Federal Capability Statement · 2026

Nightbox LLC — Federal Brief

Single-construct dual-use gene therapy платформа, applicable к solid tumor oncology и host-directed medical countermeasures. US small business, AI-augmented R&D, scalable AAV9-deliverable payload.

Идентификаторы компании

Core Capability

NKG2D-LIF6: 2,123 bp chimeric receptor-effector gene therapy construct, combining human NKG2D extracellular domain (binds MICA и MICB stress ligands, selectively expressed на solid tumor cells) с elephant LIF6 — re-functionalized pseudogene, driving elephant cancer-resistance phenotype (Vazquez et al. 2018, Cell Reports).

Single-construct gene therapy delivery через AAV9 — обходит autologous cell-processing и manufacturing complexity CAR-T entirely. Manufacturable at clinical-grade scale existing CMOs без bespoke infrastructure.

Dual-Use Relevance

NKG2D recognition mechanism — generalizable host-directed platform для cellular stress states. Lead indication — solid tumor oncology; recognition-plus-effector architecture модульна и re-targetable для:

• Post-exposure medical countermeasures против engineered biothreats
• Host-directed antiviral response (replacing pathogen-specific approaches)
• Rapid-deployment gene therapy для stockpileable medical countermeasures
• Combat trauma applications (recognition retargeted к damage-associated molecular patterns)

Differentiators

• Manufacturing scalability: single-payload AAV9 vs CAR-T autologous processing — material implications для Strategic National Stockpile
• Чистая intellectual property: zero prior art на specific chimera; provisional patent in progress
• AI-augmented R&D: production Claude-based agent stack для construct design, freedom-to-operate analysis и competitive intelligence — empirical case study в современной federal R&D operating model
• Solo founder, low overhead: Phase 1-enabling work proceeding on bootstrap capital, suited для SBIR Phase I scope

Текущий статус

Стратегический National Security Context

Federal investment в domestic biotech и AI инфраструктуру materially below adversary baselines:

• 2,794 active cell-therapy clinical trials в Китае vs 700 в США — four-to-one gap.
• CARsgen filed world's first solid-tumor CAR-T New Drug Application в сентябре 2025 в Китае — а США.
• Россия launched EnteroMix mRNA cancer vaccine в июне 2025.
• $138B в 2025 cell-therapy и biologics deals flowed from China к Western pharma — США сейчас net importer late-stage assets.
• Hong Kong 18A biotech IPOs raised $6.43B в 2025 (16x 2024 total).
• Zero US solid-tumor CAR-Ts approved за 8 лет clinical trials.

Nightbox structured close этот gap: US-incorporated small business, single-construct gene therapy, обходящая CAR-T manufacturing bottleneck, AI-augmented R&D operating model, compressing timeline от concept до pre-IND, dual-use архитектура relevant across medical countermeasure spectrum.

Target Federal Programs

Полная solicitation map: /federal/sbir-roadmap — named PA/RFA numbers, deadlines, set-asides, program officers.

• NIH NCI SBIR Omnibus PA-26-273 — Phase I gene therapy oncology, 5 сентября 2026 cycle
• USAF SBIR DAF26BX02-NV501 — Voice-Enabled AI Assistant for Austere Env (SilverDuck/UniGPU match), opens 05/27, closes 06/24 2026
• NIH NIAID SBIR PA-25-301 — host-directed medical countermeasures track, dual-use angle
• ARPA-H — Cancer Moonshot 2.0 + Resilient Systems portfolios; abstract in prep
• BARDA DRIVe — solid tumor immune modulation BAA-26-100-SOL-00007
• DARPA BTO — Programmable Pharmaceuticals successor; capability brief in prep
• DTRA · JPEO-CBRND · ASPR — Strategic National Stockpile gene-therapy stockpileability angle
• DIU · AFWERX · NavalX — AI-augmented R&D operating-model demos, OTA pathway

Для further information, draft solicitation responses или pre-IND collaboration discussions, контакт: artem@nightboxllc.com.