Aktis Oncology (NASDAQ:AKTS) used a presentation at TD Cowen’s 46th Annual Healthcare Conference to outline its strategy to broaden the reach of targeted radiopharmaceutical therapy beyond today’s most established targets and to provide updates on its two lead clinical programs and manufacturing and isotope supply plans.
Positioning radiopharmaceuticals as a broader oncology modality
The company described radiopharmaceuticals as a modality “approaching an inflection point,” pointing to clinical validation, commercial uptake, and strategic activity across the sector. As an example of commercial momentum, management cited Novartis’ Pluvicto as “the best-launching oncology drug in 10 years since Ibrance.”
Miniprotein radioconjugates and discovery approach
Aktis said its platform is built around miniprotein binders as the targeting format for radioconjugates. The company emphasized a combination of small size—intended to support tumor penetration and rapid renal clearance—and a defined three-dimensional structure designed to drive high affinity and selectivity to targets.
Management said its screening libraries include “more than 5 billion variants” and that it has added generative AI design capabilities to explore additional binder designs beyond traditional screening.
Lead programs: Nectin-4 and B7-H3
Aktis highlighted two lead programs with what it described as multi-indication potential:
- AKY-1189, targeting Nectin-4
- AKY-2519, targeting B7-H3
Management framed both targets as opportunities to move radiopharmaceuticals into broader solid tumor settings including bladder, breast, lung, head and neck, colorectal, and cervical cancers, among others, based on target expression rates it showed during the presentation.
AKY-1189 (Nectin-4): The company said its ongoing Phase 1b study, NECTINIUM-2, is enrolling Nectin-4-positive patients across multiple tumor types. It announced it received FDA Fast Track designation for AKY-1189 “last week.” Aktis reported that nine U.S. sites are open with more expected, and that enrollment is expected to continue through 2026 at various dose levels.
Aktis said the trial uses a Bayesian backfill design that can expand dose cohorts of interest to up to 30 patients each to accelerate dose finding and optimization. The company expects to submit an initial data cut for presentation at a medical conference in early 2027.
In discussing prior patient dosimetry work conducted outside the U.S., management said earlier data were presented about a year and a half ago at the EORTC-NCI-AACR Symposium. It said those results showed high initial uptake in tumors across five evaluated tumor types selected for Nectin-4 positivity, with evidence suggesting tumor “hang time.” The company also highlighted that absorbed dose in key normal tissues—including bone marrow—was not higher than published reports for approved radiopharmaceuticals such as Pluvicto and Lutathera, which it said supported the therapeutic index rationale.
AKY-2519 (B7-H3): Aktis said it has moved quickly on this program and previously described initial clinical imaging data in its S-1 filing. The company said imaging suggested relatively high tumor uptake with low and brief exposure to normal tissues. It expects to present imaging and quantitative dosimetry data at a medical conference in the middle part of this year.
Aktis said it plans to submit an IND in the first half of this year for Phase 1b dose escalation and expects the Phase 1b dose escalation to start in the second half of the year.
Manufacturing, actinium supply, and vertical integration
Management said the company has built an end-to-end supply chain that is functioning “as designed” for its ongoing Phase 1b work, and it is aiming to further verticalize manufacturing by building its own facility for final-step manufacturing (chelation fill-finish). Aktis described multiple points of redundancy across the supply chain, including internal ownership of CMC development and the use of multiple contract manufacturers for fill-finish while building internal capability.
On isotopes, management said its approach is “isotope-agnostic,” but that clinical development has prioritized Actinium-225 to maximize efficacy potential due to its four alpha emissions and to support centralized manufacturing and distribution. The company said it announced three commercial actinium supply agreements in 2022 and has signed additional agreements since then. In Q&A, management said it has studied multiple production methods—including generator-based, linear accelerator, and cyclotron-based production—and believes “all the methods so far are working,” adding that it is comfortable with its contracted supply base and the industry’s scaling trajectory.
Collaboration and outlook
Aktis also referenced a disclosed $1.2 billion discovery collaboration with Eli Lilly, stating that the partnership has “already hit the first milestones” and is “going very well.”
Looking ahead, management said the company’s near-term focus over the next one to two years includes generating additional clinical data for both lead programs—dose finding, safety, and preliminary response—while advancing platform development and aiming to provide visibility on two additional programs over the next couple of years.
In closing remarks, the company argued that a key underappreciated point for investors is that radiopharmaceutical therapy and antibody-drug conjugates represent “orthogonal” mechanisms of cell kill, with resistance mechanisms that are not shared, which it said could make radiopharmaceuticals additive across the patient treatment journey.
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.
