A Phase IIa, Single Centre, Open Label, Proof of Concept Study Concerning Efficacy of the Novel Intravenous Contrast Agent SN132D in Patients With Suspected Endometriosis.

This is a Phase IIa, open-label, non-randomised and non-placebo-controlled study. The study is designed to evaluate the diagnostic value and safety of a single intravenous dose of SN132D in up to 18 participants with suspected endometriosis. Magnetic resonance imaging (MRI) will be performed pre- and post-infusion of SN132D.

Start Date17 Nov 2022

Sponsor / Collaborator

Spago Nanomedical AB

NCT04080024

/ CompletedPhase 1

A First-in-human Clinical Evaluation of the Novel Intravenous Contrast Agent SN132D in Patients With Breast and Pancreatic Cancer

This phase I, first-in-human (FIH) study is open-label, non-randomised and non-placebo-controlled. The study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of a single intravenous dose of SN132D in approximately 24 patients with breast and pancreatic cancer. Magnetic resonance imaging (MRI) will be performed pre- and post-infusion of SN132D.

Start Date23 Aug 2019

Sponsor / Collaborator

Spago Nanomedical AB

[+2]

100 Clinical Results associated with Pegfosimer Manganese

100 Translational Medicine associated with Pegfosimer Manganese

100 Patents (Medical) associated with Pegfosimer Manganese

Literatures (Medical) associated with Pegfosimer Manganese

01 Nov 2024·Nanomedicine-Nanotechnology Biology and Medicine

Size-dependent renal filtration model explains human pharmacokinetics of a functional nanoparticle: The SPAGOPIX-01 clinical trial

Article

Author: Lekmeechai, Sujinna ; Ekengard, Erik ; Yousefpour, Nooshin ; Björnberg, Olof ; Axelsson, Oskar

The pharmacokinetics in patients dosed with the nanoparticle-based MRI contrast agent SN132D is explained by a size dependent clearance mechanism and this behavior was modeled numerically. Blood samples from 14 patients were analyzed for silicon (a component of the nanoparticle) by ICP-OES. The pharmacokinetic model has only one free parameter and relies on a measured size distribution of the contrast agent and well-established properties of the renal and cardiovascular systems. The model fits well (R² = 0.9910) with experimental data from samples taken from ten minutes to two weeks after start of infusion. These results support that the cut-off diameter for human renal filtration is 5.5 nm. The agreement between experiment and model implies that there is little or no plasma protein binding to the nanoparticles.

PloS oneQ3 · CROSS-FIELD

Novel Nano-Sized MR Contrast Agent Mediates Strong Tumor Contrast Enhancement in an Oncogene-Driven Breast Cancer Model

Q3 · CROSS-FIELD

ArticleOA

Author: Miyazaki, Hideki ; Pietras, Kristian ; Petoral, Rodrigo ; Leander, Peter ; Aaltonen, Emil ; Eriksson, Per-Olof ; Lauritzson, Petter ; Axelsson, Oskar ; Månsson, Sven ; Hansson, Lennart

The current study was carried out to test the potential of a new nanomaterial (Spago Pix) as a macromolecular magnetic MR contrast agent for tumor detection and to verify the presence of nanomaterial in tumor tissue. Spago Pix, synthesized by Spago Nanomedical AB, is a nanomaterial with a globular shape, an average hydrodynamic diameter of 5 nm, and a relaxivity (r1) of approximately 30 (mM Mn)-1 s-1 (60 MHz). The material consists of an organophosphosilane hydrogel with strongly chelated manganese (II) ions and a covalently attached PEG surface layer. In vivo MRI of the MMTV-PyMT breast cancer model was performed on a 3 T clinical scanner. Tissues were thereafter analyzed for manganese and silicon content using inductively coupled plasma-atomic emission spectroscopy (ICP-AES). The presence of nanomaterial in tumor and muscle tissue was assessed using an anti-PEG monoclonal antibody. MR imaging of tumor-bearing mice (n = 7) showed a contrast enhancement factor of 1.8 (tumor versus muscle) at 30 minutes post-administration. Contrast was retained and further increased 2-4 hours after administration. ICP-AES and immunohistochemistry confirmed selective accumulation of nanomaterial in tumor tissue. A blood pharmacokinetics analysis showed that the concentration of Spago Pix gradually decreased over the first hour, which was in good agreement with the time frame in which the accumulation in tumor occurred. In summary, we demonstrate that Spago Pix selectively enhances MR tumor contrast in a clinically relevant animal model. Based on the generally higher vascular leakiness in malignant compared to benign tissue lesions, Spago Pix has the potential to significantly improve cancer diagnosis and characterization by MRI.

INVESTIGATIVE RADIOLOGY

First-in-Human Safety, Tolerability, Efficacy, and Pharmacokinetics of Pegfosimer Manganese (SN132D) for Contrast-Enhanced MRI of Breast Cancer

Article

Author: Lekmeechai, Sujinna ; Hargreaves, Paul ; Wärnberg, Fredrik ; Karakatsanis, Andreas ; Curiac, Dan ; Hansen, Mats ; Axelsson, Oskar

Objectives::

The primary objective of the first-in-human (FIH) study was to evaluate the safety and tolerability of the manganese (Mn)-based contrast agent pegfosimer manganese in participants with newly diagnosed breast cancer, and secondary objectives included preliminary efficacy, and pharmacokinetics (PK) of the agent.

Methods::

A single intravenous 1-hour infusion of pegfosimer manganese was administered to 2 cohorts; 6 participants at the starting dose of 10 μmol Mn/kg, followed by 8 participants at the expansion dose of 20 μmol Mn/kg, cohorts 1 and 2, respectively. The safety was evaluated based on reported adverse events (AEs), including serious AEs, physical examination, vital signs, electrocardiogram, and safety laboratory parameters. Magnetic resonance imaging (MRI) acquisition was performed precontrast and postcontrast to assess the clinical relevance of images in primary breast tumors, liver, and pancreas relative to reference tissue. PK parameters were calculated from a noncompartmental analysis of the plasma Mn concentrations versus time.

Results::

There was a total of 29 AEs reported to all participants of the 2 cohorts. The AEs were mostly of mild to moderate severity and possibly or probably related to the contrast agent. No clinically significant changes in the safety laboratory parameters were reported, except for transiently elevated transaminases observed at the end of the infusion. Clinically relevant low-background MRI scans for clinical visualization of primary breast tumor, liver, and pancreas were obtained at the expanded dose level. Pegfosimer manganese has an initial plasma half-life of approximately 7 minutes.

Conclusion::

The FIH study of pegfosimer manganese demonstrated an acceptable safety profile and sufficient contrast enhancement for clinically relevant MRI sequences in participants with primary breast tumors.

News (Medical) associated with Pegfosimer Manganese

15 Jan 2025

·www.accesswire.com

Spago Nanomedical Article on SPAGOPIX-01 Clinical Results Accepted for Publication in Investigative Radiology

LUND, SWEDEN / ACCESSWIRE / January 15, 2025 / Spago Nanomedical (STO:SPAGO.ST)(FRA:7UX.F) Spago Nanomedical AB (publ) announced today that a manuscript on product candidate pegfosimer manganese has been accepted for publication in the highly regarded peer reviewed scientific journal Investigative Radiology. The publication provides further scientific support for the SpagoPix development program.The article, entitled ‘Safety, Tolerability, Efficacy and Pharmacokinetics of Pegfosimer manganese (SN132D) for Contrast Enhanced MRI of Breast Cancer\', has been accepted for publication in the September 2025 issue of Investigative Radiology.The article focuses on results from the clinical study SPAGOPIX-01 (NCT04080024) in which the product candidate pegfosimer manganese (formerly SN132D) demonstrated acceptable safety and clinically relevant contrast enhancement in magnetic resonance imaging (MRI) of primary tumors in patients with breast cancer.\"A publication in one of the leading scientific journals in the medical imaging field is a strong validation of the extensive clinical development work behind the SpagoPix program. The publication also supports our ongoing business development work aimed at finding potential partners or other solutions for further development of the program,\" says CEO Mats Hansen.The SpagoPix development program, with pegfosimer manganese, aims to improve the precision of MRI of suspected cancers and endometriosis by launching a selective contrast agent for more precise visualization of tumors and other lesions. Initial clinical results show that pegfosimer manganese provides clinically relevant contrast in malignant breast tumors while maintaining good safety. Selective contrast enhancement has also been observed in endometriosis lesions in a Phase IIa clinical study (NCT05664828). Continued clinical development within the SpagoPix program will take place in collaboration with a partner, which will require out-licensing, commercial partnership, or by means of other external financing.For further information, please contact Mats Hansen, CEO Spago Nanomedical AB, +46 46 811 88, [email protected]Spago Nanomedical AB is a Swedish company in clinical development phase. The company´s development projects are based on a platform of polymeric materials with unique properties for more precise treatment and diagnosis of cancer and other debilitating diseases. Spago Nanomedical´s share is listed on Nasdaq First North Growth Market (ticker: SPAGO). For further information, see www.spagonanomedical.se.FNCA Sweden AB is the Certified Adviser of the company.AttachmentsSpago Nanomedical article on SPAGOPIX-01 clinical results accepted for publication in Investigative RadiologySOURCE: Spago NanomedicalRelated Documents:

Clinical ResultPhase 2

23 May 2024

·www.biospace.com

Spago Nanomedical Receives Declarations of Intent from the Largest Owner, Board and Management Team Regarding the Exercise of TO12

LUND, SWEDEN / ACCESSWIRE / May 23, 2024 / Spago Nanomedical (STO:SPAGO.ST)(FRA:7UX.F) Spago Nanomedical AB (publ) ("Spago Nanomedical" or the "Company") has received declarations of intent from, among others, the Company's largest owner, Peter Lindell, as well as all members of the Company's board of directors and management team, regarding the intention to exercise the warrants of series TO12 ("Warrants") for subscription of newly issued shares corresponding to their respective holdings of Warrants. In total, these declarations of intent are expected to result in the exercise of approximately 60 percent of the outstanding Warrants. "The commitments we received from our largest owner and all members of the board and management team to exercise their warrants underline the progress we are making, most recently within the Tumorad program with the ongoing "first-in-human" study in patients with advanced cancer. I am very grateful and look forward to managing that trust," says CEO Mats Hansen. Spago Nanomedical issued a total of 127,321,212 Warrants within the framework of a rights issue of units during the fourth quarter of 2023. The exercise period for the Warrants lasts until May 30, 2024. One (1) Warrant entitles the holder to subscribe for one (1) new share in the Company. The subscription price per share subscribed for through the exercise of Warrants has been set at SEK 0.20. Upon utilization of all Warrants, Spago Nanomedical will receive approximately SEK 25.5 million before issuance costs. The proceeds from the exercise of Warrants are intended to be used to secure results from the phase I part of the clinical phase I/IIa study Tumorad-01, including information on biodistribution that may point to the possibility of achieving a therapeutic effect. The results from the phase I part will also form the basis for decisions regarding the focus and commencement of the phase IIa part of the study, as well as to strengthen the organization as the Company takes the next development step with the Tumorad program. The Tumorad development program aims to give more patients with cancer the opportunity for treatment with effective radionuclide therapy. The drug candidate Lu177-SN201 is based on the clinically effective isotope lutetium-177, which is already successfully used for cancer treatment, linked to the Company's unique nanomedical platform material. Clinical results in the Company's other development program, SpagoPix, as well as non-clinical results in Tumorad, show that the material is safe and accumulates in growing tumors, resulting in prolonged survival with Lu177-SN201 in various cancer models. The first clinical study in cancer patients is progressing according to plan and the goal is to generate results at an early stage that support the continued clinical development. For further information, please contact Mats Hansen, CEO Spago Nanomedical AB, +46 46 811 88, mats.hansen@spagonanomedical.se Spago Nanomedical AB is a Swedish company in clinical development phase. The company´s development projects are based on a platform of polymeric materials with unique properties for more precise treatment and diagnosis of cancer and other debilitating diseases. Spago Nanomedical´s share is listed on Nasdaq First North Growth Market (ticker: SPAGO). For further information, see FNCA Sweden AB is the Certified Adviser of the company. IMPORTANT INFORMATION The information in this press release neither contains nor constitutes an offer to acquire, subscribe for, or otherwise trade shares, warrants, or other securities in the Company. Copies of this announcement are not made and may not be distributed, published or sent to the United States, Australia, Hong-Kong, Japan, Canada, Switzerland, Singapore, South Africa or New Zealand or any other jurisdiction where distribution of this press release would be unlawful or require registration or other measures. This announcement is for informational purposes only and does not constitute a prospectus or other offer to sell or an invitation to an offer to acquire any security in the United States or any other jurisdiction. This announcement does not constitute a prospectus for the purposes of Regulation (EU) 2017/1129 of the European Parliament and the Council (the "Prospectus Regulation"). This press release does not contain and does not constitute an invitation or an offer to acquire, sell, subscribe or otherwise trade in shares, warrants, unit rights or other securities of Spago Nanomedical in the United States or elsewhere. Topics discussed in this announcement may constitute forward looking statements. Forward looking statements are statements that are not historical facts that can be identified by the use of words such as, "believe", "expect", "anticipate", "intend", "estimate", "will", "may", "continue", "should" and similar expressions. Forward looking statements in this press release are based on various assumptions, many of which in turn are based on further assumptions. Although Spago Nanomedical believes these assumptions were reasonable when made, these assumptions are inherently associated with known and unknown material risks, uncertainties, unforeseen events and other important factors that are difficult or impossible to predict and that are beyond its control. Such risks, uncertainties, unforeseen events and other important factors could cause actual events to differ materiality from the expectations expressed or implied in this announcement by such forward looking statements. Information, opinions and forward looking statements contained in this announcement speak only as at its date, and may be changed without notice. Attachments Spago Nanomedical receives declarations of intent from the largest owner, board and management team regarding the exercise of TO12 SOURCE: Spago Nanomedical View the original press release on accesswire.com

Phase 1

17 May 2024

·www.biospace.com

The Exercise Period for Spago Nanomedical's Warrants of Series TO12 Commences Today

LUND, SE / ACCESSWIRE / May 17, 2024 / Spago Nanomedical (STO:SPAGO.ST)(FRA:7UX.F) Spago Nanomedical AB (publ) ("Spago Nanomedical" or the "Company") issued a total of 127,321,212 warrants of series TO12 ("Warrants") within the framework of a rights issue of units during the fourth quarter of 2023. The exercise period for the Warrants commences today, on May 17, 2024, and continues until May 30, 2024. One (1) Warrant entitles the holder to subscribe for one (1) new share in the Company. The subscription price per share subscribed for through the exercise of Warrants has been set at SEK 0.20. Upon full utilization of all Warrants, Spago Nanomedical will receive approximately SEK 25.5 million before issuance costs. The proceeds from the exercise of Warrants are intended to be used to secure results from the phase I part of Tumorad-01, which may support decisions regarding the focus and commencement of the phase IIa part of the study, as well as to further strengthen the organization as the Company takes the next step in the development of the Tumorad program. The Tumorad development program aims to give more patients with cancer the opportunity for treatment with effective radionuclide therapy. The candidate drug Lu177-SN201 is based on the clinically effective isotope lutetium-177 linked to the Company's unique and clinically validated nanomaterial. Clinical results in the Company's second development program, SpagoPix, as well as non-clinical results in Tumorad show that the material is safe and accumulates in growing tumors, resulting in prolonged survival with Lu177-SN201 in various cancer models. The first clinical study in cancer patients is ongoing and the goal is to generate results at an early stage that support the continued clinical development. Warrant exercise in brief The exercise period for the Warrants runs from May 17, 2024, to May 30, 2024. One (1) Warrant entitles the holder to subscribe for one (1) new share in the Company at a subscription price of SEK 0.20 per share. Trading of Warrants on Nasdaq First North Growth Market takes place until May 27, 2024. Warrants that are not exercised for subscription of new shares by May 30, 2024, expire without value. Holders of warrants who have their holdings nominee-registered (holdings in securities custody services, investment savings accounts (ISK) or endowment insurances) must notify the exercise of warrants by contacting their respective nominee and follow the nominee's instructions regarding subscription and payment. This should take place well before May 30, 2024, as different nominees have different processing times. Holders of warrants who have their holdings directly registered (holdings on a VP account) must notify the exercise of warrants by filling in and submitting an application form for the exercise, so that the application form is received by the issuing agent, Hagberg & Aneborn Fondkommission AB, no later than May 30, 2024. The Application form is available on the Company's, Hagberg & Aneborn Fondkommission AB's, and Redeye AB's respective websites ( , , ). Upon full utilization of all Warrants, Spago Nanomedical will receive approximately SEK 25.5 million before issuance costs. The subscription price of SEK 0.20 per new share has been determined in accordance with the terms of the Warrants, under which the subscription price per new share shall equal seventy (70) percent of the volume-weighted average price (VWAP) of the Company's share on Nasdaq First North Growth Market during a period of ten (10) trading days immediately preceding, and including, May 16, 2024, however, not less than SEK 0.20 and not more than SEK 0.80 per share. Complete terms and conditions for the Warrants are available on the Company's website, . Increase in the number of shares and share capital Upon full utilization of all 127,321,212 Warrants, the Company's share capital will increase by SEK 12,732,121.20 to SEK 35,203,666.60 through the issuance of 127,321,212 new shares, resulting in the total number of outstanding shares in the Company increasing from 224,715,454 to 352,036,666. For further information, please contact Mats Hansen, CEO Spago Nanomedical AB, +46 46 811 88, mats.hansen@spagonanomedical.se Spago Nanomedical AB is a Swedish company in clinical development phase. The company´s development projects are based on a platform of polymeric materials with unique properties for more precise treatment and diagnosis of cancer and other debilitating diseases. Spago Nanomedical´s share is listed on Nasdaq First North Growth Market (ticker: SPAGO). For further information, see FNCA Sweden AB is the Certified Adviser of the company. IMPORTANT INFORMATION The information in this press release neither contains nor constitutes an offer to acquire, subscribe for, or otherwise trade shares, warrants, or other securities in the Company. Copies of this announcement are not made and may not be distributed, published or sent to the United States, Australia, Hong-Kong, Japan, Canada, Switzerland, Singapore, South Africa or New Zealand or any other jurisdiction where distribution of this press release would be unlawful or require registration or other measures. This announcement is for informational purposes only and does not constitute a prospectus or other offer to sell or an invitation to an offer to acquire any security in the United States or any other jurisdiction. This announcement does not constitute a prospectus for the purposes of Regulation (EU) 2017/1129 of the European Parliament and the Council (the "Prospectus Regulation"). This press release does not contain and does not constitute an invitation or an offer to acquire, sell, subscribe or otherwise trade in shares, warrants, unit rights or other securities of Spago Nanomedical in the United States or elsewhere. Topics discussed in this announcement may constitute forward looking statements. Forward looking statements are statements that are not historical facts that can be identified by the use of words such as, "believe", "expect", "anticipate", "intend", "estimate", "will", "may", "continue", "should" and similar expressions. Forward looking statements in this press release are based on various assumptions, many of which in turn are based on further assumptions. Although Spago Nanomedical believes these assumptions were reasonable when made, these assumptions are inherently associated with known and unknown material risks, uncertainties, unforeseen events and other important factors that are difficult or impossible to predict and that are beyond its control. Such risks, uncertainties, unforeseen events and other important factors could cause actual events to differ materiality from the expectations expressed or implied in this announcement by such forward looking statements. Information, opinions and forward looking statements contained in this announcement speak only as at its date, and may be changed without notice. Attachments The exercise period for Spago Nanomedical's warrants of series TO12 commences today SOURCE: Spago Nanomedical View the original press release on accesswire.com

Phase 1

100 Deals associated with Pegfosimer Manganese

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Endometriosis	Phase 2	Sweden	Spago Nanomedical AB	17 Nov 2022
Breast Cancer	Phase 1	Sweden	Spago Nanomedical AB	23 Aug 2019
Pancreatic Cancer	Phase 1	Sweden	Spago Nanomedical AB	23 Aug 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05664828 (Biospace) Manual	Phase 2	Endometriosis	-	SN132D	lsxgnjlopl(urggyboqym) = the primary endpoint of measuring the MRI enhancing effect in endometriotic lesions that was identified by the treating gynaecologist was met. Contrast enhancement with pegfosimer manganese was observed in the majority of lesions confirmed by unenhanced ultrasound bbwddfmdfl (trijdohgbr ) View more	Positive	15 Dec 2023
NCT04080024 (SPAGOPIX-01, SABCS2023)	Phase 1	Breast Cancer	12	SN132D 10 μmol Mn/kg	jckawzofil(vtpzpdsntn) = qnxgzjvrwm qsfppyhkch (swlsrfxusy ) View more	Positive	01 Mar 2023
NCT04080024 (SPAGOPIX-01, SABCS2023)	Phase 1	Breast Cancer	12	SN132D 20 μmol Mn/kg	jckawzofil(vtpzpdsntn) = rrsiyhrnzb qsfppyhkch (swlsrfxusy ) View more	Positive	01 Mar 2023

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