MK-1484 / Merck (MSD), Sutro Biopharma - LARVOL DELTA

Development of a ready-to-use cell-based functional neutralizing antibody assay for MK-1484, a PEGylated IL-2 mutein that preferentially activates effector T-cells. (PubMed, Bioanalysis) - "The functional reporter assay was successfully developed and qualified as a ready-to-use format for MK-1484 (cut point S/N 0.62; sensitivity 4.0 µg/mL), overcoming cell-line instability, lengthy recovery, and IL-2 starvation by using MK-1484 itself for post-thaw recovery and reducing the workflow from ~6 to 2 days. The ready-to-use functional NAb assay is fit-for-purpose for early-phase testing when combined with a more sensitive wild-type IL-2 NAb assay as the primary safety screen, and may be adaptable to other IL-2-based biotherapeutics, subject to case-by-case evaluation."

Journal • IL2 • STAT5 • STAT5AWqe

A Study of MK-1484 as Monotherapy and in Combination With Pembrolizumab (MK-3475) In Advanced or Metastatic Solid Tumors (MK-1484-001) (clinicaltrials.gov) - P1 | N=70 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Monotherapy • Oncology • Solid Tumor

A Study of MK-1484 as Monotherapy and in Combination With Pembrolizumab (MK-3475) In Advanced or Metastatic Solid Tumors (MK-1484-001) (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jan 2026 ➔ May 2026 | Trial primary completion date: Jan 2026 ➔ May 2026

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Sutro Biopharma Achieves “First in Human” Milestone in Cytokine Derivatives Collaboration with Merck (Sutro Biopharma Press Release) - "Sutro Biopharma, Inc...today announced that the first patient has been dosed in a Phase 1 study of an investigational candidate resulting from the collaboration between Sutro and Merck, known as MSD outside the United States and Canada, for the development of a novel cytokine derivative therapeutic for the treatment of cancer. As a result of this milestone, Sutro will receive a $10 million payment from Merck."

Commercial • Pipeline update • Trial status • Oncology

A Study of MK-1484 as Monotherapy and in Combination With Pembrolizumab (MK-3475) In Advanced or Metastatic Solid Tumors (MK-1484-001) (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Monotherapy • Oncology • Solid Tumor

Merck to Hold Investor Event to Highlight Oncology Portfolio and Pipeline (Merck (MSD) Press Release) - "Merck...will provide a detailed overview of the company’s oncology portfolio and pipeline at an investor event today at the 2022 American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago at 7 a.m. CT/8 a.m. ET. At this year’s ASCO, data for Merck’s oncology portfolio and pipeline will be presented from nearly 120 abstracts in more than 25 cancer types."

Clinical data • Oncology • Solid Tumor

A Study of MK-1484 as Monotherapy and in Combination With Pembrolizumab (MK-3475) In Advanced or Metastatic Solid Tumors (MK-1484-001) (clinicaltrials.gov) - P1 | N=70 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

Combination therapy • Monotherapy • New P1 trial • Oncology • Solid Tumor