TKI

HUTCHMED Highlights Clinical Data to be Presented at the Upcoming 2021 ESMO Virtual Conference

Retrieved on: 
Tuesday, September 7, 2021

HUTCHMED has initiated an extensive, globally-focused clinical development pathway for amdizalisib.

Key Points: 
  • HUTCHMED has initiated an extensive, globally-focused clinical development pathway for amdizalisib.
  • Savolitinib is an oral, potent, and highly selective mesenchymal epithelial transition receptor (MET) tyrosine kinase inhibitor (TKI) that has demonstrated clinical activity in advanced solid tumors.
  • It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, as a single treatment and in combination with other medicines.
  • In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing agreement to jointly develop and commercialize savolitinib.

Turning Point Therapeutics Granted Sixth Regulatory Designation for Repotrectinib

Retrieved on: 
Wednesday, August 11, 2021
Large-cell lung carcinoma, Priority review, Collection, New Drug Application, SAN, NASDAQ, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SEC, SRC, NSCLC, Therapy, COVID-19, Breakthrough therapy, Plasma protein binding, FDA, ALK, TKI, Form 10-Q, Communication, GLOBE, MET, Private Securities Litigation Reform Act, ROS1, Accelerated approval (FDA), Safety, EML4-ALK positive lung cancer, Food, Cancer, Review, NDA, Fast, Turning Point, TRK, Pharmaceutical industry, Medical device

SAN DIEGO, Aug. 11, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced the U.S. Food and Drug Administration (FDA) granted a sixth regulatory designation to lead drug candidate, repotrectinib.

Key Points: 
  • SAN DIEGO, Aug. 11, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced the U.S. Food and Drug Administration (FDA) granted a sixth regulatory designation to lead drug candidate, repotrectinib.
  • We are pleased to receive our fourth Fast-Track designation and sixth overall regulatory designation for repotrectinib as we continue to work toward our goal of getting this ROS1 targeted therapy to patients quickly, said Athena Countouriotis, M.D., president and chief executive officer.
  • Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of repotrectinib, the potential benefits of Fast Track Designation and the regulatory approval path for repotrectinib.
  • These forward-looking statements are based upon Turning Point Therapeutics current expectations and involve assumptions that may never materialize or may prove to be incorrect.

AMDL, a Subsidiary of China Biotech Services, is Exclusively Licensed to Distribute FDA Approved Lung & Colon Cancer Companion Diagnostic Assay in Several Asian Regions Including China

Retrieved on: 
Tuesday, August 10, 2021
Pillar, Technology, Patent, Cetuximab, Targeted therapy, IVD, Colorectal cancer, TKI, FDA, CRC, Food and Drug Administration, Massachusetts General Hospital, Panitumumab, Cancer, Pathology, SER, Assay, EGFR, PCR, La Gran Colombia University, Dana–Farber Cancer Institute, Partnership, PMA, KRAS, DNA, Yale University, NSCLC, B-cell lymphoma, CH, Science, Patient, Hospital Insurance and Diagnostic Services Act, Hong Kong Science and Technology Parks Corporation, Harvard University, Large-cell lung carcinoma, Coronavirus, NGS, Biotechnology, Lung, ASEAN, Leukemia, Company, News

Pillar, an invested enterprise of CH BIOTECH SER, received the Premarket Approval ("PMA") on its oncoReveal(TM) Dx Lung and Colon Cancer Assay from FDA on July 30th, 2021.

Key Points: 
  • Pillar, an invested enterprise of CH BIOTECH SER, received the Premarket Approval ("PMA") on its oncoReveal(TM) Dx Lung and Colon Cancer Assay from FDA on July 30th, 2021.
  • The Assay is a NGS tissue-based companion diagnostic test for qualitative detection of somatic mutations in DNA derived from non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).
  • China Biotech Services Holdings Limited (CH BIOTECH SER) was included in the MSCI Hong Kong Micro Cap Index in May 2018.
  • This press release is issued by the Porda Havas International Financial Communications Group on behalf of China Biotech Services Holdings Limited.

Turning Point Therapeutics Reports Second-Quarter Financial Results, Provides Operational Updates

Retrieved on: 
Monday, August 9, 2021
SRC, Turning Point, TKI, MET, Cancer, Pharmacokinetics, CARE, ROS1, Partnership, Stomach, Safety, Private Securities Litigation Reform Act, Fast Track, COVID-19, Patient, CEO, Compte rendu, ALK, International Society, KRAS, SIOP, NASDAQ, International Society of Paediatric Oncology, Adult, AACR, Food, Adenocarcinoma, Research, Achievement, TRK, GEJ, Molecular Cancer Research, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SEC, Conference, Large-cell lung carcinoma, Hand, Congress, Investment, Discovery, GLOBE, FDA, Â, SAN, Least, NSCLC, EML4-ALK positive lung cancer, D, G&A, IND, Medicine, Pharmaceutical industry, Lithium

Acceptance of TRIDENT-1 clinical data for presentation at the 2021 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in October.

Key Points: 
  • Acceptance of TRIDENT-1 clinical data for presentation at the 2021 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in October.
  • Achievement of the milestones resulted in revenue of $5 million to Turning Point under its collaboration agreement with Zai Lab.
  • These forward-looking statements are based upon Turning Point Therapeutics current expectations and involve assumptions that may never materialize or may prove to be incorrect.
  • Turning Point Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Immunotherapy May Be Effective for a Subgroup of Metastatic Colorectal Cancer Patients, City of Hope Study Finds

Retrieved on: 
Monday, August 9, 2021
Science, Other Science, Research, Oncology, General Health, Health, Diabetes, Other Health, Liver disease, Technology, Disease, Colorectal cancer, U.S. News & World Report, Translational Genomics Research Institute, Haematopoietic system, TKI, MSS, Immunotherapy, Neoplasm, Center, List of American Medical Association journals, JAMA Network Open, HIV disease progression rates, Large intestine, Cancer, Biomedical Research, National Cancer Institute, Judy, News, Korea Disease Control and Prevention Agency, National Comprehensive Cancer Network, Liver, Patient, CAR, City of Hope, City, PD-L1, PD-1, Diabetes, Immune system, YouTube, Instagram, Twitter, NCI, Pharmaceutical industry, Medical imaging

City of Hopes findings, published in JAMA Network Open today, are important because immunotherapy traditionally has been seen as ineffective against microsatellite stable (MSS) colorectal cancer, which represents 95% of all metastatic colorectal cancer cases.

Key Points: 
  • City of Hopes findings, published in JAMA Network Open today, are important because immunotherapy traditionally has been seen as ineffective against microsatellite stable (MSS) colorectal cancer, which represents 95% of all metastatic colorectal cancer cases.
  • The retrospective study included 95 City of Hope patients with MSS metastatic colorectal cancer who received immune checkpoint inhibitor PD-1/PD-L1 targeted therapy once their disease became resistant to chemotherapy.
  • Colorectal cancer patients without liver metastases could benefit from immunotherapy considerably more than patients with liver metastases.
  • Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy .

Arcus Biosciences Reports Second Quarter 2021 Financial Results and Provides Operational Highlights

Retrieved on: 
Thursday, August 5, 2021
Oncology, Health, Genetics, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Company, Lung, Cancer, RDE, Chief executive officer, Research, List of life sciences, NT5E, Investment, Orr, Population, Pancreatic cancer, PFS, IND, Partnership, TKI, Autumn, Patient, Board, Docetaxel, Data, Non-small-cell lung carcinoma, New York Stock Exchange, Prostate, Prostate cancer, AstraZeneca, MCRPC, D, NP, Board of directors, Safety, Colon, Conference, Pharmaceutical industry, Medical imaging

Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today reported financial results for the second quarter ended June 30, 2021 and provided operational highlights.

Key Points: 
  • Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today reported financial results for the second quarter ended June 30, 2021 and provided operational highlights.
  • Based on this dataset, Arcus and Gilead will continue preparations for additional Phase 3 studies of dom-based combinations.
  • Results from the interim analysis for ARC-7 are expected to be submitted later this year for a presentation in 4Q21 or in 1H22.
  • Management will host a conference call today, August 5, 2021 to discuss second quarter 2021 financial results and recent corporate highlights.

 Pillar Biosciences Receives Premarket Approval from FDA for its oncoReveal™ Dx Lung and Colon Cancer Assay

Retrieved on: 
Thursday, August 5, 2021
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Pillar, Chief executive officer, IVD, Lung, NGS, Corporate development, KRAS, Large-cell lung carcinoma, Partnership, TKI, Eli Lilly, Health, Patient, Cetuximab, Cancer, PMA, Non-small-cell lung carcinoma, Merck, Food and Drug Administration, Precision medicine, Cdx, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CRC, Column, DNA, DX, Genome, EGFR, Food, Panitumumab, Medical imaging, Pharmaceutical industry, Pillar Biosciences, Pillar’s Technology Platform, PILLAR BIOSCIENCES, PILLAR’S TECHNOLOGY PLATFORM

Pillar Biosciences , an innovative next-generation sequencing (NGS) solutions in-vitro diagnostics (IVD) company, today announced the U.S. Food and Drug Administration (FDA) has given Premarket Approval (PMA) to its oncoReveal Dx Lung and Colon Cancer Assay, an NGS tissue-based companion diagnostic test for the qualitative detection of somatic mutations in DNA derived from non-small cell lung cancer (NSCLC) and colorectal (CRC) cancer tumors.

Key Points: 
  • Pillar Biosciences , an innovative next-generation sequencing (NGS) solutions in-vitro diagnostics (IVD) company, today announced the U.S. Food and Drug Administration (FDA) has given Premarket Approval (PMA) to its oncoReveal Dx Lung and Colon Cancer Assay, an NGS tissue-based companion diagnostic test for the qualitative detection of somatic mutations in DNA derived from non-small cell lung cancer (NSCLC) and colorectal (CRC) cancer tumors.
  • This panel is intended to be used on the Illumina MiSeq Dx instrument, Illuminas NGS platform for in vitro diagnostic testing.
  • We are committed to providing high quality and accurate IVD tests to enable better treatment decisions for cancer patients, said Gang Song, Ph.D., Founder and CEO at Pillar Biosciences.
  • Our FDA-approved product can be used by any lab that conducts NGS testing, making precision medicine accessible to all cancer patients.

HUTCHMED and AstraZeneca Initiate Phase II Trial of ORPATHYS® in Patients with MET Amplified Gastric Cancer

Retrieved on: 
Wednesday, July 28, 2021
Enzymes, Tyrosine kinase receptors, Companies, Tyrosine kinase inhibitor, AstraZeneca, Tyrosine kinase, C-Met, TKI, Quinazolines, Pyrrolidines

Patients whose tumors harbor MET amplification were treated with ORPATHYS monotherapy, reporting an ORR of 50% (10/20, 95% CI: 28.0, 71.9).

Key Points: 
  • Patients whose tumors harbor MET amplification were treated with ORPATHYS monotherapy, reporting an ORR of 50% (10/20, 95% CI: 28.0, 71.9).
  • ORPATHYS is an oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI) that has demonstrated clinical activity in advanced solid tumors.
  • In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing agreement to jointly develop and commercialize ORPATHYS.
  • Joint development in China is led by HUTCHMED, while AstraZeneca leads development outside of China.

NCCN Announces Selected Projects to Study Neratinib in Collaboration with Puma Biotechnology, Inc.

Retrieved on: 
Thursday, July 15, 2021
Software, Organic compounds, Chemical compounds, NCCN, Neratinib, Twitter, Instagram

Proposals were peer reviewed by a Scientific Review Committee, which consisted of leading expert medical oncologists from NCCN Member Institutions.

Key Points: 
  • Proposals were peer reviewed by a Scientific Review Committee, which consisted of leading expert medical oncologists from NCCN Member Institutions.
  • Puma is providing $1.4 million in funding and will also supply the neratinib tablets for use in the studies.
  • In an effort to improve collaboration in cancer research, the NCCN ORP also maintains a shared resources website and an informed consent database .
  • Visit NCCN.org for more information and follow NCCN on Facebook @NCCNorg , Instagram @NCCNorg , and Twitter @NCCN .

Tiziana Announces Strategic Initiative with Takanawa Japan K.K., Pharma Team, to Identify a Partner in Japan and Other Asian Countries for Further Clinical Development of Milciclib in Patients with Advanced Hepatocellular Carcinoma.

Retrieved on: 
Wednesday, May 5, 2021
Aromatic compounds, Tyrosine kinase inhibitor, Organic compounds, Chemical compounds, TKI, Chloroarenes, Aromatic amines, Quinazolines, Protein kinase inhibitors, Lestaurtinib, Matuzumab

The clinical data, presented at the American Society of Clinical Oncology (ASCO)1, demonstrated that the treatment was well-tolerated and produced clinical activity.

Key Points: 
  • The clinical data, presented at the American Society of Clinical Oncology (ASCO)1, demonstrated that the treatment was well-tolerated and produced clinical activity.
  • Recently, a patent covering the use of Milciclib in combination with a tyrosine kinase inhibitor (TKI) or other drugs was granted2.
  • The granted claims provide complete freedom to further develop a combination of Milciclib with an approved TKI for treatment of patients with advanced HCC or other cancers.
  • Takanawa also supports companies entering the Japanese and Asian market as well as Japanese companies to enter overseas markets.