Aktis Oncology (NASDAQ:AKTS) outlined its strategy to expand targeted radiopharmaceutical therapies beyond currently approved cancer targets during a presentation at the Jefferies Healthcare Conference, emphasizing its clinical-stage pipeline, isotope supply arrangements and planned data readouts.
Nora Lee, an investment banking analyst in Jefferies’ healthcare group, introduced the session. Aktis Oncology Chief Executive Officer Matthew Roden described the company as a “targeted radiopharmaceutical company” focused on bringing radiopharmaceutical treatments to patient groups that currently do not have access to such options.
Company Positions Platform as Expansion of Radiopharmaceutical Market
Roden said current radiopharmaceutical approvals remain concentrated in limited target areas, including PSMA in prostate cancer and SSTR2-targeted agents. Aktis is seeking to develop radiopharmaceuticals against new targets expressed across multiple solid tumor types.
The company’s approach is built around what Roden called a “mini-protein radioconjugate” platform. He said the mini-proteins are typically 40 to 60 amino acids and are designed to penetrate tumors, clear quickly from plasma and bind a broad range of targets with high affinity and selectivity.
Roden compared the potential evolution of radiopharmaceuticals to the antibody-drug conjugate field, saying format optimization could help expand the modality’s use. Aktis has built proprietary screening libraries encoding more than 6 billion variants and is also using generative AI tools to screen additional sequences, he said.
Lead Programs Target Nectin-4 and B7-H3
Aktis has advanced two assets into Phase 1b dose escalation studies. The lead program, AKY-1189, targets Nectin-4-expressing solid tumors. The second, AKY-2519, targets B7-H3. Roden said both programs could be first-in-class radioconjugates at launch if successful.
Beyond those two programs, Roden said Aktis has multiple undisclosed preclinical assets and expects to name two additional clinical candidates early next year. The company also has a discovery collaboration with Eli Lilly using Aktis’ platform to discover mini-protein radioconjugates against targets outside Aktis’ focused target space. Roden said Aktis disclosed earlier this year that it had reached the first milestone under that partnership.
Roden said Nectin-4 and B7-H3 are expressed in multiple disease areas, creating potential multi-indication development opportunities. He cited Pluvicto and Padcev as examples of single disease-area drugs approved in multiple indications that are expected to reach “mega-blockbuster” status, according to consensus peak sales numbers shown in the presentation.
Supply Chain and Manufacturing Emphasized
Roden said Aktis has focused on building an end-to-end supply chain to support clinical development and potential commercialization. He highlighted the importance of on-time delivery for radiopharmaceuticals and said the company has built redundancy across multiple points in the supply chain.
The company has announced three commercial supply agreements for actinium-225 across different geographies and production methods and has signed several additional supply agreements since then, Roden said. He described the company’s isotope supply portfolio as “industry-leading.”
Aktis also has multiple contract manufacturing relationships and is developing its own GMP manufacturing suite, which Roden said is expected to open later this year.
Clinical Imaging Data Support Dose Escalation
For AKY-1189, Roden reviewed clinical imaging data that he said showed the radioconjugate entering tumors, being retained in tumors and clearing rapidly from normal tissues. He said kidney and bone marrow exposure levels were not higher than values published for approved products such as Pluvicto and Lutathera, which he said supported dose escalation to potentially active levels.
Roden said PET/CT imaging across five tumor types showed robust tumor uptake, with SUV max values ranging from high single digits to about 100 and central tendency in the 20s to 40s. He said the findings supported development not only in bladder cancer, where Nectin-4 is well known, but also in other tumor types, including breast and colorectal cancers.
The AKY-1189 Phase 1b study, called NECTINIUM-2, is in dose escalation. Roden said the company is on track and expects to present data in the first quarter of 2027. The study includes post-Padcev bladder cancer patients initially, as well as patients with uptake-positive tumors across other cancer types, including triple-negative breast cancer, hormone receptor-positive breast cancer, lung cancers and other tumors.
For AKY-2519, Roden discussed data presented at the ASCO annual meeting by Professor Mike Sathekge of NuMeRI in South Africa. He said imaging showed tumor uptake and limited normal tissue exposure, with tumor retention observed out to six days after injection in one patient case study. Roden said aggregate dosimetry data across assessed patients supported moving into dose escalation.
Roden also said work with Professor Ken Herrmann in Essen, Germany, showed uptake of AKY-2519 in additional tumor types, including newly diagnosed lung adenocarcinoma, small cell lung cancer, rectal cancer and other colorectal cancer patients.
Upcoming Milestones
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Aktis expects initial data from the Nectin-4 program, AKY-1189, in the first quarter of 2027.
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The B7-H3 prostate cancer study, BActinium-1, is open and enrolling in metastatic castration-resistant prostate cancer, including both Pluvicto-experienced and Pluvicto-naive cohorts.
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A second B7-H3 study, BActinium-2, has cleared regulatory review and is expected to begin enrolling in the second half, focusing on non-prostate tumors including non-small cell lung cancer, small cell lung cancer and other B7-H3-positive tumors.
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Aktis expects to provide data from the prostate study in 2027.
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The company expects its manufacturing site to open later this year and plans to advance two additional clinical candidates early next year.
About Aktis Oncology (NASDAQ:AKTS)
Aktis Oncology (NASDAQ: AKTS) is a biotechnology company focused on the discovery and development of new therapies for cancer. The firm concentrates on advancing oncology candidates through research and development with the goal of addressing unmet medical needs in oncology. Its work emphasizes targeted and precision approaches intended to improve the safety and efficacy profiles of cancer treatments.
The company’s activities include laboratory research, preclinical studies and clinical development as it advances its pipeline programs toward regulatory milestones.
