Innovative treatment for bladder cancer in China! Zilu Pharma has reached a $35 million agreement with Sesen Bio to bring Vicinium to Greater China!

!--webeditor: "page title" -- 2020 -0220 /PRNewswire/ -- Zilu Pharmaceuticals and Sesen Bio recently reached an exclusive licensing agreement to acquire the exclusive rights of Sesen Bio to develop and commercialize the new drug Vicineum (oportuzumab monatox, VB4-845) in Greater China (Chinese mainland, Hong Kong, Macau and Taiwan).
The Development of Vicineum is used to treat non-muscular immersion bladder cancer (NMIBC) and other types of cancer that do not respond to THE CA-Miao (BCG).
the $35 million deal.
(Details of the cooperation and The Vicineum project, see: July 2020 Business Update Presentation) grants Zilu Pharmaceuticals exclusive license to develop and commercialize Vicineum in Greater China under the terms of the agreement.
Sesen Bio will receive an advance payment of $12 million and be eligible for $23 million in technology transfer and regulatory milestone payments.
The commercialization of Vicineum in Greater China, Sesen Bio is also entitled to royalties based on net sales in Greater China.
Sesen Bio will retain the full development and commercialization of Vicineum's treatment of NMIBC in the United States and in other parts of the world except Greater China.
the terms of the agreement also include the transfer of Vicineum's production technology to Zilu Pharmaceuticals, which has world-class manufacturing expertise that represents an opportunity to expand production in the future to meet the anticipated global demand for Vicineum's treatment of NMIBC.
Vicineum is the next generation antibody drug conjugate (ADC), a localdrug fusion protein, is the tumor cell surface epithelial cell adhesion molecule (EpCAM) antigen target humanized scFv immunotoxin, by recombinant humanized anti-EpCAM antibody scFv and pseudomonasoblastal external toxin A-coupled, once the cell cells are expressed by the adhesion cell will be induced by the cell.
Vicineum consists of a stable chain of genetically engineered peptides to ensure that exotoxin A remains attached until internalized by cancer cells, thereby reducing the risk of toxicity to healthy tissue and improving safety.
preclinical studies have confirmed that EpCAM is over-expression in NMIBC cells and is almost non-expressive in normal bladder cells.
in the United States and the European Union, Vicineum was granted orphan drug qualification in 2005 and fast-track in August 2018 by the FDA for the treatment of NMIBC, which is not effective with BCG immunotherapy.
Vicineum mechanism (click on the image) bladder cancer is a common cancer, about 80% nMIBC, i.e. cancer cells are located in the bladder or have grown into the bladder cavity, but have not yet spread to muscles or other tissues.
NMIBC mainly affects men and is associated with exposure to carcinogens.
patients had a high recurrence rate after initial surgical excision, with more than 60% receiving BCG immunotherapy.
although BCG is effective in many patients, tolerance problems have been observed and many patients experience recurrence of the disease.
if BCG is not effective or if the patient needs long-term acceptance of BCG, the recommended treatment is a complete removal of the bladder.
December 2019, Sesen Bio initiated rolling submissions to the U.S. FDA for A.J. Ivy's Biologics License Application (BLA) through a rolling review process.
the FDA's rolling review mechanism allows drug companies to submit to the FDA the completed portion of their New Drug Application (NDA) or Biologics Licensing Application (BLA) without waiting for each part to be completed before reviewing the entire NDA or BLA.
May 2020, Sesen Bio received positive scientific advice from the European Medicines Agency (EMA) Committee on Human Pharmaceutical Products (CHMP) on the european regulatory approach to Vicineum. the efficacy of the
Vicinium Treatment Card-Mediate (BCG) non-answern NMIBC has been confirmed in phase III VISTA study (NCT02449239).
August 2019, Sesen Bio published data on the main and secondary endpoints of the study.
updated 12-month data further support the strong benefit risk of Vicinium's treatment of high-risk BCG-unresponsive NMIBC patients, which is the basis for the company's REPORTing of THE BLA to the U.S. FDA.
bladder cancer - (picture source-medscape.com) VISTA is a one-arm, 24-month, open-label, multicenter PHASE III study that is evaluating vicinium as a monodrug treatment for high-risk, BCG immunotherapy-responsive NMIBC patients.
study edited 133 patients with high-level NMIBC in situ cancer (CIS) or papilloma cancer (cIS or CIS) who had been treated with BCG.
study, patients entered 3 queues based on histology and adequate BCG treatment (at least 2 courses of BCG, at least 5 doses in the first course of treatment, at least 2 doses of second course of treatment) (queue 1: BCG treatment is difficult to treat or relapse CIS within 6 months;
study, patients received local administration of vicinium twice a week for 6 weeks, followed by 6 weeks of treatment once a week, followed by treatment every other week for 2 years.
until the end of 29 May 2019, primary and secondary endpoint data are updated as follows: (1) full mitigation rates: Queue1 and Queue 2 are 39% in 3 months, 6 months, 9 months, 12 months, 2 6%, 20%, 17% and 57%, 57%, 43%, 14%, Queue 1 and Queue 2 Summary shows 40%, 28%, 21%, 17% for 3 months, 6 months, 9 months, 12 months.
(2) duration of remission: the median time of queue 1 was 273 days, and the summary analysis of all CIS patients in queue 1 and 2 showed that 52% of patients who achieved full remission at the 3-month time point had a full duration of 12 months after initiation of treatment.
(3) disease recurrence time: high-risk papilloma NMIBC is associated with high progression and recurrence rate, so the recurrence time of the disease is a key secondary endpoint in patients with high-risk papilloma NMIBC, and the median disease recurrence time in patients with 3 patients in the queue is 402 days.
(4) bladder removal time: FDA guidelines state that BCG non-answerNMIBC treatment goal is to avoid bladder removal, so bladder removal time is a key secondary endpoint, the results show that using Kaplan-Meier method analysis, estimated that 75% of patients remained bladder-free for 2.5 years, 88% of respondents remained without a bladder for 3 years.
(5) No Progress Survival: Using Kaplan-Meier method analysis, 90% of patients had a progression-free survival period of 2 years.
(6) Incident-free survival: Using the Kaplan-Meier method, 29% of patients remained event-free at 12 months.
(7) Total Lifetime: Using Kaplan-Meier method analysis, 96% of patients had a total lifetime of 2 years.
(8) Safety: vicinium continues to exhibit good tolerance, with 95% of adverse events being level 1 or 2.
the most common therapeutic adverse events are difficulty urinating (14%), hematuria (13%) and urinary tract infections (12%), all of which are consistent with the characteristics of bladder cancer patients and the treatment with catheters, and are controllable and reversible.
(!--/ewebeditor:!--: !--webeditor: page title" - sizzle: Zilu Pharmaceuticals, Sesen Bio !--/ewebeditor.