UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15 (d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 24, 2020
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Item 8.01 – Other Events.
On September 24, 2020, Sesen Bio, Inc. (the “Company”) successfully completed the final of three commercial-scale Drug Product process performance qualification (“PPQ”) manufacturing runs for Vicineum™, the Company's lead product candidate, with its contract manufacturing organization partner, Baxter Oncology GmbH.
As previously disclosed, the Company has also partnered with FUJIFILM Diosynth Biotechnologies U.S.A., Inc. (“Fujifilm”) for the manufacturing process and technology transfer of Vicineum, and the Company successfully completed its commercial-scale Drug Substance PPQ manufacturing runs for Vicineum with Fujifilm in July 2020.
All of the Drug Substance PPQ batches and the first of three Drug Product PPQ batches met all quality acceptance criteria. The Company believes these results are a strong indicator for meeting the quality testing acceptance criteria for the second and third Drug Product PPQ batches. Testing of these batches is currently underway and is expected to be completed in November 2020.
The results of the quality testing of the PPQ campaigns for Drug Substance and Drug Product are a key component for the last module of the Company’s Biologics License Application (“BLA”) submission for Vicineum to the United States Food and Drug Administration, which the Company expects to complete in the fourth quarter of 2020.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS:
This Current Report on Form 8-K contains forward-looking statements, including, but not limited to, statements related to expectations regarding the timing of completion of the Company’s BLA submission for Vicineum and expectations regarding the timing for, and results of, the testing of the remaining Drug Product PPQ batches. These forward-looking statements are based on the Company’s current expectations and inherently involve significant risks and uncertainties. The Company’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. A further description of the risks and uncertainties relating to the business of the Company is contained in the Company’s most recent annual report on Form 10-K and the Company’s quarterly reports on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the SEC. The Company undertakes no duty or obligation to update any forward-looking statements contained in this report as a result of new information, future events or changes in its expectations.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: September 28, 2020
| Sesen Bio, Inc. | ||||||||
| By: | /s/ Thomas R. Cannell, D.V.M. | |||||||
| Thomas R. Cannell, D.V.M. | ||||||||
| President and Chief Executive Officer | ||||||||