Immunomedics Highlights Clinical Pipeline for Solid Cancer and Lupus Therapy

Morris Plains-based Immunomedics, Inc., a biopharmaceutical company focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, announces a historical milestone in the company’s listing at the NASDAQ stock market, which is going on 30 years strong. Only a small, elite group of biopharmaceutical companies has this longevity.

After ringing the opening bell at NASDAQ, the company held its Research and Development Day for analysts and institutional investors, highlighting the 3 major pillars that are the value drivers for the company: epratuzumab, (anti-CD22 humanized antibody), from which top-line data from the two Phase III registration trials in patients with moderate to severe lupus is expected first quarter 2015 by partner UCB; yttrium-90 (90Y)-labeled clivatuzumab tetraxetan that is being evaluated in a Phase III trial to treat patients with advanced pancreatic cancer; and the two antibody-drug conjugates (ADCs) for solid tumor therapy, IMMU-132 and IMMU-130, which are progressing in Phase II trials.

“In addition,” Company President and Chief Executive Officer, Cynthia L. Sullivan, emphasized, “we are advancing other product candidates in earlier-stage clinical trials as well as other novel technologies in preclinical studies.”

Dr. David M. Goldenberg, Chairman and Chief Scientific Officer, introduced the science underlying the agents in clinical trials, beginning with new information on the mechanism of action of epratuzumab, followed by the Company’s proprietary linker for conjugating SN-38 to the two ADCs. Before introducing the clinical investigators who summarized their experiences with the Company’s most advanced therapeutics, Dr. Goldenberg also described the scientific efforts to develop a novel and potent T-cell immunotherapy for solid cancers.

Dr. Michael J. Guarino, medical oncologist at the Christiana Care Health System, Helen F. Graham Cancer Center, in Newark, DE, summarized the current status of the clinical trials with IMMU-130, the Company’s ADC targeting CEACAM5 for colorectal cancers therapy, including two cases where IMMU-130 was able to shrink the patients’ colonic cancer metastases 52% and 66%, respectively. “The second patient is being treated at our center for almost 9 months, receiving doses twice weekly during this time, without evidence of major side effects or any immune reaction to the ADC; the patients had 4 prior therapies before entering this trial,” Dr. Guarino explained.

An update of 42 patients who had computed tomography (CT) scans following their therapy with IMMU-132 was presented by Dr. Alexander N.

Starodub, medical oncologist and Director of Clinical Research at Indiana University Health Goshen Center for Cancer Care, in Goshen, IN.

“The most exciting observation so far,” Dr. Starodub stated, “is that a high percentage of patients with advanced disease are showing high rates of disease control, with the most impressive results in triple-negative breast cancer and small-cell lung cancer patients.

These cancers are very difficult to treat, especially after failing other therapies, so it is unusual to see 2 of 7 patients with triple-negative breast cancer and 2 of 4 patients with small-cell lung cancer showing partial responses by computed tomography, or RECIST criteria.” “A 67% response rate, with one partial response and 9 with stable disease, also was achieved in advanced colorectal cancer patients,” he added. Dr. Starodub further emphasized that “a time-to-progression plot of responders shows that many are of long duration, even up to almost a year in some cases, which is most encouraging in this population of patients with advanced solid cancers that have relapsed after multiple prior therapies.”

Results of 13 pancreatic cancer patients with CT-assessments were not included in Dr. Starodub’s update but will be presented at the American Association for Cancer Research (AACR) Special Conference on Pancreatic Cancer: Innovations in Research and Treatment on Tuesday, May 20, 2014.

Additional Phase II data from the IMMU-132 trial will be provided at the 2014 Annual Meeting of American Society of Clinical Oncology (ASCO) on Monday, June 2, 2014, in a Poster Highlights Session.

The final investigator presentation was made by Dr. Allyson J. Ocean, medical oncologist and Associate Professor of Medicine at Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY. Dr.

Ocean presented the results of the Phase Ib study of fractionated 90Y-clivatuzumab tetraxetan in patients with metastatic pancreatic cancer after receiving at least 2 prior therapies. Dr. Ocean remarked that “it was a surprise to all of the investigators that this study in patients having had 2 or more prior treatments could be completed in 8 months and with so much enthusiasm.” “The trial showed that patients given clivatuzumab tetraxetan combined with low-dose gemcitabine as a radiosensitizer had better survival outcome than the control group only given the radiolabeled antibody without gemcitabine. On a personal note, I have been impressed with how well my patients tolerate this therapy and that their severe pain is reduced under this therapy,” concluded Dr. Ocean.

This study will also be presented at the AACR Special Conference on Pancreatic Cancer: Innovations in Research and Treatment on Tuesday, May 20, 2014, and at the 2014 ASCO Annual Meeting on Sunday, June 1, 2014, also in a Poster Highlights Session.

An archived version of the R&D day webcast is available on the Company’s website until May 22, 2014.

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