On January 12, 2021 DermTech, Inc. (NASDAQ: DMTK) ("DermTech"), a leader in precision dermatology enabled by a non-invasive skin genomics platform, reported that non-invasive genomic patch testing for melanoma, like DermTech’s Pigmented Lesion Assay ("PLA"), has received a recommendation from the National Comprehensive Cancer Network ("NCCN") (Press release, DermTech International, JAN 12, 2021, View Source [SID1234573923]). The recommendation indicates that there is uniform NCCN consensus that the intervention is appropriate. The NCCN Clinical Practice Guidelines in Oncology (the "NCCN Guidelines") for cutaneous melanoma recognize the use of noninvasive genomic patch testing to help guide biopsy decisions for cutaneous melanoma.

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The NCCN Guidelines are the recognized standard for clinical policy in cancer care and the most detailed clinical practice guidelines available in any area of medicine. The recommendation for pre-diagnostic non-invasive genomic patch testing can be found in the latest edition, NCCN Guidelines Version 1.21, Melanoma: Cutaneous, section ME-11, Common Follow-Up Recommendations for All Patients. The updated guidance now states: "Pre-diagnostic noninvasive genomic patch testing may also be helpful to guide biopsy decisions."

As a not-for-profit alliance of 30 leading cancer centers, the core resources made available by the NCCN are the NCCN Guidelines. These guidelines are decision tools created by leading clinicians to explain a disease and help determine the best way to treat a patient, depending on their diagnosis, disease stage and other factors, such as age. The NCCN Guidelines also help doctors make decisions, by explaining the pros and cons of each option.

"I laud the NCCN for recognizing the value of non-invasive genomic patch testing and including it in the current guidelines. This non-invasive genomic patch testing is a revolutionary change in the assessment of lesions suspicious for melanoma. Many commercial payors rely on guidelines from organizations such as NCCN as benchmarks for coverage decisions, and this NCCN recommendation indicates there is consensus that recognizes the value of the noninvasive genomic patch testing to guide biopsy decisions," said Daniel M. Siegel, M.D., Clinical Professor of Dermatology at SUNY Downstate and former President of the American Academy of Dermatology. "We are thrilled that the NCCN Guidelines recognize technology like DermTech’s as helpful in guiding biopsy decisions and foster earlier melanoma detection," said Burkhard Jansen, M.D., chief medical officer of DermTech. "Using genomic information provides clinicians with data even expert eyes cannot see and benefits patients with skin lesions clinically suspicious for melanoma. This is a significant milestone for precision genomics, and further substantiates the utility of our DermTech melanoma test, the Pigmented Lesion Assay, or PLA."

Covering 97 percent of all cancers affecting patients in the United States and updated on a continual basis, the NCCN Guidelines are developed through explicit review of evidence (clinical trials, existing treatment protocol, etc.) integrated with expert medical judgment and recommendations by panels that are made up of representatives from the 30 NCCN Member Institutions.

There are currently 73 NCCN Guidelines available free-of-charge that cover cancer detection, prevention and risk reduction, work-up and diagnosis, treatment and supportive care issues. To download the latest NCCN Guidelines, please visit: View Source

On January 12, 2021 TTC Oncology ("TTC" or the "Company") CEO and CMO Arek Dudek, MD, PhD, reported that it will be participating in the Biotech Showcase virtual conference occurring January 11-15, 2021 (Press release, TTC Oncology, JAN 12, 2021, View Source [SID1234573922]). Dr. Dudek will be providing a Company overview and update on the Company’s financing needs as well as TTC’s lead product candidate, TTC-352.

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TTC-352 is a novel, first-in-class and best-in-class orally available small molecule being developed as a treatment for patients with metastatic estrogen receptor-positive (ER+) breast cancer who have failed 2 or more prior therapies. TTC-352 is a selective human ER partial agonist (ShERPA) that induces unfolded protein response leading to breast cancer cell death and acts in a similar manner as hormone therapy by modulating estrogen actions.

Breast cancer afflicts approximately 2.1 million women in the US yearly with the majority of these cases being ER+ in which the hormone estrogen promotes tumor growth. Typically, patients with ER+ breast cancer are initially treated with hormonal therapy which blocks the tumorigenic actions of natural estrogen. However, many patients are unable to tolerate hormonal therapy which leads to discontinuation of treatment. Up to half of all patients who undergo this treatment develop resistance to therapy which can lead to cancer recurrence.

TTC Oncology has completed a Phase I human clinical trial where TTC-352 was shown to have only minimal side effects. In several women participating in the trial, TTC-352 successfully treated breast tumors resistant to multiple lines of hormonal and chemotherapy treatments. The best responders from the study include:

A 49-year-old woman with ER+, progesterone receptor-positive (PR+), HER2-breast cancer with visceral metastases. After progressing on multiple prior lines of hormonal and chemotherapies (12 total), TTC-352 induced 6% tumor shrinkage and controlled disease for 309 days with negligible toxicity
A 77-year-old woman with ER+, PR+, HER2-breast cancer with bone metastases. After trying 16 prior lines of hormonal and chemotherapy, TTC-352 treatment resulted in stable disease for 280 days with negligible toxicity
Based on these encouraging results, TTC Oncology are planning to develop TTC-352 to be commercially indicated as a second-line therapy of ER+ breast cancer.

Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor conference focused on driving advances in therapeutic development by providing a sophisticated networking platform for executives and investors that fosters investment and partnership opportunities. The conference takes place each year during the course of one of the industry’s largest gatherings and busiest weeks.

ABOUT BIOTECH SHOWCASE

Biotech Showcase is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place. Investors and biopharmaceutical executives from around the world gather in San Francisco during this bellwether week which sets the tone for the coming year. Now in its 13th year, this well-established, highly respected conference features multiple tracks of presenting companies, plenary sessions, workshops, networking, and an opportunity to schedule one-to-one meetings. Biotech Showcase is produced by Demy-Colton and EBD Group. Both organizations have a long history of producing high-quality programs that support the biotechnology and broader life sciences industry.

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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