Analysis of CPI-100: An Investigational Nanoscale Coordination Polymer Therapeutic

1.0 Introduction

CPI-100 is an investigational nanomedicine identified as being under development by Coordination Pharmaceuticals, Inc. (CPI).[1] This therapeutic candidate is formulated using CPI's proprietary nanoscale coordination polymer (NCP) platform technology, suggesting a delivery system based on nanotechnology principles.[1] Development progressed to early-stage human testing, with a Phase 1 clinical trial initiated to evaluate CPI-100 in patients diagnosed with advanced solid tumors.[1] This report synthesizes the available information regarding CPI-100, its developer, the underlying technology platform, its proposed characteristics, and the status of its clinical investigation, based exclusively on the provided documentation.

2.0 Developer Profile: Coordination Pharmaceuticals, Inc. (CPI)

Coordination Pharmaceuticals, Inc. (CPI), headquartered in Elk Grove Village, Illinois, is identified as a privately held, clinical-stage biopharmaceutical company.[1] The company was founded by Dr. Wenbin Lin [1], who holds the position of James Franck Professor of Chemistry and Professor of Radiation & Cellular Oncology at the University of Chicago.[1] This strong academic connection underscores the company's origins in university-based research.

CPI's primary focus is on oncology drug development, specifically aiming to address unmet medical needs through the application of nanotechnology-based cancer immunotherapy.[1] The company's core Nanoscale Coordination Polymer (NCP) and Radiotherapy-induced Multivalent Oligonucleotide (RiMO) technology platforms were in-licensed from the University of Chicago, granting CPI worldwide rights for development and commercialization.[2] This licensing arrangement is characteristic of an academic spin-out model, where advanced university research is translated into a commercial venture, suggesting a strong scientific basis potentially coupled with the typical funding and development hurdles faced by early-stage biotechnology firms.

CPI has advanced multiple candidates into early-stage clinical trials, leveraging its licensed platforms. Besides CPI-100 (NCT03781362), the pipeline includes CPI-200 (NCT03953742), CPI-300 (NCT04808453), RiMO-301 (NCT03444714, NCT05838729), and RiMO-401 (NCT06182579).[2] The relatively rapid succession of Investigational New Drug (IND) application approvals and Phase 1 trial initiations for these distinct candidates since approximately 2018 suggests a platform-centric development strategy. Rather than focusing resources on a single lead asset, CPI appears to be utilizing the versatility of the NCP and RiMO platforms to generate multiple therapeutic candidates concurrently.

Information regarding the company's operational scale and financial status is limited within the provided documents. It is described as a "Startup" [7], founded in 2012 or 2015.[13] Limited funding details mention an $18M Series B round completed by August 2021.[14] One source cites an employee range of 1-4 [19], while another indicates 100-250.[13] No major acquisitions or strategic partnerships, beyond the foundational license agreement with the University of Chicago, are detailed. This scarcity of public information is common for private, early-stage biotechnology companies but restricts a comprehensive external assessment based solely on the available materials.

3.0 Technology Platform: Nanoscale Coordination Polymers (NCPs)

CPI-100 is based on Coordination Pharmaceuticals' proprietary Nanoscale Coordination Polymer (NCP) technology platform.[1] NCPs are described as nanoparticles formed through the self-assembly of metal ions and organic bridging ligands.[22] A recurring structural motif is the core-shell architecture, which allows for distinct compartments within the nanoparticle, potentially for different payloads or functional components.[1]

A key characteristic of the NCP platform is its versatility. The composition, size, and shape of the nanoparticles are reportedly tunable.[23] This adaptability extends to payload capacity, with NCPs noted for their ability to carry high drug loadings and facilitate the co-delivery of multiple therapeutic agents within a single particle.[1] This capability is particularly relevant for combination therapies, allowing the simultaneous delivery of agents with potentially synergistic mechanisms or differing physicochemical properties, such as chemotherapeutics, small interfering RNAs (siRNAs), photosensitizers, or immunostimulants.[23]

NCPs are also characterized by intrinsic biodegradability and the potential for triggered payload release, responding to specific environmental cues like pH changes or redox conditions.[23] For instance, efficient endosomal escape facilitated by carbon dioxide release has been described for an siRNA-carrying NCP formulation, suggesting mechanisms to overcome intracellular delivery barriers.[26] Furthermore, the surface of NCPs can be modified, often with lipid or polyethylene glycol (PEG) coatings, to enhance stability, prolong systemic circulation time, and reduce uptake by the mononuclear phagocyte system (MPS).[23] Preclinical studies on specific NCP formulations have reported extended blood circulation half-lives, ranging from approximately 10 to 16 hours.[23]

The NCP technology platform, licensed by CPI from the University of Chicago, is supported by extensive preclinical research published by the group of founder Dr. Wenbin Lin. Publications in peer-reviewed journals such as the Journal of the American Chemical Society (JACS), Angewandte Chemie, Nature Communications, Biomaterials, and the Journal of Controlled Release document the development and application of NCPs for delivering a variety of therapeutic agents (including cisplatin, oxaliplatin, gemcitabine, siRNAs, photosensitizers like pyrolipid, and TLR agonists like R848) across different cancer models and therapeutic modalities (chemotherapy, photodynamic therapy, immunotherapy).[16] This body of work provides a substantial scientific foundation for the technology being advanced into clinical trials by CPI. The platform's apparent strengths lie in its adaptability for various payloads and its potential to address common drug delivery challenges, such as poor pharmacokinetics, tumor targeting, and the co-delivery of combination therapies, through a customizable and biodegradable nanocarrier system.

4.0 CPI-100 Overview

4.1 Composition and Formulation

CPI-100 is specifically identified as a formulation based on nanoscale coordination polymer (NCP) nanoparticles.[5] These nanoparticles are described as possessing a core-shell structure.[1] However, the precise chemical composition of the payload carried by CPI-100 remains undisclosed within the provided source materials.[5]

Despite the lack of specific chemical identity, the payload is generally characterized as having potential immunostimulatory and antineoplastic activities.[5] Several sources suggest that CPI-100 contains two synergistic agents, referred to as New Chemical Entities (NCEs) or New Molecular Entities (NMEs).[2] This points towards a combination therapy strategy encapsulated within the NCP nanoparticle.

4.2 Proposed Mechanism of Action

The intended mechanism of action for CPI-100 involves leveraging the NCP platform for selective delivery of its payload to tumor tissues.[1] Once delivered, the payload is expected to exert both direct antitumor (antineoplastic) effects and stimulate an immune response (immunostimulatory activity).[5] Descriptions suggest a therapeutic goal of activating the tumor microenvironment, potentially rendering tumors more susceptible to immune attack or enhancing the efficacy of concurrent immune checkpoint inhibitor therapies.[2] The overarching aim appears to be the initiation or stimulation of immune-mediated eradication of cancer cells.[1]

It is important to differentiate CPI-100 from other entities mentioned in the source materials. Specifically, CPI-100 should not be confused with CPI-613, a distinct compound described as an inhibitor of mitochondrial enzymes pyruvate dehydrogenase (PDH) and α-ketoglutarate dehydrogenase (KGDH).[37] Furthermore, while CPI-100 is suggested to potentially synergize with immune checkpoint inhibitor (CPI) antibodies (e.g., anti-PD-1/PD-L1) [2], the provided information does not indicate that CPI-100 itself functions as a checkpoint inhibitor antibody.[42] Additionally, there is no information within the snippets to suggest CPI-100 is a BET (Bromodomain and Extra-Terminal motif) inhibitor.[11] The mechanism appears centered on co-delivering distinct antineoplastic and immunostimulatory agents via the NCP platform.

The consistent description of CPI-100 involving both antineoplastic and immunostimulatory components strongly implies a deliberate chemo-immunotherapy strategy. The NCP platform's ability to co-deliver different agents is likely central to achieving this combined effect within the tumor microenvironment. If this approach proves successful, CPI-100 could offer a novel therapeutic modality by packaging a combination therapy into a single nanomedicine formulation. This could potentially simplify treatment regimens and enhance synergistic effects compared to the co-administration of separate agents, representing a potential advantage in the crowded oncology landscape. However, the most significant limitation in assessing CPI-100 based on the available information is the lack of disclosure regarding its specific active pharmaceutical ingredients and their precise molecular mechanisms. Without this crucial detail, evaluating the novelty, scientific rationale, potential efficacy, or specific risks associated with CPI-100 remains speculative.

5.0 Clinical Development: Phase 1 Trial (NCT03781362)

5.1 Trial Identification and Status

The primary clinical investigation identified for CPI-100 is registered under the identifier NCT03781362.[2] The study is titled "A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-100 Via Intravenous Infusion in Patients With Advanced Solid Tumors" or similar variations.[7] The trial sponsor is Coordination Pharmaceuticals, Inc..[8]

There is conflicting information regarding the trial's recruitment status within the provided documents. Several sources, including database entries dated up to early 2025, list the trial status as "Completed".[7] Conversely, other sources indicate the status as "Recruiting".[10] Given the typical duration of Phase 1 oncology trials and the dates associated with the "Completed" status entries [11], it is probable that the trial has concluded enrollment and active treatment phases. However, this discrepancy necessitates careful interpretation.

5.2 Study Design and Objectives

NCT03781362 is designated as a Phase 1 clinical trial.[2] Consistent with its first-in-human nature, the study employs an open-label, single-arm, non-randomized design.[1]

The primary objectives focus on establishing the safety profile of CPI-100, including its tolerability and identifying the Maximum Tolerated Dose (MTD). Characterizing the pharmacokinetic (PK) properties of CPI-100 is also a primary goal.[2] Secondary objectives include the preliminary assessment of any antitumor activity exhibited by CPI-100.[2]

5.3 Patient Population and Intervention

The trial enrolled patients diagnosed with advanced solid tumors.[2] One source specifies the inclusion of various breast cancer subtypes (HER2-positive, hormone receptor-positive/HER2-negative, triple-negative).[10] Eligibility criteria included adults aged 18 years and older, encompassing both males and females.[8] Further specific inclusion or exclusion criteria are not detailed in the provided information.

The investigational agent, CPI-100, was administered via intravenous infusion.[5] A dose-escalation scheme was likely used to determine the MTD, typical for Phase 1 oncology studies.

An ambiguity arises from database associations linking NCT03781362 to the drug Capecitabine (DrugBank ID DB01101).[9] These sources list NCT03781362 as a completed Phase 1 trial involving Capecitabine for advanced tumors. This could imply several possibilities: CPI-100 was studied specifically in combination with Capecitabine, the trial allowed concomitant or prior Capecitabine use, CPI-100 itself contains a Capecitabine-related component (though this contradicts the NCE description), or this is an error in the database linkage. The provided snippets do not offer sufficient detail to resolve whether CPI-100 was exclusively studied with, or contains, Capecitabine.

5.4 Timeline and Logistics

The Investigational New Drug (IND) application for CPI-100 was approved by the U.S. Food and Drug Administration (FDA) in October 2018.[1] The first patient was dosed in the trial prior to August 2019.[2] The trial was conducted in the United States [8], although specific clinical site locations are not mentioned. The total number of patients enrolled is not specified in the available documents.

Table 1: Summary of Phase 1 Trial NCT03781362 (Based on Provided Snippets)

Parameter	Detail	Source(s)
Identifier	NCT03781362	2
Title	A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-100 Via Intravenous Infusion in Patients With Advanced Solid Tumors (or similar)	7
Sponsor	Coordination Pharmaceuticals, Inc.	8
Phase	Phase 1	2
Status	Completed (conflicting reports exist suggesting "Recruiting")	7 vs 10
Conditions	Advanced Solid Tumors (including specified Breast Cancer subtypes)	2
Intervention(s)	CPI-100 (Intravenous Infusion). Potential association or combination with Capecitabine requires clarification.	5
Primary Objectives	Safety, Tolerability, Maximum Tolerated Dose (MTD), Pharmacokinetics (PK)	2
Secondary Objectives	Preliminary Antitumor Activity	2
Key Population	Adults (≥18 years), All Genders	8
Location(s)	USA	8
IND Approval	October 2018	1
First Patient Dosed	Before August 2019	2

6.0 Clinical Findings and Publications

A review of the provided source materials reveals an absence of specific clinical results pertaining to CPI-100 or the Phase 1 trial NCT03781362. No data regarding the safety, tolerability, pharmacokinetics, maximum tolerated dose, or preliminary efficacy of CPI-100 in patients were presented in these documents.

One source explicitly mentions the completion of the Phase 1 trial (NCT03781362) in 2022 but notes the associated data remain "unpublished".[11] This corroborates the lack of publicly accessible results within the scope of the reviewed materials.

Furthermore, searches within the provided documents for abstracts or presentations related to CPI-100 or NCT03781362 at major oncology conferences, such as the American Society of Clinical Oncology (ASCO), the American Association for Cancer Research (AACR), or the European Society for Medical Oncology (ESMO), did not yield relevant findings.[18] Snippets referencing these conferences pertained to other therapeutic agents or general oncology topics.

The reported completion of the Phase 1 trial, juxtaposed with the absence of disseminated results in the provided materials, is a notable observation. Typically, early-phase data, particularly safety and pharmacokinetic findings, are crucial for guiding further development and attracting potential partners or investment. The lack of available data for CPI-100 within these sources prevents any assessment of its clinical performance, safety profile, or therapeutic potential based on human trial evidence. Evaluation is therefore restricted to the preclinical rationale and the characteristics of the underlying NCP technology platform.

7.0 Related Pipeline Compounds

Coordination Pharmaceuticals is advancing several therapeutic candidates concurrently, utilizing its licensed NCP and RiMO technology platforms.[2] These related compounds provide context for CPI-100 within the company's broader research and development activities:

• CPI-200: Described as an NCP containing two synergistic NMEs. A Phase 1 trial (NCT03953742) in advanced tumors was initiated, with the first patient dosed by August 2019.[2]
• CPI-300: An NCP designed to deliver two potent NCEs. Its IND was approved in June 2021, allowing initiation of a Phase 1 trial (NCT04808453) in advanced tumors.[4] This trial is listed as "Completed" in some database entries.[13]
• RiMO-301: An agent based on the RiMO platform, intended to enhance radiotherapy via a radiotherapy-radiodynamic therapy (RT-RDT) mechanism. An initial Phase 1 trial (NCT03444714) was started.[2] Subsequently, a Phase 1b/2a study (NCT05838729) combining RiMO-301 with hypofractionated radiotherapy and a PD-1 inhibitor for head and neck cancer is listed as recruiting.[13] Database entries suggest IDO1 as a target for RiMO-301.[13]
• RiMO-401: Another RiMO-based candidate, targeting IDO1.[13] A Phase 1 dose-escalation study (NCT06182579) evaluating RiMO-401 with radiation in advanced tumors is listed as recruiting.[13]

Table 2: Coordination Pharmaceuticals Pipeline Overview (Based on Provided Snippets)

Compound Name	Technology Platform	Brief Description/Mechanism (if stated)	Indication(s)	Clinical Phase	NCT ID(s)	Status (per snippets)	Source(s)
CPI-100	NCP	Core-shell nanoparticle; Undisclosed synergistic immunostimulatory/antineoplastic agents	Advanced Solid Tumors (incl. Breast Cancer)	Phase 1	NCT03781362	Completed (conflicting reports exist)	1
CPI-200	NCP	Contains two synergistic NMEs	Advanced Tumors	Phase 1	NCT03953742	Initiated (First patient dosed Aug 2019)	2
CPI-300	NCP	Delivers two potent NCEs	Advanced Tumors	Phase 1	NCT04808453	Completed	4
RiMO-301	RiMO	Radiotherapy-Radiodynamic Therapy (RT-RDT) enhancement; IDO1 target	Advanced Tumors; Head & Neck Cancer	Phase 1; Phase 1b/2a	NCT03444714; NCT05838729	Phase 1 initiated; Phase 1b/2a Recruiting	2
RiMO-401	RiMO	IDO1 target; Dose-escalation with radiation	Advanced Malignant Solid Neoplasm	Phase 1	NCT06182579	Recruiting	13

8.0 Conclusion

CPI-100 is an investigational therapeutic agent developed by Coordination Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company originating from research conducted at the University of Chicago. The drug candidate is formulated using the company's proprietary Nanoscale Coordination Polymer (NCP) technology, designed as a core-shell nanoparticle. Based on descriptions provided, CPI-100 is intended for the tumor-targeted co-delivery of potentially synergistic agents possessing both immunostimulatory and direct antineoplastic activities, positioning it as a potential combination cancer therapy within a single nanomedicine vehicle.

The clinical development of CPI-100 advanced to a Phase 1, first-in-human trial (NCT03781362) in patients with advanced solid tumors. This study aimed to establish the safety, tolerability, pharmacokinetics, and maximum tolerated dose of intravenously administered CPI-100. While multiple sources indicate this trial has been completed, some conflicting information regarding ongoing recruitment exists within the reviewed materials.

Critically, despite the reported completion of the Phase 1 study, the provided documentation contains no specific clinical data regarding CPI-100's performance in humans. Information on its safety profile, pharmacokinetic parameters, efficacy signals, or the determined MTD is absent. Furthermore, the precise chemical identity of the active pharmaceutical ingredients within CPI-100 remains undisclosed in these sources.

Consequently, based solely on the information available in the provided materials, while CPI-100 represents an application of a versatile nanotechnology platform aimed at enabling combination cancer immunotherapy, a meaningful assessment of its clinical potential, risks, or differentiation is currently precluded. The lack of specific payload details and the absence of Phase 1 clinical results are significant information gaps hindering further evaluation.

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