On May 16, 2023 GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, reported the initiation of its Alamance study, a multi-center bladder cancer study conducted in collaboration with investigators at Memorial Sloan Kettering Cancer Center and the University of Wisconsin – Madison Carbone Cancer Center (Press release, GeneCentric Therapeutics, MAY 16, 2023, View Source [SID1234631792]). Results from the study will be used to provide further clinical and analytical validation of GeneCentric’s fibroblast growth factor receptor predictive response signature (FGFR-PRS), which is a multi-gene RNA expression test that may help identify a larger population of patients who may achieve greater clinical benefit from FGFR-targeted therapy than from currently available fusion- and/or DNA mutation-based tests. The FGFR-PRS test is being developed in collaboration with Labcorp.

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"While there has been significant progress in developing new treatment options for patients with locally advanced or metastatic bladder cancer, there remains a need for better predictive biomarkers and tests that can inform the optimal treatment for individual patients," said Gopa Iyer, M.D., Alamance Study Lead Investigator and Section Head, Urothelial Cancer at Memorial Sloan Kettering Cancer Center. "Data from the Alamance study will be invaluable in this endeavor, especially with regards to developing novel tests to guide the use of FGFR-targeted and other therapies."

In this prospectively designed real-world evidence study, clinical response data and existing tumor samples are being collected from a multi-center cohort of approximately 250 patients with locally advanced or metastatic urothelial (bladder) cancer treated with FGFR-targeted therapy (e.g., erdafitinib) or other standards of care (e.g., anti-PD-(L)1 or platinum-based chemotherapy). When complete, the Alamance study will include the largest retrospective cohort of patients treated with FGFR-targeted therapies to date.

The highly curated real-world clinical and demographic data with bulk tumor RNA transcriptome analysis from the Alamance study will be analyzed using GeneCentric’s RNA-based Tumor and Immune Micro-Environment (rT(I)ME) Explorer platform. In addition to the application of the FGFR-PRS to urothelial cancer patients, the clinicogenomic data will also be used to evaluate other signatures and tests in the growing pipeline that GeneCentric is developing in collaboration with pharmaceutical and biotechnology partners, as well as commercial reference labs.

On May 16, 2023 Iterion Therapeutics, a leading biopharmaceutical company dedicated to the development of innovative treatments for cancer, reported its collaboration in a Phase 1 clinical trial for tegavivint in patients with relapsed or refractory c-Myc-overexpressing large B-cell lymphomas (Press release, Iterion Therapeutics, MAY 16, 2023, View Source [SID1234631791]). The first patient has been enrolled to this National Cancer Institute-funded study, which is being conducted at The Ohio State University Comprehensive Cancer Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute in Columbus, Ohio.

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Diffuse large B-cell lymphomas (DLBCL) are a type of Non-Hodgkin lymphoma (NHL) that originates from white blood cells. It is estimated that each year there are more than 20,000 patients diagnosed with DLBCL resulting in greater than 7,000 deaths annually. In a subset of DLBCL, the oncogene c-MYC is overexpressed through genetic mechanisms. Patients with c-Myc-overexpressing DLBCL are less likely to respond to currently available therapies, with an overall survival (OS) rate of 30% at 2 years compared to 76% in c-MYC negative patients. Patients with relapsed/refractory c-MYC-overexpressing DLBCL represent a significant unmet clinical as their prognosis is particularly poor with very limited effective treatment options.

Tegavivint is a first-in-class small molecule inhibitor of Transducin beta-like protein 1 (TBL1), that has demonstrated safety, clinical and pharmacodynamic activity in a Phase 1 study of patients with desmoid tumors. TBL1 is an exchange adaptor protein known to regulate protein stability and acts as a master regulator of the Wnt-signaling pathway by binding to nuclear beta-catenin to protect it from degradation and promote its downstream transcriptional activity. TBL1 is highly expressed in DLBCL compared to normal B cells, with expression inversely correlated with OS in DLBCL patients treated with standard first-line treatment. Pre-clinical studies have shown tegavivint promotes DLBCL cell death in vitro and in vivo through modulating stability of key oncogenic proteins, including c-Myc.

"TBL1 and MYC have long been therapeutic targets of interest in DLBCL" states Lapo Alinari, MD, PhD, a hematologist with the OSUCCC – James and assistant professor at The Ohio State University College of Medicine. "Tegavivint provides the first opportunity to treat DLBCL patients with a targeted therapy toward TBL1 and the pre-clinical data suggests that by doing so, we can also impact MYC protein levels resulting in anti-tumor activity".

The Phase 1 dose-escalation study will enroll up to 20 patients with relapsed or refractory c-Myc-overexpressing DLBCL, who have failed at least two lines of prior treatment. The primary endpoint for the study will be to assess safety, measure dose limiting toxicities (DLTs), and define a recommended phase 2 dose (RP2D). Patients will also be followed for clinical responses, pharmacokinetics and changes in pharmacodynamic markers.

"While there have been significant advances in treatment of DLBCL, the patients targeted in this study are known to have poor prognosis and poor response to the current standard of care", states Casey Cunningham, MD, Chief Medical Officer at Iterion. "The pre-clinical data suggests that tegavivint may provide a therapeutic option where one does not currently exist"

For more information about the Phase 1 clinical trial of tegavivint in patients with large B-cell lymphomas, please visit ClinicalTrials.gov using the identifier NCT05755087. This trial is funded by the National Cancer Institute with additional support from Iterion, manufacturer of the study drug, Tegavivint. Patients on this study receive the study drug at no cost while on the clinical trial.

On May 16, 2023 Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed, reported that the United States Patent and Trademark Office has issued U.S. Patent No. 11,648,235, titled "Treatment of Glioblastoma," with claims to a method of treating glioblastoma with azeliragon (Press release, Cantex, MAY 16, 2023, View Source [SID1234631790]). This patent will expire in 2042.

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Glioblastoma is a highly malignant primary brain tumor for which current therapeutic options provide a limited life extension benefit. Earlier this year, Cantex received Food and Drug Administration Orphan Drug Designation for azeliragon.

Stephen Marcus, MD, CEO of Cantex commented, "The issuance of this patent, expiring in 2042, adds to the already strong intellectual property protection provided by Cantex’ existing composition of matter patents and the regulatory exclusivity conferred by FDA orphan drug protection. Improved treatment of glioblastoma is greatly needed and the therapeutic effect of azeliragon will be evaluated in Cantex’ phase 2 glioblastoma clinical trials."

About Azeliragon

Azeliragon is an orally administered small molecule, taken once daily, that inhibits interactions of the receptor for advanced glycation end products (known as RAGE) with certain ligands, including HMGB1 and S100 proteins in the glioblastoma microenvironment. By preventing interaction of RAGE with these ligands, azeliragon may inhibit glioblastoma and overcome its resistance to effective treatment. Azeliragon was originally under development for Alzheimer’s disease by the company from which Cantex licensed it. Clinical safety data from these trials, involving more than 2000 individuals dosed for periods up to 18 months, indicate that azeliragon is very well tolerated. Cantex is also developing azeliragon for the treatment of brain metastasis, pancreatic cancer, and breast cancer, where RAGE has been implicated in disease progression and in complications of cancer treatment. In addition, a phase 2/3 trial is currently enrolling hospitalized COVID-19 patients, evaluating the efficacy of azeliragon in the prevention of acute kidney injury.

On May 16, 2023 Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported that the Company will be presenting clinical data on its lead asset TAC01-HER2 for the treatment of human epidermal growth factor receptor 2 (HER2) positive solid tumors at the 2023 American Society Of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago, IL, June 2-6 (Press release, Triumvira Immunologics, MAY 16, 2023, View Source [SID1234631789]). The presentation by Benjamin L. Schlechter, MD, from Harvard Medical School and a Senior Physician in Gastrointestinal Oncology at the Dana-Farber Cancer Institute, will highlight updated clinical data from the ongoing Phase I/II trial of TAC01-HER2 (NCT04727151) in patients with relapsed or refractory solid tumors.

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"We are excited to present the latest clinical data from our Phase I/II trial of TAC01-HER2 in refractory solid tumors at the upcoming ASCO (Free ASCO Whitepaper) meeting as a poster and a poster discussion. The availability of updated clinical data will offer remarkable insights into the potential of TAC01-HER2 as a targeted therapy for patients who are refractory to existing HER2 targeted therapies," said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. "We are committed to delivering innovative solutions for cancer patients and addressing critical unmet medical needs and look forward to sharing the updated findings with the oncology community at this prestigious scientific meeting."

ASCO Presentation Details:

Title: A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC01-HER2 in Relapsed or Refractory Solid Tumors (TACTIC-2)
Authors: Benjamin L. Schlechter, MD, Senior Physician, Instructor in Medicine, Harvard Medical School and Attending Physician, Medical Oncology, Dana-Farber Cancer Institute
Session: Developmental Therapeutics—Immunotherapy
Poster Session Display Date and Time: 6/3/2023, 8:00 AM-11:00 AM
Poster Discussion Session Date and Time: 6/3/2023, 3:00 PM-4:30 PM
Abstract Number: 2519

Abstract titles are currently available on the ASCO (Free ASCO Whitepaper) website. A copy of the presentations will be available after the closure of the meetings, under the Presentations & Publications tab of the News & Resources section of the Company’s website.

On May 16, 2023 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, reported that about 30 accepted abstracts of clinical data from multiple trials in relation to TYVYT (sintilimab injection), olverembatinib (BCR-ABL TKI), IBI326 (equecabtagene autoleucel), IBI376 (parsaclisib), IBI110 (anti-LAG-3 monoclonal antibody), IBI939 (anti-TIGIT monoclonal antibody) and IBI351 (KRASG12C inhibitor) will be presented at the upcoming international medical conferences. A brief summary of the selected presentations is as follows (Press release, Innovent Biologics, MAY 16, 2023, View Source [SID1234631788]):

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AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING 2023 (Jun 2-6)

Topic: PD-1 blockade with sintilimab plus induction chemotherapy and concurrent chemoradiotherapy (IC-CCRT) versus IC-CCRT in locoregionally-advanced nasopharyngeal carcinoma (LANPC): A multicenter, phase 3, randomized controlled trial (CONTINUUM).[1]
Presentation Type: Oral Presentation
Presentation Time：June 5, 2023, 08:00 – 11:00 (GMT-5) Chicago, IL, U.S.
Abstract Number: LBA 6002
Main Researcher: Professor Jun Ma and Professor Liu Xu, Department of Radiation Oncology, Sun Yat-sen University Cancer Center

Topic: Efficacy and safety of IBI110 in combination with sintilimab in first-line advanced HER2-negative gastric cancer or gastroesophageal junction cancer: Updated results from a phase 1b study
Presentation Type: Poster Presentation
Abstract Number: 2576
Main Researchers: Professor Nong Xu and Professor Chenyu Mao, The First Affiliated Hospital, School of Medicine, Zhejiang University.

Topic: Efficacy and safety of IBI110 in combination with sintilimab in first-line of advanced hepatocellular carcinoma: preliminary results from a phase 1b study
Presentation Type: Poster Presentation
Abstract Number: 2577
Main Researcher: Professor Baocai Xing and Professor Ming Liu, Peking University Cancer Hospital & Institute.

Topic: Efficacy and safety of IBI351 (GFH925) monotherapy in metastatic colorectal cancer harboring KRASG12C mutation: preliminary results from a pooled analysis of two phase 1 studies
Presentation Type: Poster Presentation
Abstract Number: 3586
Main Researcher: Professor Ying Yuan and Professor Kefeng Ding, The Second Affiliated Hospital, Zhejiang University School of Medicine.

Topic: CT103A, a novel fully human BCMA-targeting CAR-T therapy, in patients with relapsed/refractory multiple myeloma: updated long-term follow-up results of phase 1b/2 study (FUMANBA-1)
Presentation Type: Poster Presentation
Abstract Number: 8025
Main Researchers: Professor Chunrui Li, Department of Hematology, Tongji Hospital of Tongji Medical College, Huazhong University of Science; Professor Lugui Qiu, State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College.

Topic: Antitumor activity of olverembatinib (HQP1351) in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST)
Presentation Type: Poster Presentation
Abstract Number: 11540
Main Researcher: Professor Haibo Qiu, Sun Yat-sen University Cancer Center.

Topic: A study to evaluate the safety, tolerability and efficacy of IBI939 in combination with sintilimab in patients with previously untreated locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC): updated efficacy and safety results
Presentation Type: Online Publication
Abstract Number: e14578
Main Researcher: Professor Ying Cheng and Professor Chunjiao Wu, Jilin Cancer Hospital.

EUROPEAN HEMATOLOGY ASSOCIATION (EHA) (Free EHA Whitepaper) 2023 Hybrid Congress (Jun 8-15)

Topic: CD47/PD-L1 bispecific antibody (IBI322) in anti-PD-1 or PD-L1 treatment-resistant classical Hodgkin lymphoma: a Phase 1 study
Presentation Type: Oral Presentation
Presentation Time: June 11, 2023, 11:30 – 12:45 (CEST) Frankfurt, Germany
Abstract Number: S216
Main Researchers: Professor Ting Niu, West China Hospital of Sichuan University; Professor Huilai Zhang, Tianjin Medical University Cancer Institute & Hospital.

Topic: A phase 2, multicenter, single-arm study of parsaclisib, a PI3kδ inhibitor, in relapsed or refractory follicular lymphoma in China: updated results from the study
Presentation Type: Poster Presentation
Abstract Number: P1099
Main Researcher: Professor Weili Zhao and Professor Zhong Zheng, Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine.

Topic: Safety and efficacy of IBI346, a first-in-class BCMA-targeting modular CAR-T cell therapy, for patients with relapsed/refractory multiple myeloma (RR MM): preliminary results from two Phase 1 studies
Presentation Type: Poster Presentation
Abstract Number: P1406
Main Researcher: Professor Zhengzheng Fu and Professor Depei Wu, The First Affiliated Hospital of Soochow University; Professor Chunrui Li, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.