On January 12, 2021 Freenome, a privately held biotechnology company that has pioneered a comprehensive multiomics platform for early cancer detection with a routine blood draw, reported that it will be presenting results for the detection of colorectal advanced adenomas from its prospective, multi-center clinical study, AI-EMERGE, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Gastrointestinal Cancers (ASCO-GI) Symposium on January 15th, 2021 (Press release, Freenome, JAN 12, 2021, View Source [SID1234573920]).

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The data from a pre-defined subset of AI-EMERGE (n=522) showed that Freenome’s novel multiomics blood test for colorectal cancer screening was able to detect colorectal advanced adenomas (AAs) with a sensitivity of 41% at a specificity of 90%. Compared with the FDA-approved mSEPT9 (methylated septin 9) blood test, Freenome’s multiomics blood test showed much higher sensitivity (41% vs. 22%)1 for detecting AAs. When compared to currently available stool-based tests, the test demonstrated much higher AA sensitivity than a fecal immunochemical test, or FIT (41% vs. 24%) and comparable AA sensitivity to FIT-DNA (41% vs. 42%)2.

These new results augment previously reported data, which showed that Freenome’s multiomics blood test can detect early-stage colorectal cancer (stage I/II) at a sensitivity of 94% and specificity of 94%3. A blood test with performance characteristics comparable or better than fecal tests can improve access and drive better adherence, facilitating early detection, and ultimately reducing mortality.

"The ability to detect advanced adenomas is incredibly important because we can remove them before they become cancerous," said Aasma Shaukat, M.D., M.P.H., Chief of Gastroenterology at Minneapolis VA Health Care System and Professor of Medicine, University of Minnesota. "That means with a blood test such as Freenome’s multiomics test, not only can we detect colorectal cancer, but we may be able to prevent colorectal cancer altogether."

"This data reflects significant progress in the development of blood-based cancer screening," added Carol Burke, M.D., Vice Chair of the Department of Gastroenterology, Hepatology, and Nutrition and Head of the Section of Polyposis in the Sanford R. Weiss MD Center for Hereditary Colorectal Cancer at Cleveland Clinic, Cleveland Ohio. "A blood test that can detect both advanced adenomas and early stage colorectal cancer could be an important tool in the fight against colorectal cancer."

Importantly, these new results also showed that Freenome’s multiomics blood test detected twice as many advanced adenomas as cell-free DNA methylation-only or single-protein approaches. Freenome’s multiomics blood test differs from single assay approaches because it combines signatures from both tumor- and non-tumor- (e.g., immune) derived sources.

"While tumor-derived signals are abundant in later-stage disease, signals from non-tumor sources predominate in earlier stages," said C. Jimmy Lin, MD, PhD, MHS, Chief Scientific Officer for Freenome. "That’s why we believe that our multiomics platform, which combines those signals, is critical in the development of next-generation, blood-based cancer screening."

The data and poster for the new results from the AI-EMERGE study will be available online at View Source at the time of presentation at ASCO (Free ASCO Whitepaper)-GI on January 15, 2021.

About Colorectal Cancer (CRC) and Screening

According to the U.S. Centers for Disease Control (CDC), colorectal cancer (CRC) is the second leading cause of death in the United States from cancers that affect both men and women. Both CRC incidence and mortality have declined steadily over the past 30 years, attributable in part to the increasing percentage of adults aged 50–75 years who are up to date with recommended CRC screening. However, only 68.8% of adults aged 50–75 years were up to date with CRC screening in 20184. A CDC study shows that compliance varies based on income, access to health insurance and other factors, including lack of awareness of the need to be screened, being offered colonoscopy only instead of a choice of tests, fear, expense, inability to take time off work, and the perceived undesirable nature of screening tests.

On January 12, 2021 Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, reported that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for NM-01, a PD-L1 imaging biomarker, and will begin making the biomarker available to academic centers and pharmaceutical companies for use in immuno-oncology (I/O) clinical trials in 2021 (Press release, Lantheus Medical Imaging, JAN 12, 2021, View Source [SID1234573919]).

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NM-01 is a proprietary radiopharmaceutical biomarker using a camelid single-domain antibody and a technetium-99 radioisotope that has demonstrated a high affinity for PD-L1 protein. NM-01 could provide a specific, non-invasive approach to patient assessment, including use in whole-body imaging, or virtual biopsy. NM-01 potentially allows detection of PD-L1 expression in tumors and could be used to evaluate patients before, during, or after treatment with I/O agents, including checkpoint inhibitors, in clinical trials. The market for checkpoint inhibitors is expected to grow from $25B in 2019 to $68B in 2026.1 Lantheus licensed NM-01 from NanoMab Technology Limited in 2019 and plans to provide NM-01 as a clinical research tool, together with support and analytics, to pharmaceutical companies and the largest academic centers conducting clinical research in I/O.

"Evaluation of patients for I/O therapy is a key challenge for companies developing new therapeutics in this high-growth field," said Etienne Montagut, Senior Vice President of Corporate Development at Lantheus. "With the filing of the DMF, Lantheus is pleased to take an important step forward in providing a novel clinical research tool with the potential to provide new information to optimize the use of I/O therapy."

NanoMab has completed a Phase 1 study using NM-01 in 30 non-small cell lung cancer (NSCLC) patients, and preliminary data of the first 16 patients were published in the February 22, 2019 issue of Journal of Nuclear Medicine (Xing et al.). Separately, an investigator-led clinical trial involving 30 patients with either NSCLC or melanoma is in progress at King’s College London and Guy’s and St Thomas’ NHS Trust (NCT04436406); the study aims to monitor treatment response. A clinical trial authorization (CTA) was also granted by the Medicines Healthcare Products Regulatory Agency (MHRA) in November 2020 for a Phase 2 clinical study on NM-01 in NSCLC patients.

"We are very encouraged by the results of the Phase I study, which validated our innovative nanobody platform and demonstrated strong correlation with tissue-based biomarker," said Dr. H.H. Ting, Chief Executive Officer of NanoMab. "We are pleased that leading cancer research centers are progressing with the use of NM-01 in I/O clinical trials."

About a Drug Master File (DMF)

A Drug Master File (DMF) is a submission to the Food and Drug Administration that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.2

On January 12, 2021 Imago BioSciences, Inc., a clinical-stage biopharmaceutical company developing innovative treatments for myeloproliferative neoplasms, reported that Hugh Young Rienhoff, Jr., M.D., CEO, will present at the 39th Annual J.P. Morgan Healthcare Conference at 4:55 p.m. EST on Thursday, January 14, 2021 (Press release, Imago BioSciences, JAN 12, 2021, View Source [SID1234573918]). An archived replay of the presentation will be available on the company’s website, www.imagobio.com, for 30 days.

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On January 12, 2021 Primmune Therapeutics reported the close of its Series A financing round with the addition of $4.0 million from Bioqube Ventures, a European life sciences venture capital firm (Press release, Primmune Therapeutics, JAN 12, 2021, View Source [SID1234573917]). This brings the total of the Series A financing raise to $31.4 million. These funds will be used to support the development of PRTX007, a novel orally-administered, small molecule toll-like receptor 7 (TLR7) agonist as a therapeutic-adjuvant for acute viral diseases and cancer.

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Concurrently, Debbie Dumont, Co-founder and Managing Partner at Bioqube Ventures has joined Primmune’s Board of Directors as an observer. Elina Zuniga, Ph.D., Professor of Molecular Biology at the University of California, San Diego has joined the company’s scientific advisory board.

"We are excited to have Bioqube Ventures join our investor syndicate because of their expertise and experience in establishing European operations. Bioqube Ventures will facilitate the establishment of our Belgium subsidiary to complement our Australian presence and enable us to effectively partner and run clinical studies in the European Union as well as in the United States and Australia," said Charlie McDermott, Chairman and Chief Executive Officer of Primmune Therapeutics. "Dr. Elina Zuniga will be important in guiding our TLR7 agonist strategy as part of our scientific advisory board given her deep knowledge regarding the interplay between toll-like receptor signaling, endogenous poly-interferon antiviral responses, and host innate immune modulation."

On January 12, 2021 ARTMS Inc. (‘ARTMS’) and Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’) reported that they have successfully produced Telix’s prostate cancer imaging product, TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11)1, using multi-Curie quantities of cyclotron-produced Gallium-68 (68Ga) via ARTMS’ proprietary Quantum Irradiation System (QIS) solid target system (Press release, Telix Pharmaceuticals, JAN 12, 2021, View Source [SID1234573916]).

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The testing demonstrated an impressive six-hour stability of TLX591-CDx, a radiopharmaceutical targeting Prostate-Specific Membrane Antigen (PSMA) for the imaging of prostate cancer using Positron Emission Tomography (PET). Testing exceeded all relevant quality control standards for both low- (50 mCi and 100 mCi) and mid-level output (over 2,500 mCi) 68Ga production runs. The "cold kit" format of TLX591-CDx enables rapid radiolabelling at room temperature with high radiochemical purity and production consistency, ideally suited for the radiopharmacy setting.

ARTMS Chief Executive Officer, Charles S. Conroy, stated, "This collaboration and successful testing represents a significant step forward for the diagnosis of prostate cancer globally. The combination of Telix’s user friendly, high quality PSMA-11 kit along with robust production of 68Ga using our solid targetry approach moves us closer to having a PET diagnostic agent on demand for clinicians. Our goal at ARTMS is to ensure that the 68Ga supply is able to meet the substantial projected clinical demand for this isotope."

Telix USA President, Dr Bernard Lambert, added, "When the Telix-ARTMS collaboration was announced in April 2020, we were confident that ARTMS’ proprietary technology to produce 68Ga from specialized solid 68Zn targets using low-energy cyclotrons would be valuable to the Molecular Imaging and Oncology community. ARTMS’ work represents a significant development in how 68Ga is able to be supplied to the market for large-scale production and, as a result, will contribute to the reliability of access to all men living with prostate cancer who require advanced prostate imaging. This outcome is a testament to both the ARTMS technology and Telix’s proprietary formulation of PSMA-11"

ARTMS will continue the development of cyclotron-produced 68Ga with a focus on optimizing production potential and satisfying regulatory requirements for use in radiopharmaceutical kits such as TLX591-CDx.

About Prostate Cancer

Prostate cancer is the second most common cancer in men following skin cancer and, in 2018, 1.3 million men were diagnosed with prostate cancer for the first time.2 Despite advances in treatment, prostate cancer still accounts for a large number of deaths and in 2018 more than 365,000 men died from their disease. Rates of diagnosis are increasing, with the highest incidences of prostate cancer occurring in the United States, Europe, and Australia and New Zealand.