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Genomic Health to Announce Third Quarter 2018 Financial Results and Host Conference Call on Tuesday, November 6, 2018

On October 30, 2018 Genomic Health, Inc. (NASDAQ: GHDX) reported that the company will host a conference call and webcast on Tuesday, November 6 at 4:30 p.m. Eastern Time to discuss its third quarter 2018 financial results (Press release, Genomic Health, OCT 30, 2018, https://www.prnewswire.com/news-releases/genomic-health-to-announce-third-quarter-2018-financial-results-and-host-conference-call-on-tuesday-november-6-2018-300738438.html [SID1234530352]). The call and webcast will follow the release of the third quarter financial results after market close.

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Conference Call Details
To access the live conference call on November 6 at 4:30 p.m. Eastern Time via phone, please dial (877) 303-7208 from the United States and Canada, or +1 (224) 357-2389 internationally. The conference call ID is 9448559. Please dial in approximately ten minutes prior to the start of the call.

To access the live and subsequently archived webcast of the presentation, go to the Investor Relations section of the company’s web site at View Source Please connect to the web site at least 15 minutes prior to the presentation to allow for any software download that may be necessary.

Mirati Therapeutics Announces Submission of IND Application for MRTX849, a KRAS G12C Inhibitor, to Treat Non-Small Cell Lung Cancer and Colorectal Cancer

On October 30, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology company, reported that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2 trial with the initial goal to evaluate safety, tolerability and pharmacokinetics of the Company’s KRAS G12C inhibitor, MRTX849, in patients with advanced solid tumors (Press release, Mirati, OCT 30, 2018, View Source [SID1234530351]). The trial will utilize an accelerated titration design with single patient cohorts and intra-patient dose escalation to rapidly achieve an active dose level for MRTX849. Phase 2 expansion cohorts will enroll patients whose tumors are driven by KRAS G12C positive mutations. The Phase 2 portion of the trial in patients with non-small cell lung cancer (NSCLC) or colorectal cancer (CRC) may provide proof of concept and the basis for accelerated approval.

"MRTX849, is a potent, highly selective inhibitor of G12C positive mutations. These mutations occur in large patient populations with NSCLC and CRC tumors, and are also present in patients with other solid tumors, such as pancreatic cancer. We submitted the IND on October 29th, 2018 and plan to begin enrolling patients soon after FDA approval is received. The trial is designed to enable early clinical efficacy data in 2019," said Charles Baum, M.D., Ph.D., President and Chief Executive Officer, Mirati Therapeutics, Inc. "KRAS has long been one of the most difficult targets in all of oncology and this program has the potential to be a breakthrough for patients with G12C positive mutations."

"KRAS has been an elusive target for researchers for more than 30 years. It’s exciting to see an IND filing that would potentially provide a therapy for patients with G12C mutations, which were once considered undruggable and who have had no viable treatment options," said Channing J. Der, Ph.D., the Sarah Graham Kenan Professor of Pharmacology at the University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center.

About MRTX849

MRTX849 is an orally-available small molecule that potently and selectively inhibits a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of NSCLC adenocarcinoma patients and 5% of colorectal cancer patients. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MTRX849 has demonstrated broad-spectrum tumor regression in a large cohort of KRAS G12C-positive pre-clinical in-vivo human tumor models. MRTX849 demonstrated complete regression of tumors in a subset of models at well-tolerated dose levels. Early proof-of-concept clinical data is anticipated in 2019.

PharmaCyte Biotech Announces Publication of United States Patent Application for Cancer Therapies

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.

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

AVID200’s Ability to Enhance Anti-tumor T-cell Activity and Promote Sensitivity to PD1 Blockade is Featured in a Poster Presentation at the 2018 BioCanRx Summit for Cancer Immunotherapy

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.

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.

LSKB Announces Completion of Enrollment for the ANGEL Study of Rivoceranib (Apatinib) in Gastric Cancer

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).

"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.