June 3, 2016
By Alex Keown, BioSpace.com Breaking News Staff
CHICAGO – A presentation at the annual meeting of the American Society of Clinical Oncology by Immunomedics has been rejected after it was discovered the company was trying to use old and previously presented data for its triple negative breast cancer drug IMMU-132, thestreet reported this morning.
Presenting old data as new is against the rules of ASCO, thestreet’s Adam Feuerstein reported. The presentation, which can currently be found on Immunomedics’ website, was previously presented at a network meeting in April. That information was also discussed on a conference call with investors, Feuerstein said. ASCO accepted the abstract on the premise it contained new or updated information. Aditya Bardia of Harvard Medical School, the lead investigator of IMMU-132, told thestreet that she was unaware of the previous presentation of the data.
However, Cynthia L. Sullivan, president and chief executive officer of Immunomedics, said she was trying to reverse ASCO’s position. In a statement on the company’s website, Sullivan said they believe the information in the presentation they were supposed to make today is different than what was presented earlier.
“Both we and our many investigators involved are disappointed that our excellent therapeutic results, achieving an interim median survival of about 14 months, may not be presented at this meeting. These results are very encouraging for TNBC patients with metastatic disease who failed multiple prior therapies,” Sullivan said.
New Jersey-based Immunomedics’ IMMU-132, its lead investigational antibody-drug conjugate, sacituzumab govitecan, earned a Breakthrough Therapy designation by the U.S. Food and Drug Administration in February. IMMU-132 is aimed at providing treatment for patients with triple-negative breast cancer (TNBC) who have failed at least two prior therapies for metastatic disease. According to company information, IMMU-132 is a first-in-class ADC “developed by conjugating the moderately-toxic drug, SN-38, site-specifically and at a high ratio of drug to antibody, to a humanized antibody that targets the Trop-2 receptor expressed by many solid cancers.” After positive Phase II data was reported, Immunomedics said it plans to pursue accelerated approval for sacituzumab govitecan as a treatment for patients with TNBC from the FDA. Triple negative breast cancer is diagnosed in about 40,000 patients annually in the United States. NBC does not express estrogen, progesterone or the HER2 receptor, which makes it resistant to most of the available targeted therapies for breast cancer treatment, including Genentech’s trastuzumab or the estrogen modulator, tamoxifen.
Shares of Immunomedics are down more than 19 percent this morning following Feuerstein’s report. The stock is currently trading at $4.29 per share. Since the Breakthrough Therapy designation, shares of Immunomedics have steadily risen from $2.42 per share to $5.30 per share as of June 2.
