NeoLIPA: a Single Center Phase II Open Label Study of Neoadjuvant LTX-315 in Combination with Pembrolizumab in Patients with Clinically Detectable and Resectable Stage III-IV Melanoma

This clinical trial aims to evaluate the effectiveness of a new treatment approach for patients with stage III or IV melanoma that has spread to other parts of the body but can still be surgically removed. The study combines two treatments: LTX-315 and pembrolizumab.
Melanoma that has spread to other parts of the body can often be treated with surgery. Despite surgery, there is a high risk of the cancer coming back. Pembrolizumab, an immune checkpoint inhibitor, can reduce this risk when given after surgery. Recent studies have shown that giving pembrolizumab before surgery, along with post-surgery treatment, might be more effective than giving it only after surgery. However, many patients still experience cancer recurrence. Combining pembrolizumab with LTX-315, which triggers a different immune response, might improve the treatment&amp;#39;s effectiveness and reduce the risk of cancer progression before surgery.
This is an open-label Phase II study, meaning both the researchers and participants will know which treatments are being given. The study will be conducted at a single center and will involve about 27 participants. They will receive LTX-315 and pembrolizumab before their planned surgery to see if this combination could be more effective than pembrolizumab alone.
The primary goal is to assess the tumors response to the neoadjuvant (pre-surgery) treatment, specifically looking at the rate of pathological complete response (pCR), where no cancer is detected in the removed tumor tissue.

开始日期2024-11-01

申办/合作机构

Oslo universitetssykehus HF

[+1]

NCT05188729

/ Completed临床2期

A Phase 2, Multicenter, Open-label, Proof-of-concept Study with Safety Run-in to Evaluate the Safety, Pharmacokinetics, and Efficacy of VP-315 in Adult Subjects with Basal Cell Carcinoma

This is a 2-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, tolerability, MTD, and objective antitumor efficacy of ascending dose strengths of VP-315 when administered intratumorally to adults with biopsy proven basal cell carcinoma (BCC).
The study is expected to enroll approximately 80 subjects with a histological diagnosis of BCC in at least 1 eligible target lesion (confirmed by punch or shave biopsy).

开始日期2022-02-01

申办/合作机构

Verrica Pharmaceuticals, Inc.

[+3]

NCT04796194

/ Unknown status临床2期

A Phase II Study of Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Patients With Percutaneously Accessible Lesions With Advanced Melanoma Refractory to Pembrolizumab

ATLAS-IT-05 is an open-label, single-arm study in patients with advanced melanoma accessible for injections (cutaneous, subcutaneous, lymph node, or intramuscular tumors) and who have either exhausted treatment options or are not eligible for, suitable for, or willing to undergo such treatments.

开始日期2021-06-01

申办/合作机构

Lytix Biopharma AS

[+2]

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项与鲁特米肽相关的文献（医药）

2025-03-03·MOLECULAR PHARMACEUTICS

Efficient Delivery of Oncolytic Peptide LTX-315 by ZIF-8: pH-Responsive Release, Improved Stability, and Reduced Hemolysis

Article

作者: Cui, Su-Su ; Chen, Yu-Zhen ; Liu, Qing ; Chen, Xin-Qi ; Wang, Cai-Yun ; Qi, Yun-Kun ; Du, Shan-Shan

The first-in-class oncolytic peptide LTX-315 has exhibited positive anticancer responses in multiple phase I/II clinical trials. Nevertheless, the linear peptide LTX-315 suffers from poor proteolytic stability and undesired toxicity, especially hemolysis, which may limit its widespread applications. Except for the direct structural modifications, drug delivery systems (DDSs) are expected to protect LTX-315 from degradation and shield its hemolytic properties. Therefore, the LTX-315 and zeolitic imidazolate framework (ZIF-8)-based nanoparticles (NPs) were constructed with a high LTX-315 encapsulation rate of 59.9%, utilizing the biomineralized "one-pot method" in an aqueous system. The release of LTX-315, in vitro anticancer potency, serum stability, anticancer durability, antimigration activity, hemolysis effect, subcellular localization, and the membrane disruption/permeation effects of LTX-315@ZIF-8 NPs were investigated. LTX-315@ZIF-8 NPs exhibited potent cytotoxicity against cancer cells. The serum stability experiment and time-inhibition curve assay indicated that ZIF-8 NPs could effectively improve the stability of LTX-315, prolong the duration of anticancer action, and enhance the cytostatic potency. Especially, the LTX-315@ZIF-8 NPs not only effectively attenuated the hemolytic toxicity of LTX-315 but also achieved the pH-responsive release of LTX-315. 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.

2025-01-01·Journal of Advanced Research

LTX-315 is a novel broad-spectrum antimicrobial peptide against clinical multidrug-resistant bacteria

Article

作者: Peng, Mingxiu ; Chan, Edward Wai-Chi ; Heng, Heng ; Zhao, Jiamin ; Tang, Yang ; Sun, Liang ; Yang, Chen ; Chen, Sheng ; Dai, Liang

INTRODUCTION:

Infections stemming from multidrug-resistant bacteria present a substantial threat to public health today. Discovering or synthesizing novel compounds is crucial to alleviate this pressing situation.

OBJECTIVE:

The main purpose of this study is to verify the antibacterial activity of LTX-315 and explore its primary action mode.

METHODS:

Through antibacterial phenotype assay screening, we obtained a potent compound named LTX-315 from diverse drug libraries, 10,926 compounds in total. Then, the bactericidal effect and its action mode were explored through biochemical and chemistry methods such as atime-killing curve, scanning electronic microscopy, isothermal titration calorimetry analysis, and nuclear magnetic resonance. Finally, the efficacy in vivo of LTX-315 against drug-resistant bacteria was proved through amice infection model.

RESULTS:

In this study, LTX-315, an oncolytic peptide, was discovered to effectively eliminate gram-positive and gram-negative pathogens, even for those multidrug-resistant strains. Through strong electrostatic interactions, LTX-315 can bind to the membrane component phosphatidylglycerol (PG) with extremely high affinity (nanomolar level). Strikingly, in contrast to the typical electrostatic interactions of antibacterial peptides, the indole group of LTX-315, situated near the alkyl chain, exhibits significantly enhanced recognition and interaction with PG due to the hydrophobic effect of the alkyl chain. Furthermore, it exerts various impacts on cell membranes, including damaging integrity, increasing permeability, and decreasing membrane fluidity. Additionally, microscopy revealed significant cell disintegration. The influence, in turn, disrupts several physiological activities inside cells, such as increasing the reactive oxygen species level, ultimately leading to cell death. Finally, the efficacy of LTX-315 in vivo against multidrug-resistant and hypervirulent Klebsiella pneumoniae was demonstrated.

CONCLUSION:

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.

2024-12-31·Oncoimmunology

LTX-315 and adoptive cell therapy using tumor-infiltrating lymphocytes generate tumor specific T cells in patients with metastatic soft tissue sarcoma

Article

作者: Albieri, Benedetta ; Petersen, Michael Mørk ; Sundvold, Vibeke ; Junker, Niels ; Sveinbjornsson, Baldur ; Nielsen, Morten ; Met, Özcan ; Rekdal, Øystein ; Clancy, Trevor ; Hovgaard, Dorrit ; Camilio, Ketil ; Krarup-Hansen, Anders ; Svane, Inge Marie ; Stratford, Richard ; Monberg, Tine

LTX-315 is an oncolytic peptide that elicits both local and systemic immune responses upon intratumoral injection. In the present pilot trial, we treated patients with metastatic soft tissue sarcoma with the combination of LTX-315 and adoptive T-cell therapy using in vitro expanded tumor-infiltrating lymphocytes. Six heavily pretreated patients were included in the trial and treated with LTX-315 of which four patients proceeded to adoptive T-cell therapy. Overall, the treatment was considered safe with only expected and manageable toxicity. The best overall clinical response was stable disease for 208 days, and in this patient, we detected tumor-reactive T cells in the blood that lasted until disease progression. In three patients T-cell reactivity against in silico predicted neoantigens was demonstrated. Additionally, de novo T-cell clones were generated and expanded in the blood following LTX-315 injections. In conclusion, this pilot study provides proof that it is feasible to combine LTX-315 and adoptive T-cell therapy, and that this treatment can induce systemic immune responses that resulted in stabilization of the disease in sarcoma patients with otherwise progressive disease. Further optimization of the treatment protocol is warranted to increase clinical activity. ClinicalTrials.gov Identifier: NCT03725605.

项与鲁特米肽相关的新闻（医药）

2025-05-19

·PRNewswire

Intra-tumoral Cancer Therapies Market to Show Tremendous Growth at a CAGR of 31.3% During the Study Period (2020-2034) | DelveInsight

As per DelveInsight's estimates, among the 7MM, the US captured the highest market of intra-tumoral cancer therapies of nearly USD 74 million in 2024, which is expected to increase due to the launch of emerging therapies such as CAN-2409, RP1 (vusolimogene oderparepvec), SP-002 (ASN-002), Bizaxofusp (MDNA55), and others. LAS VEGAS, May 19, 2025 /PRNewswire/ -- DelveInsight's Intra-tumoral Cancer Therapies Market report includes a comprehensive understanding of current treatment practices, emerging intra-tumoral cancer therapies, market share of individual therapies, and current and forecasted intra-tumoral cancer therapies market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Intra-tumoral Cancer Therapies Market Report Currently, only three Intra-tumoral Cancer Therapies are approved; namely, IMLYGIC (Talimogene laherparepvec/T-VEC; Amgen), approved in the US and Europe in 2015, DELYTACT (teserpaturev/G47Δ; Daiichi Sankyo) approved in Japan in 2021, and HENSIFY in Europe in 2019. As per DelveInsight's analysis, the total market size of intra-tumoral cancer therapies in the 7MM was USD 109 million in 2024 and is projected to grow during the forecast period (2025-2034). In 2024, the total cases of selected indication (based on current landscape and pipeline activity) were 8.9 million in the 7MM, which is anticipated to increase by 2034. Leading intra-tumoral cancer therapies companies, such as Janssen, Stamford Pharmaceuticals, Ascend Biopharmaceuticals, Replimune, Highlight Therapeutics, Cytovation ASA, Intensity Therapeutics, Ascendis Pharma, Treovir, Matica Biotechnology, QBiotics, NanOlogy, Lokon Pharma AB, EpicentRx, Medicenna Therapeutics, Philogen S.p.A., Candel Therapeutics, Lytix Biopharma, Verrica Pharmaceuticals, CEI-SCI, and others, and others, are developing novel intra-tumoral cancer therapies that are expected to enter the intra-tumoral cancer therapies market in the coming years. Some of the key intra-tumoral cancer therapies in the pipeline include INT230-6, Vusolimogene oderparepvec (RP1), Nidlegy (Daromun), G207, Ilixadencel (INTUVAX), Tigilanol tiglate, SP-002 (ASN-002), BO-112, Bizaxofusp (MDNA55), and others. In March 2025, NANOBIOTIX announced topline data from the completed dose-escalation portion of a Phase I study, conducted under the sponsorship of The University of Texas MD Anderson Cancer Center, evaluating JNJ-1900 (NBTXR3) activated by radiation therapy as a second-line or later (2L+) treatment for patients with locally advanced NSCLC eligible for re-irradiation. In March 2025, NANOBIOTIX announced an amendment to its global licensing agreement with Janssen Pharmaceutica NV. The amendment removes NANOBIOTIX's funding obligation for NANORAY- 312 and releases Johnson & Johnson from select future potential milestone payments while safeguarding NANOBIOTIX's path to sustainable cash flow through significant potential milestone payments. In March 2025, Candel Therapeutics and IDEA Pharma announced a strategic commercial partnership. Under this agreement, IDEA will provide strategic commercial input throughout the development and commercialization process for Candel's lead asset, CAN-2409. In January 2025, Lokon Pharma AB announced that the Food and Drug Administration (FDA) had granted Fast Track Designation (FTD) for the company's product candidate LOAd703 for the treatment of pancreatic cancer. In January 2025, Intensity Therapeutics announced that the Data Monitoring Committee (DMC) recommended the continuation of its Phase III sarcoma trial (INT230-6, INVINCIBLE-3) without modification based on data reviewed from July 2024 to December 2024. Some factors, such as the precedence of failure of emerging therapies, insufficient knowledge about Intra-tumoral Cancer Therapies , and several other drawbacks, might hinder the Intra-tumoral Cancer Therapies market growth. Discover which therapies are expected to grab the intra-tumoral cancer therapies market share @ Intra-tumoral Cancer Therapies Market Report Intra-tumoral Cancer Therapies Market Dynamics The intra-tumoral cancer therapies market dynamics are expected to change in the coming years. Various classes of intra-tumoral immunotherapies, including radioenhancer nanoparticles, recombinant fusion proteins, oncolytic therapy, gene therapy, synthetic dsRNA complexes, and others, are currently in preclinical and clinical development. These therapies increase drug concentration and availability within the tumor microenvironment while limiting systemic exposure and reducing the likelihood of immune-related side effects in other parts of the body. Intra-tumoral therapeutic strategies offer a powerful approach to in situ vaccine development, utilizing immune-stimulating agents to trigger local and systemic anti-tumor immune responses. Additionally, the ability of intra-tumoral immunotherapy combinations to elicit both T-cell and B-cell antitumor responses presents a potential strategy to overcome immune escape mechanisms, such as the loss of HLA-I expression on tumor cells, which are often associated with immune checkpoint therapy monoclonal antibody monotherapies. Furthermore, potential therapies are being investigated, and it is safe to predict that the treatment space will significantly impact the intra-tumoral cancer therapies market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the intra-tumoral cancer therapies market in the 7MM. However, several factors may impede the growth of the intra-tumoral cancer therapies market. The lack of standardized guidelines for intra-tumoral immunotherapy delivery results in variations in lesion selection, injection frequency, and needle technique, which directly affect treatment outcomes and safety. Patients are required to visit clinics for each dosing session, and the administration necessitates both trained radiologists and logistics support alongside skilled physicians. While research into intra-tumoral therapies has grown in recent years, several therapies, such as tilsotolimod/Ipilimumab, sotigalimab (APX005M), and vidutolimod (CMP-001), have failed clinical trials, impacting the market. Additionally, tumors with high intra-tumoral heterogeneity may lead to poorer clinical outcomes for patients. Intra-tumoral Cancer Therapies Therapeutics Market Although significant progress has been made in cancer treatment through methods like surgery, chemotherapy, radiation, immunotherapy, and targeted therapies, many of these treatments still face limitations such as systemic toxicity, inadequate tumor penetration, and poor targeting. These issues contribute to high mortality rates, underscoring the need for more precise and localized treatment options. Recently, cancer treatment strategies have increasingly focused on alternative delivery methods, including intra-tumoral administration. This approach is being actively researched, with several therapeutic candidates—such as immune receptor agonists, viral therapies, fusion proteins, monoclonal antibodies, and gene therapies—currently undergoing preclinical and clinical trials. Intra-tumoral immunotherapy, which involves directly delivering agents into or near the tumor site, is emerging as a promising approach. This strategy aims to boost localized immune responses while reducing systemic side effects. The first oncolytic virus, IMLYGIC (T-Vec; Amgen), was approved by the US FDA for treating unresectable melanoma lesions after surgery, following a Phase III trial. The European Commission approved the treatment of advanced melanoma in 2015. In 2019, Nanobiotix's HENSIFY (NBTXR3), a hafnium oxide nanoparticle therapy combined with radiation, received European approval for soft tissue sarcoma, with plans for data releases through 2025-2026 across multiple cancers. For STS the drug is approved in Europe but not yet launched. In Japan, DELYTACT (G47∆; Daiichi Sankyo) was granted conditional approval for malignant glioma, marking the first oncolytic virus for brain cancer, and is still under evaluation for its clinical benefits. IMLYGIC from Amgen is the first and only FDA-approved viral therapy that is injected directly into melanoma tumors. Despite the initial hype for this exciting intra-tumoral mode of cancer gene therapy, IMLYGIC's debut did not translate into much commercial success in the melanoma market. Limitations of the intra-tumoral administration, no statistically significant benefit in overall survival (OS), and the intense competition from immune checkpoint inhibitors (ICIs) due to their efficacy and manageable side effects are some of the main factors for ithe nsignificant revenues of this novel therapy. Learn more about the FDA-approved intra-tumoral cancer therapies @ Intra-tumoral Cancer Therapies Treatment Key Emerging Intra-tumoral Cancer Therapies and Companies The emerging pipeline of intra-tumoral cancer therapies is robust, including drugs from key players such as Candel Therapeutics (CAN-2409), Lytix Biopharma/Verrica Pharmaceuticals (LTX-315 [VP-315]), CEI-SCI (MULTIKINE), Philogen (Daromun [NIDLEGY; a combo of L19IL2 + L19TNF]), Replimune (RP2 and RP1 [vusolimogene oderparepvec]), Highlight Therapeutics (BO-112), Cytovation ASA (CY-101), Intensity Therapeutics (INT230-6), Ascendis Pharma (TransCon IL-2 β⁄γ), Treovir/Matica Biotechnology (G207), QBiotics (Tigilanol tiglate), NanOlogy (NanoPac), EpicentRx (AdAPT-001), Medicenna Therapeutics (Bizaxofusp [MDNA55]), and others. RP1 (vusolimogene oderparepvec), Replimune's lead product candidate, is based on a proprietary strain of Herpes Simplex Virus (HSV) engineered with a fusogenic protein (GALV-GP R-) and GM-CSF to enhance tumor killing potency, immunogenicity, and activation of a systemic antitumor immune response. In November 2024, Replimune announced that the FDA granted Breakthrough Therapy Designation (BTD) to RP1 in combination with nivolumab for the treatment of advanced melanoma in adult patients who have previously received an anti-PD1 regimen. Nidlegy is a biopharmaceutical product, proprietary to Philogen, designed for the treatment of skin cancer. It consists of two active ingredients, L19IL2 and L19TNF, which are manufactured independently and which are mixed prior to intralesional administration. In July 2024, Philogen and Sun Pharmaceutical announced that the European Medicines Agency (EMA) validated the submission of the Marketing Authorization Application (MAA) for Nidlegy. CAN-2409 (Candel Therapeutics) is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the HSV thymidine kinase (HSV-tk) gene to a patient's specific tumor and induce an individualized, systemic immune response against the tumor. In March 2025, according to the company's corporate highlights, the preparations for Biologics License Application (BLA) for CAN-2409 in prostate cancer are underway, with submission expected in Q4 2026. The anticipated launch of these emerging therapies are poised to transform the intra-tumoral cancer therapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the intra-tumoral cancer therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about intra-tumoral cancer therapies clinical trials, visit @ Intra-tumoral Cancer Therapies Intra-tumoral Cancer Therapies Overview Cancer is a highly diverse disease, with its signs, symptoms, and treatments varying across different types, making it crucial to create targeted therapies for individual patients. Current treatment options for cancer include immunotherapy, radiotherapy, chemotherapy, targeted drug therapies, and more. While these approaches have improved OS and patient outcomes, they still have limitations and are not effective for everyone. Researchers are therefore working to develop new treatments that can overcome these challenges, with intra-tumoral cancer therapies emerging as a promising strategy. Intra-tumoral immunotherapy represents an innovative approach, where sophisticated antibodies are directly injected into tumors instead of being administered intravenously. This method focuses on delivering immunostimulatory agents straight into primary or metastatic tumor sites to initiate or enhance an antitumor immune response. Normally, the immune system detects and eliminates early tumors, but in immunosuppressive tumor environments, malignant cells can proliferate undetected. Regulatory T cells (Tregs), drawn to the tumor by chemokines, suppress Antigen-Presenting Cells (APCs) that would otherwise trigger an immune attack on tumor antigens. Moreover, tumor cells often release anti-inflammatory and regulatory cytokines like TGF-β and IL-10, which promote tumor growth and inhibit dendritic cell (DC) activation. To counteract this immunosuppressive environment, immunostimulants can be introduced. These agents work by attracting immune cells to the tumor or by activating the immune system to recognize and destroy cancer cells. Immunostimulants activate immune cells in the presence of tumor antigens, allowing them to travel to lymph nodes, where they stimulate tumor antigen-specific T cells through cross-presentation. These activated T cells can then return to the tumor or spread to distant tumors, leading to the targeted destruction of cancer cells. Intra-tumoral Cancer Therapies Epidemiology Segmentation In 2024, the total indication-wise treated cases of Intra-tumoral Cancer Therapies were 3.3 million in the 7MM, which is anticipated to increase by 2034. The intra-tumoral cancer therapies market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Cases of Selected Indications Indication-wise Target Patient Pool of Intra-tumoral Cancer Therapies Indication-wise Treated Cases of Intra-tumoral Cancer Therapies Scope of the Intra-tumoral Cancer Therapies Market Report Intra-tumoral Cancer Therapies Therapeutic Assessment: Intra-tumoral current marketed and emerging therapies Intra-tumoral Cancer Therapies Market Dynamics: Conjoint Analysis of Emerging Intra-tumoral Cancer Therapies Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Intra-tumoral Cancer Therapies Market Access and Reimbursement Discover more about intra-tumoral cancer therapies in development @ Intra-tumoral Cancer Therapies Clinical Trials Table of Contents Related Reports Oncolytic Virus Market Oncolytic Virus Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of oncolytic virus, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key oncolytic virus companies, including Targovax, Genelux, Imugene, EpicentRx, Replimune, Genelux Corporation, Candel Therapeutics, DNAtrix, SillaJen, Treovir, Lokon Pharma AB, Istari Oncology, CG Oncology, Amgen, Daiichio Sankyo, among others. 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About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法临床3期上市批准快速通道引进/卖出

2025-01-21

·GlobeNewswire-Health Care

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

– Presented data includes a 97% Calculated Objective Response Rate (ORR) of study subjects following treatment with VP-315 – 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 WEST CHESTER, Pa., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or the “Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced the presentation of three posters that were presented at the 2025 Winter Clinical Dermatology Conference, which was held from January 17-19, in Miami, Florida. The posters featured clinical data from Part 2 of the Phase 2 study (the “Study”) of the Company’s novel oncolytic peptide, VP-315, for the treatment of basal cell carcinoma (“BCC”). Verrica presented a poster titled “Calculated Objective Response Rate (ORR) of 97% from Post-Hoc Analysis of a Phase 2 Multicenter Study to Evaluate the Efficacy of VP-315, an Investigational therapy for Basal Cell Carcinoma (BCC)” while encore presentations of two additional posters (titled “Results of a Phase 2 Multicenter Study Evaluating the Safety and Tolerability of VP-315, an Investigational therapy for Basal Cell Carcinoma” and “Results of a Phase 2 Multicenter Study to Evaluate the Efficacy of VP-315, an Investigational Therapy for Basal Cell Carcinoma”) were also made at the conference. The posters included safety and histologic clearance data from 82 patients with up to two target BCC tumors (a total of 91 tumors) in Part 2 of the Study evaluating VP-315 for the treatment of BCC, including patients with tumors on the head and neck. 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. 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. “We remain highly encouraged by the positive preliminary topline results from Part 2 of the Phase 2 study for VP-315, which we believe support a potential change in the treatment paradigm for patients with basal cell carcinoma,” said Dr. Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica. “We believe these results will support the use of VP-315 as a potential first line therapy for use in both primary and neoadjuvant settings, and that VP-315 could provide the millions of basal cell carcinoma patients diagnosed in the United States each year with a non-surgical alternative to painful, invasive surgical treatments. We believe that VP-315 could represent a multi-billion-dollar commercial opportunity for Verrica. We look forward to our discussions with the FDA about designing a development path forward for VP-315 in 2025.” About the Phase 2 Study of VP-315The Study is a 2-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, pharmacokinetics, and efficacy of VP-315 when administered intratumorally to adults with biopsy-proven BCC. The study enrolled 92 adult subjects with a histological diagnosis of BCC in at least one eligible target tumor. For additional information about this clinical trial, please visit clinicaltrials.gov, identifier NCT05188729. About VP- 315VP-315 is a potential first-in-class oncolytic chemotherapeutic peptide immunotherapy administered directly into a tumor to induce immunogenic cell death and thereby unleashing a broad spectrum of tumor antigens for T cell responses, which may offer a non-surgical option for patients suffering from skin cancer. The technology is based on pioneering research in “host defense peptides” – nature’s first line of defense towards foreign pathogens. Verrica holds an exclusive worldwide license to develop and commercialize VP-315 for certain dermatologic oncology indications, including non-metastatic melanoma and non-metastatic merkel cell carcinoma, and intends to focus initially on basal cell and squamous cell carcinomas as the lead indications for development. VP-315 has demonstrated positive tumor-specific immune cell responses in multi-indication Phase 1/2 oncology trials. About Basal Cell CarcinomaBasal cell carcinoma is the most common form of cancer in the United States, and its incidence is rising worldwide. There are approximately 3-4 million diagnoses of basal cell carcinoma in the U.S. each year, with a high unmet need for new treatment options. Basal cell carcinoma is generally treated with invasive surgery to remove the tumor, which can cause pain, infection, bleeding and scarring. About Verrica Pharmaceuticals Inc. Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica’s product YCANTH® (VP-102) (cantharidin), is the first and only commercially available treatment approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. YCANTH® (VP-102) is also in development to treat common warts and external genital warts, two of the largest remaining unmet needs in medical dermatology. Verrica is developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 (formerly LTX-315 and VP-LTX-315) for non-melanoma skin cancers, including basal cell carcinoma and squamous cell carcinoma. For more information, visit www.verrica.com. Forward-Looking StatementsAny statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include statements concerning the potential of VP-315, the Company’s research, development and regulatory plans for VP-315, the timing of the Company’s planned clinical trials for VP-315 and reporting data from the Company’s clinical trials, and the potential market size opportunity for the treatment of basal cell carcinoma. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug development process and the regulatory approval process, Verrica’s reliance on third parties over which it may not always have full control and uncertainties that are described in Vernica’s Annual Report on Form 10-K for the year ended December 31, 2023, Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 and other filings Verrica makes with the U.S. Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. FOR MORE INFORMATION, PLEASE CONTACT: info@verrica.com Investors: Kevin GardnerLifeSci Advisorskgardner@lifesciadvisors.com Chris CalabreseLifeSci Advisorsccalabrese@lifesciadvisors.com

临床结果临床2期引进/卖出免疫疗法上市批准

2024-12-20

·GlobeNewswire-Health Care

Verrica Provides Business and Operational Update

-- Dispensed applicator units in the fourth quarter of 2024 have exceeded the complete prior quarter even with significant cost reductions in sales and operational infrastructure -- Observed significant reduction in YCANTH distributor inventory levels -- New single applicator configuration for YCANTH® expected to be available in the first quarter of 2025 to help meet growing product demand, reduce acquisition costs for physician practices and expand distribution and patient access -- Continue to advance pipeline of product candidates in common warts and basal cell carcinoma WEST CHESTER, Pa., Dec. 20, 2024 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or the “Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced a business and operational update outlining the significant progress being made with respect to the new commercial strategy for YCANTH, Verrica’s lead product for the treatment of molluscum contagiosum (“molluscum”). “Over the last several weeks since our November common stock offering, we have made significant progress across a number of key initiatives to help drive demand for YCANTH,” said Jayson Rieger, PhD MBA, President and Chief Executive Officer of Verrica. “First and foremost, we are executing effectively on our previously announced commercial strategy for YCANTH, as evidenced by achievement of fourth quarter dispensed applicator units already surpassing dispensed applicator units in the prior quarter. We are growing the YCANTH business while implementing highly targeted cost management initiatives to prioritize spend that creates value and reducing or eliminating inefficient and unnecessary expenses. We are also pleased to note a significant reduction in YCANTH inventory levels from our distribution partners.” Dr. Rieger continued, “We are responding to the growing patient demand for YCANTH by increasing our distribution capabilities, making YCANTH available to more dermatologists and pediatricians through our previous distribution channels as well as through local independent pharmacies. Furthermore, we expect to provide a single applicator packaging configuration for YCANTH in the first quarter of 2025, which we anticipate will provide an added level of convenience for our independent and specialty pharmacy network. We also expect that the single applicator packaging will facilitate initial purchases of the product by health care providers who prefer same day treatment for patients by requiring significantly less cash outlay under our buy-and-bill distribution model. Finally, we expect this new packaging may increase patient access by providing added optionality to buying groups, hospitals and government entities for including YCANTH on formulary to service their patients. “As we enter 2025, we are excited about the opportunities that lie ahead for our company. As noted, we are already seeing favorable changes in the demand dynamics for YCANTH in response to our more focused and disciplined commercial strategy. Our recent financing also helped strengthen our balance sheet, while our ongoing efforts to improve Verrica’s operational efficiencies will help preserve our capital resources.” Dr. Rieger concluded, “We also believe that our pipeline opportunities provide a tremendous source of potential upside for our company. Together with our development partner, Torii Pharmaceutical, we continue to advance YCANTH (referred to as TO-208 in Japan) for the treatment of common warts, which represents the opportunity to address the single largest unmet medical need in dermatology. Additionally, encouraging preliminary data from our Phase 2 study suggests that our oncolytic peptide, VP-315, may have the potential to become a new and differentiated treatment approach for basal cell carcinoma. In summary, we have made significant progress over a short period of time, and Verrica is becoming a more focused and efficient commercial-stage company.” About YCANTH® (VP-102)YCANTH® is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin delivered via a single-use applicator that allows for precise topical dosing and targeted administration for the treatment of molluscum. YCANTH® is the first and only commercially available product approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. Approval of YCANTH® was based upon the positive results from two Phase 3 clinical trials in approximately 500 patients which demonstrated that YCANTH® was a safe and effective therapeutic for the treatment of molluscum. Approximately 228 million lives are eligible to receive YCANTH® covered by insurance. YCANTH® is available to all patients with and without insurance coverage for $25 per treatment, and further financial assistance is available for patients in need. Please visit YCANTHPro.com for additional information. YCANTH® should only be administered by a trained healthcare professional. YCANTH® is not for home use. About Verrica Pharmaceuticals Inc. Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica’s product YCANTH® (VP-102) (cantharidin), is the first and only commercially available treatment approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. YCANTH® (VP-102) is also in development to treat common warts and external genital warts, two of the largest remaining unmet needs in medical dermatology. Verrica is developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 (formerly LTX-315 and VP-LTX-315) for non-melanoma skin cancers including basal cell carcinoma and squamous cell carcinoma. For more information, visit www.verrica.com. Forward-Looking StatementsAny statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include statements about the availability of Verrica’s single applicator packaging configuration and the benefits of such configuration, the commercialization of YCANTH, cost management initiatives and preservation of capital resources, and the clinical development and benefits of Verrica’s product candidates, including YCANTH (VP-102). These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include risks and uncertainties related to market conditions, satisfaction of customary closing conditions related to the proposed public offering and other risks and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2023, Verrica’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 and other filings Verrica makes with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. FOR MORE INFORMATION, PLEASE CONTACT: Investors: Kevin Gardner LifeSci Advisors kgardner@lifesciadvisors.com Chris Calabrese LifeSci Advisors ccalabrese@lifesciadvisors.com

临床3期引进/卖出临床2期上市批准

100 项与鲁特米肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB12748

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
转移性黑色素瘤	临床2期	挪威	Lytix Biopharma AS	2024-11-01
基底细胞癌	临床2期	美国	Verrica Pharmaceuticals, Inc.	2022-02-01
皮肤肿瘤	临床2期	美国	Verrica Pharmaceuticals, Inc.	2022-02-01
局部晚期黑色素瘤	临床2期	美国	Lytix Biopharma AS	2021-06-01
局部晚期黑色素瘤	临床2期	法国	Lytix Biopharma AS	2021-06-01
局部晚期黑色素瘤	临床2期	挪威	Lytix Biopharma AS	2021-06-01
局部晚期黑色素瘤	临床2期	西班牙	Lytix Biopharma AS	2021-06-01
不可切除的黑色素瘤	临床2期	美国	Lytix Biopharma AS	2021-06-01
不可切除的黑色素瘤	临床2期	法国	Lytix Biopharma AS	2021-06-01
不可切除的黑色素瘤	临床2期	挪威	Lytix Biopharma AS	2021-06-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05188729 (Company_Website) 人工标引	临床2期	基底细胞癌	82	VP-315	顧廠鏇網糧衊醖顧淵製(膚構膚鹽壓蓋鏇獵齋蓋) = None 鏇廠衊範鏇鏇膚廠築膚 (糧衊鏇製鹽鹹壓顧蓋網 )	积极	2025-01-21
NCT03725605 (Pubmed \| Oncoimmunology)	临床2期	转移性软组织肉瘤 tumor-infiltrating lymphocytes \| neoantigens	6	LTX-315	鏇築積鏇積憲蓋鏇繭糧(糧願遞觸醖襯繭鑰襯鑰) = only expected and manageable toxicity 衊願艱艱簾淵築遞鑰鑰 (獵蓋鏇餘構憲繭窪獵廠 ) 更多	积极	2024-12-31
NCT05188729 (GlobeNewswire) 人工标引	临床2期	基底细胞癌	93	VP-315	艱醖鏇窪遞壓觸網糧觸(鬱衊築餘窪鬱鏇憲鹽選) = 遞窪廠範蓋築觸醖願艱製壓衊築鏇範築襯醖襯 (窪餘遞壓觸積醖選壓鹽 ) 更多	积极	2024-08-14
NCT03725605 (NCT03725605 \| ATLAS-IT-04 \| ###DELETE, CTgov)	临床2期	转移性软组织肉瘤	6	LTX-315 and TILs	蓋選遞鑰願積積醖構鑰(艱壓製鏇鏇廠艱獵壓網) = 壓廠憲艱蓋夢蓋壓夢夢鏇構觸艱製淵鹽淵衊鬱 (淵窪構範膚餘窪構壓餘, 醖淵醖簾鹽蓋憲製窪選 ~ 襯範齋窪製鹽艱繭壓淵) 更多	-	2023-11-08
NCT04796194 (ATLAS-IT-05, ESMO 12023 \| ESMO 22023) 人工标引	临床2期	黑色素瘤	14	LTX-315+pembrolizumab	鏇淵獵簾醖鏇醖簾夢遞(艱醖醖遞蓋鹹鬱窪製齋) = 憲壓簾積襯餘顧繭餘衊糧淵範觸鹽構築積鹽鹹 (積餘願積積醖網製網觸 ) 更多	积极	2023-10-23
NCT03725605 (ATLAS-IT-04, ASCO2022) 人工标引	临床2期	转移性软组织肉瘤	6	LTX-315	淵餘網齋淵鹽餘壓餘廠(餘衊繭範蓋窪淵製糧鏇) = 網餘襯餘製鬱構壓鹹構繭齋簾獵鏇鹽艱網鹹衊 (餘願艱鹽醖觸鹽觸願選 )	积极	2022-06-02
NCT01986426 (Pubmed \| Clin Cancer Res)	临床1期	实体瘤	-	LTX-315	選顧襯艱網餘廠簾窪簾(鏇鏇鹹獵獵蓋膚糧製構) = 範艱獵獵範製衊網夢顧願餘遞積遞鬱淵繭遞襯 (餘鹹襯網鬱築膚醖鏇憲 )	-	2021-02-04
NCT01986426 (AACR2019) 人工标引	临床1期	局部晚期黑色素瘤	27	LTX-315	鹽壓餘構淵鹹膚網願鑰(襯餘鬱鑰夢鹽窪鏇衊憲) = None 築遞網積網衊衊範淵網 (鏇構壓蓋積構膚鏇夢襯 ) 更多	积极	2019-07-01
NCT01986426 (ASCO 12018 \| ASCO 22018) 人工标引	临床1/2期	HR阳性/HER2低表达实体瘤	59	LTX-315	艱夢鬱製醖窪網顧繭夢(窪蓋製網願範繭鏇顧醖) = 蓋簾餘選衊繭淵壓窪壓鹹夢範鏇齋遞艱窪網積 (觸鬱構觸網廠簾醖鬱遞 ) 更多	积极	2018-06-04
NCT01986426 (ASCO 12018 \| ASCO 22018) 人工标引	临床1/2期	HR阳性/HER2低表达实体瘤	59	pembrolizumab+LTX-315 (TNBC)	憲築獵衊鹹夢衊憲襯蓋(廠繭範選鏇鬱顧蓋築膚) = 願簾觸構鬱築襯鑰餘顧遞顧衊願憲鑰夢製鑰醖 (憲觸齋艱鹹糧膚遞襯獵 ) 更多	积极	2018-06-04