- |||||||||| Review, Journal: Current status of the small molecule anti-HIV drugs in the pipeline or recently approved. (Pubmed Central) - Aug 22, 2024
There is a considerable progress in the development of new anti-HIV drugs and the effort will continue since HIV infections has no cure or vaccine till now. Efforts are needed to reduce the toxicity of available drugs or discover new drugs with new classes which can delay the development of resistance.
- |||||||||| sotigalimab (PYX-107) / Pyxis Oncology
Trial completion, Trial completion date, Combination therapy, IO biomarker, Metastases: APX005M With Nivolumab and Cabiralizumab in Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell Carcinoma (clinicaltrials.gov) - Jul 3, 2024
P1, N=42, Completed,
Efforts are needed to reduce the toxicity of available drugs or discover new drugs with new classes which can delay the development of resistance. Active, not recruiting --> Completed | Trial completion date: Oct 2027 --> May 2024
- |||||||||| 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,
Recruiting --> Active, not recruiting 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,
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
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,
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,
Further work is needed, as targeting B cells may offer an exciting new therapeutic option in the future. Trial completion date: Nov 2023 --> Sep 2025 | Trial primary completion date: Nov 2023 --> Sep 2025
- |||||||||| Review, Journal, IO biomarker: Harnessing the potential of CD40 agonism in cancer therapy. (Pubmed Central) - Dec 16, 2023
In this review, we present the current understanding of the mechanism of action for CD40, along with results from the clinical development of agonistic human CD40 antibodies in cancer treatment (selicrelumab, CDX-1140, APX005M, mitazalimab, 2141-V11, SEA-CD40, LVGN7409, and bispecific antibodies). This review also examines the safety profile of CD40 agonists in both preclinical and clinical settings, highlighting optimized dosage levels, potential adverse effects, and strategies to mitigate them.
- |||||||||| psilocybin (SYNP-101) / Ceruvia Lifesci
Trial completion: Psilocybin for the Treatment of Cluster Headache (clinicaltrials.gov) - Dec 15, 2023
P1, N=25, Completed,
This review also examines the safety profile of CD40 agonists in both preclinical and clinical settings, highlighting optimized dosage levels, potential adverse effects, and strategies to mitigate them. Active, not recruiting --> Completed
- |||||||||| 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.
- |||||||||| lithium carbonate ER / Generic mfg.
A Novel Mitochondrial Target as a Therapeutic Approach to Bipolar Disorder (WCC Halls A-C) - Nov 3, 2023 - Abstract #Neuroscience2023NEUROSCIENCE_3303;
We found that BD cortical organoid mitoplasts have larger peak conductances than those of HCs. Lithium, which is a long-term treatment for episodes of mania and depression, blocks ACLC in both BD and HC cortical organoid mitoplasts and appears to work synergistically with the known ATP synthase pharmacological modulator, dexpramipexole (Dex).
- |||||||||| 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.
- |||||||||| dexpramipexole (KNS-760704) / Knopp Biosciences, Biogen
FDA event, Preclinical, Journal, Immune cell: The clinically-approved compounds, pramipexole and dexpramipexole, reverse chronic allodynia from sciatic nerve damage in mice, and alter IL-1? and IL-10 expression from immune cell culture. (Pubmed Central) - Sep 25, 2023
protein production from stimulated human monocytes and dexpramipexole induced elevated IL-10 mRNA expression from rat splenocytes. The data support that clinically-approved compounds like pramipexole and dexpramipexole support their application as anti-inflammatory agents to mitigate chronic neuropathy, and provide a blueprint for future, multifaceted approaches for opioid-independent neuropathic pain treatment.
- |||||||||| 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,
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
- |||||||||| censavudine (TPN-101) / Transposon Therap, Yale University, BMS
Trial completion date, Trial primary completion date: A Phase 2a Study of TPN-101 in Patients With Progressive Supranuclear Palsy (PSP) (clinicaltrials.gov) - Jul 13, 2023
P2a, N=40, Active, not recruiting,
Active, not recruiting --> Completed | Trial completion date: Apr 2024 --> Feb 2023 | Trial primary completion date: Apr 2022 --> Nov 2022 Trial completion date: Jul 2023 --> Dec 2023 | Trial primary completion date: Jul 2023 --> Dec 2023
- |||||||||| psilocybin (SYNP-101) / Ceruvia Lifesci
Trial completion date, Trial primary completion date: Psilocybin for the Treatment of Cluster Headache (clinicaltrials.gov) - Jun 15, 2023
P1, N=24, Active, not recruiting,
Trial completion date: Jul 2023 --> Dec 2023 | Trial primary completion date: Jul 2023 --> Dec 2023 Trial completion date: Jun 2023 --> Sep 2023 | Trial primary completion date: Jun 2023 --> Jun 2022
- |||||||||| psilocybin (SYNP-101) / Ceruvia Lifesci
Trial completion, Enrollment change: Psilocybin for the Treatment of Migraine Headache (clinicaltrials.gov) - Jun 15, 2023
P1, N=14, Completed,
Trial completion date: Jun 2023 --> Sep 2023 | Trial primary completion date: Jun 2023 --> Jun 2022 Active, not recruiting --> Completed | N=24 --> 14
- |||||||||| 2-bromo-D-lysergic acid diethylamide (NYPRG-101) / Ceruvia Lifesci
A non-hallucinogenic LSD analogue with therapeutic potential in mood disorders (Montreal Bonaventure Hotel (CAN meeting headquarters)) - Jun 10, 2023 - Abstract #CANACN2023CAN_ACN_504;
2-Bromo-LSD (2-Br-LSD/BETR-001) is an LSD derivative with 5-HT2A partial agonist activity that lacks hallucinogenic effects...Our findings demonstrate that 2-Br-LSD induces cortical plasticity in vitro and in vivo, promotes active stress-coping behaviours, and reveres the behavioural effects of chronic stress. These results show that 2-Br-LSD possesses therapeutic potential and represents a promising alternative to classic psychedelics in treating depression.
- |||||||||| 2-bromo-D-lysergic acid diethylamide (NYPRG-101) / Ceruvia Lifesci
A Non-Hallucinogenic LSD Analogue With Therapeutic Potential in Mood Disorders (Sapphire AB) - Apr 29, 2023 - Abstract #SOBP2023SOBP_838;
2-Bromo-LSD (2-Br-LSD/BETR-001) is an LSD derivative with 5-HT2A partial agonist activity that lacks hallucinogenic effects...Conclusions Our findings demonstrate that 2-Br-LSD induces cortical plasticity in vitro and in vivo, promotes active stress-coping behaviours, and reveres the behavioural effects of chronic stress. These results show that 2-Br-LSD possesses therapeutic potential and represents a promising alternative to classic psychedelics in treating depression.
- |||||||||| 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,
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,
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- |||||||||| 2-bromo-D-lysergic acid diethylamide (NYPRG-101) / Ceruvia Lifesci, BETR-001 / BetterLife Pharma
Journal: A non-hallucinogenic LSD analog with therapeutic potential for mood disorders. (Pubmed Central) - Apr 3, 2023
2-Br-LSD also reverses the behavioral effects of chronic stress. Overall, 2-Br-LSD has an improved pharmacological profile compared with LSD and may have profound therapeutic value for mood disorders and other indications.
- |||||||||| censavudine (TPN-101) / Transposon Therap, Yale University, BMS
Enrollment open: TPN-101 in Aicardi-Gouti (clinicaltrials.gov) - Mar 31, 2023
P2a, N=16, Recruiting,
Overall, 2-Br-LSD has an improved pharmacological profile compared with LSD and may have profound therapeutic value for mood disorders and other indications. Not yet recruiting --> Recruiting
- |||||||||| sobetirome (AN19) / Yale University, sobetirome (QRX 411) / Annovis Bio, saracatinib (AZD0530) / AstraZeneca
The Pulmonary Fibrosis Drug Connectome (Walter E. Washington Convention Center, Area J, Hall C (Lower Level)) - Mar 25, 2023 - Abstract #ATS2023ATS_5606;
Our online drug repurposing platform represents the first use of scRNA-seq data to probe the effect of compounds in the CMap2020 database across combinatorial cell types. Given the flexibility of our signature generation, modification, and querying, we envision the IPF Connectome website as an accessible platform for real-time in silico compound identification for IPF.
- |||||||||| 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.
- |||||||||| censavudine (TPN-101) / Transposon Therap, Yale University, BMS
Trial initiation date: TPN-101 in Aicardi-Gouti (clinicaltrials.gov) - Mar 7, 2023
P2a, N=16, Not yet recruiting,
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. Initiation date: Dec 2022 --> Mar 2023
- |||||||||| censavudine (TPN-101) / Transposon Therap, Yale University, BMS
Enrollment closed: A Phase 2a Study of TPN-101 in Patients With C9ORF72 ALS/FTD (clinicaltrials.gov) - Mar 6, 2023
P2a, N=42, Active, not recruiting,
Initiation date: Dec 2022 --> Mar 2023 Recruiting --> Active, not recruiting
- |||||||||| psilocybin (SYNP-101) / Ceruvia Lifesci
Trial completion date, Trial primary completion date: Psilocybin for the Treatment of Migraine Headache (clinicaltrials.gov) - Jan 26, 2023
P1, N=24, Active, not recruiting,
This study provides theoretical evidence supporting DPX for the treatment of SAE. Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
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