3 August 2020 - - US-based late-stage clinical company Sesen Bio (NASDAQ: SESN) and China-based pharmaceutical company Qilu Pharmaceutical have entered into an exclusive licensing agreement for the manufacture, development and commercialisation of Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer and other types of cancer in China, Hong Kong, Macau and Taiwan, the companies said.

Under the terms of the agreement, Sesen granted Qilu Pharmaceutical an exclusive license to develop and commercialise Vicineum in Greater China. 

Sesen will receive an upfront payment of USD 12m and is eligible to receive up to an additional USD 23m in technology transfer and regulatory milestone payments.

Upon commercialisation 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.

Torreya acted as a financial advisor and Hogan Lovells acted as a legal advisor to Sesen for this transaction.

Vicineum, a locally administered fusion protein, is Sesen Bio's lead product candidate currently in the follow-up stage of a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive NMIBC.

In December 2019, the company initiated the BLA submission for Vicineum to the FDA under Rolling Review.

Vicineum 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.

Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized 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 Vicineum 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 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.

The activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca's immune checkpoint inhibitor durvalumab.

The VISTA trial is an open-label, multicenter, single-arm Phase 3 clinical trial evaluating the efficacy and tolerability of Vicineum as a monotherapy in patients with high-risk, bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer (NMIBC).

The primary endpoints of the trial are the complete response rate and the duration of response in patients with carcinoma in situ with or without papillary disease.

Patients in the trial received locally administered Vicineum twice a week for six weeks, followed by once-weekly treatment for another six weeks, then treatment every other week for up to two years.

Sesen Bio, Inc. is a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of patients with cancer.

The company's lead programme, Vicineum, also known as VB4-845, is currently in 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 Vicineum to the FDA under Rolling Review.

Vicineum 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.

Qilu Pharmaceutical is one of the leading vertically integrated pharmaceutical companies in China focusing on the development, manufacturing and marketing of active pharmaceutical ingredients and finished formulations.

Qilu currently has 12 subsidiaries, 10 manufacturing sites and over 23,000 employees worldwide. Qilu ranks No.8 in Chinese pharmaceutical industry by sales revenue in 2019.

Dedicated to offering more affordable medicines to the world and improving people's well-being, Qilu has exported its products to over 70 countries.

Qilu has always maintained an innovative development strategy guided by the market demand and is achieving its organic growth strategy utilizing a strong pool of 2000+ scientists spread across 5 R and D platforms based in the US (Seattle WA, Boston MA, San Francisco CA) and China (Shanghai, Jinan).

To date, Qilu has launched 200+ products with 30+ products "First to launch" in China and 3 products "D181 launch" in US. The company also has a robust pipeline, including 200+ generic products, 20+ biosimilar products and 50+ innovative products.

Qilu's finished formulations and APIs have been approved by US FDA, European Medicines Agency, Therapeutic Goods Administration of Australia, Medicines and Healthcare products Regulatory Agency of UK, PMDA of Japan and other national regulatory authorities.