Immunomedics President and CEO Cynthia L. Sullivan, and CSO and chief patent officer David M. Goldenberg, have resigned from their leadership positions as part of a settlement of a legal dispute with activist investor group venBio over an up-to-$2 billion-plus collaboration with Seattle Genetics launched in February.
Sullivan will also step down as director, while Goldenberg will remain on Immunomedics’ board. Michael R. Garone, the current chief financial officer of Immunomedics, will succeed Sullivan as an interim CEO.
Both companies today separately announced the termination of the collaboration, through which Seattle Genetics gained exclusive global rights to Immunomedics’ cancer antibody–drug conjugate (ADC) sacituzumab govitecan, also known as IMMU-132. Opposition surfaced from venBio, which sought to block the deal, contending the deal did not deliver enough benefit for Immunomedics. In March, four seats on Immunomedics’ board went to venBio-supported candidates.
As part of the settlement, Immunomedics dropped its opposition to the seating of the venBio candidates, and agreed to reimburse venBio for “reasonable fees and expenses” incurred in connection with the proxy contest and other legal wrangles between the investor group and the company.
The new board also restated its commitment to bringing IMMU-132 to market following a review, but has delayed the filing of a BLA in metastatic triple-negative breast cancer (mTNBC) to between late fourth quarter 2017 and first quarter 2018, subject to FDA input. Immunomedics said the board review confirmed that the data generated in the ongoing 100-patient phase II study of IMMU-132 in 3rd line TNBC, “can provide the basis for accelerated approval, subject to review by the FDA.”
To carry out an accelerated approval filing, Immunomedics said, it has completed a $125 million private placement of Series A-1 Convertible Preferred Stock to institutional investors.
IMMU-132 has received Breakthrough Therapy Designation in mTNBC from the FDA.
Immunomedics added that it will proceed with the final selection of a CRO to launch a confirmatory phase III study, for which the first patient is epxetced to be enrolled late in the third quarter, and will execute a manufacturing plan to build commercial inventory in preparation for a potential launch in the U.S. in 2018.
“The Immunomedics transaction would have effectively utilized our substantial expertise in antibody-drug conjugate (ADC) development to advance IMMU-132 for patients in need,” Seattle Genetics President and CEO Clay Siegall, Ph.D., said in a statement. “However, due to significant delays and lack of progress towards closing the deal, we are turning our full attention and resources to our promising pipeline and the substantial opportunities in front of us.”
Those opportunities, he added, include the readout of upcoming topline data from the Phase III ADCETRIS ECHELON-1 trial, assessing the company’s lead product Adcetris ® (brentuximab vedotin), being co-developed with Takeda Pharmaceutical, in frontline classical Hodgkin lymphoma—as well as ongoing or planned pivotal trials of vadastuximab talirine (SGN-CD33A) and enfortumab vedotin (ASG-22ME).
As part of the termination, Seattle Genetics said, it will continue to hold 3 million shares of Immunomedics common stock, as well as a warrant to purchase an additional 8.7 million shares at $4.90 per share exercisable until December 31, 2017.
