Sesen Bio to host business news update conference call » 07:5507/3107/31/20
Management holds July…
Sesen Bio announces exclusive license agreement with Qilu Pharmaceutical » 07:3207/3107/31/20
Sesen Bio and Qilu…
Sesen Bio and Qilu Pharmaceutical said in a release, "the companies have entered into an exclusive licensing agreement for the manufacture, development and commercialization of Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer, or NMIBC, and other types of cancer in China, Hong Kong, Macau and Taiwan. Under the terms of the agreement, Sesen granted Qilu Pharmaceutical an exclusive license to develop and commercialize Vicineum in Greater China. Sesen will receive an upfront payment of $12 million and is eligible to receive up to an additional $23 million in technology transfer and regulatory milestone payments. Upon commercialization in Greater China, Sesen is also entitled to receive royalties on net sales in Greater China. Sesen retains full development and commercialization rights for Vicineum for the treatment of NMIBC in the US and the rest of the world excluding Greater China. The terms of the agreement also include the transfer of the Vicineum manufacturing technology to Qilu Pharmaceutical, whose world-class manufacturing expertise represents a future opportunity for production expansion to meet the anticipated significant global demand for Vicineum for the treatment of NMIBC."
Sesen Bio to host business news update conference call » 04:5507/3107/31/20
Management holds July…
Sesen Bio to host business news update conference call » 16:0907/3007/30/20
Management holds July…
|Over a month ago|
Sesen Bio reports Q1 EPS 31c, consensus (9c) » 07:0905/1105/11/20
"In the first…
"In the first quarter of 2020, we successfully completed manufacturing of the pre-PPQ batch at Fujifilm," said Dr. Thomas Cannell, president and CEO of Sesen Bio. "We believe the commercial-scale cGMP batches of Vicinium manufactured to date at our CMOs are comparable to Vicinium previously manufactured by Sesen for use in our clinical trials. This reinforces our confidence in the upcoming PPQ campaign and our ability to demonstrate analytical comparability between clinical and commercial drug supply. The company's focus for 2020 remains the flawless execution of the PPQ campaign and the finalization of Module 3 to complete the Vicinium BLA submission."
Sesen Bio reports 'positive' interactions with EMA over vicinium » 16:4305/0705/07/20
Sesen Bio reported that…
Sesen Bio reported that the Company has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the regulatory pathway for Vicinium in Europe. The Company's lead program, Vicinium, also known as VB4-845, is currently in the follow-up stage of a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In December 2019, the Company initiated the BLA submission for Vicinium to the United States Food and Drug Administration (FDA) under Rolling Review. "We are very pleased to have received positive guidance from the CHMP on the regulatory approval pathway for Vicinium," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We strongly believe that Vicinium is a highly differentiated product candidate that is well positioned to address the considerable unmet need in NMIBC. This encouraging progress reinforces our confidence in bringing Vicinium to market in Europe, which represents a tremendous opportunity for the company. We will continue working collaboratively with the EMA to move Vicinium through the approval process as expeditiously as possible."
|Over a quarter ago|
Fly Intel: Pre-market Movers » 09:2203/1603/16/20
NNVC, MRNA, NBEV, FCEL, SESN, MNK, AMC
Check out this morning's…
Sesen Bio reports Q4 EPS (32c), consensus (8c) » 07:0303/1603/16/20
"2019 was a year of…
"2019 was a year of tremendous progress for Sesen Bio in every way, but especially in terms of our regulatory progress," said Dr. Thomas Cannell, president and CEO of Sesen Bio. "After four pivotal meetings with the FDA and the initiation of our BLA submission in 2019, we now turn our focus to finalizing the BLA for Vicinium and transforming into a commercial-ready organization in 2020. We believe Vicinium is a highly differentiated product candidate with a unique mechanism of action and clinical profile. We look forward to continuing our collaborative relationship with the FDA as we work to bring this important product to patients."
Xoma announces updates regarding partnered assets in development » 07:4603/1003/10/20
XOMA, NVS, SESN, TAK
"Last year two of…
"Last year two of our partners, Novartis and Sesen Bio, announced significant clinical developments that have the potential to offer patients with few treatment options the opportunity to access new therapies that have clinically meaningful benefits," CEO Jim Neal said. Novartis (NVS) licensed assets: Novartis presented first-of-its-kind histology data with iscalimab at the American Transplant Congress. The data showed 60 percent of iscalimab-treated transplant patients have normal kidney histology at least one year after transplant, compared with 0 percent with tacrolimus. The company highlighted iscalimab and its development plans at the Novartis R&D Day on December 5, 2019. Novartis now has seven clinical studies with iscalimab underway. Novartis launched its clinical program for gevokizumab with a clinical study in patients with metastatic colorectal cancer, gastroesophageal cancer, and renal cell carcinoma. Sesen Bio (SESN) reported positive top-line Phase 3 data and subsequently initiated its rolling Biologics License Application filing for Vicinium for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. The company has stated it anticipates completing its filing in the second half of 2020. Takeda (TAK) licensed assets: Takeda expanded the TAK-0794 clinical program and now has four studies ongoing. Takeda and Molecular Templates began enrolling patients in their first TAK-1694 clinical program. Aronora initiated a Phase 2 study with AB002 in patients with end-stage renal disease on chronic hemodialysis. AVEO Oncology expanded the clinical program testing ficlatuzumab and now is studying the compound's potential efficacy in a wide variety of oncology indications. Neal concluded, "The clinical advancements continued into 2020. In February, Rezolute, Inc., announced the launch of its Phase 2b clinical trial for RZ358 in patients with congenital hyperinsulinism. Given the insight we gained into this terrible condition during our early development of this compound and the extraordinary families we met, we are truly hopeful Rezolute succeeds in its development efforts for RZ358."
Sesen Bio to hold a conference call » 07:2512/1612/16/19
President & CEO…
President & CEO Cannell holds a conference call to provide a regulatory update for Vicinium on December 16 at 8 am. Webcast Link