Moderna Announces Interim Data from Phase 1 Study of mRNA-2752 in Solid Tumors and Lymphomas

Strategic Insights -

Moderna, Inc. has announced interim data from an ongoing Phase 1 clinical study of mRNA-2752 (Triplet) in patients with accessible solid tumors and lymphomas. The study demonstrated that the Company's mRNA Triplet program, given in combination with AstraZeneca's durvalumab, was tolerated at all dose levels tested and elicited evidence of anti-tumor activity. The recommended dose for expansion (RDE) is up to 8mg mRNA-2752 + durvalumab.

Key Takeaways:

  • The mRNA Triplet program combines three mRNAs into one therapy, injected directly into the tumor, to deliver mRNAs encoding for multiple proteins that act locally to modulate the tumor microenvironment without systemic toxicity.
  • The study demonstrated evidence of immunomodulation and expected pharmacodynamics in the tumor immune microenvironment (TME) of both injected and un-injected lesions, in both monotherapy and combination cases.
  • Interim results showed that iTu mRNA-2752 given as monotherapy and in combination with durvalumab is tolerable at all dose levels studied, with a median IL-23 plasma level maintained at.
  • Administration of iTu mRNA-2752 is associated with tumor shrinkage in both injected and un-injected lesions as monotherapy and in combination with durvalumab.
  • Durable PRs were seen in a PD-L1-low squamous-cell bladder cancer patient and a Diffuse large B-cell lymphoma (DLBCL) after progression on CAR-T.
  • Enrollment is ongoing in expansion cohorts of triple-negative breast cancer (TNBC), urothelial carcinoma, lymphoma, and immune checkpoint refractory melanoma and non-small cell lung cancer (NSCLC).

Statistics:

  • 8mg mRNA-2752 + durvalumab is the recommended dose for expansion (RDE).
  • 32 patients with accessible solid tumors and lymphomas received mRNA-2752 in combination with intravenously administered immune checkpoint blockade therapy (durvalumab) in Arm B.
  • iTu mRNA-2752 given as monotherapy and in combination with durvalumab is tolerable at all dose levels studied.
  • Median IL-23 plasma levels were maintained at.
  • Treatment response of the injected lesion was seen in a melanoma patient progressed on pembrolizumab and T-VEC.

Sources:

  • Moderna's press release, "Moderna Announces Interim Data from Phase 1 Study of mRNA-2752 in Solid Tumors and Lymphomas"
  • The Society for Immunotherapy of Cancer's (SITC) 36th Annual Meeting poster, "Phase 1 Study of mRNA-2752, a Lipid Nanoparticle Encapsulating mRNAs Encoding huOX40L, IL-23, and IL-36 Intratumoral (iTu) Injection +/- Durvalumab in Advanced Solid Tumors and Lymphoma"