Aktis Oncology (NASDAQ:AKTS) executives outlined the company’s radiopharmaceutical strategy, clinical development plans and collaboration with Eli Lilly during a Bank of America investor session hosted by analyst Alec Stranahan.
Matthew Roden, Aktis Oncology’s president and chief executive officer, said the company was built around the view that targeted radiopharmaceuticals could become “a large new category of anticancer medicines.” He said the field has been validated by approved radiopharmaceuticals such as PLUVICTO and LUTATHERA, which use fast-clearing molecules that can help spare bone marrow exposure compared with longer-circulating antibody-based approaches.
Miniprotein Platform Aims to Broaden Radiopharmaceutical Use
Roden said Aktis designed its miniproteins to clear quickly from the body, penetrate tumors deeply and internalize into tumor cells. He said the company is screening more than 6 billion variants across about 100 protein scaffolds, while also using generative AI and computational chemistry to expand the search for selective binders.
The company’s lead programs target Nectin-4 and B7-H3, which Roden described as potential first-in-class radiopharmaceutical opportunities. He said the broader radiopharmaceutical industry may be at a similar stage to antibody-drug conjugates several years ago, with a few validated products and the potential for format improvements to expand the market.
Roden said PLUVICTO’s commercial launch helped demonstrate commercial validation for the field, and he pointed to growing strategic interest in radiopharmaceuticals. Aktis, he said, is focused on “white space opportunities” in large patient populations where no radiopharmaceutical option currently exists.
AKY-1189 Trial Focuses on Nectin-4 Tumors
Aktis’ Nectin-4-targeted candidate, AKY-1189, is in a Phase 1b study. Roden said Nectin-4 is a clinically and commercially validated target, noting that Pfizer’s Padcev is focused primarily on urothelial carcinoma. Aktis is also exploring high Nectin-4-expressing tumors beyond bladder cancer, including breast, lung, cervical, colorectal and other cancers.
According to the discussion, the NECTINIUM-2 trial has been under an investigational new drug application for about one year. The study uses a Bayesian backfill design, with dose escalation generally involving three to four patients per dose level. Once a dose level of interest is identified, the trial can expand that dose level to as many as 30 patients, and this can be done at two dose levels.
The company described planned expansion cohorts that include triple-negative breast cancer, post-Padcev and pembrolizumab bladder cancer, and a 50-patient basket cohort for other tumor types.
Stranahan noted that investors are focused on a planned first-quarter 2027 update from the Phase 1b program. The company said that update is expected to include all planned dose levels once completed, as well as potentially some backfill patients, with “double-digit” patient numbers. The initial portion of the study is safety-focused, though efficacy observations will also be presented. The company said there is no formal response-rate hypothesis test in that part of the trial.
Post-Padcev Opportunity Seen as a Potential Initial Path
The company characterized the post-Padcev and pembrolizumab setting in urothelial cancer as a potential “low-hanging fruit” opportunity because there is no established standard of care. It also noted that the definition of the post-Padcev pembrolizumab population may need to be clarified with regulators, including whether it includes metastatic and perioperative settings.
On endpoints, the company said overall survival remains the “gold standard” for regulatory approval. However, it said response rate can be useful in guiding later studies and could support development tools such as Breakthrough Therapy designation, depending on durability and the broader clinical context.
B7-H3 Program Moves Into Prostate and Basket Studies
Aktis’ B7-H3-targeted radioconjugate, AKY-2519, has sites open and enrolling in a study of metastatic castration-resistant prostate cancer. The initial protocol includes both PLUVICTO-exposed and PLUVICTO-naive patients in parallel dose escalations, with planned backfill expansions.
Roden said Aktis also expects to open a second protocol in the second half of the year focused on additional tumor types, including lung, colorectal and pancreatic cancers. He said the clinical plans are supported by imaging and dosimetry data that were previewed in the company’s S-1 filing and are expected to be presented at the American Society of Clinical Oncology meeting.
At ASCO, Roden said Aktis plans to present two posters. One will examine tumor uptake using gallium-labeled AKY-2519 imaging agents across multiple tumor types. The second will focus on 16 patients with metastatic castration-resistant prostate cancer and will include PET/CT and SPECT/CT data using lutetium-labeled AKY-2519 to assess exposure over as long as six days. Roden said those data supported the dose-escalation parameters for the prostate cancer study.
Lilly Collaboration and Cash Position
Roden also discussed Aktis’ 2024 collaboration with Eli Lilly, describing it as a discovery collaboration in which Aktis uses its platform to generate miniprotein radioconjugates against Lilly-selected targets outside Aktis’ own target space. He said Aktis has already achieved the first milestone under the collaboration, which he described as worth up to $1.2 billion.
Roden emphasized that Aktis’ internal programs, including AKY-1189 and AKY-2519, remain wholly owned by Aktis and are not subject to option rights by another party.
He said Aktis reported $538 million in cash and equivalents as of March 31, giving the company the ability to invest in its clinical programs, earlier pipeline work, the Lilly collaboration and manufacturing. Roden said manufacturing is a key focus, including isotope supply, drug substance and drug product manufacturing, and delivery to patients.
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.
