On November 16, 2022 Parthenon Therapeutics, a precision oncology company inventing a novel class of anti-cancer therapies that reprogram the tumor microenvironment (TME), reported its precision medicine approach to address cancers with hight unmet need, at the Stifel Healthcare Conference (Press release, Parthenon Therapeutics, NOV 16, 2022, View Source [SID1234624172]).

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"We are delighted to showcase our pipeline and technology to the scientific community and anticipate that we will pioneer a new approach to treating patients with immune-excluded tumors. Specifically, immune exclusivity describes a distinct category of TME where a patient’s T-cells are unable to attack a tumor due to the formation of a barrier around the tumor cells. Our data have shown over 50% of solid tumors are immune-excluded, indicating a significant unmet need for these patients," said Laurent Audoly, co-founder and Chief Executive Officer of Parthenon Therapeutics. "We also presented our lead asset, PRTH-101, which targets DDR1 (Discoidin Domain Receptor 1) to open up the mechanical barrier that characterizes immune-excluded tumors, and thus make the tumors vulnerable to treatment. We are excited to be developing one of the first therapeutics and patient selection strategy to address this class of tumors, and we anticipate providing more details in the upcoming months. Notably, the second half of 2023 will be a catalyst as we will initiate our first-in-human clinical study in a well-defined patient population."

On November 16, 2022 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported a collaboration agreement to participate in an investigator-initiated, non-therapeutic pilot study to evaluate the cerebrospinal fluid tumor and immune cell microenvironment in patients with metastatic breast cancer and brain metastases and/or leptomeningeal disease (Press release, Biocept, NOV 16, 2022, View Source [SID1234624171]). The study is designed to identify biomarkers associated with central nervous system (CNS) metastasis, enabling a better understanding of treatment response, prognosis, and treatment resistance that may improve the management of CNS disease in patients with metastatic breast cancer.

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The study is being conducted by breast oncologists Michelle E. Melisko, M.D. and Laura A. Huppert, M.D. at the University of California, San Francisco (UCSF) under a grant from the California Breast Cancer Research Program and the UCSF Brain Spore. Results from cerebrospinal fluid using Biocept’s CNSide assay and matched patient blood samples will be analyzed and compared to detect and characterize cancer in the cerebrospinal fluid with the goal of identifying new targets and to guide therapeutic decisions. In addition, Drs. Huppert and Melisko will work with Dr. Chris Im in the laboratory of Dr. Max Krummel at UCSF to examine the immune-cell microenvironment in a companion study, and the results will be analyzed together.

"We hypothesize that patients with metastatic breast cancer and brain metastases and/or leptomeningeal disease will have tumor cells and cell-free tumor DNA (ctDNA) that can be detected in cerebrospinal fluid, and that higher concentrations of cerebrospinal fluid tumor cells and ctDNA will correlate with progression of brain metastases and/or development of leptomeningeal disease," said Dr. Melisko. "The ability to identify cancer biomarkers that predict an elevated risk of CNS disease progression will have prognostic and therapeutic implications in treating these patients."

"This collaborative study is designed to provide important information derived from cerebrospinal fluid samples that will better inform physicians treating patients with metastatic breast cancer involving the CNS, in particular those with leptomeningeal disease, who have a very poor prognosis if untreated," said Michael Dugan, M.D., Biocept’s Chief Medical Officer and Medical Director. "CNSide will help these physicians determine the extent of involvement, potential targets for treatment and help them evaluate the response to treatment."

"This study will also evaluate and compare the information derived from cerebrospinal fluid versus that of matched blood samples, where—based on our early experience—we believe cerebrospinal fluid could be more informative of intracranial response to treatment than related blood-based tests or radiologic changes routinely assessed by MRI," he added.

The pilot study will collect cerebrospinal fluid and blood samples from 20 patients with metastatic breast cancer and brain metastases and/or leptomeningeal disease. The samples will be analyzed for the presence, quantity and mutational profile of cerebrospinal fluid ctDNA and cerebrospinal fluid tumor cells, which will be paired with results from peripheral blood mononuclear cell samples. Exploratory analysis of changes in cerebrospinal fluid ctDNA, tumor cell, and immune cell characteristics will be performed over time in a limited number of serial samples. The cerebrospinal fluid findings will then be correlated with clinical outcomes, including CNS disease progression and survival.

The Rationale for the Study

One of the most devastating complications of metastatic breast cancer is the development of CNS disease, including brain metastases and/or leptomeningeal disease. Among patients with metastatic breast cancer, approximately 15-45% develop brain metastases and approximately 5-10% develop leptomeningeal disease during the course of their disease, resulting in significant morbidity and mortality. As patient outcomes improve with better systemic treatment options, control of CNS disease has become increasingly important to reduce morbidity and prolong survival.

Patients with leptomeningeal disease are often excluded from clinical trials and there are few effective treatments. In order to develop better tools for the diagnosis and treatment of metastatic breast cancer with CNS disease, it is critical to better understand the biology of this condition. Specifically, the profiling of the cerebrospinal fluid tumor and immune microenvironment in patients with brain metastases and/or leptomeningeal disease will enable a better understanding of the characteristics that may contribute to the development and progression of CNS disease.

About the California Breast Cancer Research Program

The mission of the California Breast Cancer Research Program (CBCRP) is to prevent and eliminate breast cancer by leading innovation in research, communication, and collaboration in the California scientific and lay communities. CBCRP is the largest state-funded breast cancer research effort in the nation and is administered by the Research Grants Program Office within the University of California Office of the President. The CBCRP funds California investigators to solve questions in basic breast cancer biology, causes and prevention of breast cancer, innovative treatments and ways to live well following a breast cancer diagnosis, and involves advocates and scientists in every aspect of CBCRP decision-making, including program planning and grant application review. Since 1994 the CBCRP has awarded more than $280 million in research funds to institutions across California, with 95% of its revenue going directly to funding research and education efforts.

About CNSide

CNSide is based on Biocept’s proprietary quantitative tumor cell capture and detection method, paired with assays to identify actionable molecular treatment targets. Given the genetic changes that can occur as metastatic cancer spreads to the central nervous system, the evaluation of cerebrospinal fluid with CNSide provides a unique opportunity to identify biomarkers such as HER2 and EGFR in patients with metastatic carcinoma or melanoma to help guide physicians in therapy selection. In addition, the quantitative tumor cell count assay can be used in a serial fashion to monitor the response to therapy more effectively than other current methods.

On November 16, 2022 Alexion, AstraZeneca Rare Disease, reported the completion of its acquisition of LogicBio Therapeutics, Inc. (NASDAQ: LOGC), a pioneering genomic medicine company (Press release, AstraZeneca, NOV 16, 2022, View Source [SID1234624170]).

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The acquisition creates an opportunity to accelerate Alexion’s growth in genomic medicines through unique technology, an experienced rare disease R&D team, and expertise in pre-clinical development. Frederic Chereau, CEO of LogicBio, will join Alexion as Senior Vice President, Strategy and Business Development.

Additional Transaction Details

The tender offer for all of the issued and outstanding shares of common stock of LogicBio expired as scheduled at one minute following 11:59 p.m., New York City time, on Tuesday, November 15, 2022. The minimum tender condition and all of the other conditions to the offer have been satisfied and on November 16, 2022, Alexion accepted for payment and will as promptly as practicable (but in any event within two business days) pay for all shares validly tendered and not validly withdrawn.

Following its acceptance of the tendered shares, on November 16, 2022, Alexion has completed its acquisition of all of LogicBio through the merger of a wholly owned subsidiary of Alexion with and into LogicBio, pursuant to Section 251(h) of the General Corporation Law of the State of Delaware, with LogicBio continuing as the surviving corporation and becoming a wholly owned subsidiary of Alexion.

In connection with the merger, all LogicBio shares of common stock not validly tendered in the tender offer have been converted into the right to receive $2.07 per share in cash, without interest thereon and net of any applicable withholding taxes, that would have been paid had such shares been validly tendered in the tender offer. In connection with the acquisition, LogicBio’s shares of common stock ceased trading on the NASDAQ Global Market. Alexion will retain LogicBio employees at their current location.

On November 16, 2022 Agendia, Inc., a commercial-stage company focused on assessing an individual tumor’s risk of metastasis and the molecular subtyping reasons for its growth, reported the first patient has enrolled in the LESS clinical trial, sponsored by Unicancer with the institutional support of Agendia (Press release, Agendia, NOV 16, 2022, View Source [SID1234624169]). In an effort to improve outcomes while preserving quality of life for early breast cancer patients, the study is designed to safely discontinue adjuvant endocrine therapy after two years for tumors with a MammaPrint Ultra Low result in post-menopausal women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. The study aims to enroll 696 patients via 45 sites within the French breast cancer intergroup Unicancer (UCBG) by October 2024.

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"We are excited to identify early breast cancer tumors and further investigate the ability to reduce endocrine therapy duration, in an effort to minimize significant and varying side effects, while maintaining high survival rates," said Fabrice André, MD, PhD, Professor in the Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France and Co-coordinating Investigator of the study.

Elise Deluche, MD, Deputy Head of Department at Centre Hospitalier Universitaire de Limoges and Co-coordinating Investigator of the study, added, "Enabling personalized treatments to prevent over- and undertreatment in breast cancer care could give women freedom from intensive long-term treatment regimens that may not increase their chance of cure."

Previous studies have shown patients with HR+/HER2- breast cancer with a MammaPrint Ultra Low result can have an excellent prognosis at 20 years with reduced endocrine therapy.

"The LESS study is an important addition to Agendia leading the field in uncovering robust insights for patients and their providers to tailor treatments unique to every tumor," said William Audeh, MD, Chief Medical Officer at Agendia. "Through our partnership with Unicancer, we are expanding knowledge on the complexity of breast cancer and enabling further personalized treatments in cancer care."

Agendia’s singular focus on breast cancer facilitates continued investment in global research to unravel the intricacies of precision medicine and drive personalized treatment planning for women with breast cancer. This study reinforces Agendia’s commitment to practice changing research that will aid decision-making, aimed at improving outcomes.

On November 16, 2022 Horizon Therapeutics plc reported that it has entered a multi-year scientific collaboration with Johns Hopkins University School of Medicine to identify new disease targets and develop therapies for patients with serious autoimmune and inflammatory conditions (Press release, Horizon Therapeutics, NOV 16, 2022, View Source [SID1234624168]). The initial focus is the emerging field of immunometabolism, the study of metabolic processes in the body, that when dysregulated, can drive autoimmunity and inflammation. This is the first project in the collaboration, with additional projects to follow.

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"Collaboration is essential to move science forward and we are very pleased to begin working with Johns Hopkins University," said Elizabeth H.Z. Thompson, Ph.D., executive vice president, research and development, Horizon. "By combining Johns Hopkins capabilities in pre-clinical research with Horizon’s expertise in autoimmunity, our teams will advance translational and research efforts to address the unique needs of different patient populations."

Horizon’s research scientists, in collaboration with Johns Hopkins University School of Medicine experts, aim to identify novel metabolic pathways that lead to chronic inflammation and autoimmunity in different subsets of myositis patients. This deeper pathway knowledge will then be used to identify novel drug targets that may be suitable for discovery of new medicines.

The collaboration comes as Horizon is increasing its presence in Maryland and will be the first tenant at the Alexandria Center at Traville Gateway campus in Rockville, Maryland. When completed, the state-of-the-art facility will support job growth and drive The Company’s continued efforts to develop new medicines.

"As Horizon deepens our footprint in the Maryland area, we believe this collaboration will bolster the world-class scientific thinking and technical capabilities that are found in the Maryland life sciences ecosystem," said Robert Stoffel, Ph.D., vice president, research, Horizon. "Working hand-in-hand with experts at Johns Hopkins University will allow our teams to better understand the biology of diseases we are investigating and identify new pre-clinical targets that could lead to novel therapeutics."