AKIR001 / Akiram Therapeutics - LARVOL DELTA

Development of an anti-CD44v6 pretargeting-based approach for gastric cancer (EANM 2026) - "In this proof-of-principle study, we characterised and investigated a novel CD44v6-targeting antibody fragment based on AKIR001 for pretargeted radiotherapy. Modification of the antibody format and functionalisation with TCO had a minimal impact on binding kinetics. 111In was used for radiolabelling of DOTAPEG8-Tetrazine in this investigation due to convenience and demonstrated functionality of the miniAKIR-TCO approach."

Gastric Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

Preclinical Evaluation of 177 Lu-Labelled CD44v6-Targeted Full-Length and scFv Antibodies for Bladder Cancer Radioimmunotherapy (EANM 2026) - "AKIR001 exhibited an affinity (KD) of ~20 pM, whereas scFv-CD44v6 showed a KDof ~0.2 nM...Spheroids also showed dose-dependent sensitivity to cisplatin alone... Taken together, we present two CD44v6-targeting antibody formats with high-affinity binding in the picomolar range and specific CD44v6 targeting in various BC models, both in vitro and in vivo. Moreover, the 177Lu-labelled constructs showed CD44v6- and activity-dependent cytotoxicity in CD44v6-expressing 3D tumour models, along with significant tumour uptake and sustained retention in vivo. Our findings highlight the therapeutic potential of CD44v6-targeted radioimmunotherapy to improve precision treatment strategies for BC."

IO biomarker • Preclinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Preliminary results from the ongoing first-in-human clinical trial of anti-CD44v6 agent [ 177 Lu]Lu-AKIR001 (EANM 2026) - P1 | "[177Lu]Lu-AKIR001 demonstrated a favourable safety profile within the investigated activity range. The results indicate that CD44v6-high lesions have potential to achieve therapeutically relevant tumour doses at higher activities and repeated administrations. These findings support continued activity escalation and evaluation of target expression-response correlation, and warrants further development of [177Lu]Lu-AKIR001 as a potential first-in-class radiotherapeutic approach."

Clinical • First-in-human • P1 data • Gynecologic Cancers • Head and Neck Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

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