Pseudomonas exotoxin

Sesen Bio Reports Second Quarter 2022 Financial Results and Business Update

Retrieved on: 
Monday, August 8, 2022
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Sesen Bio (Nasdaq: SESN ) today reported operating results for the second quarter ended June 30, 2022.

Key Points: 
  • Sesen Bio (Nasdaq: SESN ) today reported operating results for the second quarter ended June 30, 2022.
  • On July 11, 2022, Sesen Bio participated in a Type B Meeting with the US Food and Drug Administration (FDA).
  • On July 18, 2022, Sesen Bio announced that it had made the strategic decision to voluntarily pause further development of Vicineum in the US.
  • R&D Expenses: Research and development expenses for the second quarter of 2022 were $29.9 million compared to $7.2 million for the same period in 2021.

Sesen Bio Announces Strategic Decision to Pause Clinical Development of Vicineum™ in the US

Retrieved on: 
Monday, July 18, 2022
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Prescription Drug User Fee Act, Bio, PDUFA, Pseudomonas exotoxin, Private Securities Litigation Reform Act, Cancer, Patient, Security (finance), EIP, U.S. Securities and Exchange Commission, Mission statement, BCG, Safety, Therapy, Epithelial cell adhesion molecule, Endpoint security, MENA, CRL, Environment, Caregiver, BLA, COVID-19, Company, US Foods, Antigen, Risk, Health, FDA, Toxicity, Hikma Pharmaceuticals, Priority review, Pharmaceutical industry, Vaccine, Greater China, NMIBC

Sesen Bio (Nasdaq: SESN ) today announced that it has made the strategic decision to voluntarily pause further development in the US of its lead asset, Vicineum.

Key Points: 
  • Sesen Bio (Nasdaq: SESN ) today announced that it has made the strategic decision to voluntarily pause further development in the US of its lead asset, Vicineum.
  • This decision enables Sesen Bio to conserve cash while it continues to assess potential strategic alternatives with the goal of maximizing shareholder value.
  • In assessing the impact of the regulatory and commercial landscape, we have made the decision to pause the clinical development of Vicineum.
  • Sesen Bio has completed the follow-up stage of a Phase 3 clinical trial in the US for the treatment of BCG-unresponsive NMIBC.

Sesen Bio Reports First Quarter 2022 Financial Results and Business Update

Retrieved on: 
Monday, May 9, 2022
Biotechnology, Health, Oncology, D, COVID-19, U.S. Securities and Exchange Commission, CRL, Prescription Drug User Fee Act, Nasdaq, IL-6, Bio, Toxicity, Company, Private Securities Litigation Reform Act, MENA, Roche, Food, Hikma Pharmaceuticals, Research, Safety, Endpoint security, BCG, Patient, BLA, Security (finance), Pseudomonas exotoxin, Review, Caregiver, Partnership, Clinical trial, Epithelial cell adhesion molecule, FDA, Technology transfer, Cancer, Bacillus, Therapy, Environment, US Foods, Health, Biologics license application, Marketing, Antigen, Sale, CMC, Technology, Type, PDUFA, EIP, Priority review, Risk, Acquisition, Pharmaceutical industry, Vaccine, Chemistry, Shareholder, NMIBC, Greater China

Sesen Bio (Nasdaq: SESN ), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today reported operating results for the first quarter ended March 31, 2022.

Key Points: 
  • Sesen Bio (Nasdaq: SESN ), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today reported operating results for the first quarter ended March 31, 2022.
  • On March 28, 2022, Sesen Bio participated in a Type C Meeting with the FDA.
  • On January 6, 2022, Sesen Bio disclosed that it achieved a $20 million milestone payment pursuant to the Companys exclusive license agreement (Roche License Agreement) with Roche for legacy Interleukin-6 (IL-6) antagonist antibody technology owned by Sesen Bio.
  • On May 3, 2022, Sesen Bio announced that it had initiated a process to review strategic alternatives with the goal of maximizing shareholder value.

Sesen Bio Provides Strategic Update

Retrieved on: 
Tuesday, May 3, 2022
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, COVID-19, U.S. Securities and Exchange Commission, CRL, Prescription Drug User Fee Act, Mission statement, Bio, Toxicity, European Medicines Agency, Company, Private Securities Litigation Reform Act, MENA, Safety, Hikma Pharmaceuticals, Endpoint security, BCG, Patient, BLA, Security (finance), Pseudomonas exotoxin, Review, Caregiver, Partnership, Clinical trial, FDA, Epithelial cell adhesion molecule, Cancer, Environment, Therapy, Health, Sale, Antigen, PDUFA, EIP, Priority review, Risk, Acquisition, Pharmaceutical industry, NMIBC, Greater China

Our strong cash position provides us the opportunity to carefully consider a wide range of potential strategic alternatives designed to maximize shareholder value, said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio.

Key Points: 
  • Our strong cash position provides us the opportunity to carefully consider a wide range of potential strategic alternatives designed to maximize shareholder value, said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio.
  • Sesen Bio is currently in the follow-up stage of a Phase 3 clinical 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 Further Enhances Team with Key Hires

Retrieved on: 
Monday, January 10, 2022
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Clinical trial, Health, Safety, Hikma Pharmaceuticals, Risk, PDUFA, MENA, Antigen, Prescription Drug User Fee Act, Bladder cancer, Environment, Pseudomonas exotoxin, FIS (company), EIP, VISTA, Security (finance), Cancer, Patient, Nasdaq, U.S. Securities and Exchange Commission, Priority review, Endpoint security, Employment, Toxicity, Private Securities Litigation Reform Act, Spectrum Pharmaceuticals, BCG, Caregiver, Company, Epithelial cell adhesion molecule, Kansai Medical University, Bio, CRL, FDA, COVID-19, Corporate accountability for human rights violations, Therapy, Compliance, Accounting, BLA, AstraZeneca, MedImmune, Macrogen, Husson University, Pharmaceutical industry, Lease, Online gambling, Vaccine, Greater China, NMIBC, Vicineum™, Sesen Bio, VICINEUM™, SESEN BIO

We are pleased to welcome these highly qualified new employees to our team, said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio.

Key Points: 
  • We are pleased to welcome these highly qualified new employees to our team, said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio.
  • Sesen Bio is currently in the follow-up stage of its Phase 3 VISTA clinical 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 Anticipated Regulatory Path Forward for Vicineum™

Retrieved on: 
Thursday, December 9, 2021
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, EMA, European Union, Securities and Exchange Commission (Philippines), Environment, Risk, Company, Element, CRL, EIP, Toxicity, Health, Epithelial cell adhesion molecule, Therapy, European Commission, Security (finance), Union, Bio, Safety, Private Securities Litigation Reform Act, Food, VISTA, Caregiver, PDUFA, MAA, Royal commission, Patient, Protocol, Cancer, Pseudomonas exotoxin, BLA, Priority review, Endpoint security, MENA, Prescription Drug User Fee Act, European Medicines Agency, COVID-19, Clinical trial, FDA, Hikma Pharmaceuticals, Type, Antigen, Marketing, BCG, US Foods, Vaccine, Pharmaceutical industry, Medical device, Vicineum™, Sesen Bio, VICINEUM™, SESEN BIO

We are pleased to have greater clarity on the regulatory path forward to resubmit the BLA and ultimately bring Vicineum to market if approved, said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio.

Key Points: 
  • We are pleased to have greater clarity on the regulatory path forward to resubmit the BLA and ultimately bring Vicineum to market if approved, said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio.
  • 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 is currently in the follow-up stage of a Phase 3 clinical trial in the US for the treatment of BCG-unresponsive NMIBC.
  • Sesen Bio continues to monitor the rapidly evolving environment regarding the potential impact of the COVID-19 pandemic on the Company.

Sesen Bio Strengthens Medical Team

Retrieved on: 
Monday, November 29, 2021
General Health, Health, Oncology, Clinical Trials, Patient, Security (finance), Public health nursing, EIP, Safety, Caregiver, Epithelial cell adhesion molecule, Endpoint security, Environment, US Foods, CMC, Prescription Drug User Fee Act, Pseudomonas exotoxin, Company, Private Securities Litigation Reform Act, Cancer, Antigen, Priority review, Health, Horizon Therapeutics, University, BLA, U.S. Securities and Exchange Commission, Therapy, COVID-19, Pediatric nurse practitioner, University of Illinois Urbana-Champaign, Nasdaq, CRL, Risk, Bladder cancer, PDUFA, Rush University, BCG, AbbVie, FDA, Hikma Pharmaceuticals, Bio, Employment, Toxicity, MENA, HIV, Chemistry, Pharmaceutical industry, Vaccine, Vicineum™, Sesen Bio, VICINEUM™, SESEN BIO

Sesen Bio (Nasdaq: SESN ), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced the strengthening of its medical team with the hiring of Dominika Kowalski as Senior Director of Global Drug Safety.

Key Points: 
  • Sesen Bio (Nasdaq: SESN ), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced the strengthening of its medical team with the hiring of Dominika Kowalski as Senior Director of Global Drug Safety.
  • We are excited for Dominika to join our team as we continue to engage with the FDA and work toward advancing our lead product candidate, said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio.
  • 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 Director Jane Pritchett Henderson Transitions to CEO Advisor Role

Retrieved on: 
Tuesday, November 23, 2021
Research, Human Resources, FDA, Clinical Trials, Professional Services, Biotechnology, Health, Science, Oncology, Patient, Security (finance), Caregiver, EIP, Safety, Epithelial cell adhesion molecule, Environment, Endpoint security, Private Securities Litigation Reform Act, Pseudomonas exotoxin, Company, Â, MD, Cancer, Antigen, Priority review, Health, MBA, Audit committee, BLA, Director, U.S. Securities and Exchange Commission, Therapy, COVID-19, CRL, Risk, Bladder cancer, PDUFA, BCG, Board, Board of directors, Knowledge, FRCSC, FDA, Hikma Pharmaceuticals, Bio, Toxicity, MENA, Growth, Pharmaceutical industry, Management, Vaccine, Vicineum™, Sesen Bio, VICINEUM™, SESEN BIO

Ms. Henderson departed the Board in order to concentrate on other responsibilities outside of Sesen Bio, including as Chief Financial Officer of Adagio Therapeutics and as a director of two other companies.

Key Points: 
  • Ms. Henderson departed the Board in order to concentrate on other responsibilities outside of Sesen Bio, including as Chief Financial Officer of Adagio Therapeutics and as a director of two other companies.
  • On behalf of the entire Board, I would like to thank Jane for her numerous contributions over her long tenure on Sesen Bios Board, said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio.
  • 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 Reports Third Quarter 2021 Financial Results and Business Update

Retrieved on: 
Monday, November 8, 2021
Biotechnology, Pharmaceutical, Health, Cancer, Clinical trial, Security (finance), Endpoint security, Technology transfer, D, Pseudomonas exotoxin, COVID-19, University of Zurich, Therapy, Review, Risk, EIP, Safety, Hikma Pharmaceuticals, Contract, Epithelial cell adhesion molecule, Probability, IPR, European Medicines Agency, Element, MENA, Income tax, U.S. Securities and Exchange Commission, Research, Chemistry, Nature, Marketing, Patient, FDA, BCG, G&A, Private Securities Litigation Reform Act, Health, European Commission, Income, Union, Program, CRL, Bio, Environment, University, Priority review, Caregiver, MAA, Antigen, European Union, EMA, BLA, US Foods, Workforce, Organic Process Research & Development, Company, PDUFA, Toxicity, Royal commission, CMC, Dietary supplement, Medical device, Pharmaceutical industry, Life insurance, Vaccine, Vicineum™, Sesen Bio, VICINEUM™, SESEN BIO

Sesen Bio (Nasdaq: SESN ), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today reported operating results for the third quarter ended September 30, 2021.

Key Points: 
  • Sesen Bio (Nasdaq: SESN ), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today reported operating results for the third quarter ended September 30, 2021.
  • On October 29, 2021, Sesen Bio participated in a productive CMC Type A Meeting with the FDA (CMC Type A Meeting).
  • On August 20, 2021, Sesen Bio withdrew its marketing authorization application (MAA) to the European Medicines Agency (EMA) for Vysyneum1 for the treatment of BCG-unresponsive NMIBC.
  • Sesen Bio continues to monitor the rapidly evolving environment regarding the potential impact of the COVID-19 pandemic on the Company.

Sesen Bio Announces Productive CMC Type A Meeting with the FDA

Retrieved on: 
Monday, November 1, 2021
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Safety, MAA, US Foods, Pseudomonas exotoxin, Priority review, Hikma Pharmaceuticals, Cancer, PDUFA, European Union, Bio, EMA, Caregiver, U.S. Securities and Exchange Commission, Patient, BLA, Private Securities Litigation Reform Act, FDA, Endpoint security, BCG, Food, Epithelial cell adhesion molecule, Review, Risk, European Commission, Security (finance), CMC, CRL, MENA, Royal commission, Antigen, Company, Marketing, Clinical trial, COVID-19, Environment, EIP, Union, Health, Therapy, Toxicity, Dietary supplement, Pharmaceutical industry, Vaccine, Vicineum™, Sesen Bio, VICINEUM™, SESEN BIO

During the CMC Type A Meeting, the Company and the FDA reviewed issues related to CMC to be further discussed during the review of the BLA for Vicineum upon potential resubmission.

Key Points: 
  • During the CMC Type A Meeting, the Company and the FDA reviewed issues related to CMC to be further discussed during the review of the BLA for Vicineum upon potential resubmission.
  • We are pleased by the collaborative dialogue with the FDA during our CMC Type A Meeting, said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio.
  • As previously disclosed, Sesen Bio is preparing for a separate Type A Meeting to discuss the recommendations specific to additional clinical/statistical data and analyses that the FDA raised in the CRL (Clinical Type A Meeting), which the Company expects to occur later this year.
  • The Company intends to use the information from the CMC Type A Meeting and the Clinical Type A Meeting to synchronize the regulatory reviews of Vicineum for the treatment of BCG-unresponsive NMIBC in the US and the European Union.