AKIR001 / Akiram Therapeutics - LARVOL DELTA

Preclinical efficacy and dosimetry of CD44v6-directed terbium-161 radionuclide therapy. (PubMed, Theranostics) - P1 | "[161Tb]Tb-AKIR001 demonstrated favorable biodistribution and dosimetry profiles, together with encouraging therapeutic effects without signs of severe toxicity. Compared to [177Lu]Lu-AKIR001, [161Tb]Tb-AKIR001 may offer added advantages in certain therapeutic contexts, and our results highlight [161Tb]Tb-AKIR001 as a promising candidate for further development in targeted radionuclide therapy."

Journal • Preclinical • Genito-urinary Cancer • Hematological Disorders • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma

[177Lu]Lu-AKIR001 for CD44v6-Positive Pancreatic Cancer: Preclinical Efficacy and Combination Strategies. (PubMed, J Nucl Med) - " [177Lu]Lu-AKIR001 demonstrated activity-dependent therapeutic potential in mice bearing PDAC xenografts. Combination therapy with paclitaxel indicated potential synergistic benefit, but further investigation and optimization are warranted."

Journal • Preclinical • Hematological Disorders • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

[177Lu]Lu-AKIR001 First-in-human Study (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Karolinska University Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Cervical Cancer • Gynecologic Cancers • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • Vulvar Cancer • ALK • BRAF • NTRK • PD-L1

Akiram Therapeutics: Cohort 2a completed and cohort 2b cleared to start in Phase I trial of AKIR001 (Cision) - "All patients planned for cohort 2a have now been enrolled, and no dose-limiting toxicities or other safety concerns have been observed. Following review of the cohort 2a data, the Safety Review Committee has approved initiation of cohort 2b. In this next step of the dose-escalation stage, the protein dose will be increased while maintaining the same activity level used in cohort 2a."

First-in-human • P2a data • Trial status • Cervical Cancer • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Anaplastic Carcinoma • Vulvar Cancer