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Therapeutic vaccine for patients with solid tumors with certain types of KRAS or NRAS mutant variants: G12D, G12R, G12V, G12A, G12C, G12S, G13D.
Key inclusion criteria: for patients with a CT scan that shows no evidence of recurrent disease but who have positive for circulating tumor DNA and/or elevated serum tumor biomarkers (such as CA19-9 and CEA) despite prior standard therapy including surgery and chemotherapy/radiation therapy where applicable.

ELI-002 2P is a tumor vaccine comprised of a lymph-node targeted amphiphile (AMP)-modified G12D and G12R mutant KRAS peptides together with an AMP-modified CpG oligonucleotide adjuvant. Preliminary antitumor activity in KRAS mutated pancreatic ductal adenocarcinoma.
UPDATE February 2024:
Results regarding CRC and other solid tumors from the phase 1 dose escalation study (AMPLIFY-201, NCT04853017):

“The phase 1 trial involved 25 patients whose pancreatic or colorectal cancer had G12D and G12R KRAS mutations and were at high risk of the cancer returning after surgery. The results demonstrated this vaccine is safe and appears to stimulate the patient’s immune system to create cancer-fighting cells:

• 84% of patients had the desired immune response, meaning that immune T cells targeting KRAS-mutated cancer cells were activated and grew in number.
• Also in 84% of patients, a marker for lingering cancer cells — the amount of tumor DNA circulating in the blood — was reduced. In 24% of patients, the tumor DNA was completely absent.
• Perhaps most significant, patients who had a higher T cell response also experienced a longer time without the disease returning, known as relapse-free survival.”
  (See article in Helpful Links)The vaccine in this trial, NCT05726864, targets more variants than that one: G12D, G12R, G12V, G12A, G12C, G12S, G13D.

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Inclusion Criteria

Inclusion Criteria:

KRAS/NRAS mutated (G12D, G12R, G12V, G12A, G12C, G12S, G13D) solid tumor
Phase 1 only: positive for circulating tumor DNA and/or elevated serum tumor biomarkers (such as CA19-9 and CEA) despite prior standard therapy including surgery and chemotherapy/radiation therapy where applicable
Screening CT is negative for recurrent disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

Exclusion Criteria:

Presence of tumor mutations where specific therapy is approved
Known brain metastases
Use of immunosuppressive drugs