On March 30, 2021 BostonGene Corporation, a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, reported that eight abstracts were selected for poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, which will be conducted virtually from April 10 – 15, 2021 and May 17 – 21, 2021 (Press release, BostonGene, MAR 30, 2021, View Source [SID1234577379]).

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The presentations underscore the importance of the application of novel and cutting-edge analytical tools to improve the diagnosis and treatment for cancer patients. These tools were applied across a wide range of cancers to further understand tumor biology and identify biomarkers for diverse therapies in an effort to propel precision medicine to the forefront of clinical decision making.

"We are proud to present at the AACR (Free AACR Whitepaper) Annual Meeting. These results demonstrate BostonGene’s unique ability to identify novel and personalized treatment options through next generation multi-platform analytics, further advancing and optimizing outcomes for each cancer patient," said Nathan Fowler, MD, Chief Medical Officer at BostonGene.

Details of the poster presentations are below:

Title: AI-driven multifaceted predictive biomarkers of response to tyrosine kinase inhibition and immune checkpoint blockade in clear cell renal cell carcinoma
Session: PO.CL06.06 – Immune Response to Therapies
Poster: 516
Presenter: Natalia Miheecheva, MSc, BostonGene

Research conducted with Washington University School of Medicine in St Louis.

Title: Association of circulating myeloid derived suppressor cells with systemic lymphopenia following chemoradiotherapy in glioblastoma
Session: PO.CL06.04 – Immune Mechanisms Invoked by Therapies
Poster: 507
Presenter: Dinesh Thotala, PhD, Washington University School of Medicine in St Louis

Research conducted with Washington University School of Medicine in St Louis.

Title: Astraea: A first-in-class biomarker database integrating genomic, transcriptomic, and tumor microenvironment properties for precision oncology
Session: PO.BSB01.03 – Database Resources
Poster: 205
Presenter: Azamat Gafurov, MSc, BostonGene

Title: Evaluating the clinical utility of RNA-seq-based PD-L1 expression and cellular deconvolution as alternatives to conventional immunohistochemistry in clear cell renal cell carcinoma
Session: PO.BSB01.02 – Application of Bioinformatics to Cancer Biology
Poster: 161
Presenter: Natalia Miheecheva, MSc, BostonGene

Research conducted with Washington University School of Medicine in St Louis.

Title: Integrated multiregional transcriptomic and multi-parameter single-cell imaging analysis of clear cell renal cell carcinoma elucidates diverse cellular communities present within the tumor microenvironment
Session: PO.TB06.04 – Immune Cells in the Tumor Microenvironment
Poster: 2742
Presenter: Natalia Miheecheva, MSc, BostonGene

Research conducted with Washington University School of Medicine in St Louis.

Title: MutAnt: Mutation annotation machine learning algorithm for pathogenicity evaluation of single nonsynonymous nucleotide substitutions in cancer cells
Session: PO.BSB02.01 – Artificial Intelligence and Machine Learning
Poster: 192
Presenter: Aleksandr Sarachakov, MSc, BostonGene

Title: Predictors of treatment responses in a preoperative window of opportunity trial of nivolumab in resectable squamous cell carcinoma of the head and neck
Session: PO.ET02.03 – Role of the Microenvironment in Therapeutic Response
Poster: 1441
Presenter: Nikita Kotlov, MSc, BostonGene

Research conducted with Thomas Jefferson University.

Title: Tumor immune microenvironment based molecular functional clustering reveals a prognostic signature that predicts overall survival in patients with gastric cancer
Session: PO.TB06.08 – Tumor Immune System Interactions
Poster: 3182
Presenter: Prashant V. Thakkar, Weill Cornell Medicine

Research conducted with Weill Cornell Medicine.

The e-poster website will be launched Saturday, April 10, 2021, the first day of the AACR (Free AACR Whitepaper) Virtual Annual Meeting. All e-posters will be made available for browsing on the AACR (Free AACR Whitepaper) Annual Meeting website on this date.

Additionally, the abstracts will be published in an online-only Proceedings supplement to the AACR (Free AACR Whitepaper) journal Cancer Research after the completion of the AACR (Free AACR Whitepaper) Virtual Annual Meeting.

On March 30, 2021 Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, reported it has acquired the exclusive, worldwide rights to develop, manufacture and commercialize NTI-1309, an innovative PET oncology imaging agent from Noria Therapeutics, Inc (Press release, Lantheus Medical Imaging, MAR 30, 2021, View Source [SID1234577378]).

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NTI-1309 targets fibroblast activation protein (FAP), a target with potential broad imaging applicability and targeting implications in oncology. FAP is overexpressed in the tumor microenvironment, specifically in tumor-associated fibroblasts, which are believed to modulate tumor progression and immune response. Given its expression in tumors coupled with low expression in normal tissue, FAP has the potential to become an important biomarker for precision medicine in cancer. Already a focus of significant research by academics and the pharmaceutical industry, a FAP biomarker has potential to address unmet medical needs and to impact the clinical management of stroma-dense tumors, such as breast, colon, lung and pancreatic cancer.

Under terms of the agreement, Noria will drive the early clinical development of NTI-1309, leveraging its experience with early-stage imaging development. Upon completion of the Phase 1 study, NTI-1309 will be integrated into Lantheus’ portfolio of imaging biomarkers and included in the offering to academic centers and pharmaceutical companies for use in oncology drug development programs. Simultaneously, Lantheus will assess options for bringing this important biomarker to market through Lantheus-sponsored trials.

"Lantheus is committed to advancing innovative imaging biomarker solutions to find, fight and follow cancer," said Etienne Montagut, Senior Vice President of Corporate Development at Lantheus. "We believe FAP is a promising target for cancer imaging and has broad potential to inform diagnosis and staging, to guide patient selection for therapy, and to monitor response to treatment across multiple tumor types. This partnership with Noria enables us to progress this development program in a timely fashion, leverage our established leadership in imaging and state of the art artificial intelligence, and position us to monetize this biomarker offering, which has the potential to unlock deep, data-driven insights to inform R&D and clinical decision-making."

"The Noria team is excited to partner with a proven leader in imaging diagnostics with the experience and resources to advance this development program. Noria is pleased to have been entrusted by Lantheus to continue the development of NTI-1309, leveraging our platform and very experienced team," said Allan M. Green, MD, PhD, JD, Co- Founder and CEO of Noria Therapeutics, Inc.

Terms of the transaction include an upfront license and development fee to Noria, certain development and regulatory milestones, and royalties if NTI-1309 is commercialized.

On March 30, 2021 Guardant Health, Inc. (Nasdaq: GH) reported that the Centers for Medicare & Medicaid Services (CMS) has approved Advanced Diagnostic Laboratory Test (ADLT) status for the Guardant360 CDx test (Press release, Guardant Health, MAR 30, 2021, View Source [SID1234577377]). The Guardant360 CDx test is the first FDA-approved liquid biopsy for comprehensive tumor mutation profiling across all solid cancers.

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Under the Protecting Access to Medicare Act of 2014 (PAMA), CMS determination confirms that the Guardant360 CDx test meets the criteria for ADLT status, which is reserved for innovative products that provide novel clinical information that cannot be obtained by any other method, and for FDA-approved tests. Obtaining ADLT status initiates a specific, market-based approach to pricing the test for Medicare patients. During the nine-month period beginning April 1, 2021 and ending December 31, 2021, Guardant Health will collect, assess and submit private-payer payment rate data for the test, the median of which will be used by CMS to determine the Medicare pricing, beginning January 1, 2022. During this nine-month period, the Guardant360 CDx test will be reimbursed at a rate of $5,000 for all Medicare patients.

"Obtaining ADLT status for our Guardant360 CDx test is an important milestone that not only demonstrates the value that our FDA-approved liquid biopsy test brings to patients with advanced cancer, but also paves the way for broader payer coverage," said Helmy Eltoukhy, Guardant Health CEO. "We believe this milestone is a critical step to ensuring that all patients have access to our Guardant360 CDx test, so that their treatment is informed by comprehensive genomic profiling in-line with today’s medical guidelines."

Each year, more than 600,000 people die from cancer in the United States,1 many of whom may have benefitted from comprehensive genomic profiling (CGP) to guide a more personalized treatment plan based on a growing list of effective CGP-informed targeted therapies. Clinical studies show that patients receiving targeted therapies have improved progression-free survival and higher overall response rates relative to chemotherapy or immunotherapy.2-8 Guardant360 CDx offers patients and clinicians a simple, faster blood test to help inform personalized treatment options.

On March 30, 2021 Schrödinger (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, reported that it will host a webcast to review the preclinical data being presented from its CDC7 program during a virtual poster session at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Schrodinger, MAR 30, 2021, View Source [SID1234577376]). The company will also provide an overview of two other internal programs, MALT1 and Wee1, as well as highlight the role of its computational platform in accelerating the discovery of its novel molecules. The webcast will take place Monday, April 12, 2021, at 10:00 a.m. ET.

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The webcast will be available under "News & Events" in the investors section of Schrödinger’s website, View Source and will be archived for approximately 7 days.

On March 30, 2021 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints reported the closing of a $73 million Series B1 and B2 financing (Press release, Immune-Onc Therapeutics, MAR 30, 2021, View Source [SID1234577375]). The round was led by Oceanpine Capital with participation from additional new investors including Octagon Capital and Sphera Healthcare, and existing investors, including Northern Light Venture Capital and Vivo Capital. In conjunction with this round of financing, Oceanpine CEO and managing partner Dave Chenn joins the Immune-Onc Board of Directors. In addition, the company received a strategic capital investment from The Leukemia & Lymphoma Society’s Therapy Acceleration Program (LLS TAP), directed toward advancing the company’s work to treat blood cancers.

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"We are delighted that this high-caliber group of new and existing investors share our excitement about the transformative potential of myeloid checkpoint inhibition and believe in Immune-Onc’s ability to deliver on this promise with our pipeline of first-in-class cancer immunotherapies," said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "This round of investment was substantially over-subscribed, enabling the company to accelerate the clinical development of multiple novel assets, and deliver what we believe is the next breakthrough in immunotherapy treatment for many of the world’s most devastating cancers."

Proceeds from the financing will allow Immune-Onc to advance its portfolio of blood cancer and solid tumor immunotherapies targeting myeloid checkpoints with a focus on the LILRB family. Immune-Onc has raised more than $110 million from investors since the company began operations in 2016. In August 2020, the company announced it had been awarded a Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) to support clinical development of IO-202.

"We are enthusiastic about Immune-Onc’s novel approach to cancer immunotherapy targeting myeloid checkpoints and their leading portfolio of first-in-class assets," said Dave Chenn, CEO and managing partner of Oceanpine Capital. "We have full confidence in the company’s highly experienced management team and are excited to be at the forefront of this new area of research and development through our investment in Immune-Onc supporting their next phase of growth."

Immune-Onc’s Pipeline

Immune-Onc’s research and development programs focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints to overcome immune resistance of cancer. The company has invested in proprietary models, assays and tools to interrogate the biology and translate this cutting-edge research into the development of novel therapies.

Immune-Onc’s lead program IO-202, a first-in-class antibody targeting LILRB4 (also known as ILT3), is being developed to treat blood cancers, including acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML), and solid tumors. In hematologic malignancies, preclinical studies showed that IO-202 converts a "don’t kill me" to a "kill me" signal by activating T cell killing and converts a "don’t find me" to a "find me" signal by inhibiting infiltration of hematologic cancer cells.

In September 2020, Immune-Onc initiated a Phase I trial evaluating IO-202 in AML with monocytic differentiation and in CMML. The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designation status for treatment of AML in October 2020. The company is also evaluating IO-202 in solid tumors and will present preclinical data for the first time on April 10, 2021 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (#AACR21).

Immune-Onc has active preclinical programs targeting other members of the LILRB family including IO-108, a novel antagonist antibody targeting LILRB2 (also known as ILT4) which is currently in the IND-enabling stage. The company presented preclinical data supporting IO-108 for the treatment of solid tumors at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting and plans to submit an investigational new drug application in mid-2021. Other preclinical assets include IO-106, a first-in-class anti-LAIR1 antibody, and multiple undisclosed programs for solid tumors and hematologic malignancies.

About The Leukemia & Lymphoma Society and Therapy Acceleration Program (TAP)

The Leukemia & Lymphoma Society (LLS) is a global leader in the fight against cancer. The LLS mission is to cure leukemia, lymphoma, Hodgkin’s disease and myeloma, and improve the quality of life of patients and their families. LLS TAP is a strategic initiative that builds business alliances and collaborations with biotechnology companies and academic researchers to identify potential breakthrough therapies with the ability to change the standard of care. LLS TAP funds late-stage pre-clinical studies, and proof of concept or registrational clinical trials to help advance therapeutics along the drug development and approval pathway. To learn more, visit www.LLS.org/therapy-acceleration-program. Follow LLS on Facebook, Twitter, and Instagram.