On July 20, 2021 Fight Colorectal Cancer (Fight CRC), the nation’s leading colorectal cancer (CRC) patient advocacy organization, and Guardant Health, Inc. (Nasdaq: GH), a leader in precision oncology, reported that it will be recognizing clinical researchers and advocates who have demonstrated exceptional leadership during the pandemic in getting people back to routine colorectal cancer screening (Press release, Fight CRC, JUL 20, 2021, View Source [SID1234584986]).

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The award, called "Back to Screening Award for Research Advocacy Excellence," will honor key contributions made by Fight CRC research advocates, as well as Principal Investigators participating in Guardant Health’s ECLIPSE trial, a clinical study evaluating the use of a blood test to screen for colorectal cancer. Selected recipients of the award will be honored at Fight CRC’s "Path to a Cure" event in December 2021. Notably, this year’s event will convene a group of research and advocacy experts who will be tasked with mapping out a path leading to a cure for colorectal cancer. The framework will be shared with the National Cancer Institute (NCI) and National Institutes of Health (NIH) to request action to help achieve this goal.

"The COVID-19 pandemic forced colorectal cancer screening to a standstill in some communities. The data shows drastic declines in 2020, compared to the same timepoints in prior pre-pandemic years," said Anjee Davis, President of Fight CRC. "Despite these challenges, herculean efforts were made by Fight CRC research advocates and Principal Investigators participating in the ECLIPSE trial to continue to move the needle forward to improve colorectal cancer screening rates and, ultimately, save lives. Fight CRC and Guardant Health have been focused on our shared goal of getting people back to routine cancer screening after the pandemic."

The ECLIPSE trial, a 10,000-plus patient study, is currently underway to evaluate the performance of Guardant Health’s blood test to detect colorectal cancer in an average-risk adult population.1 If successful, Guardant Health expects data from the trial will support a premarket approval (PMA) submission to the FDA. Despite the incredible pressure that the pandemic put on enrolling patients into the study, which requires patients to consent to undergo an invasive, inpatient colonoscopy procedure, the trial is expected to complete enrollment by the end of 2021. The test is intended to offer a non-invasive, patient-friendly blood testing option that could bridge the gap to the Centers of Disease Control’s (CDC) target compliance goal of 80 percent.2,3

Today, it is estimated that only 66% of adults 50 years and older3 are screened despite compelling evidence that routine cancer screening can reduce colorectal cancer mortality, the second leading cause of cancer death.3 The problem is expected to get worse. The Journal of the American Medical Association recently predicted that COVID-19–related reductions in care utilization may result in an estimated 1.2 to 2 million fewer colorectal cancer screenings between 2020 and 2023.4

Colorectal cancer is on the rise for younger adults too. The U.S. Preventative Services Task Force (USPSTF) recently lowered the recommended age to start screening from 50 to 45.5 This increases the pool of people who need to be screened by an additional 21 million Americans aged 45 to 49.6 By 2030, it is expected that colorectal cancer will be the leading cause of cancer related death for those aged 20 to 49, making colorectal cancer screening increasingly a priority for all Americans.7

"Given what we have learned during the pandemic about its detrimental impact on cancer screening and healthcare disparities among underserved communities, it has become abundantly clear that a non-invasive, patient-friendly blood test to routinely screen for colorectal cancer is desperately needed," said Helmy Eltoukhy, Guardant Health CEO. "We look forward to recognizing the exceptional performance of the institutions participating in our ECLIPSE trial who have worked tirelessly to conclude this trial so that one day soon we can offer patients a more accessible solution for routine colorectal cancer screening. We are proud to stand together with Fight CRC to not only honor these investigators, but to also recognize the incredible dedication of the Fight CRC advocates for their unwavering commitment to CRC screening during these difficult times."

On July 20, 2021 Microbial cancer detection firm Micronoma reported that it is collaborating with the University of New South Wales, Sydney under a $4 million grant from the Australian government to apply artificial intelligence technology toward developing microbial biomarkers for the early detection of liver cancer (Press release, Micronoma, JUL 20, 2021, View Source [SID1234585497]).

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Amany Zekry and Emad El-Omar, both professors at UNSW Medicine & Health, are leading the effort alongside co-principal investigator and Micronoma CSO Eddie Adams.

The group will use Micronoma’s AI-driven microbial biomarker technology to detect, validate, and translate blood-borne microbial-derived biomarkers for the early detection of HCC — something the company has already been working on internally.

Micronoma CEO Sandrine Miller-Montgomery said in a statement that interest in the link between circulating microbiome signatures and cancer early detection has been growing since the firm’s proof-of-concept publication in Nature last year.

"Developing a method to enable the identification of robust microbial plasma biomarker signatures of HCC is in our product pipeline, and this collaboration enables us to fast-track product development," she added.

On July 20, 2021 RemedyBio, an immunology focused discovery and development company, reported the final closing of an additional €8M ($9.4M) in equity financing from the EIC Fund, completing a €10.5M ($12.4M) funding award to the company by the EIC Accelerator (Press release, Remedy Biologics, JUL 20, 2021, View Source [SID1234644116]). This additional €8M financing complements the EIC grant funding of €2.5M ($3M) already awarded to RemedyBio in June 2020, to develop a Rapid Pandemic Response Platform based on its proprietary NanoreactorTM platform. This financing follows RemedyBio’s selection from almost 4,000 company proposals submitted to the EIC Accelerator in 2020.

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RemedyBio’s technology is designed to rapidly and simultaneously analyze millions of single immune cells from an individual sample. After succeeding in flagging powerful new antibodies against SARS-CoV-2 from the immune system of COVID-19 infected patients, the platform is now being tuned to respond to new variants and future diseases. The aim is to create a rapid passive therapy against new strains of COVID-19 and, primarily, to control future pandemics more rapidly, by making therapies for new viruses available in less than 90 days.

"This financing from the EIC Fund will enable us to advance our technology development and therapeutic discovery activities, and forge collaborations with leading pharma partners and key clinical and research groups," said Daniel Crowley, CEO of RemedyBio. "We are delighted to have the support of the EIC Fund. It fills an important financing gap, supporting European companies with innovative technologies to create deep scientific programs and commercial partnerships. In our case, this will drive transformative biological insights and new therapy discoveries."

This investment will fund the significant development of RemedyBio’s innovative, proprietary Nanoreactor platform as well as advancing its key therapeutic pipeline assets. The Nanoreactor platform has been developed by RemedyBio, originating from intellectual property exclusively licensed from Dublin City University (DCU), following a decade-long R&D programme led by Dr. Paul Leonard, the company’s chief scientist and co-founder. The platform has created a step-change in the speed, scale and quality of single cell analysis and discovery, paving the way for powerful new antibodies and cell therapies. Its high-throughput identification capabilities open fresh insights into immune system interactions – driving a new era in precision medicine against viral diseases, cancer and auto-immune disorders.

"At Enterprise Ireland, we welcome this substantial EIC Fund investment in an Irish high potential start-up," said Garrett Murray, national director for Horizon Europe at Enterprise Ireland. "RemedyBio is a great example of an Irish company that has succeeded in winning competitive funding through the EIC and, in Ireland, through the Disruptive Technology Innovation Fund (DTIF) for oncology cell therapy applications, to help fund its development

and advance its scaling strategy. Enterprise Ireland is here to support and advise ambitious and innovative Irish start-ups considering application for competitive EIC financing as part of their funding journey."
Heidi Kakko, member of the Investment Committee of the European Innovation Council Fund said, "This financing round will enable Remedy Biologics to develop a Rapid COVID- 19 Passive Therapy Response Platform. We are glad the EIC Fund is supporting this breakthrough company, which is playing a pioneering role in creating new solutions in immune therapeutics. This shows how the EU contribution is crucial in tackling the Covid19 response."
About the EIC Fund
Established in June 2020, the European Innovation Council Fund (EIC Fund) is a breakthrough initiative of the European Commission to make direct equity and quasi- equity investments (between €500.000 and €15 million) in European high impact and deep tech start-ups and scale ups. The EIC Fund provides patient capital and invests in companies from any sector, across all EU countries and countries associated to Horizon 2020.
The EIC Fund aims to fill a critical financing gap and its main purpose is to have a high impact by accompanying companies with disruptive technologies in their growth. Its objective is to crowd in market players, further sharing risks by building a large network of capital providers and strategic partners suitable for co-investments and follow-on funding. The Fund pays particular attention to empower and support female founders as well as contributing to reduce the innovation divide among EU countries. www.eic.ec.europa.eu/investment-opportunities
About Enterprise Ireland
Enterprise Ireland (EI) services are geared towards helping Irish companies win international sales. These services include funding support, export assistance, development of competitiveness in international markets, R&D and assistance with R&D collaboration. EI also provides access to its global network of contacts. www.enterprise-ireland.com

On July 20, 2021 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its President and Chief Executive Officer, Rodney Varner, will be participating in a webinar series with CEO Roadshow to provide a company overview to investors on a monthly basis from July through September 2021 (Press release, Genprex, JUL 20, 2021, View Source [SID1234584969]).

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Details for the monthly CEO Roadshow webinar series:

Host: CEO Roadshow

Dates and Times:

Wednesday, July 21 at 12 p.m. EDT
Wednesday, August 18 at 11 a.m. EDT
Wednesday, September 22 at 11 a.m. EDT
Webinar Link: https://bit.ly/3eoHeie

Mr. Varner will be available for questions following each company presentation. The webinars will be recorded and available for replay on Genprex’s website for a period of time. Replays will also be available on CEORoadshow.com following each webinar.

The CEO Roadshow webinar series features small and mid-cap stocks that are on the verge of a breakout or have other near-term developments making them an attractive long-term investment opportunity.

On July 20, 2021 Immunicom, Inc., a clinical stage biotech, reported that shared preliminary data from its metastatic triple-negative breast cancer (mTNBC) clinical trial with its novel breakthrough Immunopheresis therapy at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2021 (Press release, Immunicom, JUL 20, 2021, View Source [SID1234584987]). Immunicom’s subtractive immunotherapies are designed to remove immune inhibitors and enhance patients natural immune response without compromising quality-of-life as is typically seen after treatment with chemo-/immuno-oncology agents. ASCO (Free ASCO Whitepaper)’s Annual Meeting is one of the world’s premier scientific gatherings of cancer specialists and researchers.

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Immunicom is investigating its FDA-designated breakthrough Immunopheresis therapy, which is a filtration-based subtractive treatment designed to capture sTNF-R proteins that are shed by cancer cells and inhibit a patient’s natural anti-tumor immune activity. Immunicom presented data for the second cohort of mTNBC patients treated with Immunopheresis in combination with weekly chemotherapy procedures (paclitaxel [60 mg/m2] plus carboplatin [AUC2] combination), which were found to be generally safe and provided early, promising signs of antitumor activity.

Immunicom previously presented data for the initial cohort of patients treated with Immunopheresis alone at AACR (Free AACR Whitepaper)’s Annual Meeting 2021, revealing an 80% decrease of the inhibitory sTNF-R proteins and observation of sustained quality-of-life while on therapy with minimal side effects (details here).

"The ASCO (Free ASCO Whitepaper) data expand on our breakthrough Immunopheresis therapy, specifically in combination with low-dose chemotherapy to demonstrate potential for synergistic and enhanced activity of sTNFR pulldown in late-stage patients who have failed multiple prior lines of therapy," said Dr. Robert Segal, Immunicom Chief Medical Officer. "The goal of halting disease progression and the potential of going into disease remission with this approach, where side-effects are minimal, has significant implications for the health and well-being of these patients with terminal disease. To be able to continue with normal daily activities, is in stark contrast to what these patients might normally experience if they choose to undergo a last-ditch treatment effort with yet another round of standard chemotherapy."

Immunicom’s abstract, "Extracorporeal pulldown of soluble TNFRs to unleash the activity of endogenous TNFα in chemorefractory triple-negative breast cancer patients – first-in-human experience" was published in ASCO (Free ASCO Whitepaper)’s June 2021 Journal of Clinical Oncology. The study’s principal investigator and lead author is Piotr Wysocki, MD, PhD, Department Head of Oncology at the Jagiellonian University – Medical College Hospital in Krakow, and President of the Polish Society of Clinical Oncology.