On March 8, 2022 DermTech, Inc. (NASDAQ: DMTK) ("DermTech" or the "Company"), a leader in precision dermatology enabled by a non-invasive skin genomics platform, reported that SKIN: The Journal of Cutaneous Medicine has published its original research study, with Daniel M. Siegel, MD, MS as the lead author (Press release, DermTech International, MAR 8, 2022, View Source [SID1234609702]). A nationally recognized reimbursement expert, Dr. Siegel is a clinical professor of dermatology at SUNY Downstate Medical Center and a former president of the American Academy of Dermatology. By incorporating the Pigmented Lesion Assay ("PLA") into the current care pathway of assessing pigmented skin lesions or moles suspicious for melanoma, the study highlights the potential reduction in cost for commercial health insurance plans, in addition to a higher quality of care for patients and improved health outcomes.

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The PLA, a component of the DermTech Melanoma Test, objectively measures genomic markers associated with melanoma within skin tissue samples collected via non-invasive adhesive patches, or Smart Stickers. It is used to identify high-risk lesions and help providers determine the next best treatment: either a biopsy and histopathologic evaluation or clinical surveillance of the lesion in question. Comparatively, the traditional care pathway for evaluating suspicious moles is visual assessment, which is subjective, followed by a potentially avoidable surgical biopsy and histopathologic assessment.

The findings outlined in the publication, "Cost-Benefit Analysis of the Pigmented Lesion Assay When Introduced into the Visual Assessment / Histopathology Pathway for Lesions Clinically Suspicious for Melanoma," suggests that use of the PLA to rule out melanoma can minimize avoidable surgical procedures on benign lesions and decrease downstream costs of late-stage melanoma diagnoses, which reduces overall cost of care. To determine the per member per month ("PMPM") net savings of incorporating the PLA into the current care pathway, a Return on Investment ("ROI") model was developed from a U.S. payor perspective. This model predicted annual net savings of $0.54 PMPM for commercial health plans over a three-year period with incorporation of the PLA.

"There is a clear need for objective, cost-effective technologies to help improve the assessment, classification and management of skin lesions and moles suspicious for melanoma," said Dr. Siegel. "The PLA offers just that, helping to make sure that the lesions and moles most likely to be malignant are the ones being biopsied."

The published findings in SKIN can be found here: View Source

"This research study is a testament to how the PLA has the potential to reduce costs for health insurance plans and improve patient care by limiting the number of potentially avoidable biopsies," said John Dobak, MD, CEO of DermTech. "As we continue to leverage genomics to advance melanoma detection and dermatology as a whole, we continue to believe that the PLA has the potential to be incorporated into additional insurance plans."

On March 8, 2022 Researchers at City of Hope, one of the largest cancer research and treatment organizations in the United States, have data pointing to the limitations of Signatera, a popular liquid biopsy or blood draw test reported that is used to detect the recurrence of colorectal cancer in patients who have had their disease surgically removed (Press release, City of Hope, MAR 8, 2022, View Source [SID1234609701]). The study was published today in JAMA Open Network.

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"A liquid biopsy measuring circulating tumor DNA is a novel way to test for residual disease in patients who have recently received curative resection for colon cancer. Identifying early disease recurrence is important as it may allow for potential curative interventions," said Marwan Fakih, M.D., co-director of City of Hope’s Gastrointestinal Cancer Program and lead author of the new study.

City of Hope researchers evaluated 48 study participants who had had their colorectal cancer resected. The scientists sought to identify which technique might be superior in identifying residual disease and early cancer recurrence by comparing the use of Signatera’s circulating tumor DNA (ctDNA) analysis, which is often used to screen for colorectal cancer, to the standard-of-care recommended by the National Comprehensive Cancer Network (NCCN): X-rays via computed tomography (CT) scan and a carcinoembryonic antigen (CEA) test, which measures a tumor marker via a blood draw.

Fifteen patients experienced colorectal cancer recurrence. Within this group, standard-of-care surveillance was better at identifying early disease. For example, Signatera did not identify patients who had early recurrence in the lungs. Three patients received a negative ctDNA test, but standard-of-care surveillance techniques identified disease recurrence in their lungs.

"Imaging remains the most important surveillance assay in the follow-up of resected colorectal cancers. Clinicians should continue to abide by NCCN guidelines. For those who decide to implement ctDNA into their surveillance algorithm, they should be aware of the limitations associated with this assay," Fakih said, referencing current clinical trials elsewhere where clinicians are de-intensifying chemotherapy based on a negative ctDNA test by Signatera.

It may be premature to base treatment decisions solely on ctDNA results "given the limitations of Singatera sensitivity," said Fakih, the Judy & Bernard Briskin Distinguished Director of Clinical Research and a professor in City of Hope’s Department of Medical Oncology & Therapeutics Research.

Fakih added that using liquid biopsies to identify disease recurrence is an attractive, noninvasive option. Liquid biopsy is convenient and, unlike CT, does not expose patients to low doses of radiation. However, scientists are still working to develop a reliable and sensitive liquid biopsy to detect colorectal cancer recurrence. Nevertheless, there is promise.

"ctDNA was able to identify several recurrences in the liver and lymph nodes ahead of imaging," Fakih said. "For now, ctDNA can be considered, if any at all, as a complement to the standard approach recommended by the NCCN, but one must be cognizant of its limitations."

JAMA Network Open published the study under the title, "Evaluation of comparative surveillance strategies of circulating tumor DNA, imaging and carcinoembryonic antigen levels in patients with resected colorectal cancer."

On March 8, 2022 Palleon Pharmaceuticals, a company pioneering the field of glyco-immunology to treat cancer and inflammatory diseases, reported dosing of the first patient in the company’s Phase 1/2 study of E-602 in patients with advanced cancers (Press release, Palleon Pharmaceuticals, MAR 8, 2022, View Source [SID1234609700]). The study, called GLIMMER-01 (Glycan-Mediated Immune Regulation), is the first clinical study of Palleon’s novel approach to cancer immunotherapy which targets immunosuppressive sialoglycans.

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E-602 is Palleon’s lead program in oncology and the first candidate generated from the company’s EAGLE platform. E-602 is composed of two engineered human sialidase molecules fused to a human monoclonal antibody. Preclinical studies have demonstrated that E-602 degrades terminal sialic acids on immunosuppressive sialoglycans on both tumor cells and immune cells, restoring both innate and adaptive antitumor immunity.

"We’re very excited to bring our first therapeutic candidate into the clinic. This milestone is significant not just for Palleon, but for the broader immuno-oncology community, as we test a bold new approach to releasing immune suppression by modifying cancer cell-surface glycans," said Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon. "We continue to pursue research at the forefront of glyco-immunology to advance other novel therapies for cancer and inflammatory diseases into the clinic and ultimately to patients."

The GLIMMER-01 trial (NCT05259696) is an open-label, dose-escalation, and dose-expansion study. It will evaluate safety, pharmacodynamic effects, and antitumor activity of E-602, both as a single agent and in combination with pembrolizumab (anti-PD-1). The study will enroll patients with previously treated non-small cell lung cancer, colorectal cancer, melanoma, pancreatic cancer, and ovarian cancer.

"First generation immune checkpoint inhibitors demonstrated remarkable efficacy for patients with many types of cancer. However, only a minority of patients benefit from these therapies," said David Feltquate, M.D., Ph.D., Chief Medical Officer of Palleon. "Novel approaches to overcoming immune resistance are needed. Today marks an important milestone for the nascent field of glyco-immunology as we explore the potential of altering the immune suppressing effects of inhibitory sialoglycans."

On March 8, 2022 Ambrx Biopharma Inc., or Ambrx (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, reported that Feng Tian, Ph.D., Chairman of the Board, President, and CEO of Ambrx, will present at Oppenheimer’s 32nd Annual Healthcare Conference taking place March 15-17, 2022 (Press release, Ambrx, MAR 8, 2022, View Source [SID1234609699]).

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Dr. Tian is scheduled to present on Thursday, March 17, at 12:40 p.m. Eastern Time.

Interested parties can access the live webcast for this conference from the Investor Relations section of the company’s website at www.ambrx.com. The webcast replay will be available after the conclusion of the panel discussion for approximately 90 days.

On March 8, 2022 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic and medical imaging applications, reported that Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes, will participate in an upcoming corporate event hosted by Oppenheimer & Co. Inc (Press release, NorthStar Medical Radiostopes, MAR 8, 2022, View Source [SID1234609698]). The fireside chat, "Radiopharmaceutical Therapies Come of Age," will be held in virtual format on Monday, March 14, 2022, at 1:00 p.m. ET. Topics of discussion will include: development strategy for targeted radiotherapy using alpha and beta-emitting radioisotopes; supply, manufacturing and transportation challenges; and strategies for limiting systemic toxicities. Additional information is available here.

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"NorthStar continues to expand our leadership position in the rapidly growing area of therapeutic radioisotopes, which are used in targeted precision radiopharmaceuticals for the treatment of cancer, respiratory and other diseases," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. "NorthStar is poised to be the first commercial-scale producer of therapeutic radioisotopes copper-67 and actinium-225, and strongly positioned for continued rapid growth. We look forward to sharing information about our innovative and environmentally sustainable approach to radioisotope production with the investor community at this Oppenheimer fireside chat."