FDA Accepts Investigational New Drug Application for KVA12123 to Treat Advanced Solid Tumors

Article

The FDA’s decision to grant KVA12123 an investigational new drug application now allows its manufacturer, Kineta, to begin a clinical trial assessing its safety and efficacy across several solid tumors.

The FDA has accepted an investigational new drug application (IND) for KVA12123 for the treatment of patients with advanced solid malignancies, according to a press release from developer Kineta.1

There are plans for a phase 1/2 clinical trial to assess KVA12123 alone or in combination with pembrolizumab (Keytruda) in a patient population with advanced solid cancers. The trial will assess the safety, tolerability, pharmacokinetics, pharmacokinetics, and treatment response for both the monotherapy and combination regimen. The trial is expected to start enrolling patients by the end of the year.

“The FDA acceptance of the IND enables Kineta to initiate the phase 1/phase 2 clinical trial in cancer patients with advanced solid tumor and demonstrates Kineta’s ability to execute on our clinical objectives,” Shawn Iadonato, PhD, CEO at Kineta, said in a press release. “We believe KVA12123 has the potential to improve clinical responses in [patients with] cancer as a monotherapy as well as in combination with currently approved immunotherapies.”

Iadonato noted that the company expects to release interim results from the trial in late 2023.

KVA12123 is a differentiated VISTA blocking immunotherapeutic that might work to resolve immunosuppression within the tumor microenvironment. Moreover, it is a human engineered IgG1 monoclonal antibody that binds to VISTA via a unique epitope that is administered through intravenous infusion.

The agent was designed to fulfill a role in which current checkpoint inhibitors don't perform well, thus potentially fulfilling an unmet need. According to the release, the agent may be an effective treatment for those with head and neck, colorectal, ovarian, renal cell, and lung cancers, as well as additionally difficult to treat solid tumors.

Findings from a non-human primate toxicology phase 1/2 study of KVA12123 in solid tumors showed that there were no reported deaths, overt clinical signs or weight loss.2 Moreover, there were no treatment-related data for clinical pathology end point or changes in cytokine release syndrome levels.

Based on this, the agent was pushed forward to be assessed as part of the aforementioned study. In part A, KVA12123 will be evaluated at several escalating dose levels, including 3 mg, 10 mg, 30 mg, 100 mg, 300 mg, and 1000 mg every 2 weeks. In part B, the agent will be assessed in combination with pembrolizumab every 3 weeks at several dose levels, including 30 mg, 100 mg, 300 mg, and 1000 mg.

Reference

  1. Kineta announces FDA acceptance of investigational new drug (IND) application for KVA12123 for the treatment of advanced solid tumors. News release. Kineta. November 15, 2022. Accessed November 15, 2022. http://bit.ly/3EybsNL
  2. Lustig K, Frazier E, Kabi N, et al. KVA12123: an anti-VISTA monoclonal antibody with strong single agent anti-tumor activity and no evidence of cytokine mediated toxicity. 2021 Society for Immunotherapy of Cancer; November 8-November 12; Boston, MA; abstract 425.
Related Videos
Cancer vaccines are a “cross-cutting approach” that may be applicable across several cancer types, according to Catherine J. Wu, MD.
mRNA may be a potential modality for developing cancer-based vaccines, according to Catherine J. Wu, MD.
Analyzing the KRAS mutation across various cancer types may be a worthwhile target when using a cancer vaccine or immunotherapy, says Catherine J. Wu, MD.
The AACR Health Disparities Report highlights the changes needed to achieve health equity for patients with cancer.
Robert A. Winn, MD, gives insight into how institutions and community practices can improve access to cancer care.
In the October edition of Snap Recap, we review the latest FDA news and the vote from the last ODAC meeting.
In this September edition of Snap Recap, we share our highlights from Prostate Cancer Awareness Month, news in the breast cancer space, and the latest FDA updates.
Implementing tax benefits for manufacturers who produce chemotherapy drugs may be one solution to increase drug production in the United States, according to Lucio N. Gordan, MD.
Lucio N. Gordan, MD, describes how his practice deals with increasing costs of limited chemotherapy agents to ensure that patients with cancer continue to receive treatment.
Related Content
Striving for Health Care Equity by Closing the Cancer Care Gap

Striving for Health Care Equity by Closing the Cancer Care Gap

April 18th 2024
Article

“If you were to ask me what the 1 magic thing would be, it would be that we would adopt a concept of 1 team, one fight nationally, and that we would be able to have our structures and our coordination of care.”

Edward S. Kim, MD, MBA, and Richard T. Lee, MD discuss how integrative oncology techniques such as acupuncture have impacted patient quality of life at their practice.

Creating a First-of-Its-Kind Integrative Oncology Program at City of Hope

March 18th 2024
Podcast

Edward S. Kim, MD, MBA, and Richard T. Lee, MD discuss how integrative oncology techniques such as acupuncture have impacted patient quality of life at their practice.

Results from 3 DESTINY trials led to the accelerated approval of fam-trastuzumab deruxtecan-nxki for patients with unresectable or metastatic HER2-positive solid tumors.

FDA Grants Accelerated Approval to T-DXd in Advanced HER2+ Solid Tumors

April 5th 2024
Article

Results from 3 DESTINY trials led to the accelerated approval of fam-trastuzumab deruxtecan-nxki for patients with unresectable or metastatic HER2-positive solid tumors.

Primary care physicians cannot afford to dismiss younger people who present with symptoms of cancer in the face of increasing cancer incidence, according to Monique Gary, DO, MSc, FACS.

Addressing Rising Cancer Incidence and Burden in Younger Populations

March 11th 2024
Podcast

Primary care physicians cannot afford to dismiss younger people who present with symptoms of cancer in the face of increasing cancer incidence, according to Monique Gary, DO, MSc, FACS.

An updated guideline from ASCO highlights appropriate use of vaccines for patients with cancer receiving treatments such as CAR T-cell therapy or B-cell depleting therapy.

Updated ASCO Guideline Issues Vaccine Recommendations in Cancer Populations

March 31st 2024
Article

An updated guideline from ASCO highlights appropriate use of vaccines for patients with cancer receiving treatments such as CAR T-cell therapy or B-cell depleting therapy.

Investigators will evaluate the preliminary efficacy and safety of NST-628 in adult patients with solid tumors harboring mutations in the RAS-MAPK pathway as part of a phase 1 trial.

FDA Clears IND for Novel Molecular Glue in Advanced Solid Tumors

March 29th 2024
Article

Investigators will evaluate the preliminary efficacy and safety of NST-628 in adult patients with solid tumors harboring mutations in the RAS-MAPK pathway as part of a phase 1 trial.