City of Hope Researcher Advises Doctors Against Overreliance on a Popular Liquid Biopsy Used to Screen for Colorectal Cancer Recurrence

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."

Palleon Pharmaceuticals Announces First Patient Dosed in Phase 1/2 Study of Lead Glyco-Immunology Drug Candidate for Oncology

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."

Ambrx Biopharma Inc. to Present at Oppenheimer’s 32nd Annual Healthcare Conference

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.

NorthStar Medical Radioisotopes to Participate in Upcoming Oppenheimer & Co. Inc. Event, “Radiopharmaceutical Therapies Come of Age”

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."

Fulgent Genetics Announces $250 Million Share Repurchase Program

On March 8, 2022 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent" or the "Company"), a technology-based genetic testing company focused on transforming patient care in oncology, infectious and rare diseases, and reproductive health, reported that its Board of Directors has authorized a share repurchase program under which Fulgent may repurchase up to $250 million in shares of its common stock (Press release, Fulgent Pharma, MAR 8, 2022, View Source [SID1234609697]).

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"Given the volatility we have seen in our share price, we believe current trading levels present an attractive opportunity to implement a share repurchase program as a way to return capital to our shareholders," said Paul Kim, Chief Financial Officer of Fulgent. "With our current cash, cash equivalents and investments in marketable securities position now exceeding $1.0 billion, we believe we remain extremely well capitalized to make strategic investments to drive growth as we implement this share repurchase program."

The timing and amount of any shares repurchased will be determined by Fulgent’s management based on its evaluation of market conditions and other factors. Share repurchases under the program may be made through a variety of methods, which may include open market purchases, in block trades, accelerated share repurchase transactions, exchange transactions, or any combination of such methods. The repurchase program may be suspended or discontinued at any time. Any repurchased shares will be available for use in connection with its stock plans and for other corporate purposes.

The repurchase program will be funded using Fulgent’s working capital. Fulgent had approximately 30.3 million shares of common stock outstanding as of March 7, 2022.