It was founded in 1982, almost forty years ago, and doesn’t have a commercial product on the market. But that appears likely to soon change.
Immunomedics, based in Morris Plains, New Jersey, is a bit of a peculiarity in the biopharma industry. Notably, it was founded in 1982, almost forty years ago, and doesn’t have a commercial product on the market. But that appears likely to soon change.
In 2017, the company underwent a major shift after a proxy battle that saw the board of directors replaced and eventual change in the executive team. The company’s founder, chair and chief scientific officer, David Goldenberg, and his wife Cynthia Sullivan, who was also the company’s chief executive officer, were ousted from the company.
Now, the company is looking at a possible drug approval in mid-2020 with a packed pipeline waiting in the wings. Usama Malik, the company’s chief financial officer and chief business officer, took time to speak with BioSpace about the company and its new commercial focus.
As he noted, “Dr. Goldenberg is a prolific scientist, very well published, and created a lot of pretty phenomenal science, but over the course of the last decade hadn’t commercialized much and had pretty much focused on basic research. The new board and management team saw the potential of the science and wanted to advance it into the clinic and ultimately bring it to market.”
The company’s overall focus is on antibody drug conjugates (ADCs), which Malik says had a lot of interest for a while, which faded, but appears to be coming back. An ADC is an antibody that targets a specific cancer antigen linked by a molecule to a chemotherapy drug. This allows a very toxic chemotherapy agent to be delivered directly to the cancer cells, hopefully avoiding systemic toxicities.
The company’s lead product is sacituzumab govitecan for metastatic triple-negative breast cancer (mTNBC). The company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in 2018. However, the agency issued a Complete Response Letter (CRL) in January 2019.
The basis of the rejection wasn’t the drug or the company’s science but related to problems related to Chemistry, Manufacturing and Control (CMC) matters at Immunomedics’ Morris Plains, New Jersey Facility. They refiled the application in December 2019, which was accepted. They also turned to a new CMO, Samsung Biologics.
Malik said, “We believe we have a unique and differentiated construct for the ADC and the first BLA submitted for triple-negative metastatic breast cancer, which is a very tough disease. There really hasn’t been any innovation in that space in a very long time. It’s a very aggressive disease that progresses fast and generally has a very poor prognosis.”
What the company feels is differentiating about sacituzumab is the molecular linker and the toxic molecule they chose to deliver. The typical construct of an ADC, Malik explains, is to use a strong linker with a very toxic chemotherapeutic attached. The chemotherapy is delivered into the tumor and the linker cleaves at that point so the very toxic chemical is delivered directly into the tumor.
“Our differentiator,” he says, “is we use a moderate linker which allows the ADC to not only deliver the chemotherapy into the tumor, but into the tumor microenvironment so other tumors in the vicinity might be impacted by the toxin. We also use a more moderate toxin, as opposed to a very toxic chemical, which helps us on the tolerability and safety side of things.”
In Phase II trials supporting the FDA application, sacituzumab had a 31% overall response rate, which is quite a bit better than historical response rates for mTNBC for existing treatments.
The company is hopeful for the approval and is ready for launch. “We were ready a year ago before the CRL,” Malik said. “We had a deal with Johnson & Johnson to use our sales force to launch Janssen’s Balversa,” a treatment for metastatic urothelial cancer, the most common form of bladder cancer. “Now the sales force is back in training for our product, so we’ll be ready in the next couple months. They’ll be ready even if the approval comes in a couple months early.”
In addition to the upcoming PDUFA date, the company is evaluating sacituzumab in several other cancers, what Malik refers to as a “pipeline in a product.” In addition to the mTNBC trial, the drug is being studied in several other cancers, such as ovarian and non-small cell lung cancer (mNSCLC) and in broader breast cancer indications.
It also has IMMU-130 being evaluated in a Phase II trial in colorectal cancer and IMMU-140 in hematologic cancers, which is in preclinical development.
Immunomedics has also created a number of partnerships. “On the clinical side,” Malik said, “AstraZeneca is developing our drug in combination with their checkpoint inhibitor in triple-negative breast cancer and bladder cancer in the frontline setting.”
Roche is paying to develop sacituzumab with their checkpoint inhibitor in triple-negative breast cancer and Clovis is running clinical trials and paying for combination studies with sacituzumab and Clovis’ Rubraca in triple-negative breast cancer and metastatic urothelial cancer. They also have a deal with the University of Wisconsin to study the drug in prostate cancer.
They also inked a licensing deal with Everest Medicines for sacituzumab for Greater China. Malik said, “It’s the largest ever asset deal done for China, with $125 million up front and $710 million in milestones and attractive royalties of 14 to 20% in Greater China.”
Immunomedics has also been raising quite a bit of money outside the partnerships. The most recent was a secondary market offering in December 2019 that raised $275 million.
“Our ambition for 2020 through 2021,” Malik said, “is commercialization in the U.S. We’re in regional conversations in Europe and we hope to start lighting up Europe in 2020 to 2021. We have a number of pivotal registrational trials for sacitizumab and we want to expand into other indications and frontline settings with checkpoint inhibitors.”
They also hope to use various funds raised to expand their efforts with IMMU-130 and IMMU-140.
“Last but not least,” Malik said, “we plan to continue to invest in our supply chain, bringing additional CMOs into the universe of our manufacturing partnerships to ensure ongoing supply continuity as well as optimizing our cost of goods over time. Those are our key areas of focus and investment for 2020 through 2021.”
The company has also launched a search for a new chief executive officer and hopes to have something to announce about that in the near future.
Malik said, “We expect we’ll put a very capable and competent chief executive officer in place to help us focus and expand our strategy into the U.S. and globally across multiple indications and expand the pipeline. That’s another area to keep an eye out for in the coming months.”
