ELI-002 7P is a vaccine being developed to treat resected pancreatic cancer and offers a “new twist on an older vaccine technology,” according to Dr. Suresh Nair.
Nair is the physician-in-chief at the Lehigh Valley Topper Cancer Institute in Pennsylvania. In a recent interview with CURE®, he discussed ELI-002 7P, which is currently being investigated in a phase 2 trial, and may one day drastically change the treatment landscape for pancreatic and other cancers.
“I’ve been a medical oncologist in the community setting for 35 years with a strong focus on immunotherapy treatment and research and I feel as excited about this trial as I did [when] we were part of the first phase 2 testing of [Opdivo (nivolumab)] in melanoma back in 2013,” Nair said.
CURE®: Can you a high-level overview of this current pancreatic cancer vaccine that’s being worked on?
Nair: This is an off-the-shelf vaccine, which does not require collecting tumor tissue from the patient to develop a vaccine. It’s like the mRNA vaccine. This vaccine targets a common mutation found on pancreatic cancer. About 90% of pancreatic cancers have one of seven KRAS mutations, and this is the newer version of this vaccine that’s in the phase 2 testing. Is called ELI-002 7P which covers all seven. In the initial testing, they covered two of the KRAS mutations.
It’s a peptide vaccine. So it’s the older technology, but it’s been modernized by putting a lipid side chain, which is allowing this vaccine to attach to what are called dendritic cells on the draining lymph nodes, and it basically teaches the immune system to fight and defeat cancer recurrence by targeting these specific genetic mutations. It’s a very new twist on older vaccine technology.
What have prior studies of ELI-002 shown?
Dr. Nair discussed ELI-002 7P, an experimental cancer vaccine.
What’s really created all this excitement is that the phase 1 results were published in Nature Medicine in January 2024. [The vaccine] was found to be safe with … milder, common vaccine side effects, such as fever, chills and nausea. They were not severe (grade 3 or 4 side effects). So from a safety [standpoint,] it was found to be tolerable.
Then it had a signal of potential efficacy. They tested the phase 1 vaccine on patients who had had surgery for stage 1 to 3 pancreatic cancer, and then were starting to have early recurrence by rise of the tumor marker, but still have negative CT scans. So they just had early microscopic cancer. About a third of the patients were able to eliminate this early recurrence by a series of about 12 vaccines. This is even before adding an immunotherapy drug to the vaccine. It was purely the vaccine’s effect in immunizing the patient’s body against the cancer.
What can patients expect in the next step of this research?
Now it’s the randomized phase 2 portion. They’ve expanded from the initial sites to about 20 sites in the U.S. now. It’s been accruing, and it’s expected to finish the phase two randomized accrual by the end of the year.
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Two-thirds of the patients will be selected to get the vaccine, and one-third will be on observation. The phase 2 trial is a little different from the phase 1, in that you don’t have to have early recurrence to qualify. You need to be a patient with stage 1 to 3 resected pancreatic cancer and finish six months of the standard chemotherapy and have a negative CT scan. The fourth [criteria] is to be in that 90% that has an identifiable KRAS mutation. There is a small subset of NRAS mutation that this vaccine also works in. So that will be part of the screening for the trial.
We’ll be sending the tumor tissue to Elicio (the manufacturer of ELI-002 7P), and they’ll make sure that the vaccine will be effective against their mutation. Because these are patients that have already had surgery and already had chemotherapy, there is about a month or so of initial screening involved, which involves testing the mutations. [Trial participation] also involves the apheresis session to collect T cells at baseline, and then it’s repeated again six weeks later, as the research part of the screening.
What are you most excited about regarding the ongoing pancreatic cancer vaccine research?
I think what is exciting is that this is really bringing a lot of hope that we could increase the two-year, progression-free survival (percentage of patients who are still alive without disease worsening) of resected pancreatic cancer. If this testing is positive, about 25% of all cancers have a KRAS mutation. So there’s potential to expand this research to other cancers. That’s why there’s so much excitement.
The fact that this is something that’s produced in a lab, so there’s not as much delay and not as many technical barriers for this, [is also exciting].
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