Delving into the Latest Updates on Molgramostim biosimilar(Reliance GeneMedix Ltd.) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Colony-stimulating factors

Synonyms

GM-CSF, Molgramostim biosimilar, Neustim

Target

CSF-2R

Action

stimulants

Mechanism

CSF-2R stimulants(Granulocyte-macrophage colony-stimulating factor receptor stimulants)

Therapeutic Areas

Hemic and Lymphatic Diseases

Active Indication

Neutropenia

Inactive Indication-

Originator Organization

Reliance GeneMedix Ltd.

Active Organization

Reliance GeneMedix Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 1191632844

The sequence is quoted from: *****

Arginine vasopressin (AVP) has disparate impacts on immune responses by divergent receptors on cells including DCs. This study was conducted with the aim of investigating the impact of AVP on the maturation and expression of the inhibitory immune checkpoint molecules in tolerogenic monocyte-derived DCs. CD14 marker was used to separate monocytes from peripheral blood mononuclear cells (PBMCs) by MACS method. To differentiate monocytes from DCs, we utilized GM-CSF and IL-4 cytokines. Tolerogenic DCs were generated using vitamin D3 and dexamethasone. We added LPS and AVP to the culture medium on day 6 after incubation of DCs at 37 °C. Finally, we assessed the surface molecules by flow cytometry and used real-time PCR to evaluate the expression of genes related to the inhibitory immune checkpoints. Based on the obtained data, AVP increased the expression of CD11c (P ≤ 0.0001), HLA-DR (P ≤ 0.01), and CD86 (P ≤ 0.01) in AVP-mDCs. Also, the expression of all the immune checkpoint genes including CTLA-4 (P ≤ 0.001), BTLA (P ≤ 0.001), PDL-1 (P ≤ 0.05), B7H7 (P ≤ 0.001), LAG3 (P ≤ 0.01), and VISTA (P ≤ 0.001) in AVP-mDCs was increased in comparison to the control group. Vasopressin caused the generation of mature and tolerogenic DCs. Our data may help to consider AVP-mDCs to take part in autoimmune disease therapy, transplanted tissue rejection impedance, and allergies.

01 Dec 2025·Immunologic Research

RAD001-mediated mTOR targeting in human monocyte-derived dendritic cells shifts them toward an immunogenic phenotype

Article

Author: Vaysi, Edris ; Masoumi, Javad ; Alizadeh, Nazila ; Naseri, Bahar ; Alipour, Shiva ; Baradaran, Behzad ; Hemmat, Nima ; Hatami-Sadr, Amirhossein

Dendritic cells (DCs) are essential for promoting T lymphocyte responses since they are specialist antigen-presenting cells. In order to maintain tolerance or initiate immune responses, DCs must be activated in a balanced and regulated manner via diverse signaling pathways. By using a variety of pharmacological components, we can interfere with their different signaling pathways such as the mammalian target of rapamycin (mTOR) to appropriately modulate DC activity. In the current study, we administered RAD001 to DCs to examine the impact of mTOR inhibition on both the maturation stage and the expression of inflammatory and anti-inflammatory molecules in DCs. Pure monocytes were cultivated and stimulated with GM-CSF and IL-4 to generate immature DCs, which were then treated with RAD001. The phenotype of the DCs was determined by labeling surface markers and analyzing them using flow cytometry. Afterward, real-time PCR was carried out to evaluate the expression of inflammatory and anti-inflammatory genes. The administration of RAD001 to DCs led to a significant upregulation in the gene expression of inflammatory molecules such as IL-12, IL-1β, tumor necrosis factor (TNF)-α, and nuclear factor kappa-light-chain-enhancer of activated B cells (NF-KB). Conversely, RAD001 treatment resulted in a decrease in the gene expression of anti-inflammatory factors IL-10 and indoleamine 2,3-dioxygenase (IDO). However, the expression of differentiation and antigen presentation-related markers CD11c and human leukocyte antigens (HLA)-DR in RAD001-treated DCs was lower and higher compared to the control group that did not receive the treatment, respectively. Taken together, our findings indicated that RAD001 treatment of DCs can be a promising therapeutic approach for the generation of immunogenic DCs in order to barricade tumor growth. However, there is a need for further investigation to evaluate the impacts of mTOR inhibition by RAD001 in DCs on cellular immune responses in vitro and in vivo.

01 Jun 2025·Biomaterials

In situ production and precise release of bioactive GM-CSF and siRNA by engineered bacteria for macrophage reprogramming in cancer immunotherapy

Article

Author: Kang, Jun ; Wang, Hanjie ; Zhang, Yingying ; Sun, Dawei ; Liu, Xinyu ; Liu, Jing ; Fan, Yali ; Wang, Yaxin ; Zhang, Xinyu ; Bai, Guijie ; Li, Lianyue

In the immunosuppressive tumor microenvironment (TME), tumor-associated macrophages (TAMs) predominantly exhibit an immunosuppressive M2 phenotype, which facilitates tumor proliferation and metastasis. Although current strategies aimed at reprogramming TAMs hold promise, their sustainability and effectiveness are limited due to repeated injections. Herein, a bacterial therapy platform containing two engineered strains was developed. One strain was engineered to produce and secrete granulocyte-macrophage colony-stimulating factor (GM-CSF) to promote M2-like TAMs repolarization to M1-like TAMs, while the other strain was designed to secrete small interfering RNA (siRNA) targeting signal regulatory protein α (SIRPα). The two strains can continuously and efficiently produce bioactive therapeutic agents in situ, exerting a sustained and synergistic therapeutic effect in TAMs to inhibit tumor growth. To enhance treatment efficacy, optogenetic strategy was implemented to effectively control the production of GM-CSF, and outer membrane vesicles (OMVs) produced by engineered bacteria were utilized to protect the siRNA from degradation in the external environment. The experimental results indicated that the bacterial therapy platform could continuously produce and release bioactive GM-CSF and SIRPα siRNA, exhibiting significant therapeutic activity. In vivo experiments further demonstrated that this platform showed more sustained and stable therapeutic effects compared to conventional drug therapies. Additionally, the combination of these two engineered strains yielded the highest ratio of M1/M2 TAMs (0.80) and the lowest ratio of F4/80⁺SIRPα⁺TAMs (3.46 %) than single strain therapy. Our study expanded the potential of engineered bacteria as pharmaceutical factories for in vivo therapeutic applications.

1

News (Medical) associated with Molgramostim biosimilar(Reliance GeneMedix Ltd.)

17 Dec 2024

·www.prnewswire.com

Neuvotion Expands Partnership with Intelligent Product Solutions and Commercializes NeuStim™ Technology for Stroke and Spinal Cord Injury

STAMFORD, Conn., Dec. 17, 2024 /PRNewswire/ -- Neuvotion, Inc. is an early-stage medical device company developing AI-driven neuromodulation technologies and products for use in the neurorehabilitation, brain-computer interface (BCI), and physical therapy markets. Today Neuvotion has announced their expanded partnership with Intelligent Product Solutions (IPS), a leading engineering firm located in New York. Forward Industries, the parent company of IPS, has made an undisclosed investment deal with Neuvotion, Inc. to further propel the company towards market launch of its first product, NeuStim™. Continue Reading Neuvotion expands partnerships to launch groundbreaking products in neuromodulation and neurorehabilitation markets. Post this NeuStim(TM) from Neuvotion "Neuvotion's mission is to develop and bring innovative technologies to the medical market that significantly improve patient outcomes, independence, and overall quality of life," said Chad Bouton, Neuvotion's founder and CEO. "We are extremely excited about the growth of Neuvotion and our expanded partnership with IPS." "We are proud to help Neuvotion innovate in the rapidly growing neuromodulation and neurorehabilitation markets," said Bob Wild, COO of Intelligent Product Solutions. "NeuStim™ is truly groundbreaking and has the potential to significantly improve recovery outcomes for patients recovering from stroke or spinal cord injury. IPS, with our multidisciplinary team of designers, engineers, and scientists is thrilled to provide medical device design and engineering expertise as Neuvotion brings their life-changing solutions to market." About Neuvotion, Inc. Neuvotion is an early-stage medical device company developing solutions for facilitating and restoring movement and sensation to the millions of patients experiencing impairment from stroke, spinal cord injury, and other conditions. Neuvotion's technologies combine high-precision neurostimulation and artificial intelligence to accelerate rehabilitation while making physical and occupational therapy more effective and efficient. About Intelligent Product Solutions Intelligent Product Solutions (IPS), a subsidiary of Forward Industries (NASDAQ: FORD), is an award-winning global product design and development company with headquarters in New York. IPS specializes in every stage of product development, from research and discovery to manufacturing, with expertise in systems architecture, industrial and UI/UX design, mechanical engineering, software development, electrical engineering, embedded systems, and manufacturing. To learn more about IPS, visit or contact [email protected]. If you would like more information about this topic, please email [email protected]. SOURCE Neuvotion, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

100 Deals associated with Molgramostim biosimilar(Reliance GeneMedix Ltd.)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L03AA03	DB12525

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Neutropenia	-	Reliance GeneMedix Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2023	Not Applicable	Neutropenia	9	GM-CSF therapy	jckmmotqjg(jeginmbqdt) = gwxeqwevbd iqgcajstrh (ventbamctp ) View more	-	08 Jun 2023
AACR2022	Phase 1	Glioblastoma Multiforme Adjuvant	15	Pelareorep + GM-CSF + standard chemoradiotherapy	(wiyvfqjolj) = igrxycnqfu hlhlknrewz (xldrwgpcxm )	-	15 Jun 2022
				Standard chemoradiotherapy	(wiyvfqjolj) = osiouojpws hlhlknrewz (xldrwgpcxm )
ASCO2021	Not Applicable	High Risk Neuroblastoma Consolidation	73	Naxitamab and GM-CSF	xikdkvlovl(hldohygyhv) = 2 kedmjabbqu (gjrjqqrxar ) View more	Positive	28 May 2021
Tandem Meetings ASTCT and CIBMTR2020	Not Applicable	Neoplasms	-	G-CSF and GM-CSF	cmcfplnkpt(msfybqosze) = kldzvyyrbl ttbdifxaez (iexhhuaetr )	Positive	01 Mar 2020
				G-CSF (Healthy donors)	cmcfplnkpt(msfybqosze) = vbfizmwtqq ttbdifxaez (iexhhuaetr )
AACR2016	Phase 1	Ovarian Cancer	51	E39’	(mlulgwnhzj) = enwfbqjnrc xyyvifjxju (jqdixazzuw )	Positive	15 Jul 2016
				E39 + GM-CSF	(mlulgwnhzj) = ziwayhfrbo xyyvifjxju (jqdixazzuw )
AACR2015	Phase 2	Adjuvant	301	AE37+GM-CSF	(pbhdkarjxh) = qnblmjmfwm ajracnjgux (xbgxvhtobz )	-	01 Aug 2015
				GM-CSF alone	(pbhdkarjxh) = sdnaxcuzar ajracnjgux (xbgxvhtobz )
Tandem Meetings ASTCT and CIBMTR2015	Not Applicable	Multiple Myeloma	111	G-CSF	bfsbyythoe(rslxtndujp) = yxmkelgbqs hlajbknisl (dfuwysetej ) View more	Negative	01 Feb 2015
				GM-CSF	bfsbyythoe(rslxtndujp) = vkumqyqhnt hlajbknisl (dfuwysetej ) View more
ANBL0931 (ASCO2014)	Phase 3	High Risk Neuroblastoma	105	ch14.18 combined with GM-CSF	zznakgicno(zuwpuhesbz) = dhgwqvoyes dzmqqbyjys (cismhlqlvr ) View more	-	20 May 2014
				ch14.18 combined with IL2	zznakgicno(zuwpuhesbz) = zyhbwbbfef dzmqqbyjys (cismhlqlvr ) View more
ASCO2012	Phase 2	Platinum-Resistant Epithelial Ovarian Carcinoma	21	nab-paclitaxel	hinjuvcalf(vinmqcmqxi) = zvuerqkvtv rwokoejrsm (rzouxvgqmn )	-	20 May 2012
				GM-CSF	hinjuvcalf(vinmqcmqxi) = bcypgsvwgo rwokoejrsm (rzouxvgqmn )
DoD prostate cancer clinical trials consortium trial (ASCO_GU2012)	Phase 2	Metastatic castration-resistant prostate cancer Maintenance	114	GM-CSF (Observation)	mpsvmvjasr(qkwibznitr) = kpamqauqcl xayvxejeql (tsmhmrwbmf ) View more	-	10 Feb 2012
				GM-CSF	mpsvmvjasr(qkwibznitr) = sxewjhsdio xayvxejeql (tsmhmrwbmf ) View more

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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