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DRUG CLASS:

IL-12 modulator

14d
Enrollment open • Combination therapy • Metastases
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sasanlimab (PF-06801591)
3ms
This is an Open Label, Two-part, Multicenter, Phase I Trial to Investigate the Safety, Tolerability, and PK of KGX101 Monotherapy and Combination Therapy With Envafolimab in Patients With Advanced or Metastatic Solid Tumors. (clinicaltrials.gov)
P1, N=54, Recruiting, Kangabio AUSTRALIA LTD PTY | Not yet recruiting --> Recruiting | N=27 --> 54 | Trial completion date: Sep 2026 --> May 2026 | Trial primary completion date: Jan 2026 --> May 2026
Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
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Enweida (envafolimab)
4ms
Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 in Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=218, Recruiting, Suzhou Abogen Biosciences Co., Ltd. | N=160 --> 218 | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
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Loqtorzi (toripalimab-tpzi) • ABO2011
7ms
Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 Monotherapy in Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=160, Recruiting, Suzhou Abogen Biosciences Co., Ltd. | Enrolling by invitation --> Recruiting | Phase classification: P1 --> P1/2 | N=40 --> 160 | Trial completion date: Nov 2025 --> Dec 2026 | Trial primary completion date: May 2025 --> Dec 2025
Enrollment status • Phase classification • Enrollment change • Trial completion date • Trial primary completion date • Metastases
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ABO2011
10ms
Cancer immunotherapy with enveloped self-amplifying mRNA CARG-2020 that modulates IL-12, IL-17 and PD-L1 pathways to prevent tumor recurrence. (PubMed, Acta Pharm Sin B)
Mechanistically, CARG-2020 potently activates Th1 immune mechanisms and inhibits expression of genes related to T cell exhaustion and cancer-promoting inflammation. The ability of CARG-2020 to prevent tumor recurrence and to provide survival benefit makes it a promising candidate for its development for human cancer immunotherapy.
Journal • PD(L)-1 Biomarker • IO biomarker
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IL17A (Interleukin 17A) • IL17RA (Interleukin 17 Receptor A)
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CARG-2020
1year
A Study to Evaluate ABO2011 Monotherapy in Advanced Solid Tumors (clinicaltrials.gov)
P1, N=40, Enrolling by invitation, Suzhou Abogen Biosciences Co., Ltd. | Recruiting --> Enrolling by invitation
Enrollment status • Metastases
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ABO2011
almost2years
RPTR-168 in Patients With Human Papillomavirus Strain 16 (HPV-16) E6/E7 Positive Tumors and Melanoma (clinicaltrials.gov)
P1/2, N=7, Terminated, Repertoire Immune Medicines | Trial completion date: May 2024 --> Oct 2022 | Active, not recruiting --> Terminated | Trial primary completion date: May 2024 --> Sep 2022; Development program terminated
Trial completion date • Trial termination • Trial primary completion date
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PD-L1 (Programmed death ligand 1) • PRAME (Preferentially Expressed Antigen In Melanoma)
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PD-1 expression
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RPTR-168
2years
Oncolytic herpes simplex virus delivery of dual CAR targets of CD19 and BCMA as well as immunomodulators to enhance therapeutic efficacy in solid tumors combined with CAR T cell therapy. (PubMed, Front Oncol)
Efficacy studies demonstrated that combination with T7011 and CAR-T or CAR-T cells showed significant synergistic anti-tumor responses in several solid tumor models. These studies indicated that the new generation of oHSV T7011 can be a promising combinational therapy with CD19 or BCMA-specific CAR T cells for the treatment of a broad range of solid tumors.
Journal • CAR T-Cell Therapy • PD(L)-1 Biomarker • IO biomarker
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CD19 (CD19 Molecule)
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CD19 expression
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MVR-C5252
2years
A novel bispecific BCA356 targeting tumour antigen CAIX conjugated to an attenuated IL12 demonstrates pre-clinical efficacy with potential for limited systemic toxicity (SITC 2022)
Conclusions BCA356 specifically targets CAIX-expressing tumour cells and similar to wild type IL-12 cytokine, has the potential to reduce tumour proliferation with optimal activation of pro-inflammatory cytokines. Through these in vitro and in vivo studies, we demonstrate that BCA356 by its CAIX-targeted IL-12v delivery approach is both efficacious and safe.
Preclinical
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CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IL2 (Interleukin 2) • CA9 (Carbonic anhydrase 9) • STAT4 (Signal Transducer And Activator Of Transcription 4)
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CD8 expression • CA9 overexpression • CA9 expression
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BCA356
2years
Pharmacologically-controlled expression of membrane-bound IL-12 results in T-cell therapy with enhanced potency in preclinical solid tumor models (SITC 2022)
Here, we use a DRD derived from carbonic anhydrase 2 and the FDA-approved inhibitor acetazolamide (ACZ) as a stabilizing ligand...Conclusions The cytoDRiVE® platform enables enhanced regulation of IL-12 armored T-cells in multiple preclinical solid tumor models, potentiating an improved therapeutic window for IL12 in ACT. Ethics Approval All animals studies were IACUC approved.
Preclinical
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CD19 (CD19 Molecule) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
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acetazolamide
2years
RPTR-168 in Patients With Human Papillomavirus Strain 16 (HPV-16) E6/E7 Positive Tumors and Melanoma (clinicaltrials.gov)
P1/2, N=7, Active, not recruiting, Repertoire Immune Medicines | Recruiting --> Active, not recruiting | N=24 --> 7
Enrollment closed • Enrollment change
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PD-L1 (Programmed death ligand 1) • PRAME (Preferentially Expressed Antigen In Melanoma)
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PD-1 expression
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RPTR-168
over2years
ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy (clinicaltrials.gov)
P1, N=60, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting --> Recruiting
Enrollment open
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IFNG (Interferon, gamma)
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ABO2011
over2years
ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy (clinicaltrials.gov)
P1, N=60, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
New P1 trial
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IFNG (Interferon, gamma)
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ABO2011
over3years
SENTI-101, a preparation of mesenchymal stromal cells engineered to express IL-12 and IL-21, induces localized and durable anti-tumor immunity in preclinical models of peritoneal solid tumors. (PubMed, Mol Cancer Ther)
Consistent with this mechanism of action, co-administration of mSENTI-101 with checkpoint inhibitors leads to synergistic improvement in anti-tumor response. Collectively, these data warrant potential clinical development of SENTI-101 for patients with peritoneal carcinomatosis and high-grade ovarian cancer.
Preclinical • Journal
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IL21 (Interleukin 21)
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SENTI-101
over3years
Clinical • Enrollment open
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PD-L1 (Programmed death ligand 1)
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PD-1 expression
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RPTR-168
over3years
Sarcoma IL-12 overexpression facilitates NK cell immunomodulation. (PubMed, Sci Rep)
We conclude that LV/hu-IL-12 transduction of sarcoma elicits a specific immune reaction and the humanized NSG.Tg(Hu-IL-15) xenograft, with mature human NK cells, can define in vivo anti-tumor effects and systemic toxicities. IL-12 immunomodulation through autologous tumor transduction and reintroduction merits exploration for sarcoma treatment.
Journal • IO biomarker
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IFNG (Interferon, gamma)
over3years
[VIRTUAL] CARG-2020 artificial oncolytic virus delivering three immune-modulators prevents tumor recurrence in a syngeneic model of ovarian cancer (AACR 2021)
CARG-2020 is able to prevent the establishment of recurrent disease in a syngeneic mouse model of recurrent ovarian cancer. Our results provide rationale for the further development of this platform as a therapeutic modality for ovarian cancer patients.
Oncolytic virus
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PD-L1 (Programmed death ligand 1)
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CARG-2020
over3years
Clinical • New P1/2 trial
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PD-L1 (Programmed death ligand 1)
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PD-1 expression
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RPTR-168
almost4years
Oncolytic effects of the recombinant Newcastle disease virus, rAF-IL12, against colon cancer cells in vitro and in tumor-challenged NCr-Foxn1nu nude mice. (PubMed, PeerJ)
Alternative modalities such as the use of viral-based therapeutic cancer vaccine is still limited, with only the herpes simplex virus (HSV) expressing granulocyte-macrophage colony- stimulating factor (GM-CSF) or talimogene laherparepvec (T-Vec) being approved in the USA and Europe so far...Besides, rAF-IL12 intra-tumoral delivery was considered safe and was not hazardous to the host as evidenced in pathophysiology of the normal tissues and organs of the mice as well as from the serum biochemistry profile of liver and kidney. Therefore, this study proves that rAF-IL12 had better cytotoxicity effects than its parental AF2240-i and could potentially be an ideal treatment for colon cancer in the near future.
Preclinical • Journal
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IFNG (Interferon, gamma) • IL2 (Interleukin 2) • CASP8 (Caspase 8) • CSF2 (Colony stimulating factor 2) • GZMB (Granzyme B)
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Imlygic (talimogene laherparepvec)
4years
[VIRTUAL] Fibroblast activating protein (FAP)-targeting IL-12 (anti-FAP/IL-12) TMEkine™ potentiates anti-cancer effects in preclinical cancer models (SITC 2020)
Conclusions These findings provide evidences that the treatment of anti-FAP/IL-12 TMEkine™ induced anti-cancer effects without serious adverse effects. Anti-FAP/IL-12 has a strong potential to provide a therapeutic option for cancer-specific immunomodulator and cancer cell eradication.
Preclinical • IO biomarker
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IFNG (Interferon, gamma)
4years
[VIRTUAL] Fibroblast activating protein (FAP)-targeting IL-12 (anti-FAP/IL-12) TMEkine™ potentiates anti-cancer effects in preclinical cancer models (SITC 2020)
Conclusions These findings provide evidences that the treatment of anti-FAP/IL-12 TMEkine™ induced anti-cancer effects without serious adverse effects. Anti-FAP/IL-12 has a strong potential to provide a therapeutic option for cancer-specific immunomodulator and cancer cell eradication.
Preclinical • IO biomarker
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IFNG (Interferon, gamma)