Oncopore (ruxotemitide) / Lytix, Verrica - LARVOL DELTA

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

MYELOSUPPRESSION FOLLOWING LYMPHODEPLETING CHEMOTHERAPY AS PART OF ADOPTIVE CELL THERAPY FOR PATIENTS WITH PROGRESSIVE SOFT TISSUE SARCOMA AFTER STANDARD CHEMOTHERAPY (CTOS 2024) - "It is therefore important to consider both short- and long-term effect on the bone marrow.We have recently conducted a clinical trial with the combination of ACT using tumor-infiltrating lymphocytes (TILs) and injections of the oncolytic peptide LTX-315 (Lytix Biopharma)...Prior to TIL infusion, patients received preparative lymphodepleting chemotherapy with two days of cyclophosphamide and five days of fludarabine phosphate... These data demonstrates that bone marrow recovery following lymphodepleting chemotherapy in sarcoma patients is comparable to what is observed in melanoma patients. In one case, however, a patient experienced prolonged myelosuppression four months after treatment most likely due to the lymphodepleting chemotherapy."

Clinical • Hematological Malignancies • Melanoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • IL2

Lytix Biopharma presents updated phase II results from skin cancer study (BCC) at the DNB Nordic Healthcare Conference (Lytix Biopharma Press Release) - P2 | N=92 | NCT05188729 | Sponsor: Verrica Pharmaceuticals Inc. | "The study investigates Lytix’s lead drug candidate LTX-315 in BCC patients and shows impressively an: 97 percent overall response rate (ORR). Additional efficacy data, previously reported in August 2024 shows 86 percent overall reduction of tumor size, in addition to 51 percent complete clearance rate of basal cell carcinomas (total removal). Lytix has significantly reduced its development risk, based on positive phase II results and progress towards a potential phase III study."

P2 data • Basal Cell Carcinoma

First patient treated in new phase II clinical trial at Radiumhospitalet in Oslo – promising use of Lytix cancer treatment in patients with early-stage melanoma (Lytix Biopharma Press Release) - "Lytix Biopharma...announces that the first patient has been treated in a new Phase II trial (NeoLIPA). The study evaluates the effect of Lytix’s lead drug candidate, LTX-315, in early-stage patients diagnosed with melanoma....The investigator-led trial run by Oslo University Hospital (Radiumhospitalet) will enroll approximately 27 patients. The NeoLIPA trial will be led by Dr. Henrik Jespersen, Head of Melanoma at Oslo University Hospital and interim results from the study are expected in H2 2025."

P2 data • Trial status • Melanoma

Verrica Pharmaceuticals Announces Acceptance of Two Abstracts Featuring Positive Preliminary Topline Results of VP-315 for the Treatment of Basal Cell Carcinoma at the 2024 Fall Clinical Dermatology Conference (GlobeNewswire) - P2 | N=92 | NCT05188729 | Sponsor: Verrica Pharmaceuticals Inc. | "Approximately 51% of tumors treated in Part 2 achieved complete histological clearance and patients with residual tumor on average achieved approximately 71% reduction in tumor size. There were no Treatment Related Serious Adverse Events, and most Treatment Related Adverse Events were mild to moderate. The Company 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 to determine the next steps for the development of VP-315 for the treatment of BCC in the first half of 2025."

P2 data • Basal Cell Carcinoma

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

Combination therapy • New P2 trial • Melanoma • Oncology • Solid Tumor

VP-315-201: Open-Label Proof of Concept Study of VP-315 in Basal Cell Carcinoma (clinicaltrials.gov) - P2 | N=92 | Completed | Sponsor: Verrica Pharmaceuticals Inc. | Recruiting ➔ Completed

Trial completion • Basal Cell Carcinoma • Genetic Disorders • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Skin Nodular Basal Cell Carcinoma

Verrica Pharmaceuticals Announces Positive Preliminary Topline Results from Part 2 of Phase 2 Clinical Study of VP-315, an Investigational Oncolytic Peptide-Based Immunotherapy for the Treatment of Patients with Basal Cell Carcinoma (GlobeNewswire) - P2 | N=80 | NCT05188729 | Sponsor: Verrica Pharmaceuticals Inc. | "51% of lesions treated resulted in complete histologic clearance, with no residual tumor cells (n=93). Histological reduction of tumor size in those subjects with remaining tumor was 71% (n=90). All patients treated with VP-315 had a reduction in tumor size with an overall reduction of tumor size in all subjects (those with no residual tumor and those with residual tumor) of 86% (n=90). The Company 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 to determine next steps for the development of VP-315 for the treatment of BCC in the first half of 2025. The Company also plans to submit the final Phase 2 data for presentation at future medical meetings."

FDA event • P2 data • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor

Verrica Pharmaceuticals to Report Second Quarter Financial Results and Release Preliminary Topline Results from Part 2 of Phase 2 Trial of VP-315 for the Treatment of Basal Cell Carcinoma on August 14, 2024 (GlobeNewswire) - "Verrica Pharmaceuticals Inc...announced that it will host a conference call and live webcast at 8:30 a.m. ET on Wednesday, August 14, 2024, to discuss the Company's financial results for the second quarter ended June 30, 2024, and provide an overview of topline results from Part 2 of the Phase 2 trial of VP-315 for the treatment of basal cell carcinoma."

P2 data • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor

Exploring the Cytotoxic Potential of Snake-Derived Peptides: Targeting Breast Cancer and Ovarian Clear Cell Carcinoma (EACR 2024) - "Conclusion Snake-derived peptides demonstrate potent cytotoxicity primarily through membranolytic mechanisms and show promising efficacy in targeting cancer cells, surpassing the effectiveness of the clinical-phase control peptide LTX-315. Future work aims to explore additional cell death mechanisms and enhance bioactive peptide efficacy as complementary cancer therapy."

Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • CASP3

Synthesis and structural optimization of oncolytic peptide LTX-315. (PubMed, Bioorg Med Chem) - "In general, the cost-effective synthesis and stability-guided structural optimizations were conducted on LTX-315, affording the highly hydrolysis resistant MS-20 which possessed durable anticancer activity. Meanwhile, this study also provided a reliable reference for the future optimization of anticancer peptides through the solid-phase S-alkylation and L-type to D-type amino acid substitutions."

Journal • Hematological Disorders • Oncology

Verrica Pharmaceuticals Reports First Quarter 2024 Financial Results (GlobeNewswire) - "Preliminary Phase 2 results for VP-315 in the treatment of basal cell carcinoma (BCC) expected in the second quarter of 2024....Research and development expenses were $4.9 million in the first quarter of 2024, compared to $2.7 million for the same period in 2023. The increase of $2.2 million was primarily related to increased clinical costs for VP-315 of $1.5 million and increased headcount related costs of $0.6 million."

Commercial • P2 data • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor

A Transformable Specific-Responsive Peptide for One-Step Synergistic Therapy of Bladder Cancer. (PubMed, Small) - "The TSRP is composed of: i) Recognition unit could specifically target and inhibit the biological function of FGFR-1; ii) Transformable unit could self-assembly and trigger nanofibers formation; iii) Reactive unit could specifically cleaved by MMP-2/9 in tumor micro-environment; iv) Immune unit, stimulate the release of immune cells when LTX-315 (Immune-associated oncolytic peptide) exposed...All above processes together contribute to the increasing survival rate of tumor-bearing mice by nearly 4-folds. This work presented a unique design for the biological application of one-step synergistic therapy of bladder cancer."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CALR • CD8 • FGFR1 • MMP2 • MMP9

Lytix Biopharma announces approval of the Phase II study in early-stage skin cancer (melanoma) representing a significant commercial opportunity (Lytix Biopharma Press Release) - "Lytix Biopharma announces that the Norwegian Medical Products Agency has approved the clinical trial application for a Phase II Neoadjuvant study in early-stage melanoma, a severe form of skin cancer. In this study, Lytix`s lead candidate LTX-315 will be given in combination with another type of immunotherapy before surgery. The study is called NeoLIPA and will be led by Dr. Henrik Jespersen, Head of Melanoma Oncology at Radiumhospitalet (Oslo University Hospital).....The Oslo University Hospital plan to start recruiting patients before the summer. The neoadjuvant study will be a Phase II, open-label study recruiting 27 patients with clinically detectable and resectable stage III-IV melanoma."

New P2 trial • Melanoma