TORL-3-600: A Clinical-Stage CDH17-Targeted Antibody-Drug Conjugate for Advanced Cancers

1. Introduction to TORL-3-600

TORL-3-600 (also designated TORL3600) is a novel, first-in-human antibody-drug conjugate (ADC) currently undergoing clinical investigation for the treatment of advanced malignancies.[1] Developed by TORL BioTherapeutics, LLC, this agent represents a targeted therapeutic strategy directed against Cadherin 17 (CDH17), a cell surface protein with restricted expression in normal tissues but notable overexpression in certain gastrointestinal cancers.[2]

TORL-3-600 belongs to the ADC therapeutic class, which combines the target specificity of a monoclonal antibody (mAb) with the potent cell-killing activity of a cytotoxic payload.[2] This approach aims to deliver chemotherapy selectively to cancer cells expressing the target antigen, potentially enhancing efficacy while minimizing systemic toxicity compared to traditional chemotherapy.[11] The design of TORL-3-600 involves a fully humanized mAb directed against CDH17, conjugated via a cleavable linker to the microtubule-disrupting agent monomethyl auristatin E (MMAE).[6] The intended mechanism involves binding to CDH17 on tumor cells, internalization, lysosomal trafficking, linker cleavage, and intracellular release of MMAE, leading to cell cycle arrest and apoptosis.[2]

TORL BioTherapeutics operates through an exclusive strategic partnership with the Slamon Research Laboratory at the University of California, Los Angeles (UCLA), a center recognized for its contributions to identifying key cancer targets like HER2 and CDK4/6.[7] TORL-3-600 emerged from this collaboration, which aims for rapid translation of validated preclinical findings into clinical development.[7]

Currently, TORL-3-600 is being evaluated in a Phase 1 clinical trial (NCT05948826) initiated in late 2023.[1] While the company's pipeline overview on its website has listed the program as preclinical [7], multiple recent press releases and clinical trial registry data confirm its advancement into Phase 1 human testing.[2] The relatively swift progression from preclinical validation, reported in early 2024 [6], to the initiation of the Phase 1 trial underscores the efficiency sought by the TORL Bio/UCLA partnership model.[7] Although preclinical studies demonstrated activity in models of colorectal, gastric, and pancreatic cancers [6], initial clinical communications and funding allocations emphasize its development for CDH17-positive colorectal cancer (CRC).[2] This focus likely stems from the particularly high prevalence of CDH17 expression observed in CRC tumor samples (approximately 90%) [6], providing a strong biological rationale for initial clinical investigation in this patient population.

2. Target Rationale and Mechanism of Action

2.1. Cadherin 17 (CDH17) as a Therapeutic Target in Oncology

Cadherin 17 (CDH17) is a calcium-dependent cell-cell adhesion molecule belonging to the cadherin superfamily.[6] It functions as a single-pass transmembrane protein. In healthy adult tissues, CDH17 expression is highly restricted, primarily confined to the lateral surfaces of epithelial cells lining the intestine and pancreatic ducts.[6] This limited expression profile in normal tissues is a desirable characteristic for an ADC target, as it suggests a potential for reduced on-target toxicity in non-malignant cells.

In contrast to its restricted normal expression, CDH17 is frequently overexpressed in several gastrointestinal malignancies, including colorectal, gastric, and pancreatic cancers.[6] Immunohistochemical analyses of large human tumor microarrays (TMAs) have quantified this overexpression, revealing detectable CDH17 expression in approximately 90.1% of colorectal cancer samples, 51.8% of gastric cancer samples, and 20.4% of pancreatic cancer samples.[6] Given that these cancers, particularly in advanced stages, represent significant unmet medical needs with often limited effective treatment options [24], the selective and frequent overexpression of CDH17 makes it a highly attractive target for the development of novel antibody-based therapies, including ADCs like TORL-3-600.[6]

2.2. Molecular Design and Proposed Mechanism of TORL-3-600

TORL-3-600 is engineered as an ADC comprising three key components: a targeting antibody, a cytotoxic payload, and a linker system.

• Antibody: The targeting moiety is a fully humanized monoclonal antibody specific for human CDH17. This antibody was initially generated using traditional hybridoma technology, immunizing mice with a combination of engineered cells overexpressing full-length human CDH17 and purified recombinant human CDH17 extracellular domain protein.[6] Subsequent humanization aims to reduce immunogenicity in patients. While not definitively confirmed for the originator drug in the available data, information associated with a research-grade biosimilar refers to the antibody component as "CDH17-ADC-653-h43", potentially indicating the specific humanized clone used.[26]
• Payload: The cytotoxic agent is monomethyl auristatin E (MMAE), a potent synthetic antineoplastic agent.[6] MMAE functions as a tubulin inhibitor, disrupting microtubule assembly and dynamics, which leads to cell cycle arrest at the G2/M phase and subsequent apoptosis.[2] The choice of MMAE aligns with established ADC development strategies, as it is utilized in several clinically approved ADCs, providing a known profile regarding potency and potential toxicities.[11]
• Linker: MMAE is conjugated to the anti-CDH17 antibody via a cleavable linker.[6] Cleavable linkers are designed to be stable in systemic circulation but are susceptible to cleavage within the target tumor cell environment, typically within the lysosome, to release the active payload. While the specific chemical nature of the linker in TORL-3-600 is not detailed, this design principle is common for ADCs employing intracellularly active payloads like MMAE. Contextual information mentions advancements in linker technologies, such as glutathione-responsive silyl ethers, though direct application to TORL-3-600 is not specified.[5]

The proposed mechanism of action for TORL-3-600 follows the canonical steps for an internalizing ADC:

1. Target Binding: The ADC circulates systemically and selectively binds to CDH17 expressed on the surface of cancer cells.[6]
2. Internalization & Trafficking: Upon binding, the CDH17-ADC complex is internalized by the tumor cell, typically via receptor-mediated endocytosis, and subsequently trafficked to the lysosomal compartment.[6] Preclinical studies have confirmed that binding of TORL-3-600 induces internalization and lysosomal translocation, a critical step for payload delivery.
3. Payload Release: Within the acidic and enzyme-rich environment of the lysosome, the cleavable linker is processed, liberating the MMAE payload into the cell cytoplasm.[6]
4. Cytotoxicity: The released MMAE binds to tubulin, inhibiting microtubule polymerization and disrupting the cellular cytoskeleton. This leads to cell cycle arrest and induction of apoptosis, ultimately causing the death of the CDH17-expressing cancer cell.[2]

3. Preclinical Evaluation

The advancement of TORL-3-600 into clinical trials was supported by a comprehensive preclinical evaluation program assessing its binding characteristics, mechanism of action, efficacy, and safety profile.

3.1. In Vitro Characterization

Initial studies focused on confirming the antibody's interaction with its target. Selective binding of the TORL-3-600 antibody component to CDH17 was demonstrated using flow cytometry assays on various human cancer cell lines, including those endogenously expressing CDH17 and engineered cell lines designed to overexpress the target protein.[6] Furthermore, immunofluorescence studies confirmed that the binding of the antibody to cell surface CDH17 resulted in the internalization of the antibody-receptor complex, a prerequisite for the intracellular delivery of the conjugated payload.[6]

3.2. In Vivo Efficacy Studies

The anti-tumor activity of TORL-3-600 was investigated in various mouse xenograft models derived from human cancers known to express CDH17. These included both cell line-derived xenograft (CDX) models and patient-derived xenograft (PDX) models, the latter often considered more representative of clinical tumor heterogeneity.[6]

• Colorectal Cancer (CRC) Models: Treatment with TORL-3-600 demonstrated significant anti-tumor activity in CDH17-positive CRC models. In four different CDX models, treatment resulted in substantial tumor growth inhibition (TGI), ranging from 103.6% to 140.4%, indicating tumor regression. Similarly, in three different CDH17-positive CRC PDX models, TGI values ranged from 63.3% to 102.2%.[6] Notably, the anti-tumor responses observed in these CRC models were reported to be durable, sustained for up to nine weeks after the cessation of treatment.[6]
• Pancreatic Cancer Model: Sustained inhibition of tumor progression was also observed in a CDX model derived from a CDH17-positive pancreatic cancer cell line, with a TGI of 85.8%.[6]
• Target Specificity Control: To confirm that the observed efficacy was dependent on CDH17 expression, TORL-3-600 was also tested in CDH17-negative human colon cancer models (both CDX and PDX). In these models, significantly reduced anti-tumor responses were observed (TGI ranging from 37.3% to 58.2%), supporting the conclusion that TORL-3-600's activity is mediated through its specific interaction with CDH17.[6]

The robust efficacy demonstrated across multiple CDH17-positive models, including the clinically relevant PDX models, combined with the evidence of target specificity and response durability, provided strong support for the therapeutic potential of TORL-3-600.

3.3. Target Expression Confirmation

Parallel studies utilized immunohistochemistry (IHC) assays to confirm and quantify CDH17 expression patterns in preclinical models (CDX, PDX) and, importantly, in large collections of human patient tumor samples organized into TMAs.[6] These TMA analyses corroborated the high frequency of detectable CDH17 expression in CRC (90.1%), substantial expression in gastric cancer (51.8%), and notable expression in pancreatic cancer (20.4%), reinforcing the clinical relevance of CDH17 as a target in these malignancies.[6]

3.4. Preclinical Safety and Pharmacokinetics (PK)

Safety assessments conducted alongside the in vivo efficacy studies indicated that the doses of TORL-3-600 tested were well tolerated in mice, with no dose-limiting toxicities observed.[6] Subsequently, TORL-3-600 successfully completed formal Investigational New Drug (IND)-enabling toxicology studies. These studies yielded acceptable pharmacokinetic (PK) and toxicity profiles, meeting the regulatory requirements for initiating human clinical trials.[6]

Collectively, the preclinical data package, demonstrating specific target binding, efficient internalization, potent and durable target-dependent anti-tumor activity in relevant xenograft models, and an acceptable safety profile, provided a compelling scientific rationale for advancing TORL-3-600 into Phase 1 clinical evaluation.[6]

4. Clinical Development: Phase 1 Study (NCT05948826)

Based on the promising preclinical data, TORL-3-600 has entered clinical development with an ongoing Phase 1 trial.

4.1. Trial Identification and Status

The first-in-human study of TORL-3-600 is registered on ClinicalTrials.gov under the identifier NCT05948826.[1] The study is also referred to by the sponsor protocol number TORL3600-001 and the collaborative group identifier TRIO-055.[12] It is a Phase 1 study, titled "A Phase 1, First in Human, Dose-Escalation Study of TORL-3-600 in Participants With Advanced Cancer".[4] The trial began recruiting participants on September 29, 2023, and is currently active and recruiting, specifically within the dose-escalation phase as of late 2024.[2] The estimated primary completion date is September 15, 2026, with the same date listed for the estimated overall study completion.[2]

4.2. Study Design and Objectives

This is an open-label, multi-center, dose-escalation study designed to evaluate TORL-3-600 in patients with advanced solid tumors.[1] Participants receive TORL-3-600 intravenously.[3] While the initial enrollment criteria are broad regarding tumor type, the ultimate focus is expected to align with CDH17-expressing cancers, particularly CRC, based on preclinical rationale and sponsor communications.[6]

The primary objectives are standard for a first-in-human dose-escalation trial:

• To assess the safety and tolerability profile of TORL-3-600.[1]
• To determine the Maximum Tolerated Dose (MTD).[1]
• To identify the Recommended Phase 2 Dose (RP2D) for future studies.[1]

Secondary objectives include:

• To characterize the pharmacokinetic (PK) profile of TORL-3-600.[1]
• To obtain preliminary evidence of anti-tumor activity.[1]

The enrollment strategy of initially including patients with various advanced solid tumors allows for more rapid accrual during the dose-escalation phase, where safety is paramount. It is anticipated that subsequent expansion cohorts, initiated after the RP2D is determined, will focus specifically on patients with confirmed CDH17-positive tumors to better evaluate efficacy signals in the target population.

4.3. Eligibility Criteria

The study enrolls adult patients with advanced solid tumors who meet specific criteria.[1]

Key Inclusion Criteria:

• Histologically confirmed diagnosis of an advanced solid tumor.[1]
• Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).[1]
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, indicating good functional status.[1]
• Adequate hematologic, renal, and hepatic organ function.[1]

Key Exclusion Criteria:

• Persistent acute toxicities (Grade >1 by NCI CTCAE v5.0, excluding alopecia or acceptable lab values) from prior cancer therapies.[29]
• Receipt of prior chemotherapy, investigational agents, or other cancer therapies within specified washout periods (14 days for small molecules, 28 days for biologics) before the first dose of TORL-3-600.[15]
• Presence of progressive or symptomatic brain metastases.[15]
• Serious, uncontrolled intercurrent medical conditions or active, uncontrolled infections.[1]
• History of significant cardiac disease.[1]
• History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).[29]
• Diagnosis of another malignancy within the previous 3 years, with exceptions for certain low-risk, definitively treated cancers (e.g., basal/squamous cell skin carcinoma, ductal carcinoma in situ of the breast, low-Gleason prostate cancer).[1]
• Current pregnancy or breastfeeding.[29]

4.4. Study Endpoints

The trial employs standard endpoints for Phase 1 oncology studies.[1]

Primary Endpoints:

• Safety & Tolerability: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
• Maximum Tolerated Dose (MTD): Defined as the highest dose level at which fewer than 33% of the initial cohort of DLT-evaluable participants (typically 6 patients) experience a dose-limiting toxicity (DLT) during the first treatment cycle (usually 28 days).
• Recommended Phase 2 Dose (RP2D): The dose selected for further investigation in Phase 2 studies, based on an integrated assessment of the MTD, overall safety data, pharmacokinetic profile, and any preliminary signs of anti-tumor activity observed during dose escalation.

Secondary Endpoints:

• Anti-tumor Activity (Preliminary): Assessed using RECIST v1.1 criteria, including:
• Objective Response Rate (ORR): Percentage of participants achieving a best overall response of Complete Response (CR) or Partial Response (PR).
• Duration of Response (DOR): Time from the first documented CR or PR until disease progression or death from any cause.
• Progression-Free Survival (PFS): Time from the start of treatment until objective disease progression or death from any cause.
• Time to Response (TTR): Time from the start of treatment to the first documented CR or PR.
• Pharmacokinetics (PK): Comprehensive characterization of the TORL-3-600 ADC concentration profile in serum over time, including:
• Maximum concentration (Cmax), Minimum concentration (Cmin)
• Time to maximum concentration (Tmax), Time to minimum concentration (Tmin)
• Steady-state parameters (Cmax,ss, Cmin,ss, Tmin,ss)
• Area under the concentration-time curve (AUClast, AUCinf)
• Terminal elimination half-life (t1/2)
• Apparent volume of distribution during the terminal phase (Vz)

The detailed PK assessment is critical at this stage to understand the drug's behavior in humans, inform dosing schedules, and explore potential relationships between drug exposure and clinical outcomes (efficacy and toxicity).

4.5. Participating Sites

The TORL3600-001 trial is being conducted at multiple clinical sites in North America.[3] Identified participating institutions include:

• United States: University of California, Los Angeles (UCLA) - Jonsson Comprehensive Cancer Center (JCCC) Clinical Research Unit (Los Angeles, CA); Mary Crowley Cancer Research (Dallas, TX); Washington University School of Medicine - Siteman Cancer Center (St. Louis, MO); Providence Medical Foundation (Fullerton, CA); Sarah Cannon Research Institute (Denver, CO); Fort Wayne Medical Oncology and Hematology Inc. (Fort Wayne, IN).
• Canada: University Health Network, Princess Margaret Cancer Centre (Toronto, ON); McGill University Health Centre (Montréal, QC).

4.6. Phase 1 Trial Summary Table

The key details of the ongoing Phase 1 clinical trial for TORL-3-600 are summarized in Table 1.

Table 1: Summary of Phase 1 Trial NCT05948826 (TORL3600-001 / TRIO-055)

Parameter	Detail	Source Snippet(s)
Trial Identifier	NCT05948826; TORL3600-001; TRIO-055	1
Phase	1	1
Title	A Phase 1, First in Human, Dose-Escalation Study of TORL-3-600 in Participants With Advanced Cancer	4
Sponsor	TORL BioTherapeutics, LLC	1
Status	Recruiting (Dose Escalation Phase)	2
Start Date	September 29, 2023	15
Est. Primary Completion	September 15, 2026	2
Est. Study Completion	September 15, 2026	15
Population	Patients with Advanced Solid Tumors	1
Intervention	TORL-3-600 (Intravenous)	1
Primary Objectives	Evaluate safety & tolerability; Determine MTD; Identify RP2D	1
Key Primary Endpoints	Incidence/Severity of AEs/SAEs; MTD determination; RP2D selection	1
Key Secondary Endpoints (Efficacy)	ORR, DOR, PFS, TTR (per RECIST 1.1)	1
Key Secondary Endpoints (PK)	Cmax, Cmin, Tmax, Tmin, t1/2, AUC (last, inf), Vz, Steady-state parameters (Cmax,ss, Cmin,ss, Tmin,ss)	1
Key Locations	USA (CA, CO, IN, MO, TX), Canada (ON, QC)	3

5. Development Context and Corporate Overview

The development of TORL-3-600 occurs within the specific strategic framework of TORL BioTherapeutics.

5.1. TORL BioTherapeutics and the Slamon Research Lab Partnership

TORL BioTherapeutics is a clinical-stage company established with the mission to discover, develop, and commercialize novel antibody-based therapies (mAbs and ADCs) for cancer.[7] Its foundation lies in an exclusive, strategic partnership with the Slamon Research Laboratory at UCLA, headed by Dr. Dennis Slamon.[7] This collaboration grants TORL the rights to a portfolio of drug candidates targeting novel cancer antigens identified and preclinically validated within the Slamon lab, which has a significant track record in identifying clinically impactful targets like HER2 and CDK4/6.[7] This model is designed to facilitate a rapid and capital-efficient pathway from target discovery to clinical proof-of-concept, leveraging the lab's expertise and validation platforms.[7] The development of TORL-3-600 exemplifies this approach.[12] The credibility associated with the Slamon lab's prior successes in target identification potentially enhances the prospects for targets selected through this established discovery engine, including CDH17.

5.2. TORL-3-600 within the Company's ADC Pipeline

TORL-3-600 is a key component of a broader pipeline of antibody-based therapeutics, particularly ADCs, being advanced by TORL BioTherapeutics.[7] The company emphasizes a strategy of targeting specific molecular or genetic signatures in tumors, often involving the development of companion diagnostics to ensure patient selection.[7]

Other clinical-stage programs progressing alongside TORL-3-600 include [7]:

• TORL-1-23: An ADC targeting Claudin 6 (CLDN6). This appears to be the company's lead asset, having advanced into a pivotal, registration-enabling Phase 2 study (CATALINA-2, NCT06690775) for platinum-resistant ovarian cancer (PROC).[12]
• TORL-2-307 Program: Comprising both a monoclonal antibody (TORL-2-307MAB, NCT05159440) and an ADC (TORL-2-307ADC, NCT05156866) targeting Claudin 18.2 (CLDN18.2), both in Phase 1 trials for CLDN18.2-positive solid tumors.
• TORL-4-500: An ADC targeting Delta-like non-canonical Notch Ligand 1 (DLK1), currently in a Phase 1 trial (NCT06005740) for DLK1-positive solid tumors.

This diverse pipeline demonstrates TORL's commitment to leveraging its platform across multiple novel targets and antibody modalities. While TORL-1-23 is currently the most advanced program, TORL-3-600 represents another significant effort targeting a distinct pathway in gastrointestinal cancers.

5.3. Recent Financing and Strategic Implications

In April 2024, TORL BioTherapeutics announced the successful closing of an oversubscribed $158 million Series B-2 financing round.[2] This brought the company's total capital raised to over $350 million since its public launch in April 2023.[7] The financing was led by Deep Track Capital and saw participation from numerous prominent biotechnology venture capital firms (e.g., RA Capital, Perceptive Advisors, Avidity Partners, Goldman Sachs Alternatives, UC Investments, Vertex Ventures) as well as a strategic investment from Bristol Myers Squibb (BMS).[5]

The substantial size of the financing and the caliber of the investors underscore significant confidence in TORL's scientific platform, its pipeline of ADCs and mAbs, and its management team. The continued participation of BMS, a major pharmaceutical company with significant oncology interests, may indicate strategic interest in TORL's technology or specific assets. The raised capital provides a robust financial foundation for the company's development activities. Crucially, the proceeds are explicitly intended to fund the ongoing Phase 1 clinical trials for TORL-3-600 (targeting CDH17+ CRC), TORL-2-307 (anti-CLDN18.2), and TORL-4-500 (anti-DLK1), alongside advancing the lead program TORL-1-23 through its pivotal Phase 2 study.[12] This allocation ensures the continued near-term clinical evaluation of TORL-3-600.

6. Summary and Future Outlook

TORL-3-600 is a clinical-stage antibody-drug conjugate targeting Cadherin 17 (CDH17), a protein selectively overexpressed in colorectal, gastric, and pancreatic cancers, with particularly high prevalence in CRC.[5] Developed by TORL BioTherapeutics through its strategic partnership with the UCLA Slamon Research Lab, the ADC employs a clinically validated payload, MMAE, attached via a cleavable linker to a humanized anti-CDH17 antibody.[6] Its mechanism relies on target binding, internalization, and intracellular release of MMAE to induce tumor cell death.[6]

Preclinical studies have provided a strong rationale for clinical development, demonstrating specific binding, internalization, potent and durable anti-tumor efficacy in CDH17-positive CRC and pancreatic cancer xenograft models (including PDX models), and acceptable safety and PK profiles in mice.[6]

TORL-3-600 is currently being evaluated in a multi-center Phase 1 dose-escalation trial (NCT05948826) in patients with advanced solid tumors.[1] The primary goals are to establish the safety profile, MTD, and RP2D, while secondary objectives include PK characterization and preliminary assessment of anti-tumor activity.[1] Supported by recent substantial financing, the program is positioned to progress through this initial phase of clinical testing.[12]

Future development milestones will include the determination of the RP2D and the subsequent initiation of expansion cohorts. These cohorts will likely focus on enrolling patients with confirmed CDH17-positive tumors, particularly CRC, given the high target expression and preclinical efficacy data.[6] The success of TORL-3-600 in later-stage trials will depend critically on the validation of a reliable companion diagnostic assay to accurately identify patients whose tumors express CDH17, aligning with the company's biomarker-driven strategy.[7] While the preclinical data are encouraging, the full therapeutic potential and safety profile of TORL-3-600 in humans remain to be elucidated through the ongoing and future clinical investigations. Furthermore, its ultimate clinical utility will be assessed within the context of the existing and emerging therapeutic landscape for CDH17-positive gastrointestinal cancers, which includes other investigational agents targeting CDH17.[10] Key details regarding the specific antibody clone and linker chemistry, as well as comprehensive patent information, were not fully available in the reviewed materials.[26]

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