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After FDA rejection, Immunomedics tries again with breast cancer drug

Immunomedics on Tuesday said it will resubmit an experimental cancer drug to the Food and Drug Administration, trying for a second time to win approval of the treatment after the agency rejected it earlier this year. If Immunomedics succeeds, sacituzumab govitecan would be the biotech’s first commercial product in its 37-year history. The company has applied for accelerated approval of the drug as a third-line therapy for metastatic triple-negative breast cancer.Cantor Fitzgerald analyst Varun Kumar expects the drug could be approved by mid-2020, assuming the cancer therapy again receives Priority Review status from the FDA. The agency turned back Immunomedics’ first submission in January, citing manufacturing issues.

For a year marked by an FDA rejection, manufacturing problems and a CEO departure, Immunomedics appears to have weathered the storm.

Eight months after Immunomedics submitted its application for sacituzumab govitecan, the FDA issued a Complete Response Letter over manufacturing issues, according to the company. Roughly a month later, in February, CEO Michael Pehl resigned, opening a still-ongoing search for the company’s next chief executive.

The Morris Plains, New Jersey-based biotech’s stock suffered through those announcements, but has steadily risen in value over the past two months. Shares traded at about $19 apiece on Tuesday, up from $15 at the beginning of 2019.

Part of that resurgence can be explained by the company’s efforts around its regulatory resubmission.

In April, the company agreed to use its salesforce to do product detailing for Janssen’s cancer drug Balversa (erdafitinib). Later that month, Immunomedics signed away Asian commercial rights to sacituzumab govitecan to a Chinese company for $65 million upfront, $60 million more upon FDA approval and up to $700 million in potential milestone payments.

With sacituzumab, the company will start by targeting a third-line approval in metastatic triple-negative breast cancer (mTNBC), comprising a U.S. patient population of about 8,000. From there, however, Immunomedics plans to rapidly expand the antibody-drug conjugate’s label.

Due to the regulatory delay for the initial application, a confirmatory Phase 3 study in mTNBC has finished enrollment and is expected to read out results in mid-2020, according to a recently updated company presentation. That trial is testing the drug against physician’s choice of chemotherapy, measuring both progression-free and overall survival.

The biotech has also partnered with other industry players to test combination treatments that could be second- or first-line therapies in mTNBC. These studies pair the drug with Roche’s Tecentriq (atezolizumab), AstraZeneca’s Imfinzi (durvalumab) and Clovis Oncology’s Rubraca (rucaparib). The deal with Roche was signed this September, while agreements with AstraZeneca and Clovis were inked in 2018.

Immunomedics is also running clinical trials for a second targeted indication in metastatic urothelial cancer. Interim results from a Phase 2 study showed a 29% overall response rate in the first 35 enrolled patients with an average follow-up time of four months. That trial could be the basis for an accelerated approval application, the company said.

Sacituzumab is Immunomedics’ key asset and its commercial potential largely drives the company’s $3.6 billion market value. Jefferies analyst Chris Howerton, for instance, forecasts $3.1 billion in peak 2033 sales.