作者： canwell

The 2025 European Society for Medical Oncology (ESMO) Annual Congress was held in Oct 17-19, Berlin, Germany. CanWell presented preliminary safety and efficacy data from its Phase 1b/2a clinical trial of CAN1012, a first-in-class IFNα-biased TLR7 agonist, in combination with toripalimab for advanced solid tumors, in a poster presentation format.

• ​CAN1012 is an IFNα-biased TLR7 agonist​

CAN1012 preferentially inducing IFN-α but inducing minimal pro-inflammatory cytokines such as IL-6, contributing to the favorable safety profile.

• ​CAN1012 plus toripalimab demonstrates superior safety

Among enrolled subjects, Grade 3 treatment-related adverse events (TRAEs) occurred in only 3.5% (with no Grade >3 TRAEs), and all other adverse events were mild (Grade 1–2). No cytokine release syndrome (CRS) or DLT events were observed,

• ​CAN1012 plus toripalimab may address unmet needs in PD-1-resistant advanced melanoma​

In patients with advanced melanoma who relapsed or metastasized after PD-1 inhibitor treatment, the combination therapy achieved an objective response rate (ORR) of 37.5% and a disease control rate (DCR) of 100%.

• CAN1012 plus toripalimab could become a first-line option for dedifferentiated liposarcoma (DDLPS), addressing a lack of effective therapies​

In patients with DDLPS, the combination therapy yielded an ORR of 25%, significantly higher than the ORR of doxorubicin monotherapy (2.9%) – the current treatment standard. Given that DDLPS is insensitive to conventional radiotherapy and chemotherapy, there is an urgent unmet clinical need.

The expansion part of the trial is on-going to generate additional data on safety and efficacy in DDLPS and melanoma.

CanWell Pharma will present its latest development progress at the 16th World ADC held on Nov 3-6, 2025, in San Diego, CA. The presentation will be in the form of a poster. The poster will cover the newest research and development updates on company StarLinker dual/tri-payload ADCs, which had made significant progress against tumor heterogeneity and overcoming drug resistance, while maintaining excellent tolerability in preclinical safety studies.

Date: Nov 3-6, 2025

Location: Town & Country San Diego, 500 Hotel Circle North, San Diego, CA, 92108, United States

CanWell Pharma will present latest updates on company clinical development of CAN1012 at ESMO 2025 – Annual Meeting held on October 17-21, 2025 in Berlin. The presentation will be in a poster format during a poster session at the conference. The poster covers newest clinical study updates on the safety and efficacy of our IFN-α biased TLR7 agonist CAN1012 alone or combined with an anti-PD-1 antibody toripalimab from Phase 1 and IIa.

Poster Title (5550): Efficacy of an IFN-α Biased TLR7 Agonist CAN1012 Alone or Combined With the Anti-PD-1 Antibody Toripalimab

Date: October 17-21, 2025

Location: Messe Berlin, Berlin, Germany

CanWell Pharma will update company’s ADC programs at ADC & Novel Conjugates Partnering & Investment Summit held on September 9-10, 2025 in Boston. It covers newest research updates on StarLinker dual/tri-payload ADCs, which had been making tremendous progress in preclinical efficacy studies overcoming tumor heterogeneity and drug resistance, while maintaining excellent tolerability in preclinical safety studies.

Date: September 9-10, 2025

Location: Hyatt Regency Boston, One Avenue de Lafayette, Boston, MA 02111, United States

CanWell Pharma will present the latest research developments at the 39th of The Society for Immunotherapy of Cancer (SITC) Annual Meeting held on Nov6-10, 2024 in Houston, TX. The research developments are from its two different studies and will be conducted on the following two posters:

Date: Nov8, 2024

Location: Exhibit Halls A B George R. Brown Convention Center

Poster 1 (No. 689)

Results From A Phase I Dose Escalation Trial of CAN1012 in Patients With Solid Tumors

Poster 2 (No. 1345)

CAN2109: Preclinical Development of A Novel Long-Acting Immunogenic Cell Death (ICD) Inducer for Cancer Therapy

CanWell Pharma will present its latest research developments at the 15^th World ADC in San Diego, CA held on Nov 5-7, 2024. The presentation will be conducted on a poster during Poster Session of the conference. The poster covers newest research updates on Dual-Payload ADCs, which may make significant progress in overcoming tumor heterogeneity and drug resistance.

Poster Title: Dual-Payload ADCs for Overcoming Drug Resistance and Tumor Heterogeneity

Date: Nov 5-6, 2024

Location: The Exhibition Hall

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CanWell Pharma announced that its First-in-Class innovative drug CAN2109, has been granted IND approval by the China National Medical Products Administration (NMPA).  CanWell plans to immediately initiate the patient enrollment to evaluate CAN2109’s safety, PK, PD and clinical activity for the treatment of various solid tumors.

CAN2109 is a novel long-acting Immunogenic cell death (ICD) inducer, which acts as a bi-functional immune modulator to kill tumor cells while preserving tumor antigens for efficient cross-priming of tumor-specific T cells.  CAN2109 not only possesses direct tumor cell killings, but also induces strong cell-mediated immune responses including both CD4+ and CD8+ T cells activation. In addition, CAN2109 synergizes with checkpoint inhibitors to induce systemic immunity with regression of local and distant tumors.

CanWell Pharma announced that its First-in-Class innovative drug CAN2109, has been granted clinical approval by the US Food and Drug Administration (FDA) and it will soon conduct Phase I clinical trial for various solid tumors.

CAN2109 is a novel long-acting Immunogenic cell death (ICD) inducer, which acts as a bi-functional immune modulator to kill tumor cells while preserving tumor antigens for efficient cross-priming of tumor-specific T cells.  CAN2109 not only possesses direct tumor cell killings, but also induces strong cell-mediated immune responses including both CD4+ and CD8+ T cells activation. In addition, CAN2109 synergizes with checkpoint inhibitors to induce systemic immunity with regression of local and distant tumors.

CanWell announced today that the preclinical research results and clinical plan of the company’s TLR7 agonist CAN1012 would be presented at the 4th STING & TLR Targeted Therapy Summit in 2023.

CAN1012 is a highly selective small-molecule TLR7 agonist developed by CanWell with global intellectual property rights. Preclinical studies have shown that it has high selectivity and potency, with low toxicities. It can exert sustained stimulation of the target cells in the tumor microenvironment, transforming “cold” tumors with low immune response into “hot” tumors with augmented immune response, playing a crucial bridging role in the innate and adaptive immune systems. In addition, it may be administered in combination with various drugs such as immunotherapy checkpoint inhibitors, as well as radiotherapy and chemotherapy, to produce highly synergistic effects.

The CAN1012 Phase I clinical trial is an open-label, multicenter, dose-escalation, and dose-expansion study aimed at evaluating the safety, tolerability, and preliminary efficacy of the drug in late-stage solid tumor patients as a single agent, and determining the maximum tolerated dose and recommended Phase II dose. Currently, the study is being conducted simultaneously in China and the United States.

The 4th STING & TLR Targeted Therapy Summit brought together more than 100 industry-leading immune targeted therapy organizations from the large biopharmaceutical industry and academic institutions. The event provides a unique opportunity to present and share the latest development and progress in the field of STING and TLR agonist based therapeutics.