Vicineum™

Sesen Bio Reports Fourth Quarter and Full-Year 2021 Financial Results and Anticipated Regulatory Path Forward for the Company’s Lead Product Candidate, Vicineum™

Retrieved on: 
月曜日, 2月 28, 2022
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Vicineum™, Sesen Bio, VICINEUM™, SESEN BIO

On October 29, 2021, Sesen Bio participated in a productive Chemistry, Manufacturing and Controls (CMC) Type A Meeting with the FDA.

Key Points: 
  • On October 29, 2021, Sesen Bio participated in a productive Chemistry, Manufacturing and Controls (CMC) Type A Meeting with the FDA.
  • On December 8, 2021, Sesen Bio participated in a productive Clinical Type A Meeting with the FDA.
  • The trial may include both patients who have received adequate BCG and patients who have received less than adequate BCG.
  • The Company intends to work cooperatively with the FDA in preparing for an additional Phase 3 clinical trial for Vicineum.

Sesen Bio Further Enhances Team with Key Hires

Retrieved on: 
月曜日, 1月 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: 
木曜日, 12月 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: 
月曜日, 11月 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: 
火曜日, 11月 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: 
月曜日, 11月 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: 
月曜日, 11月 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.

Sesen Bio Expands CMC and Clinical Teams

Retrieved on: 
火曜日, 10月 12, 2021
Biotechnology, Pharmaceutical, Health, Oncology, Hikma Pharmaceuticals, Company, Pseudomonas exotoxin, MAA, Risk, US Foods, Priority review, Caregiver, BLA, CRL, Endpoint security, COVID-19, Food, Epithelial cell adhesion molecule, Marketing, Cancer, Safety, Nasdaq, PDUFA, European Medicines Agency, FDA, CMC, Health, Cyprus Securities and Exchange Commission, Toxicity, BCG, EMA, Bio, Institute of Analytical Sciences, Private Securities Litigation Reform Act, Security (finance), Antigen, Environment, EIP, Therapy, Patient, Employment, MENA, 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 expansion of its chemistry, manufacturing, and control (CMC) and clinical development teams with the hiring of Eun Jang as Senior Director, Analytical Sciences, and Chrie Kaefring as Director, Clinical Operations.

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 expansion of its chemistry, manufacturing, and control (CMC) and clinical development teams with the hiring of Eun Jang as Senior Director, Analytical Sciences, and Chrie Kaefring as Director, Clinical Operations.
  • I am delighted to welcome Eun and Chrie to Sesen Bio to further strengthen our capabilities across our CMC and clinical teams, said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio.
  • These hirings come as Sesen Bio is preparing for CMC and clinical Type A meetings with the US Food and Drug Administration (FDA) for Vicineum.
  • Sesen Bio, Inc. is a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of patients with cancer.

Sesen Bio Receives Complete Response Letter from FDA for Vicineum™ (oportuzumab monatox-qqrs)

Retrieved on: 
金曜日, 8月 13, 2021
Science, Other Science, Biotechnology, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, CRL, Regulation of tobacco by the U.S. Food and Drug Administration, U.S. Securities and Exchange Commission, BCG, PDUFA, Bio, CMC, Caregiver, Environment, EIP, Pseudomonas exotoxin, BLA, Company, Food, Private Securities Litigation Reform Act, Epithelial cell adhesion molecule, Antigen, COVID-19, Risk, FDA, Toxicity, Marketing, Security (finance), Hikma Pharmaceuticals, Health, Patient, Priority review, Cancer, MENA, ID, Safety, Therapy, Endpoint security, Investor relations, Medical device, Vaccine, Pharmaceutical industry, Vicineum™, Sesen Bio, VICINEUM™, SESEN BIO

Members of the Sesen Bio management team will host a conference call Monday, August 16, 2021, at 8:00 AM ET.

Key Points: 
  • Members of the Sesen Bio management team will host a conference call Monday, August 16, 2021, at 8:00 AM ET.
  • On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum.
  • 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.
  • On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum.

Sesen Bio Strengthens Executive Leadership Team as the Company Approaches the Potential Approval and Commercial Launch of Vicineum™

Retrieved on: 
水曜日, 8月 11, 2021
Research, Infectious Diseases, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Other Science, BLA, Industry, Therapy, US Foods, Health, Safety, Caregiver, Company, Bio, Patient, Emory University School of Law, Head, Toxicity, Food, Risk, Consultant, U.S. Securities and Exchange Commission, Ernst, Compliance, Epithelial cell adhesion molecule, Security (finance), Priority review, MENA, Cancer, Pseudomonas exotoxin, Private Securities Litigation Reform Act, COVID-19, Hikma Pharmaceuticals, Environment, Employment, Georgia, Villanova University, Antigen, Orexigen Therapeutics, Nasdaq, FDA, EIP, Marketing, Law, PDUFA, Culture, LLP, BCG, Management, Lease, Vaccine, Pharmaceutical industry, Vicineum™, Sesen Bio, VICINEUM™, SESEN BIO

Mr. Knighton joins Sesen Bio from TherapeuticsMD, where he served as Chief Compliance Officer and supported the launch of three products between 2018 and 2020.

Key Points: 
  • Mr. Knighton joins Sesen Bio from TherapeuticsMD, where he served as Chief Compliance Officer and supported the launch of three products between 2018 and 2020.
  • In connection with the hiring of Mr. Knighton, Sesen Bio intends to grant a non-statutory stock option.
  • 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.