On June 3, 2021 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported it has begun offering early access to its new Personalized Cancer Monitoring (PCM) platform as a laboratory-developed test performed at an Invitae central laboratory (Press release, Invitae, JUN 3, 2021, View Source [SID1234583450]). The service employs a novel combination of a tumor profile, blood tests and personalized assays based on a patient’s tumor with the goal of detecting circulating tumor DNA (ctDNA) before it is detectable by imaging or other conventional methods, offering earlier detection of cancer recurrence.

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

"Far too many patients who undergo treatment for cancer still relapse, and the cause is often the development of new cancer cell populations. One promising strategy for identifying recurrence early is to detect these cancer cells persisting in a patient after treatment, known as minimal residual disease (MRD), that cannot be detected with standard monitoring such as imaging," said Robert Nussbaum, M.D., chief medical officer of Invitae. "PCM has the potential to determine a therapy’s effectiveness much sooner than current monitoring methods, allowing clinicians to more efficiently refine and optimize treatment plans. In addition, patients whose cancer has been cured by tumor resection may be spared from unnecessary and potentially harmful adjuvant therapy, while those at risk of relapse can be diagnosed earlier and treated with the necessary therapies."

During the early access program, academic and pharmaceutical researchers will be able to utilize the pan-cancer, CAP-accredited and CLIA-certified PCM platform with testing and reporting completed by Invitae’s recently acquired laboratory in Iselin, New Jersey. Full commercial availability of PCM as a laboratory-developed test is expected later this year.

PCM is a pan-cancer, tumor-informed, liquid biopsy assay developed by Invitae to detect MRD and monitor for cancer recurrence. Clinical researchers may have the ability to have residual disease and/or cancer recurrence detected earlier than the current standard of care for most patients. By detecting residual disease/recurrence earlier, patients can be considered for therapy sooner, which may result in improved outcomes.

PCM includes three basic steps: 1. A patient’s surgically removed tumor or tumor biopsy and blood undergoes whole exome sequencing to create a patient specific tumor fingerprint. 2. Approximately 50 tumor-specific variants are selected for inclusion on a personalized ctDNA panel. 3. Patient-specific assays are created that can be used over time with minimally invasive blood draws to monitor for disease recurrence.

The platform is powered by Invitae’s Anchored Multiplex PCR (AMP) chemistry to perform error-corrected, next-generation sequencing. It is designed to identify traces of a patient’s original tumor DNA circulating in a patient’s blood, or ctDNA. Because ctDNA is a biomarker for MRD, AMP chemistry enables high sensitivity detection of MRD status. Detecting minute amounts of ctDNA while confidently determining MRD status may allow for earlier detection of relapse after treatment.

The high sensitivity and specificity of the PCM assay has been validated both in the laboratory and among NSCLC patients in the TRACERx study. Clinical validation studies will continue, as will the use of PCM to address research questions in support of meaningful clinical applications. Once more data become available in these important areas, PCM and other liquid biopsy approaches for monitoring MRD have the potential to become a mainstay in personalized oncology.

PCM could be applied in a variety of ways to help improve patient care and prolong survival outcomes. Its possible applications in the clinical setting include monitoring for recurrence, monitoring a patient’s response to therapy to guide treatment decisions, and improving clinical trial designs to help get new therapies to market sooner.

On June 3, 2021 -Imago BioSciences, Inc. ("Imago"), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), reported the appointment of Wan-Jen Hong, M.D., as chief medical officer (Press release, Imago BioSciences, JUN 3, 2021, View Source [SID1234583449]). Dr. Hong will be responsible for leading the clinical development of the Imago pipeline of therapies targeting LSD1 in various cancers and other bone marrow diseases. Dr. Hong joins Imago from Genentech, where she served as Group Medical Director in their late-stage clinical development group.

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"I am delighted to welcome Wan-Jen to our team, and we look forward to her leadership and guidance as we continue to advance our pipeline of therapies to treat diseases of the bone marrow," said Hugh Young Rienhoff, Jr., M.D., chief executive officer of Imago BioSciences. "Wan-Jen’s extensive background in hematology and oncology will be a strong asset for Imago as we complete our Phase 2 studies of bomedemstat for the treatment of myeloproliferative disorders, including essential thrombocythemia and myelofibrosis."

Dr. Hong is a physician scientist with more than 10 years of clinical and scientific expertise in hematology and oncology disorders. In her most recent role at Genentech, Dr. Hong worked on the development of several molecules across multiple indications in hematology and oncology, and played a leading role in the indication expansion of venetoclax (VENCLEXTA) in acute myeloid leukemia. Prior to Genentech, Dr. Hong was a clinical instructor in hematology at the Stanford University School of Medicine and is currently an adjunct clinical faculty member in its Division of Hematology. She earned a bachelor’s degree in chemical engineering and biology from Massachusetts Institute of Technology and completed both her medical doctorate and clinical training, including a hematology/oncology fellowship, at Stanford University.

"Imago has generated significant data on its lead asset bomedemstat in several indications," said Dr. Wan-Jen Hong, chief medical officer, Imago BioSciences. "Patients with myeloproliferative neoplasms and other hematological disorders continue to face significant challenges despite the current treatments. I am excited to work with the Imago team to develop bomedemstat as a new treatment option for patients with unmet medical needs."

On June 3, 2021 ImaginAb Inc, a leading biotechnology company focused on developing next generation radiopharmaceutical imaging and therapy agents, reported that it has secured an additional $12.8 million in growth capital (Press release, ImaginAb, JUN 3, 2021, View Source;utm_medium=rss&utm_campaign=imaginab-completes-12-8-million-financing-to-accelerate-growth-plans [SID1234583448]).

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The financing was led by existing investors Adage Capital and Cycad Group and includes new investors Norgine Ventures and Theravance Respiratory Company. Current investor Jim Pallotta of the Raptor Group also participated in the financing.

"ImaginAb’s vision is to be the lead in diagnostic and treatment choices, helping patients live better and healthier lives" noted Ian Wilson, ImaginAb’s CEO.

"This latest round of financing will ensure that we have the financial strength to continue our growth trajectory including further recruitment and expansion of our ongoing CD8 ImmunoPET clinical trials being administered in over 20 hospitals in North America, Europe and Australia, and Increased R&D activities leveraging platform technology to develop ‘best in class’ therapeutic radiopharmaceuticals (RPT)."

K. Leonard Judson, Chairman of ImaginAb commented,

"We are pleased to secure this financing to support our imaging and RPT initiatives. ImaginAb is an innovative leader within the ImmunoPET imaging field and have experienced strong revenue growth over the last 12 months as our technology continues to be embraced by our pharma and biotech partners".

Judson continued "We are excited about our ongoing Phase II trial, and the potential insights our agent offers into the patient’s health—enabling better patient selection and treatment monitoring for immuno-oncology therapies and other drugs".

On June 3, 2021 Resverlogix Corp. ("Resverlogix") (TSX:RVX) and EVERSANA, the pioneer of next generation commercial services to the global life sciences industry, reported a partnership to support planned commercialization of apabetalone in the United States, Canada (where authorization has been granted to conduct clinical studies of apabetalone for COVID-19) and/or potentially expanding to additional global markets, as Emergency Use Authorization and/or a New Drug Application or equivalent is issued or approved (Press release, EVERSANA, JUN 3, 2021, View Source [SID1234583447]).

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In preparation for launch, Resverlogix will utilize EVERSANA’s fully integrated commercialization services that include market access, agency services, clinical and commercial field teams, medical science liaisons, channel management, patient services, health economics and outcomes research, and compliance, with each service optimized by data and predictive analytics.

Apabetalone is an investigational, phase 3 clinical candidate with safety data in more than 4,200 man years of treatment. As previously published, apabetalone has the potential to combat COVID-19 through a unique dual mechanism. First, apabetalone treatment prevents SARS-CoV-2 from infecting human cells; and second, it reduces the inflammation and cytokine storm response, which can result in organ damage and long-term negative impacts. Apabetalone is also being studied for important benefits for patients with high-risk cardiovascular disease, chronic kidney disease and other indications while maintaining a well-described safety profile.

"With EVERSANA’s integrated commercialization solution, we are poised to swiftly and efficiently deliver apabetalone to patients who desperately need it," said Donald McCaffrey, President and CEO of Resverlogix. "We are proud to be on the front line with the global scientific medical community as we fight the ongoing threat of this and future pandemics."

"We believe in apabetalone’s potential to save the lives of patients still facing the tragic impact of COVID-19 and its numerous growing variants as well as the millions of patients facing multiple diseases that have the potential to be treated by this much-needed therapy," said Jim Lang, Chief Executive Officer of EVERSANA. "Our COMPLETE end-to-end commercialization engine is mobilized and ready to move swiftly in anticipation of authorizations and approvals."

There can be no assurance that regulatory approval will be obtained.

On June 3, 2021 Crown Bioscience (CrownBio), a JSR Life Sciences Company, reported that they have entered into separate, yet complementary, portfolio license agreements with the ATCC and the U.S. Department of Health and Human Services, as represented by the National Cancer Institute (NCI) of the National Institute of Health (NIH) (Press release, Crown Bioscience, JUN 3, 2021, View Source [SID1234583446]). By entering into five-year agreements with these premier biomaterial resource providers, CrownBio clients will directly benefit from a priority status that will make cell lines more readily available with simplified logistics.

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Through its XenoSelect and OmniScreen panels, CrownBio already offers its clients highly customizable, broad in vitro screening panel services, paired with industry-leading bioinformatics capabilities and a breadth of established "matched" downstream in vivo models. CrownBio clients will now have access to an extended and unrivaled portfolio of cell lines, with the knowledge and peace of mind that all necessary licensing is in place.

The license agreement with ATCC grants CrownBio expedited access to more than 140 cell lines and associated datasets, as well as future access to an additional 4000 cell lines through an umbrella licensing structure. Similarly, to meet CrownBio’s ongoing global client needs for supplies of NIH cell lines, a new portfolio license has been signed with the NIH. With this agreement, CrownBio will provide access to 100 cell lines available through the NCI Repository of Tumors and Tumor Cell Lines and other sources, that were developed in NCI labs.

Henry Li, PhD, CSO of CrownBio said, "We greatly value our relationships with both ATCC and NIH, which are two of CrownBio’s largest cell line partners. We are excited that these new agreements will enable us to offer our clients expanded and prioritized cell line availability and supply. Together, these agreements exemplify CrownBio’s dedication to ensuring our clients have easy access to an industry-leading range of in vitro and in vivo models for drug discovery."