First Patient Dosed in Phase 1/2 Trial Assessing Novel Immunotherapy Alone, With Keytruda


Researchers conducting the VISTA-101 study will assess the safety and efficacy of KVA12123 alone and with Keytruda, in addition to determining the recommended dose of the therapy.

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KVA12123 with or without Keytruda is being studied for multiple cancer types.

The first patient has been dosed in a phase 1/2 clinical study assessing the immunotherapy KVA12123 alone and with Keytruda (pembrolizumab) for the treatment of patients with advanced solid tumors.

KVA12123 is a novel immunotherapy aimed at blocking VISTA, a protein highly expressed in renal cell carcinoma, colorectal, ovarian, head and neck, and non-small cell lung cancers, according to a press release from Kineta, the manufacturer of the therapy. This is designed to address immunosuppression, or the immune system’s ability to fight infections and other diseases, in the tumor microenvironment.

“New cancer immunotherapies continue to transform the standard of care and have significantly improved overall survival for patients with cancer,” Dr. Evan Yu, section head for cancer medicine at the Fred Hutchinson Cancer Center in Seattle and principal investigator of the study, said in the release.

“Despite the introduction of these novel therapies, most patients still progress following treatment leaving an urgent medical need for new treatments,” said Yu. “We are excited to kick off this phase 1 trial to evaluate Kineta’s VISTA-blocking immunotherapy as a potential approach to alleviate immunosuppression and promote antitumor immune responses in the tumor microenvironment.”

Researchers conducting the VISTA-101 study are aiming to enroll approximately 314 patients with advanced solid tumors, according to the study’s listing on In particular, patients will have a confirmed, locally advanced (cancer that spread to nearby tissue or lymph nodes) or metastatic (cancer that spread from the place where it started to other places in the body) solid tumor that has progressed or did not respond to standard-of-care therapy and for which no curative therapy exists.

The main goal of the study is to evaluate the tolerability, safety, pharmacokinetics (the activity of drugs in the body over time such as absorption and distribution in the body), tumor response and immunogenicity (the ability for tissues and cells to provoke an immune response) of KVA12123 alone and with Keytruda.

The VISTA-101 study will be conducted in four different parts; parts A and B focus on dose escalation of KVA12123 alone and with Keytruda to determine the recommended dose for the other parts of the study. The second phase consists of parts C and D, which will focus on dose expansion and allow researchers to further focus on the safety and efficacy of a specific dose of the therapy.

“KVA12123 represents a potentially promising new treatment option for a number of difficult-to-treat cancers,” said Shawn Iadonato, chief executive officer of Kineta.

The company anticipates a readout of phase 1 initial data to occur by the end of this year.

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