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- | sotigalimab (PYX-107) / Pyxis Oncology
Trial completion date: Phase I Study of APX005M in Pediatric CNS Tumors (clinicaltrials.gov) - Apr 4, 2024
P1, N=32, Active, not recruiting, Sponsor: Pediatric Brain Tumor Consortium
Trial completion date: Mar 2024 --> Sep 2024
- | Keytruda (pembrolizumab) / Merck (MSD), sotigalimab (PYX-107) / Pyxis Oncology
Trial completion date, Trial primary completion date, Combination therapy, Metastases: APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma (clinicaltrials.gov) - Mar 2, 2024
P1/2, N=32, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
Trial completion date: Mar 2024 --> Sep 2024 Trial completion date: Apr 2024 --> Apr 2025 | Trial primary completion date: Apr 2024 --> Apr 2025
- | sotigalimab (PYX-107) / Pyxis Oncology
Journal, IO biomarker, Metastases: Neoadjuvant CD40 agonism remodels the tumor immune microenvironment in locally advanced esophageal/gastroesophageal junction cancer. (Pubmed Central) - Jan 30, 2024
These findings indicate that a single dose of sotigalimab leads to enhanced antigen presentation that can activate T cells and induce new T cell clones. This restructuring of the TME provides elements which are critical to the development of effective antitumor immune responses and improved clinical outcomes.
- || sotigalimab (PYX-107) / Pyxis Oncology, Opdivo (nivolumab) / Ono Pharma, BMS
P2 data, Journal, Combination therapy, Metastases: A Phase II Trial of the CD40 Agonist Sotigalimab (APX005M) in Combination with Nivolumab in Subjects with Metastatic Melanoma with Disease Progression on Anti-PD-1. (Pubmed Central) - Jan 8, 2024
Sotigalimab plus nivolumab had a favorable safety profile consistent with the toxicity profiles of each agent. The combination resulted in durable and prolonged responses in a subset of patients with anti-PD-1-resistant melanoma, warranting further evaluation in this setting.
- ||| sotigalimab (PYX-107) / Pyxis Oncology
Trial termination, Metastases: A Study to Evaluate Sotigalimab (APX005M) in Subjects With Unresectable or Metastatic Melanoma (clinicaltrials.gov) - Dec 22, 2023
P2, N=45, Terminated, Sponsor: Apexigen America, Inc.
The combination resulted in durable and prolonged responses in a subset of patients with anti-PD-1-resistant melanoma, warranting further evaluation in this setting. Completed --> Terminated; Business decision (not due to safety reason).
- || sotigalimab (PYX-107) / Pyxis Oncology
Trial completion date, Trial primary completion date: INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer (clinicaltrials.gov) - Dec 20, 2023
P2, N=58, Active, not recruiting, Sponsor: University of Texas Southwestern Medical Center
Completed --> Terminated; Business decision (not due to safety reason). Trial completion date: Nov 2023 --> Sep 2025 | Trial primary completion date: Nov 2023 --> Sep 2025
- | cabiralizumab (BMS-986227) / Ono Pharma, BMS, sotigalimab (APX005M) / Pyxis Oncology, Opdivo (nivolumab) / Ono Pharma, BMS
Journal, PD(L)-1 Biomarker, IO biomarker: A bedside to bench study of anti-PD-1, anti-CD40, and anti-CSF1R indicates that more is not necessarily better. (Pubmed Central) - Nov 19, 2023
P1
While it is impossible to directly infer human doses from murine studies, careful intra-species evaluation can provide important insight. Cabiralizumab dose optimization is necessary for this patient population with limited treatment options.
- selicrelumab (RG7876) / Roche, sotigalimab (APX005M) / Pyxis Oncology
Evaluation of efficacy and toxicity of human CD40 agonistic antibodies in C57BL/6-hCD40/hFc?RIIB HuGEMMTM (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_806;
However, Fc?RIIB engagement exacerbated the irAE response with enhanced liver damage, pro-inflammatory cytokine secretion, and immune cell infiltration into livers. Conclusions This study revealed that human CD40 agonistic antibodies evaluated in C57BL/6-CD40/Fc?RIIB HuGEMMTM mice reproduce the efficacy and toxicity phenotypes observed in clinic, demonstrating the improved clinical relevance of this HuGEMMTM model to evaluate future biologic molecules targeting CD40.
- sotigalimab (APX005M) / Pyxis Oncology
Neoadjuvant CD40 agonism remodels the tumor immune microenvironment in locally advanced esophageal/gastroesophageal junction cancer (Upper Level - Ballroom 6AB - San Diego) - Sep 13, 2023 - Abstract #SITC2023SITC_126;
P2
Trial Registration Related to trial #NCT03165994 Background Sotigalimab (sotiga) is an agonistic anti-CD40 monoclonal antibody that can stimulate anti-tumor immune responses...The high rates of clinical response with this treatment are associated with both pre-existing and treatment-induced T cell populations. Sotiga can therefore mediate the conversion of an immune-suppressive (
- | sotigalimab (APX005M) / Pyxis Oncology
Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date: APX005M in Patients With Recurrent Ovarian Cancer (clinicaltrials.gov) - Sep 11, 2023
P2, N=0, Withdrawn, Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Sotiga can therefore mediate the conversion of an immune-suppressive ( N=90 --> 0 | Trial completion date: Jul 2026 --> Sep 2023 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2024 --> Sep 2023
- || sotigalimab (PYX-107) / Pyxis Oncology
Trial completion, Metastases: A Study to Evaluate Sotigalimab (APX005M) in Subjects With Unresectable or Metastatic Melanoma (clinicaltrials.gov) - Sep 1, 2023
P2, N=44, Completed, Sponsor: Apexigen America, Inc.
N=90 --> 0 | Trial completion date: Jul 2026 --> Sep 2023 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2024 --> Sep 2023 Active, not recruiting --> Completed
- || sotigalimab (PYX-107) / Pyxis Oncology
Trial completion, Trial completion date, Trial primary completion date, Combination therapy: APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers (clinicaltrials.gov) - Jul 20, 2023
P2, N=34, Completed, Sponsor: Apexigen America, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed | Trial completion date: Apr 2024 --> Feb 2023 | Trial primary completion date: Apr 2022 --> Nov 2022
- sotigalimab (APX005M) / Apexigen
A phase II trial with safety lead-in to evaluate the addition of sotigalimab, a CD40 agonistic monoclonal antibody, to standard-of-care doxorubicin for the treatment of advanced sarcoma. (On Demand | Hall A; Poster Bd # 499) - Apr 26, 2023 - Abstract #ASCO2023ASCO_2828;
P2
Final analysis of the primary endpoint awaits further follow-up on recently enrolled patients. Subtype-specific analysis suggests improvement in median PFS for DDLPS over historical controls: 11.9 mos vs 4 mos (Stacchiotti S. Ann Oncol 2020; Livingston M. Sci Rep 2017).
- | Keytruda (pembrolizumab) / Merck (MSD), sotigalimab (PYX-107) / Pyxis Oncology
Enrollment closed, Combination therapy, Metastases: APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma (clinicaltrials.gov) - Apr 18, 2023
P1/2, N=34, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
Subtype-specific analysis suggests improvement in median PFS for DDLPS over historical controls: 11.9 mos vs 4 mos (Stacchiotti S. Ann Oncol 2020; Livingston M. Sci Rep 2017). Recruiting --> Active, not recruiting
- || sotigalimab (PYX-107) / Pyxis Oncology
Enrollment closed: Phase I Study of APX005M in Pediatric CNS Tumors (clinicaltrials.gov) - Apr 4, 2023
P1, N=32, Active, not recruiting, Sponsor: Pediatric Brain Tumor Consortium
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- sotigalimab (APX005M) / Apexigen, Opdivo (nivolumab) / Ono Pharma, BMS
Mass spectrometry-based protein biomarker analysis in chemoimmunotherapy combinations identifies unique immune signatures in pancreatic cancer (Section 29; Poster Board #4) - Mar 14, 2023 - Abstract #AACR2023AACR_6890;
Herein we demonstrate the value of both an unbiased approach, as well as the use of peptide level data for novel biomarker identification. We identify numerous proteins and peptides that have the potential to be used for better patient treatment stratification in the case of mPDAC and immunotherapy.
- sotigalimab (APX005M) / Apexigen, Opdivo (nivolumab) / Ono Pharma, BMS, STRIKE2001 / Strike Pharma
Modular peptide cargo delivery by targeting CD40 enables ligandome driven, precision immunotherapy via the Adaptable Drug Affinity Conjugate (ADAC (Section 23; Poster Board #7) - Mar 14, 2023 - Abstract #AACR2023AACR_5092;
Data suggest that the novel candidate drug (STRIKE2001), now developed based on the ADAC concept[2], retains similar agonistic activity in its bispecific, IgG2 format and does not inhibit CD40L binding to the CD40 protein...Sotigalimab and/or nivolumab with chemotherapy in first-line metastatic pancreatic cancer: clinical and immunologic analyses from the randomized phase 2 PRINCE trial...Cancer Immunol Res 1 January 2014; 2 (1): 80-90. https://doi.org/10.1158/2326-6066.CIR-13-0067
- cabiralizumab (BMS-986227) / Ono Pharma, BMS, sotigalimab (APX005M) / Apexigen, Opdivo (nivolumab) / Ono Pharma, BMS
A bedside to bench study of anti-PD-1, anti-CD40, and anti-CSF1R indicates that more is not necessarily better (Section 40; Poster Board #28) - Mar 14, 2023 - Abstract #AACR2023AACR_4683;
Our study suggests that more anti-CSF1R might not be better. Further optimization of cabiralizumab dosing is necessary to evaluate the clinical potential in combination with anti-PD-1 and anti-CD40 in a difficult-to treat patient population whose therapeutic options are limited.
- sotigalimab (APX005M) / Apexigen, Opdivo (nivolumab) / Ono Pharma, BMS
Clinical benefit of granulocyte-colony stimulating factor (GCSF) use during chemoimmunotherapy treatment for metastatic pancreatic adenocarcinoma (mPDAC). (Available On Demand; Poster Board No. N4) - Jan 17, 2023 - Abstract #ASCOGI2023ASCO_GI_1004;
P1b/2
These potential benefits of GCSF usage warrant further evaluation in other chemo-IO trials as well as prospective evaluation in pre-clinical and clinical settings. Clinical trial information: NCT03214250.
- | sotigalimab (PYX-107) / Pyxis Oncology
Trial completion date, Trial primary completion date: Phase I Study of APX005M in Pediatric CNS Tumors (clinicaltrials.gov) - Jan 12, 2023
P1, N=45, Recruiting, Sponsor: Pediatric Brain Tumor Consortium
Clinical trial information: NCT03214250. Trial completion date: Sep 2023 --> Mar 2024 | Trial primary completion date: Mar 2023 --> Sep 2023
- || Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead, sotigalimab (PYX-107) / Pyxis Oncology
Enrollment open, Metastases: Switch Maintenance in Pancreatic (clinicaltrials.gov) - Jan 11, 2023
P1/2, N=46, Recruiting, Sponsor: James Cleary, MD, PhD
Trial completion date: Sep 2023 --> Mar 2024 | Trial primary completion date: Mar 2023 --> Sep 2023 Not yet recruiting --> Recruiting
- sotigalimab (APX005M) / Apexigen
Tissue assessment of therapeutic responses to neoadjuvant short course radiotherapy with and without anti-CD40 immunotherapy sotigalimab (sotiga) in rectal cancer. (On Demand | Level 1, West Hall; Poster Board No. K13) - Dec 13, 2022 - Abstract #ASCOGI2023ASCO_GI_854;
P2
On treatment biopsies during neoadjuvant therapy for rectal cancer enables deep assessment of therapeutic response, provides insight into action of investigational agents, and may identify therapy specific predictive biomarkers. Our data shows that SCRT can induce immune responses and adaptive immune responses can be further induced by sotiga.
- sotigalimab (APX005M) / Apexigen
Use of high-dimensional and spatial immune profiling to explore sotigalimab (CD40 agonist) activation of antigen presenting cells and T cells in the tumor microenvironment in patients with esophageal/gastroesophageal junction cancer. (Available On Demand; Poster Board No. K16) - Dec 13, 2022 - Abstract #ASCOGI2023ASCO_GI_268;
Sotiga induced dramatic changes in the tumor microenvironment including increased frequency of activated T cells and APCs, and decreased frequency of Tregs. A distinct signature of T cell infiltration in baseline tumor biopsies was observed in patients who achieved a pCR versus those who did not, potentially identifying patients that may benefit from this novel treatment strategy.
- | sotigalimab (APX005M) / Apexigen, Opdivo (nivolumab) / Ono Pharma, BMS
Biomarker, Journal, PD(L)-1 Biomarker, IO biomarker: Two types of biomarker-dependent chemo-immunotherapy for pancreatic cancer? (Pubmed Central) - Oct 26, 2022
studied the combination of chemotherapy (gemcitabine and nab-paclitaxel) with either an anti-PD1 (nivolumab) or an anti-CD40 (sotigalimab) antibody in metastatic pancreatic cancer. They showed clinical benefit in individuals with unique biomarkers for each treatment combination.
- Keytruda (pembrolizumab) / Merck (MSD), sotigalimab (APX005M) / Apexigen
Intratumoral sotigalimab with pembrolizumab activates antigen-presenting cells and induces local and distant anti-tumor responses in first-line metastatic melanoma: Results of a phase I/II study (153ABC) - Oct 6, 2022 - Abstract #SITC2022SITC_1096;
P1/2
More biomarker and clinical response data are anticipated in November. Trial Registration NCT02706353 Ethics Approval The study was approved by FDA and the Institutional Review Board
- sotigalimab (APX005M) / Apexigen, Opdivo (nivolumab) / Ono Pharma, BMS
Mass spectrometry-based protein biomarker analysis in chemoimmunotherapy combinations identifies unique immune signatures in pancreatic cancer (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_929;
Conclusions Herein we demonstrate the value of both an unbiased approach, as well as the use of peptide level data for novel biomarker identification. We identify numerous proteins and peptides that have the potential to be used for better patient treatment stratification in the case of mPDAC and immunotherapy.
- ||| sotigalimab (PYX-107) / Pyxis Oncology, Opdivo (nivolumab) / BMS
Trial completion, Trial completion date, Metastases: PRINCE: Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma (clinicaltrials.gov) - Oct 3, 2022
P1b/2, N=129, Completed, Sponsor: Parker Institute for Cancer Immunotherapy
We identify numerous proteins and peptides that have the potential to be used for better patient treatment stratification in the case of mPDAC and immunotherapy. Active, not recruiting --> Completed | Trial completion date: Sep 2022 --> Feb 2022
- | sotigalimab (APX005M) / Apexigen
Trial completion date, Trial primary completion date: APX005M in Patients With Recurrent Ovarian Cancer (clinicaltrials.gov) - Sep 7, 2022
P2, N=90, Not yet recruiting, Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Active, not recruiting --> Completed | Trial completion date: Sep 2022 --> Feb 2022 Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Dec 2023 --> Dec 2024
- | Zyclara (imiquimod) / Mochida, Viatris, Bausch Health, Keytruda (pembrolizumab) / Merck (MSD), sotigalimab (PYX-107) / Pyxis Oncology
Trial completion date, Trial primary completion date, Metastases: Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer (clinicaltrials.gov) - Aug 11, 2022
P1, N=150, Recruiting, Sponsor: M.D. Anderson Cancer Center
Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Dec 2023 --> Dec 2024 Trial completion date: May 2022 --> May 2025 | Trial primary completion date: May 2022 --> May 2025
- | sotigalimab (APX005M) / Apexigen, Opdivo (nivolumab) / Ono Pharma, BMS
Biomarker, Journal, PD(L)-1 Biomarker: Distinct Treatment-Related Immunologic Biomarkers Are Identified in PDAC. (Pubmed Central) - Aug 10, 2022
Trial completion date: May 2022 --> May 2025 | Trial primary completion date: May 2022 --> May 2025 Nivolumab or sotigalimab plus chemotherapy modestly improved overall survival, but only nivo + chemo met the primary endpoint.
- sotigalimab (APX005M) / Apexigen
A multicenter phase II study of sotigalimab (CD40 agonist) in combination with neoadjuvant chemoradiation for resectable esophageal and gastroesophageal junction (GEJ) cancers (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_3024;
P2
Conclusions Sotiga combined with neoadjuvant chemoradiation for esophageal/GEJ cancers was generally well tolerated and achieved pCR rates in both AC and SCC that compare favorably to historical data and are promising for this treatment strategy. Additional evaluations of clinical outcomes (including DFS, OS) and immune-based biomarkers are ongoing.
- || sotigalimab (PYX-107) / Pyxis Oncology
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases: APX005M With Nivolumab and Cabiralizumab in Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell Carcinoma (clinicaltrials.gov) - Jul 26, 2022
P1, N=42, Active, not recruiting, Sponsor: Yale University
Additional evaluations of clinical outcomes (including DFS, OS) and immune-based biomarkers are ongoing. Recruiting --> Active, not recruiting | N=120 --> 42 | Trial completion date: Oct 2024 --> Oct 2027 | Trial primary completion date: May 2022 --> Nov 2022
- || sotigalimab (PYX-107) / Pyxis Oncology
Enrollment closed: INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer (clinicaltrials.gov) - Jul 18, 2022
P2, N=58, Active, not recruiting, Sponsor: University of Texas Southwestern Medical Center
Recruiting --> Active, not recruiting | N=120 --> 42 | Trial completion date: Oct 2024 --> Oct 2027 | Trial primary completion date: May 2022 --> Nov 2022 Recruiting --> Active, not recruiting
- | sotigalimab (PYX-107) / Pyxis Oncology
Trial completion date, Trial primary completion date: Phase I Study of APX005M in Pediatric CNS Tumors (clinicaltrials.gov) - Jun 22, 2022
P1, N=45, Recruiting, Sponsor: Pediatric Brain Tumor Consortium
Recruiting --> Active, not recruiting Trial completion date: Sep 2022 --> Sep 2023 | Trial primary completion date: Mar 2022 --> Mar 2023
- || sotigalimab (APX005M) / Apexigen, Opdivo (nivolumab) / Ono Pharma, BMS
P2 data, Journal, PD(L)-1 Biomarker, IO biomarker: Sotigalimab and/or nivolumab with chemotherapy in first-line metastatic pancreatic cancer: clinical and immunologic analyses from the randomized phase 2 PRINCE trial. (Pubmed Central) - Jun 22, 2022
P1b/2
A patient subset benefitting from sotiga/nivo/chemo was not identified. Collectively, these analyses suggest potential treatment-specific correlates of efficacy and may enable biomarker-selected patient populations in subsequent PDAC chemoimmunotherapy trials.
- || Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead, sotigalimab (PYX-107) / Pyxis Oncology
New P1/2 trial, Metastases: Switch Maintenance in Pancreatic (clinicaltrials.gov) - Jun 15, 2022
P1/2, N=46, Not yet recruiting, Sponsor: James Cleary, MD, PhD
- ||| sotigalimab (APX005M) / Apexigen, Opdivo (nivolumab) / Ono Pharma, BMS
PRINCE #ASCO22 from @laceykitch 📌Ph 2, RCT, 3 arms, M1 PDAC 1st L -A: G/Abx + nivo -B: G/Abx + sotigalimab (CD40 agonist) - C: G/Abx + nivo + sotiga 🎯1o endpoint: 1y OS rate (vs historic control) ✅ 1y OS rate in arm A: 57,7% (vs 35%) 📝Promising results. Need Ph3 validation (Twitter) - Jun 13, 2022
- |||| sotigalimab (APX005M) / Apexigen, Opdivo (nivolumab) / Ono Pharma, BMS
Clinical, P2 data: The #OncoAlertTopTweet 🚨 Day 1⃣ #ASCO22 Tweet @Aiims1742 In @NatureMedicine for #ASCO22 Sotigalimab and/or nivolumab with chemo🧪 in first-line metastatic #PancreaticCancer: clinical and immunologic analyses from the randomized phase 2 PRINCE trial🤴 @weoncologists (Twitter) - Jun 4, 2022
- |||| sotigalimab (APX005M) / Apexigen, Opdivo (nivolumab) / Ono Pharma, BMS
Clinical: Sotigalimab and/or nivolumab with chemotherapy in first-line metastatic pancreatic cancer: clinical and immunologic analyses from the randomized phase 2 PRINCE trial @NatureMedicine https://t.co/ELWl11coRS (Twitter) - Jun 4, 2022
- |||| sotigalimab (APX005M) / Apexigen, Opdivo (nivolumab) / Ono Pharma, BMS
Clinical: Sotigalimab and/or nivolumab with chemotherapy in first-line metastatic pancreatic cancer: clinical and immunologic analyses from the randomized phase 2 PRINCE trial | Nature Medicine https://t.co/KNqIokDx9S (Twitter) - Jun 4, 2022
- |||| sotigalimab (APX005M) / Apexigen, Opdivo (nivolumab) / Ono Pharma, BMS
Clinical: In @NatureMedicine for #ASCO22 Sotigalimab and/or nivolumab with chemotherapy in first-line metastatic #PancreaticCancer: clinical and immunologic analyses from the randomized phase 2 PRINCE trial @parkerici @CancerResearch @sitcancer https://t.co/hrDaE0Zi28 (Twitter) - Jun 3, 2022
- | sotigalimab (PYX-107) / Pyxis Oncology
Enrollment closed, Combination therapy: APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers (clinicaltrials.gov) - Apr 29, 2022
P2, N=34, Active, not recruiting, Sponsor: Apexigen, Inc.
Collectively, these analyses suggest potential treatment-specific correlates of efficacy and may enable biomarker-selected patient populations in subsequent PDAC chemoimmunotherapy trials. Recruiting --> Active, not recruiting
- sotigalimab (APX005M) / Apexigen, Opdivo (nivolumab) / Ono Pharma, BMS
Distinct biosignatures associate with survival after chemoimmunotherapy in a randomized, three-arm phase II study in patients with metastatic pancreatic cancer. (Available On Demand) - Apr 28, 2022 - Abstract #ASCO2022ASCO_5876;
P1b/2
From in-depth translational and ML analyses of randomized phase II trial of first-line chemoimmunotherapy in mPDAC patients, we identified novel biomarkers that associated with OS distinctly in each arm. Clinical trials in first-line mPDAC exploiting these previously unappreciated biomarkers and aiming to enrich patients for response, are warranted to further advance chemoimmunotherapy in this disease.
- Emerging immuno-therapies for advanced pancreatic cancer: An overview of available literature. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_2056;
The combination of pembrolizumab and trametinib with stereotactic radiotherapy (SBRT) reported a median progression-free survival (PFS) and overall survival (OS) of 25 and 18 months compared to gemcitabine and SBRT combination of 22 and 16 months, respectively...Sotigalimab, an agonistic CD40 antibody combined with nivolumab, was found to have an ORR of 58%, PFS of 12 months, and OS of 20 months after a follow-up of almost 18 months. Due to the high mortality associated with advanced pancreatic cancer, there is increasing interest in Novel immunotherapies-based approaches, with some showing promising results.
- || sotigalimab (PYX-107) / Pyxis Oncology
Trial completion date, Trial primary completion date: INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer (clinicaltrials.gov) - Apr 22, 2022
P2, N=58, Recruiting, Sponsor: University of Texas Southwestern Medical Center
Due to the high mortality associated with advanced pancreatic cancer, there is increasing interest in Novel immunotherapies-based approaches, with some showing promising results. Trial completion date: Nov 2022 --> Nov 2023 | Trial primary completion date: Nov 2022 --> Nov 2023
- | sotigalimab (APX005M) / Apexigen
Trial initiation date: APX005M in Patients With Recurrent Ovarian Cancer (clinicaltrials.gov) - Apr 20, 2022
P2, N=90, Not yet recruiting, Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Trial completion date: Nov 2022 --> Nov 2023 | Trial primary completion date: Nov 2022 --> Nov 2023 Initiation date: Feb 2022 --> Sep 2022
- || cabiralizumab (BMS-986227) / Ono Pharma, BMS, sotigalimab (APX005M) / Apexigen, Opdivo (nivolumab) / Ono Pharma, BMS
Clinical, P1 data, Journal: A phase I study of APX005M and cabiralizumab with/without nivolumab in patients with melanoma, kidney cancer or non-small cell lung cancer resistant to anti-PD-(L)1. (Pubmed Central) - Apr 5, 2022
P1
This first in-human study of patients with anti-PD-1/PD-L1-resistant tumors treated with dual macrophage-polarizing therapy, with or without nivolumab demonstrated safety and pharmacodynamic activity. Optimization of the dosing frequency and sequence of this combination is warranted.
- | sotigalimab (PYX-107) / Pyxis Oncology
Enrollment closed, Metastases: A Study to Evaluate Sotigalimab (APX005M) in Subjects With Unresectable or Metastatic Melanoma (clinicaltrials.gov) - Mar 10, 2022
P2, N=44, Active, not recruiting, Sponsor: Apexigen, Inc.
Optimization of the dosing frequency and sequence of this combination is warranted. Recruiting --> Active, not recruiting
- Keytruda (pembrolizumab) / Merck (MSD), sotigalimab (APX005M) / Apexigen
Intratumoral CD40 agonist sotigalimab with pembrolizumab induces broad innate and adaptive immune activation in local and distant tumors in metastatic melanoma (La Nouvelle Orleans A-B, Convention Center) - Mar 9, 2022 - Abstract #AACR2022AACR_1737;
Importantly, these immunologic changes were correlated with clinical response. Collectively, this combination therapy is well tolerated and has a notable clinical response rate, accompanied by broad innate and adaptive immune activation at both local and distant lesions.
- | Keytruda (pembrolizumab) / Merck (MSD), sotigalimab (PYX-107) / Pyxis Oncology
Trial completion date, Trial primary completion date, Combination therapy, Metastases: APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma (clinicaltrials.gov) - Mar 2, 2022
P1/2, N=41, Recruiting, Sponsor: M.D. Anderson Cancer Center
Collectively, this combination therapy is well tolerated and has a notable clinical response rate, accompanied by broad innate and adaptive immune activation at both local and distant lesions. Trial completion date: Dec 2022 --> Apr 2024 | Trial primary completion date: Dec 2021 --> Apr 2024