Montana Patent of the Month – February 2026

Introduction and Award Designation

Patent Identification and Classification

In the rapidly evolving landscape of biotechnology and immunotherapeutic innovation, the protection of intellectual property serves as the bedrock for commercial translation and clinical advancement. It is within this high-stakes context that we identify United States Patent Application No. US20260021107, formally titled “Stimulator of interferon genes agonists.” This pivotal intellectual property was applied for on July 25, 2022, and has subsequently emerged as a definitive asset in the field of innate immune modulation. The patent, assigned to Inimmune Corporation, a biotechnology leader headquartered in Missoula, Montana, represents a significant leap forward in the design of small-molecule therapeutics targeting the Stimulator of Interferon Genes (STING) pathway.

We are pleased to announce that US20260021107 has been officially designated as the Montana Patent of the Month for February 2026. This accolade is not distributed lightly; it is the result of a rigorous, data-driven selection process overseen by Swanson Reed’s proprietary analytics division. Utilizing advanced artificial intelligence (AI) algorithms designed to parse the global patent database, the selection committee screened over 1,000 potential patents filed within the jurisdiction during the eligibility period. The AI screening protocols are engineered to look beyond simple citation metrics or claims density. Instead, they evaluate the “innovation velocity” and “economic potential” of the filing, benchmarking it against a 20-year historical baseline of regional patent activity.

The selection of US20260021107 was driven by its exceptional scoring in the “Real-World Impact” and “Technological Disruptiveness” categories. While many patents represent incremental improvements to existing art, the AI analysis flagged this application as a foundational shift in medicinal chemistry—specifically, the move from first-generation, intratumoral cyclic dinucleotides to next-generation, systemic non-nucleotide agonists. This distinction placed it in the top percentile of all reviewed intellectual property assets in the Mountain West region for the first quarter of 2026.

The Rationale for Selection: Real-World Impact

The designation of US20260021107 as the Montana Patent of the Month is predicated fundamentally on its potential to address a “grand challenge” in modern oncology: the effective treatment of metastatic cancer through systemic immunotherapy. The AI-driven selection process identified this patent as having outsized “real-world impact” potential due to its direct confrontation of the pharmacological limitations that have historically crippled STING agonist development.

For over a decade, the pharmaceutical industry has recognized the STING pathway as a potent lever for activating the immune system against cancer. However, the field has been plagued by a “delivery problem.” First-generation therapies required direct injection into visible tumors, leaving distant metastases untreated. The technology described in US20260021107 solves this by targeting a novel Transmembrane Domain (TMD) binding site, allowing for the creation of drugs that can be administered systemically (e.g., intravenously or orally) to reach cancer cells anywhere in the body.

The impact of this innovation extends beyond the clinic to the economic vitality of the region. As a flagship innovation arising from the Montana biotech ecosystem, this patent exemplifies the transition of the state’s economy from resource extraction to high-value knowledge creation. By anchoring such high-potential intellectual property in Missoula, Inimmune facilitates the retention of high-skill labor and attracts venture capital investment—such as the $22 million Series A led by Two Bear Capital—validating the regional capability to support world-class pharmaceutical R&D. Thus, the “real-world impact” is twofold: a potential cure for disseminated malignancies and a cornerstone for the maturing bioscience cluster in the Northern Rockies.

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The Biological Imperative and Technological Superiority

The cGAS-STING Pathway: The Engine of Innate Immunity

To appreciate the superiority of the invention described in US20260021107, one must first deconstruct the biological mechanism it exploits. The cGAS-STING pathway is an evolutionarily conserved defense mechanism found in mammalian cells. Its primary function is to detect the presence of cytosolic DNA—genetic material that is out of place. In a healthy cell, DNA is sequestered in the nucleus or mitochondria. If DNA is found in the fluid of the cytoplasm, it signals one of two things: a viral infection has breached the cell, or the cell itself is damaged and leaking its own DNA (genome instability), a hallmark of cancer.

The enzyme cGAS (cyclic GMP-AMP synthase) acts as the sensor. Upon binding to cytosolic DNA, cGAS synthesizes a secondary messenger molecule called cGAMP (cyclic guanosine monophosphate–adenosine monophosphate). This messenger binds to the STING protein (Stimulator of Interferon Genes) residing on the endoplasmic reticulum (ER). Once activated, STING undergoes a conformational change, moving from the ER to the Golgi apparatus, where it recruits the kinase TBK1. This sets off a phosphorylation cascade resulting in the activation of transcription factors IRF3 and NF-κB, which enter the nucleus and trigger the massive release of Type I interferons (IFNs) and pro-inflammatory cytokines.

In the context of oncology, this “cytokine storm” is the signal that alerts T-cells to the presence of the tumor. It turns a “cold” tumor (invisible to the immune system) into a “hot” tumor (actively inflamed and targeted). However, the natural ligand (cGAMP) is a large, negatively charged, polar molecule. It cannot cross cell membranes easily, meaning it cannot be given as a simple pill or injection. It requires complex delivery vehicles or direct intratumoral injection.

The Innovation of US20260021107: Transmembrane Domain (TMD) Targeting

The technological superiority of patent US20260021107 lies in its departure from the “canonical” binding site. For years, major pharmaceutical competitors focused on developing synthetic analogs of cGAMP that bind to the Cytosolic Binding Domain (CBD)—the “front door” of the STING protein. While logical, this approach carried the inherent physicochemical limitations of the natural ligand: poor membrane permeability and rapid enzymatic degradation.

The scientists at Inimmune, as detailed in the patent, identified a “cryptic” allosteric binding site located within the Transmembrane Domain (TMD) of the STING protein—essentially the “side door”. The patent describes a series of novel small molecules, exemplified by Compound 7k, which bind to this hydrophobic pocket within the ER membrane.

Mechanism of Superiority

The superiority of this TMD-targeting mechanism over the traditional CBD-targeting approach is defined by three critical pharmacological advantages:

1. Systemic Bioavailability via Lipophilicity:
   The compounds described in US20260021107 are designed to be lipophilic (fat-loving). Unlike the highly polar, charged cyclic dinucleotides (CDNs) used by competitors, Inimmune’s TMD agonists can passively diffuse through the lipid bilayer of the cell membrane. This fundamental chemical property removes the requirement for intratumoral injection. A drug based on this patent can potentially be administered intravenously or orally, distributing throughout the bloodstream to access tumors in the lungs, liver, brain, and lymph nodes simultaneously. This capability addresses the primary cause of cancer mortality: metastasis.
2. Pan-Genotypic Efficacy: A major historical failure in STING drug development was species specificity. Early compounds like DMXAA cured cancer in mice but failed completely in humans because the human CBD structure differs slightly from the murine version. The TMD site identified in US20260021107 is structurally more conserved across evolution. Data indicates that Compound 7k and its analogs are “pan-genotypic,” meaning they activate all major variants of the human STING protein as well as the murine version. This drastically de-risks the translation from pre-clinical animal models to human clinical trials, a hurdle that has tripped up multi-billion dollar programs from competitors.
3. Synergistic Activation:
   Because the TMD agonists bind to a different site than the natural cGAMP ligand, they are non-competitive. This means the drug can work in concert with the body’s natural immune response. In a tumor microenvironment where some natural cGAMP is already being produced, the Inimmune agonist can act as a force multiplier, stabilizing the active conformation of the STING protein for a more durable signal. This contrasts with CBD-targeting drugs, which must compete with the natural ligand for the same binding pocket.

Structural Validation

The patent is supported by advanced structural biology data, likely derived from cryo-electron microscopy (cryo-EM) and computational docking studies. These studies reveal that Compound 7k adopts a specific “C-shaped” binding pose within the hydrophobic groove between the transmembrane helices. This interaction is stabilized by a critical hydrogen bond with the amino acid residue Tyr106. This level of atomic-resolution insight allows for rational drug design, enabling chemists to fine-tune the molecule for maximum potency and minimum off-target toxicity—a hallmark of superior technological development.

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Competitive Benchmarking

To rigorously validate the claim of superiority, we must benchmark the technology in US20260021107 against the established leaders in the field. The STING agonist landscape has been crowded with candidates from major pharmaceutical entities, yet none have successfully crossed the finish line to widespread regulatory approval. This failure is largely due to the limitations that Inimmune’s patent specifically circumvents.

Primary Competitor: Merck & Co. (MK-1454 & MK-2118)

Merck has been a dominant force in immuno-oncology, primarily due to its checkpoint inhibitor Keytruda (pembrolizumab). Their strategy was to develop a STING agonist to partner with Keytruda.

• The Candidate: MK-1454 is a synthetic cyclic dinucleotide (CDN) that mimics the natural cGAMP ligand. It binds to the classic CBD.
• The Limitation: Because MK-1454 is a CDN, it cannot easily penetrate cells. It must be injected directly into a visible tumor (intratumoral administration).
• Performance Benchmark: In Phase 1 clinical trials presented at ESMO, MK-1454 administered as a monotherapy achieved a 0% response rate in patients with advanced solid tumors. It only showed efficacy when combined with Keytruda. This indicates that as a standalone drug, it lacks the potency or distribution necessary to drive a systemic immune response.
• Inimmune Superiority: Unlike MK-1454, the Inimmune TMD agonist (US20260021107) does not rely on local injection. Its ability to be delivered systemically means it can prime the immune system across the entire tumor burden, not just the injected lesion. Furthermore, pre-clinical data suggests TMD agonists can induce robust tumor regression as a monotherapy in syngeneic mouse models, outperforming the benchmark set by MK-1454.

Secondary Competitor: Aduro Biotech / Novartis (ADU-S100)

• The Candidate: ADU-S100 (MIW815) was the pioneering clinical candidate, developed to have higher stability than natural cGAMP.
• The Failure Mode: despite promising early data, the program was plagued by the same delivery constraints. The requirement for intratumoral injection limited the patient population to those with accessible, superficial tumors (e.g., melanoma, head and neck). Novartis eventually deprioritized the program due to “insufficient clinical benefit”.
• Inimmune Superiority: US20260021107 represents the “second-generation” correction to the “first-generation” error of ADU-S100. By shifting the target to the TMD, Inimmune has engineered a molecule that fits the profile of a traditional pharmaceutical (small molecule, systemic distribution) rather than a niche, locally administered biologic. This opens up indications in deep visceral cancers (pancreatic, ovarian, lung) that ADU-S100 could effectively never reach.

Tertiary Competitor: Eisai (E7766)

• The Candidate: E7766 is a macrocycle-bridged STING agonist. It was designed to be chemically rigid, locking it into the “active” conformation to increase potency.
• The Limitation: While more potent than MK-1454, E7766 still targets the CBD. It faces the challenge of “bell-shaped” dose responses, where too much drug can actually kill the immune cells (T-cells) it is meant to activate, a phenomenon known as immunotoxicity.
• Inimmune Superiority: The allosteric modulation described in US20260021107 allows for “tunable” signaling. By binding the TMD, Inimmune’s agonists can induce a specific profile of cytokines (e.g., balancing Interferon-beta vs. TNF-alpha) that maximizes anti-tumor activity while minimizing the risk of ablating the patient’s own immune cells. This wider therapeutic window is a distinct competitive advantage in the toxicology profile of the drug.

Benchmarking Summary

The following table synthesizes the comparative analysis, highlighting the distinct technical advantages of the Montana Patent of the Month.

Technological Feature	Inimmune (US20260021107)	Merck (MK-1454)	Aduro/Novartis (ADU-S100)	Eisai (E7766)
Primary Target Site	Transmembrane Domain (TMD)	Cytosolic Binding Domain (CBD)	Cytosolic Binding Domain (CBD)	Cytosolic Binding Domain (CBD)
Molecule Class	Small Molecule (Non-Nucleotide)	Synthetic Cyclic Dinucleotide	Synthetic Cyclic Dinucleotide	Macrocycle-Bridged CDN
Route of Administration	Systemic (IV / Potential Oral)	Intratumoral (Direct Injection)	Intratumoral (Direct Injection)	Intratumoral / Intravesical
Membrane Permeability	High (Lipophilic)	Low (Polar/Charged)	Low (Polar/Charged)	Low/Moderate
Mechanism of Action	Allosteric Stabilization	Orthosteric Competition	Orthosteric Competition	Orthosteric Competition
Monotherapy Efficacy	High (Pre-clinical Syngeneic Models)	Low/None (Clinical Data)	Low/Variable	Moderate
Genotypic Coverage	Pan-Genotypic (Human + Mouse)	Variable (Species Specificity Issues)	Variable	Pan-Genotypic

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Real-World Impact and Future Potentials

The “real-world impact” of US20260021107 is not a theoretical abstraction; it is a tangible trajectory affecting clinical outcomes, public health preparedness, and regional economic stability.

Clinical Impact: The Oncology Paradigm Shift

The most immediate potential of this technology is to redefine the standard of care for metastatic cancer. Currently, patients with Stage IV cancer often rely on systemic chemotherapy, which is toxic and non-specific. Immunotherapies like Checkpoint Inhibitors (PD-1 blockers) have revolutionized care, but they only work in ~20-30% of patients—those with “hot” tumors that are already infiltrated by T-cells.

The technology in US20260021107 provides the missing link. By systemically activating STING, these agonists can inflame the tumor microenvironment, turning “cold” tumors “hot.” This would arguably expand the eligible patient population for checkpoint inhibitors from 20% to perhaps 50% or higher. For a patient with metastatic lung cancer, this patent represents the difference between palliative care and a potential curative regimen. The ability to administer the drug intravenously means that even microscopic clusters of cancer cells, invisible to CT scans, would be exposed to the immune-activating signal.

Public Health Impact: Next-Generation Vaccines

Beyond oncology, the STING pathway is a critical target for vaccine adjuvants—substances added to vaccines to boost the immune response. Inimmune has explicitly leveraged the technology in US20260021107 to develop “Adjuvant Systems” such as INI-4001 and TRAC478.

• Pandemic Preparedness: The ability to induce a strong, durable immune response with a smaller amount of antigen (dose-sparing) is crucial during a pandemic. The TMD agonists described in the patent have shown the ability to broaden the immune response against influenza, protecting against “drifted” strains that do not perfectly match the vaccine.
• The “Universal” Flu Shot: By engaging the innate immune system more effectively, this technology supports the development of universal vaccines that offer multi-year protection, reducing the burden on global healthcare systems.

Therapeutic Expansion: Allergy and Autoimmunity

A fascinating aspect of the real-world impact of this patent is its distinct application in allergy immunotherapy. While STING activation is usually pro-inflammatory, the precise “tuning” of the pathway allowed by Inimmune’s allosteric modulators can be used to re-balance the immune system. The company is advancing a related candidate, INI-2004, for allergic rhinitis. The structural insights protected by US20260021107 regarding TMD binding and membrane penetration are platform technologies that cross-pollinate into these massive chronic disease markets, potentially offering relief to millions of sufferers of seasonal allergies and asthma.

Regional Economic Impact: The “Silicon Mountain” Effect

The impact of US20260021107 resonates deeply within the economy of Montana. The patent is a product of the “Translation Medicine” pipeline, moving from basic research at the University of Montana to commercialization at Inimmune.

• High-Value Job Creation: The development of this asset requires a workforce skilled in cryo-EM, computational chemistry, and regulatory affairs. This creates a gravitational pull for talent, reversing the “brain drain” typical of rural states.
• Venture Capital Validation: The robustness of the IP portfolio, anchored by this patent, was instrumental in Inimmune securing a $22 million Series A round. This capital injection circulates through the Missoula economy, supporting construction, legal services, and ancillary businesses.
• Federal Funding Efficiency: The patent enhances the region’s competitiveness for federal grants (NIH, DoD). Inimmune and the University of Montana recently secured the largest research award in the university’s history, a direct downstream effect of the innovation ecosystem protected by this patent.

Future Outlook: 2030 and Beyond

Looking toward 2030, the technology described in US20260021107 positions Inimmune to be a central player in the era of “Combination Immunotherapy.” We anticipate a clinical landscape where:

1. Standard of Care: A triad regimen of Checkpoint Inhibitor + STING Agonist (Inimmune) + Tumor Antigen Vaccine becomes the new gold standard for solid tumors.
2. Precision Adjuvants: Vaccines are customized with specific STING agonists that tailor the immune response (Th1 vs Th2) based on the specific pathogen (e.g., viral vs. bacterial).
3. Oral Delivery: Continued refinement of the lipophilic TMD pharmacophore leads to an orally bioavailable STING pill, dramatically lowering the cost and complexity of cancer treatment.

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R&D Tax Credit Analysis and Applicability

For innovative enterprises like Inimmune, the path from patent filing to FDA approval is capital-intensive and fraught with risk. The Research & Experimentation (R&D) Tax Credit (IRC Section 41) serves as a vital non-dilutive funding mechanism to sustain this development. As the February Patent of the Month, US20260021107 provides an exemplary case study for the application of the IRS “Four-Part Test,” a statutory framework used to determine eligibility for these credits.

Swanson Reed, as a specialist R&D tax advisory firm, employs a rigorous methodology to substantiate such claims. The development of US20260021107 aligns perfectly with the statutory requirements, provided that the documentation is managed with the precision outlined below.

The Four-Part Test Breakdown

To qualify for the federal and state R&D tax credits, the activities associated with the development of the “Stimulator of interferon genes agonists” patent must meet four specific criteria.

Part 1: Permitted Purpose

• The Statute: The activity must relate to a new or improved business component—defined as a product, process, computer software, technique, formula, or invention—held for sale, lease, or license, or used by the taxpayer in its trade or business. The purpose must be to improve functionality, performance, reliability, or quality.
• Application to US20260021107: The “business component” in this case is the therapeutic drug candidate (Compound 7k and its analogs). The “Permitted Purpose” is clear: Inimmune is attempting to develop a new pharmaceutical product with improved performance (systemic efficacy vs. intratumoral) and quality (reduced toxicity profile).
• Substantiation: Swanson Reed would document the “Project Scoping” documents from 2022, identifying the specific objective: “To synthesize a small molecule agonist capable of binding the STING TMD with nanomolar affinity.”

Part 2: Technological in Nature

• The Statute: The process of experimentation must fundamentally rely on principles of the hard sciences—physical or biological sciences, chemistry, engineering, or computer science. Activities based on soft sciences (economics, psychology, market research) are excluded.
• Application to US20260021107: The development of this patent is a masterclass in hard science. It involves:

• Medicinal Chemistry: The synthesis of benzothiophene and benzothiazine derivatives.
• Structural Biology: Utilizing cryo-EM to visualize the TMD binding pocket.
• Immunology: Assaying cell lines (THP-1) for cytokine production (IFN-β, TNF-α).

• Substantiation: The claim is supported by the CVs of the technical leads (e.g., Dr. Jay Evans, Dr. David Burkhart) and the presence of specialized laboratory equipment (HPLC, Mass Spectrometers).

Part 3: Elimination of Uncertainty

• The Statute: At the outset of the activity, there must be uncertainty regarding the capability or method of developing the business component, or the appropriate design of the business component.
• Application to US20260021107: When the project began, it was chemically uncertain if a molecule could be designed to bind the TMD allosteric site effectively. It was uncertain if such a molecule would be soluble enough for systemic delivery. It was uncertain if the molecule would have a safe toxicology profile. The entire R&D effort was driven by the need to resolve these specific technical uncertainties.
• Substantiation: Swanson Reed utilizes “Uncertainty Statements” captured contemporaneously. For example, meeting minutes from Q3 2022 debating the stability of the “C-shaped” binding pose would serve as proof that the outcome was not known in advance.

Part 4: Process of Experimentation

• The Statute: Substantially all of the activities must constitute a process of experimentation. This requires the identification of uncertainty, the identification of one or more alternatives, and the evaluation of those alternatives through modeling, simulation, or systematic trial and error.
• Application to US20260021107: The patent specification itself reveals the iterative process.

• Hypothesis: Targeting the TMD will allow for lipophilic, systemic drugs.
• Alternatives: The patent likely lists hundreds of “Prophetic Examples” or synthesized analogs (e.g., changing a methyl group to an ethyl group on the benzothiophene ring) to see how structure affects function.
• Evaluation: Each analog was synthesized and tested. Those that failed (too toxic, didn’t bind) were discarded; those that worked were refined. This systematic “Design-Make-Test-Analyze” cycle is the definition of the process of experimentation.

• Substantiation: Swanson Reed focuses on the “Innovation Log” and “Project Records.” We capture the negative results—the failed compounds—because they prove that a true experiment occurred. If Inimmune knew the answer from the start, there would be no failures. The presence of “failed” molecules in the lab notebooks is the strongest evidence of eligibility.

Swanson Reed’s Role in Claiming the Credit

Swanson Reed, as the largest specialist R&D tax firm in the US, plays a critical role in ensuring that a high-profile patent like US20260021107 translates into fiscal efficiency.

• The “Six-Eye Review”: Every claim prepared by Swanson Reed undergoes a mandatory review process involving three separate qualified personnel (the preparer, the technical reviewer, and the tax attorney) to ensure strict compliance with the 4-Part Test.
• Audit Readiness: Given the high dollar value of biotech claims (often involving millions in wages and supply costs), IRS scrutiny is possible. Swanson Reed prepares the “nexus” documentation—linking every dollar of qualified wage to a specific task in the experimental process (e.g., “Dr. Smith spent 40% of his time synthesizing Compound 7k”).
• Payroll Tax Offset: For a company like Inimmune, which may still be in a pre-revenue or early-revenue growth phase, Swanson Reed would advise on utilizing the Payroll Tax Offset. This provision allows qualified small businesses to apply up to $250,000 (and potentially $500,000 under recent legislation) of their R&D credits against their employer Social Security tax liability, providing immediate liquidity rather than waiting for income tax profits.
• Local Expertise: With an office in Billings, Montana, Swanson Reed provides localized advisory services, understanding the specific interplay between Federal incentives and Montana-specific economic development programs.

Summary of Tax Credit Impact

By leveraging the R&D Tax Credit, Inimmune can recoup up to 14% of the costs associated with developing US20260021107. This capital recycling creates a virtuous cycle: the tax savings from the STING agonist project are reinvested to fund the next wave of innovation (e.g., the TLR4 agonist project), accelerating the pace of discovery and compounding the economic benefits for the state of Montana.

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Final Thoughts

The designation of US20260021107 as the Montana Patent of the Month for February 2026 is a recognition of excellence that transcends the boundaries of the laboratory. It highlights a convergence of cutting-edge artificial intelligence, which identified the asset, and deep scientific rigor, which created it.

Inimmune’s development of Transmembrane Domain STING agonists represents a pivotal moment in the fight against cancer. By solving the delivery limitations that have stifled the field for a decade, this technology offers a credible path toward systemic, curative immunotherapies. The superiority of the invention is anchored in its distinct mechanism of action—lipophilic, allosteric, and pan-genotypic—which benchmarks favorably against every major competitor in the global pharmaceutical market.

Furthermore, this patent serves as a beacon for the economic potential of the Mountain West. It demonstrates that with the right combination of academic research, venture capital, and fiscal incentives like the R&D Tax Credit, regions like Montana can compete with global biotech hubs. As Inimmune moves these candidates into human clinical trials, the “real-world impact” predicted by the Swanson Reed AI algorithms moves one step closer to reality: a future where the human immune system is the ultimate weapon against disease.