A 1997 report on a Phase 2 trial of recombinant human IL-12 found that 12 of 17 patients were hospitalized and two died. Investigators traced the severe toxicity to the dosing schedule, because a single priming dose given two weeks earlier in the Phase 1 protocol was absent from the Phase 2 regimen.3
How far along is DAX-044?
The program is still in preclinical development, and no human data have been reported. Audax says preclinical studies show a potentially best-in-class therapeutic index for an IL-12 agent, a characterization the company has not yet tested in patients.1
Audax also cautions that Astellas may not exercise its option and that milestone payments may never be received.1
“DAX-044 is a promising investigational immuno-oncology program with a differentiated mechanism designed to selectively activate anti-tumor immune responses,” Iwaya says.
Jai Rautela, PhD, MBA, chief executive officer of Audax, frames the deal around the clinical timeline.
“This partnership will expedite the planned phase 1 clinical evaluation of DAX-044 for the benefit of patients with various types of solid tumor,” he says.
EVERSANA Acquires Health Economics Firm Estima Scientific
EVERSANA has acquired Estima Scientific, a London-based HEOR technology and services company founded in 2019. Financial terms were not disclosed.2
Estima pairs specialist consulting with proprietary software, including web-based generative artificial intelligence (AI) applications for economic modeling, systematic literature reviews and network meta-analysis.2 Its team, including co-founders Tim Reason and Andy Gimblett, will join EVERSANA’s global workforce, and its expertise will be folded into EVERSANA’s market access and value and evidence solutions, with continuity planned for existing clients.2
How are health technology assessment bodies treating AI?
HEOR work supports the evidence manufacturers submit to payers and to health technology assessment bodies. The release says Estima’s solutions have been validated by large pharmaceutical customers and by assessment bodies, including the National Institute for Health and Care Excellence (NICE), but it does not describe what that validation covered.2
NICE’s August 2024 position statement says any use of AI should follow the principle of “augmentation, not replacement, of human involvement,” and that the submitting organization remains accountable for the content of its submission.4
“The company’s global scale and end-to-end commercial infrastructure will allow us to accelerate how pharmaceutical companies build and communicate evidence-based value to payers, helping patients gain faster access to life-changing therapies,” says Reason, co-founder of Estima Scientific.
What is the strategic rationale?
The deal builds on EVERSANA’s AI Agency platform, launched in 2025 and expanded in August 2026.2
“As we scale to serve global clients, adding best-in-class companies that embrace a technology first mindset is critical to our success. The Estima Scientific team checks every box and will seamlessly fit into our organization,” says Mark Thierer, CEO of EVERSANA.
Because the price and integration timeline were not disclosed, the transaction’s financial scale and its effect on Estima’s existing client contracts remain unclear.2
Sources
- Astellas and Audax Biosciences enter exclusive option and license agreement for DAX-044, a novel immune-targeted IL-12 antibody-cytokine fusion for immuno-oncology. News release. PR Newswire. October 27, 2026. Accessed October 28, 2026. https://www.prnewswire.com/news-releases/astellas-and-audax-biosciences-enter-exclusive-option-and-license-agreement-for-dax-044-a-novel-immune-targeted-il-12-antibody-cytokine-fusion-for-immuno-oncology-302920594.html
- EVERSANA expands global commercialization and AI-powered HEOR capabilities with acquisition of UK-based Estima Scientific. News release. PR Newswire. October 28, 2026. Accessed October 28, 2026. https://www.prnewswire.com/news-releases/eversana-expands-global-commercialization-and-ai-powered-heor-capabilities-with-acquisition-of-uk-based-estima-scientific-302921421.html
- Leonard JP, Sherman ML, Fisher GL, et al. Effects of single-dose interleukin-12 exposure on interleukin-12-associated toxicity and interferon-gamma production. Blood. 1997;90(7):2541-2548.
- Use of AI in evidence generation: NICE position statement. National Institute for Health and Care Excellence. August 15, 2024. Accessed October 28, 2026. https://www.nice.org.uk/position-statements/use-of-AI-in-evidence-generation-NICE-position-statement