Irinotecan

Theriva™ Biologics Reports First Quarter 2024 Operational Highlights and Financial Results

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火曜日, 5月 7, 2024
Cancer, FOLFIRINOX, Safety, Pancreatic cancer, Research, Irinotecan, Cell, HCT, Phase II, SJD, Intravenous therapy, ASCO, Therapy, Science, Vice, Patient, Gene, Society, IDMC, GMP, Clinical trial, Annual general meeting, Pharmaceutical industry

ROCKVILLE, Md., May 07, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today reported financial results for the first quarter ended March 31, 2024, and provided a corporate update.

Key Points: 
  • The trial is expected to enroll 92 evaluable patients and is expected to complete enrollment in the third quarter of 2024.
  • The trial has completed enrollment into the second cohort and a data readout are expected in the third quarter of 2024.
  • First Quarter Ended March 31, 2024 Financial Results
    General and administrative expenses decreased to $1.9 million for the three months ended March 31, 2024, from $2.2 million for the three months ended March 31, 2023.
  • Cash and cash equivalents totaled $18.3 million as of March 31, 2024, compared to $23.2 million as of December 31, 2023.

Repare Therapeutics Provides Business and Clinical Update and Reports First Quarter 2024 Financial Results

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火曜日, 5月 7, 2024
Research, FDA, Genetics, Clinical Trials, Biotechnology, Pharmaceutical, Health, Science, Oncology, Other Science, Net, Safety, Food, Irinotecan, CCNE1, PPP2R1A, Lung cancer, BID, ESMO, Adolescence, PLK4, PKMYT1, Data, Bristol Myers Squibb, Patient, WEE1, FBXW7, Biomarker, Clinical trial, Annual general meeting, Therapy, NSCLC, FOLFIRI, G&A, Pharmaceutical industry

Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today reported financial results for the first quarter ended March 31, 2024.

Key Points: 
  • Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today reported financial results for the first quarter ended March 31, 2024.
  • “This was a quarter of clinical progress as we await key, near-term data on a rich set of distinctive clinical approaches for our four wholly-owned compounds in 2024,” said Lloyd M. Segal, President and Chief Executive Officer of Repare.
  • We are seeing continuing trends of patient response and benefit, and we are on track to report the updated dataset in the fourth quarter of 2024.
  • The increase in revenue for the three-month period was primarily due to the $40.0 million Roche milestone achievement in the first quarter of 2024.

Theriva™ Biologics to Present Preclinical Data Supporting the Potential Synergy of VCN-01 and First-Line Pancreatic Cancer Chemotherapy Regimens at the American Society for Cell and Gene Therapy 27th Annual Meeting

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月曜日, 4月 22, 2024
Combination, Cancer, FOLFIRINOX, Pancreatic cancer, Poster, Animal, Irinotecan, Cell, PDAC, Real-time, Therapy, Patient, Gene, Society, Neoplasm, Oncolytic adenovirus, Pharmaceutical industry

ROCKVILLE, Md., April 22, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the presentation of preclinical data demonstrating enhanced anti-tumor effects in human pancreatic cancer xenograft-bearing mice treated with lead product candidate VCN-01 and liposomal irinotecan. These data support the potential synergy of VCN-01 and first-line pancreatic cancer chemotherapy regimens, and will be featured in a poster presentation at the American Society for Cell and Gene Therapy (ASGCT) 27th Annual Meeting, being held both virtually and in Baltimore from May 7-11, 2024.

Key Points: 
  • These data support the potential synergy of VCN-01 and first-line pancreatic cancer chemotherapy regimens, and will be featured in a poster presentation at the American Society for Cell and Gene Therapy (ASGCT) 27th Annual Meeting, being held both virtually and in Baltimore from May 7-11, 2024.
  • “We look forward to leveraging these findings and evaluating the combination of VCN-01 with additional first-line pancreatic cancer chemotherapy regimens, including NALIRIFOX and FOLFIRINOX.
  • In vivo: Synergy of VCN-01 plus liposomal irinotecan was observed in animals bearing subcutaneous human pancreatic tumors.
  • Combination therapy with VCN-01 + liposomal irinotecan at either dose displayed significantly reduced tumor growth compared to each treatment alone.

GenFleet Therapeutics Announces FDA's Clinical Trial Approval for GFH925 (KRAS G12C Inhibitor) Monotherapy in Phase III Registrational Study Treating Metastatic Colorectal Cancer

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金曜日, 4月 19, 2024
FDA, Total, Colorectal cancer, Mutation, Immunology, Lung cancer, Priority review, NMPA, National Medical Products Administration, Cetuximab, Progression-free survival, New Drug Application, Irinotecan, Oxaliplatin, Recurrence, RAS, CRC, ESMO, Medicine, ASCO, Canadian International Council, Disease, Incidence, Patient, Liver, Peritoneum, Food and Drug Administration, BTD, Lung, Death, Biology, Clinical trial, EGFR, Therapy, Cancer, NSCLC, Breakthrough therapy, Prevalence, Pharmaceutical industry

"We appreciate the FDA's recognition of GFH925' efficacy and safety profile, as this is our first global phase III monotherapy study in treating advanced stage CRC.

Key Points: 
  • "We appreciate the FDA's recognition of GFH925' efficacy and safety profile, as this is our first global phase III monotherapy study in treating advanced stage CRC.
  • We believe the approval of our proposed trial design highlights the potential of GFH925 monotherapy in this indication, thus bringing more therapeutic options and clinical benefits to the patients.
  • Targeting KRAS G12C Mutation in Colorectal Cancer, A Review: New Arrows in the Quiver, International Journal of Molecular Science, Mar.
  • Disease Burden of Total and Early-Onset Colorectal Cancer in China from 1990 to 2019 and Predictions of Cancer Incidence and Mortality, Clinical Epidemiology, Feb. 2023
    4.

Theratechnologies Preclinical Data Presentation at AACR 2024 Highlights Versatility and Flexibility of SORT1+ Technology™ Oncology Platform

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月曜日, 4月 8, 2024
Gene silencing, Irinotecan, Colorectal cancer, Immunotherapy, Triple-negative breast cancer, Mouse, Observation, Endocytosis, Cancer, Christian democracy, SN-38, Senior, Camptothecin, Conjugation, AACR, TSX, Treatment, Neoplasm, CRC, Poster, HT-29, TNBC, PDC, Vaccine

MONTREAL, April 08, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today presented preclinical data that highlight the versatility and flexibility of the Company’s SORT1+ Technology™ platform.

Key Points: 
  • MONTREAL, April 08, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today presented preclinical data that highlight the versatility and flexibility of the Company’s SORT1+ Technology™ platform.
  • The study also demonstrated synergistic anti-tumor efficacy and good tolerability with the combination of two peptide drug conjugates with different payloads.
  • “In addition to our lead peptide-drug conjugate, sudocetaxel zendusortide, these latest data highlight the promising tolerability and anti-tumor effects of our investigational camptothecin-peptide conjugates, further demonstrating the versatility and flexibility of the platform.
  • In the poster presented at AACR, the investigators noted that SORT1 gene silencing inhibits camptothecin-conjugate uptake in human HT-29 colorectal adenocarcinoma cells.

Theriva™ Biologics Announces Presentation at the American Society for Cell and Gene Therapy 27th Annual Meeting

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月曜日, 4月 8, 2024
Combination, Irinotecan, Patient, Gene, FOLFIRINOX, Oncolytic adenovirus, Cancer, PDAC, Society, Therapy, Cell, Pharmaceutical industry

Data will be featured in a poster presentation at the American Society for Cell and Gene Therapy (ASGCT) 27th Annual Meeting, being held both virtually and in Baltimore from May 7-11, 2024.

Key Points: 
  • Data will be featured in a poster presentation at the American Society for Cell and Gene Therapy (ASGCT) 27th Annual Meeting, being held both virtually and in Baltimore from May 7-11, 2024.
  • “We look forward to presenting data at the upcoming ASGCT meeting that further highlight the potential of our systemically administered oncolytic adenovirus, VCN-01, to synergistically combine with an expanding range of standard-of-care chemotherapies for difficult-to-treat cancers,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics.
  • “ Our on-going VIRAGE Phase 2b trial is evaluating VCN-01 in combination with gemcitabine/nab-paclitaxel to treat metastatic pancreatic ductal adenocarcinoma (PDAC).
  • ET

ProLynx announces initiation of the Phase II Topology clinical trial of its DNA-damaging agent PLX038 in triple-negative breast cancer at the Institut Curie

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月曜日, 3月 25, 2024
Cloud, RB1, Hydrolysis, Irinotecan, Progression-free survival, Patient, SAN, Biomarker, Research, DNA, Cancer, Cmax, SN-38, Clinical trial, Curie Institute (Paris), Safety, Prodrug, Homologous recombination, ADC, TNBC, Teaching, PEG

Patients will have been previously treated with at least two therapies, including the antibody-drug conjugate (ADC) sacituzumab govitecan (SG; Trodelvy).

Key Points: 
  • Patients will have been previously treated with at least two therapies, including the antibody-drug conjugate (ADC) sacituzumab govitecan (SG; Trodelvy).
  • The TOPOLOGY trial is run by Institut Curie (Paris and Saint Cloud, France), with principal investigator Prof. Francois-Clement Bidard .
  • PLX038 is a long-acting prodrug of the topoisomerase 1 (Top1) inhibitor, SN-38, which is also the active component of anti-cancer agents irinotecan and the ADC SC.
  • Institut Curie has 3 sites (Paris, Saint-Cloud and Orsay) with over 3,700 health professionals working on treatment, research and teaching ([email protected]) Information on this clinical trial is available at clinicaltrials.gov, NCT06162351.

NuCana Reports Fourth Quarter and Year-End 2023 Financial Results and Provides Business Update

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水曜日, 3月 20, 2024
Lung cancer, Apoptosis, Docetaxel, FOLFIRI, Irinotecan, Immunotherapy, Progression-free survival, Patient, Lung, Dicarboxylic acid, Standard of care, Cancer, Bevacizumab, Melanoma, NCNA, Therapy, PFS, Pharmaceutical industry

EDINBURGH, United Kingdom, March 20, 2024 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced financial results for the fourth quarter and year ended December 31, 2023 and provided an update on its broad clinical development program with its transformative ProTide therapeutics.

Key Points: 
  • EDINBURGH, United Kingdom, March 20, 2024 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced financial results for the fourth quarter and year ended December 31, 2023 and provided an update on its broad clinical development program with its transformative ProTide therapeutics.
  • As of December 31, 2023, NuCana had cash and cash equivalents of £17.2 million compared to £17.8 million as of September 30, 2023 and £41.9 million as of December 31, 2022.
  • NuCana continues to advance its various clinical programs and reported a net loss of £7.7 million for the quarter ended December 31, 2023, as compared to a net loss of £15.2 million for the quarter ended December 31, 2022.
  • Net loss for the year ended December 31, 2023 was £27.6 million, compared to a net loss of £32.0 million for the year ended December 31, 2022.

OneOme Introduces RightMed Oncology: Empowering Clinicians to Personalize Treatment and Reduce Toxicity Risk with Pharmacogenomics

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火曜日, 4月 2, 2024
FDA, Other Health, Practice Management, Pharmaceutical, Surgery, Managed Care, Oncology, Mental Health, Hospitals, Genetics, Clinical Trials, Biotechnology, Science, Other Science, Research, Health, Toxicity, DPYD, Irinotecan, Clinical professor, PMID, UGT1A1, Risk, Mayo Clinic, Mental health, Wastewater treatment, Cancer, Doctor of Philosophy, MD, Medicine, E pluribus unum, Safety, Patient safety, Pain management, DPD, Colorectal cancer, Vomiting, Clinical Pharmacogenetics Implementation Consortium, Pharmaceutical industry

The RightMed oncology portfolio empowers innovative health systems, oncology practices and prescribers to be as focused or comprehensive as their program requires.

Key Points: 
  • The RightMed oncology portfolio empowers innovative health systems, oncology practices and prescribers to be as focused or comprehensive as their program requires.
  • Using PGx can inform usage and dosage decisions for a wide range of chemotherapy and supportive care medications.
  • For more information about RightMed Oncology, please visit OneOmeInstitute.com/Oncology or reach out directly to discuss a PGx program for your health system.
  • OneOme aims to improve patient safety, reduce overall cost of care, and improve patients' health outcomes.

Summary of opinion: Onivyde pegylated liposomal (previously known as Onivyde), 21/03/2024 Positive

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水曜日, 4月 3, 2024
European Commission, Civil service commission, Patient, Irinotecan, Oxaliplatin, Committee, Dicarboxylic acid, Medication package insert, Marketing, CHMP, Pancreas

On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Onivyde pegylated liposomal.

Key Points: 
  • On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Onivyde pegylated liposomal.
  • The marketing authorisation holder for this medicinal product is Les Laboratoires Servier.
  • Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
  • 1New text in bold