MDK-703 / Medikine - LARVOL DELTA

ORCHID-1: A Dose Escalation/Expansion Study of MDK-703 in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=26 | Terminated | Sponsor: Medikine, Inc. | N=150 ➔ 26 | Trial completion date: Sep 2025 ➔ Apr 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jun 2025 ➔ Apr 2024; Corporate decision

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

ORCHID-1: A Dose Escalation/Expansion Study of MDK-703 in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=150 | Active, not recruiting | Sponsor: Medikine, Inc. | Recruiting ➔ Active, not recruiting

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

A mechanistically novel peptide agonist of the IL-7 receptor that addresses limitations of IL-7 cytokine therapy. (PubMed, PLoS One) - "The novel peptide agonist reported here scores very low in predicted immunogenicity, and because the peptide lacks sequence similarity with IL-7, the problematic immunogenic neutralization of endogenous cytokine should not occur. The properties we report here implicate MDK-703 as a candidate for clinical evaluation in oncology, anti-viral and other infectious disease, vaccine enhancement, and treatment of lymphopenia."

Journal • Infectious Disease • Oncology • IL7

A phase 1 single ascending dose study evaluating the safety, tolerability, and pharmacodynamic effects of MDK-703, an IL-7 mimetic with extended half-life (SITC 2022) - P1 | "Results As of July 28, 2022, the first cohort of subjects has been dosed. It is expected that preliminary data for three ascending dose cohorts will be available in November 2022 (Clinical trial information: NCT05366634 )"

Clinical • P1 data • PK/PD data • Oncology • CD4 • CD8 • IL7

A Single Ascending Dose Study to Evaluate MDK-703 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=26 | Completed | Sponsor: Medikine, Inc. | Recruiting ➔ Completed

Trial completion

ORCHID-1: A Dose Escalation/Expansion Study of MDK-703 in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=150 | Recruiting | Sponsor: Medikine, Inc.

Combination therapy • Metastases • Monotherapy • New P1/2 trial • Oncology • Solid Tumor

Medikine Presents Preliminary Results of a Single-Dose Phase 1 Healthy Subject Study of MDK-703, a Peptide-Based Mimetic of Interleukin-7 (IL-7) (Businesswire) - P1 | N=30 | NCT05366634 | Sponsor: Medikine, Inc | "Medikine, Inc...announced preliminary safety, tolerability, and pharmacokinetic/pharmacodynamic data from its Phase 1 clinical trial in healthy subjects for its lead program, MDK-703, a peptide-based interleukin-7 (IL-7) mimetic with an extended half-life...demonstrated that MDK-703 was well-tolerated and safe after a single intramuscular administration at doses of both 10 and 30 ug/kg. Additionally, MDK-703 demonstrated drug exposure in blood consistent with high bioavailability and, as expected, produced extended elevation of CD8 and CD4 T cells compared to baseline with minimal effects on regulatory T cells (Treg) and natural killer (NK) cells. Further analysis showed that MDK-703 produced expansion of memory T cells, specifically CD8 and CD4 T-stem cell memory (Tscm), T-central memory, and T-effector memory cells, in blood."

P1 data • Oncology • Solid Tumor

Medikine to Present Preliminary Phase 1 Clinical Trial Results for MDK-703 at the Society for Immunotherapy of Cancer’s 37th Annual Meeting (SITC 2022) (Businesswire) - "Medikine...announced today that it will deliver two poster presentations at the upcoming Society for Immunotherapy of Cancer’s 37th Annual Meeting (SITC 2022)....The first poster presentation will highlight preliminary Phase 1 safety, tolerability, and pharmacokinetic/pharmacodynamic data on Medikine’s lead program, MDK-703, an Fc-peptide fusion protein incorporating an IL-7 PEPTIKINE discovered using Medikine’s innovative platform technology. A second poster will detail preclinical data on MDK-1654, Medikine’s dual-acting agonist that incorporates both IL-7 and non-alpha IL-2/15 PEPTIKINEs."

P1 data • Preclinical • Oncology

A Single Ascending Dose Study to Evaluate MDK-703 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Medikine, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

Medikine Initiates First Clinical Trial of its Lead Program, an Interleukin-7 Mimetic, Under Management Team with Expertise in Next-Generation Cytokine Drug Discovery and Development (Businesswire) - "Company plans to investigate MDK-703 in solid tumors following completion of the Phase 1 clinical trial....Medikine, Inc...announced it has initiated dosing of MDK-703, an extended half-life IL-7 mimetic. The Phase 1 clinical trial, in healthy volunteers, will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single, ascending intramuscular doses of MDK-703 compared to placebo. Top-line results from the clinical trial are expected in the fourth quarter of 2022."

P1 data • Trial status • Oncology • Solid Tumor

A Single Ascending Dose Study to Evaluate MDK-703 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Medikine, Inc.

New P1 trial

In vitro and in vivo properties of MDK703: An Fc-peptide fusion IL-7Rαγc agonist unrelated in structure to IL-7 (AACR 2022) - "MDK-703 offers an attractive alternative to IL-7-based drug candidates currently in clinical development. The structural novelty of MDK-703 eliminates the risk of ADAs that neutralize endogenous IL-7. A first human trial of MDK703 is anticipated in 2022."

Preclinical • Oncology • CD4 • CD8 • IL7

Medikine to Highlight Preclinical Data on its Lead Program MDK-703, an IL-7 Mimetic, at the 2022 Annual Meeting of the American Association for Cancer Research (AACR) (Businesswire) - "Medikine...announced today that it will deliver a poster presentation at the AACR Annual Meeting 2022. The poster highlights preclinical data on Medikine’s lead program MDK-703, an Fc-peptide fusion protein incorporating an IL-7 PEPTIKINE discovered using Medikine’s innovative platform technology....The poster presents data on the effects of MDK-703 on CD8, CD4, and memory T-cell populations in human cells in vitro and when administered to non-human primates and CD34-engrafted humanized mice....Medikine expects MDK-703 to enter first-in-human clinical trials in mid-2022."

New trial • Preclinical • Oncology