Policy & Regulation
Sesen Bio Reports Successful Pre-BLA Meeting with FDA for Vicinium
12 June 2019 - - US-based late-stage clinical company Sesen Bio (NASDAQ: SESN) has completed a successful Type B Pre-Biologics License Application meeting regarding the approval path for Vicinium for the treatment of patients with high-risk, Bacillus Calmette-Guérin (BCG) unresponsive, non-muscle invasive bladder cancer (NMIBC), the company said.
The company has reached alignment with the US Food and Drug Administration on an Accelerated Approval Pathway for Vicinium along with Rolling Review, and the company expects to initiate submission of the BLA in 4Q19.
The FDA also indicated that the nonclinical data, the clinical pharmacology data, and the safety database are sufficient to support a BLA submission, and that no additional clinical trials are necessary for a BLA submission.
Rolling Review of the BLA enables individual modules to be submitted and reviewed on an ongoing basis, rather than waiting for all sections to be completed before submission.
The final module submission for the BLA will be CMC, and Sesen Bio plans to meet with the FDA in the second half of 2019 to discuss the content and timing of that module.
On May 21, 2019 Sesen Bio announced a positive outcome from its previous meeting with the FDA, a Type C CMC meeting, where Sesen Bio reached agreement with the FDA on the Analytical Comparability Plan, and confirmed, subject to final comparability data to be provided in the BLA submission, that no additional clinical trials were deemed necessary for comparability.
Sesen Bio plans to schedule two additional meetings with the FDA in the second half of 2019, a Type C meeting to discuss the details of a post-marketing confirmatory trial in support of the Accelerated Approval Pathway for Vicinium, and a Type B CMC meeting to discuss the submission strategy of the CMC module.
Vicinium, a locally-administered fusion protein, is Sesen Bio's lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC).
It is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicinium is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalised by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety.
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 conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of Bacillus Calmette-Guérin and whose disease is now BCG-unresponsive.
Additionally, Sesen Bio believes that Vicinium's cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors.
The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca's immune checkpoint inhibitor durvalumab.
Sesen Bio is a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of patients with cancer.
The company's lead programme, Vicinium, also known as VB4-845, is currently in a Phase 3 registration trial, the VISTA trial, for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
Vicinium is a locally-administered targeted fusion protein composed of an anti-EPCAM antibody fragment tethered to a truncated form of Pseudomonas Exotoxin A for the treatment of high-risk NMIBC.