While Immunomedics Inc. resolves issues posed by a complete response letter (CRL) regarding the antibody-drug conjugate sacituzumab govitecan for metastatic triple-negative breast cancer, the company announced a license agreement with Everest Medicines II Ltd. to develop, register and commercialize the drug in much of Asia outside of Japan.

Immunomedics will receive an up-front payment of $65 million and an additional $60 million based on FDA approval of sacituzumab govitecan, as well as potential development, regulatory and sales milestone payments of $710 million and escalating tiered royalties of 14% to 20% on net sales within a territory that includes greater China and South Korea. Everest is responsible for costs associated with the drug's clinical development and commercialization in that territory.

Earlier this year, Morris Plains, N.J.-based Immunomedics said the obstacles presented by the CRL were "fully addressable" and related entirely to chemistry, manufacturing and control matters with none related to sites, data or partnerships. Analysts have said they believe the CRL will delay approval for 12 months. (See BioWorld, Jan. 22, 2019.)

Late last week, Cowen Inc. analysts reported that a Freedom of Information Act request netted them a copy of the FDA's Establishment Inspection Report of Immunomedics' manufacturing facility that took place last August. The report cited 13 Form 483 observations. The issues, the Cowen analysts said, appeared to fall into the broad categories of documentation, testing procedures and minor modifications of the facility. The Cowen analysts said all the issues "appear resolvable."

No definite timeline for the resolutions has been announced but Immunomedics' management has said it is pushing to have the timeline as short as possible.

There are other obstacles to be managed among the company executives in the meantime. Immunomedics' chief medical officer, Robert Iannone, is leaving the company slightly more than a year since he arrived from Astrazeneca plc for "personal and family reasons," Lauren Wood, Immunomedics head of corporate communications, told BioWorld Asia.

"After traveling for work over the past five years, he has a deep desire to be close to his family. Rob has found an opportunity minutes away from his home in Pennsylvania that allow him to stay close to his family instead of traveling on a weekly basis," she said, adding that he will be an Immunomedics consultant once his departure is finalized.

Iannone's departure comes after the late February loss of the company's CEO, Michael Pehl, who also left for "personal reasons," the company noted. Pehl, who had been on the job 15 months since joining Immunomedics from Celgene Corp., left soon after the FDA issued the CRL for sacituzumab govitecan, also known as IMMU-132.

Everest deal a positive

Despite the C-suite musical chairs and the CRL, analysts like the Everest deal. On March 29, Jefferies analysts noted that the Asia strategy aligns with Immunomedics' view of developing its noncore territories. "We view this sizeable deal positively and as a demonstration of the confidence in '132's approval and commercial potential."

Cowen analysts were also on board. "We continue to believe that IMMU is undervalued for sacituzumab," they noted.

Despite the warm words, Wall Street handed Immunomedics some tough numbers on March 29, as the stock (NASDAQ:IMMU) was lower by 5.39% at the close of trading and remains down 14.2% for the past 12 months.

Everest was chosen because of its clinical and regulatory infrastructure, Wood said, known also for its partnerships with Novartis AG, Morphosys AG and Arena Pharmaceuticals Inc. in the past two years.

"We ran a very competitive bid process over the last year, and ultimately made our decision based on three factors: (a) deal economics (b) partner capability and reputation and (c) fit between the two companies for a successful long-term partnership," she added.

Everest Medicines is a C-Bridge, capital-backed biopharmaceutical company focused on developing and commercializing pharmaceuticals for patients in greater China and other Asian markets.

Late last year, Immunomedics submitted updated phase II data on the ADC in metastatic triple-negative breast cancer to support an ongoing FDA priority review while also reaching an accord with the agency on the design of a registration-enabling trial for the drug in HR-positive/HER2-negative metastatic breast cancer (mBC), it said. The company also outlined the design of an upcoming global phase III trial that will evaluate IMMU-132 in about 400 patients with HR-positive/HER2-negative mBC who have failed prior hormonal and CDK 4/6 inhibitor therapies, as well as at least two prior chemotherapies. The primary endpoint of the open-label study will be progression-free survival, with additional secondary endpoints including overall survival, clinical benefit rate, health-related quality of life, and safety and tolerability. Eligible patients will be randomized 1-to-1 to receive either IMMU-132 or physicians' choice of chemotherapy and will be treated until tumor progression, unacceptable toxicity, study withdrawal or death. (See BioWorld, Dec. 7, 2018.)

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