On October 15, 2020 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported that the U.S. Centers for Medicare & Medicaid Services (CMS) have issued a negative reimbursement proposal in connection with the National Coverage Determination (NCD) of Epi proColon, Epigenomics’ blood test for colorectal cancer screening (Press release, Epigenomics, OCT 15, 2020, View Source [SID1234568567]).

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The proposed NCD is preliminary. According to the statutes, a 30-day public comment period will now begin, which will be used to further convince CMS of the benefits of Epi proColon in the fight against colorectal cancer. The public response during the initial public comment period at the beginning of the NCD was overwhelmingly positive. Following the comment period, CMS will publish their final decision within 60 days. If the final decision is also negative, the Company will take the opportunity to appeal the decision.

On October 15, 2020 Insilico Medicine reported that Taisho Pharmaceutical Co., Ltd. and Insilico have entered into a research collaboration to identify novel therapeutics against aging (Press release, Insilico Medicine, OCT 15, 2020, View Source [SID1234568546]). Insilico Medicine will utilize both the target discovery and generative chemistry parts of its Pharma .AI platform in this collaboration. It will use its proprietary Pandomics Discovery Platform to identify novel targets for senolytic drugs and Chemistry42 platform for a molecular generation. This collaboration brings together Insilico’s state-of-art artificial intelligence (AI) technologies in drug discovery with Taisho’s expertise in drug development, aimed to extend the human healthspan.

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Insilico partners with Taisho
"We’re delighted to collaborate with Taisho pharmaceutical, a well-recognized leader in the pharmaceutical industry and healthcare sector. It is believed that aging is a universal phenomenon that we cannot stop. However, emerging scientific evidence has shown that one may be able to reverse some of the age-associated processes. Through this collaboration, we will adopt our AI-powered drug discovery suites together with Taisho’s validation platform to explore the new space of anti-aging solutions," said Jimmy Yen-Chu Lin, PhD, CEO of Insilico Medicine Taiwan, a fully-owned subsidiary of Insilico Medicine

Under the terms of the agreement, Insilico Medicine will receive an upfront payment and milestone payments upon achievement of specified goals. Insilico Medicine will be responsible for early research phase target identification and molecular generation and Taisho will work collaboratively with Insilico in validating the results in various in vitro and in vivo assays. Taisho has the exclusive option to acquire Insilico’s co-ownership of the successfully developed programs under agreed payment.

"It is our great honor to be collaborating with the scientists of Taisho Pharmaceutical, one of the top 100 pharmaceutical companies in the world operating since 1912. The high level of the scientists we are interfacing, and our previous successes in the application of the Pharma.AI platform for discovery of novel targets and molecules in fibrosis, and previous experience in senolytic drug discovery give us confidence that this collaboration will be successful," said Alex Zhavoronkov, PhD, founder and CEO of Insilico Medicine.

On October 15, 2020 Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation status to APX005M for the treatment of esophageal and gastroesophageal junction cancer and for the treatment of pancreatic cancer (Press release, Apexigen, OCT 15, 2020, View Source [SID1234568545]).

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"These orphan drug designations are important regulatory milestones for Apexigen in its mission to treat cancer patients and for APX005M, which has the potential to meaningfully impact the standard of care across multiple types of solid tumors. We are evaluating APX005M in a broad clinical program that includes more than 10 clinical trials in various indications and therapeutic combinations," said Xiaodong Yang, MD, PhD, Chief Executive Officer of Apexigen.

The FDA’s Office of Orphan Drug Products grants orphan status to support the development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the United States. Orphan drug designation qualifies the sponsor for various development incentives, including tax credits for qualified clinical testing, up to seven years of marketing exclusivity for the orphan indication and waiver of certain FDA fees.

About APX005M

APX005M is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. APX005M targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. Binding of APX005M to CD40 on antigen presenting cells (i.e., dendritic cells, monocytes and B-cells) initiates a multi-faceted immune response bringing multiple components of the immune system (e.g., T cells, macrophages) to work in concert against cancer. APX005M is currently in Phase 2 clinical development for the treatment of cancers such as pancreatic cancer, esophageal and gastroesophageal junction cancers, melanoma, non-small cell lung cancer, rectal cancer and sarcoma in various combinations with immunotherapy, chemotherapy, radiation therapy or a cancer vaccine. Additional information on clinical trials for APX005M can be found at www.clinicaltrials.gov.

On October 15, 2020 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the Company will be presenting esophagogastric cancer data for its DKN-01 monoclonal antibody at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting, being held November 9-14, 2020 virtually (Press release, Leap Therapeutics, OCT 15, 2020, View Source [SID1234568544]).

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Leap Presentation Details:

Title: Tumoral DKK1 expression correlates with better clinical outcomes in patients with advanced esophagogastric cancer (EGC) treated with DKN-01
Presenter: Samuel J. Klempner, MD, Massachusetts General Hospital Cancer Center
Abstract ID: 262
Date: Available on demand on Monday, November 9, 2020 at 8:00 a.m. ET

About DKN-01
DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin signaling, a signaling pathway frequently implicated in tumorigenesis and suppressing the immune system. DKK1 has an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK ligands on tumor cells. The U.S. Food and Drug Administration has granted DKN-01 Orphan Drug Designation for the treatment of gastric and gastroesophageal junction cancer and Fast Track Designation in combination with tislelizumab for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express high DKK1 protein, following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy.

On October 15, 2020 GenesisCare reported that People delaying their annual cancer screenings and ignoring signs and symptoms of cancer may end up being diagnosed with later-stage metastatic disease reports leading oncology provider (Press release, GenesisCare, OCT 15, 2020, View Source [SID1234568543]).

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The latest reporting from GenesisCare centers saw an increase in patients presenting with advanced (metastatic) disease, increasing the risk of mortality, and a noticeable decline in reported new patient cases since the COVID-19 pandemic started.

Throughout the 290 GenesisCare cancer treatment locations across the U.S., physicians have recorded a double-digit percentage of declines in new patient cases for curative breast, lung, and prostate cancers.

This decline followed the restrictions on elective medical procedures beginning in March of 2020 as well as reduced visits to primary care and outpatient services.

Key findings include:

– Breast cancer: the percentage of women presenting with stage three or four cancer increased to 18.1% from 12.1% the previous year.
– Lung cancer: the percentage of patients presenting with stage three or four lung cancer also increased to 38% from 32.6% the previous year.

"Across the United States and internationally, we have documented a significant reduction in new cancer diagnoses and an increase in metastatic patients within our large network of cancer treatment centers," Dr. Constantine Mantz, Chief Policy Officer and Radiation Oncologist at GenesisCare’s US offices said.

"We believe this is due to factors including the closure of cancer screening programs, and the general public delaying annual cancer screening appointments due to fears of contracting the virus."

A recent research letter published in JAMA Oncology, researchers found little risk of a COVID-19 infection for cancer patients visiting healthcare facilities, as long as the facility followed all the necessary safety protocols.

"The new national figures around cancer patients presenting at later stage metastatic disease is unprecedented, and the concern is that this may be occurring because people are not participating in screening and following up on symptoms," Dr.Mantz said.

"Early diagnosis and treatment of cancer are critical to improving patients’ outcomes and reducing the risk of mortality."

"We want to remind people of the importance of continuing their annual health screenings and not ignoring early signs and symptoms of cancer," he said.

Founder and Global Chief Executive Officer of GenesisCare, Dan Collins observed that, as one of the largest providers of integrated oncology care in the United States and the world, the GenesisCare team has seen the direct impact of lockdowns and restrictions on cancer treatments during the pandemic.

"Cancer doesn’t stop, and our teams and centers can’t either," Mr Collins said.

"Patients across the country are looking for reassurance that hospitals and healthcare providers are taking the necessary precautions to protect them from COVID-19."

Mr Collins said learning from the early days of the pandemic in Europe the company had increased telehealth options and enhanced safety precautions at its healthcare facilities to ensure patients can be treated safely.

"Since the start of the pandemic, we have implemented stringent safety and quality measures in Australia, the UK, Spain – and now the US – to keep our patients and staff safe."

"Our committed clinical teams understand how vital it is for patients to receive access to their essential care at the right time."

For more information on GenesisCare, visit genesiscare.com (formally 21st Century Oncology). To view the full list of precautions GenesisCare US centers are taking to ensure patient and staff safety, visit View Source