Investigational Agent GS-2121: Profile, Clinical Development, and Strategic Implications in Oncology

Date of Report: May 8, 2025

1. Executive Summary

GS-2121 is an orally administered small molecule investigational antineoplastic agent currently under development by Gilead Sciences Inc..1 The compound is in the early stages of clinical evaluation, specifically Phase 1, for the treatment of advanced solid tumors.1 A defining characteristic of GS-2121 at this juncture is the lack of publicly disclosed information regarding its precise mechanism of action (MoA) and its specific biological target(s) within cancer cells or the tumor microenvironment. This is a notable aspect, as the MoA is typically a foundational piece of information for investigational oncology drugs. The ongoing first-in-human (FIH) clinical trial (NCT06532565) is designed to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of GS-2121, both as a monotherapy and, significantly, in combination with zimberelimab, an anti-PD-1 (programmed cell death protein 1) antibody.4 The inclusion of zimberelimab in the initial clinical investigations suggests a therapeutic hypothesis involving modulation of the anti-tumor immune response or synergy with immune checkpoint blockade, positioning GS-2121 within the immuno-oncology landscape, a key area of focus for Gilead Sciences. The "unknown" status of its MoA presents both challenges and potential opportunities, underscoring the importance of the data that will emerge from the ongoing Phase 1 study, particularly from its translational research components.

2. Introduction to GS-2121: An Investigational Oral Antineoplastic Agent

GS-2121, also identified by synonyms GS 2121 and GS2121, is a novel therapeutic candidate originating from the oncology pipeline of Gilead Sciences Inc..1 It is classified as a small molecule drug, a common modality in oncology that often allows for oral administration, potentially offering advantages in terms of patient convenience and treatment compliance compared to intravenously administered biologics.2 Consistent with this classification, GS-2121 is being developed as an oral tablet formulation.1 The development of orally available antineoplastic agents remains a significant focus in oncology research, aiming to provide effective and more accessible treatment options for patients with various malignancies.

The fundamental characteristics of GS-2121 are summarized below:

Table 1: GS-2121 Key Drug Profile

Attribute	Details	Source(s)
Drug Name	GS-2121	1
Synonyms	GS 2121, GS2121	3
Developer	Gilead Sciences Inc.	1
Drug Type	Small molecule	2
Administration Route	Oral (tablet)	1
Therapeutic Area(s)	Oncology (Advanced Solid Tumors)	1
Highest Phase	Phase 1	1
Known Target/MoA	Unknown / Undefined	3

The early-stage nature of GS-2121, being in Phase 1 development, signifies that its clinical journey is primarily focused on establishing safety in humans and identifying an appropriate dose for subsequent, more extensive efficacy studies.

3. Pharmacological Profile and Mechanism of Action

GS-2121 is being investigated within the broad therapeutic area of oncology, with its current clinical evaluation centered on patients with advanced solid tumors.1 This patient population is typical for Phase 1 oncology trials, particularly for agents with novel or unconfirmed mechanisms, as it allows for the assessment of safety and potential signals of activity across a spectrum of malignancies.

A critical and somewhat unusual aspect of GS-2121's current public profile is that its specific mechanism of action (MoA) is explicitly stated as "Unknown" or "Undefined mechanism" in multiple pharmaceutical intelligence databases.[1] This lack of disclosure regarding the drug's molecular target and how it exerts its anti-cancer effects has several implications. Firstly, it may indicate that Gilead Sciences is protecting highly novel intellectual property related to a newly discovered target or pathway. Secondly, the MoA could be complex, involving multiple targets or pathways, making it difficult to summarize concisely at this early stage. Thirdly, it is possible that while a clear biological effect has been observed preclinically, the precise molecular interactions are still undergoing full characterization. Finally, it could be a strategic decision to withhold this information for competitive reasons in the fast-moving oncology landscape. The absence of a known MoA makes it more challenging for external observers to predict which specific tumor types might derive the most benefit or to anticipate a unique side-effect profile beyond general concerns associated with cytotoxic or cytostatic small molecules.

Despite the undisclosed MoA, insights can be gleaned from Gilead's broader oncology strategy and the choice of combination partner in the ongoing clinical trial. Gilead's oncology research focuses on three key biological pathways: triggering tumor-intrinsic cell death, promoting immune-mediated tumor killing, and remodeling the tumor-permissive microenvironment.[6] The decision to evaluate GS-2121 in combination with zimberelimab, an anti-PD-1 antibody, from the outset of Phase 1 development strongly suggests a therapeutic hypothesis involving the immune system.[4] This implies that GS-2121 may:

• Possess direct immunomodulatory properties.
• Act to sensitize tumors to the effects of PD-1 blockade, potentially by upregulating PD-L1 expression on tumor cells or by altering the immune cell infiltrate within the tumor.
• Target pathways that confer resistance to immune checkpoint inhibitors.
• Modify the tumor microenvironment to become less immunosuppressive and more conducive to an effective anti-tumor immune response.

Consequently, while the direct molecular target of GS-2121 remains unknown, its clinical development strategy points towards a role in enhancing or complementing immuno-oncology approaches. The elucidation of its MoA through ongoing and future research will be pivotal in guiding its continued development.

The deliberate withholding of MoA information by a major pharmaceutical entity like Gilead is noteworthy. In the highly competitive oncology sector, such a strategy can be employed to safeguard a potentially pioneering discovery, allowing the company to establish a clinical lead and secure comprehensive patent protection before competitors can initiate parallel research programs. This approach suggests a high degree of confidence in the novelty and potential value of GS-2121's underlying science. The broad "advanced solid tumors" indication for the Phase 1 trial, rather than a more narrowly defined population, further supports an exploratory approach. Gilead is likely aiming to identify initial signals of efficacy across diverse cancer histologies, which could, in turn, help to refine the understanding of the MoA or identify specific patient subgroups most likely to respond. The concurrent evaluation of both monotherapy and combination therapy will be instrumental in dissecting the intrinsic activity of GS-2121 versus its synergistic potential with PD-1 blockade.[4] Ultimately, the safety data emerging from the Phase 1 trial will be of paramount importance in characterizing GS-2121's tolerability, a task made more complex by the absence of a known target to predict potential off-target effects.

4. Clinical Development Program for GS-2121

GS-2121 is currently in Phase 1 of clinical development, the earliest stage of human testing.1 This phase is critical for establishing the safety profile of a new investigational drug, determining how it is processed by the human body (pharmacokinetics), and identifying the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) for subsequent studies.

The cornerstone of GS-2121's current clinical evaluation is a first-in-human (FIH) study identified by the ClinicalTrials.gov identifier NCT06532565, Gilead's internal identifier GS-US-579-6764, and the EU Clinical Trial Number EUCT2024-511739-81.[2] The official title of this study is "A Phase 1 Study to Evaluate the Safety and Tolerability of GS-2121 as Monotherapy and in Combination in Adults With Advanced Solid Tumors".[4] This study is designed as a Phase 1/1b, open-label trial.[4] The Phase 1 portion (Part 1) will focus on dose escalation to determine the MTD/RP2D, while the Phase 1b portion (Part 2) will involve expansion cohorts to further assess safety, tolerability, and preliminary efficacy in specific tumor types or biomarker-defined populations. Being open-label, both investigators and participants are aware of the treatment being administered, a common design for early-phase safety-focused trials.

The primary objectives of the NCT06532565 study are to assess the safety and tolerability of GS-2121 administered as a monotherapy and when given in combination with zimberelimab, and to establish the MTD and/or RP2D for GS-2121 in both settings.[2] Key primary outcome measures include the number of participants experiencing Dose Limiting Toxicities (DLTs) during the initial treatment cycles (up to 28 days), and the overall incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) throughout the study and for a period after the last dose.[4]

Secondary outcome measures are comprehensive and designed to provide a multi-faceted understanding of GS-2121's behavior and effects. These include detailed pharmacokinetic profiling of GS-2121 (and zimberelimab in combination arms) to understand its absorption, distribution, metabolism, and excretion (e.g., Cmax​, Tmax​, AUC, t1/2​).[4] Exploratory pharmacodynamic biomarkers will be assessed to gain insights into the biological effects of GS-2121, which is particularly crucial given its unknown MoA. Preliminary anti-tumor activity will also be evaluated through measures such as Objective Response Rate (ORR), Duration of Response (DOR), and Progression-Free Survival (PFS), using the standardized Response Evaluation Criteria in Solid Tumors (RECIST v1.1).[4]

The study is enrolling adult participants diagnosed with histologically or cytologically confirmed advanced solid tumors who have either progressed on standard therapies, are intolerant to them, or for whom no standard therapy is available or appropriate.[4] Participants must have measurable disease according to RECIST v1.1 criteria and a good Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1), indicating they are largely ambulatory and capable of self-care. Notably, the protocol mandates the provision of pretreatment tumor tissue for molecular analysis, and for certain "backfill" cohorts in Parts A and C, fresh pre- and on-treatment biopsies are required.[4] This emphasis on tissue collection is a strong indicator of Gilead's commitment to translational research, aiming to identify pharmacodynamic markers, understand the drug's impact on the tumor microenvironment, and potentially uncover or confirm its MoA. Exclusion criteria are typical for such FIH oncology trials and include recent anti-cancer therapies, active central nervous system (CNS) metastases, significant immunodeficiency or autoimmune disease, other active malignancies, uncontrolled infections, and pre-existing severe cardiac conditions.[4]

The NCT06532565 trial commenced recruitment on July 26, 2024.[2] The estimated primary completion date is June 1, 2028 [3], reflecting the anticipated duration required for dose escalation across multiple cohorts (both monotherapy and combination), subsequent expansions, and comprehensive safety and PK/PD assessments. The study is actively recruiting participants in the United States and Canada.[2] The association with an EU Clinical Trial Number (EUCT2024-511739-81) also signals Gilead's intent for global development, with likely future expansion to European sites [4], facilitating broader patient access and data generation.

Table 2: Overview of Clinical Trial NCT06532565 (GS-US-579-6764)

Attribute	Details	Source(s)
Trial IDs	NCT06532565, GS-US-579-6764, NCI-2024-08813, EUCT2024-511739-81	2
Official Title	"A Phase 1 Study to Evaluate the Safety and Tolerability of GS-2121 as Monotherapy and in Combination in Adults With Advanced Solid Tumors"	2
Phase	Phase 1/1b	4
Study Type	FIH, Open-label, Dose-escalation & Expansion	4
Status	Recruiting	2
Sponsor	Gilead Sciences, Inc.	2
Primary Purpose	Treatment	4
Interventions	GS-2121 (oral, monotherapy); GS-2121 (oral) + Zimberelimab (IV, anti-PD-1)	2
Primary Objectives	Assess safety & tolerability; Determine MTD/RP2D of GS-2121 mono and combo	2
Key Primary Outcome Measures	DLTs (up to 28 days); Incidence of AEs & SAEs (throughout study + 28 days post-treatment)	4
Key Secondary Outcome Measures	PK of GS-2121 & Zimberelimab; PD biomarkers; ORR, DOR, PFS (RECIST v1.1)	4
Patient Population	Adults with advanced solid tumors, progressed on/intolerant to/ineligible for standard therapy, measurable disease, ECOG 0-1. Specific tissue requirements.	4
Start Date	July 26, 2024	2
Est. Primary Completion Date	June 1, 2028	3
Locations	USA, Canada; EU planned	2

5. Strategic Context: GS-2121 within Gilead's Oncology Portfolio

The development of GS-2121 aligns closely with Gilead Sciences' articulated strategy for advancing its oncology pipeline. The company has a stated focus on innovating across multiple therapeutic modalities, including small molecules, antibody-drug conjugates (ADCs), and cell therapies.6 As an oral small molecule, GS-2121 fits squarely within this diversified approach. Gilead's oncology research is structured around targeting three fundamental biological pathways: 1) inducing tumor-intrinsic cell death, 2) promoting immune-mediated tumor killing, and 3) remodeling the tumor-permissive microenvironment.6 While the precise MoA of GS-2121 is not public, its investigation in combination with zimberelimab strongly suggests an alignment with the latter two pathways, or potentially the first if it induces immunogenic cell death that synergizes with checkpoint blockade.

A cornerstone of Gilead's oncology strategy is the exploration of combination therapies, with the company highlighting "12+ Unique combination studies across our pipeline".[6] The immediate evaluation of GS-2121 with zimberelimab in its FIH trial is a direct manifestation of this strategic emphasis.[4] Zimberelimab, an anti-PD-1 antibody, is an internal asset for Gilead and serves as a backbone for various combination approaches within their pipeline, as seen in studies with etrumadenant and GS-1811.[7] The pairing of GS-2121 with zimberelimab aims to leverage potential synergies to enhance or broaden the efficacy of PD-1 blockade, a well-established immuno-oncology approach.

Gilead's historical involvement with oral immuno-oncology agents further contextualizes the development of GS-2121. The company previously advanced GS-4224 (also known as evixapodlin or OX-4224), an oral small molecule PD-L1 inhibitor, through early clinical development.[8] GS-4224 functions by causing dimerization of PD-L1, thereby blocking its interaction with PD-1.[8] Although GS-4224 was subsequently licensed to OmRx Oncology for development in non-small cell lung cancer (NSCLC) primarily in low- and middle-income countries [10], Gilead's initial investment in this molecule underscores a sustained strategic interest in orally bioavailable drugs that can modulate immune checkpoint pathways. This prior experience demonstrates both technical capability and a recognition of the potential advantages of oral immuno-oncology agents, such as improved patient convenience, potentially different pharmacokinetic and pharmacodynamic profiles compared to antibodies, and flexible dosing for managing immune-related toxicities. GS-2121 could represent a next-generation asset in this domain, possibly targeting a novel, complementary, or broader mechanism than direct PD-L1 inhibition to achieve enhanced anti-tumor effects or overcome resistance to existing therapies.

The development of GS-2121, particularly its nature as an oral small molecule with an undisclosed MoA being tested in combination with an anti-PD-1 antibody, is a clear reflection of Gilead's multi-pronged strategy to build a robust oncology franchise. This strategy leverages internal innovation alongside external collaborations and acquisitions.[13] The journey of GS-2121 will not only determine its own therapeutic future but also contribute valuable knowledge to Gilead's overarching approach to novel MoAs in immuno-oncology and the optimization of combination regimens with its existing checkpoint inhibitors.

6. Preclinical Data Summary

Publicly available details regarding specific preclinical studies and their outcomes for GS-2121 are limited. However, AdisInsight notes "Preclinical trials in Solid tumours in USA (PO) before August 2024 (NCT06532565)".5 This indicates that a package of preclinical data was generated to support the Investigational New Drug (IND) application and the subsequent initiation of the Phase 1 clinical trial, NCT06532565.

While the provided research material does not contain specific in vitro or in vivo preclinical results for GS-2121, the progression of any investigational drug to FIH clinical trials is contingent upon a substantial body of preclinical evidence. Regulatory authorities, such as the U.S. Food and Drug Administration (FDA), require comprehensive data demonstrating an acceptable safety profile in animal models and a sound scientific rationale for potential efficacy in humans. Therefore, it can be inferred that GS-2121 demonstrated adequate safety margins and plausible anti-tumor activity or target engagement in preclinical settings to justify its advancement into human testing.

Typically, such preclinical programs for an oral oncology small molecule like GS-2121 would encompass:

• In vitro studies: Assessing the compound's activity against various cancer cell lines, potentially elucidating aspects of its MoA, determining concentrations needed for biological effects, and evaluating specificity.
• In vivo studies: Utilizing animal models of cancer (e.g., human tumor xenografts in immunocompromised mice, or syngeneic models in immunocompetent mice if an immune-mediated effect is hypothesized) to evaluate anti-tumor efficacy, dose-response relationships, and combination effects (e.g., with anti-PD-1 antibodies).
• Pharmacokinetic (PK) and Pharmacodynamic (PD) studies: Characterizing the absorption, distribution, metabolism, and excretion (ADME) of GS-2121 in animals, and correlating drug exposure with biological effects or target modulation.
• Toxicology studies: Comprehensive safety assessments in at least two animal species to identify potential organ toxicities, establish a no-observed-adverse-effect level (NOAEL), and inform the starting dose for human trials.

The design of the ongoing Phase 1 trial (NCT06532565), including the initial starting dose of GS-2121, the dose escalation strategy, and the decision to combine it with zimberelimab, would have been directly informed by these preclinical findings. For instance, preclinical evidence of synergy between GS-2121 and PD-1/PD-L1 blockade would provide the rationale for the combination arms. The oral route of administration (PO) noted for preclinical trials [5] is consistent with its administration as a tablet in the clinical setting.[1]

7. Regulatory Landscape

GS-2121 is currently classified as an investigational drug and is in Phase 1 clinical development.1 At this early stage, specific regulatory designations such as Fast Track, Breakthrough Therapy, or Orphan Drug status have not been reported for GS-2121 in the available information.1 This is not uncommon for assets in early Phase 1, as such designations are typically sought once preliminary clinical data demonstrating potential to address significant unmet medical needs or offer substantial improvement over existing therapies become available.

Clinical trial authorizations have been secured for GS-2121 in the United States and Canada, as evidenced by the active recruitment in these countries for the NCT06532565 study.[2] Furthermore, the association of this trial with a European Union Clinical Trial Number (EUCT2024-511739-81) indicates Gilead's intention to conduct or current approval for conducting trials in Europe.[4] While specific EU member states participating are not detailed in the provided snippets, the European Medicines Agency's (EMA) Clinical Trials Information System (CTIS) would be the repository for such details once trials are formally registered and active in the EU.[14] This multi-regional approach from the outset of Phase 1 development reflects a global clinical development strategy, common for large pharmaceutical companies like Gilead, aimed at optimizing patient recruitment, gathering diverse data, and preparing for eventual simultaneous regulatory submissions in key markets.

8. Future Outlook and Expert Analysis

The future trajectory of GS-2121 will be heavily influenced by the outcomes of the ongoing Phase 1/1b trial (NCT06532565). Initially targeting "advanced solid tumors," the specific indications for later-phase development will be guided by signals of anti-tumor activity observed in the dose escalation and expansion cohorts, as well as by the eventual elucidation of its mechanism of action. If GS-2121's MoA indeed involves immunomodulation or synergy with checkpoint inhibitors, its development might prioritize tumor types where PD-1/PD-L1 inhibitors have established activity, or, more significantly, in settings where resistance to these agents is prevalent, representing a high unmet medical need.

Several challenges and opportunities characterize the path forward for GS-2121. The primary challenge remains its undisclosed MoA. A clear understanding of its biological target and pathway is crucial for rational drug development, including the selection of appropriate patient populations (potentially biomarker-driven), prediction and management of side effects, and understanding mechanisms of resistance. The oncology landscape, particularly for advanced solid tumors and immuno-oncology combinations, is intensely competitive. GS-2121 will need to demonstrate a compelling efficacy and safety profile, or a unique therapeutic niche, to differentiate itself.

Conversely, significant opportunities exist. If GS-2121 possesses a truly novel MoA that proves effective and is well-tolerated, especially in combination regimens, it could offer a new therapeutic option for patients who have exhausted or are unsuitable for current treatments. Its oral route of administration is a distinct advantage, offering patient convenience and potentially facilitating long-term or maintenance therapy if proven safe and effective.[1]

Upcoming data readouts from NCT06532565 will be critical. Initial data on safety, tolerability, MTD, and RP2D from both monotherapy and combination cohorts will be the first major milestone. Any early signals of anti-tumor activity (e.g., ORR) or meaningful modulation of exploratory biomarkers will be highly anticipated by the oncology community. The translational data derived from the mandatory tumor biopsies [4] holds particular importance, as it may provide the first public insights into GS-2121's biological activity and potentially its MoA.

The success of GS-2121 may ultimately depend not only on its intrinsic monotherapy activity but, perhaps more critically, on its capacity to substantially augment the efficacy of zimberelimab or other checkpoint inhibitors. Addressing the significant challenge of primary or acquired resistance to immuno-oncology therapies is a major focus in cancer research. If GS-2121 can effectively synergize with PD-1 blockade to induce deeper, more durable responses, or to overcome resistance mechanisms, it would represent a significant therapeutic advance. The extended timeline for the primary completion of the Phase 1 study, estimated for June 2028 [3], suggests that definitive, potentially registrational, data are several years away. In the interim, the scientific and medical communities will look for updates at major oncology conferences (such as ASCO, ESMO, AACR) for early indicators of GS-2121's safety and efficacy profile. Given Gilead's extensive oncology pipeline and its history of strategic portfolio management through internal development and external acquisitions [6], the emerging data for GS-2121 will be rigorously evaluated internally to determine its continued priority and resource allocation within the company's broader R&D efforts.

9. Conclusion

GS-2121 is an orally administered small molecule investigational agent being advanced by Gilead Sciences through early-stage Phase 1 clinical development for the treatment of advanced solid tumors. A key feature of its current profile is the publicly undisclosed nature of its specific mechanism of action and biological target(s). The ongoing first-in-human trial (NCT06532565) is evaluating GS-2121 both as a monotherapy and, significantly, in combination with the anti-PD-1 antibody zimberelimab, indicating a strategic positioning within the immuno-oncology domain.

The most pressing unanswered question surrounding GS-2121 is its MoA. The results from the Phase 1 trial, particularly data from translational research involving tumor biopsies and pharmacodynamic biomarker assessments, will be paramount in illuminating its biological activity, guiding patient selection, and shaping its future development pathway. The concurrent investigation of monotherapy and combination therapy from this early stage underscores a strategy aimed at understanding both the intrinsic properties of GS-2121 and its potential to synergize with established immuno-oncology backbones.

The development of GS-2121 highlights the ongoing pursuit of novel oral agents in oncology that can be effectively integrated into combination strategies, particularly with immune checkpoint inhibitors. This aligns with Gilead Sciences' broader R&D focus on expanding its oncology portfolio with innovative therapies that address unmet medical needs. The progression of GS-2121 will be closely monitored by the oncology community, as emerging data may reveal a new therapeutic modality and further define its potential role in the treatment of advanced cancers.

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