NeoImmuneTech has been cleared to initiate a Phase 1b/2a trial to determine the optimal dosing and evaluate the anti-tumor activity of its Hyleukin-7 (NT-I7), used in combination with Merck’s Keytruda (pembrolizumab), for the treatment of relapsed or refractory advanced solid tumors.
Under its investigational new drug (IND) application, now cleared by the U.S. Food and Drug Administration (FDA), NeoImmuneTech will conduct the study in people who have received prior immune checkpoint inhibitors like Keytruda and in those who have never received any such treatment.
Data from this study will be used to support the clinical development of this combination therapy in specific tumor types.
“As a company, we are striving to develop a safe and effective immunotherapy for patients with [relapsed or refractory] advanced solid tumors, including those who have not been responsive to single-agent CPIs [checkpoint inhibitors],” NgocDiep Le, MD, PhD, chief medical officer and executive vice president of NeoImmuneTech, said in a press release.
“This clearance marks the next step towards our goal of combining Hyleukin-7 with advanced cancer therapeutics such as pembrolizumab,” Le said.
Hyleukin-7, NeoImmuneTech’s lead product candidate, is a clinical-stage, long-acting, human interleukin-7 (IL-7) — a cytokine that is required for the survival and development of immune T-cells. It also is necessary for the body to mount a sustained immune response against cancer.
Cytokines are molecules that mediate and regulate the body’s immune and inflammatory responses. T-cells are immune cells that target and destroy microbes or other cells that are seen as threats by the immune system.
Keytruda, developed by Merck (known as MSD in the U.S. and Canada), is an immune checkpoint inhibitor that boosts the anti-tumor activity of immune cells. It does so by preventing the PD-1 receptor — a protein found on the surface of immune cells — from interacting with other proteins. That hinders cancer cells’ ability to evade being targeted and destroyed by immune cells.
The favorable pharmacokinetic, pharmacodynamic, and safety profiles of Hyleukin-7 make it an optimal combination partner to add to current standard-of-care immunotherapies, including checkpoint inhibitors like Keytruda.
Pharmacokinetic properties are analyzed to assess how a medication is absorbed, distributed, metabolized, and then eliminated from the body, while pharmacodynamic properties are evaluated to assess the effects a medication has in the body.
“We are constantly looking for better and safer treatment options for our patients, as only a fraction of them can benefit from currently available immunotherapies,” said Aung Naing, MD, FACP, associate professor in the department of investigational cancer therapeutics at the University of Texas MD Anderson Cancer Center.
“This agent has the potential to augment and broaden the reach of current treatments such as pembrolizumab, due to its T cell amplifying mechanism of action,” said Naing, who also will be leading the trial. “We hope this study yields results helpful for our patients in dire need.”
Hyleukin-7 is currently being evaluated in multiple clinical trials of solid tumors, including (NCT02659800; NCT03687957; NCT03901573; NCT04054752). Plans are already underway to test the effects of the medication in blood cancers and other immunology-focused indications.
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