1stOncology™: Cancer Intelligence Service – Page 6475 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Gracell Biotechnologies Doses First Patients in First-in-Human Clinical Trial Evaluating GC012F, its Dual-Targeting FasTCAR-T Therapy, in B-Cell Non-Hodgkin’s Lymphoma

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]

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

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.

Edison Oncology Announces Treatment of First Patient in Orotecan® (irinotecan HCI oral solution) Phase I/IIa Clinical Trial for Patients with Recurrent Pediatric Solid Tumors

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]).

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.

Curis to Release Fourth Quarter 2021 Financial Results and Hold Conference Call on February 24, 2022

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.

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.

Paige and Flagship Biosciences Announce Partnership to Expand Access to Immuno-Oncology Biomarker Analysis Tools

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]).

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."

Lunaphore and Massachusetts General Hospital Pathology Department to Develop Spatial Biology-Based Cancer Diagnostics

On February 17, 2022 Lunaphore, a Swiss life sciences company developing technology to enable spatial biology in every laboratory, reported it has entered a collaboration with the Pathology Department at Massachusetts General Hospital to develop an in vitro diagnostic (IVD) that evaluates sensitivity of solid tumors to poly-ADP ribose polymerase (PARP) inhibitors, with an initial focus on ovarian, breast and prostate cancers (Press release, Lunaphore Technologies, FEB 17, 2022, View Source [SID1234608247]). The project will be led by Markus D. Herrmann, M.D., Ph.D., Director of Computational Pathology at Massachusetts General Hospital, who is also Assistant Professor of Pathology at Harvard Medical School. Lunaphore and Dr. Herrmann will collaborate to develop a multiplexed immunofluorescence assay that can measure the expression of multiple proteins using the COMET platform currently installed at Massachusetts General Hospital.

"Spatial biology tools enhance the visualization and quantification of the expression of multiple proteins at once, providing valuable information for treatment decisions," said Diego G. Dupouy, Ph.D., Chief Technology Officer of Lunaphore. "This partnership will further solidify spatial biology’s role in both improved diagnostics and treatment selection with targeted therapies."

PARP inhibitors are targeted therapies that are designed to kill cancer cells by preventing them from repairing their damaged DNA. The DNA repair pathway called homologous recombination is of clinical interest as tumors with homologous recombination deficiency (HRD) have been found to be sensitive to PARP inhibitors. However, current methods of identifying HRD in tumors have been varied and imperfect. For example, current biomarker assays are not able to identify epigenetic changes in HRD genes with traditional genotyping assays.

"We look forward to developing a quantitative image-based proteomic assay to comprehensively assess DNA repair at the single-cell level in spatial tissue context and to better predict response to PARP inhibitor therapy," said Dr. Herrmann. "Adopting spatial biology methods can help us gain pathophysiological insight into the biological processes involved in DNA repair in tumor tissue that may yield clinically actionable biomarkers to improve treatment selection and patient outcomes."