Royalty Report: Drugs, Cancer, Antibody – Collection: 336734

License Grant

The Licensee licensed the exclusive rights to certain intellectual property to support development of its therapeutic candidates from the Hospital.

License Property

The intellectual property licensed in 2018 was categorized as “Patent Family 1” and a provision patent filing related to the Company’s nanoparticle technology was added to Patent Family 1. A second patent family (Patent Family 2) was created which includes Licensor intellectual property targeting PD-L1.

The therapeutic candidates include but not limited to TTX-siPDL1.

TTX-siPDL1 is a novel PD-L1 inhibitor.

TTX-siPDL1 incorporates a siRNA against PD-L1 as its functional component, it inactivates PD-L1 at the post-transcriptional level, that is, it triggers the degradation and/or translational repression of the PD-L1 mRNA, preventing the cell from expressing the PD-L1 antigen.

PD-L1 is a protein.   The immune system has T cells that help fight off diseases. T cells are like soldiers that help the body fight infections and other diseases, including cancer. Cancer cells can escape this attack by expressing this protein. PD-L1 works like a “stop sign” to inactivate T cells.

Field of Use

Field of use is for treatment of tumors in a range of cancers, including breast, pancreatic, ovarian and colon cancer, glioblastomas and others.

License Grant

The agreement granted exclusive development and commercialization rights to the Licensor's fully human, immune-oncology anti-PD-L1 monoclonal antibody (mAb) STI-A1014 for the greater Chinese market.

License Property

The mAb is novel, proprietary, and fully human. The Licensor is currently developing production quality cell lines for their anti-PD-L1 antibody, STI-A1010, which will lay the foundation for Investigational New Drug, or IND, -enabling studies in the U.S. in 2014. The Licensor anticipates that a Phase I clinical trial for their lead candidate anti-PD-L1 antibody could be initiated in 2015.  The mAb's are derived from the Licensor's proprietary G-MAB® library platform and chosen based on cancer targets.

Patent Antigen binding proteins that bind PD-L1

Field of Use

The individual mAbs discovered from the Licensor's library potentially give a multitude of therapeutic options to target and attack cancer cells. This could be either directly, such as (i) recruitment of immune effector functions, including, but not limited to, antibody-dependent cellular cytotoxicity, or ADCC, or (ii) antagonistic suppression of cellular signaling processes required for cancer proliferation and metastasis; or indirectly, via modulation host biology, such as (a) enhancement of immune activity in the tumor, or (b) normalization of the tumor microenvironment, including anti-angiogenesis for cutting off blood supplies to the tumor.

License Grant

Licensor sold Leronlimab to Licensee where Licensee is responsible for all development, manufacturing and commercialization efforts.

License Property

Leronlimab (PRO 140) is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases including certain liver diseases.

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control.  Blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer.

Field of Use

The field of use is for the treatment in HIV infection, tumor metastases, and other diseases including certain liver diseases.

HIV (human immunodeficiency virus) is a virus that attacks cells that help the body fight infection.
Metastasis means that cancer spreads to a different body part from where it started.
Liver cancer is the growth and spread of unhealthy cells in the liver.

Licensee is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor.

License Grant

The Company was granted an exclusive license to develop and commercialize envafolimab for the treatment of sarcoma in North America from Chinese Licensor.

The Company is responsible for conducting, and will bear the costs of, any Phase 1, Phase 2, Phase 3, or post-approval clinical trial in North America for envafolimab in the indications of refractory and first line treatment of soft tissue sarcoma. Licensees are responsible for conducting, and will bear the costs of, IND-enabling studies (other than those specific to the sarcoma indication) and the preparation of CMC activities sections of an investigational new drug (IND) application for envafolimab. Licensees have agreed to manufacture and supply, or to arrange for a third party manufacturer to manufacture and supply, envafolimab to the Company at pre-negotiated prices that vary based on clinical or commercial use. Licensees retained the right to develop envafolimab in all territories outside of North America as well as within North America for all indications other than soft tissue sarcoma.

License Property

Envafolimab is an investigational single-domain antibody (“sdAb”) with affinity to PD-L1 administered by subcutaneous injection without an adjuvant.  Envafolimab is being developed by Licensee for the treatment of various cancer indications.  Envafolimab is a camelid IgG4 single domain antibody with single digit nanomolar affinity to PD-L1.

Envafolimab, which is also known as KN035, is an investigational PD-L1 single domain antibody administered by subcutaneous injection, for the treatment of soft tissue sarcoma in North America.

Single-domain antibodies are a novel class of therapeutic protein that contain the unique structural and functional properties of naturally-occurring heavy chains and lack light chains.  On February 6, 2019, the FDA approved the first single-domain antibody, Cablivi® (caplacizumab), for adults with acquired thrombotic thrombocytopenic purpura.

PD-L1 is an immune-inhibitory checkpoint molecule expressed on epithelial and vascular endothelial cells, as well as by a number of immune cells, and is utilized by tumor cells as an immune escape mechanism.

Field of Use

Envafolimab is also known as KN035, an investigational PD-L1 single domain antibody administered by subcutaneous injection, for the treatment of soft tissue sarcoma.

Sarcoma is the general term for a broad group of cancers that begin in the bones and in the soft (also called connective) tissues (soft tissue sarcoma).