Trifluridine/tipiracil

Oncolytics Biotech® Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights

Retrieved on: 
Thursday, March 7, 2024
Neoplasm, Research, Toxicity, SCCA, FOLFIRINOX, Trifluridine/tipiracil, PR, Society, Breast, Health, Poster, Immunotherapy, Anal cancer, Pancreatic cancer, Fast Track, Anal, Progression-free survival, SITC, Pelareorep, Annual general meeting, Congress, Cancer, Gastrointestinal cancer, AB, International, Cohort, ESMO, Conference, Safety, TILS, Tumor microenvironment, Clinical trial, Survival, MOA, Oncology, Colorectal cancer, TIL, Blood, FDA, TSX, Thought, Pancreatic Cancer Action Network, Anal canal, PDAC, Patient, ONC, Pharmaceutical industry

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Key Points: 
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    SAN DIEGO and CALGARY, AB, March 7, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced recent operational highlights and financial results for the fourth quarter and year ended December 31, 2023.
  • General and administrative expenses for the fourth quarter of 2023 were $4.2 million, compared to $3.7 million for the fourth quarter of 2022.
  • Research and development expenses for the fourth quarter of 2023 were $4.7 million, compared to $4.8 million for the fourth quarter of 2022.
  • The net loss for the fourth quarter of 2023 was $3.9 million, compared to a net loss of $8.6 million for the fourth quarter of 2022.

Oncolytics Achieves Success Criteria for Efficacy in the Third-Line Colorectal Cancer Cohort of the GOBLET Study

Retrieved on: 
Monday, October 23, 2023
Survival, Patient, DOI, ESMO, September 18, ECOG, Progression-free survival, Metastasis, Colorectal cancer, Gastrointestinal cancer, European Society for Medical Oncology, AB, Trifluridine/tipiracil, Poster, CRC, Microsatellite instability, Pelareorep, Oncology, Cancer, ONC, TSX, SAN, Nursing, Pharmaceutical industry, Oncolytics Biotech

SAN DIEGO and CALGARY, AB, Oct. 23, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY), (Oncolytics) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the poster presentation of interim results from the Phase 1/2 GOBLET study evaluating a combination treatment of pelareorep in patients with third-line (3L) metastatic colorectal cancer (CRC) regardless of microsatellite instability status at the European Society for Medical Oncology meeting (ESMO 2023), taking place in Madrid, Spain.

Key Points: 
  • These data demonstrated a 40% overall disease control rate and provided further encouraging data for pelareorep," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics.
  • Notably, this is the second GOBLET study cohort in a row that has met its success criteria, further supporting pelareorep's ability to synergize with atezolizumab.
  • GOBLET Study 3L Metastatic CRC Patient Overview:
    Patients in the CRC cohort, presented at ESMO 2023, are undergoing third-line treatment with a combination of pelareorep, atezolizumab, and trifluridine/tipiracil.
  • The enrolled patient population included patients with an ECOG score of ≤1 and confirmed colorectal cancer, regardless of microsatellite instability status.

Oncolytics Achieves Success Criteria for Efficacy in the Third-Line Colorectal Cancer Cohort of the GOBLET Study

Retrieved on: 
Monday, October 23, 2023
Survival, Patient, DOI, ESMO, September 18, ECOG, Progression-free survival, Metastasis, Colorectal cancer, Gastrointestinal cancer, European Society for Medical Oncology, AB, Trifluridine/tipiracil, Poster, CRC, Microsatellite instability, Pelareorep, Oncology, Cancer, ONC, TSX, SAN, Nursing, Pharmaceutical industry, Oncolytics Biotech

SAN DIEGO and CALGARY, AB, Oct. 23, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY), (Oncolytics) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the poster presentation of interim results from the Phase 1/2 GOBLET study evaluating a combination treatment of pelareorep in patients with third-line (3L) metastatic colorectal cancer (CRC) regardless of microsatellite instability status at the European Society for Medical Oncology meeting (ESMO 2023), taking place in Madrid, Spain.

Key Points: 
  • These data demonstrated a 40% overall disease control rate and provided further encouraging data for pelareorep," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics.
  • Notably, this is the second GOBLET study cohort in a row that has met its success criteria, further supporting pelareorep's ability to synergize with atezolizumab.
  • GOBLET Study 3L Metastatic CRC Patient Overview:
    Patients in the CRC cohort, presented at ESMO 2023, are undergoing third-line treatment with a combination of pelareorep, atezolizumab, and trifluridine/tipiracil.
  • The enrolled patient population included patients with an ECOG score of ≤1 and confirmed colorectal cancer, regardless of microsatellite instability status.

Bayer Unveils Latest Data from Oncology Portfolio at ESMO Congress 2023

Retrieved on: 
Thursday, October 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)

Oncolytics Biotech® To Present Two Posters on the Pelareorep-Based GOBLET Study at ESMO 2023

Retrieved on: 
Monday, October 16, 2023
HIV disease progression rates, Trifluridine/tipiracil, ORR, OS, Liver, PDAC, Safety, Interim, ESMO, Immunodeficiency, SD, Cancer, PFS, PD, MSS, CBR, Progression-free survival, Outer ring road, Patient, Pharmaceutical industry

SAN DIEGO  and CALGARY, AB, Oct. 16, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the publication of two abstracts for posters to be presented during the upcoming European Society for Medical Oncology (ESMO) Congress 2023, taking place from October 20th to 24th at the IFEMA Madrid Conference Center in Madrid, Spain.

Key Points: 
  • Primary objectives were safety and efficacy, measured by Stage 1 success criterion of >3 confirmed responses (PDAC segment).
  • T cell receptor sequencing (TCR-seq) was also performed during the course of treatment.
  • Updated efficacy and TCR-seq results will be presented at ESMO; final PFS and OS are pending.
  • The authors concluded from these data that the pelareorep combination was well-tolerated and the primary efficacy success criterion was met.

Oncolytics Biotech® To Present Two Posters on the Pelareorep-Based GOBLET Study at ESMO 2023

Retrieved on: 
Monday, October 16, 2023
HIV disease progression rates, Trifluridine/tipiracil, ORR, OS, Liver, PDAC, Safety, Interim, ESMO, Immunodeficiency, SD, Cancer, PFS, PD, MSS, CBR, Progression-free survival, Outer ring road, Patient, Pharmaceutical industry

SAN DIEGO  and CALGARY, AB, Oct. 16, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the publication of two abstracts for posters to be presented during the upcoming European Society for Medical Oncology (ESMO) Congress 2023, taking place from October 20th to 24th at the IFEMA Madrid Conference Center in Madrid, Spain.

Key Points: 
  • Primary objectives were safety and efficacy, measured by Stage 1 success criterion of >3 confirmed responses (PDAC segment).
  • T cell receptor sequencing (TCR-seq) was also performed during the course of treatment.
  • Updated efficacy and TCR-seq results will be presented at ESMO; final PFS and OS are pending.
  • The authors concluded from these data that the pelareorep combination was well-tolerated and the primary efficacy success criterion was met.

FDA Approves LONSURF® (trifluridine/tipiracil) in Combination With Bevacizumab for Adult Patients With Metastatic Colorectal Cancer (mCRC)

Retrieved on: 
Wednesday, August 2, 2023
The New England Journal of Medicine, Bevacizumab, Acupuncture & Electro-Therapeutics Research, Progression-free survival, OS, Oncology, PFS, City, HIV disease progression rates, RAS, MD, Patient, Trifluridine/tipiracil, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry

PRINCETON, N.J., Aug. 2, 2023 /PRNewswire/ -- Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved LONSURF® (trifluridine/tipiracil) as a single agent or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

Key Points: 
  • PRINCETON, N.J., Aug. 2, 2023 /PRNewswire/ -- Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved LONSURF® (trifluridine/tipiracil) as a single agent or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
  • "Notably, the use of LONSURF plus bevacizumab in these patients did not result in an increase in potentially intolerable side effects that might limit the utility of this combination."
  • On July 31, 2023, Servier, which conducted the SUNLIGHT trial with Taiho Oncology, received approval from the European Commission for LONSURF in combination with bevacizumab for the treatment of adult patients with mCRC who have received two prior anti-cancer treatment regimens, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents.
  • The Marketing Authorization covers the 27 countries of the European Union as well as Iceland, Northern Ireland, Liechtenstein and Norway.

Natera Announces Completion of Enrollment to the Randomized, Phase III ALTAIR Trial of Signatera™ in Colorectal Cancer

Retrieved on: 
Friday, July 28, 2023
Science, Biotechnology, Research, Oncology, Health, Medical Devices, Genetics, Clinical Trials, VEGA, DNA, CRC, ALTAIR, American Society of Clinical Oncology, Rated R, ASCO, MRD, Patient, Risk, Trifluridine/tipiracil, Medicine, Neoplasm, Recurrence, III, Society, NTRA, Disease, Medical imaging, Medical device, Nature Medicine, Natera

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced the completion of enrollment to the randomized, double-blind phase III ALTAIR clinical trial (JapicCTI-205363/NCT04457297).

Key Points: 
  • Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced the completion of enrollment to the randomized, double-blind phase III ALTAIR clinical trial (JapicCTI-205363/NCT04457297).
  • ALTAIR is the circulating tumor DNA (ctDNA)-guided treatment escalation arm of the CIRCULATE-Japan adaptive trial platform evaluating the utility of the Signatera molecular residual disease (MRD) test in patients with stage II-IV resectable colorectal cancer (CRC).
  • CIRCULATE-Japan also includes the observational GALAXY study and the randomized phase III VEGA trial for ctDNA-guided treatment de-escalation.
  • “We are proud to partner with our collaborators from CIRCULATE-Japan to accelerate precision medicine and transform care for patients with resectable CRC.”

Servier Targets Transformative Treatment of Cancer at ASCO 2023

Retrieved on: 
Thursday, May 25, 2023
Glioma, Bevacizumab, Capecitabine, INDIGO, Central European Summer Time, European Hematology Association, Survival, American Society of Clinical Oncology, Research, Acute myeloid leukemia, ASCO, MDS, AML, Azacitidine, Patient, Trifluridine/tipiracil, Cancer, EHA, IDH, IDH1, Chondrosarcoma, Safety, Society, European Commission, Cholangiocarcinoma, Dietary supplement, Nursing, Pharmaceutical industry, Laboratoires Servier

BOSTON and PARIS, May 25, 2023 /PRNewswire/ -- Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, will showcase new data across its robust oncology portfolio at the American Society of Clinical Oncology (ASCO) annual meeting June 2-6, 2023. These latest data, including a plenary session selection, underscore the breadth of Servier's oncology pipeline and portfolio and the company's commitment to improving outcomes for difficult and hard-to-treat cancers with high unmet medical needs.

Key Points: 
  • These latest data, including a plenary session selection, underscore the breadth of Servier's oncology pipeline and portfolio and the company's commitment to improving outcomes for difficult and hard-to-treat cancers with high unmet medical needs.
  • Among the data to be presented is a late breaking abstract featuring the results from the Phase 3 INDIGO study of vorasidenib in patients with residual or recurrent grade 2 IDH-mutant glioma.
  • "Servier is leading the scientific research with IDH inhibition across a variety of difficult to treat cancers, and this year at ASCO, we are excited to showcase data that has the potential to shift the treatment paradigm for patients with IDH-mutant glioma," said Susan Pandya, M.D., Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier.
  • Servier abstracts being presented at EHA are listed below (all times in Central European Summer Time) and are available online on the EHA website here .

Gritstone bio Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Updates

Retrieved on: 
Thursday, March 9, 2023
SIV, Vaccine, Cancer, HIV, Neoplasm, Trifluridine/tipiracil, United States Patent and Trademark Office, MOS, Clinical trial, NCI, 1836 U.S. Patent Office fire, KRAS, ESMO, Fungal infection, Infection, CRC, National Cancer Institute, Simian immunodeficiency virus, Conference, Collaboration, CROI, Research, NIAID, Patient, FDA, DNA, Circulating tumor DNA, RECIST, Patent, Gilead Sciences, OS, MRR, Regorafenib, Progression-free survival, Therapy, ChAdOx1, NSCLC, Messenger, Immunotherapy, CORAL, SLATE, Pharmaceutical industry, Cryptocurrency, Nature Medicine, Gritstone

-- Gritstone to host conference call today at 4:30pm ET --

Key Points: 
  • -- In August 2022, interim results from the Phase 1/2 trial of GRANITE, Gritstone’s individualized neoantigen vaccine for solid tumor cancers, were published in Nature Medicine ( here ).
  • -- In August 2022, Gritstone reported 6-month neutralizing antibody data from the first two cohorts of its CORAL-BOOST trial.
  • -- In October 2022, Gritstone shared interim positive results from the ongoing Phase 1 CORAL-BOOST and CORAL-CEPI studies at a Company-sponsored webinar .
  • Collaboration, license, and grant revenues were $19.9 million for the year ended December 31, 2022, compared to $48.2 million for the prior year.