TRB-061: A Selective TNFR2 Agonist for Inflammatory Disease

I. Executive Summary

TRB-061 is an investigational biological therapeutic being developed by TRexBio, Inc. It functions as a novel, selective agonist of Tumor Necrosis Factor Receptor 2 (TNFR2).[1] The core mechanism of action involves augmenting the activity and proliferation of tissue-resident regulatory T cells (Tregs), key mediators of immune suppression, with the goal of restoring immune homeostasis in inflamed tissues.[1] This approach contrasts with conventional therapies that often rely on broad immunosuppression. The primary indications targeted for TRB-061 are moderate-to-severe Atopic Dermatitis (AD) and Inflammatory Bowel Diseases (IBD), including Ulcerative Colitis (UC).[5]

Currently, TRB-061 is advancing through Investigational New Drug (IND)-enabling studies, positioning it as TRexBio's most advanced wholly-owned asset.[1] A Phase 1 clinical trial (NCT06934252), designed to assess safety, pharmacokinetics, and pharmacodynamics in healthy volunteers and AD patients, is anticipated to commence in the first half of 2025.[5] Preclinical studies have provided validation for this progression, demonstrating potent in vivo Treg expansion in humanized mouse models and achieving proof-of-concept in relevant animal models of colitis and skin inflammation.[1]

TRexBio, the developer, utilizes a proprietary "Deep Biology Platform" focused on human tissue immunology to identify novel targets and pathways.[1] The company secured significant Series B financing ($84 million) in late 2024, largely earmarked for TRB-061's clinical advancement, with participation from prominent strategic investors including Eli Lilly, Pfizer Ventures, and Johnson & Johnson Innovation.[5] Existing collaborations with Lilly and Johnson & Johnson further validate the company's platform technology.[4]

The successful initiation and execution of the Phase 1 trial represent a critical upcoming milestone for TRB-061 and TRexBio. If the drug's mechanism of restoring immune homeostasis translates effectively and safely in humans, TRB-061 could offer a differentiated therapeutic option in the competitive landscape of inflammatory diseases.

II. Introduction to TRB-061

TRB-061 is an investigational large molecule biological product, identified as a protein therapeutic, currently under development by TRexBio, Inc..[7] Officially selected as a development candidate in late 2023, TRB-061 (also referred to as TRB 061 or TRB061) functions as an agonist targeting Tumor Necrosis Factor Receptor 2 (TNFR2).[1] It is formulated for subcutaneous administration, a route often preferred for patient convenience in managing chronic conditions.[12]

Within TRexBio's portfolio, TRB-061 holds strategic significance as the company's most advanced wholly-owned therapeutic candidate.[1] It follows the company's partnered asset, TRB-051 (partnered with Eli Lilly), which entered Phase 1 clinical testing in mid-2024.[8] The advancement of TRB-061 underscores TRexBio's strategy to cultivate internal assets alongside its established pharmaceutical collaborations, thereby building independent value and retaining greater control over the development and commercialization trajectory of key programs. The progression of TRB-061 into clinical trials, planned for the first half of 2025, marks a pivotal step for this internal pipeline asset.[8]

III. Target Rationale and Mechanism of Action

Target Identification and Rationale

The therapeutic target for TRB-061 is Tumor Necrosis Factor Receptor 2 (TNFR2), also designated as Tumor Necrosis Factor Receptor Superfamily Member 1B.[1] TNFR2 is recognized for its high expression levels on regulatory T cells (Tregs), particularly those residing within specific tissues such as the skin and gut.[1] Tregs are a crucial subset of T lymphocytes that play a central role in maintaining immune system balance, preventing excessive inflammatory responses, and promoting tissue repair.[1] The therapeutic potential of activating TNFR2 to treat autoimmune and inflammatory conditions is widely acknowledged within the field.[1] TRexBio utilized its "Deep Biology Platform," which analyzes high-resolution human tissue data, to identify TNFR2 as a key tissue Treg-enriched target suitable for therapeutic intervention.[1]

Mechanism of Action

TRB-061 is engineered as a selective agonist of TNFR2.[1] Upon binding to TNFR2 on the surface of Tregs, TRB-061 is designed to trigger downstream signaling pathways that lead to the preferential augmentation, activation, and expansion of these immunosuppressive cells, particularly within the local tissue environment.[1] This targeted activation aims to enhance the natural suppressive functions of Tregs, inducing a state that actively dampens inflammation and promotes a return to immune homeostasis at the site of disease.[1]

This mechanism represents a distinct therapeutic philosophy compared to many existing treatments for inflammatory diseases. Standard therapies, such as broad TNF inhibitors or JAK inhibitors, often function through widespread immunosuppression, which can be effective but may carry risks associated with globally dampening immune responses.[5] In contrast, TRB-061 seeks to restore balance by selectively amplifying the body's endogenous regulatory mechanisms (Tregs).[6] By focusing on enhancing the "off switch" of the immune response specifically within affected tissues (skin and gut), this approach holds the potential for achieving durable clinical benefit, possibly including remission, while potentially mitigating the systemic side effects associated with broader immunosuppression.[1] The emphasis on tissue-resident Tregs suggests a strategy aimed at resolving inflammation locally, which could offer advantages in terms of both targeted efficacy and safety profile.[1]

IV. Preclinical Evidence Package

The progression of TRB-061 towards clinical evaluation is supported by a body of preclinical data demonstrating target engagement, mechanism of action confirmation, and efficacy in relevant disease models. Key findings have been highlighted in company communications and scientific presentations, such as the PEGS Boston Summit.[1]

A critical piece of evidence is the demonstration of potent in vivo Treg expansion mediated by TRB-061.[1] Studies conducted in humanized mouse models, which incorporate human immune system components, confirmed that TRB-061 effectively engages its human TNFR2 target on relevant cells within a living system and induces the intended biological response – an increase in the Treg population.[1] The use of humanized models strengthens the potential translatability of these findings to human subjects compared to studies solely relying on standard animal models.

Furthermore, TRexBio has established in vivo proof-of-concept (PoC) for TRB-061 in animal models directly relevant to its target indications. The drug candidate demonstrated protective effects in preclinical models of both colitis (relevant to IBD/UC) and skin inflammation (relevant to Atopic Dermatitis).[1] This indicates that the observed Treg expansion translates into a functional therapeutic benefit in disease contexts mimicking human conditions.

Mechanistic studies underpinning these efficacy findings confirm that TRB-061 functions as a selective TNFR2 agonist.[1] Data generated through TRexBio's platform and translational studies illustrate that agonism of TNFR2 by TRB-061 induces not only the expansion but also a functionally suppressive state in tissue Tregs.[1] The selectivity of TRB-061 for TNFR2 is emphasized, suggesting a design aimed at minimizing off-target interactions and potentially enhancing the safety profile by avoiding unintended activation of other cellular pathways.[1]

Data presented at the PEGS Summit further summarized these points, describing TRB-061 as a selective, potent TNFR2 agonist that augments Tregs in vivo, provides protection in inflammatory models, and whose signaling properties suggest differentiated clinical opportunities.[13] This latter point implies a deeper understanding of the downstream molecular events triggered by TRB-061, potentially revealing unique characteristics or applications for the drug beyond initial expectations, perhaps related to specific signaling cascades or patient subsets particularly responsive to this mechanism. Collectively, the preclinical package provides a robust rationale, combining target engagement with functional efficacy in relevant models, supporting the advancement of TRB-061 into first-in-human clinical trials.

V. Clinical Development Strategy

TRB-061 is currently advancing through the final stages of preclinical development, with Investigational New Drug (IND)-enabling studies either ongoing or completed.[1] TRexBio has consistently stated its plan to initiate the first-in-human (FIH) clinical trial for TRB-061 in the first half of 2025.[1] This clinical entry is a primary objective supported by the company's recent $84 million Series B financing.[8]

Phase 1 Trial Design (NCT06934252)

The planned FIH study is registered under the identifier NCT06934252 and is titled "A Phase 1a/1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TRB-061 Administered Subcutaneously in Healthy Participants and Participants With Moderate-to-Severe Atopic Dermatitis".[12]

• Objectives: The primary goals are to evaluate the safety, tolerability, pharmacokinetics (PK; how the body processes the drug), and pharmacodynamics (PD; how the drug affects the body, likely including Treg biomarkers) of single and multiple subcutaneous doses of TRB-061.[12]
• Design: The trial employs a standard, efficient three-part structure common for early-phase biologics development:
• Part 1 (Single Ascending Dose - SAD): Healthy adult volunteers will receive a single subcutaneous dose of TRB-061 or a placebo. This part aims to establish initial safety and PK/PD characteristics at increasing dose levels, with participants observed for 12 weeks post-dose.[12]
• Part 2 (Multiple Ascending Dose - MAD in Healthy): Healthy adult volunteers will receive three doses of TRB-061 or placebo, administered once every four weeks over an 8-week period. This part assesses safety, PK accumulation, and PD effects with repeat dosing, followed by a 10-week observation period.[12]
• Part 3 (MAD in Patients): Patients with moderate-to-severe Atopic Dermatitis (AD) will be randomized to receive one of two dose levels of TRB-061 or placebo for 12 weeks. This crucial part provides the first assessment of safety, tolerability, PK, and PD in the target patient population, along with preliminary signals of clinical activity. Responders will have extended follow-up (36 weeks), while non-responders complete earlier (16 weeks). An open-label extension option may be available for placebo non-responders.[12] This inclusion of patients in Phase 1b allows for an earlier read on potential efficacy compared to waiting for a dedicated Phase 2 study, potentially accelerating decision-making.[6]
• Endpoints: While not explicitly detailed in all sources, endpoints are expected to include: safety and tolerability assessments (adverse events, laboratory tests, ECGs), PK parameters (e.g., Cmax, AUC, half-life), PD biomarkers (likely measuring Treg levels and activation status), and clinical efficacy measures in Part 3 (standard AD assessments such as EASI score, IGA score, pruritus).[12]
• Eligibility: Key criteria include healthy adults for Parts 1 and 2, and adults with moderate-to-severe AD diagnosed for at least 12 months for Part 3. Exclusions cover significant medical conditions, specific prior medication use (immunosuppressants, biologics, investigational drugs), hypersensitivity, active infections (TB, COVID-19), pregnancy/lactation, significant ECG abnormalities (e.g., QTcF >470 ms), and recent substance abuse.[12]
• Timeline: The estimated study completion date is June 2027, with primary completion potentially occurring earlier (July 2026 cited in one source).[12] This timeframe underscores the multi-year commitment required even for Phase 1 development.

Target Indications

• Atopic Dermatitis (AD): AD is the initial patient population being studied in the Phase 1b portion of NCT06934252.[1] The rationale is supported by the high expression of TNFR2 on Tregs within skin tissue and the preclinical proof-of-concept demonstrated in skin inflammation models.[1]
• Ulcerative Colitis (UC) / Inflammatory Bowel Diseases (IBD): UC/IBD is consistently mentioned as a second key area of interest for TRB-061 development.[1] This is based on the high expression of TNFR2 on gut-resident Tregs and positive results from preclinical colitis models.[1] Clinical investigation in IBD may follow the initial studies in AD.

VI. Developer Profile and Strategic Context: TRexBio, Inc.

Company Background and Technology

TRexBio, Inc., founded in 2018 and seed-funded by SV Health Investors, is a biotechnology company headquartered in South San Francisco, California.[4] The company's core mission is to develop novel therapeutics for immune-mediated diseases by deciphering the complex immune biology within human tissues.[1] Central to this effort is its proprietary "Deep Biology Platform." This platform integrates high-resolution sequencing of human tissue samples (sourced via academic collaborations with institutions like UCSF and Oxford), advanced computational biology tools, and scalable translational biology assays.[1] The platform focuses specifically on mapping the behavior of regulatory T cells (Tregs) within tissues to identify and functionally characterize unique, tissue-enriched targets for therapeutic intervention.[1] The company's leadership team includes Johnston Erwin (CEO), Laura Berner (COO), Melanie Kleinschek (CSO), and recent additions Ariella Kelman (CMO) and Brandon Hants (CFO) brought on to support the transition into clinical development.[1]

Pipeline Overview

TRexBio is building a pipeline focused primarily on immunology, leveraging its Deep Biology platform to advance multiple large molecule candidates. TRB-061 is the lead wholly-owned program.

Table 1: TRexBio Pipeline Summary

Program ID	Target / Mechanism	Therapeutic Area	Indication(s)	Development Stage	Ownership / Partner	References
TRB-061	TNFR2 Agonist	Derm, GI	Atopic Derm, IBD/UC	IND Enabling / Ph1 Planned H1 2025	Wholly Owned	1
TRB-071	Immunology (Mechanism Undisclosed)	Immunology	Undisclosed	IND Enabling	Wholly Owned	6
TRB-081	Immunology	Immunology	Undisclosed	Lead Optimization	Wholly Owned	18
TRB-051	Immunology (Effector Cell Modulator)	Immunology	Autoimmune/Inflamm.	Phase 1	Eli Lilly	8
TRB-041	Immunology	Immunology	Undisclosed	Lead Optimization	Eli Lilly	18
Unnamed	Immunology (Treg Modulation)	Immunology	Autoimmune/Inflamm.	Preclinical	Johnson & Johnson	4

This pipeline structure demonstrates a balanced strategy, advancing internal assets like TRB-061 while leveraging partnerships to progress other programs and validate the platform. This approach allows for risk diversification and multiple potential sources of future value.

Funding and Collaborations

TRexBio's progress has been supported by substantial venture capital funding and strategic partnerships. In November 2024, the company announced the close of an oversubscribed $84 million Series B financing round.[5] This round was led by Delos Capital and saw participation from new investors Avego BioScience Capital and Agent Capital, alongside strong support from existing investors, including the venture arms of Eli Lilly, Pfizer, and Johnson & Johnson, as well as SV Health Investors, Alexandria Venture Investments, and Polaris Partners.[5] This follows earlier Series A funding ($59M) and an extension ($26M).[15] The significant backing, particularly from strategic pharmaceutical investors, signals considerable confidence in TRexBio's scientific approach, platform technology, and the potential of its pipeline, including TRB-061.

The company has established key collaborations with major pharmaceutical companies:

• Eli Lilly: A research collaboration and license agreement initiated in January 2023 covers up to three immunology targets identified using TRexBio's platform, including TRB-051 and TRB-041.[5] Lilly initiated a Phase 1 trial for TRB-051 in June 2024, triggering a significant milestone payment to TRexBio. The deal holds potential for over $1.1 billion in future milestones plus royalties.[9] TRexBio also benefited from residency at Lilly Gateway Labs early in its development.[9]
• Johnson & Johnson Innovative Medicine (formerly Janssen): An immunology discovery collaboration was announced in January 2022.[4] In January 2024, Johnson & Johnson exercised its first option for an exclusive license to develop and commercialize a program derived from the collaboration, resulting in a milestone payment to TRexBio.[4]

These partnerships not only provide non-dilutive funding and potential downstream revenue but also serve as crucial external validation of the productivity and potential of TRexBio's Deep Biology Platform in generating promising therapeutic candidates.

VII. Competitive Environment

The therapeutic landscape for immune-mediated diseases is densely populated and highly competitive, featuring well-established drug classes such as TNF inhibitors (e.g., Humira) and JAK inhibitors (e.g., Rinvoq), which generate substantial global revenues.[5] Despite the success of these agents, significant unmet needs remain regarding efficacy in all patients, long-term safety, and the ability to induce durable remission rather than just symptom management.

This context fuels intense research and development into novel mechanisms of action. One such emerging area is the modulation of regulatory T cells (Tregs).[5] Several biotechnology companies are exploring strategies to harness Tregs for therapeutic benefit in autoimmune and inflammatory conditions, although approaches vary. Some focus on ex vivo expansion and reinfusion of Treg cells (cell therapy), such as Kyverna Therapeutics and Sonoma Biotherapeutics mentioned in the competitive landscape.[5]

TRB-061 fits within this Treg-focused space but employs a distinct pharmacological approach: in vivo activation and expansion of endogenous, tissue-resident Tregs via selective agonism of TNFR2.[1] This mechanism differentiates it from both broad immunosuppressants and Treg cell therapies. Compared to cell therapies, a biologic agonist like TRB-061 offers potential advantages in manufacturing scalability and off-the-shelf availability. Compared to broader immunosuppressants, its selectivity for TNFR2 on Tregs aims for a more targeted effect, potentially enhancing safety and promoting physiological resolution of inflammation.[1]

The specific target, TNFR2, is itself gaining recognition as a promising node for immunomodulation, described as having the potential to unlock a "new pillar of therapeutic care".[1] While this recognition highlights the opportunity, it also implies that TRexBio is unlikely to be the only company investigating TNFR2 agonism. Indeed, other entities like Dualyx and Odyssey Therapeutics have been mentioned in relation to TNFR2 agonist programs, suggesting an emerging competitive field specifically around this target.[26] Therefore, while TRB-061's mechanism appears differentiated, its ultimate success will depend on demonstrating clear clinical advantages in efficacy, safety, or durability compared to both existing standards of care and other novel Treg-modulating or TNFR2-targeting therapies that may emerge.

VIII. Synthesis and Outlook

TRB-061 represents a novel therapeutic candidate with the potential to address significant unmet needs in inflammatory diseases like Atopic Dermatitis and Ulcerative Colitis. Developed by TRexBio, it embodies the company's core strategy of leveraging deep insights into human tissue immunology to create targeted therapies. As a selective TNFR2 agonist, TRB-061 aims to restore immune balance by activating and expanding tissue-resident regulatory T cells (Tregs), offering a potentially more physiological and durable approach compared to conventional broad immunosuppression.[1]

The program's strengths lie in its strong preclinical foundation, which includes demonstrated in vivo Treg expansion in humanized systems and proof-of-concept in relevant disease models.[1] This is further bolstered by the validation of TRexBio's underlying "Deep Biology Platform" through productive collaborations with major pharmaceutical partners like Eli Lilly and Johnson & Johnson.[4] The recent successful $84 million Series B financing, featuring robust support from both venture capital and strategic corporate investors, provides the necessary capital and signals strong external confidence to advance TRB-061 into clinical testing.[5]

However, significant risks inherent to early-stage drug development remain. TRB-061 is yet to be tested in humans, and the translation of preclinical findings into clinical efficacy and safety is uncertain. While TNFR2 agonism holds promise, the long-term consequences of selectively modulating this pathway in humans require careful evaluation in clinical trials. Furthermore, the immunology landscape is highly competitive, with numerous established and emerging therapies vying for market share.[5]

The most critical near-term milestone for TRB-061 and TRexBio is the planned initiation of the Phase 1a/1b clinical trial (NCT06934252) in the first half of 2025.[1] Data emerging from this trial over the subsequent 1-2 years, particularly the safety profile and the initial PK, PD, and efficacy signals from the Atopic Dermatitis patient cohort, will be pivotal. Positive results would significantly de-risk the program, validate the TNFR2 agonist approach, and likely catalyze further development, potentially including expansion into IBD indications. Concurrently, TRexBio aims to advance its earlier-stage pipeline, including TRB-071 and nominating its next candidate in 2024, further building on its platform.[1]

In conclusion, TRB-061 stands as a promising, potentially first-in-class therapeutic based on a scientifically compelling mechanism aimed at restoring tissue immune homeostasis. Its successful clinical development would not only offer a valuable new option for patients with inflammatory diseases but also solidify TRexBio's position as an innovator in tissue-focused immunology. The upcoming Phase 1 trial initiation marks a crucial inflection point, setting the stage for validating the therapeutic potential of TRB-061 in humans.

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