Molecular Targeting Technologies, Inc. Features EBTATE Advances at The 2022 SNMMI Meeting In Vancouver, BC

On June 9, 2022 Molecular Targeting Technologies, Inc. (MTTI), a clinical stage oncology company, reported that it will highlight advances on its EvaTheraTM radiotheranostics platform at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) meeting in Vancouver, BC, on June 11-15, 2022 (Exhibit booth #1715) (Press release, Molecular Targeting Technologies, JUN 9, 2022, View Source [SID1234615839]). The EvaThera platform includes EBTATETM (177Lu-DOTA-EB-TATE) for Neuroendocrine Neoplasms (NENs), Hürthle cell thyroid and nasopharyngeal cancers and EBRGDTM (177Lu-DOTA-EB-RGD) for glioblastoma multiforme and non-small cell lung cancer

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A video featuring the EBTATE story (see link below) will be released at the meeting.

View Source

In addition, two abstracts highlighting MTTI’s EBTATE & our PET imaging agent,18F-glucarate, were selected for oral and poster presentations:

(i) Evaluation of Safety, Biodistribution and Dosimetry of a long-Acting Radiolabeled Somatostatin Analogue 177Lu-DOTA-EB-TATE with and without Amino Acid Infusion by Qingxing Liu, Yuanyuan Jiang, Koon Pak, Guochang Wang, Jingjing Zhang, Xiaoyuan Chen and Zhaohui Zhu (oral presentation)

EBTATE treatment without amino acid infusion, normally used in current treatments to block drug impact on non-target organs, has acceptable, minor effects on the kidneys and does no harm to kidney function. EBTATE may significantly improve patient comfort vs. current treatments.

(ii) Assessment of 18F-glucarate as a potential PET tracer for cancer imaging by Junling Li, Huaiyu Zheng, Levi Beverly, Brian Gray, Koon Pak and Chin K. Ng (poster presentation)

18F-glucarate uptake in both in vitro and in vivo correlated well with the degree of cell death and shows early tumor response to chemotherapy, enabling faster assessment of treatment efficacy.

Fusion Pharmaceuticals Provides Updates on FPI-1434 and FPI-1966 Clinical Programs

On June 9, 2022 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported updates on its Phase 1 clinical trial evaluating FPI-1434 as a monotherapy for the treatment of solid tumors expressing IGF-1R and its Phase 1 clinical trial evaluating FPI-1966 for the treatment of solid tumors expressing FGFR3 (Press release, Fusion Pharmaceuticals, JUN 9, 2022, View Source [SID1234615807]). In the FPI-1434 trial, the Company now expects to report Phase 1 safety, pharmacokinetics, and imaging data, including any evidence of anti-tumor activity, and details on the dosing regimen, in the first half of 2023, rather than in the second half of 2022. Fusion is also updating guidance for FPI-1966 and expects to dose the first patient in this study in the second half of 2022, rather than in the second quarter of 2022.

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"Fusion is pioneering the development of next-generation, alpha-emitting radiopharmaceuticals, and we are working to identify the most effective dosing regimen that maximizes the therapeutic window in new these treatment paradigms," said Fusion Chief Executive Officer John Valliant, Ph.D. "To this end, we are evaluating two potential dosing regimens in our FPI-1434. Initial data from a sub-study of the "cold antibody" dosing regimen, to be presented in full next week at the Society of Nuclear Medicine and Medical Imaging (SNMMI) annual meeting, showed encouraging early results of the ability to maximize the therapeutic window and drive higher doses into the tumor. Following the protocol amendment to incorporate the cold antibody study arm, sites have been slow to initiate and, as a result, patient enrollment in this portion of the study is now lagging our prior forecasts, delaying the availability of the data from our original expectations. While our timelines are extended, we believe it is important to pursue optimization of this cold antibody dosing regimen and we look forward to presenting the full dataset in the first half of 2023.

Dr. Valliant continued: "We’ve experienced similar study site startup challenges in our Phase 1 trial of FPI-1966. As a result, we are updating guidance for timing of the first patient to be dosed, and now expect it to occur in the second half of this year. Delays are resulting from what we believe is a combination of staffing/resourcing shortages and administrative complications with various review boards for radiopharmaceuticals at the trial sites, and we have mitigation plans in place to address them. Importantly, our conviction in these programs and investigator enthusiasm remains strong, particularly given our pursuit of cancer types with high unmet medical need."

Overview of FPI-1434 Phase 1 Clinical Trial

In the Phase 1 study, Fusion is exploring various dosing levels of FPI-1434 as well as two dosing regimens: one with FPI-1434 alone, 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.
Data observed from a completed cold-antibody sub-study demonstrate the potential of pre-dosing cold antibody prior to FPI-1434 to increase the tumor to non-tumor distribution ratio of the radiopharmaceutical and thereby potentially improve the therapeutic window. As a result, Fusion initiated the dosing regimen evaluating pre-administration of cold antibody prior to FPI-1434 following a protocol amendment to the ongoing Phase 1 study of FPI-1434. Fusion expects to present more detailed data from the cold-antibody sub-study at the Society of Nuclear Medicine and Medical Imaging (SNMMI) 2022 Annual Meeting taking place in Vancouver, British Columbia from June 11-14, 2022.
Given the protocol amendment to include the dosing regimen evaluating pre-administration of cold-antibody and the time required to generate sufficient data to be able to provide information on both dosing paradigms, as well as ongoing enrollment challenges relating to staffing and resourcing issues at trial sites, and additional review boards required at trial sites for novel alpha-emitting radiopharmaceuticals, Fusion now expects to report Phase 1 safety, pharmacokinetics, and imaging data, including any evidence of anti-tumor activity, and details on the dosing regimen, in the first half of 2023.
Overview of FPI-1966 Phase 1 Clinical Trial

The Phase 1, non-randomized, open-label clinical trial of FPI-1966 in patients with solid tumors expressing FGFR3, intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose, has been initiated.
The first cohort in this study will comprise four sub-groups in which various doses of non-radiolabeled vofatamab (cold antibody) will be evaluated to assess the impact of pre-dosing on tumor uptake.
As previously disclosed, Fusion experienced initial challenges with study site initiations and is further experiencing enrollment challenges similar to the FPI-1434 study, including study backlogs as COVID-19 headwinds ease, staffing shortages at trial sites, and additional review boards required at trial sites for novel alpha-emitting radiopharmaceuticals. As a result, Fusion now expects to dose the first patient in the FPI-1966 Phase 1 study in the second half of 2022. In addition, Fusion plans to provide updated guidance for preliminary pharmacokinetic, imaging and safety data from the first patient cohort once patient enrollment begins.
About FPI-1434
FPI-1434 is a radioimmunoconjugate designed to target and deliver alpha emitting medical isotopes to cancer cells expressing IGF-1R, a receptor that is overexpressed on many tumor types. FPI-1434 utilizes Fusion’s Fast-Clear linker to connect a human monoclonal antibody that targets IGF-1R with actinium-225, a powerful alpha-emitting isotope with desirable half-life and decay chain properties.

About FPI-1966
FPI-1966 is a targeted alpha therapy designed to target and deliver an alpha emitting medical isotope, actinium-225, to cancer cells expressing FGFR3; a receptor that is overexpressed on several tumor types, including head and neck and bladder cancers. FPI-1966 utilizes Fusion’s Fast-Clear linker to connect vofatamab, the human monoclonal antibody that targets FGFR3, with actinium-225. Vofatamab was previously evaluated as a therapeutic agent in a Phase 1b/2 trial and was reportedly well-tolerated.

Revolution Medicines to Participate in the 43rd Annual Goldman Sachs Global Healthcare Conference

On June 9, 2022 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, reported that the company will participate in the 43rd Annual Goldman Sachs Global Healthcare Conference (Press release, Revolution Medicines, JUN 9, 2022, View Source [SID1234615824]). Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines, will be the featured participant in a live fireside chat at the event.

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Details of the company’s participation are as follows:

Conference Date: June 13 – 16, 2022
Fireside Chat Details: 1:20 p.m. Pacific on Wednesday, June 15, 2022
A live webcast of the fireside chat can be accessed at: View Source An archived replay of the webcast will be available on the investors section of the company’s website for at least 14 days following the event.

Healthcare Is Personal: GE Healthcare’s Total Molecular Imaging Solutions Enable Precision Health & Theranostics for Personalized Prostate Cancer Care

On June 9, 2022 GE Healthcare reported that cutting-edge molecular imaging solutions that enable and increase access to precision health and theranostics to help improve patient outcomes across care areas, including prostate cancer – the most prevalent cancer in men and the third most prevalent cancer overalli (Press release, GE Healthcare, JUN 9, 2022, View Source [SID1234615840]).

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Where most medical therapies are designed with the ‘average’ patient in mind, theranostics brings together diagnoses and treatment in one application, providing a more targeted and personalized therapy than ever before. Clinicians and patients are especially seeing much success with theranostics in prostate cancer – a highly manageable disease, but one that is difficult to treat when diagnosed at a late stage – claiming more than 1.4 million lives annuallyii.

During the COVID-19 pandemic, clinical adoption of theranostics slowed due to a delay in elective procedures and the increased risk posed to its often-immunocompromised patients. However, a surge in demand for theranostics infrastructureiii is now anticipated following the U.S. Federal Drug Administration’s (FDA) approval of several new drugs and therapies. This includes the diagnostic tracer Gallium-68 PSMA-11 and therapy drug Lutetium-177 PSMA-617, which are key to applying theranostics in prostate cancer.

"Healthcare is timely and personal – and its delivery should be too," explains Jean-Luc Procaccini, President & CEO, Molecular Imaging & Computed Tomography, GE Healthcare. "Theranostics has the potential to transform care from a look at the ‘average’ patient to a precise look at ‘each’ individual. Already, it is providing hope to late-stage prostate cancer patients by aiding with the diagnosis of the disease, the accurate quantification of its progression, and the delivery of targeted, personalized therapies – all in the same session. And soon, we hope to see it adopted earlier in the disease care pathway and across oncology to benefit more patients around the world."

To prepare for the creation of dedicated theranostics centers, SNMMI and related international molecular imaging societies recently published a new guide for healthcare systems globallyiii. Focusing on safety protocols and operational procedures, the guide provides a framework that highlights best practices that can be applied across care areas.

"Nuclear medicine is entering a new age of precision theranostics, in which next-generation alpha- and beta-labeled radiotherapeutics are tailored to individual cancer patients using the latest diagnostic PET radiopharmaceuticals," explains Dr. Peter Scott, Associate Professor of Radiology, Division Director of Nuclear Medicine, University of Michigan. "With the FDA approval of a new PSMA-agent for treatment of prostate cancer, the future is here. Patients, their families and referring physicians are all demanding access to theranostics, creating an unprecedented demand for higher and higher amounts of radioactive metals. The only way to meet the global need for PET radionuclides like Gallium-68 and Copper-64 is through commercial solid-target solutions suitable for routine use."

As the industry prepares to usher in this new era of precision health and personalized medicine, GE Healthcare is proud to offer innovative molecular imaging solutions to healthcare systems around the world.

Discovery with the Molecule Journey: Enabling Precision Health: The enablement of theranostics in prostate cancer care begins with the production of radioisotopes for use in diagnostic tracers – namely Gallium-68 PSMA-11 – which is administered to the patient, attaches to specific cancer cells, and releases radioactive emissions to provide detailed molecular information unique to each patient.

However, shortages of the generators that produce Gallium-68 historically have created serious challenges for clinicians and limited patient access. In response, GE Healthcare is proud to introduce a new Solid Target Platform for its PETtrace cyclotron which – in combination with its FASTlab 2 New Edition platform – can produce 100x the amount of Gallium compared to a generator for increased theranostics capabilities and access in prostate cancer patient careiv.

While solid targets have been around for some time, they have traditionally been viewed as research tools and required complicated infrastructure and highly trained operators. Now, with GE Healthcare’s TRACERcenter Solutions and new PETtrace Solid Target Platform, healthcare systems can more easily access the equipment, tracers and staff training necessary to deliver a more cost-effective, personalized solution.

Diagnosis: Accurately Staging & Quantifying Disease: To read the emissions released by the Gallium-68 PSMA-11 tracer, the patient must be imaged using a highly sensitive PET/CT scanner. This technology provides the clinician detailed information that is used to better understand the structure and function of each patient’s tissue and disease state to help form personalized therapy recommendations. The more sensitive the PET/CT, the more accurate the images and quantification.

To this end, GE Healthcare is now shipping its Discovery MI Gen 2 premium digital PET/CT system, which provides next-level digital detection with an axial field of view (FOV) scalable up to 30 centimeters to achieve a 125 percent increase in sensitivityv. This helps translate to 33 percent improvement in scan times or dose amountsvi.

These capabilities are further supported by Q.Clear, which offers up to 2x improvement in both image quality (SNR) and quantitation accuracy (SUVvii), and MotionFree for up to 67 percent improvement in lesion volume measurements, helping inform clinicians’ prostate cancer therapy recommendationsviii.

Additionally, this scanner includes a CT that is designed to allow TrueFidelity deep-learning image reconstruction to enable image sharpness and improved noise textureix. Discovery MI Gen 2 proclaims up to a 41 percent increase in small lesion detectabilityx.

Treatment: Delivering & Monitoring Targeted Therapy: With regard to therapy, the FDA recently approved Lutetium-177 PSMA-617 – an exceptional therapy for advanced prostate cancer – in March 2022. It works by binding to and delivering a small amount of radiation to prostate cancer cells anywhere in the body to help patients with advanced prostate cancer live longer and maintain quality of lifexi.

To help clinicians evaluate the success of these therapies, GE Healthcare developed its breakthrough StarGuide SPECT/CT system with 12 cutting-edge CZT detectors that not only scan patients in 3D to provide more information to clinicians but are also optimized for Theranostics procedures – including imaging this latest Lutetium-177-based prostate cancer therapy.

Compared to conventional technologies, StarGuide’s Digital Focus CZT detectors offer improved volume sensitivity and SPECT resolutionxii, which is especially valuable for imaging both peaks of Lutetium-177 emissions, which in turn helps clinicians pinpoint the size, shape, and position of lesions with exceptional accuracy. Paired with GE Healthcare’s innovative Q.Clear solution for SPECT reconstruction, the resulting images provide outstanding quantification for the diagnosis and staging of disease and monitoring of treatment.

Increasing Accuracy & Efficiency: Artificial intelligence (AI) also offers new opportunities to streamline workflows, provide accurate data, and help expedite diagnoses across care areas – all valuable offerings in today’s resource constrained healthcare environment.

That’s why GE Healthcare also offers the Xeleris V image processing solution with a collection of AI-enabled clinical applications to help simplify and enhance workflows. This includes Q.Thera AIxiii, which is designed to leverage Q.Volumetrix MI to help clinicians automatically and accurately segment areas of interest – including AI-based kidney segmentation – for quantitation and dosimetry calculations, all with the goal to help reduce the time required for the user to process and calculate dose – enabling them to spend more time with patients.

The advancement of imaging technologies and continuous evolution and discovery of new tracers and targeted therapies is ushering in a new era in healthcare – one in which precision health and theranostics exist at its core. Prostate cancer is only the beginning, with many more applications under development for the future.

GE Healthcare is proud to offer clinicians unique opportunities to make personalized care decisions and treatment response assessments for the benefit of patients around the world. The company is uniquely positioned to advance these efforts as the only partner with solutions spanning from molecular imaging diagnostics, cyclotrons, chemistry synthesis, PET/CT, PET/MR, nuclear medicine, advanced digital solutions, and pharma partnerships to cover the breadth of steps from discovery to diagnosis to treatment.

I-Mab Alters Collaboration with Ferring Pharma for Developing IBD Candidate

On June 9, 2022 Shanghai I-Mab reported that it will alter its collaboration with Switzerland’s Ferring Pharma to develop olamkicept, a potential therapy for inflammatory bowel disease (Press release, I-Mab Biopharma, JUN 9, 2022, View Source [SID1234615863]). In 2016, I-Mab acquired rights to develop olamkicept. a selective interleukin-6 inhibitor, in Greater China and Korea. Now, Ferring will invest in the global development of olamkicept, while I-Mab will have an option to collaborate with Ferring in olamkicept’s global development at a pre-defined milestone. No details were given, though Ferring mal underwrite a China Phase III trial of olamkicept, and I-Mab will opt into global development later.

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