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

On October 15, 2020 Heska Corporation (NASDAQ: HSKA; "Heska" or the "Company"), a leading provider of advanced veterinary diagnostic and specialty products, reported its third quarter 2020 financial performance in a press release before the market opens on Thursday, November 5, 2020 and to host an earnings call to discuss the results following the release at 9 a.m. MT / 11 a.m. ET (Press release, Heska, OCT 15, 2020, View Source [SID1234568542]).

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To access the conference call:
From within the United States, please dial 1-866-548-4713
From outside of the United States, please dial 1-323-794-2093
Reference Conference ID: 9707717

The earnings call will be webcast live from the Company’s investor relations website at: Heska Third Quarter 2020 Earnings Call Webcast.

A telephonic replay will be available beginning at 2:00 p.m. ET Thursday, November 5 and will continue through 11:59 p.m. ET on Thursday, November 19, 2020. The webcast will be archived for 90 days.

On October 15, 2020 ViewRay, Inc. (Nasdaq: VRAY) reported details relating to the release of its third quarter 2020 financial results (Press release, ViewRay, OCT 15, 2020, View Source [SID1234568541]).

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ViewRay will hold a conference call to discuss results on Thursday, November 5, 2020 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525-7129 for international callers. The conference ID number is 9819479. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call. In addition, a telephonic replay of the call will be available until November 12, 2020. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 9819479.