Royalty Report: Drugs, Cancer, Biotechnology – Collection: 192822

License Grant

The Licensee entered into a settlement and license agreement with the Licensor resolving the worldwide patent infringement litigation related to the use of an anti-PD-1 antibody for the treatment of cancer, such as Keytruda. The Licensee will pay royalties on the worldwide sales of Keytruda for a non-exclusive license to market Keytruda in any market in which it is approved.

License Property

anti-PD-1 antibody drug, nivolumab, produceScomplete or partial responses in non-small-cell lung cancer, melanoma, and renal-cell cancer, in a clinical trial with a total of 296 patients.

Field of Use

This agreement pertains to the pharmaceutical industry.  Anti-PD-1 antibody for the treatment of cancer, such as Keytruda.

License Grant

This amendment increases the royalties for dostarlimab and adds terms for Zejula.

License Property

Dostarlimab is an anti-PD-1 antagonist antibody.

Zejula TM is an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor.

Field of Use

Dostarlimab is under development for multiple oncological disorders, including endometrial cancer, non-small cell lung cancer, ovarian cancer, colorectal cancer and mismatch repair deficient solid tumors.

Zejula, which has received US approval for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

License Grant

The Licensee has the exclusive right to develop, manufacture and commercialize Opdivo in all territories worldwide except Japan, South Korea and Taiwan (where the Licensor was responsible for all development and commercialization prior to the amendment). The alliance agreement was amended to provide for additional collaboration activities in Japan, South Korea and Taiwan pertaining to Opdivo and several other Licensee compounds including ipilimumab, lirilumab, urelumab and BMS-986016 (anti-LAG3). Both parties have the right and obligation to jointly develop and commercialize the compounds. The Licensee is responsible for supply of the product.

License Property

The agreement is to develop and commercialize Opdivo, an anti-PD-1 human monoclonal antibody being investigated as an anti-cancer treatment. Opdivo (nivolumab) is a fully human monoclonal antibody that binds to the programmed death receptor-1 (PD-1) on T and NKT cells. It is being investigated as an anticancer treatment. It is in Phase III trials (which commenced in 2012) in non-small cell lung cancer, renal cell cancer and melanoma.

Field of Use

The parties jointly own a patent covering Opdivo as a composition of matter that expires in 2027 in the U.S. (excluding potential patent term extension). In December 2014, the FDA approved Opdivo for unresectable (inoperable) or metastatic melanoma, and disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor. Opdivo was also approved in Japan in July 2014 for the same indication. The FDA has granted Fast Track designation for Opdivo in three tumor types non-small cell lung cancer, renal cell carcinoma and metastatic melanoma, and it is in the registrational process for melanoma and non-small cell lung cancer in the U.S. and Europe. The FDA granted Breakthrough Therapy designation for Hodgkin Lymphoma in 2014.

License Grant

The Chinese Licensor and U.S. Licensee, by this collaboration is for the development and commercialization of toripalimab, Licensor’s anti-PD-1 antibody, in the United States and Canada. Upon satisfaction of closing conditions, The Parties will co-develop toripalimab, and Licensee will be responsible for all commercial activities in the licensed territory.

Under the terms of the agreement, Licensee will also be granted options to Licensor’s TIGIT-targeted antibody and next generation engineered IL-2 cytokine for evaluation as potential combination therapies with toripalimab, as well as certain negotiation rights to two early-stage checkpoint inhibitor antibodies.
–
JS006, an antibody targeting TIGIT.
–
JS018, a next-generation engineered IL-2 cytokine
–
Two additional undisclosed early-stage novel immuno-oncology drug candidates.

License Property

Toripalimab is a Chinese domestic anti-PD-1 monoclonal antibody, also approved for the second-line treatment of patients with unresectable or metastatic melanoma, and, supplemental NDAs of toripalimab for the third-line treatment of recurrent/ metastatic nasopharyngeal carcinoma and second-line treatment of metastatic urothelial carcinoma.

JS006 is an antibody targeting TIGIT, a clinically validated immune inhibitory checkpoint. Anti-TIGIT antibodies have demonstrated synergistic anti-tumor activity in combination with anti-PD-1 antibodies.

JS018 is a next-generation engineered IL-2 cytokine designed to inhibit stimulation of regulatory T cells while retaining stimulatory activity on effector T cells and natural killer (“NK”) cells. The option to JS018 is exercisable prior to initiation of Phase 2 clinical development.

Field of Use

This transaction expands Licensees late-stage pipeline into the rapidly growing checkpoint inhibitor market and in oncology with biosimilars.

By this Collaboration, the Parties plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare and highly prevalent cancers, including non-small cell lung cancer (“NSCLC”).