Society of Nuclear Medicine and Molecular Imaging

Perspective Therapeutics Announces First Patient Dosed in Phase 1/2a Dose Escalation Trial of VMT01 of its Targeted Alpha-Particle Therapy (TAT), for Treatment of MC1R-positive Metastatic Melanoma

Retrieved on: 
Friday, August 11, 2023

The trial is a first-in-human, non-randomized, multi-center open-label dose escalation, dose expansion study of 212Pb-VMT01 in patients with histologically confirmed melanoma and a positive MC1R imaging scan.

Key Points: 
  • The trial is a first-in-human, non-randomized, multi-center open-label dose escalation, dose expansion study of 212Pb-VMT01 in patients with histologically confirmed melanoma and a positive MC1R imaging scan.
  • “MC1R is implicated in the development of melanoma making it a promising target for potential treatment using radionuclide therapy,” said Thijs Spoor, Chief Executive Officer at Perspective Therapeutics.
  • “Today we achieved an important milestone as we work to access the potential of VMT01 as a targeted alpha-particle therapy for MC1R+ metastatic melanoma."
  • Additional CDMO manufacturing sites are expected to be brought online in the coming months to enable broader coverage for sites across the US.

IEEE EMBS Hosts Inaugural Women in Biomedical Engineering Forum in Sydney to Promote Diversity and Inclusion Across the STEM Fields

Retrieved on: 
Wednesday, July 12, 2023

The forum represents the launch of IEEE EMBS’ strategic initiative to promote diversity and inclusion within the biomedical engineering field and to provide women with the opportunity to network and share their perspectives with like-minded professionals, clinicians, and researchers.

Key Points: 
  • The forum represents the launch of IEEE EMBS’ strategic initiative to promote diversity and inclusion within the biomedical engineering field and to provide women with the opportunity to network and share their perspectives with like-minded professionals, clinicians, and researchers.
  • EMBS was among the first societies within IEEE to promise gender-diversified workshops, conferences, and panels at its events in 2021.
  • The 2023 WIBME forum is another step in this commitment and is a headline feature of the 45th Annual International Conference of the IEEE EMBS in Sydney.
  • The forum is structured as a full-day session with four keynote speakers – world-renowned women in biomedical engineering – and two panel discussions on key industry topics.

New Preliminary Findings on Potential Response Indicator of Rakuten Medical's Alluminox Treatment from Phase 2 Window of Opportunity Study at SNMMI 2023

Retrieved on: 
Friday, June 30, 2023

SAN DIEGO, June 30, 2023 /PRNewswire/ -- Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell targeting therapies based on its proprietary Alluminox™ platform, today announced that new interim evaluation data from the ASP-1929-103 study has been presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2023 Annual Meeting held from June 24 to 27.  ASP-1929-103 is a Phase 2, open-label, single-arm, window of opportunity study* of Alluminox treatment (photoimmunotherapy: PIT) using an antibody-dye conjugate ASP-1929 with fluorescence imaging (ClinicalTrials.gov Identifier: NCT05182866) in patients with operable primary or recurrent head and neck squamous cell carcinoma (HNSCC) or cutaneous squamous cell carcinoma (cuSCC).  

Key Points: 
  • ASP-1929-103 is the very first clinical trial of Alluminox treatment in operable cancer.
  • As part of this trial, early time point (1 day) 18F-FDG PET/CT imaging was investigated as a potential response indicator of Alluminox treatment.
  • The preliminary, descriptive imaging analysis based on interim evaluation of 6 patients in ASP-1929-103 study presented during the meeting showed that 18F-FDG PET/CT imaging demonstrates a therapeutic response 1 day after Alluminox treatment using ASP-1929.
  • ASP-1929-103 is a Phase 2, open-label, single-arm, window of opportunity study* of Alluminox treatment (PIT) using an anti-EGFR antibody-dye conjugate, ASP-1929 with fluorescence imaging in patients with operable primary or recurrent HNSCC or cuSCC.

Blue Earth Therapeutics Announces Results of Early Clinical and Preclinical Studies of Investigational 177Lu-rhPSMA-10.1 in Treatment of Prostate Cancer

Retrieved on: 
Wednesday, June 28, 2023

177Lu-rhPSMA-10.1 is an investigational radiohybrid (rh) Prostate-Specific Membrane Antigen-targeted therapeutic radiopharmaceutical for the treatment of prostate cancer.

Key Points: 
  • 177Lu-rhPSMA-10.1 is an investigational radiohybrid (rh) Prostate-Specific Membrane Antigen-targeted therapeutic radiopharmaceutical for the treatment of prostate cancer.
  • Also being presented are results of Blue Earth Therapeutics’ preclinical studies that examined the therapeutic dose response of 177Lu-rhPSMA-10.1 and the therapeutic efficacy of 177Lu-rhPSMA-10.1 as compared to several other compounds.
  • 177Lu-rhPSMA-10.1 is the first clinical candidate in Blue Earth Therapeutics’ oncology development program of advanced targeted therapeutic radiopharmaceuticals.
  • The preclinical efficacy results in prostate cancer xenografts reported here support a promising therapeutic profile for 177Lu-rhPSMA-10.1.

Blue Earth Diagnostics Announces Reader Reproducibility Results from Phase 3 LIGHTHOUSE Trial of POSLUMA® (Flotufolastat F 18) Injection in Newly Diagnosed Prostate Cancer

Retrieved on: 
Tuesday, June 27, 2023

Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced inter- and intra-reader reproducibility results from its Phase 3 LIGHTHOUSE trial of POSLUMA® (flotufolastat F 18) injection (formerly referred to as 18F-rhPSMA-7.3) in newly diagnosed prostate cancer.

Key Points: 
  • Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced inter- and intra-reader reproducibility results from its Phase 3 LIGHTHOUSE trial of POSLUMA® (flotufolastat F 18) injection (formerly referred to as 18F-rhPSMA-7.3) in newly diagnosed prostate cancer.
  • The results were reported in an oral presentation at the 2023 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting.
  • Newly FDA-approved POSLUMA represents a new class of purposely engineered, high-affinity PSMA-targeted PET radiopharmaceuticals based on novel radiohybrid technology.
  • The LIGHTHOUSE Phase 3 clinical trial ( NC04186819 ) was a prospective, Phase 3, multi-center, single-arm, imaging study conducted in the United States and Europe to evaluate the safety and diagnostic performance of POSLUMA PET in men with newly diagnosed prostate cancer.

Molecular Partners to Present on its Radio DARPin Therapy (RDT) Platform at SNMMI 2023

Retrieved on: 
Tuesday, June 27, 2023

ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., June 27, 2023 (GLOBE NEWSWIRE) -- Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, has announced it will present on its Radio DARPin Therapy (RDT) Platform at the 2023 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting being held from June 24-27 in Chicago, Illinois.

Key Points: 
  • Molecular Partners’ RDT platform represents a unique and innovative approach for the delivery of radioactive payloads to solid tumors.
  • Molecular Partners is developing a portfolio of RDTs, both proprietary as well as in collaboration with external partners.
  • The tumor-associated protein Delta-like ligand 3 (DLL3) is the first disclosed target of Molecular Partner’s proprietary RDT candidates.
  • Molecular Partners has also demonstrated that through DARPin engineering it can reduce the uptake of DARPin radio conjugates in the kidneys and therefore reduce kidney damage, a key limitation of protein-based radio therapies.

New ZIRCON Phase III Data Presented at SNMMI: Potential Utility of TLX250-CDx in Staging and Monitoring ccRCC

Retrieved on: 
Monday, June 26, 2023

New data demonstrates the ability of TLX250-CDx to detect extrarenal lesions, supporting potential clinical utility in the metastatic or recurrent setting, and for staging and informing treatment decisions.

Key Points: 
  • New data demonstrates the ability of TLX250-CDx to detect extrarenal lesions, supporting potential clinical utility in the metastatic or recurrent setting, and for staging and informing treatment decisions.
  • TLX250-CDx PET/CT detected more lesions in liver and bone than diagnostic CT imaging alone.
  • Data presented here in Chicago on extrarenal lesions demonstrates potential utility of TLX250-CDx for staging and monitoring high risk patients where there is a great deal of interest from the clinician community."
  • Telix is in the process of implementing an expanded access program in the United States and establishing named patient programs for TLX250-CDx in Europe.

New ZIRCON Phase III Data Presented at SNMMI: Potential Utility of TLX250-CDx in Staging and Monitoring ccRCC

Retrieved on: 
Monday, June 26, 2023

New data demonstrates the ability of TLX250-CDx to detect extrarenal lesions, supporting potential clinical utility in the metastatic or recurrent setting, and for staging and informing treatment decisions.

Key Points: 
  • New data demonstrates the ability of TLX250-CDx to detect extrarenal lesions, supporting potential clinical utility in the metastatic or recurrent setting, and for staging and informing treatment decisions.
  • TLX250-CDx PET/CT detected more lesions in liver and bone than diagnostic CT imaging alone.
  • Data presented here in Chicago on extrarenal lesions demonstrates potential utility of TLX250-CDx for staging and monitoring high risk patients where there is a great deal of interest from the clinician community."
  • Telix is in the process of implementing an expanded access program in the United States and establishing named patient programs for TLX250-CDx in Europe.

Blue Earth Diagnostics Announces Results of Post-hoc Analysis Assessing Impact of Urinary Activity on Interpretation of POSLUMA® (Flotufolastat F 18) Injection PET/CT in Prostate Cancer

Retrieved on: 
Monday, June 26, 2023

The analysis was based on data from Blue Earth Diagnostics’ prospective Phase 3 LIGHTHOUSE and SPOTLIGHT studies that evaluated the diagnostic performance and safety of POSLUMA in newly diagnosed and recurrent prostate cancer.

Key Points: 
  • The analysis was based on data from Blue Earth Diagnostics’ prospective Phase 3 LIGHTHOUSE and SPOTLIGHT studies that evaluated the diagnostic performance and safety of POSLUMA in newly diagnosed and recurrent prostate cancer.
  • The results as reported expanded on the initial data from a single reader that were detailed in the abstract.
  • The results were reported at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, held June 24 – 27, in Chicago, Ill.
  • Results from the SPOTLIGHT study were published online on April 26, 2023 in the Journal of Urology: DOI: 10.1097/JU.0000000000003493 .3

Fusion Pharmaceuticals to Present Interim Data from Phase 1 Trial of FPI-1434 in Patients with Solid Tumors Expressing IGF-1R

Retrieved on: 
Monday, June 26, 2023

HAMILTON, ON and BOSTON, June 26, 2023 /PRNewswire/ --  Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced the presentation of interim data from the dose escalation portion of the Phase 1 trial of [225Ac]-FPI-1434 (FPI-1434) in patients with solid tumors expressing IGF-1R. The data will be presented by Neeta Pandit-Taskar, M.D., of Memorial Sloan Kettering Cancer Center, tomorrow at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting and will include molecular imaging, safety and pharmacokinetics (PK) from two dosing regimens: one with FPI-1434 alone ("hot only"), and another in which a small dose of cold antibody (naked IGF-1R antibody without the isotope) is administered prior to each dose of FPI-1434 ("cold/hot"). The poster presentation is available via the SNMMI Annual Meeting mobile application.

Key Points: 
  • "Antibody drug conjugates (ADCs) have shown tremendous success recently, driven in part by the benefits of using more potent payloads.
  • The Phase 1, multi-center, open-label clinical trial is designed to investigate the safety, tolerability and pharmacokinetics of FPI-1434 in patients with solid tumors expressing IGF-1R.
  • The trial is also designed to establish the maximum tolerated dose for FPI-1434 and the recommended Phase 2 dose.
  • To access the live call, please dial 1-877-870-4263 (U.S.), 1-855-669-9657 (Canada) or 1-412-317-0790 (international) and reference Fusion Pharmaceuticals.