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Major Upcoming Catalyst Makes Sesen Bio A Stock to Watch Out For!

12 Feb Major Upcoming Catalyst Makes Sesen Bio A Stock to Watch Out For!

Sesen Bio, Inc. (NASDAQ: SESN) is focused on creating targeted fusion protein therapeutics (TFPTs) for treatment of cancers. The Company is looking at a major catalyst in 2021, the approval of Vicineum, a potential best-in-class therapeutic for the treatment of non-muscle invasive bladder cancer (NMIBC) in the U.S. Sesen intends to submit the MAA for Vicineum to the EMA in early 2021, and anticipates an EU approval in 2022.

The Company has submitted a completed Biologics License Application (BLA) to the FDA, supported by data from Phase 3 VISTA trial and positive chemistry, manufacturing and controls (CMC) data. The Company has requested for a priority review and is expecting a potential approval in mid-2021. Sesen is estimating peak revenue of $1B-$3B globally and $400M-$900M in the U.S.

Sesen Bio, Inc. (NASDAQ: SESN)

Market Cap: $366.03M; Current Share Price: 2.80 USDChart
Data by YCharts

Bladder cancer, the 6th most common form of cancer, occurs when the cells lining the walls of the uterus grow controllably, forming a tumor. A hollow organ located in the lower pelvis, the bladder stores urine and release it through a tube called uretha. The most common form of bladder cancer is Urothelial carcinoma, also known as transitional cell carcinoma (TCC). The disease is further is categorized into squamous cell carcinomas, adenocarcinomas, small cell carcinoma and sarcoma.

Based on the extent to which it has spread, bladder cancer is further segmented into Non-invasive cancers that are only in the inner layers of cells and invasive cancers that spread to the inner layers and other parts of the body. Non-muscle invasive cancers include both non-invasive and invasive tumors that have not permeated into the main muscle layer of the bladder according to cancer.org. Smoking, workplace exposure, arsenic exposure, chemotherapy or radiation ,race and ethnicity and age are some of the risk factors. The average of diagnosis is 73 years with 90 percent of cases being diagnosed in people older than 55 years of age. Furthermore, more than 83,730 adults (64,280 men and 19,450 women) will be diagnosed with bladder cancer and nearly 17,200 (12,260 men and 4,940 women) will succumb to the disease in the U.S in 2021.

Treatment is usually dependent on the stage of the cancer and is usually a combination of different therapies such as such as surgery, intravesical therapy, chemotherapy, radiation and immunotherapy. According to a report by GlobalData, the bladder cancer therapeutics market is expected to reach approximately $1.17 billion by 2025, growing at a CAGR of 12.5%, from $360 million in 2015.  Increasing research and development, rising awareness and development of innovative therapies will drive the growth in the market.

Positive Application Orientation Meeting
In January 2021, the Company participated in a productive Application Orientation Meeting with the FDA and will learn of its BLA acceptance by February 16, 2021. Once the BLA is accepted the Company will also receive a decision about Target PDUFA date for approval, Necessity of an FDA Advisory Committee meeting and Priority vs. Standard review.

Dr. Thomas Cannell, president and chief executive officer of Sesen Bio, commented,

“We continue to believe Vicineum has a favorable risk-benefit profile which positions it to be best-in-class, and we are encouraged by the high level of time and engagement the FDA has demonstrated toward our review. We look forward to continuing to work with the FDA to expeditiously bring Vicineum to the market.” 

Hitting the Ground Running
In July 2020, the Company entered into an exclusive licensing agreement with Qilu for Vicineum in China, Hong Kong, Macau and Taiwan. Sesen received $12 million as an upfront payment and is eligible to receive an additional $23 million in technology transfer and regulatory milestone payments. In addition, the Company will also receive royalties on net sales in Greater china. The agreement also involves transfer of Vicineum manufacturing technology to Qilu Pharmaceutical, in anticipation of global demand for Vicineum for the treatment of NMIBC. The Companies have also signed agreement to bring Qilu as additional CMO.

In December 2020, the Company entered into an exclusive licensing agreement with Hikma Pharmaceuticals (HIK.L), for registration and commercialization of Vicineum in all 19 Middle East and North Africa (MENA) markets. The terms of the agreement are confidential but include an upfront payment to Sesen Bio, sales related milestone payments, and royalties on net sales in the region

In October 2020, Sesen entered into an agreement with Cardinal Health (NYSE: CAH) for end-to-end 3PL, order-to-cash management and specialty pharmaceutical distribution services for commercialization of Vicinuim in the U.S.

Sesen is a late-stage company adopting a novel fusion protein approach to activate the body’s natural immune response system. The Company’s lead candidate is Vicineum, a targeted fusion protein composed of an anti-EPCAM antibody fragment tethered to a truncated form of Pseudomonas Exotoxin A, which is capable of targeting cancer cells, with minimal peripheral toxicity. The candidate successful completed a phase 3 VISTA Trial for treatment of non-muscle invasive bladder cancer (NMIBC) in patients who already underwent treatment with bacillus Calmette-Guérin (BCG), the current standard of care.

Image Source: Company

In May 2019, the Company released updated, preliminary primary and additional secondary endpoint data which demonstrated Vicineums’s clinically meaningful efficacy and favorable safety and tolerability. In December 2019, Sesen submitted a BLA submission for Vicineum to the FDA under rolling review.

Image Source: Company

Furthermore, Company is evaluating the candidate for the treatment of additional cancers such as squamous cell carcinoma of the head and neck (SCCHN). Results from a phase 1 trial of an injectable form of Vicineum show anti-tumor activity and safety. In addition, patients demonstrated responses in non-injected tumors as well, implying vicineum’s ability to promote anti-tumor response and compatibility with other immunotherapies.

In phase 2 trials in the U.S, Vicineum has demonstrated a reduction in the bidirectional size of the targeted tumor in 71 percent (10/14) of patients evaluated in the study. The Company is keen on exploring Vicineum in combination with checkpoint inhibitors. The National Cancer Institute is conducting a phase 1 study to understand the safety and tolerability of Vicineum in combination with AstraZeneca’s anti-PD-L1, Imfinzi (durvalumab). The Company will take up additional combinations and trails based on the results from the trial.

Sesen is also developing deBouganin (VB6-845d), a highly potent plant toxin that can be de-immunized for systemic delivery.

Key Takeaways

  • Vicineum has a unique dual Mechanism of Action (MOA) that is a highly differentiated offering from existing treatment options. Its small size enables tumor penetration and far improved drug delivery. In January 2021, the Company released an independent analysis by ICER, a health technology assessment body that found Vicineum superior to the best supportive care, and showed Complete Response and Recurrence-Free Survival rates better than expected. In addition, the treatment also resulted in a decrease in cumulative health care costs of $101,000 by year five as compared to standard care options.
  • Sesen is looking at filling the gap in the NMIBC therapeutics space that is plagued by manufacturing issues such as shortages, impurities in formulation supply constraints of specific strains, and CMC / Manufacturing issues plaguing major players in the market such as Merck (NYSE: MRK), Sanofi (NASDAQ: SNY), FerGene to name a few. The Company has partnered with world-class contract manufacturers Fujifilm (FUJIY) and Baxter (NYSE: BAX) for a highly reliable and inexpensive manufacturing process.
  • The Company intends to target a highly concentrated US market of more than 1500 urologists who treat nearly 75 percent of the BCG patients through a sales team of 40-50 representatives in the U.S In addition, it plans to create an efficient digital and social media strategy through use of paid search, videos, website, Facebook, Twitter etc to create awareness and reach patients and caregivers.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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