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	<title>Akiram Therapeutics</title>
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	<title>Akiram Therapeutics</title>
	<link>https://akiramtherapeutics.se</link>
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		<title>New JNM publication strengthens the scientific foundation for AKIR001</title>
		<link>https://akiramtherapeutics.se/new-jnm-publication-strengthens-the-scientific-foundation-for-akir001/</link>
		
		<dc:creator><![CDATA[Sciety Communications]]></dc:creator>
		<pubDate>Thu, 28 May 2026 08:00:00 +0000</pubDate>
				<category><![CDATA[Press Release]]></category>
		<guid isPermaLink="false">https://akiramtherapeutics.se/?p=970</guid>

					<description><![CDATA[Akiram Therapeutics, a Swedish biotech company specializing in molecular radiotherapy, announces that new preclinical data on its lead candidate AKIR001 have been published in The Journal of Nuclear Medicine. The results demonstrate selective tumor uptake, clear antitumor effects, and favorable tolerability in preclinical pancreatic cancer models, further strengthening the scientific foundation for AKIR001. The article...]]></description>
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<figure class="wp-block-image size-large"><img fetchpriority="high" decoding="async" width="1024" height="659" src="https://akiramtherapeutics.se/wp-content/uploads/2026/05/Akiram-preclinical-data-pancreas-cancer-JNM-1024x659.jpg" alt="" class="wp-image-971" srcset="https://akiramtherapeutics.se/wp-content/uploads/2026/05/Akiram-preclinical-data-pancreas-cancer-JNM-1024x659.jpg 1024w, https://akiramtherapeutics.se/wp-content/uploads/2026/05/Akiram-preclinical-data-pancreas-cancer-JNM-300x193.jpg 300w, https://akiramtherapeutics.se/wp-content/uploads/2026/05/Akiram-preclinical-data-pancreas-cancer-JNM-768x494.jpg 768w, https://akiramtherapeutics.se/wp-content/uploads/2026/05/Akiram-preclinical-data-pancreas-cancer-JNM.jpg 1280w" sizes="(max-width: 1024px) 100vw, 1024px" /><figcaption class="wp-element-caption"><br><em>Source: The Journal of Nuclear Medicine / Gustafsson A et al. (2026).</em></figcaption></figure>



<p class="wp-block-paragraph"></p>



<p class="wp-block-paragraph"><strong>Akiram Therapeutics, a Swedish biotech company specializing in molecular radiotherapy, announces that new preclinical data on its lead candidate AKIR001 have been published in The Journal of Nuclear Medicine. The results demonstrate selective tumor uptake, clear antitumor effects, and favorable tolerability in preclinical pancreatic cancer models, further strengthening the scientific foundation for AKIR001.</strong></p>



<p class="wp-block-paragraph">The article <em>[<sup>177</sup>Lu]Lu-AKIR001 for CD44v6-Positive Pancreatic Cancer: Preclinical Efficacy and Combination Strategies</em> presents new preclinical data for AKIR001 in models of pancreatic cancer, one of the most aggressive cancer types with a significant unmet medical need. The findings demonstrate dose-dependent tumor growth inhibition and support the effective targeting of CD44v6 with molecular radiotherapy in CD44v6-positive tumors.</p>



<p class="wp-block-paragraph">The lead candidate is currently undergoing Phase I clinical evaluation at Karolinska University Hospital.</p>



<p class="wp-block-paragraph">The publication has also been highlighted by the Society of Nuclear Medicine and Molecular Imaging (SNMMI) through its official channels. The recognition reflects the growing interest in targeted radiopharmaceuticals and CD44v6 as a therapeutic target in difficult-to-treat cancers.</p>



<p class="wp-block-paragraph">“The study provides additional scientific support for AKIR001 and reinforces the preclinical foundation of our CD44v6-targeted strategy in molecular radiotherapy. The recognition by SNMMI also reflects the growing interest in targeted radiopharmaceuticals and CD44v6 as a therapeutic target,” says Marika Nestor, CEO of Akiram Therapeutics.</p>



<p class="wp-block-paragraph"><strong>About the Phase I trial</strong><br>The ongoing Phase I clinical trial at Karolinska University Hospital enrolls patients with CD44v6-positive solid tumors who currently lack available treatment options. The trial evaluates safety, tolerability, and pharmacokinetics.<br>The trial is registered at <a href="https://clinicaltrials.gov/study/NCT06639191">ClinicalTrials.gov: NCT06639191</a>.</p>



<p class="wp-block-paragraph"><strong>About AKIR001</strong><br><sup>177</sup>Lu-AKIR001 is a CD44v6-targeted drug candidate for molecular radiotherapy developed by Akiram Therapeutics. Preclinical studies have demonstrated high tumor specificity, favorable tolerability, and clear antitumor effects in CD44v6-positive tumor models.</p>



<p class="wp-block-paragraph"><strong>Reference</strong><br>Gustafsson A et al. <em>[177Lu]Lu-AKIR001 for CD44v6-Positive Pancreatic Cancer: Preclinical Efficacy and Combination Strategies.</em> Journal of Nuclear Medicine (2026).<br>DOI: 10.2967/jnumed.125.271705<br>Full text: <a href="https://jnm.snmjournals.org/content/early/2026/04/22/jnumed.125.271705">https://jnm.snmjournals.org/content/early/2026/04/22/jnumed.125.271705</a></p>



<p class="wp-block-paragraph"><strong>For more information, please contact:</strong><br>Marika Nestor, CEO<br>Email: <a href="mailto:marika.nestor@akiramtherapeutics.com">marika.nestor@akiramtherapeutics.com</a></p>



<p class="wp-block-paragraph"><strong>About Akiram Therapeutics</strong><br>Akiram Therapeutics is a Swedish clinical-stage biotechnology company developing innovative targeted radiation therapy for cancer. The therapy is based on a proprietary antibody targeting the cancer marker CD44v6, linked to a radiation component. The drug candidate has demonstrated promising preclinical results in cancer types where effective treatments are currently lacking, and the company sees potential to achieve first-in-class status and orphan drug designation. Akiram is dedicated to advancing research in molecular radiotherapy, with a focus on head and neck cancer, lung cancer, and aggressive thyroid cancer. Headquartered in Uppsala, Sweden, the team comprises experts in radiation research, precision oncology, and drug development. For more information, visit Akiram’s <a href="https://akiramtherapeutics.se/">website</a> and follow the company on <a href="https://linkedin.com/company/akiram-therapeutics/">LinkedIn</a>.</p>
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		<title>AKIR001 advances to cohort 3 in Phase I trial</title>
		<link>https://akiramtherapeutics.se/akir001-advances-to-cohort-3-in-phase-i-trial/</link>
		
		<dc:creator><![CDATA[Sciety Communications]]></dc:creator>
		<pubDate>Wed, 13 May 2026 08:00:00 +0000</pubDate>
				<category><![CDATA[Press Release]]></category>
		<guid isPermaLink="false">https://akiramtherapeutics.se/?p=966</guid>

					<description><![CDATA[Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, announces that cohort 2b in the ongoing Phase I clinical trial evaluating the drug candidate 177Lu-AKIR001 has been completed. Following the safety review, the study has advanced to cohort 3. The results continue to support a favorable safety profile, enabling further dose escalation and evaluation of...]]></description>
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<figure class="wp-block-image size-large"><img decoding="async" width="1024" height="487" src="https://akiramtherapeutics.se/wp-content/uploads/2026/05/Akiram-Therapeutics-AKIR001-advances-to-cohort-3-Phase-I-trial-1-1024x487.png" alt="" class="wp-image-954" srcset="https://akiramtherapeutics.se/wp-content/uploads/2026/05/Akiram-Therapeutics-AKIR001-advances-to-cohort-3-Phase-I-trial-1-1024x487.png 1024w, https://akiramtherapeutics.se/wp-content/uploads/2026/05/Akiram-Therapeutics-AKIR001-advances-to-cohort-3-Phase-I-trial-1-300x143.png 300w, https://akiramtherapeutics.se/wp-content/uploads/2026/05/Akiram-Therapeutics-AKIR001-advances-to-cohort-3-Phase-I-trial-1-768x365.png 768w, https://akiramtherapeutics.se/wp-content/uploads/2026/05/Akiram-Therapeutics-AKIR001-advances-to-cohort-3-Phase-I-trial-1-1536x731.png 1536w, https://akiramtherapeutics.se/wp-content/uploads/2026/05/Akiram-Therapeutics-AKIR001-advances-to-cohort-3-Phase-I-trial-1-2048x975.png 2048w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>



<p class="wp-block-paragraph"><strong>Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, announces that cohort 2b in the ongoing Phase I clinical trial evaluating the drug candidate <sup>177</sup>Lu-AKIR001 has been completed. Following the safety review, the study has advanced to cohort 3. The results continue to support a favorable safety profile, enabling further dose escalation and evaluation of higher activity levels according to the study protocol. </strong></p>



<p class="wp-block-paragraph">The trial is conducted at Karolinska University Hospital, which also serves as the study sponsor, and is designed to evaluate the safety, tolerability, and pharmacokinetic profile of the drug candidate.</p>



<p class="wp-block-paragraph">In cohort 2b, the protein dose was evaluated while maintaining the same activity level as in the previous cohort. Following review of the cohort 2b data, the Safety Review Committee approved continued dose escalation, allowing the study to proceed to cohort 3.</p>



<p class="wp-block-paragraph">Across the cohorts evaluated to date, no dose-limiting toxicities have been observed, and imaging data have demonstrated selective tumor uptake and accumulation in tumor tissue in treated patients. Several patients have also received repeat treatment based on medical assessment, further supporting the tolerability, manageability, and feasibility of repeated administration. Taken together, the findings support continued clinical evaluation in the ongoing trial.</p>



<p class="wp-block-paragraph">Akiram’s drug candidate&nbsp;<sup>177</sup>Lu-AKIR001 is a targeted radiopharmaceutical that combines an antibody directed against CD44v6 — a cancer marker associated with several aggressive tumor types — with the therapeutic radioisotope lutetium-177. Through this mechanism, radiation can be delivered selectively to tumor cells while minimizing exposure to healthy tissue.</p>



<p class="wp-block-paragraph">“Advancing to cohort 3 marks an important step in our clinical development program. The results support further evaluation of dose levels, and the next stage will be central to further defining dosing parameters and treatment characteristics ahead of future stages of development,” says Marika Nestor, CEO of Akiram Therapeutics.</p>



<p class="wp-block-paragraph">“The decision to proceed to cohort 3 follows a thorough safety evaluation. We look forward to continuing the study and collecting additional clinical data,” says Dr. Luigi De Petris, Principal Investigator at Karolinska University Hospital.</p>



<p class="wp-block-paragraph">The trial enrolls patients with CD44v6-positive solid tumors who currently lack available treatment options.</p>



<p class="wp-block-paragraph">The project is the result of a successful national collaboration between leading clinical and academic institutions in precision oncology and has been supported by the Swedish Cancer Society, the Sjöberg Foundation, the Erling-Persson Foundation, the Swedish Research Council, and Vinnova, Sweden’s Innovation Agency.</p>



<p class="wp-block-paragraph">The trial is registered at&nbsp;<a href="https://clinicaltrials.gov/study/NCT06639191" target="_blank" rel="noreferrer noopener">ClinicalTrials.gov: NCT06639191</a>.</p>



<p class="wp-block-paragraph"><strong>Akiram’s drug candidate AKIR001</strong><br>Developed through antibody phage display and affinity maturation targeting the cancer marker CD44v6, <sup>177</sup>Lu-AKIR001 combines a CD44v6-directed antibody with the therapeutic radioisotope lutetium-177. Preclinical studies have demonstrated high tumor specificity, favorable dosimetry, and antitumor activity in CD44v6-expressing xenograft models.</p>



<p class="wp-block-paragraph"><strong>For more information, please contact:</strong><br>Marika Nestor, CEO<br>Email:&nbsp;<a href="mailto:marika.nestor@akiramtherapeutics.se">marika.nestor@akiramtherapeutics.com</a></p>



<p class="wp-block-paragraph"><strong>About Akiram Therapeutics</strong><br>Akiram Therapeutics is a Swedish clinical-stage biotechnology company developing innovative targeted radiation therapy for cancer. The therapy is based on a proprietary antibody targeting the cancer marker CD44v6, linked to a radiation component. The drug candidate has demonstrated promising preclinical results in cancer types where effective treatments are currently lacking, and the company sees potential to achieve first-in-class status and orphan drug designation. Akiram is dedicated to advancing research in molecular radiotherapy, with a focus on head and neck cancer, lung cancer, and aggressive thyroid cancer. Headquartered in Uppsala, Sweden, the team comprises experts in radiation research, precision oncology, and drug development. For more information, visit <a href="https://akiramtherapeutics.se/">Akiram’s website</a> and follow the company on <a href="https://linkedin.com/company/akiram-therapeutics/">LinkedIn</a>. </p>



<p class="wp-block-paragraph"></p>



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		<title>Marika Nestor featured in SSF’s Om Vetenskap podcast</title>
		<link>https://akiramtherapeutics.se/marika-nestor-featured-in-ssfs-om-vetenskap-podcast/</link>
		
		<dc:creator><![CDATA[Sciety Communications]]></dc:creator>
		<pubDate>Thu, 30 Apr 2026 13:42:53 +0000</pubDate>
				<category><![CDATA[News]]></category>
		<guid isPermaLink="false">https://akiramtherapeutics.se/?p=943</guid>

					<description><![CDATA[How can drugs be designed to target diseased cells with high precision? In a recent episode of Om Vetenskap, the podcast by the Swedish Foundation for Strategic Research (SSF), Akiram Therapeutics’ CEO and co-founder, Professor Marika Nestor, discusses the development of targeted radiopharmaceutical therapies and their potential to transform cancer treatment. The episode explores the...]]></description>
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<p class="wp-block-paragraph"><strong>How can drugs be designed to target diseased cells with high precision? In a recent episode of <em>Om Vetenskap</em>, the podcast by the Swedish Foundation for Strategic Research (SSF), Akiram Therapeutics’ CEO and co-founder, Professor Marika Nestor, discusses the development of targeted radiopharmaceutical therapies and their potential to transform cancer treatment.</strong></p>



<figure class="wp-block-image size-full"><img decoding="async" width="800" height="450" src="https://akiramtherapeutics.se/wp-content/uploads/2026/04/Malsokande-molekyl-hemsida.jpg" alt="" class="wp-image-944" srcset="https://akiramtherapeutics.se/wp-content/uploads/2026/04/Malsokande-molekyl-hemsida.jpg 800w, https://akiramtherapeutics.se/wp-content/uploads/2026/04/Malsokande-molekyl-hemsida-300x169.jpg 300w, https://akiramtherapeutics.se/wp-content/uploads/2026/04/Malsokande-molekyl-hemsida-768x432.jpg 768w" sizes="(max-width: 800px) 100vw, 800px" /></figure>



<p class="wp-block-paragraph">The episode explores the concept of targeted therapies designed to seek out and act directly on diseased cells rather than affecting the entire body. The conversation highlights recent advances in the field, how it is being developed, and what it could mean for the future of healthcare.</p>



<p class="wp-block-paragraph">Marika Nestor participates alongside Peter Nilsson, Professor of Organic Chemistry at Linköping University, in a discussion led by SSF’s Sofie Pehrsson.</p>



<p class="wp-block-paragraph">Listen to the episode (in Swedish):<br><a href="https://strategiska.se/malsokande-lakemedelsmolekyler/">https://strategiska.se/malsokande-lakemedelsmolekyler/</a></p>



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		<title>AKIR001 study selected as overall featured article in The Journal of Nuclear Medicine</title>
		<link>https://akiramtherapeutics.se/akir001-study-selected-as-overall-featured-article-in-the-journal-of-nuclear-medicine/</link>
		
		<dc:creator><![CDATA[Sciety Communications]]></dc:creator>
		<pubDate>Fri, 13 Feb 2026 07:00:00 +0000</pubDate>
				<category><![CDATA[Press Release]]></category>
		<guid isPermaLink="false">https://akiramtherapeutics.se/?p=925</guid>

					<description><![CDATA[The preclinical study underpinning the clinical development of Akiram Therapeutics’ lead candidate AKIR001, published in The Journal of Nuclear Medicine (JNM), has been selected as best basic investigation and overall featured article for the February issue. An image from the article also appears on the cover. AKIR001 is developed by Akiram Therapeutics, a Swedish biotech...]]></description>
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<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="576" src="https://akiramtherapeutics.se/wp-content/uploads/2026/02/JNM-Featured-article-Feb-issue-2026-1024x576.png" alt="" class="wp-image-926" srcset="https://akiramtherapeutics.se/wp-content/uploads/2026/02/JNM-Featured-article-Feb-issue-2026-1024x576.png 1024w, https://akiramtherapeutics.se/wp-content/uploads/2026/02/JNM-Featured-article-Feb-issue-2026-300x169.png 300w, https://akiramtherapeutics.se/wp-content/uploads/2026/02/JNM-Featured-article-Feb-issue-2026-768x432.png 768w, https://akiramtherapeutics.se/wp-content/uploads/2026/02/JNM-Featured-article-Feb-issue-2026-1536x864.png 1536w, https://akiramtherapeutics.se/wp-content/uploads/2026/02/JNM-Featured-article-Feb-issue-2026.png 1920w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /><figcaption class="wp-element-caption"><em>Cover of the February 2026 issue (Vol. 67, No. 2) of The Journal of Nuclear Medicine, featuring Figure 4 from the AKIR001 study. Source: Mortensen ACL et al. Journal of Nuclear Medicine (2026). © SNMMI.</em></figcaption></figure>



<p class="wp-block-paragraph"><strong>The preclinical study underpinning the clinical development of Akiram Therapeutics’ lead candidate AKIR001, published in The Journal of Nuclear Medicine (JNM), has been selected as best basic investigation and overall featured article for the February issue. An image from the article also appears on the cover.</strong></p>



<p class="wp-block-paragraph">AKIR001 is developed by Akiram Therapeutics, a Swedish biotech company developing targeted radiopharmaceutical therapies for cancer. The candidate targets CD44v6 and is currently under evaluation in a first-in-human Phase 1 clinical trial.</p>



<p class="wp-block-paragraph">The article presents the preclinical validation of AKIR001. The data demonstrate selective tumor uptake, favorable dosimetry, and clear antitumor effects in relevant models, strengthening the scientific foundation for the ongoing study in patients with CD44v6-positive tumors.</p>



<p class="wp-block-paragraph">“We are pleased to see the study recognized both as best basic investigation and as overall featured article in JNM,” says Marika Nestor, CEO of Akiram Therapeutics. “It is a strong recognition of the preclinical work behind AKIR001 and adds further weight as the program advances in clinical development.”</p>



<p class="wp-block-paragraph"><strong>About the Phase 1 clinical trial</strong><br>The ongoing first-in-human Phase 1 trial is conducted and sponsored by Karolinska University Hospital. The study evaluates safety, tolerability, pharmacokinetics and biodistribution in patients with tumors that express CD44v6, including anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, gynecological squamous cell carcinoma and non-small cell lung cancer.</p>



<p class="wp-block-paragraph">The trial is registered at ClinicalTrials.gov:<br><a href="https://clinicaltrials.gov/study/NCT06639191">https://clinicaltrials.gov/study/NCT06639191</a></p>



<p class="wp-block-paragraph"><strong>Reference</strong><br>Mortensen ACL et al.&nbsp;<em>Preclinical Validation of [177Lu]Lu-AKIR001, a CD44v6-Targeted Radiotherapeutic Entering First-in-Human Trials.</em>&nbsp;<em>Journal of Nuclear Medicine </em>(2026).<br>DOI: 10.2967/jnumed.125.270782.</p>



<p class="wp-block-paragraph">February issue (Vol. 67, No. 2):<br><a href="https://jnm.snmjournals.org/content/67/2/269">https://jnm.snmjournals.org/content/67/2/269</a></p>



<p class="wp-block-paragraph">Cover image:<br><a href="https://jnm.snmjournals.org/content/67/2.cover-expansion">https://jnm.snmjournals.org/content/67/2.cover-expansion</a></p>
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		<title>Cohort 2a completed and cohort 2b cleared to start in Phase I trial of AKIR001</title>
		<link>https://akiramtherapeutics.se/akiram-therapeutics-cohort-2a-completed-and-cohort-2b-cleared-to-start-in-phase-i-trial-of-akir001/</link>
		
		<dc:creator><![CDATA[Sciety Communications]]></dc:creator>
		<pubDate>Tue, 16 Dec 2025 08:05:06 +0000</pubDate>
				<category><![CDATA[Press Release]]></category>
		<guid isPermaLink="false">https://akiramtherapeutics.se/?p=919</guid>

					<description><![CDATA[Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, announces the completion of cohort 2a in the clinical Phase I trial evaluating the drug candidate 177Lu-AKIR001. Cohort 2a investigated a higher activity dose than the run-in cohort. The results aligned with earlier findings, demonstrating continued favorable safety and encouraging tumor uptake. The trial is...]]></description>
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<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="578" src="https://akiramtherapeutics.se/wp-content/uploads/2025/12/Akiram-Therapeutics-cohort-2a-completed-2b-cleared-phase-I-clinical-trial-1024x578.png" alt="" class="wp-image-920" srcset="https://akiramtherapeutics.se/wp-content/uploads/2025/12/Akiram-Therapeutics-cohort-2a-completed-2b-cleared-phase-I-clinical-trial-1024x578.png 1024w, https://akiramtherapeutics.se/wp-content/uploads/2025/12/Akiram-Therapeutics-cohort-2a-completed-2b-cleared-phase-I-clinical-trial-300x169.png 300w, https://akiramtherapeutics.se/wp-content/uploads/2025/12/Akiram-Therapeutics-cohort-2a-completed-2b-cleared-phase-I-clinical-trial-768x433.png 768w, https://akiramtherapeutics.se/wp-content/uploads/2025/12/Akiram-Therapeutics-cohort-2a-completed-2b-cleared-phase-I-clinical-trial-1536x867.png 1536w, https://akiramtherapeutics.se/wp-content/uploads/2025/12/Akiram-Therapeutics-cohort-2a-completed-2b-cleared-phase-I-clinical-trial-2048x1156.png 2048w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></figure>



<p class="wp-block-paragraph"><strong>Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, announces the completion of cohort 2a in the clinical Phase I trial evaluating the drug candidate <sup>177</sup>Lu-AKIR001. Cohort 2a investigated a higher activity dose than the run-in cohort. The results aligned with earlier findings, demonstrating continued favorable safety and encouraging tumor uptake.</strong></p>



<p class="wp-block-paragraph">The trial is conducted at Karolinska University Hospital, which also serves as the study sponsor. The purpose of the study is to assess safety, tolerability, and pharmacokinetics in patients with advanced, difficult-to-treat solid tumors.</p>



<p class="wp-block-paragraph">Akiram’s drug candidate <sup>177</sup>Lu-AKIR001 is a targeted radiopharmaceutical combining a CD44v6-directed antibody with the therapeutic radioisotope lutetium-177. This mechanism enables selective &nbsp;and precise delivery of radiation to tumor cells while limiting exposure to healthy tissue.</p>



<p class="wp-block-paragraph">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. Cohort 2b aims to identify the most favorable protein dose for the remaining cohorts in the Phase I trial and for further clinical development of AKIR001.</p>



<p class="wp-block-paragraph">“Completing cohort 2a marks solid and steady progress in our dose-escalation strategy,” says Marika Nestor, CEO of Akiram Therapeutics. “The consistency of the safety profile together with encouraging tumor uptake provides confidence as the study advances into the next step of the dose-escalation stage and confirms that development remains on track. Protein-dose optimization is central to preparing for subsequent stages of evaluation.”</p>



<p class="wp-block-paragraph">“Following a thorough safety assessment, we are pleased to now proceed to cohort 2b,” says Dr. Luigi De Petris, Principal Investigator at Karolinska University Hospital.</p>



<p class="wp-block-paragraph">The trial enrolls patients with anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, gynecological squamous cell carcinoma, and non-small cell lung cancer.</p>



<p class="wp-block-paragraph">The project is the result of a successful national collaboration between leading clinical and academic institutions in the field of precision oncology and has been supported by the Swedish Cancer Society, the Sjöberg Foundation, the Erling-Persson Foundation, the Swedish Research Council, and Vinnova, Sweden’s Innovation Agency.</p>



<p class="wp-block-paragraph">The trial is registered at <a href="https://clinicaltrials.gov/study/NCT06639191" target="_blank" rel="noreferrer noopener">ClinicalTrials.gov: NCT06639191</a>.</p>



<p class="wp-block-paragraph"><strong>About Akiram’s drug candidate AKIR001</strong><br>Developed through antibody phage display and affinity maturation targeting the cancer marker CD44v6, <sup>177</sup>Lu-AKIR001 combines a CD44v6-directed antibody with the therapeutic radioisotope lutetium-177. Preclinical studies have demonstrated high tumor specificity, favorable dosimetry, and antitumor activity in CD44v6-expressing xenograft models.</p>



<p class="wp-block-paragraph"><strong>For more information, please contact:<br></strong>Marika Nestor, CEO<br>Email: <a></a><a href="mailto:marika.nestor@akiramtherapeutics.com">marika.nestor@akiramtherapeutics.com</a></p>



<p class="wp-block-paragraph"><strong>About Akiram Therapeutics</strong><br>Akiram Therapeutics is a Swedish biotechnology company in clinical phase, developing innovative targeted radiation therapy for cancer. The therapy is based on a proprietary antibody that targets a radiation component to the cancer marker CD44v6. The drug candidate has demonstrated promising preclinical results in cancer types where effective treatments are currently lacking, and the company sees potential to achieve first-in-class status and orphan drug designation. Akiram is dedicated to advancing research in molecular radiotherapy, with a focus on head and neck cancer, lung cancer, and aggressive thyroid cancer. Headquartered in Uppsala, Sweden, the team comprises experts in radiation research, precision oncology, and drug development. For more information, visit Akiram’s <a href="https://akiramtherapeutics.se/">website</a> and follow the company on <a href="https://linkedin.com/company/akiram-therapeutics/">LinkedIn</a>.</p>
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		<title>AKIR001 publication in The Journal of Nuclear Medicine supports ongoing clinical development</title>
		<link>https://akiramtherapeutics.se/akir001-publication-in-the-journal-of-nuclear-medicine-supports-ongoing-clinical-development/</link>
		
		<dc:creator><![CDATA[Sciety Communications]]></dc:creator>
		<pubDate>Wed, 03 Dec 2025 08:13:10 +0000</pubDate>
				<category><![CDATA[Press Release]]></category>
		<guid isPermaLink="false">https://akiramtherapeutics.se/?p=908</guid>

					<description><![CDATA[Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, announces that data on its CD44v6-targeted radiotherapeutic candidate AKIR001 have been published in The Journal of Nuclear Medicine, one of the leading journals in nuclear medicine. The publication summarizes key studies underpinning the ongoing first-in-human Phase 1 trial at Karolinska University Hospital. It reports high...]]></description>
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<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="621" src="https://akiramtherapeutics.se/wp-content/uploads/2025/12/JNM-AKIR001-illustration-1024x621.png" alt="" class="wp-image-909" srcset="https://akiramtherapeutics.se/wp-content/uploads/2025/12/JNM-AKIR001-illustration-1024x621.png 1024w, https://akiramtherapeutics.se/wp-content/uploads/2025/12/JNM-AKIR001-illustration-300x182.png 300w, https://akiramtherapeutics.se/wp-content/uploads/2025/12/JNM-AKIR001-illustration-768x466.png 768w, https://akiramtherapeutics.se/wp-content/uploads/2025/12/JNM-AKIR001-illustration.png 1280w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /><figcaption class="wp-element-caption">Source: The Journal of Nuclear Medicine (© SNMMI) — Mortensen ACL et al., 2025.</figcaption></figure>



<p class="wp-block-paragraph"><strong>Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, announces that data on its CD44v6-targeted radiotherapeutic candidate AKIR001 have been published in <em>The Journal of Nuclear Medicine</em>, one of the leading journals in nuclear medicine. The publication summarizes key studies underpinning the ongoing first-in-human Phase 1 trial at Karolinska University Hospital. It reports high tumor selectivity, favorable safety and dosimetry findings, and antitumor effects in multiple preclinical models.</strong></p>



<p class="wp-block-paragraph">The article, titled <em>“Preclinical Validation of [177Lu]Lu-AKIR001, a CD44v6-Targeted Radiotherapeutic Entering First-in-Human Trials,”</em> presents foundational data supporting the clinical development of AKIR001. The study shows that the candidate exhibits a favorable tumor-to-organ profile, with sustained retention in tumors and low uptake in normal tissue — key characteristics of radiopharmaceuticals. The combined findings from biodistribution, dosimetry and specificity analyses confirm that <sup>177</sup>Lu-AKIR001 demonstrates clear and selective targeting of CD44v6-expressing tumors.</p>



<p class="wp-block-paragraph">The efficacy and safety results further strengthen the rationale for clinical evaluation, with clear dose-dependent antitumor activity and low uptake in normal tissues across several preclinical systems. These findings provide important scientific validation for Akiram’s CD44v6-targeted approach and support the ongoing first-in-human trial in patients with tumors that express CD44v6.</p>



<p class="wp-block-paragraph">“These results bring together years of systematic development around our CD44v6 platform—spanning antibody engineering, dosimetry, in vivo studies and safety assessments. Having the work peer-reviewed adds an extra layer of confidence as the drug is now being evaluated in patients at Karolinska University Hospital. For us, it reaffirms that we are advancing on a solid and well-supported scientific foundation,” says Marika Nestor, CEO of Akiram Therapeutics.</p>



<p class="wp-block-paragraph"><strong>About the Phase 1 clinical trial<br></strong>The ongoing first-in-human Phase 1 trial is conducted and sponsored by Karolinska University Hospital. The study evaluates safety, tolerability, pharmacokinetics and biodistribution in patients with tumors that express CD44v6, including anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, gynecological squamous cell carcinoma and non-small cell lung cancer.<br>The trial is registered at ClinicalTrials.gov: <a href="https://clinicaltrials.gov/study/NCT06639191" target="_blank" rel="noreferrer noopener">https://clinicaltrials.gov/study/NCT06639191</a></p>



<p class="wp-block-paragraph"><strong>Reference<br></strong>Mortensen ACL et al. <em>Preclinical Validation of [177Lu]Lu-AKIR001, a CD44v6-Targeted Radiotherapeutic Entering First-in-Human Trials.</em> <em>Journal of Nuclear Medicine</em> (2025).<br>DOI: 10.2967/jnumed.125.270782.<br>Full text: <a href="https://jnm.snmjournals.org/content/early/2025/11/06/jnumed.125.270782" target="_blank" rel="noreferrer noopener">https://jnm.snmjournals.org/content/early/2025/11/06/jnumed.125.270782</a></p>



<p class="wp-block-paragraph"><strong>For more information, please contact:<br></strong>Marika Nestor, CEO<br>Email: <a></a><a href="mailto:marika.nestor@akiramtherapeutics.com">marika.nestor@akiramtherapeutics.com</a></p>



<p class="wp-block-paragraph"><strong>About Akiram Therapeutics</strong><br>Akiram Therapeutics is a Swedish biotechnology company in clinical phase, developing innovative targeted radiation therapy for cancer. The therapy is based on a proprietary antibody that targets a radiation component to the cancer marker CD44v6. The drug candidate has demonstrated promising preclinical results in cancer types where effective treatments are currently lacking, and the company sees potential to achieve first-in-class status and orphan drug designation. Akiram is dedicated to advancing research in molecular radiotherapy, with a focus on head and neck cancer, lung cancer, and aggressive thyroid cancer. Headquartered in Uppsala, Sweden, the team comprises experts in radiation research, precision oncology, and drug development. For more information, visit Akiram’s <a href="https://akiramtherapeutics.se/">website</a> and follow the company on <a href="https://linkedin.com/company/akiram-therapeutics/">LinkedIn</a>.</p>
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		<title>A pioneer in targeted radiotherapy – Marika Nestor featured in Onkologi i Sverige</title>
		<link>https://akiramtherapeutics.se/a-pioneer-in-targeted-radiotherapy-marika-nestor-featured-in-onkologi-i-sverige/</link>
		
		<dc:creator><![CDATA[Sciety Communications]]></dc:creator>
		<pubDate>Mon, 10 Nov 2025 12:18:59 +0000</pubDate>
				<category><![CDATA[News]]></category>
		<guid isPermaLink="false">https://akiramtherapeutics.se/?p=890</guid>

					<description><![CDATA[What drives a cancer researcher to start a biotech company? In a newly published feature in Onkologi i Sverige, our CEO and co-founder, Professor Marika Nestor, shares insights from her journey through academia, innovation, and translational cancer research. The article traces her early steps into science, the growth of her all-female research group in Uppsala,...]]></description>
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<p class="wp-block-paragraph"><strong>What drives a cancer researcher to start a biotech company? In a newly published feature in <em>Onkologi i Sverige</em>, our CEO and co-founder, Professor Marika Nestor, shares insights from her journey through academia, innovation, and translational cancer research.</strong></p>



<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="479" src="https://akiramtherapeutics.se/wp-content/uploads/2025/11/Marika-Nestor_Onkologi-i-Sverige_Akiram-Nov2025-1.jpg-1-1024x479.jpg" alt="" class="wp-image-895" srcset="https://akiramtherapeutics.se/wp-content/uploads/2025/11/Marika-Nestor_Onkologi-i-Sverige_Akiram-Nov2025-1.jpg-1-1024x479.jpg 1024w, https://akiramtherapeutics.se/wp-content/uploads/2025/11/Marika-Nestor_Onkologi-i-Sverige_Akiram-Nov2025-1.jpg-1-300x140.jpg 300w, https://akiramtherapeutics.se/wp-content/uploads/2025/11/Marika-Nestor_Onkologi-i-Sverige_Akiram-Nov2025-1.jpg-1-768x359.jpg 768w, https://akiramtherapeutics.se/wp-content/uploads/2025/11/Marika-Nestor_Onkologi-i-Sverige_Akiram-Nov2025-1.jpg-1-1536x719.jpg 1536w, https://akiramtherapeutics.se/wp-content/uploads/2025/11/Marika-Nestor_Onkologi-i-Sverige_Akiram-Nov2025-1.jpg-1-2048x958.jpg 2048w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /><figcaption class="wp-element-caption">Marika Nestor</figcaption></figure>



<p class="wp-block-paragraph">The article traces her early steps into science, the growth of her all-female research group in Uppsala, and her longstanding focus on developing targeted radiopharmaceutical therapies for difficult-to-treat cancers. It also touches on the founding of Akiram Therapeutics as a way to bring research closer to clinical application and patient benefit.</p>



<p class="wp-block-paragraph">Read the full article (in Swedish) on <em>Onkologi i Sverige</em>:<br><a href="https://www.onkologiisverige.se/nestorn-i-stralterapi-pa-en-stralande-vag-mot-nya-cancerlakemedel/" data-type="link" data-id="https://www.onkologiisverige.se/nestorn-i-stralterapi-pa-en-stralande-vag-mot-nya-cancerlakemedel/" target="_blank" rel="noreferrer noopener">Nestorn i strålterapi: på en strålande väg mot nya cancerläkemedel</a></p>



<p class="wp-block-paragraph"></p>





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		<title>Akiram Therapeutics research selected as Top Rated Oral Presentations at EANM 2025</title>
		<link>https://akiramtherapeutics.se/akiram-therapeutics-research-selected-as-top-rated-oral-presentations-at-eanm-2025/</link>
		
		<dc:creator><![CDATA[Sciety Communications]]></dc:creator>
		<pubDate>Tue, 30 Sep 2025 07:15:00 +0000</pubDate>
				<category><![CDATA[Press Release]]></category>
		<guid isPermaLink="false">https://akiramtherapeutics.se/?p=905</guid>

					<description><![CDATA[Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, will contribute to several academic presentations at the EANM Congress 2025 in Barcelona, October 4–8. Two have been selected as Top Rated Oral Presentations, highlighting continued development of the CD44v6-targeting antibody used in the company’s clinical-stage radiopharmaceutical—currently being investigated in a Phase I clinical trial....]]></description>
										<content:encoded><![CDATA[
<p class="wp-block-paragraph"><strong>Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, will contribute to several academic presentations at the EANM Congress 2025 in Barcelona, October 4–8. Two have been selected as Top Rated Oral Presentations, highlighting continued development of the CD44v6-targeting antibody used in the company’s clinical-stage radiopharmaceutical—currently being investigated in a Phase I clinical trial.</strong></p>



<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="576" src="https://akiramtherapeutics.se/wp-content/uploads/2025/11/Akiram-Therapeutics-research-Top-Rated-Oral-Presentationn-EANM-2025-1024x576.jpg" alt="" class="wp-image-906" srcset="https://akiramtherapeutics.se/wp-content/uploads/2025/11/Akiram-Therapeutics-research-Top-Rated-Oral-Presentationn-EANM-2025-1024x576.jpg 1024w, https://akiramtherapeutics.se/wp-content/uploads/2025/11/Akiram-Therapeutics-research-Top-Rated-Oral-Presentationn-EANM-2025-300x169.jpg 300w, https://akiramtherapeutics.se/wp-content/uploads/2025/11/Akiram-Therapeutics-research-Top-Rated-Oral-Presentationn-EANM-2025-768x432.jpg 768w, https://akiramtherapeutics.se/wp-content/uploads/2025/11/Akiram-Therapeutics-research-Top-Rated-Oral-Presentationn-EANM-2025-1536x864.jpg 1536w, https://akiramtherapeutics.se/wp-content/uploads/2025/11/Akiram-Therapeutics-research-Top-Rated-Oral-Presentationn-EANM-2025-2048x1152.jpg 2048w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></figure>



<p class="wp-block-paragraph">This marks the second consecutive year that research involving Akiram’s CD44v6-targeting platform has been selected for oral presentation at EANM. The 2025 contributions stem from ongoing work in Professor Marika Nestor’s academic group at Uppsala University, exploring novel strategies such as expanding to additional radioisotopes, combination treatment, and dosimetry approaches for CD44v6-targeted radionuclide therapy. The work complements the ongoing clinical evaluation of the radiopharmaceutical candidate in advanced solid tumors.</p>



<p class="wp-block-paragraph">“We’re honored to once again be part of the EANM Congress,” says Marika Nestor, CEO of Akiram Therapeutics. “It’s encouraging to see how the scientific foundation of our CD44v6 platform continues to grow—while our clinical candidate moves through its first human trial. These efforts reflect our long-standing commitment to collaboration, innovation, and patient impact.”</p>



<p class="wp-block-paragraph"><strong>Presentations at EANM 2025</strong></p>



<ul class="wp-block-list">
<li><strong>Oral Presentation (Top Rated)<br>Title: </strong><em>Tb, or Not Tb – Exploring Terbium-161 for CD44v6-Targeted Radionuclide Therapy</em><br><strong>Presentation No.:</strong> OP-414<br><strong>Date &amp; Time:</strong> October 6, 3:30 PM, Room 114<br><strong>Speaker:</strong> Amanda Gustafsson</li>



<li><strong>Oral Presentation (Top Rated)</strong><br><strong>Title: </strong><em>Combining CD44v6-Targeted Radionuclide Therapy with Chemotherapy for Treatment of Pancreatic Ductal Adenocarcinoma</em><br><strong>Presentation No.:</strong> OP-519<br><strong>Date &amp; Time:</strong> October 7, 8:40 AM, Room 114<br><strong>Speaker:</strong> Amanda Gustafsson</li>



<li><strong>e-Poster</strong><br><strong>Title: </strong><em>Optimizing CD44v6-Targeted Radioimmunotherapy: A Retrospective Red Marrow Dosimetry Comparison of <sup>186</sup>Re, <sup>177</sup>Lu, and <sup>161</sup>Tb</em><br><strong>Poster No.:</strong> EP-1160<br><strong>Date:</strong> October 4–8, during congress hours<br><strong>Author:</strong> Jens Hemmingsson</li>
</ul>



<p class="wp-block-paragraph">CD44v6 is a cell surface marker found in several aggressive cancer types, making it a relevant target for precision radiotherapy. The antibody targeting CD44v6 is also used in Akiram’s radiopharmaceutical candidate&nbsp;<sup>177</sup>Lu-AKIR001, which is currently being evaluated in a Phase I trial sponsored by Karolinska University Hospital. The study assesses safety and pharmacokinetics in patients with advanced solid tumors. The trial is registered at&nbsp;<a href="https://clinicaltrials.gov/study/NCT06639191" target="_blank" rel="noreferrer noopener">ClinicalTrials.gov: NCT06639191</a>.&nbsp;</p>



<p class="wp-block-paragraph"><strong>EANM in brief</strong><br>The annual EANM Congress is one of the premier global platforms where leading experts and industry representatives from around the world gather to discuss advancements and future trends in nuclear medicine. Read more:&nbsp;<a href="https://eanm25.eanm.org/" target="_blank" rel="noreferrer noopener">https://eanm25.eanm.org/</a></p>



<p class="wp-block-paragraph"><strong>For more information, please contact:</strong><br>Marika Nestor, CEO<br>Email:&nbsp;<a href="mailto:marika.nestor@akiramtherapeutics.se">marika.nestor@akiramtherapeutics.com</a></p>



<p class="wp-block-paragraph"><strong>About Akiram Therapeutics</strong><br>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.&nbsp;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.&nbsp;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&nbsp;<a href="https://akiramtherapeutics.se/" target="_blank" rel="noreferrer noopener">Akiram’s website</a>&nbsp;and follow Akiram on&nbsp;<a href="https://linkedin.com/company/akiram-therapeutics/" target="_blank" rel="noreferrer noopener">LinkedIn</a>.</p>
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		<title>Clinical Phase I clinical trial with AKIR001 progresses to next step following completion of first cohort</title>
		<link>https://akiramtherapeutics.se/clinical-phase-i-clinical-trial-with-akir001-progresses-to-next-step-following-completion-of-first-cohort/</link>
		
		<dc:creator><![CDATA[Sciety Communications]]></dc:creator>
		<pubDate>Mon, 25 Aug 2025 07:42:30 +0000</pubDate>
				<category><![CDATA[Press Release]]></category>
		<guid isPermaLink="false">https://akiramtherapeutics.se/?p=855</guid>

					<description><![CDATA[Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, announces the completion of the first cohort in the clinical Phase I trial evaluating the drug candidate 177Lu-AKIR001. No safety signals have been observed, and the trial is now proceeding to the next stage as planned. The trial is being conducted at Karolinska University Hospital,...]]></description>
										<content:encoded><![CDATA[
<p class="wp-block-paragraph"><strong>Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, announces the completion of the first cohort in the clinical Phase I trial evaluating the drug candidate 177Lu-AKIR001. No safety signals have been observed, and the trial is now proceeding to the next stage as planned.</strong></p>



<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="467" src="https://akiramtherapeutics.se/wp-content/uploads/2025/08/Akiram-Therapeutics-AKIR001-Phase1-trial-first-cohort-completed-1-1024x467.jpg" alt="" class="wp-image-858" srcset="https://akiramtherapeutics.se/wp-content/uploads/2025/08/Akiram-Therapeutics-AKIR001-Phase1-trial-first-cohort-completed-1-1024x467.jpg 1024w, https://akiramtherapeutics.se/wp-content/uploads/2025/08/Akiram-Therapeutics-AKIR001-Phase1-trial-first-cohort-completed-1-300x137.jpg 300w, https://akiramtherapeutics.se/wp-content/uploads/2025/08/Akiram-Therapeutics-AKIR001-Phase1-trial-first-cohort-completed-1-768x350.jpg 768w, https://akiramtherapeutics.se/wp-content/uploads/2025/08/Akiram-Therapeutics-AKIR001-Phase1-trial-first-cohort-completed-1-1536x700.jpg 1536w, https://akiramtherapeutics.se/wp-content/uploads/2025/08/Akiram-Therapeutics-AKIR001-Phase1-trial-first-cohort-completed-1-2048x933.jpg 2048w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></figure>



<p class="wp-block-paragraph">The trial is being conducted at Karolinska University Hospital, which also serves as the study sponsor. The aim is to evaluate safety, tolerability, and pharmacokinetics in patients with advanced, difficult-to-treat solid tumors.</p>



<p class="wp-block-paragraph">Akiram’s drug candidate&nbsp;<sup>177</sup>Lu-AKIR001 is a targeted radiopharmaceutical that combines an antibody directed against CD44v6—a cancer marker associated with several aggressive tumor types—with the therapeutic radioisotope lutetium-177. Through this mechanism, radiation can be delivered directly to tumor cells while minimizing impact on surrounding healthy tissue.<strong></strong></p>



<p class="wp-block-paragraph">All patients planned for the first dose cohort have now been enrolled. No dose-limiting toxicities or other safety concerns have been observed.<strong></strong></p>



<p class="wp-block-paragraph">“Completing the first cohort marks an important milestone for AKIR001. Our goal is to develop a treatment that reaches tumors with high selectivity and has a favorable safety profile. These initial clinical data support the next step in development,” says Marika Nestor, CEO of Akiram Therapeutics.</p>



<p class="wp-block-paragraph">“The completion of cohort 1 without unexpected side effects represents an important step forward. The results suggest that the drug is well tolerated at the doses tested so far, and we are pleased to proceed as planned,” says Dr. Luigi De Petris, Principal Investigator at Karolinska University Hospital.</p>



<p class="wp-block-paragraph">The trial is enrolling patients with anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, gynecological squamous cell carcinoma, and non-small cell lung cancer. In the next phase, additional patients will be included to gather further data on dose response, safety, and early signs of efficacy.<strong></strong></p>



<p class="wp-block-paragraph">The study is the result of a successful national collaboration between leading clinical and academic institutions in the field of precision oncology. The project is supported by the Swedish Cancer Society, the Sjöberg Foundation, the Erling-Persson Foundation, the Swedish Research Council, and Vinnova, Sweden’s Innovation Agency.</p>



<p class="wp-block-paragraph">The trial is registered at <a href="https://clinicaltrials.gov/study/NCT06639191" target="_blank" rel="noreferrer noopener">ClinicalTrials.gov: NCT06639191</a>.</p>



<p class="wp-block-paragraph"><a href="https://www.karolinska.se/om-oss/centrala-nyheter/2025/08/forsta-delen-i-malinriktad-radiofarmaceutisk-cancerstudie-slutford-vid-karolinska-universitetssjukhuset/" data-type="link" data-id="https://www.karolinska.se/om-oss/centrala-nyheter/2025/08/forsta-delen-i-malinriktad-radiofarmaceutisk-cancerstudie-slutford-vid-karolinska-universitetssjukhuset/">Read the announcement from&nbsp;Karolinska University Hospital (in Swedish).</a></p>



<p class="wp-block-paragraph"><strong>About Akiram’s drug candidate</strong><br>Developed through antibody phage display and affinity maturation targeting the CD44v6 cancer marker, <sup>177</sup>Lu-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 tumor types with high CD44v6 expression.</p>



<p class="wp-block-paragraph"><strong>For more information, please contact:</strong><br>Marika Nestor, CEO<br>Email: <a href="mailto:marika.nestor@akiramtherapeutics.com">marika.nestor@akiramtherapeutics.com</a></p>



<p class="wp-block-paragraph"><strong>About Akiram Therapeutics</strong><br>Akiram Therapeutics is a Swedish biotechnology company in clinical phase, developing innovative targeted radiation therapy for cancer. The therapy is based on a proprietary antibody that targets a radiation component to the cancer marker CD44v6. The drug candidate has demonstrated promising preclinical results in cancer types where effective treatments are currently lacking, and the company sees potential to achieve first-in-class status and orphan drug designation. Akiram is dedicated to advancing research in molecular radiotherapy, with a focus on head and neck cancer, lung cancer, and aggressive thyroid cancer. Headquartered in Uppsala, Sweden, the team comprises experts in radiation research, precision oncology, and drug development. For more information, visit Akiram’s <a href="https://akiramtherapeutics.se/">website</a> and follow the company on <a href="https://linkedin.com/company/akiram-therapeutics/">LinkedIn</a>.</p>



<p class="wp-block-paragraph"></p>
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		<title>First patient enrolled in Phase 1 clinical trial of Akiram’s cancer drug candidate AKIR001</title>
		<link>https://akiramtherapeutics.se/first-patient-enrolled-in-phase-1-clinical-trial-of-akirams-cancer-drug-candidate-akir001/</link>
		
		<dc:creator><![CDATA[Sciety Communications]]></dc:creator>
		<pubDate>Wed, 30 Apr 2025 06:19:58 +0000</pubDate>
				<category><![CDATA[Press Release]]></category>
		<guid isPermaLink="false">https://akiramtherapeutics.se/?p=845</guid>

					<description><![CDATA[Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, today announces that the first patient has been enrolled in the Phase 1 clinical trial of its drug candidate 177Lu-AKIR001. The trial is being conducted at Karolinska University Hospital, which also acts as the study sponsor, and marks an important milestone in Akiram’s efforts to...]]></description>
										<content:encoded><![CDATA[
<p class="wp-block-paragraph"><strong>Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, today announces that the first patient has been enrolled in the Phase 1 clinical trial of its drug candidate <sup>177</sup>Lu-AKIR001. The trial is being conducted at Karolinska University Hospital, which also acts as the study sponsor, and marks an important milestone in Akiram’s efforts to develop a new targeted treatment for difficult-to-treat cancers.</strong></p>



<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="683" src="https://akiramtherapeutics.se/wp-content/uploads/2025/04/Akiram-Therapeutics-first-patient-enrolled-clinical-phase-1-trial-1024x683.jpg" alt="" class="wp-image-847" srcset="https://akiramtherapeutics.se/wp-content/uploads/2025/04/Akiram-Therapeutics-first-patient-enrolled-clinical-phase-1-trial-1024x683.jpg 1024w, https://akiramtherapeutics.se/wp-content/uploads/2025/04/Akiram-Therapeutics-first-patient-enrolled-clinical-phase-1-trial-300x200.jpg 300w, https://akiramtherapeutics.se/wp-content/uploads/2025/04/Akiram-Therapeutics-first-patient-enrolled-clinical-phase-1-trial-768x512.jpg 768w, https://akiramtherapeutics.se/wp-content/uploads/2025/04/Akiram-Therapeutics-first-patient-enrolled-clinical-phase-1-trial-1536x1024.jpg 1536w, https://akiramtherapeutics.se/wp-content/uploads/2025/04/Akiram-Therapeutics-first-patient-enrolled-clinical-phase-1-trial-2048x1365.jpg 2048w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></figure>



<p class="wp-block-paragraph">This is the first-in-human trial with AKIR001 and aims to evaluate the drug’s safety, tolerability, and pharmacokinetic profile. The trial follows a dose-escalation design and targets patients with advanced, difficult-to-treat tumors.</p>



<p class="wp-block-paragraph">Akiram’s drug candidate <sup>177</sup>Lu-AKIR001 is a targeted radiopharmaceutical that combines an antibody directed against CD44v6—a cancer marker associated with several aggressive tumor types—with the therapeutic radioisotope lutetium-177. Through this mechanism, radiation can be delivered directly to tumor cells while minimizing damage to surrounding healthy tissue.</p>



<p class="wp-block-paragraph">The trial is enrolling patients with anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, gynecological squamous cell carcinoma, and non-small cell lung cancer. It is expected to run for 18–24 months with patients recruited on a rolling basis. As the sponsor, Karolinska University Hospital is responsible for conducting the trial in accordance with applicable regulations and with patient safety as a top priority.</p>



<p class="wp-block-paragraph">“The launch of the clinical trial with AKIR001 marks the beginning of a new chapter for Akiram. Our vision has always been to develop a treatment that can offer new opportunities for patients with difficult-to-treat cancers, where treatment options are often limited. Seeing our drug candidate now being evaluated in collaboration with Karolinska University Hospital—one of Europe’s leading cancer centers—is a major milestone and a strong motivator for our continued work,” says Marika Nestor, CEO of Akiram Therapeutics.</p>



<p class="wp-block-paragraph">“The enrollment of the first patient means that we have now initiated dose escalation and systematic evaluation of AKIR001’s safety and potential. This is an important first step in understanding how the drug behaves clinically and the potential role a CD44v6-targeted therapy could play in tumor types where treatment options today remain limited,” says Dr. Luigi De Petris, Principal Investigator at Karolinska University Hospital.</p>



<p class="wp-block-paragraph">The trial is registered at <a href="https://clinicaltrials.gov/study/NCT06639191" target="_blank" rel="noreferrer noopener">ClinicalTrials.gov: NCT06639191</a>.<strong></strong></p>



<p class="wp-block-paragraph"><strong>About Akiram’s drug candidate</strong><br>Developed through antibody phage display and affinity maturation targeting the CD44v6 cancer marker, <sup>177</sup>Lu-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.</p>



<p class="wp-block-paragraph"><strong>For more information, please contact:</strong><br>Marika Nestor, CEO<br>Email: <a href="mailto:marika.nestor@akiramtherapeutics.com">marika.nestor@akiramtherapeutics.com</a></p>



<p class="wp-block-paragraph"><strong>About Akiram Therapeutics</strong><br>Akiram Therapeutics is a Swedish biotechnology company in clinical phase, developing innovative targeted radiation therapy for cancer. The therapy is based on a proprietary antibody that targets a radiation component to the cancer marker CD44v6. The drug candidate has demonstrated promising preclinical results in cancer types where effective treatments are currently lacking, and the company sees potential to achieve first-in-class status and orphan drug designation. Akiram is dedicated to advancing research in molecular radiotherapy, with a focus on head and neck cancer, lung cancer, and aggressive thyroid cancer. Headquartered in Uppsala, Sweden, the team comprises experts in radiation research, precision oncology, and drug development. For more information, visit Akiram’s <a href="https://akiramtherapeutics.se/">website</a> and follow the company on <a href="https://linkedin.com/company/akiram-therapeutics/">LinkedIn</a>.</p>
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