On October 29, 2018 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the FDA has allowed the Investigational New Drug (IND) application for Athenex’s oral version of Eribulin currently named Eribulin ORA (Press release, Athenex, OCT 29, 2018, View Source;p=RssLanding&cat=news&id=2373833 [SID1234530318]).

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This FDA action allows Athenex to commence its clinical trial program, currently planned for first half of 2019. Eribulin, an effective treatment for metastatic breast cancer and liposarcoma, is currently limited to intravenous administration. Utilizing Athenex’s proprietary Orascovery platform with Eribulin, we were able to demonstrate that good oral absorption of Eribulin is possible, based on preclinical studies. In addition, the Eribulin active pharmaceutical ingredient (API) has been developed internally using a novel synthetic approach. We believe these developments demonstrate the broad utility of the Orascovery platform and commitment of Athenex to becoming a major global oncology biopharmaceutical company.

Dr. Michael Smolinski, Athenex’s Head of Preclinical Research, commented, "Athenex is delighted that the FDA has allowed the IND of Eribulin ORA. The demonstration of a favorable pharmacokinetic profile, with lowered peak plasma concentration and longer duration of the drug within the desired plasma concentration range, provides the potential for a better efficacy and an improved safety profile for Eribulin, similar to what we have observed with Oraxol (oral form of paclitaxel) and others. We have also developed a novel and efficient synthetic process for Eribulin with an excellent purity profile. This is the eighth US IND allowance that Athenex has obtained, reflecting the passion and dedication of the company to bringing new therapies to cancer patients."

Eribulin is an anticancer drug marketed by Eisai Company under the trade name Halaven. It is used to treat certain patients with breast cancer and liposarcoma. Eribulin is a synthetic derivative of the natural product Halichondrin B. The potent anticancer effects of this agent come primarily from its unique means of targeting microtubule dynamics, a process critical to cell proliferation.

Dr. Rudolf Kwan, Athenex’s Chief Medical Officer, stated, "Eribulin is approved for the treatment of metastatic breast cancer patients who have received at least two prior chemotherapy regimens for late-stage disease, including both anthracycline- and taxane-based chemotherapies. It is important to note that Eribulin is active in paclitaxel resistant tumors. This profile is expected to create a number of synergistic opportunities with the other drug candidates in our Orascovery clinical pipeline. We look forward to initiating the Phase I clinical studies soon."

The lead compound in Athenex’s Orascovery program, Oraxol, is currently in a pivotal Phase III study. The Orascovery platform was developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

On October 29, 2018 Epigenomics AG (FSE: ECX, OTCQX: EPGNY) reported that it has received CE Mark for its blood test to aid in detecting liver cancer among patients with cirrhosis two months ahead of schedule (Press release, Epigenomics, OCT 29, 2018, View Source [SID1234530252]). The test will be commercialized under the brand name "HCCBloodTest". In 2019, the company plans to initiate a prospective clinical trial in the U.S. for submission to the FDA. Additionally, Epigenomics is evaluating options to expedite CFDA approval in China.

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In a recently reported clinical study, the HCCBloodTest demonstrated high sensitivity of 90.6 percent at a specificity of 87.2 percent for the indication of liver cancer. Furthermore, the blood test exhibited higher diagnostic accuracy compared to alpha-fetoprotein (AFP), a widely used serum diagnostic marker for liver cancer.

According to the World Health Organization (WHO), liver cancer is the second most common cause of death from cancer worldwide with Hepatocellular carcinoma (HCC) accounting for 70-90 percent of primary liver cancers (PLC)*. A major risk-factor for developing HCC is liver cirrhosis. Globally, Epigenomics estimates the liver cirrhosis surveillance market to be in excess of 10 million tests per year making it more than a three billion Euro market opportunity globally.

In Europe, liver cirrhosis is responsible for over 170,000 deaths per year* and Epigenomics estimates approximately three million patients per year in Western Europe are eligible for liver surveillance resulting in a total available market of over one billion Euros per year. Epigenomics is currently evaluating the best potential commercial partnership opportunities for the distribution of the product.

"We are very excited about the opportunity to launch the first liquid biopsy IVD test for liver cancer", said Greg Hamilton, CEO of Epigenomics AG. "Detecting liver cancer in cirrhosis patients represents a significant medical need worldwide. Based on the initial performance data of the test, we are moving forward with prospective clinical studies to capitalize on the opportunity to address this deadly disease."

On October 29, 2018 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology, reported that it will report financial results for third quarter 2018 on Tuesday, November 6, 2018 after U.S. financial markets close (Press release, Aclaris Therapeutics, OCT 29, 2018, View Source [SID1234530355]).

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Management will conduct a conference call at 5:00 PM ET that day to discuss the Company’s financial results and provide a general business update. A live webcast of the event can be accessed on the Events and Presentations page on the Investors section of the Aclaris website at View Source A replay of the webcast will be archived on the Aclaris website following the event.

To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 7694929 prior to the start of the call.

On October 29, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), reported that Dr. Ramesh Kumar, CEO, will be meeting with potential Investors and Business Development partners at the 2018 Bio-Europe International Partnering Conference in Copenhagen (Press release, Onconova, OCT 29, 2018, View Source [SID1234530289]).

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Dates: Monday – Wednesday, November 5-7, 2018
Venue: Bella Center – Copenhagen, Denmark

On October 29, 2018 Significant developments in cancer research were presented by NantHealth (NASDAQ: NH) and NantOmics at the ESMO (Free ESMO Whitepaper) conference in Munich, Germany this week (Press release, NantHealth, OCT 29, 2018, View Source;p=RssLanding&cat=news&id=2373856 [SID1234530256]). NantHealth, a leader in breakthrough cancer research and solutions to improve patient care and lower healthcare costs, in conjunction with NantOmics, a leader in molecular diagnostic testing, conducted one oral presentation and four papers, including a few demonstrating the promise of the company’s Liquid GPS, a blood-based molecular test that provides oncologists with a powerful tool for non-invasive tumor profiling and quantitative monitoring of treatment response. ESMO (Free ESMO Whitepaper) is the world’s second largest cancer symposium where researchers and clinicians come together to study the latest breakthroughs in treatment.

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"We continue to be on the cutting edge of cancer research and that, coupled with the advancements we’re making in all areas of cancer diagnostics, treatment plans and provider solutions, are all important steps in supporting physicians and patients," said Dr. Sandeep Reddy, Chief Medical Officer, NantHealth. "Our researchers and scientists are working very hard to tackle some of the toughest challenges in cancer research and sharing them as quickly as possible. Our Liquid GPS tumor profiling is dramatically changing the way that physicians identify and treat different types of cancer."

The oral presentation, Gene mutation status in circulating tumor DNA (ctDNA) and first-line FOLFOXIRI plus bevacizumab (bev) in metastatic colorectal cancer (mCRC) harboring RAS mutation, authored by Y. Sunakawa, et al, includes investigational data suggesting that circulating DNA markers may predict outcomes in mCRC and can guide treatment decisions for these patients.

Additional papers were reviewed showing breakthroughs in immune oncology, including:

Title: Differential expression of PD-L1 and immune biomarkers by age: Decreased expression in pediatric/AYA patients with advanced cancer
Author: Dr. Omid Hamid, et al
Description: Whole exome and RNA sequencing of 1,467 patients highlights younger patients (age < 24) with advanced cancer appear to have lower levels of CTLA4 and PD-L1 expression.
Key Takeaway: Immune checkpoint drugs have not yet been approved in pediatric and adolescent/young adult patients. Large dataset results show it may be necessary to employ new combinations to be used in younger patients such as Nant’s Cancer Vaccine, immunotherapy that combines the delivery of metronomic, low-dose chemotherapy and radiation therapy with natural killer (NK) cell-based technology to enhance patient’s immune system response against cancer cells.

Title: PD-L1 expression is strongly associated with TIGIT, FOXP3 and LAG3 across advanced cancers, but not OX40, TIM3 and IDO
Author: Dr. Sumanta K. Pal, et al
Description: RNA sequencing reveals immune checkpoint gene expression was not significantly different in TMB high versus low groups. In patients demonstrating the highest PD-L1 expression, higher expression of CTLA4, TIGIT, FOXP3 and LAG3 were also observed.
Key Takeaway: While researchers are focused on TMB as a more promising biomarker for Immuno-Oncology (IO) therapy than PDL1, this research shows PDL1 may be a marker of generalized tumor inflammation and could be the reason those tumors respond to IO drugs.

Title: Predicting survival benefit of capecitabine plus cisplatin in patients with metastatic gastric cancer using quantitative proteomics
Author: D. Yan, et al
Description: Targeted proteomic analysis of metabolic enzymes required for intracellular activation of the chemotherapeutic drug capecitabine identifies specific enzymes and expression cutoffs which are significantly associated with extended survival in metastatic gastric cancer patients given this drug regimen.
Key Takeaway: Clinical tissue analysis of specific proteomic biomarkers could be used to better personalize the usage of chemotherapeutic agents.

Title: Development and validation of neuroendocrine tumor marker panel in small biopsies using multiplexed mass spectrometry
Author: S. Thyparambil, et al
Description: Immunohistochemical analysis of neuroendocrine tumor markers is performed on only a small subset of cancer. In spite of the approval of several new agents with specific activity against neuroendocrine tumors. A multiplexed clinical tissue proteomics assay was developed to add analysis of neuroendocrine markers into a larger diagnostic panel in order to better identify candidates for neuroendocrine specific therapy.
Key Takeaway: A three protein targeted proteomics assay can identify neuroendocrine tumors with high sensitivity and specificity. The expanded use of this technology may efficiently identify patients for optimal therapy.