On May 18, 2021 The United States Preventive Services Task Force (USPSTF) reported its final colorectal cancer screening recommendation that screening begin at age 45 (Press release, Exact Sciences, MAY 18, 2021, View Source [SID1234580201]). Exact Sciences’ (NASDAQ: EXAS) Cologuard, referred to as sDNA-FIT, is included as a recommended screening option for all average-risk patients between the ages of 45 and 75.

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Colorectal cancer is the second leading cause of cancer death in the United States, in part because many cancers go undetected until later stages when treatment options are limited.1 Colorectal cancer can be prevented or detected early through screening. However, approximately 44 million average-risk adults 45-74 are currently eligible for screening, including ˜19 million between the ages of 45 and 49.2§

According to this updated recommendation, all average-risk adults age 45 and older should now be screened for colorectal cancer. Colorectal cancer incidence has been increasing in American adults under the age of 50.3 Between 2004 and 2015, health care providers diagnosed more than 130,000 cases of colorectal cancer in Americans under age 50.4 More than half of these cases were diagnosed at later stages (stages III or IV), which are associated with lower survival rates than earlier stages (stages I or II).4 Only about one out of 10 people over the age of 50 with stage IV colorectal cancer survives beyond five years.1

"Health care providers often turn to the USPSTF guidelines when discussing cancer prevention with their patients," said Paul Limburg, M.D., Chief Medical Officer, Screening at Exact Sciences. "These final guidelines will encourage more clinicians to offer colorectal cancer screening to their patients starting at age 45."

Cologuard is a U.S. Food & Drug Administration (FDA)-approved non-invasive stool DNA test used to screen for colorectal cancer in average risk patients. In a large clinical study of nearly 10,000 patients 50 and older, Cologuard found 92% of colorectal cancers,5 including 94% in stages I and II.5,6,7* In September 2019, the FDA approved Cologuard for average-risk individuals beginning at age 45, expanding the Cologuard label to include this critical younger adult population.

A recent study showed that among average-risk adults between the ages of 45 and 49, Cologuard demonstrated test specificity of 95.2% in participants with non-advanced precancerous lesions.7 In patients with negative colonoscopy findings, Cologuard demonstrated specificity of 96.3%.7 According to the authors, using Cologuard to screen these younger individuals could help mitigate risks and reduce costs from unnecessary diagnostic procedures.

USPSTF guidelines play a key role in addressing the public health crisis caused by colorectal cancer. Under these final guidelines, colorectal cancer screening remains a Grade A recommendation for people ages 50-75 and screening for ages 45 to 49 is a Grade B recommendation. The task force continues to include Cologuard (referred to in the guidelines as sDNA-FIT) among the recommended screening test options. Since it was first included in the 2016 USPSTF recommendation, Cologuard has been used to screen more than 5 million Americans.

"We are proud of the role Cologuard has played in getting more people screened for colorectal cancer," said Kevin Conroy, chairman and CEO of Exact Sciences. "The task force’s recommendation that colorectal cancer screening begin at age 45 for all average risk people means that Cologuard can continue to positively impact screening rates as people work with their healthcare providers to choose the option that is right for them."

Making sure people have full access to using stool-based tests like Cologuard is critical to reaching the unscreened. A recent study conducted by researchers at Mayo Clinic showed that when given a choice, most individuals at average risk of colorectal cancer said they would prefer a stool-based screening test for colorectal cancer over colonoscopy.8

*Statistic calculated using data from the pivotal study and reported within the Ahlquist review article. Cologuard sensitivity, per stage of cancer: I: 90% (n=29); II: 100% (n=21); III: 90% (n=10); IV: 75% (n=4).1

§ Estimates based on US population aged 45-74 and 45-49 as of 2018, adjusted for the reported rates of high-risk conditions and prior screening history for CRC.

1 Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021. CA Cancer J Clin. 2021;71:7-33. doi:10.3322/caac/21654

2 Piscitello A, Edwards DKV. Estimating the screening-eligible population size, aged 45 to 74, at average risk to develop colorectal cancer in the United States. Cancer Prev Res. 2020;13(5):443-448. doi:10.1158/1940-6207.CAPR-19-05

3 Wolf A, Fontham E, Church TR, et al. Colorectal cancer screening for average-risk adults: 2018 guideline update from the American Cancer Society. CA Cancer J Clin. 2018;68:250-281. doi:10.3322/caac.21457

4 Virostko J, Capasso A, Yankeelov TE, et al. Recent trends in the age at diagnosis of colorectal cancer in the US National Cancer Data Base, 2004-2015. Cancer. 2019;25(21):3828-3835. doi:10.1002/cncr.32347

5 Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297. doi:10.1056/NEJMoa1311194

6 Ahlquist DA. Multi-target stool DNA test: a new high bar for non-invasive screening. Dig Dis Sci. 2015;60(3):623-633. doi:10.1007/s10620-014-3451-5

7 Cologuard Physician Brochure. Exact Sciences Corporation. Madison, WI.

8Imperiale TF, Kisiel JB, Itzkowitz SH, et al. Specificity of the Multi-Target Stool DNA Test for Colorectal Cancer Screening in Average-Risk 45–49 Year-Olds: A Cross-Sectional Study. Cancer Prev Res. 2021;14(4):489-496. doi: 10.1158/1940-6207.CAPR-20-0294

9Zhu X, Parks PD, Weiser E. National Survey of Patient Factors Associated with Colorectal Cancer Screening Preferences. Cancer Prev Res. 2021;14(5):603-614. doi: 10.1158/1940-6207.CAPR-20-0524

On May 18, 2021 Merck KGaA, Darmstadt, Germany, a leading science and technology company, reported changes in its operating model for the Healthcare business sector (Press release, Merck KGaA, MAY 18, 2021, View Source [SID1234580217]). Chris Round will become President of EMD Serono leading the North America Healthcare business; Andrew Paterson will assume the position of Chief Marketing Officer; and recruitment is ongoing for the position of Head of China & International.

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"Our redesigned Healthcare organization creates dedicated leadership for our strategic priorities with a focus on growth," said Peter Guenter, Member of the Executive Board of Merck KGaA, Darmstadt, Germany, and CEO Healthcare. "Our clear intent is to bring meaningful value to more patients with our current and future portfolio."

Given the priority of North America as a driver of future growth for the Healthcare business sector of Merck KGaA, Darmstadt, Germany, dedicated leadership in this key market is essential. To this end, Chris Round will assume the role of President of EMD Serono, leading the US and Canada Healthcare business. Round has been with the organization since 2017, previously serving as Head of International and Core Franchises, and Head of EMEA. Round brings 25 years of global pharmaceutical experience to this position, including 20 years at Merck & Co., Inc. He will be based in Rockland, Massachusetts, USA.

The ongoing launches of BAVENCIO (avelumab), MAVENCLAD (cladribine) tablets and TEPMETKO (tepotinib) are critical elements of the business sector’s growth strategy. Global launch excellence for existing and future therapies will be led by Andrew Paterson, who will assume the role of Chief Marketing Officer for Healthcare. Paterson will lead the Speciality Franchises of Merck KGaA, Darmstadt, Germany, including Oncology, Neurology & Immunology and Fertility. In addition, Paterson will lead Global Market Access & Pricing and Global Strategic Insights. Paterson brings nearly 30 years of leadership experience in the biopharmaceutical industry to this appointment. He previously led both North America and the Global Innovative Medicine Franchises. Paterson will also be based in Rockland.

The executive role, Head of China & International, will lead China and Japan as well as the regions Europe, Latin America, Asia-Pacific, Middle East, Africa and Russia, and the franchise of Cardiovascular Metabolism & Endocrinology (CM&E). Recruitment for this position is ongoing.

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On May 18, 2021 Coeptis Pharmaceuticals, Inc., a wholly-owned subsidiary of Vinings Holdings Inc. (OTC PINK: NDYN), reported entry into two separate exclusive option agreements with VyGen-Bio, Inc., a majority-owned subsidiary of Vycellix, Inc., involving technologies being studied to potentially improve the treatment of CD38-related cancers (Press release, Coeptis Pharmaceuticals, MAY 18, 2021, View Source [SID1234580233]). The technologies are CD38-GEAR-NK, a cell therapy product being developed to protect CD38+ natural killer (NK) cells from destruction by anti-CD38 monoclonal antibodies (mAbs), and CD38-Diagnostic, an in vitro diagnostic tool being developed to analyze if cancer patients might be appropriate candidates for anti-CD38 mAb therapy. Both technologies are being developed from VyGen-Bio’s Gene-Edited Antibody Resistant NK (GEAR-NK) platform, which was discovered by scientists at the Karolinska Institutet in Sweden.

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The first option agreement involves co-development rights to CD38-GEAR-NK, which is an autologous, NK cell-based investigational therapeutic derived from a patient’s own cells and gene-edited to enable combination therapy with anti-CD38 mAbs, potentially minimizing the risks and side effects from CD38-positive NK cell fratricide. The first indication is expected to be multiple myeloma, an incurable cancer of plasma cells. Per the option agreement, Coeptis has paid VyGen-Bio a non-refundable fee for the exclusive option to purchase the co-development rights to the technology. Coeptis has until December 31, 2021 to exercise the option and pay the specified exercise consideration.

The second option agreement involves co-development rights to CD38-Diagnostic, which is an investigational in vitro screening tool to potentially pre-determine which cancer patients are most likely to benefit from targeted anti-CD38 mAb therapies, either as monotherapy or in combination with CD38-GEAR-NK. Per the option agreement, Coeptis has paid VyGen-Bio a non-refundable fee for the exclusive option to purchase the co-development rights to the technology. Coeptis has until December 31, 2021 to exercise the option and pay the specified exercise consideration.

"At Coeptis, we are focused on identifying and advancing technologies that have the potential to disrupt conventional treatment paradigms and improve patient outcomes," said Dave Mehalick, President and CEO of Coeptis Pharmaceuticals. "The option agreements with VyGen-Bio epitomize this business strategy as each technology may offer the potential to vastly improve the treatment of CD38-related cancers, including multiple myeloma, chronic lymphocytic leukemia, and acute myeloid leukemia, by identifying those patients who are most likely to benefit from anti-CD38 mAbs and then potentially ‘super charging’ a patient’s immune system by protecting CD38+ NK cells from destruction by anti-CD38 mAbs."

Mr. Mehalick continued, "We envision these agreements with VyGen-Bio to be an important step in support of our focus in cell and gene therapy."

On May 18, 2021 Grey Wolf Therapeutics ("Grey Wolf"), a drug discovery company focused on developing first-in-class immuno-oncology agents, reported that it has been awarded £1.1M ($1.5M) in grant funding following a successful application to the prestigious Innovate UK Biomedical Catalyst (BMC) competition (Press release, Grey Wolf Therapeutics, MAY 18, 2021, View Source [SID1234580182]). Peter Joyce, CEO of Grey Wolf, noted that the company was "Delighted to receive this grant from Innovate UK, which will allow Grey Wolf to work with The University of Oxford ("Oxford") and the University of Southampton ("Southampton") to expand the ERAP1 program and accelerate the company’s path through clinical development".

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Over the past decade, immunotherapies have begun to transform cancer treatments, with significant impacts on clinical outcomes and survival rates. However, it has since become apparent that only a small subset of cancers and patient groups respond to these therapies. Clinical data suggests that one of the reasons behind this is due to low neoantigen expression at the cell surface.

In response to the urgent need for new therapeutics, Grey Wolf are developing small molecule inhibitors that target ERAP1 and ERAP2; two key enzymes in the antigen presentation pathway. Rather than targeting the immune system, this approach aims to directly alter the tumour cells to improve neoantigen expression and therefore, immune visibility.

The ERAP enzymes are responsible for trimming peptides prior to loading onto Major Histocompatibility Complex (MHC) Class I and presentation at the cell surface. These enzymes often over- or under-trim peptides in the endoplasmic reticulum, leading to a potential loss of immunogenic peptides and neoantigen presentation. Grey Wolf ERAP1 inhibitors significantly alter the neoantigen presentation on the surface of tumour cells, leading to greater recognition and destruction by the immune system.

The investment awarded through Innovate UK will be focused on identifying patient subgroups where ERAP1 inhibition could be particularly efficacious based on either cancer type or genetic background, thus providing the foundation for future breakthrough designations and accelerated approval. Collaborating with the world leading capabilities of Nicola Ternette’s group in Oxford and Edd James’ group at the Centre for Cancer Immunology in Southampton will be vital to the success of the project. The Ternette Lab are recognised leaders in the field of immunopeptidomics and the study of antigen presentation by MHC. Nicola Ternette and her team will use the technique to characterise neoantigens that are expressed following ERAP1 inhibition. As experts in ERAP biology, the James lab will examine the mechanistic effects of ERAP1 inhibition on T cell and tumour biology using a number of bespoke pharmacological models.

Peter Joyce, CEO, Grey Wolf Therapeutics: "We are delighted to have been awarded this highly competitive funding from Innovate UK which will enable us to accelerate the development of our ERAP1 inhibitor program and broaden the potential utility of this first-in-class therapy for patients. The award allows Grey Wolf to also build on our strong associations with two world class research groups at the University of Oxford and Southampton and represents a great opportunity to demonstrate the UKs leading role in global biotechnology."

Assoc. Prof. Nicola Ternette, The University of Oxford: "The funding from Innovate UKwill enable us to use Grey Wolf’s highly selective and potent ERAP1 inhibitors to mine their effects across the immunopeptidomes of different cancer types and genetic backgrounds. The truly exciting aspect of our research here will be gaining a fundamental understanding of the biology that can directly translate into clinical development of the therapy."

Prof. Edd James, University of Southampton: "We’re excited to build on our collaboration with Grey Wolf through this grant and apply our unique understanding of ERAP1 biology to exploit the translational potential of this approach."

On May 18, 2021 BiomX Inc. (NYSE American: PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, reported that the Company will host a conference call and a live audio webcast on Monday, May 24, 2021, at 8:00 a.m. EDT, to report first quarter 2021 financial results and provide business updates (Press release, BiomX, MAY 18, 2021, View Source [SID1234580218]). To participate in the conference call, please dial 1-877-407-0724 (U.S.), 1-809-406-247 (Israel) or 1-201-389-0898 (International). The live and archived webcast will be available in the Investors section of the Company’s website at www.biomx.com.

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