Transitional epithelium

4D pharma Announces Clinical Trial Collaboration and Supply Agreement with Merck KGaA, Darmstadt, Germany and Pfizer to Evaluate MRx0518 in Combination with BAVENCIO® for the Treatment of Locally Advanced or Metastatic Urothelial Carcinoma

Retrieved on: 
Monday, February 8, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Health, Clinical medicine, Medicine, Breakthrough therapy, Merck, Cancer treatments, Antineoplastic drugs, Avelumab, Merck & Co., Transitional cell carcinoma, Transitional epithelium, Merck Group, MRx0518, 4D pharma

Under the collaboration, 4D pharma intends to commence a clinical trial in 2021 to evaluate BAVENCIO in combination with MRx0518 as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.

Key Points: 
  • Under the collaboration, 4D pharma intends to commence a clinical trial in 2021 to evaluate BAVENCIO in combination with MRx0518 as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.
  • With this second clinical trial collaboration for MRx0518 with a leading immune checkpoint inhibitor, 4D is able to evaluate MRx0518 in a new combination and earlier treatment setting.
  • The study is being conducted in collaboration with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA.
  • A fourth clinical trial of MRx0518 in combination with BAVENCIO (avelumab) in the first-line maintenance setting for urothelial carcinoma, conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc., is expected to initiate in 2021.

Infinity Pharmaceuticals Provides Update for Eganelisib in Patients with Metastatic Urothelial Cancer

Retrieved on: 
Wednesday, January 6, 2021
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Drugs, Breakthrough therapy, Clinical medicine, Health sciences, Monoclonal antibodies, Antineoplastic drugs, Bristol-Myers Squibb, Orphan drugs, Nivolumab, Transitional cell carcinoma, Transitional epithelium, MUC

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today provided an update on MARIO-275, the Companys randomized, placebo controlled Phase 2 study evaluating the benefit of adding eganelisib to nivolumab (Opdivo) in platinum-refractory, I/O nave patients with advanced, metastatic urothelial cancer (mUC) over nivolumab monotherapy which is approved in this setting.

Key Points: 
  • Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today provided an update on MARIO-275, the Companys randomized, placebo controlled Phase 2 study evaluating the benefit of adding eganelisib to nivolumab (Opdivo) in platinum-refractory, I/O nave patients with advanced, metastatic urothelial cancer (mUC) over nivolumab monotherapy which is approved in this setting.
  • The MARIO-275 study provided Infinity with important insights to shape the future of eganelisib in urothelial cancer, said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals.
  • We are leveraging the clinical and translational learnings from MARIO-275 in planning a new, registration-enabling study of eganelisib in patients with advanced urothelial cancer.
  • MARIO-275 is a global, randomized, placebo-controlled combination study of eganelisib combined with Opdivo in I/O nave urothelial cancer.

Basilea reports interim results from phase 1/2 study FIDES-02 exploring derazantinib in patients with advanced urothelial cancer

Retrieved on: 
Tuesday, October 13, 2020
Drugs, Breakthrough therapy, Orphan drugs, Clinical medicine, Cancer treatments, Atezolizumab, Transitional cell carcinoma, Basilea Pharmaceutica, Transitional epithelium, Cancer immunotherapy

Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today interim results from the phase 1b part of the ongoing phase 1/2 study FIDES-02.

Key Points: 
  • Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today interim results from the phase 1b part of the ongoing phase 1/2 study FIDES-02.
  • The phase 2 substudies include patients with FGFR-positive advanced urothelial cancer receiving treatment with derazantinib alone or in combination with atezolizumab as first-line therapy or after progression on prior FGFR-inhibitor therapy.
  • This RP2D corresponds to the derazantinib monotherapy dose used in the phase 2 study FIDES-01 and the standard dose for atezolizumab as a single agent in urothelial cancer.
  • We have now moved to the next important step in the development of derazantinib, by exploring potential synergies of derazantinib and atezolizumab in our ongoing clinical study in patients with advanced urothelial cancer.

Urothelial Carcinoma Diagnostics Market Is Expected To Progress At A CAGR Of Over 11% During The Forecast Period (2020-2030)

Retrieved on: 
Tuesday, October 6, 2020
Transitional epithelium, Transitional cell carcinoma

According to the latest report published by PMR, the Global Urothelial Carcinoma Diagnostics Market Was Valued At US$ 1 Bn In 2020, And Is Expected To Progress At A CAGR Of Over 11% During The Forecast Period (20202030).

Key Points: 
  • According to the latest report published by PMR, the Global Urothelial Carcinoma Diagnostics Market Was Valued At US$ 1 Bn In 2020, And Is Expected To Progress At A CAGR Of Over 11% During The Forecast Period (20202030).
  • The reagent and kits segment, under product type, is expected to contribute more than 70% of revenue share in the urothelial carcinoma diagnostics market.
  • Based on end user, the hospitals segment accounts for a major revenue share in the urothelial carcinoma diagnostics market.
  • Leading players launching rapid diagnostic products with advances technology are expected to dominate the urothelial carcinoma diagnostics market space.

Urothelial Carcinoma Diagnostics Market Is Expected To Progress At A CAGR Of Over 11% During The Forecast Period (2020-2030)

Retrieved on: 
Tuesday, October 6, 2020
Transitional epithelium, Transitional cell carcinoma

According to the latest report published by PMR, the Global Urothelial Carcinoma Diagnostics Market Was Valued At US$ 1 Bn In 2020, And Is Expected To Progress At A CAGR Of Over 11% During The Forecast Period (20202030).

Key Points: 
  • According to the latest report published by PMR, the Global Urothelial Carcinoma Diagnostics Market Was Valued At US$ 1 Bn In 2020, And Is Expected To Progress At A CAGR Of Over 11% During The Forecast Period (20202030).
  • The reagent and kits segment, under product type, is expected to contribute more than 70% of revenue share in the urothelial carcinoma diagnostics market.
  • Based on end user, the hospitals segment accounts for a major revenue share in the urothelial carcinoma diagnostics market.
  • Leading players launching rapid diagnostic products with advances technology are expected to dominate the urothelial carcinoma diagnostics market space.

Infinity Receives Fast Track Designation for Eganelisib in Combination with a Checkpoint Inhibitor and Chemotherapy for First-Line Treatment of Advanced TNBC

Retrieved on: 
Tuesday, September 29, 2020
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Drugs, Clinical medicine, Cancer treatments, Orphan drugs, Breakthrough therapy, RTT, Cancer immunotherapy, Antineoplastic drugs, Atezolizumab, Transitional cell carcinoma, Nivolumab, Transitional epithelium

Earlier this year Infinity also received Fast Track designation for eganelisib in combination with the checkpoint inhibitor Opdivo for the treatment of advanced urothelial cancer which the company is studying in MARIO-275, the companys global, randomized, controlled Phase 2 study in patients with advanced urothelial cancer.

Key Points: 
  • Earlier this year Infinity also received Fast Track designation for eganelisib in combination with the checkpoint inhibitor Opdivo for the treatment of advanced urothelial cancer which the company is studying in MARIO-275, the companys global, randomized, controlled Phase 2 study in patients with advanced urothelial cancer.
  • Fast Track designation is an exciting regulatory milestone that bolsters our momentum in TNBC, said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals.
  • MARIO-3 is the first eganelisib combination study in front-line advanced cancer patients and is evaluating eganelisib in combination with Tecentriq and Abraxane in front-line TNBC and in combination with Tecentriq and Avastin in front-line RCC.
  • In collaboration with Arcus Biosciences, Infinity is evaluating a checkpoint inhibitor-free, novel combination regimen of eganelisib plus AB928 (dual adenosine receptor antagonist) plus Doxil in advanced TNBC patients.

RemeGen Announces US FDA Has Granted Breakthrough Therapy Designation for Disitamab Vedotin (RC48) in Urothelial Cancer

Retrieved on: 
Friday, September 25, 2020
Breakthrough therapy, Clinical medicine, Cancer treatments, Drugs, Carcinoma, Transitional cell carcinoma, Transitional epithelium, Monoclonal antibodies, Cancer immunotherapy, Enfortumab vedotin

"An estimated 81,400 new cases of urothelial cancer and 17,980 deaths are predicted in the United States in 2020i," said Jianmin Fang, Ph.D., founder, CEO and CSO of RemeGen.

Key Points: 
  • "An estimated 81,400 new cases of urothelial cancer and 17,980 deaths are predicted in the United States in 2020i," said Jianmin Fang, Ph.D., founder, CEO and CSO of RemeGen.
  • "The high prevalence of metastatic urothelial cancer underscores the need for effective and accessible treatment methods for patients.
  • This Breakthrough Therapy designation will bring RemeGen one step closer to finding a safe and effective treatment for this devastating disease.
  • We look forward to working with the FDA to advance the clinical development of disitamab vedotin."

GeneCentric Therapeutics and Erasmus University Medical Center Enter Bladder Cancer Research Collaboration

Retrieved on: 
Wednesday, August 5, 2020
Biotechnology, Pharmaceutical, Health, Oncology, Branches of biology, RTT, Biology, Clinical medicine, Aging-associated diseases, Bladder cancer, Transitional epithelium, Cancer, Biomarker, Urinary bladder

GeneCentric Therapeutics, Inc. and Erasmus University Medical Center (EUMC) today announced that they have entered into a research collaboration to identify RNA-based drug response markers and novel, targeted therapies in the setting of non-muscle invasive bladder cancer (NMIBC).

Key Points: 
  • GeneCentric Therapeutics, Inc. and Erasmus University Medical Center (EUMC) today announced that they have entered into a research collaboration to identify RNA-based drug response markers and novel, targeted therapies in the setting of non-muscle invasive bladder cancer (NMIBC).
  • Erasmus MC is the largest University Medical Center in the Netherlands.
  • Research activities focus on: identification and validation of novel urinary and tumor biomarkers to improve the diagnosis and prognosis of urothelial cancer; functional genomics studies in chemo-resistant muscle-invasive bladder cancer; prediction models for non-muscle invasive bladder cancer; development of digital pathology tools for bladder cancer; development of pre-clinical research models.
  • GeneCentric Therapeutics, Inc., based in Research Triangle Park, N.C., is an RNA-based genomic solutions provider.

Nucleix Presents Two Bladder EpiCheck® Studies at EAU20 Virtual Congress, Including Interim Data in Patients with Upper Tract Urothelial Cancer

Retrieved on: 
Friday, July 17, 2020
Research, Surgery, Genetics, Clinical trials, Biotechnology, Health, General Health, Science, Oncology, Urology, Neoplasms, Cancer, Bladder cancer, RTT, Transitional cell carcinoma, Transitional epithelium, Urinary bladder, Ureteroscopy, Papillary urothelial neoplasm of low malignant potential, Urine cytology, Bladder EpiCheck®, Nucleix

The first presentation, titled Feasibility of the EpiCheck test in upper tract tumor: interim analysis of a prospective trial, evaluated 47 patients who underwent an ureteroscopy for primary or recurrent upper tract urothelial cancer (UTUC) since June 1, 2018.

Key Points: 
  • The first presentation, titled Feasibility of the EpiCheck test in upper tract tumor: interim analysis of a prospective trial, evaluated 47 patients who underwent an ureteroscopy for primary or recurrent upper tract urothelial cancer (UTUC) since June 1, 2018.
  • This interim analysis reported a significantly higher overall sensitivity of Bladder EpiCheck compared to cytology in voided urine (75% vs 39%, p=0.03).
  • We are encouraged that these data demonstrate the promise of Bladder EpiChecks ability to accurately rule-out high-grade upper tract urothelial cancer with a simple voided urine test.
  • We are building an EpiCheck franchise, beginning with our Bladder EpiCheck testing kit marketed in Europe for bladder cancer recurrence.

FDA Approves BAVENCIO as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma

Retrieved on: 
Tuesday, June 30, 2020
Clinical medicine, Neoplasms, Health, Breakthrough therapy, Merck, Carcinoma, Avelumab, Transitional cell carcinoma, Monoclonal antibodies, Merkel-cell carcinoma, Transitional epithelium, Cancer immunotherapy

For patients that do not progress on platinum-containing chemotherapy, BAVENCIO is administered as a first-line maintenance treatment until disease progression or unacceptable toxicity.

Key Points: 
  • For patients that do not progress on platinum-containing chemotherapy, BAVENCIO is administered as a first-line maintenance treatment until disease progression or unacceptable toxicity.
  • BAVENCIO (avelumab) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.
  • In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC).
  • A fatal adverse reaction (sepsis) occurred in one (0.3%) patient with locally advanced or metastatic urothelial carcinoma (UC) receiving BAVENCIOplus best supportive care (BSC) as first-line maintenance treatment.