Traditional B-cell mitogens often fail to promote effective cell division in vitro for mature B-cell neoplasms, hindering chromosome analysis. The combination of DSP30 and IL-2 (DSP30/IL-2) has been suggested as a better alternative. This review evaluates DSP30/IL-2 efficiency using a systematic review and meta-analysis of 20 studies. Studies comparing the successful culture rate (SCR) and/or abnormalities detection rate (ADR) of DSP30/IL-2 against traditional mitogens and/or fluorescence in situ hybridization (FISH) were included. Subgroup analyses were performed for cases of chronic lymphocytic leukemia (CCL) and other B-cell neoplasms (OBCN). The findings show no significant difference in SCR between DSP30/IL-2 and traditional mitogens, but DSP30/IL-2 significantly increases ADR. However, DSP30/IL-2's ADR is lower than that of FISH. Analyses by CLL and OBCN subgroups showed similar results. Overall, DSP30/IL-2 is a superior alternative for cytogenetic studies in mature B-cell neoplasms.

16 Mar 2025·Journal of the advanced practitioner in oncology

Tumor-Infiltrating Lymphocyte Cell Therapy for the Treatment of Advanced Melanoma: From Patient Identification to Posttreatment Management

Review

Author: Joseph, Jannakie ; Swank, Jennifer ; Prieto, Peter A ; Harding, Susan ; Ranjan, Smita ; Rodriguez, Emily Webb ; Mcintyre, Lori ; Gray, Lissa ; Kottschade, Lisa

Adoptive cell therapy with tumor-infiltrating lymphocytes (TILs) was recently approved for patients with advanced melanoma (metastatic or unresectable) previously treated with immune checkpoint inhibitors and BRAF/MEK targeted therapies (where appropriate). Tumor-infiltrating lymphocytes isolated from patient-derived tumor tissues enter the tumor microenvironment and recognize tumor-specific antigens, leading to the destruction of tumor cells. The multistep TIL cell therapy journey is led by a multidisciplinary health care team. Patients selected for TIL cell therapy undergo tumor tissue procurement for TIL generation, followed by preparative lymphodepletion before receiving a single-dose infusion of TIL and a short course of high-dose interleukin-2. Successful implementation of TIL cell therapy requires well-established procedures and workflows to select and screen patients, procure tumor tissue, administer TIL cell therapy, and monitor patients during treatment and after discharge. The advanced practice provider plays a central role in a patient’s TIL treatment journey by planning and coordinating care across the health-care system, educating patients and staff, and providing direct and supportive patient care. Here, we review the treatment landscape for advanced melanoma and clinical data supporting TIL cell therapy. We also provide guidance related to patient selection, tumor tissue procurement, TIL cell therapy regimen, safety monitoring, symptom management, and post-discharge follow-up.

01 Sep 2024·BIOMATERIALS

Engineered probiotics with sustained release of interleukin-2 for the treatment of inflammatory bowel disease after oral delivery

Article

Author: Liu, Yi ; Niu, Le ; Yang, Yang ; Chen, Qian ; Zhu, Jiafei ; Chen, Linfu ; Bai, Boxiong ; Liu, Nanhui ; Wu, Yumin ; Miao, Yu ; Li, Maoyi

Inflammatory bowel disease (IBD) is a kind of auto-immune disease characterized by disrupted intestinal barrier and mucosal epithelium, imbalanced gut microbiome and deregulated immune responses. Therefore, the restoration of immune equilibrium and gut microbiota could potentially serve as a hopeful approach for treating IBD. Herein, the oral probiotic Escherichia coli Nissle 1917 (ECN) was genetically engineered to express secretable interleukin-2 (IL-2), a kind of immunomodulatory agent, for the treatment of IBD. In our design, probiotic itself has the ability to regulate the gut microenvironment and IL-2 at low dose could selectively promote the generation of regulatory T cells to elicit tolerogenic immune responses. To improve the bioavailability of ECN expressing IL-2 (ECN-IL2) in the gastrointestinal tract, enteric coating Eudragit L100-55 was used to coat ECN-IL2, achieving significantly enhanced accumulation of engineered probiotics in the intestine. More importantly, L100-55 coated ECN-IL2 could effectively activated Treg cells to regulate innate immune responses and gut microbiota, thereby relieve inflammation and repair the colon epithelial barrier in dextran sodium sulfate (DSS) induced IBD. Therefore, genetically and chemically modified probiotics with excellent biocompatibility and efficiency in regulating intestinal microflora and intestinal inflammation show great potential for IBD treatment in the future.

News (Medical) associated with Interleukin-2(Sanofi)

21 Apr 2025

·pipelinereview.com

Coya Therapeutics Announces Publication of GLP-1/LD IL-2 Combination Biologic (COYA 303) Demonstrating Synergistic Enhancement of Regulatory T Cell Function and Protection Against Treg Apoptosis (Cell Death)

COYA 303 is an investigational biologic combination of COYA 301, Coya’s low-dose interleukin 2 (LD IL-2) and a GLP-1 receptor agonist (GLP-1RA), designed to deliver a multi-targeted immunomodulatory therapeutic in autoimmune and neurodegenerative diseases COYA 303 produced a statistically significantly higher Treg suppressive effect on pro-inflammatory myeloid cells and enhanced Treg survival in in vitro human immune cells, compared to the individual components – LD IL-2 and GLP-1RA HOUSTON, TX, USA I April 21, 2025 I Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, today announced publication of the results of a study designed to evaluate the effects of COYA 303 (LD IL-2 and GLP-1RA), Coya’s investigational biologic combination to suppress pro-inflammatory myeloid cells, enhance Treg suppressive function, and modulate T cell proliferation, in an in vitro system of human immune cells obtained from healthy donors. The research was conducted at the Houston Methodist Research Institute and was led by Dr. Aaron Thome and Dr. Stan Appel. The research article has been published in the Journal NeuroImmune Pharmacology and Therapeutics and can be accessed here . Dr. Arun Swaminathan, Coya’s Chief Executive Officer, stated, “We believe COYA 303 could offer a differentiated and synergistic approach to addressing multiple conditions, including in neurodegenerative conditions such as Alzheimer’s Disease, in which GLP-1 RAs have recently shown promise. We believe the potential of this proprietary combination could lead to value-creating opportunities and may open up a new avenue of research within the GLP-1RA drug class.” LD IL-2 preferentially binds the IL-2 receptor alpha, which is predominantly expressed on Tregs to enhance their anti-inflammatory suppressive function. Treg dysfunction has been well documented in several autoimmune and neurodegenerative diseases characterized by persistent inflammation. GLP-1RAs also exhibit several immune-modulating effects, with myeloid cells and regulatory subsets, such as Tregs, expressing a large concentration of GLP-1 receptors. Although increased Treg numbers and enhanced suppressive function are seen with LD IL-2 treatment, their longevity and suppressive function can be limited by the effects of pronounced and sustained inflammatory environments. Therefore, a combination therapy approach that dampens the inflammatory microenvironment while enhancing Treg survival and function may provide synergistic anti-inflammatory therapeutic effects. Dr. Fred Grossman, Coya’s Chief Medical Officer commented, “ We believe the encouraging results of this study provide support for our multi-targeted combination approach as a potentially viable treatment option for serious and life-threatening conditions of high unmet need driven by chronic inflammation and Treg dysfunction, for which currently available treatments provide limited benefits.” Summary of Study Results Following pro-inflammatory activation of myeloid cells co-cultured with Tregs, the addition of COYA 301 (LD IL-2) alone enhanced Treg suppressive function by 15%. Similarly, when GLP-1RA alone was added to the system, Treg suppressive function increased by 20%. In contrast, when COYA 303 was added to the cell system a statistically significant increase in Treg suppressive function of 42% (p < 0.001) was observed, when compared to the increase observed with each of the single agents. Consistent with these results, treatment with COYA 303 promoted Treg survival by modulating the apoptotic pathway. COYA 303 significantly reduced BAX transcript levels during prolonged incubation (p < 0.01). These findings suggest a direct effect of COYA 303 supporting Treg survival through the inhibition of Treg apoptosis. These data show that the combination approach of COYA 303 enhances Treg suppressive function in highly inflammatory microenvironments, while also promoting Treg survival by preventing apoptosis. Additional details and results of the research study can be found here . About Coya Therapeutics, Inc. Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions, including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system. Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. For more information about Coya, please visit www.coyatherapeutics.com SOURCE: Coya Therapeutics

Clinical ResultImmunotherapyCell Therapy

10 Apr 2024

·www.fiercebiotech.com

AACR: Synthekine hopes new IL-2 will be the high-alpha in a beta class

Responding to some of the challenges of its peers, Synthekine built a molecule called an IL-2 alpha/beta, dubbed STK-012. IL-2 medicines have shown the ability to kill tumors. Unfortunately, they aren’t very specific and have come to be associated with toxicities. Synthekine is hoping to avoid activating lymphocytes such as natural killer cells that can cause these issues, creating a safer and more tolerable medicine. That’s what early data from a phase 1a/1b trial of STK-012 seem to show, CEO Debanjan Ray told Fierce Biotech on the sidelines of the American Association for Cancer Research annual meeting Monday. The results are very early, with just a handful of partial responses. And Ray is well aware of the struggles of other IL-2s in the clinic—see Sanofi’s many challenges with the target. Responding to some of the hurdles faced by his peers, Ray said that with STK-012, Synthekine has built a molecule called an IL-2 alpha/beta that is meant to stimulate CD25+ antigen-activated T cells but avoid the same reaction with the NK cells that can drive toxicity in IL-2 meds. The early-stage trial tested the med in 47 patients with advanced solid tumors including non-small cell lung cancer, renal cell carcinoma and ovarian cancer. Most of the patients had three or more lines of therapy prior to entering the trial, which tested seven dose levels on two dosing schedules. Of the 40 evaluable patients, three had a partial response as of data cutoff and 12 had stable disease. In a group of 15 patients who had not previously responded to immune checkpoint inhibitors and were minimally pretreated, three had a best overall response of partial response and six had stable disease. “The promise of IL-2 in the treatment of solid tumors has yet to be realized as IL-2 analogues developed to date have had limited efficacy and an unacceptable toxicity profile,” said Naiyer Rizvi, M.D., Synthekine’s chief medical officer, in a Tuesday statement. The therapy was associated with favorable safety, pharmacokinetics and pharmacodynamics, with a profile that was different from aldesleukin and non-alpha IL-2 analogues. The early data suggest that STK-012 is selective for T cells that express CD25. Ray also noted that the response was durable in multiple subjects, with some continuing to benefit for as much as a year after the data cutoff. Synthekine’s presentation included one patient case study of a 72-year-old female who had stage 4 clear cell renal cell carcinoma and had previously had two prior lines of therapy. The patient had “innumerable lung metastases and a large primary renal mass.” At Week 12, the photos show a reduction in tumors. “You don't need to be a radiologist to really see this difference,” Ray said. Synthekine has selected the every-three-weeks schedule to go forward. Ray said next steps include focusing on the ongoing dose expansion, monotherapy arm including one cohort focusing on renal cancer. While early, Synthekine’s work has attracted some Big Pharma partners, including Sanofi. The French pharma signed a $40 million deal with Synthekine in January to work on IL-10 receptor agonists designed to treat inflammatory diseases. Merck & Co. has also linked up with the biotech but for autoimmune diseases, signing a deal that could be worth up to $525 million in biobucks in November 2021. Editor's note: This story was updated at 5 p.m. ET to clarify details about the dose expansion and Synthekine's partnership with Sanofi.

AACR

28 Dec 2023

·www.globenewswire.com

Iovance Biotherapeutics Announces Clinical Program Update for LN-145 in Non-Small Cell Lung Cancer

Dec. 27, 2023 -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced a clinical program update for LN-145 TIL therapy in non-small lung cancer (NSCLC). The U.S. Food and Drug Administration (FDA) placed a clinical hold on the IOV-LUN-202 trial on December 22, 2023, in response to a recently reported Grade 5 (fatal) serious adverse event potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen. IOV-LUN-202 is investigating LN-145 in patients who have progressed on or after chemotherapy and anti-PD-1 therapy for advanced (unresectable or metastatic) non-small cell lung cancer (NSCLC) without EGFR, ROS or ALK genomic mutations and had received at least one line of an FDA-approved targeted therapy if indicated by other actionable tumor mutations. These patients have a poor prognosis, limited treatment options, and a real-world overall survival of less than six months.1 The clinical hold for IOV-LUN-202 has no impact on any other Iovance clinical trials and is independent of the FDA’s Priority Review of the biologics license application (BLA) for lifileucel in advanced melanoma. The BLA remains on track toward the Prescription Drug User Fee Act (PDUFA) action date of February 24, 2024. Iovance will pause enrollment and the LN-145 TIL treatment regimen for new patients in IOV-LUN-202 during the clinical hold. Patients previously treated with LN-145 in the IOV-LUN-202 trial will continue to be monitored and followed according to the trial protocol. Patients who have already undergone tumor resection will continue to receive the LN-145 TIL treatment regimen with additional precautions and risk mitigations. Preliminary data for IOV-LUN-202 was reported in July of 2023. An updated analysis in November of 2023 showed additional ongoing responses and duration of response greater than six months for 71% of the confirmed responders in the trial. These results from IOV-LUN-202 in previously treated patients with advanced NSCLC continue to support the potential benefit of one-time TIL therapy, including the opportunity for more durable responses than available second line chemotherapies. Iovance is committed to bringing TIL therapy to patients with NSCLC and to continuing activities that support regulatory approval in this indication. Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, “Iovance remains dedicated to addressing a significant unmet medical need for patients with advanced NSCLC, who have poor prognosis following disease progression and limited treatment options. We will work with the FDA to safely resume enrollment in the IOV-LUN-202 trial as soon as possible.” More than 700 patients have been treated with Iovance TIL therapies across multicenter clinical trials in solid tumor cancers, including more than 100 patients treated with LN-145 for lung cancer. In clinical trial results reported to date, treatment-emergent adverse events were consistent with the underlying disease and known adverse event profiles of non-myeloablative lymphodepletion and interleukin-2. 1National Cancer Database, NSCLC survival from >1 million patients assessed. Lou Y et al. Survival trends among non-small-cell lung cancer patients over a decade: impact of initial therapy at academic centers. Cancer Med. 2018. Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. Our lead late-stage TIL product candidate, lifileucel for metastatic melanoma, has the potential to become the first approved one-time cell therapy for a solid tumor cancer. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com. The content above comes from the network. if any infringement, please contact us to modify.

Priority ReviewClinical Result

100 Deals associated with Interleukin-2(Sanofi)

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 3	-	Sanofi	-
Neoplasms	Phase 3	-	Transgene SA	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AUA2014	Not Applicable	Metastatic Renal Cell Carcinoma	5,341	IL-2 therapy	badcalneuw(ckthwiapwy) = nuvjelchom qpllvvnznf (dwytfhlxed )	-	01 Apr 2014
IAS2003	Not Applicable	-	17	HAART interruption	jvjmeuieqn(bmvcwkexej) = wgamxxrmcm garucwitsz (pzdwomzhaz )	-	01 Jan 2003
				HAART continuation	jvjmeuieqn(bmvcwkexej) = nxdaadkiac garucwitsz (pzdwomzhaz )
UK Vanguard (IAS2001)	Not Applicable	HIV Infections	5	IL-2 therapy (4.5 MU)	uyrcnesice(khldiojbek) = wktzqypdrd jybmbxsbfe (hmymsqsqgq )	-	01 Jan 2001
				IL-2 therapy (7.5 MU)	uyrcnesice(khldiojbek) = qrvvvrudka jybmbxsbfe (hmymsqsqgq )

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