Open Label Randomized Clinical Study of Plasmid Encoding p62/SQSTM1 (ELenagen) in in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer

Phase II, two arm prospective study of efficacy and safety of ELENAGEN in combination with gemcitabine in comparison with gemcitabine alone in patients with platinum-resistant ovarian cancer.

Start Date15 Nov 2019

Sponsor / Collaborator

CureLab Oncology, Inc.

100 Clinical Results associated with Elenagen

100 Translational Medicine associated with Elenagen

100 Patents (Medical) associated with Elenagen

Literatures (Medical) associated with Elenagen

21 Jan 2020·Oncotarget

Response of a chemo-resistant triple-negative breast cancer patient to a combination of p62-encoding plasmid, Elenagen, and CMF chemotherapy

Article

Author: Gabai, Vladimir L. ; Sufianov, Albert A. ; Kolesnikov, Sergey I. ; Ponomarenko, Dmitry M. ; Shneider, Alexander M.

Triple-negative breast cancers are often characterized by aggressive behavior and short clinical course once they become chemotherapy-resistant. We describe below a patient who has shown a response to combination of chemotherapy with Elenagen, a plasmid encoding p62. Elenagen was tested in a previous phase I/II study in patients with refractory solid tumors and shown to be safe. Also, plasmid ability to halt tumor progression and restore sensitivity to chemotherapy was found. Preclinical data supports effects on tumor grade and change the tumor's microenvironment in spontaneous canine breast cancers. We describe here a 48-year old female with triple-negative and BRCA1/2-negative breast cancer who had a primary resistance to chemotherapy and negative dynamics despite the use of multiple lines of treatments. Elenagen was applied intramuscularly at a dose of 1 mg weekly in combination with standard chemotherapy scheme CMF (cyclophosphamide, methotrexate, fluorouracil). In this patient we observed partial tumor regression (by 33%) and 19 weeks of progression-free survival. This first observed objective response to a combination of Elenagen with chemotherapy demonstrates that even in heavily pretreated chemo-resistant triple-negative tumor, the addition of Elenagen to a chemotherapy regimen can cause an objective response and increase in progression-free survival. Such a regimen is worthy of further study in a larger number of patients.

28 Aug 2018·AgingQ3 · MEDICINE

p62 /SQSTM1 coding plasmid prevents age related macular degeneration in a rat model

Q3 · MEDICINE

Article

Author: Kolosova, Nataliya G. ; Kolesnikov, Sergey I. ; Fursova, Anzhela Zh. ; Sherman, Michael Y. ; Sufianov, Albert A. ; Kozhevnikova, Oyuna S. ; Stefanova, Natalia A. ; Venanzi, Franco ; Muraleva, Natalia A. ; Telegina, Darya V. ; Shneider, Alexander M. ; Gabai, Vladimir L.

P62/SQSTM1, a multi-domain protein that regulates inflammation, apoptosis, and autophagy, has been linked to age-related pathologies. For example, previously we demonstrated that administration of p62/SQSTM1-encoding plasmid reduced chronic inflammation and alleviated osteoporosis and metabolic syndrome in animal models. Herein, we built upon these findings to investigate effect of the p62-encoding plasmid on an age-related macular degeneration (AMD), a progressive neurodegenerative ocular disease, using spontaneous retinopathy in senescence-accelerated OXYS rats as a model. Overall, the p62DNA decreased the incidence and severity of retinopathy. In retinal pigment epithelium (RPE), p62DNA administration slowed down development of the destructive alterations of RPE cells, including loss of regular hexagonal shape, hypertrophy, and multinucleation. In neuroretina, p62DNA prevented gliosis, retinal thinning, and significantly inhibited microglia/macrophages migration to the outer retina, prohibiting their subretinal accumulation. Taken together, our results suggest that the p62DNA has a strong retinoprotective effect in AMD.

08 Aug 2017·Oncotarget

Safety and efficacy of p62 DNA vaccine ELENAGEN in a first-in-human trial in patients with advanced solid tumors

Article

Author: Manikhas, Georgy M. ; Grudinin, Mikhail P. ; Zyryanov, Alexandr V. ; Chursov, Andrey ; Sufianov, Albert A. ; Tsyb, Anatoly F. ; Kolesnikov, Sergei I. ; Orlova, Rashida V. ; Orlov, Sergei V. ; Klimova, Irina D. ; Burkhanova, Lilya A. ; Oshchepkov, Basile N. ; Shneider, Alexander M. ; Ponomarenko, Dmitry M. ; Komissarov, Andrey B. ; Badrtdinova, Irina I. ; Shcherbinina, Vita ; Venanzi, Franco ; Zaitzeva, Olga Y. ; Zhukova, Natalia V. ; Baum, Svetlana R. ; Filippova, Elena V. ; Dvornichenko, Viktoria V. ; Gabai, Vladimir L. ; Chapygina, Yulia A. ; Kiselev, Oleg I.

Elenagen is a plasmid encoding p62/SQSTM1, the first DNA vaccine possessing two mutually complementing mechanisms of action: it elicits immune response against p62 and mitigates systemic chronic inflammation. Previously, Elenagen demonstrated anti-tumor efficacy and safety in rodent tumor models and spontaneous tumors in dogs. This multicenter I/IIa trial evaluated safety and clinical activity of Elenagen in patients with advanced solid tumors. Fifteen patients were treated with escalating doses of Elenagen (1- 5 mg per doses, 5 times weekly) and additional 12 patients received 1 mg dose. Ten patients with breast and ovary cancers that progressed after Elenagen were then treated with conventional chemotherapy. Adverse events (AE) were of Grade 1; no severe AE were observed. Cumulatively twelve patients (44%) with breast, ovary, lung, renal cancer and melanoma achieved stable disease for at least 8 wks, with 4 of them (15%) had tumor control for more than 24 wks, with a maximum of 32 wks. The patients with breast and ovary cancers achieved additional tumor stabilization for 12-28 wks when treated with chemotherapy following Elenagen treatment. Therefore, Elenagen demonstrated good safety profile and antitumor activity in advanced solid tumors. Especially encouraging is its ability to restore tumor sensitivity to chemotherapy.

News (Medical) associated with Elenagen

14 Nov 2024

·www.prnewswire.com

CureLab Oncology Seeks to Revolutionize Chronic Pain Management with Novel p62-Based Therapy

Patent application paves the way for a potential breakthrough in chronic pain treatment, offering renewed hope for millions BOSTON, Nov. 14, 2024 /PRNewswire/ -- CureLab Oncology, a clinical-stage biotech company dedicated to pioneering innovative therapies, announced a patent application for an innovative chronic pain treatment centered on its p62/SQSTM1 DNA plasmid. This development, which leverages CureLab's chronic inflammation therapeutic, Elenagen™, signifies a potential paradigm shift in addressing chronic pain, a pervasive health challenge that affects millions globally. Continue Reading With this patent, CureLab Oncology positions its lead therapeutic, Elenagen™, to address the limitations of existing chronic pain treatments, such as NSAIDs (nonsteroidal anti-inflammatory drugs), acetaminophen, COX-2 inhibitors, antidepressants, anti-seizure medications, and opioids. With this patent, CureLab Oncology aims to address the limitations of existing chronic pain treatments, such as NSAIDs (nonsteroidal anti-inflammatory drugs), acetaminophen, COX-2 inhibitors, antidepressants, anti-seizure medications, and opioids. While these medications offer varying degrees of pain relief, they often come with a range of side effects, including gastrointestinal problems, kidney problems, stomach bleeding, ulcers, dizziness, drowsiness, nausea, and potential addiction. The patent emphasizes the urgent need for more effective chronic pain medications with fewer side effects. The patent application encompasses the utilization of p62/SQSTM1 DNA to combat a wide spectrum of chronic pain conditions, including arthritis, back pain, headaches, cancer pain, neuropathic pain, and fibromyalgia. This therapeutic strategy operates by modulating the body's inflammatory response, a critical factor in the development and persistence of chronic pain. "Chronic pain often stems from persistent inflammation, a complex biological response that can disrupt the body's natural healing processes," explained Dr. Alexander Shneider, CEO of CureLab Oncology. "Elenagen, our innovative p62-based therapy, targets this underlying inflammation, promoting resolution and potentially alleviating pain at its source." This groundbreaking therapy holds immense promise for both humans and animals suffering from chronic pain. Preclinical investigations employing animal models have illuminated the efficacy of this therapy in mitigating pain severity and augmenting the quality of life. Notably, the therapy exhibits a favorable safety profile, with no substantial adverse effects detected in the studies. The global chronic pain treatment market is expected to reach $131.4 billion by 2030, growing at a compound annual growth rate (CAGR) of 4.3% from 2023 to 2030. This growth is driven by the increasing prevalence of chronic pain, the aging population, and the rising demand for effective and non-addictive pain management options. With its potential for fewer side effects and broader applications compared to current treatments, CureLab's p62-based therapy is positioned to meet the growing demand of the growing chronic pain market. "Our patenting strategy for this chronic pain treatment aligns with our successful approach for other therapies," said Ilya Lapshin, general counsel for CureLab Oncology. "By initially filing a provisional patent application in the USA and subsequently seeking worldwide protection, we aim to secure comprehensive intellectual property rights for this groundbreaking innovation." To see CureLab's portfolio of patents, visit curelaboncology.com/ip and curelabveterinary.com/ip. About Elenagen CureLab's lead investigational compound is code-named Elenagen, an experimental DNA therapy that consists of a circular piece of DNA called a plasmid that includes a gene for a human protein called p62/SQSTM1. In clinical studies conducted ex-US, Elenagen demonstrated desirable safety profile and statistically significant clinical benefit for cancer patients enhancing the anti-cancer effects of chemotherapy. Experimental results also demonstrate mitigation of chronic inflammation, anti-aging effects, and stimulation of an immune response to the tumor. About CureLab Oncology CureLab Oncology Inc. is a pre-IPO, clinical-stage biotech company headquartered in the greater Boston area, Massachusetts. CureLab is dedicated to advancing new and safer therapeutics for solid tumors and other oncology and inflammatory indications. To learn more, visit curelab.com. Media contact: Tim Cox, ZingPR, [email protected] SOURCE CureLab Oncology Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

01 Jul 2024

·www.curelaboncology.com

Digital Journal highlights CureLab Oncology's innovative approach with Elenagen

In the article "New Anti-Cancer Drug Works in Unexpected Ways," Digital Journal explores CureLab Oncology's development of Elenagen, a plasmid DNA therapy delivering the p62 gene. Contrary to initial assumptions that Elenagen functions by increasing p62 levels in recipient cells, the research reveals it reprograms aged, pro-inflammatory stem cells to adopt characteristics of youthful, anti-inflammatory ones. This reprogramming leads to the secretion of long-lasting signals that mimic Elenagen's effects, offering potential treatments for conditions beyond cancer, such as osteoporosis and metabolic disorders. Digital Journal is a respected platform covering advancements in science and technology. Its feature on Elenagen explains the innovative nature of CureLab Oncology's research and its potential to revolutionize treatments for various diseases. The article highlights the company's commitment to exploring novel therapeutic pathways, positioning CureLab Oncology at the forefront of medical innovation.

Clinical Study

27 Jun 2024

·www.prnewswire.com

CureLab Oncology Files Patent Application for Groundbreaking Wound-Healing Therapy

Novel p62-based treatment accelerates wound healing and reduces complications BOSTON, June 27, 2024 /PRNewswire/ -- CureLab Oncology, a clinical-stage biotech company, has filed a patent application with worldwide potential for a revolutionary wound-healing therapy based on its p62/SQSTM1 DNA plasmid. This innovative approach, leveraging CureLab's chronic inflammation therapeutic, Elenagen™, addresses a critical unmet need in the treatment of both acute and chronic wounds. The therapy offers the potential to significantly improve patient outcomes, reduce healthcare costs, and transform the standard of care in this field. The patented therapy leverages the unique properties of the p62 plasmid to accelerate the natural healing process, reduce inflammation, and prevent complications such as sepsis, infection, tissue necrosis, and scarring. Preclinical studies in animal models have demonstrated the therapy's effectiveness in a variety of wound types, including cuts, burns, diabetic ulcers, and pressure sores. "This patent application is a major milestone for CureLab Oncology and underscores our commitment to developing innovative therapies that address significant medical challenges," said Alexander Shneider, Ph.D., CEO of CureLab Oncology. "Chronic and acute wounds affect millions of people worldwide, and our p62-based therapy has the potential to revolutionize how we treat these debilitating conditions." The global wound care market is projected to reach USD 37.08 billion by 2032, growing at a compound annual growth rate (CAGR) of 7.5% from 2024 to 2032. This growth is fueled by the rising prevalence of chronic diseases like diabetes, an aging population, and advancements in wound care technologies. "Our patenting strategy for this wound-healing product mirrors our successful approach with other therapies," said Ilya Lapshin, general counsel for CureLab Oncology. "By initially filing a provisional patent application in the USA and subsequently seeking worldwide protection, we aim to secure comprehensive intellectual property rights for this groundbreaking innovation." About Elenagen CureLab's lead investigational compound is code-named Elenagen, an experimental DNA therapy that consists of a circular piece of DNA called a plasmid that includes a gene for a human protein called p62/SQSTM1. In clinical studies conducted ex-US, Elenagen demonstrated desirable safety profile and statistically significant clinical benefit for cancer patients enhancing the anti-cancer effects of chemotherapy. Experimental results also demonstrate mitigation of chronic inflammation, anti-aging effects, and stimulation of an immune response to the tumor. About CureLab Oncology CureLab Oncology Inc. is a pre-IPO, clinical-stage biotech company headquartered in the greater Boston area, Massachusetts. CureLab is dedicated to advancing new and safer therapeutics for solid tumors and other oncology and inflammatory indications. To learn more, visit curelab.com. Media contact: Tim Cox, ZingPR, [email protected] SOURCE CureLab Oncology Inc.

100 Deals associated with Elenagen

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Platinum-Resistant Ovarian Carcinoma	Phase 2	Belarus	CureLab Oncology, Inc.	15 Nov 2019
Solid tumor	Phase 2	Russia	CureLab Oncology, Inc.	10 Sep 2014
Neoplasms	Phase 2	-	CureLab Oncology, Inc.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05979298 (Pubmed \| Front Oncol)	Phase 3	Platinum-Resistant Ovarian Carcinoma Adjuvant CA125	-	Gemcitabine	ytrvnnivtf(yxwhwavfoj) = kogswysoan ixofxovvge (rswthqztfb )	Positive	12 Feb 2024
				Elenagen + Gemcitabine	ytrvnnivtf(yxwhwavfoj) = ocuubjluse ixofxovvge (rswthqztfb )
ESMO2022 Manual	Not Applicable	Platinum-Resistant Ovarian Carcinoma Adjuvant	40	p62-plasmid+Gemcitabine	nxdbscngov(qbkvcscccd) = No Grade 3-4 toxicities were observed in both arms scycxepeze (gbxthcgcqd ) View more	Positive	10 Sep 2022
				Gemcitabine

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