The biopharmaceutical company has tapped into the State’s popular Technology Business Tax Certificate Transfer Program (NOL) Program over the years to further its goal.
Immunomedics is creating drugs that target aggressive types of cancerous solid tumors, such as triple-negative breast cancer, lung cancer, pancreatic cancer and colorectal cancer. These therapies are designed for patients who have not responded favorably to previous lines of treatment.
The U.S. Food and Drug Administration (FDA) awarded Fast Track status last year to Immunomedics’ lead ADC, sacituzumab govitecan (IMMU-132), for the treatment of patients with metastatic non-small cell lung cancer.
The FDA previously granted Fast Track status to IMMU-132 for the therapy of patients with triple-negative breast or small-cell lung cancers. IMMU-132 has also been designated an orphan drug by the FDA for the treatment of patients with small-cell lung or pancreatic cancers.
“In a Phase 2 clinical trial, IMMU-132 has produced encouraging results in patients with advanced solid cancers that include triple-negative breast, small-cell and non-small-cell lung cancers, esophageal, urinary bladder, and other epithelial cancers,” said Peter P. Pfreundschuh, Immunomedics Chief Financial Officer and Vice President of Finance.
Immunomedics has benefited repeatedly from the NOL Program. Administered by the EDA and the New Jersey Department of Treasury's Division of Taxation, this competitive program enables eligible technology and biotechnology companies to sell New Jersey tax losses and/or research and development tax credits to raise cash to finance their growth and operations.
Since the program’s inception in 1999, more than 500 technology and life sciences companies have received a total of more than $860 million.
Pfreundschuh was present at a recent HealthCare Institute of New Jersey (HINJ) roundtable discussion that touched upon resources available to the Garden State’s pharmaceutical industry. During the discussion, Pfreundschuh told New Jersey state leaders what a difference the NOL program has meant to his company.
“The $5.1 million cash proceeds from the NOL program have allowed us to continue with our aggressive agenda to advance a currently ongoing Phase 3 pivotal study in patients with advanced pancreatic cancer, and support the ongoing clinical trials with our ADC,” he said.
@NJEDATech asked Pfreundschuh about Immunomedics’ experience in New Jersey and its plans for the future:
What advantages does Immunomedics see in locating itself in New Jersey?
We have found numerous advantages to locating our headquarters in New Jersey. In terms of human resources, New Jersey has a highly educated workforce trained in science and technology, from which we can recruit.
In addition, the State is home to a significant number of multinational pharmaceutical and biotechnology companies for potential scientific collaborations and commercial licensing.
Finally, resources such as the NOL program provide small, unprofitable biotechnology companies like ours with an important source of non-dilutive financing to fund our working capital needs.
What is Immunomedics’ biggest success to date?
We have pioneered a new approach in cancer therapy using ADCs that are different from the current industry paradigm. We’re very encouraged by the Phase II results of IMMU-132 in a variety of solid tumors.
Patients enrolled in this program have had many prior therapies, and have limited options to treat their cancer. Based on these promising results, IMMU-132 was recently recognized as one of the “Most Promising Clinical Candidates” at the recent World ADC Awards in San Diego.
What’s on the horizon for the company?
Our main focus currently is to consummate a licensing partnership with large pharma or biotech to advance IMMU-132 to a Phase 3 registration trial in patients with metastatic triple-negative breast cancer.
Trial design, including a Special Protocol Assessment agreement, with the FDA has been completed. Clinical materials for the Phase 3 study and beyond are being prepared and tested by outside manufacturers.
Our second ADC, labetuzumab govitecan (IMMU-130), has completed a Phase 2 study in patients with metastatic colorectal cancer. Plans for a Phase 3 study in this indication are underway.
In addition, the pivotal Phase 3 clinical trials of yttrium-90-(90Y)-labeled clivatuzumab tetraxetan in patients with relapsed, advanced pancreatic cancer is expected to complete patient enrollment in 2016, with results anticipated shortly thereafter.