Kineta, Merck Strike Deal to Pair Anti-VISTA Antibody with Keytruda

Merck_Kena Betancur/Getty Images

Kineta, Inc. struck a collaboration deal with Merck to pair its anti-VISTA monoclonal antibody with Keytruda (pembrolizumab) as a potential treatment for advanced solid tumors, the companies announced Monday. 

Seattle-based Kineta will assess its investigational antibody KVA12123 as a standalone treatment and in combination with Merck's vaunted checkpoint inhibitor against solid tumors. The two companies anticipate the initiation of clinical trials later this year.

KVA12123 is an inhibitor of VISTA. It is a key driver of immunosuppression in the microenvironment of cancer tumors. Kineta noted in its announcement that following treatment with a checkpoint inhibitor such as Keytruda, VISTA is up-regulated. 

The up-regulation is associated with treatment failures and poor prognosis for cancer patients. KVA12123 is designed to bind to VISTA and inhibit that up-regulation.

In preclinical studies, KVA12123 demonstrated promising anti-tumor activity both as a single agent and in combination with PD-1 checkpoint inhibitor therapy. Kineta now hopes to replicate that success in the clinic.

Merck's anti-PD-1 Keytruda has become a powerhouse oncology drug that generated more than $17 billion for the company last year. Since it was first approved in 2014, Keytruda has received 33 approvals across 16 tumor types from the FDA. 

In addition to Kineta, multiple companies evaluate Keytruda in combination with their cancer therapies. Keytruda is slated to become the world's top-selling drug by 2025, according to analyst predictions.

Shawn Iadonato, chief executive officer of Kineta, noted that treatment with checkpoint inhibitors like Keytruda has become a first-line treatment in multiple cancer indications. Despite this class of drugs' success, a significant number of cancer patients still do not respond to the medication. 

Iadonato said in a brief statement that Kineta believes KVA12123 is a potential best-in-class VISTA blocking immunotherapy that could lead to improved treatments for patients. He suggested KVA12123 has the potential to deliver a differentiated product profile across a range of solid tumors.

Initial target indications for KVA12123 include non-small cell lung cancer, colorectal, renal cell carcinoma, head and neck, and ovarian cancer. These indications represent a significant unmet medical need with a large worldwide commercial opportunity for KVA12123.

Kineta will initiate a Phase I/II trial assessing KVA12123, a fully human engineered IgG1 monoclonal antibody. The trial will assess the safety, tolerability, pharmacokinetics and anti-tumor responses of KVA12123 alone and in combination with Keytruda. Topline data is anticipated in late 2023. 

Financial terms of the collaboration were not disclosed. Under terms that were announced, Kineta will be responsible for initiating the Phase I/II clinical study. The trial is expected to begin in the fourth quarter of 2022.

In addition to KVA12123, Kineta has also developed a set of anti-CD27 agonist antibodies. In preclinical studies, Kineta's selected lead anti-CD27 agonist mAbs generated T cell proliferation and secretion of cytokines involved in T cell priming and recruitment. These demonstrated the antibody's ability to provide new anti-tumor responses.

Back to news