On September 8, 2021 Cernostics, pioneer of the worlds’ first precision medicine test to predict future development risk of esophageal cancer from Barrett’s esophagus (BE), TissueCypher Barrett’s Esophagus Assay, reported that it has become a participating ("in- network") provider for Geisinger Health Plan (GHP)’s more than 550,000 plan members in Central, North Central and East Central Pennsylvania (Press release, Cernostics, SEP 8, 2021, View Source;utm_medium=rss&utm_campaign=cernostics-contracts-with-geisinger-health-plan-to-become-an-in-network-provider-for-tissuecypher-barretts-esophagus-assay [SID1234587389]). The TissueCypher Barrett’s Esophagus Assay has been a covered service for GHP members since a January 2021 decision determined that it was "medically necessary" for the evaluation of biopsies from certain BE patients, becoming the first commercial health care plan to have a coverage policy for TissueCypher.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This decision by GHP comes in response to multiple recent peer-reviewed publications that independently validated the clinical validity and clinical utility of the TissueCypher Barrett’s Esophagus Assay.

Objectively and accurately predicting progression from BE to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) is critical as the incidence of esophageal cancer is growing in the US at one of the fastest rates of all cancers. Once diagnosed, EAC is highly lethal, so early detection and advanced warning in patients with BE by TissueCypher provides valuable clinical decision support to physicians managing these patients.

"We’ve collaborated with Cernostics in the development of the clinical evidence demonstrating the value of TissueCypher for risk-stratification of patients with BE. TissueCypher uses biomarker information not available by any other technology and has allowed us to determine optimal treatment and follow-up strategies in an informed and intelligent way. Importantly, the test can be run on previously obtained biopsies. It’s exciting to see that our patients and gastroenterologists now have access to this important technology as a covered benefit and in-network lab service," said Dr. David Diehl, Director of Interventional Endoscopy at Geisinger Medical Center.

Mike Hoerres, Chief Executive Officer of Cernostics, added, "We are proud to work with Geisinger, one of the leading integrated healthcare delivery systems in the US, to bring TissueCypher testing to our neighbors throughout Pennsylvania. We see this as a great way to support the legacy and vision of Abigail Geisinger, delivering state-of-the-art medicine to the communities we serve right here in Pennsylvania."

On September 8, 2021 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ("Diffusion" or the "Company"), an innovative biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, reported that Robert Cobuzzi, Jr., Ph.D., Chief Executive Officer, will present at the H.C. Wainwright 23rd Annual Global Investment Conference taking place September 13-15, 2021 (Press release, Diffusion Pharmaceuticals, SEP 8, 2021, https://www.diffusionpharma.com/diffusion-pharmaceuticals-to-present-at-the-23rd-annual-h-c-wainwright-global-investment-conference/ [SID1234587388]). The prerecorded presentation will be available starting at 7 a.m. ET on September 13, 2021 and will be accessible via the conference’s virtual platform by registered conference attendees. The presentation will be archived and available for viewing for 90 days, following the conference.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Cobuzzi will provide an overview of Diffusion’s business highlights and recent corporate and clinical achievements, as well as anticipated milestones in the clinical programs for trans sodium crocetinate (TSC), Diffusion’s lead product candidate. Diffusion has completed the first of three Oxygenation Trials, which are intended to guide the selection of indications and doses to be pursued for future development of TSC. Diffusion plans to select the initial indication by year-end 2021, and initiate a Phase 2 trial in that indication in the first half of 2022.

Additionally, Dr. Cobuzzi and members of the Diffusion management team will be participating in virtual one-on-one meetings with registered investors and pharmaceutical company executives.

Details of the presentation are as follows:

Event: H.C. Wainwright 23rd Annual Global Investment Conference
Date: September 13-15, 2021
Time: Presentation available starting at 7 a.m. ET on September 13, 2021
Registration: View Source
Following the conclusion of the event, a recording of Dr. Cobuzzi’s presentation will be available under "Presentations" in the Investors section of the Company’s website at View Source

On September 8, 2021 HiberCell, a clinical stage biotechnology company developing therapeutics to treat cancer relapse and metastasis, reported that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track designation for HC-5404-FU, an orally administered PERK inhibitor (PERKi) for patients with solid tumors (Press release, HiberCell, SEP 8, 2021, View Source [SID1234587387]). As reported in June 2021, the company initiated a first-in-human, Phase 1a clinical trial for HC-5404-FU in select solid tumors filed their Investigational New Drug (IND) application, and received FDA authorization to begin clinical studies in late 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A Fast Track designation from the FDA provides several benefits for HiberCell’s HC-5404-FU PERKi therapeutic, including more frequent meetings with the FDA to discuss the drug development plan, additional written communications from the FDA regarding the design of the proposed clinical trials, the use of biomarkers, and Rolling Review, which means HiberCell can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until all sections of the NDA are completed. Additionally, with this designation, HC-5404-FU will automatically be considered for Accelerated Approval and Priority Review. Accelerated Approval is based on a surrogate endpoint reasonably likely to predict clinical benefit; Priority Review shortens the FDA review process from ten months to six.

"The Fast Track designation is an important step as HiberCell focuses on advancing this first-in-class clinical asset," said Alan Rigby, PhD, chief executive officer at HiberCell. "Importantly, this designation will allow us to work closely with the FDA to quickly move HC-5404-FU through our ongoing clinical trial, HC-404-FCP-2011. The trial is a first in-human, Phase 1a, multi-center, open-label study to establish the maximum tolerated dose (MTD) and evaluate the safety and tolerability following oral dosing of HC-5404-FU in a dose-escalating fashion. Up to 24 qualified subjects at five US sites, who have specific solid tumors, including renal cell carcinoma (RCC), gastric cancer (GC), and other solid tumors are planned for enrollment in this study. This Phase 1a study will be expanded into a Phase 1b/2a through a protocol amendment with the dose and tumor type(s) identified in Phase 1a as the most appropriate for further clinical development."

On September 8, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that Chief Executive Officer Harout Semerjian will present at the upcoming H.C. Wainwright & Co 23rd Annual Global Investment Virtual Conference taking place September 13-15, 2021 (Press release, GlycoMimetics, SEP 8, 2021, https://ir.glycomimetics.com/news-releases/news-release-details/glycomimetics-present-upcoming-hc-wainwright-co-annual-global-0 [SID1234587386]). The presentation will be available on the company’s website at the "Investors" tab for 30 days, beginning Monday, September 13 at 7:00 a.m. EDT.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To access the live webcast and subsequent archived recordings for the presentation, please visit the GlycoMimetics website at View Source

On September 8, 2021 XBiotech Inc. (NASDAQ: XBIT) ("XBiotech") reported that Benjamin Musher M.D., will chair XBiotech’s clinical program for pancreatic cancer (Press release, XBiotech, SEP 8, 2021, View Source [SID1234587376]). The Company is developing a novel cancer drug, Natrunix, to be used in combination with cytotoxic anti-cancer agents. Natrunix specifically blocks a substance that has been shown to stimulate tumor blood supply and break down connective tissue, which can support tumor growth and destruction of healthy tissue. The anti-inflammatory activity of Natrunix is also being evaluated for its ability to reduce the toxicity and injury caused by the cytotoxic anti-cancer agents themselves.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

XBiotech’s pancreatic cancer program, 1-BETTER, launched with a randomized, double-blind, placebo-controlled Phase 1-2 study, allows the Company to evaluate dose levels, drug interaction and anti-cancer activity for Natrunix. Dr. Musher is Medical Director of Medical Oncology at Dan L. Duncan Comprehensive Cancer Center and Associate Professor at Baylor College of Medicine. Dr. Musher is a member of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and has authored numerous peer-reviewed articles in oncology, including treatments for pancreatic cancer. In addition to Natrunix, Dr. Musher has investigated cutting-edge pancreatic cancer therapies, including the use of tumor-targeting viruses. He has also researched and published on clinical practices relating to the treatment of pancreatic cancer, to better understand the decision-making processes and challenges faced by oncologists in the treatment of this extremely challenging form of cancer.

As chair of the 1-BETTER pancreatic cancer program, Dr. Musher will lead the clinical program and personally treat pancreatic cancer patients at the Dan L. Duncan Comprehensive Cancer Center, at St. Luke’s Hospital in Houston, Texas. Dr. Musher stated, "Pancreatic cancer is a devastating disease and remains the third leading cause of cancer-related death in the United States. Most patients with metastatic pancreatic cancer are eligible for only cytotoxic chemotherapy, which generally yields short-lived responses and can cause significant toxicity. More effective and rationally designed therapies are therefore desperately needed. By targeting cancer-related inflammation, Natrunix may facilitate better control of tumor growth, reduce toxicity from chemotherapy, and improve well-being of patients with advanced pancreatic cancer."

Dr. Musher will oversee the 1-BETTER study that will involve at least 20 other leading cancer centers around the country. The study will evaluate Natrunix in combination with ONIVYDE and 5-fluorouracil and generate preliminary data on overall survival, progression-free survival, time-to-treatment failure, and objective response rates. Numerous quality-of-life measures will also be explored, hopefully showing a reduction in chemotherapy-related toxicity.

John Simard, President and CEO of XBiotech commented, "We are honored to have Dr. Musher chair this study for which we are eagerly anticipating results."

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.