On February 17, 2022 REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up that is seeking to revolutionize precision oncology through diagnostic innovation, reported that has launched its first genomic test (Press release, REVEAL GENOMICS, FEB 17, 2022, View Source [SID1234608252]). The HER2DX test predicts the risk of HER2+ breast cancer recurrence in newly diagnosed patients and the likelihood that they will respond to pharmacological treatment. This innovative tool, which combines a patient’s clinical data and the tumor’s genomic profile, is the world’s first specialized genomic test for HER2+ breast cancer.

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"This is our first product launch. It encapsulates our vision, which is to help patients and physicians improve outcomes and quality of life by using more accurate information," says Dr. Patricia Villagrasa-Gonzalez, CEO of REVEAL GENOMICS.

HER2DX is a 27-gene plus clinical feature-based classifier that provides accurate estimates of the risk of recurrence and the probability of achieving a response to anti-HER2 drugs in early-stage HER2+ breast cancer. HER2DX is currently provided as a Laboratory Developed Test (LDT) whose quality system is based on the UNE-EN-ISO 9001:2015 standard for collecting, receiving, and processing biological samples. It is also undergoing ISO 15189 accreditation. The reliability of the test has been described in a study1 published in The Lancet’s EBioMedicine.

HER2DX uses smart analytical software to stratify patients into low- and high-risk groups. The HER2DX algorithm was derived from a dataset of 434 patients and was validated in an external dataset of 268 patients. The algorithm was also validated using the data of more than 1,000 patients available from public datasets.

HER2DX is performed on RNA isolated from FFPE breast cancer tissues where only one sample is necessary. The results are obtained in 7-10 working days. The current assay measures the expression level of 27-genes by digital multiplex technology, and then REVEAL GENOMICS proprietary software, weighted together with clinical variables, outputs an individual patient-level risk score and a pCR likelihood score.

An excellent debut on the diagnostic test market
As a result of the launch of the HER2DX test in Spain in January of this year, the company has already signed deals with Spanish private hospitals, which now include the test in their treatment portfolio. "Based on our stepwise reimbursement approach, we are initially targeting hospitals in Spain and Italy and will subsequently be expanding to other E.U. countries and the U.S., where we are exploring marketing strategic partners," Dr. Villagrasa-Gonzalez explains.

Another goal of the company for upcoming years is to see HER2DX become the routine test option in public and private hospitals. Consequently, it is currently conducting the required clinical studies so that the test is recommended in national and international clinical guidelines and so that it can be covered by health reimbursement arrangements in the short term.

Dr. Villagrasa-Gonzalez adds that "over the past few months, we have put a lot of effort into bringing HER2DX to market. Considering that the company has only been in existence for 18 months, to have developed and brought our first product to market is definitive proof that we have a solid project."

REVEAL GENOMICS was incorporated in September 2020 with private funding. This year, the company plans to increase its capital with injections from additional private sources. Moreover, it is preparing a round of Series A funding for 2023 to provide the initial boost for its international expansion.

On February 17, 2022 Gracell Biotechnologies Inc. ("Gracell" or the "Company",NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that it has dosed multiple patients in a clinical trial evaluating GC012F, the Company’s autologous CAR-T therapeutic candidate dual-targeting B cell maturation antigen (BCMA) and CD19 in B-cell non-Hodgkin’s lymphoma (B-NHL) (Press release, Gracell Biotechnologies, FEB 17, 2022, View Source [SID1234608251]). NHL is the fifth most common cancer in the U.S.[1]

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The Phase 1 investigator-initiated trial (IIT), being conducted in China, is a first-in-human study evaluating FasTCAR-enabled BCMA/CD19 dual-targeting GC012F for the treatment of relapsed or refractory (r/r) B-NHL. GC012F is the first BCMA/CD19 dual-targeting CAR-T in human trials for B-NHL. Most B-NHL cells express CD19, and data also suggest that 39% to 97% clinical samples of NHL cells also express BCMA. [2] [3] [4] By simultaneously targeting BCMA and CD19, GC012F is designed to improve efficacy outcome in r/r B-NHL patients.

GC012F, developed using Gracell’s proprietary FasTCAR platform which enables next-day manufacturing, GC012F is currently also being evaluated in IIT studies in China including relapsed/refractory multiple myeloma. In November 2021, GC012F was granted Orphan Drug Designation by the U.S. Food and Drug Administration.

"Dual-targeting CD19 and BCMA represents an innovative approach for the treatment of B-NHL. This study of GC012F for r/r B-NHL marks an important step in the product candidate’s development to expand to additional indications and we look forward to confirming its potential to treat B-NHL, an indication for which patients are in need of additional treatment options," said Dr. Martina A. Sersch, Chief Medical Officer of Gracell. "We are confident that this study will further validate GC012F, our FasTCAR platform and our dual-CAR technology."

[1] View Source

[2] Blood Cancer Journal (2020) 10:73

[3] Blood. 2017;130:2755.

[4] Hum Gene Ther. 2018; 29(5): 585.

About GC012F

GC012F is a FasTCAR-enabled dual-targeting CAR-T product candidate that is currently being evaluated in IIT studies in China for the treatment of multiple myeloma and B-cell non-Hodgkin’s lymphoma. GC012F simultaneously targets CD19 and BCMA to drive fast, deep and durable responses, which can improve efficacy and reduce relapse in multiple myeloma and B-NHL patients.

About B-NHL

Non-Hodgkin’s lymphoma (NHL) is a group of blood cancers that developed from lymphocytes, most commonly derived from B cells (B-NHL). Globally, approximately 510,000 patients are diagnosed with NHL every year with over 77,000 patients diagnosed in the United States, and approximately 68,000 diagnosed in China in 2020. B-NHL accounts for approximately 85% of NHL diagnoses.

About FasTCAR

CAR-T cells manufactured on Gracell’s proprietary FasTCAR platform appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next day manufacturing, FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, increasing the accessibility of cell therapies for cancer patients.

On February 17, 2022 Edison Oncology Holding Corp. ("Edison Oncology"), a company established to develop and commercialize novel therapies targeting the fight against cancer reported that the first patient has received treatment with Orotecan (irinotecan HCI oral solution) in a Phase I/IIa clinical trial for patients with recurrent pediatric solid tumors (Press release, Edison Oncology, FEB 17, 2022, View Source [SID1234608250]).

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The clinical trial will enroll up to 20 patients with recurrent pediatric and solid tumors, including but not limited to neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, hepatoblastoma and medulloblastoma. The trial endpoints will characterize the pharmacokinetics of Orotecan vs. unformulated irinotecan in an already established oral treatment regimen, document safety and tolerability, and assess tumor response. The trial is currently enrolling patients at Duke University Children’s Hospital and Cincinnati Children’s Hospital Medical Center, with opening of additional sites anticipated in the near future.

"We are excited to have treated the first patient treated with Orotecan, our novel oral formulation of irinotecan, which we believe has the potential to improve the quality of life for pediatric and adult cancer patients, improve patient compliance and reduce costs" said Jeffrey Bacha, Edison Oncology’s chief executive officer.

Further details of the trial can be found on clinicaltrials.gov (NCT04337177).

About Orotecan

Orotecan is a patented, novel formulation of irinotecan that was developed to improve palatability and

clinical utility of an established oral delivery regimen for numerous pediatric cancers.

On February 17, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the Company will release its fourth quarter 2021 financial results on Thursday, February 24, 2022, after the close of U.S. markets (Press release, Curis, FEB 17, 2022, View Source [SID1234608249]). Management will host a conference call on the same day at 4:30 pm ET.

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To access the live conference call, please dial (888) 346-6389 from the United States or (412) 317- 5252 from other locations, shortly before 4:30 pm ET. The conference call can also be accessed on the Curis website at www.curis.com in the ‘Investors’ section. A replay of the financial results conference call will be available on the Curis website shortly after completion of the call.

On February 17, 2022 Paige, the global leader in AI-based diagnostic software in pathology, and Flagship Biosciences, a leader in data-centric pathology and tissue analysis, reported a partnership to provide access to Flagship’s TissueInsight, an AI-aided diagnostics software that quantifies PD-L1 expression in immunohistochemistry tissue samples, directly through the Paige Platform (Press release, Paige AI, FEB 17, 2022, View Source [SID1234608248]).

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For rapid and precise cancer care, pathologists and oncologists need dependable diagnostic testing to connect patients to individualized immuno-oncology therapies. TissueInsight is a clinical diagnostic immuno-oncology service which provides Clinical Laboratory Improvement Amendments (CLIA)-reportable PD-L1 results along with data about the tumor microenvironment (TME), such as information about tumor infiltrating lymphocytes (TILs) and macrophages. TissueInsight automatically reads a tissue slide and provides rapid, data-rich tissue interpretations and removes the inherent variability of subjective manual tissue scoring.

"By enabling pathologists to access Flagship’s PD-L1 analysis tool directly within the Paige Platform, we are providing pathologists and oncologists quicker access to biomarker testing results that will inform treatment planning," said Andy Moye, Ph.D., CEO at Paige. "This partnership can make it easier and more efficient for pathologists to quantify a prominent immunotherapy biomarker and can help improve patient care."

TissueInsight will be available directly in the FullFocus platform, enabling a complete and seamless digital pathology workflow. "TissueInsight’s integration with Paige’s platform will truly provide a diagnostic service unmatched in the industry," said Trevor Johnson, CEO at Flagship Biosciences. "TissueInsight is the only turnkey digital pathology solution for IHC scoring and we look forward to partnering with Paige to successfully integrate, deploy, and promote adoption of our innovative technology."

"Immunohistochemistry scoring of PD-L1 has traditionally been a time-consuming, manual process that is subject to variability between pathologists," said David Klimstra, M.D., Founder and Chief Medical Officer at Paige. "TissueInsight augments our native Paige capabilities by providing an easy-to-use and accurate software that produces more information of clinical value than can be generated manually."