Oncopore (ruxotemitide) / Lytix, Verrica - LARVOL DELTA

Q2 2026 highlights and developments and post-quarter (Lytix Biopharma Press Release) - "The NeoLIPA Phase II neoadjuvant melanoma study continued to progress: 85% of planned patients enrolled as of August 2026; Top-line results remain expected in the second half of 2026….Verrica Pharmaceuticals has stated they continue to prepare for a Phase III program for ruxotemitide (VP-315) in basal cell carcinoma, including CRO selection and manufacturing of Phase III clinical supplies."

New P3 trial • P2 data • Preclinical • Basal Cell Carcinoma • Melanoma

RADA32-LTX315-Simvastatin Hydrogel (RLS) Enhances Radiotherapy Efficacy in Glioblastoma by Modulating Tumor Microenvironment and Immune Response (ASTRO 2026) - No abstract available

Biomarker • Clinical • Tumor microenvironment • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Lytix Biopharma Q2 2026: FDA Feedback Clears Path to Registrational Phase III Trial for Ruxotemitide (LTX-315) in Patients with Resectable High-Risk Melanoma, Marking Defining Milestone (Lytix Biopharma Press Release) - "No objection from the U.S. Food and Drug Administration (FDA) on the registrational study design for ruxotemitide in combination with pembrolizumab in high-risk resectable melanoma, removing a key source of uncertainty on the path to full approval."

FDA event • Melanoma

Lytix Biopharma ASA…announces its collaboration in a new investigator-initiated Phase II study in melanoma (ALETTA) in Europe (Cision) - "The study, led by Prof. Christian Blank, MD, PhD, will investigate ruxotemitide (formerly LTX-315) in combination with ipilimumab plus nivolumab, a standard of care in early-phase melanoma patients alongside pembrolizumab....The ALETTA study is a multi-arm Phase II study is evaluating ruxotemitide in patients with resectable stage III melanoma....Patient enrollment in the ipilimumab/nivolumab plus ruxotemitide comparison is expected to begin in early 2027....Total planned enrolment across the multi-arm study exceeds 260 patients, of which 47 will be randomized within the ipilimumab/nivolumab plus ruxotemitide comparison arm relevant to Lytix."

Licensing / partnership • New P2 trial • Melanoma

Antimicrobial Peptides of the Skin: Roles in Skin Cancer and Clinical Applications. (PubMed, Exp Dermatol) - "This review provides a comprehensive discussion of AMPs, including dermcidin, psoriasin (S100A7), human cathelicidin (LL-37), RNase-7 and the human β-defensins, in the context of skin cancer research and clinical developments. These AMPs influence skin tumorigenesis through microbiome regulation, innate immune pathways and chronic inflammation, and although the mechanistic details are subject to scrutiny, several AMP-derived therapies, including LL-37 and LTX-315, have been developed for their potential in cutaneous oncology."

Journal • Review • Dermatology • Genetic Disorders • Melanoma • Oncology • Skin Cancer • Solid Tumor

Self-assembled manganese-based nanoplatforms synergizing immunogenic cell death and STING activation for triple-negative breast cancer. (PubMed, Mater Today Bio) - "In this study, we developed a manganese-based nanoparticle, termed HLM315, via one-step self-assembly of alendronate-modified hyaluronic acid (HA-AL), the amphiphilic cationic peptide LTX-315, and Mn2+ under weakly alkaline conditions. Ultimately, HLM315 systematically reshaped the TME and potently inhibited the tumor growth in TNBC orthotopic mouse model. Overall, HLM315 establishes a coordinated antitumor immune cascade and offers a promising strategy to enhance immunotherapy efficacy in TNBC."

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • STING

Safety and efficacy of intratumoral (IT) ruxotemitide (LTX 315) in combination with pembrolizumab in patients with unresectable advanced melanoma or triple-negative breast cancer (TNBC). (ASCO 2026) - P1, P2 | "IT ruxotemitide plus pembrolizumab demonstrated durable antitumor activity and manageable safety in heavily pretreated patients with advanced or metastatic melanoma or TNBC with injectable disease. These findings support further clinical evaluation of this combination in melanoma and TNBC."

Clinical • Combination therapy • Metastases • Breast Cancer • Carcinoid Tumor • Cardiovascular • Cutaneous Melanoma • Hypertension • Hypotension • Melanoma • Oncology • Pruritus • Solid Tumor • Triple Negative Breast Cancer

Lytix Biopharma Reports Phase II Data in Melanoma and Triple-Negative Breast Cancer for Ruxotemitide (LTX-315) in Combination with Pembrolizumab (Euronext Press Release) - "The poster...presents pooled data from two open-label Phase II studies of intratumoral ruxotemitide plus pembrolizumab in patients with advanced melanoma who had progressed following prior anti PD-1/PD-L1 therapy and in patients with metastatic TNBC. Antitumor activity was observed in heavily pretreated patients with advanced melanoma and metastatic TNBC, two populations with limited therapeutic options; Durable responses was obtained in melanoma patients in the context of prior PD-1/PD-L1-refractory disease; Systemic activity was noted, including tumor regression in non-injected lesions, supporting the potential of ruxotemitide to induce broader immune activation following local intratumoral administration; The safety profile observed across the studies was broadly consistent with the known effects of intratumoral immunotherapy and pembrolizumab, and the combination was manageable."

P2 data • Melanoma • Triple Negative Breast Cancer

Vp-315 demonstrates potential abscopal effect in untreated non-target basal cell carcinoma (bcc) tumors (SID 2026) - "The therapeutic effects of VP-315 extended beyond treated lesions. Reductions in untreated NTLs suggest a potential abscopal effect consistent with broader immune activation within the tumor microenvironment of remote NTLs."

Late-breaking abstract • Basal Cell Carcinoma • Melanoma • Non-melanoma Skin Cancer • Oncology • Solid Tumor

STING agonist-primed supramolecular oncolytic hydrogel vaccine for tuning tumors against themselves. (PubMed, J Control Release) - "Here, we report a supramolecular hydrogel vaccine based on the oncolytic peptide LTX-315, designed to locally deliver a STING agonist and thereby mobilize antitumor immunity against the tumor itself...Moreover, the vaccine induced robust T-cell memory and systemic antitumor immunity, indicating its potential to prevent tumor recurrence and metastasis. This work provides a generalized in situ vaccination strategy that leverages the tumor itself as a source of antigen, offering a promising and translatable approach for personalized cancer immunotherapy."

Journal • Colon Cancer • Colorectal Cancer • Melanoma • Oncology • Solid Tumor

Intratumoral (IT) ruxotemitide (LTX‑315) in combination with pembrolizumab in patients with unresectable advanced melanoma refractory to PD-1/PD-L1 therapy: Final results from the ATLAS-IT-05 study (AACR 2026) - "IT ruxotemitide plus pembrolizumab demonstrated durable antitumor activity and manageable safety in heavily pretreated patients with CPI-refractory advanced or metastatic melanoma with injectable disease. These findings support further clinical evaluation of this combination in melanoma."

Clinical • Combination therapy • Metastases • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

Non-melanoma skin cancer treated with electrochemotherapy: Clinical outcomes and tolerability (AACR 2026) - "Electric pulses were delivered using the OncoPore device (BIOTEX SRL, Buenos Aires, Argentina). ECT with intravenous bleomycin represents a safe, effective, and well-tolerated therapeutic option for patients with non-melanoma skin cancer. The high objective response rate, minimal toxicity, and favorable cosmetic results support its implementation in outpatient settings. Furthermore, its efficacy in a patient with epidermolysis bullosa suggests potential applicability in selected fragile-skin conditions."

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

Lytix Biopharma ASA Reports Promising Final Phase II Results for Ruxotemitide (LTX-315) in Combination with Pembrolizumab in PD-1/PD-L1 Refractory Advanced Melanoma (Cision) - "Key efficacy findings from the study include: Objective response rate (ORR): 13.6% among evaluable patients (n=22); Clinical benefit rate (CBR): 40.9%; Durable responses lasting beyond 24 months in responding patients; Median progression-free survival (PFS): 6.3 months.... The safety profile observed in the study was consistent with the known effects of intratumoral immunotherapy and pembrolizumab. The most common treatment-related adverse events were injection-site reactions (95.7%), fatigue (30%), pruritus (26.1%), hypotension (26.1%), and anemia (21.7%). No treatment-emergent adverse events led to discontinuation of pembrolizumab."

P2 data • Melanoma

Verrica Pharmaceuticals…announced acceptance of a late-breaking abstract reporting Phase 2 exploratory data of VP-315, Verrica’s novel oncolytic peptide for the treatment of basal cell carcinoma (GlobeNewswire) - "The data will be presented at the upcoming 2026 Society for Investigative Dermatology (SID) Annual Meeting, which will take place from May 13-16, 2026, in Chicago, Illinois."

Late-breaking abstract • P2 data • Basal Cell Carcinoma

Unlocking immune resistance and metastasis of PDAC via dual acting circularized nanodisc (AACR 2024) - "Therefore, we engineered ultrasmall circularized nanodiscs (cND) that encapsulate oncolytic peptide LTX-315 and fibroblast remodeling Notch signaling inhibitor...Moreover, the tumor infiltration of CD86+ MHCII+ dendritic cells and cytotoxic CD8+ T cells was enhanced after treatment with the cND. Overall, our dual strategy of targeting pancreatic CSCs and CAFs via oncolytic/Notch blocking cND boosted the anti-tumor and anti-metastatic efficacy of aPD-L1 therapy to eliminate primary PDAC tumor and suppress its metastasis."

Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CAFs • CALR • CD8 • CD86

Ultrasound-propelled oncolytic biomimetic microbubbles as in situ vaccines reprogram tumor immunosuppressive microenvironment. (PubMed, Mater Today Bio) - "Despite its promising profiles, the clinical application of oncolytic peptides (such as LTX-315) is hampered by ticklish reasons like rapid plasma clearance, suboptimal biodistribution, and potential toxicity toward normal tissues...After being combined with anti-programmed death-1 (αPD-1) therapy, the integrated LCMBs + αPD-1 regimen elicited robust anticancer immune responses, so the primary tumor, tumor recurrence, and distant metastasis were notably restrained. In summary, this study developed a novel biomimetic LCMBs delivery platform to enhance the therapeutic efficacy of highly cytotoxic oncolytic peptides and promote anticancer immunotherapy, thereby effectively inhibiting tumor recurrence and metastasis."

Journal • Oncology

Lytix Biopharma: Q4 2025 Presentation and Publication of H2 2025 Interim Report (Lytix Biopharma Press Release) - "The ATLAS-IT-05 Phase II study in advanced melanoma was completed, with preparation of the clinical study report ongoing and expected to be finalized in the first quarter of 2026; Evaluating all strategic opportunities to accelerate the development of LTX-401."

Clinical • Trial status • Hepatocellular Cancer • Melanoma

Immunobiological mechanisms of action of oncolytic peptides. (PubMed, J Immunother Cancer) - "For instance, LTX-315 (studied as VP-315 in basal cell carcinoma (BCC)) has recently been shown to enable complete and durable responses in patients with BCC, and emerging evidence points to a significant activity of LTX-315 in immunologically cold tumors. Here, we summarize recent mechanistic, preclinical, and clinical advances in OLP development, underscoring their potential as a versatile and powerful modality of cancer immunotherapy."

Journal • Review • Basal Cell Carcinoma • Non-melanoma Skin Cancer • Oncology

Oncolytic peptide LTX-315 targets PD-L1 to improve antitumor immune response of nanosecond pulse electric field in liver cancer. (PubMed, J Immunother Cancer) - "LTX-315; Antitumor immune response; nsPEF; Liver cancer."

IO biomarker • Journal • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • CD8 • PD-1 • PD-L1

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