On October 30, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that its Patent Application titled "Encapsulated Cells Producing Cytochrome P450 and Methods of Use Thereof," which covers a targeted therapy to treat solid cancerous tumors, was published in the United States on September 27, 2018, (Publication No. US 2018/0271794 A1) (Press release, PharmaCyte Biotech, OCT 30, 2018, View Source [SID1234530350]). Unlike the previously announced PCT Application, which was international in nature, this Patent Application is specific to the United States.

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PharmaCyte Biotech’s Chief Executive Officer, Kenneth L. Waggoner, stated, "This patent application in concert with the previously announced PCT application (Publication No. WO 2018/175576) that was filed to gain protection in most major markets worldwide, if granted, will provide protection for PharmaCyte’s technology for 20 years without a gap in patent protection – until March 2038.

"Publication of this U.S. Patent Application by the U.S. Patent and Trademark Office (USPTO) is significant in allowing us to protect our unique complex cancer therapy for many years in this country. This development becomes more and more important as we progress with our clinical trial in patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC).

"As described in the Patent Application, through use of the Cell-in-a-Box live-cell encapsulation technology, PharmaCyte may be able to develop unique therapies for other forms of solid tumors, particularly where safety and efficacy are of major concern."

This Patent Application also includes methods of treating cancerous tumors other than pancreatic cancer, such as those of the liver, breast and colon. This could be accomplished by using cancer prodrugs such as ifosfamide and its "sister" drug cyclophosphamide together with encapsulated live human cells that overexpress a form of the cytochrome P450 enzyme system normally found in the liver (the same encapsulated cells used in PharmaCyte’s pancreatic cancer therapy). The patent application also includes using PharmaCyte’s platform technology with other cancer chemotherapy prodrugs against a variety of tumors other than those noted above. In all cases, the Cell-in-a-Box cellulose-based-live-cell encapsulation technology will be used to prepare the "biologic" part of any of the cancer treatments.

The original Provisional Patent Application that preceded the current application was filed with the USPTO on March 21, 2017, well before the Bavarian Nordic patents expired. The current application was filed with the USPTO on March 21, 2018. There should be no gap in patent protection assuming PharmaCyte’s patent application is granted

On October 29, 2018 Forbius, a clinical stage company developing biotherapeutics targeting EGFR and TGF-β pathways, reported a poster presentation demonstrating the ability of AVID200, an isoform selective TGF-β inhibitor, to enhance the anti-tumor activity of T-cells (Press release, Forbius, OCT 29, 2018, View Source [SID1234531669]). Notably, AVID200 significantly enhanced the activity of anti-PD-L1 immune checkpoint inhibition in vivo. This presentation highlights the collaborative work done with the laboratory of Dr. James Koropatnick, Director of the Strategic Training Program in Cancer Research and Technology Transfer at the London Health Sciences Centre. This research is sponsored by the previously announced peer-reviewed BioCanRx grant with a total project value of CAD$1,655,297, and BioCanRx contributing CAD$675,000.

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About AVID200
Forbius developed AVID200 to be a highly potent and isoform-selective TGF-β inhibitor. AVID200 neutralizes TGF-β1 and-β3 with pM potency. These isoforms are known to be drivers of fibrosis and tumor immune resistance. In contrast, TGF-β2 is a positive regulator of hematopoiesis and normal cardiac function, and blockade of TGF-β2 is therefore undesirable. The ability of AVID200 to selectively target TGF-β1 and -β3 positions it to be an effective and well-tolerated therapeutic in fibrotic diseases and immuneoncology.

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.