TRK

Nuvalent Presents New Preclinical Data Supporting Profiles of HER2-Selective Inhibitor, NVL-330, and ROS1-Selective Inhibitor, Zidesamtinib, at AACR Annual Meeting 2024

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星期一, 四月 8, 2024
Penetrance, HER2, Mutagenesis, EGFR, Cell, Patient, CNS, Cancer, ENU, Human, Senior, TRK, AACR, Crizotinib, ROS1, Drug discovery, Vaccine

CAMBRIDGE, Mass., April 8, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the presentation of new preclinical data for its novel HER2-selective inhibitor, NVL-330, and novel ROS1-selective inhibitor, zidesamtinib (NVL-520). The two posters will be presented at the American Association for Cancer Research (AACR) Annual Meeting taking place from April 5 – 10 in San Diego. The posters will also be available on the Nuvalent website at www.nuvalent.com following the presentations.

Key Points: 
  • The two posters will be presented at the American Association for Cancer Research (AACR) Annual Meeting taking place from April 5 – 10 in San Diego.
  • The posters will also be available on the Nuvalent website at www.nuvalent.com following the presentations.
  • "Today's presentations continue to reinforce the differentiated profiles of our drug candidates," said Henry Pelish, Ph.D., Senior Vice President of Drug Discovery at Nuvalent.
  • These mutagenesis screens provide additional preclinical support for zidesamtinib's potential to drive deep and durable responses for patients with ROS1-driven cancers.

Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-520

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星期二, 二月 27, 2024
NSCLC, BTD, ROS1, FDA, Food, TRK, Brain, CNS, Patient, Diagnosis, TKI, Cancer

There remains no clear standard of care for patients who have been previously treated with two or more ROS1 TKIs.

Key Points: 
  • There remains no clear standard of care for patients who have been previously treated with two or more ROS1 TKIs.
  • "We're very encouraged by today's announcement of FDA breakthrough therapy designation for NVL-520, as it recognizes the continued need for innovation for patients with ROS1-positive NSCLC who have exhausted available therapies.
  • We look forward to providing an update from the ARROS-1 trial of NVL-520 at a medical meeting later this year."
  • Under the designation, the FDA provides intensive guidance, organizational commitment involving senior managers, and eligibility for rolling review and other actions to expedite review.

InnoCare Announces First Pediatric Patient Dosed in Clinical Trial of pan-TRK Inhibitor Zurletrectinib in China

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星期三, 一月 24, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Patient, TRK, Incidence, Melanoma, Breast cancer, HKEX, Cancer, Lung cancer, Safety, Sun, Clinical trial, Colorectal cancer, Adolescence, NTRK, Trial of the century, Pancreatic cancer, Pharmaceutical industry

Zurletrectinib, developed by InnoCare, is a pan-TRK inhibitor which markedly inhibits the activity of the wild type TRKA, TRKB and TRKC, as well as mutant TRKA with resistant mutations G595R or G667C.

Key Points: 
  • Zurletrectinib, developed by InnoCare, is a pan-TRK inhibitor which markedly inhibits the activity of the wild type TRKA, TRKB and TRKC, as well as mutant TRKA with resistant mutations G595R or G667C.
  • InnoCare has been advancing the registrational trial of zurletrectinib in China and is expecting to submit the new drug application in the second half of 2024.
  • Dr. Jasmine, the Co-founder, Chairwoman, and CEO of InnoCare, said, “NTRK gene fusion is a driving factor for various adult and pediatric cancers.
  • It is inspiring that we continue to make positive progress in our clinical research of zurletrectinib for patients of different ages with NTRK gene fusion.

Bayer Unveils Latest Data from Oncology Portfolio at ESMO Congress 2023

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星期四, 十月 12, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Congress, Disease, Trifluridine/tipiracil, Hepatocellular carcinoma, NSCLC, PLT, ORR, Bevacizumab, Observational study, Liver transplantation, Safety, Lung cancer, Mutation, RAS, Metastasis, Cancer, NTRK, European Society for Medical Oncology, ESMO, FDA, Prostate-specific antigen, Docetaxel, Quality of life (healthcare), Radium, Phase, REG, BAY, ADT, Patient, PSA, CNS, HCC, TRK, Radium-223, TKI, Pharmaceutical industry, Bayer

Bayer will present new data from across its oncology portfolio at the upcoming European Society for Medical Oncology (ESMO) Congress taking place in Madrid, Spain from October 20-24, 2023.

Key Points: 
  • Bayer will present new data from across its oncology portfolio at the upcoming European Society for Medical Oncology (ESMO) Congress taking place in Madrid, Spain from October 20-24, 2023.
  • The breadth of new data showcases Bayer’s ongoing commitment to supporting patients living with cancer.
  • In addition, Bayer will present new data on health-related quality of life (HRQoL) deterioration-free survival (DetFS) by PSA decline in the Phase III ARAMIS trial in patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
  • Details on presentations from Bayer for the 2023 ESMO Congress are listed below:
    Regorafenib (REG) in patients (pts) with unresectable hepatocellular carcinoma (uHCC) in real-world (RW) practice: Final analysis of the prospective, observational REFINE study by prior liver transplantation (PLT)

Nuvalent Reports Preliminary Phase 1 Clinical Data from ALKOVE-1 Trial that Support Best-In-Class Potential of NVL-655 for Patients with ALK-Positive NSCLC

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星期五, 十月 13, 2023
Index, Incidence, HIV disease progression rates, Physician, Neoplasm, ROS1, AST, NSCLC, Brain, ORR, Toxic leukoencephalopathy, Caregiver, MTD, PK, Toxicity, Safety, Mutation, Half-life, Cancer, Nausea, FDA, RECIST, Harvard Medical School, Clinical trial, Trae Elston, History, Patient, EDT, Assistant, ANE, ALT, CNS, ALK, TRK, TKI, Medical imaging, Pharmaceutical industry, Vaccine, Nursing

CAMBRIDGE, Mass., Oct. 13, 2023 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced updated preliminary data from the Phase 1 dose-escalation portion of its ongoing ALKOVE-1 Phase 1/2 clinical trial of NVL-655 for patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors. These data will be presented today at the 35th AACR-NCI-EORTC (ANE) Symposium in Boston, Massachusetts.

Key Points: 
  • Preliminary activity data as of the cut-off date were available from 51 heavily pre-treated response-evaluable NSCLC patients.
  • In the subset of 41 patients treated at dose levels of 50 mg QD or higher, the ORR was 44% (18/41).
  • The Phase 2 cohorts are intended to support potential registration in patients with ALK-positive NSCLC who are both lorlatinib-naïve and lorlatinib-treated.
  • In addition to the planned Phase 2 cohorts, Nuvalent intends to use these preliminary data in patients with heavily pre-treated ALK-positive NSCLC to guide discussions with physicians that will inform development strategies in TKI-naïve ALK-positive NSCLC.

Zai Lab Announces Breakthrough Therapy Designation Granted for Repotrectinib for Treatment of Patients with NTRK-positive TKI-pretreated advanced solid tumors in China

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星期三, 八月 30, 2023
TKI, Policy, New Drug Application, NDA, Quality of life, Medicine, NSCLC, HKEX, Patient, NTRK, National Medical Products Administration, Breakthrough, CDE, Center for Drug Evaluation and Research, NMPA, TRK, Pharmaceutical industry

The Breakthrough Therapy Designation for repotrectinib was supported by data from both global and Chinese NTRK-positive TKI-pretreated patients enrolled in the Phase 1/2 TRIDENT-1 study.

Key Points: 
  • The Breakthrough Therapy Designation for repotrectinib was supported by data from both global and Chinese NTRK-positive TKI-pretreated patients enrolled in the Phase 1/2 TRIDENT-1 study.
  • “We are excited to receive our fourth Breakthrough Therapy Designation for repotrectinib in China.
  • Today’s recognition further supports repotrectinib as a potential first-in-class treatment for patients with NTRK-positive, TKI-pretreated solid tumors in China,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab.
  • Drugs granted Breakthrough Therapy Designations receive priority communications and guidance from the CDE to promote and expedite the drug development process.

Cullgen Announces First-In-Human Dose in Phase I/II Trial of CG001419, a First-in-Class TRK Protein Degrader for Treatment of Cancer Patients

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星期四, 七月 27, 2023
Biotechnology, General Health, Health, Clinical Trials, PK, Inc., Therapy, Cancer, Judgement, Phases of clinical research, Patient, Physician, NTRK, Safety, TRK, Vaccine, Pharmaceutical industry

Cullgen Inc., a leading biotechnology company developing small molecule therapeutics based on its proprietary uSMITE™ platform of targeted protein degradation technology, today announced that it has initiated dosing with its orally bioavailable pan-TRK degrader, CG001419, in a Phase I/II clinical trial for patients with solid tumors.

Key Points: 
  • Cullgen Inc., a leading biotechnology company developing small molecule therapeutics based on its proprietary uSMITE™ platform of targeted protein degradation technology, today announced that it has initiated dosing with its orally bioavailable pan-TRK degrader, CG001419, in a Phase I/II clinical trial for patients with solid tumors.
  • CG001419 is a potential first-in-class, highly active small molecule developed to selectively degrade both mutant and wild-type TRK proteins.
  • In preclinical research, CG001419 demonstrated strong potency against solid tumors harboring various oncogenic TRK abnormalities, such as NTRK gene fusions and wild-type TRK protein over-expression.
  • Patients that complete the Phase Ia trial may transition into the Phase Ib or Phase II portions of the trial depending on safety and tolerability results, the patient’s NTRK aberration type, and the judgment of physicians.

InnoCare Announces Approval of Clinical Trial of pan-TRK Inhibitor Zurletrectinib for the Treatment of Pediatric Patients in China

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星期三, 七月 26, 2023
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Clinical trial, Cancer, Lung cancer, Thyroid cancer, Trial of the century, Sarcoma, SSE, HKEX, Patient, Colorectal cancer, NTRK, Adolescence, Safety, Breast cancer, TRK, Pharmaceutical industry

This is following the clinical trial of zurletrectinib for adolescent patients (12 to 18 years old) after showing good safety and efficacy in adult patients.

Key Points: 
  • This is following the clinical trial of zurletrectinib for adolescent patients (12 to 18 years old) after showing good safety and efficacy in adult patients.
  • Dr. Jasmine, the Co-founder, Chairwoman and CEO of InnoCare, said, “NTRK gene fusion is more common among pediatric patients.
  • By now, our clinical study with zurletrectinib has covered NTRK fusion patients at all ages.
  • We will continue to accelerate the clinical trials of zurletrectinib, looking forward to providing better treatment options for patients early.”

Latest Vitrakvi® (larotrectinib) Subgroup Analyses at ASCO 2023 Showcase Long-Term Efficacy and Safety Profile in Adult and Pediatric Patients with NTRK Gene Fusion Cancer, Across Solid Tumors

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星期五, 六月 2, 2023
General Health, Pharmaceutical, Health, Oncology, Hypersensitivity, DTC, IRC, Central nervous system, NGS, Trae tha Truth, Lung cancer, Mutation, NTRK1, CNS, ASCO, Bayer, Food and Drug Administration Amendments Act of 2007, American Society of Clinical Oncology, Dor, Myalgia, Patient, Data, NTRK, Anemia, Annual general meeting, Disease, Anaplastic thyroid cancer, ALT, ATC, FDA, AST, Society, NTRK2, Thyroid cancer, ORR, TC, Food, Safety, TRK, Pharmaceutical industry

The data was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6, 2023.

Key Points: 
  • The data was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6, 2023.
  • Patients should be selected for therapy based on a Food and Drug Administration (FDA)-approved test.
  • The results encourage wider adoption of next-generation sequencing (NGS) testing for identifying patients with solid tumors harboring NTRK gene fusions, including lung cancer.
  • Vitrakvi was evaluated in updated subgroup analyses of patients (n=30; data cut-off July 20, 2022) with TRK fusion thyroid cancer (TC).

Bayer Presents New Data Across Oncology Portfolio at the 2023 ASCO Annual Meeting

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星期四, 五月 25, 2023
Pharmaceutical, Health, Oncology, Docetaxel, Thyroid, Observational study, Mutation, ADT, Radium, Science, ASCO, DEAR, American Society of Clinical Oncology, Metastasis, Patient, NTRK, Annual general meeting, Disease, Copanlisib, RWE, Radium-223, FDA, Aryl hydrocarbon receptor, Safety, Society, ORR, TC, Enza, TRK, Medical imaging, Pharmaceutical industry, Daro District, Bayer

Bayer will highlight scientific research in oncology at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting , taking place from June 2-6, 2023.

Key Points: 
  • Bayer will highlight scientific research in oncology at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting , taking place from June 2-6, 2023.
  • These presentations continue to underscore the company’s commitment to drive treatment approaches through science and innovation in the oncology space.
  • Data featuring NUBEQA® (darolutamide) and Xofigo® (radium Ra 223 dichloride) will be showcased at ASCO.
  • NUBEQA data includes results from the DEAR trial, a retrospective, observational study evaluating real-world evidence (RWE) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC).