Akiram Therapeutics' drug candidate AKIR001 cleared to start Phase 1 clinical trial
Akiram Therapeutics, a Swedish biotech company specializing in molecular radiation therapy, announces that the Swedish Medical Products Agency has approved the initiation of a Phase 1 clinical trial for its drug candidate 177Lu-AKIR001. This marks a key milestone in the company’s development of a pioneering cancer treatment aimed at offering new hope for patients with hard-to-treat tumors.
Akiram Therapeutics has developed a new type of targeted radioimmunotherapy, 177Lu-AKIR001. The therapy holds the potential to become a first-in-class treatment in multiple cancer types, including anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer. The drug is composed of a target recognition molecule, to which therapeutic radioactivity is coupled for effect on tumor cells.
The academic trial will be led by Karolinska University Hospital, overseeing all clinical aspects including patient recruitment and trial management. The primary goal is to assess the safety and tolerability of 177Lu-AKIR001. Recruitment is expected to begin in the fall of 2024 and will continue for two years. The study is funded by grants from, among others, the Sjöberg Foundation, the Erling Persson Foundation, and the Swedish Cancer Society. Akiram Therapeutics contributes to the study by providing the drug candidate 177Lu-AKIR001.
"177Lu-AKIR001 has the potential to transform how we treat hard-to-treat tumors and could represent a major advancement in precision medicine," says Renske Altena, Senior Physician and Primary Investigator in oncology and internal medicine at Karolinska Comprehensive Cancer Center. "By targeting the radiation specifically at the cancer marker CD44v6, we hope to achieve greater precision and higher efficacy than current treatment options, especially for patients whose tumors no longer respond to existing therapies."
Renske Altena adds, "For patients with aggressive and treatment-resistant cancer types, we hope this innovation can bring about a real change in their treatment plans and quality of life. A successful tailored treatment would be a significant step forward in oncology and precision medicine."
"The start of the Phase 1 clinical trial is a significant milestone for Akiram and an important step forward in molecular radiation therapy," says Marika Nestor, CEO and co-founder of Akiram Therapeutics. "We are excited to collaborate with Karolinska University Hospital and are confident in AKIR001's potential to improve treatment outcomes for patients."
The study is registered on ClinicalTrials.gov: NCT06639191.
About Akiram’s drug candidate
Developed through antibody phage display and affinity maturation targeting the CD44v6 cancer marker, 177Lu-AKIR001 combines the radiation component lutetium-177 with a targeted molecule. Preclinical studies have demonstrated its potential as a promising, first-in-class radiopharmaceutical therapy for cancers with high CD44v6 expression.
For more information, please contact:
Marika Nestor, CEO
Email: marika.nestor@akiramtherapeutics.com
About Akiram Therapeutics
Akiram Therapeutics is a Swedish biotech company focused on the development of targeted radioimmunotherapy for cancer, which is based on a proprietary antibody targeting the cancer marker CD44v6 combined with a radiation component. The therapy has generated strong preclinical results in cancer models in conditions that currently lack effective treatments. With the potential for its drug candidate to be classified as an orphan drug and recognized as first-in-class, the company is dedicated to advancing research in this field, including indications in head and neck cancer, lung cancer, and aggressive thyroid cancer. Headquartered in Uppsala, Sweden, Akiram Therapeutics is staffed with experts in radiation science research, cancer precision medicine, and drug development. To learn more, please visit Akiram’s website and follow Akiram on LinkedIn.
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