Oncopore (ruxotemitide) / Lytix, Verrica - LARVOL DELTA

ATLAS-IT-05: Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Advanced Melanoma (clinicaltrials.gov) - P2 | N=23 | Completed | Sponsor: Lytix Biopharma AS | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Jul 2025

Trial completion • Trial completion date • Melanoma • Oncology • Solid Tumor • BRAF

On November 11, 2025, Dr. Henrik Jespersen’s team presented an interim update at the Nordic Melanoma Meeting on the Phase II NeoLIPA study (Cision) - "44% pathological complete response (pCR) and 55% major pathological response (MPR) among the first nine evaluable patients. Overall pathological response seen in 88% of patients, with a favorable safety profile. No relapses reported to date."

P2 data • Melanoma

…Received clear and positive feedback from the FDA about the study design for a Phase 3 development program for our oncology asset, VP-315, for basal cell carcinoma, the most common form of skin cancer (GlobeNewswire)

FDA event • Basal Cell Carcinoma

Lytix Biopharma presents new phase II data for ruxotemitide (BioStock) - "The treatment demonstrated an objective response rate of 97 percent and complete histological tumor freedom in 51 percent of patients with basal cell carcinoma, with a good safety profile."

P2 data • Basal Cell Carcinoma

Exploratory analysis of a phase 2 multicenter study evaluating local immune activation in the tumor microenvironment 12 weeks post VP-315, an investigational therapy for basal cell carcinoma (BCC) (SITC 2025) - P2 | "VP-315 is a promising treatment for non-surgical first line BCC therapy in a primary or neoadjuvant setting and this data supports the clinical efficacy and histological clearance observations previously reported.Acknowledgements LTX-315 is being studied as VP-315 in BCC.Trial Registration NCT05188729Ethics Approval This study was approved by Advarra Institutional Review Board; protocol number Pro00058474.Consent Written informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal."

Biomarker • Clinical • IO biomarker • P2 data • Tumor microenvironment • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • CD20 • CD4 • CD68 • CD8 • FOXP3 • PD-L1

Exploratory analysis of a phase 2 multicenter study evaluating local immune activation in the tumor microenvironment 12 weeks post VP-315, an investigational therapy for basal cell carcinoma (BCC) (SITC 2025) - P2 | "VP-315 is a promising treatment for non-surgical first line BCC therapy in a primary or neoadjuvant setting and this data supports the clinical efficacy and histological clearance observations previously reported.Acknowledgements LTX-315 is being studied as VP-315 in BCC.Trial Registration NCT05188729Ethics Approval This study was approved by Advarra Institutional Review Board; protocol number Pro00058474.Consent Written informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal."

Biomarker • Clinical • IO biomarker • P2 data • Tumor microenvironment • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • CD20 • CD4 • CD68 • CD8 • FOXP3 • PD-L1

Verrica Pharmaceuticals to Present New Data on VP-315 from its Phase 2 Trial in Basal Cell Carcinoma (BCC) at the 40th Society for Immunotherapy of Cancer (SITC) Annual Meeting (GlobeNewswire) - "The abstract will be available on the SITC website on or about November 4, 2025, at 9 a.m. ET."

P2 data • Basal Cell Carcinoma

Bacteria biohybrids integrating anticancer peptide-loaded nanoparticles for tumor immunotherapy through pyroptosis activation. (PubMed, Biomater Sci) - "Here, we introduce P/L@EcN, a bacteria biohybrid system that conjugates ROS-responsive, ruxotemitide (LTX-315)-loaded poly(ethylene glycol)-block-poly(lactide-co-glycolide) (PEG-PLGA) nanoparticles (P/L-NPs) with the tumor-targeting probiotic Escherichia coli Nissle 1917 (EcN) via copper-free azide-alkyne click chemistry...In an in vivo orthotopic breast cancer model, P/L@EcN enhanced anti-tumor immunity by remodeling the tumor microenvironment, promoting the macrophage M1/M2 ratio, and reducing myeloid-derived suppressor cells (MDSCs), ultimately achieving significant tumor growth suppression without systemic toxicity. Together, these findings establish P/L@EcN as a promising biohybrid immunotherapy strategy that integrates bacterial-mediated targeting with immune activation, offering a powerful approach for cancer treatment."

Journal • Breast Cancer • Colorectal Cancer • Immune Modulation • Immunology • Oncology • Solid Tumor

Verrica Pharmaceuticals Reports Second Quarter 2025 Financial Results (GlobeNewswire) - "Completed Successful End of Phase 2 Meeting for VP-315 for Basal Cell Carcinoma....The Company...plans on providing a comprehensive overview of this program, including additional genomic and immune response data for VP-315, later this year at a scientific conference."

Clinical data • FDA event • Basal Cell Carcinoma

Long-Acting In Situ Cancer Vaccines by Oncolytic STING-Activating Microgels. (PubMed, Small) - "Here, oncolytic STING-activating microgels (OSAM) that release oncolytic peptide LTX-315 and STING adjuvant diABZI in a sustained manner (>4 weeks) have been developed to elicit long-acting and powerful antitumor immunity...One single intratumoral administration of OSAM markedly promoted the infiltration of cytotoxic T lymphocytes and natural killer cells, which combining with anti-CTLA-4 microgels afforded exceptional therapeutic benefits in several different murine tumor models with a cure rate of 40%-71%. These oncolytic STING-activating microgels introduce a new and powerful strategy to in situ cancer vaccines."

Journal • Oncology • STING

Oncolytic microgels with regulated antibody release augment tumor immunotherapy. (PubMed, J Control Release) - "Here, oncolytic microgels (OMG) that possess similar antitumor activity and immune activation to oncolytic peptide LTX-315 and are capable of sustained release of immune checkpoint inhibitors have been developed to potentiate cancer immunotherapy...In the B16F10 melanoma model, a single tumoral injection of anti-PD-1 and anti-CTLA-4-loaded OMG (P1C4@OMG) effectively reversed suppressive tumor microenvironment and enhanced anti-tumor immune response, achieving potent tumor suppression and striking survival benefits. This study heralds oncolytic microgels with regulated antibody release as a safe and unique platform for cancer immunotherapy."

Journal • Melanoma • Oncology • Solid Tumor

Radiofrequency hyperthermia enhances the antitumor efficacy of oncolytic peptide LTX-315 in liver cancer cells by activating of cGAS-STING pathway. (PubMed, Int J Hyperthermia) - "After combination therapy, significant increases in CD8+ T cells, CD8+/IFN-γ+ T cells, CD8+/TNF-α+ T cells, and natural killer cells, along with a decrease in Tregs, were observed in tumors (p < 0.001). RFH significantly enhanced the effects of LTX-315 on orthotopic HCC by activating the cGAS-STING pathway."

Journal • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • CD8 • IFNG • TNFA

Developing Potent and Selective Anticancer Therapy through Chemical Approaches and the Combination of Cationic Amphipathic Oncolytic Peptides. (PubMed, J Med Chem) - "Among the derivatives, MAF-10L exhibited superior anticancer activity but elevated hemolysis, which was mitigated through combination therapy with LTX315. These findings underscore the potential of cationic amphipathic peptides as a basis for selective anticancer treatments and highlight the benefits of peptide combinations in reducing adverse effects while enhancing the therapeutic efficacy."

Journal • Hematological Disorders • Oncology

Verrica Pharmaceuticals Reports Quarterly 2025 Financial Results (GlobeNewswire) - "...We continue to advance our novel oncolytic peptide, VP-315, which has shown promising safety and efficacy data in a Phase 2 trial for the treatment of basal cell carcinoma, as we have recently held our end-of-Phase 2 meeting with the FDA that will help us to design a Phase 3 program."

FDA event • Basal Cell Carcinoma

Cationic antimicrobial peptides: potential templates for anticancer agents. (PubMed, Front Med (Lausanne)) - "CAMPs present several advantages such as high specificity for targeting cancer cells, minimal toxicity to normal cells, reduced probability of inducing resistance, stability under physiological conditions, ease of chemical modification, and low production costs. This review focuses on CAMPs with anticancer properties such as KLA, bovine lactoferricin derivatives, and LTX-315, and briefly explores common bioinformatics tools for Anticancer Peptides (ACPs) selection pipeline from AMPs."

Journal • Review • Oncology

An injectable oncolytic hydrogel platform for in situ dendritic cell vaccination to boost antitumor immunity. (PubMed, Biomater Sci) - "To overcome these limitations, we developed an injectable thermosensitive hydrogel (LC-Gel) that incorporates the oncolytic peptide LTX-315 and the chemokine CCL21 to generate in situ DC vaccines aimed at enhancing anti-tumor immunity...Moreover, LC-Gel is shown to trigger long-term immune memory for eliciting a distant anti-tumor effect. In summary, our study introduces an innovative in situ DC vaccination strategy using an injectable oncolytic hydrogel platform for cancer immunotherapy."

Journal • Breast Cancer • Oncology • Solid Tumor • CCL21

Oncolytic peptide LTX-315 plus an anti-CTLA-4 antibody induces a synergistic anti-cancer immune response in residual tumors after radiofrequency ablation of hepatocellular carcinoma. (PubMed, Cell Death Dis) - "Overall, the results of this study demonstrated that LTX-315 plus anti-CTLA-4 antibody could synergistically improve the immunosuppressive microenvironment of residual tumors and induce a strong anti-tumor immunity after iRFA of HCC. This combination treatment strategy may offer a new alternative to reduce the tumor recurrence after RFA of malignant solid tumors with large sizes or in high-risk locations."

IO biomarker • Journal • Hepatocellular Cancer • Oncology • Solid Tumor • CD8 • PD-1

Neoadjuvant LTX-315 in combination with pembrolizumab in resectable stage III/IV melanoma (NeoLIPA trial): Protocol for a single center phase II open label study (EADO-WCM 2025) - "In addition we will collect serial tissue biopsies and blood for extensive exploratory analyses using mRNA sequencing, imaging mass cytometry, multiplex flow cytometry and quantification of circulating tumor DNA. Results N/A Conclusions N/A"

Clinical • Combination therapy • IO biomarker • P2 data • Melanoma • Oncology • Solid Tumor

Lytix Biopharma Q4 2024: Solid clinical results strengthen the path to Phase III and further advancements in 2025 (Lytix Biopharma Press Release) - "LTX-315:...Verrica is preparing for FDA discussions in H1 2025 to outline the path toward a Phase III trial....The ATLAS-IT-05 trial, which focuses on late-stage, heavily pre-treated patients, is expected to conclude in H2 2025."

FDA event • Trial status • Melanoma

Lytix Biopharma receives Notice of Allowance for U.S. patent application covering its LTX-315 clinical program (Lytix Biopharma Press Release) - "Lytix Biopharma...announces that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 18/598,719 with the title 'Immune Checkpoint Inhibitor Combinations'. This U.S. Patent will not only fortify Lytix Biopharma's intellectual property portfolio by protecting the use of LTX-315 in conjunction with PD-1 immune checkpoint inhibitor but also enhances our competitive edge in the burgeoning U.S. pharmaceutical market. The patent will extend the effective patent life of LTX-315, enabling us to secure our market position in the U.S. and maximize the value of our clinical programs."

Patent • Oncology

Efficient Delivery of Oncolytic Peptide LTX-315 by ZIF-8: pH-Responsive Release, Improved Stability, and Reduced Hemolysis. (PubMed, Mol Pharm) - "The mechanism investigation indicated that LTX-315@ZIF-8 NPs possessed potent membranolytic activity and reduced the mitochondrial membrane potential to trigger cell death. Collectively, this paper not only established a robust strategy to improve the stability and reduce the hemolytic properties of LTX-315 but also provided a reliable reference for the future delivery of oncolytic peptides."

Journal • Hematological Disorders • Oncology

Verrica Pharmaceuticals Announces Presentation of Three Posters Featuring Positive Preliminary Topline Results of VP-315 for the Treatment of Basal Cell Carcinoma at the 2025 Winter Clinical Dermatology Conference (GlobeNewswire) - P2 | N=92 | NCT05188729 | Sponsor: Verrica Pharmaceuticals Inc. | "In the newly-presented poster, Verrica conducted a post-hoc analysis of the data from the Study and announced a Calculated ORR of 97%, defined as the percentage of study subjects who do not demonstrate disease progression and who experience at least a 30% level of tumor reduction along with partial or complete response following treatment The Company still expects genomic and T-cell (immune response) data in the first quarter of 2025 and plans to request an End-of-Phase 2 meeting with the FDA in the first half of 2025 to determine the next steps for the development of VP-315 for the treatment of BCC."

FDA event • P2 data • Basal Cell Carcinoma

Posters highlight the safety data, tolerability data, and antitumor efficacy data of VP-315 for the treatment of basal cell carcinoma as determined by histological clearance (GlobeNewswire) - "P2 | N=92 | NCT05188729 | Sponsor: Verrica Pharmaceuticals Inc. | "Part 2 of the Study was designed to explore dosing regimens to help Verrica identify the recommended regimen for a Phase 3 study program. Approximately 51% of tumors treated in the Study achieved complete histological clearance, while those patients with a residual tumor achieved, on average, approximately 71% reduction in tumor size. There were no Treatment Related Serious Adverse Events, and most Treatment Related Adverse Events were mild to moderate."

P2 data • Basal Cell Carcinoma

LTX-315 is a novel broad-spectrum antimicrobial peptide against clinical multidrug-resistant bacteria. (PubMed, J Adv Res) - "The unique mechanism of LTX-315 involves high-affinity binding to PG and subsequent membrane disruption, providing a novel approach against multidrug-resistant bacteria compared to conventional antibiotics. As a potential candidate, it shows promise in effectively treating bacterial infections, particularly those caused by drug-resistant bacteria, thereby addressing the escalating challenge of antibiotic resistance worldwide."

Journal • Infectious Disease • Pneumonia

NeoLIPA: Neoadjuvant LTX-315 in Combination with Pembrolizumab in Resectable Stage III/IV Melanoma (clinicaltrials.gov) - P2 | N=27 | Recruiting | Sponsor: Oslo University Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor