Company Spotlight: Immunomedics

(RTTNews) - Shares of Immunomedics Inc (IMMU) touched a new 52-week high yesterday, and are up more than 97% year-to-date.

Immunomedics is a clinical-stage biopharmaceutical company with a pipeline of antibody-drug conjugates ("ADCs") that are designed to have high anti-tumor efficacy and low overall toxicity.

The Company markets LeukoScan in Europe, Canada and in other markets outside the U.S. LeukoScan is indicated for diagnostic imaging for determining the location and extent of infection and inflammation in bone of patients with suspected osteomyelitis, including patients with diabetic foot ulcers.

The Company's ADCs include:

-- Sacituzumab govitecan, also known as IMMU-132, under phase II trials in select types of solid cancers including metastatic triple-negative breast cancer, small-cell lung cancer, non-small-cell lung cancer, urothelial cancer and certain other cancers. -- Labetuzumab govitecan, or "IMMU-130, which is also under phase II testing, for the treatment of metastatic colorectal cancer.

In February of this year, Immunomedics had entered into an exclusive global licensing agreement with Seattle Genetics (SGEN) for Sacituzumab govitecan, with potential payments of up to roughly $2 billion, plus royalties.

Under the agreement, Seattle Genetics was to develop, fund, manufacture and commercialize Sacituzumab govitecan.

However, venBio Select Advisor LLC, the largest shareholder of Immunomedics, who felt that the deal undervalued the potential of Sacituzumab Govitecan, filed an injunction to block the deal, following which it was put on hold by a Delaware judge on March 9, 2017.

Finally, on May 5, 2017, Immunomedics abandoned the deal, regaining full rights of Sacituzumab Govitecan.

Sacituzumab Govitecan has received Breakthrough Therapy Designation from the FDA for the treatment of patients with triple-negative breast cancer who have failed at least two prior therapies for metastatic disease.

In a single-arm phase II study, Sacituzumab govitecan produced tumor shrinkage from baseline measurements in 81% of 85 assessable patients, with two complete responses and 23 partial responses. The interim median duration of response for those with objective responses was almost 11 months, while the interim median overall survival for all 85 patients was almost 19 months.

The Company plans to begin enrolling metastatic triple-negative breast cancer patients in a phase III confirmatory trial during the second half of 2017. A BLA for Sacituzumab Govitecan in the indication of triple-negative breast cancer is planned for submission during the late fourth quarter of 2017 or the first quarter of 2018.

As for the second compound Labetuzumab govitecan, it has demonstrated encouraging results in a phase II study in patients with metastatic colorectal cancer.

Other programs:

-- Epratuzumab, under a phase III trial in children with relapsed acute lymphoblastic leukemia that is being carried out at clinical sites in Australia, Europe, and Israel. The study is being conducted by IntreALL Inter-European study group.

Immunomedics had licensed Epratuzumab for all autoimmune disease indications to UCB in May 2006. But last February, UCB pulled out of the deal, following the drug candidate's failure in two phase III trials in systemic lupus erythematosus, dubbed EMBODY 1 and EMBODY 2.

-- IMMU-114, which is being evaluated as a subcutaneously administered monotherapy for patients with non-Hodgkin lymphoma or chronic lymphocytic leukemia in a phase 1 study.

-- Milatuzumab, which has completed initial phase I studies in patients with relapsed multiple myeloma, non-Hodgkin lymphoma or chronic lymphocytic leukemia.

-- Veltuzumab (anti-CD20) for cancer and autoimmune diseases, under phase II testing.

Recent events

On May 5, 2017, Immunomedics announced that Cynthia Sullivan will be stepping down as president and CEO and relinquish all her positions with the Company. Michael Garone, the current chief financial officer of Immunomedics, has been named the interim CEO.

David Goldenberg, founder of the Company, is resigning from the posts of chief scientific officer and chief patent officer, but will continue as a director on the Board.

Shares of Immunomedics have traded in a range of $1.95 to $7.29 over the last 1 year. The stock closed Thursday's (May 11) trading at $7.26, up 6.14%.