Oportuzumab monatox

Sesen Bio Strengthens Senior Leadership Team

Retrieved on: 
Tuesday, June 1, 2021
Biotechnology, Pharmaceutical, Health, Bayer, Kenilworth, New Jersey, Merck & Co., Schering-Plough, Bladder cancer, Oportuzumab monatox, Vicineum™, Sesen Bio, VICINEUM™, SESEN BIO

Prior to joining Sesen Bio, Ms. Drake spent her career at Merck & Co., Inc in various leadership roles.

Key Points: 
  • Prior to joining Sesen Bio, Ms. Drake spent her career at Merck & Co., Inc in various leadership roles.
  • Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC.
  • Sesen Bio, Inc. is a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of patients with cancer.
  • Sesen Bio continues to monitor the rapidly evolving environment regarding the potential impact of the COVID-19 pandemic on the Company.

Sesen Bio Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Friday, May 21, 2021
Biotechnology, Pharmaceutical, Health, Oncology, Cancer, Clinical medicine, Medicine, Bladder cancer, Carcinogenesis, Oportuzumab monatox, Epithelial cell adhesion molecule, Cancer immunotherapy, Cancer cell, Checkpoint inhibitor, Oncology, Vicineum™, Sesen Bio, VICINEUM™, SESEN BIO

The option was granted as a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4).\nVicineum, a locally administered fusion protein, is Sesen Bio\xe2\x80\x99s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

Key Points: 
  • The option was granted as a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4).\nVicineum, a locally administered fusion protein, is Sesen Bio\xe2\x80\x99s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
  • In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells.
  • Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC.
  • Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors.

Sesen Bio Announces Commercial Launch Readiness Progress as the Company Approaches the Potential Approval and Launch of Vicineum™

Retrieved on: 
Tuesday, May 4, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Bladder cancer, Oportuzumab monatox, Vicineum™, Sesen Bio, VICINEUM™, SESEN BIO

She also held various leadership positions in sales, launch strategy, marketing, account management, risk management, and policy.

Key Points: 
  • She also held various leadership positions in sales, launch strategy, marketing, account management, risk management, and policy.
  • At every level, she excelled at building new capabilities as well as developing strategy and priorities to drive execution for commercial success.
  • Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC.
  • However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

Dr. Thomas Cannell, President and CEO of Sesen Bio, and Dr. Michael Jewett, FRCSC, FACS, to Participate in Canaccord Genuity “Horizons in Oncology” Virtual Conference

Retrieved on: 
Thursday, April 8, 2021
Oncology, Health, Other Health, General Health, Clinical trials, Pharmaceutical, Biotechnology, Health informatics, Bladder cancer, Jewett, Food and Drug Administration, Oportuzumab monatox, Health, Vicineum™, Sesen Bio

He has appeared before the FDA as an expert including the presentation that led to the historic approval of BCG for NMIBC.

Key Points: 
  • He has appeared before the FDA as an expert including the presentation that led to the historic approval of BCG for NMIBC.
  • Dr. Jewett has published more than 400 peer-reviewed papers, mostly in Uro-oncology and in technology assessment and medical informatics.
  • In December 2020, Dr. Jewett was appointed to the Order of Canada based on his achievements listed above, among others.
  • Sesen Bio, Inc. is a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of patients with cancer.

Sesen Bio Reports Fourth Quarter and Full-Year 2020 Financial Results and Significant Regulatory and Commercial Readiness Progress for the Company’s Lead Product Candidate Vicineum™

Retrieved on: 
Monday, March 15, 2021
Biotechnology, Pharmaceutical, Health, Oncology, Bladder cancer, Monoclonal antibodies, Food and Drug Administration, Oportuzumab monatox, Vicineum™, Sesen Bio

The FDA also stated that they are not currently planning to hold an advisory committee meeting to discuss the BLA for Vicineum.

Key Points: 
  • The FDA also stated that they are not currently planning to hold an advisory committee meeting to discuss the BLA for Vicineum.
  • On March 5, 2021, Sesen Bio submitted the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Vicineum for the treatment of BCG-unresponsive NMIBC.
  • Under the Agreement, Qilu will be part of the contract manufacturing network for the global commercial supply of Vicineum.
  • Vicineum, a locally administered fusion protein, is Sesen Bios lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

Sesen Bio Submits Marketing Authorization Application to the European Medicines Agency for Vicineum™

Retrieved on: 
Monday, March 8, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Monoclonal antibodies, Oportuzumab monatox, Coronavirus disease, Health, Medical specialties, Vicineum™, Non-Muscle Invasive Bladder Cancer, Sesen Bio

We will continue working collaboratively with the EMA to move Vicineum through the regulatory process as expeditiously as possible.

Key Points: 
  • We will continue working collaboratively with the EMA to move Vicineum through the regulatory process as expeditiously as possible.
  • Sesen Bio is currently going through the tradename approval process with the EMA for oportuzumab monatox.
  • Sesen Bio, Inc. is a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of patients with cancer.
  • Sesen Bio continues to monitor the rapidly evolving environment regarding the potential impact of the COVID-19 pandemic on our Company.

Sesen Bio Announces Conference Call with Neal Shore, M.D., FACS to Provide Clinical Perspective on the Company’s Lead Product Candidate Vicineum™

Retrieved on: 
Tuesday, March 2, 2021
Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Clinical trials, Other Health, Medical specialties, Urology, Bladder cancer, Cancer, Clinical medicine, Medicine, Oportuzumab monatox

Neal Shore, M.D., FACS is the medical director of the Carolina Urologic Research Center and is an internationally recognized expert in Urologic Oncology.

Key Points: 
  • Neal Shore, M.D., FACS is the medical director of the Carolina Urologic Research Center and is an internationally recognized expert in Urologic Oncology.
  • Shore is a paid consultant to Sesen Bio and served as a clinical investigator for the Phase 2 and Phase 3 clinical trials of Vicineum for NMIBC.
  • Vicineum, a locally administered fusion protein, is Sesen Bios lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC).
  • Sesen Bio, Inc. is a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of patients with cancer.