers including gastric cancer, CRC, HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to significantly improve clinical outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. LSKB has received notification designating rivoceranib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the US FDA, as well as the MFDS in South Korea.

On Octpber 29, 2018 CStone Pharmaceuticals (CStone) reported the initiation in China of a Phase I clinical trial for CS3006, a small-molecule MEK1/2 inhibitor (Press release, CStone Pharmaceauticals, OCT 29, 2018, View Source [SID1234530446]). A first patient has been successfully enrolled and dosed at the 307th Hospital of the Chinese People’s Liberation Army in Beijing.

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"CS3006 is a highly selective mitogen-activated protein kinase (MEK) inhibitor developed by CStone", commented CStone’s chairman and Chief Executive Officer Dr. Frank Jiang. "We are very optimistic that current data for CS3006 compares favorably with other MEK inhibitors on the market currently. In addition, CS3006 is viewed as having great potential as part of combination therapy with CStone’s other pipeline candidates. We will continue to work to explore the value of CS3006 to provide effective new treatment options for cancer patients."

Dr. Jason Yang, CStone’s Chief Medical Officer, noted: "We completed patient enrollment in a first-in-human study for CS3006 initiated in Australia during the first-half of this year, a study that is progressing smoothly. This China Phase I bridging trial will further assess CS3006’s safety and preliminary efficacy in Chinese patients with solid tumors, and provide a foundation for further development. Thanks to the support of all parties involved, we have been surprised by the progress of CS3006 in China and will continue to push forward to insure CS3006 can benefit Chinese patients as soon as possible."

The Phase I study will be led by Dr. Xu Jianming of the 307th Hospital of the Chinese People’s Liberation Army, who said: "We are pleased to enroll the first patient in this study. We hope that this MEK inhibitor could provide patients a viable new treatment option either as a monotherapy or in combination with other immunotherapy drugs. We look forward to working together with CStone in assessing the safety and efficacy of CS3006 in patients with late-stage tumors."

About the MEK pathway

The RAS-RAF-MEK-ERK signal transduction pathway is among the most fundamental intracellular signaling pathways found in the majority of cells and is responsible for regulating key cellular activities such as cell growth, proliferation, survival, and apoptosis. MEK1 and MEK2 are serine/threonine protein kinases that act downstream of RAS and RAF to activate ERK. The inhibition of MEK can affect tumor cell survival, proliferation, and differentiation. Currently, three MEK inhibitors have been approved and marketed globally: Novartis’s MEKINIST (trametinib), Roche’s COTELLIC (cobimetinib) and Array’s Mektovi (binimetinib).

On October 29, 2018 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported that it will present data from its ongoing studies utilizing Cchek, Anixa’s artificial intelligence (AI) driven early cancer detection technology, at the 33rd Annual Meeting of The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Anixa Biosciences, OCT 29, 2018, View Source [SID1234530445]). Cutting-edge research will be presented by experts in the field of applied cancer immunotherapy and translational research. Anixa will be presenting both an oral and poster presentation. The meeting will be held November 9–11, 2018 in Washington, D.C. and will be attended by both U.S. and international researchers, regulators, and healthcare professionals who are involved in cancer research and clinical care.

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Oral Presentation:

Title: Using artificial intelligence to distinguish subjects with prostate cancer (PCa) from benign prostatic hyperplasia (BPH) through immunophenotyping of MDSCs and lymphocyte cell populations
Presenter: George A. Dominguez, Ph.D.
Abstract ID: 10805
Session: Concurrent Session 215: Myeloid Derived Suppressor Populations
Date and Time: Saturday, November 10, 2018; 6:15 PM – 6:30 PM ET

Poster Presentation:

Title: Using artificial intelligence to distinguish subjects with prostate cancer (PCa) from benign prostatic hyperplasia (BPH) through immunophenotyping of MDSCs and lymphocyte cell populations
Authors: George A. Dominguez, Ph.D.; John Roop; Alex Polo; Anthony J. Campisi; Dmitry I. Gabrilovich, MD, Ph.D.; Amit Kumar, Ph.D.
Poster Number: O2
Category: Biomarkers and Immune Monitoring
Location: Walter E. Washington Convention Center, Hall E
Date and Time: Friday, November 9, 2018 (8 AM – 8 PM ET) and Saturday, November 10, 2018 (8 AM – 8:30 PM ET); Presentation – Saturday, November 10, 2018 (12:20 – 1:50 PM ET and 7 – 8:30 PM ET)

To receive a copy of the presentations, please email your request to SITC (Free SITC Whitepaper)[email protected] starting November 11, 2018 and include your name, title, and contact information.

"We are pleased to be presenting at SITC (Free SITC Whitepaper). As SITC (Free SITC Whitepaper) restricts detailed discussion of presentation contents ahead of the conference, we will make presentation information available after the conference," stated Dr. Amit Kumar, President and CEO of Anixa Biosciences.

Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)
The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (www.sitcancer.org) is a 501(c)(3) not-for-profit organization that has been serving scientists, clinicians, academicians, patients, patient advocates, government representatives and industry leaders from around the world since 1984. With more than 2,000 members, SITC (Free SITC Whitepaper) is the world’s leading member-driven organization specifically dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. SITC (Free SITC Whitepaper) aims to make cancer immunotherapy a standard of care and the word "cure" a reality for cancer patients everywhere.

On October 29, 2018 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that it will report financial results for the quarter ended September 30, 2018 on Friday, November 2, 2018 (Press release, CytRx, OCT 29, 2018, View Source [SID1234530444]). CytRx executives Eric L. Curtis, President and Chief Operating Officer, and John Caloz, Chief Financial Officer, will hold a conference call and webcast beginning at 11:00 a.m. Eastern Time (8:00 a.m. Pacific Time) on that day to discuss the financial results as well as provide an overview of corporate strategy and achievements.

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To access the conference call, dial (+1)844-358-6753 (U.S. and Canada) or (+1)216-562-0397 (international callers) and enter the conference ID number: 4382473. A live and archived webcast will be available in the investor relations section of the company’s website, www.cytrx.com. A replay of the call and webcast will begin approximately two hours after the live call has ended. To access the replay, dial (+1)855-859-2056 (U.S. and Canada) or (+1)404-537-3406 (international callers) and enter the conference ID number: 4382473

On October 29, 2018 Thermo Fisher Scientific, the world leader in serving science, and Symphogen, a clinical-stage antibody oncology-focused company, reported that have entered into a two-year collaborative partnership to deliver validated, platform workflows for simplified characterization and quality monitoring of complex therapeutic proteins (Press release, Thermo Fisher Scientific, OCT 29, 2018, View Source [SID1234530443]).

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Building on a decade-long relationship, the new collaboration will develop protein analysis workflows to accelerate drug development for biopharmaceutical innovators, biosimilar manufacturers, contract research organizations, and contract development and manufacturing organizations.

Symphogen will use the Thermo Scientific Q Exactive Plus Orbitrap liquid chromatography-tandem mass spectrometry (LC-MS/MS) system with BioPharma Option to create, test and validate platform workflows for intact and native mass analysis of therapeutic monoclonal antibody (mAb) mixtures. Additional focus will be placed on the development of automated multi-attribute method (MAM) workflows for monitoring critical quality attributes of proteins using high-resolution accurate-mass mass spectrometry in a quality control environment.

"The growing demand for more targeted and personalized treatment modalities results in the development of increasingly complex drug products, requiring research and development of advanced workflows to monitor their structure, manufacturing variation and quality," said John Rontree, senior director pharma & biopharma, chromatography and mass spectrometry, Thermo Fisher Scientific. "The collaboration with Symphogen, in addition to our commitment to the opening of Global Customer Solution Centers, will enable us to jointly leverage our established mass spectrometry technology, along with the expertise of our customers, to develop and implement novel, easy-to-use analytical strategies for complex mAb mixtures needed by drug manufacturers to drive the development of new therapies for cancer patients."

"Through this collaboration, we can leverage the knowledge and world-class technology provided by Thermo Fisher to effectively address our needs," said Dan Bach Kristensen, Ph.D., principal scientist, Symphogen. "The exceptional spectral resolution enabled by the Q Exactive BioPharma mass spectrometry platform means we now have a highly powerful tool for simple, reliable characterization and quality monitoring of complex biopharmaceutical products."

The Q Exactive Plus Orbitrap LC-MS/MS system is the latest addition to the Thermo Fisher portfolio of products used by Symphogen, which includes Thermo Scientific ultra high-performance liquid chromatography (UHPLC) systems and Thermo Scientific Chromeleon Chromatography Data Systems (CDS).

For more information about Thermo Fisher’s chromatography and mass spectrometry workflows for biopharmaceutical characterization, please visit www.thermofisher.com/contactmebiopharma.