Neon Therapeutics has dosed the first lung cancer patient with its investigational vaccine NEO-PV-01, in combination with the checkpoint inhibitor Keytruda (pembrolizumab) and chemotherapy, in a Phase 1b clinical trial.
Specifically, the study is addressing the combination in patients with either untreated or advanced metastatic nonsquamous non-small cell lung cancer.
The trial (NCT03380871) is being conducted in collaboration with Merck, which is known as MSD outside of the U.S. and Canada, and is currently recruiting participants in the U.S.
“Treating our first patient in this clinical study marks an important milestone for Neon,” Richard Gaynor, MD, president of research and development at Neon Therapeutics, said in a press release. “We see a strong mechanistic rationale to explore the combination and sequence of a personal neoantigen cancer vaccine, anti-PD-1 therapy, and chemotherapy. These data will help us understand the potential of NEO-PV-01 to improve durability and response rates of patients treated in combination with existing immuno-oncology drugs.”
NEO-PV-01 is a personalized vaccine based on the genetic information of a patient’s cancer cells. Using the company’s proprietary RECON computational pipeline, researchers are able to identify specific mutations that could result in new tumor-specific targets. Then they produce up to 20 small proteins mimicking such targets and inject them into the patient.
The patient’s immune system recognizes these small proteins as foreign and mounts an immune attack, becoming primed to attack cancer cells. NEO-PV-01 is administered alongside Hiltonol (poly-ICLC), which boosts the immune response.
The new trial was designed to evaluate the safety and tolerability of NEO-PV-01 in combination with Keytruda and chemotherapy — Alimta (pemetrexed) and Paraplatin (carboplatin) — in 15 lung cancer patients. Researchers also are hoping to examine early signs of the combination’s effectiveness.
Participants will receive Keytruda plus chemotherapy every three weeks for 12 weeks. Then, each patient will receive a personalized version of NEO-PV-01 under the skin, while continuing Keytruda therapy.
The study’s main goal is to determine the rate of negative effects, including those leading to treatment withdrawal. Additional objectives include the proportion of patients responding to the treatment, those who benefit from it and achieve at least stable disease, duration of response, time to disease progression or death, and overall survival. Researchers also will examine immune responses after treatment.
Those interested in participating may click here.
The company also is recruiting participants for a second Phase 1 trial (NCT02897765) assessing NEO-PV-01 in combination with another PD-1 inhibitor, Opdivo (nivolumab). The study is being conducted in collaboration with Bristol-Myers Squibb and will enroll some 50 adult patients with unresectable or advanced skin, bladder, or lung cancers.
