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GE Healthcare Introduces Omni Legend: A First-of-its-Kind All-Digital PET/CT System to Drive Efficiency, Enhance Diagnostics, and Deliver on Precision Medicine

On October 16, 2022 At the European Association of Nuclear Medicine (EANM) Annual Meeting, GE Healthcare reported Omni Legendi, the first system on its all-new, all-digital PET/CT platform (Press release, GE Healthcare, OCT 16, 2022, View Source [SID1234622043]). This cutting-edge system features a brand-new category of digital BGO (dBGO) detector material with a small crystal size that delivers more than two times the sensitivity of prior digital scannersii, enabling faster total scan timesiii and impressive small lesion detectabilityiv. It is designed to improve operational efficiency, enhance the patient experience, and increase diagnostic power, ideally helping to enable improved patient outcomes.

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Additionally, the system’s theranosticsv capabilities and ability to image short life tracers, as well as dynamic protocolsvi, help empower clinicians with greater clinical information across more oncology, cardiology, and neurology procedure types than ever before.

"Sensitivity and image quality are everything in PET/CT," explains John Kennedy, Ph.D., Chief Physicist, Nuclear Medicine Department, Rambam Health Care Campus, and Lecturer at Technion – Israel Institute of Technologyvii. "Omni Legend delivers on both – meeting all our image quality criteria for oncology and providing impressive sensitivity to image high count tracers for cardiac and neuro imaging, which helps better inform patient diagnoses and monitoring. Also, we have been able to increase patient throughput by more than a third thanks to the system’s fast total scan times – even achieving 35 patient scans in a 9.5-hour shift – and reduce dose by 40% versus the previous equipment that was installed. This not only enables better patient access and experience but also allows us to increase overall hospital efficiencyviii."

As the pace of change in healthcare continues to increase, health plan leaders cite managing costs and driving operational efficiency as the top two challenges they face todayix. This is consistent with comments by global Molecular Imaging departments, which note operational efficiency as a top barrier to growing PET/CT procedure volumesx.

Omni Legend is GE Healthcare’s response to these growing challenges, helping healthcare systems overcome today’s barriers with a collection of intuitive workflow solutions enhanced by artificial intelligence (AI), including its new Precision DLi solution for deep learning image processing in PET/CT as well as its AI-based Auto Positioning Camera.

"Having access to high-quality images to determine patient care is foundational to administering quality healthcare," adds Prof. Zohar Keidar, Director of Nuclear Medicine & the PET/CT Department at Rambam and an Associate Clinical Professor at the Technion Faculty of Medicinevii. "With this in mind, a department like ours – which has a very heavy workload – requires a system that enables flexibility for emergency cases, in addition to our already packed schedules. Omni Legend provides that flexibility. Within a few short weeks/months, we were able to increase our number of scans by 150 percent – going from 30 to 45 patient scans per day. We used to have a long wait list; but today, if something is urgent, we can quickly scan a patient while keeping our other scheduled appointmentsviii. And the system’s clinical protocols afford us additional flexibility, allowing us to stage patients on any scanner, regardless of the system the patients was previously scanned on – affording us new opportunities in fleet management."

More than a new processing technique, Precision DLi is engineered using Deep Learning with a sophisticated deep neural network trained on thousands of images created with different reconstruction methods. It was designed to provide the image quality performance benefits most associated with hardware-based Time-of-Flight, such as better contrast-to-noise ratio, contrast recovery, and quantitative accuracy.

The capabilities of Omni Legend are further elevated by the inclusion of Q.Clear (BSREM), GE Healthcare’s pioneering PET image reconstruction technology, and MotionFree, the company’s proven, deviceless respiratory motion correction technology. Q.Clear helps to ensure reliable quantification, while MotionFree operates seamlessly in the background to correct respiratory motion artifacts for all patient types.

Furthermore, the new system’s operational efficiency solutions help improve the PET/CT imaging experience for both the technologist and the patient with convenient features that provide:

A fast data quality assurance process that saves time with streamlined calibration;
Simplified protocol selection on the gantry touchscreen and a new user interface to enable an easy PET/CT process from start to finish; and
Enhanced patient positioning capabilities as a result of AI-based Auto Positioning that automatically centers the patient for a completely hands-free positioning experience.
This streamlined patient setup frees up technologists to focus on making patients feel more comfortable. Omni Legend also features LED ambient lighting to encourage a calming mood as well as a graphic pattern for the patient to view in the system to help in both alleviating stress and reducing movement for nervous patients.

"We built our scalable Omni platform from the ground up to meet the needs of our customers and their patients today and in the future," shares Jean-Luc Procaccini, President & CEO, Molecular Imaging & Computed Tomography, GE Healthcare. "With the patient in mind, we leaned on our longstanding technological leadership and strong clinical collaborations to enhance the scan experience with entirely new components designed to help improve clinical outcomes. The result is an all-digital detector, a cutting-edge deep learning solution, and workflow enhancements to help enable more personalized care."

Omni Legend was designed with theranostics in mind, enabling clinicians to reach new levels of sensitivity and detectability for incredibly clear images. Already, the system boasts the highest sensitivity per cm in the marketxi and images Gallium 68 for diagnosis, staging, or restaging.

Future-ready capabilities include a multi-directional, upgradable platform that can potentially expand in each of the core dimensions of PET/CT imaging, including axial field-of-view, digital detector technology, software, CT capabilities, and imaging of new tracers.

Pacylex Announces Orphan Drug Designation Granted to PCLX-001 for the Treatment of Acute Myeloid Leukemia

On October 14, 2022 Pacylex reported that the U.S. Food and Drug Administration (FDA) granted PCLX-001 Orphan Drug Designation for "treatment of patients with acute myeloid leukemia (Press release, Pacylex Pharmaceuticals, OCT 14, 2022, View Source [SID1234645060])." PCLX-001 is a first-in-class N-myristoylation inhibitor in clinical development by Pacylex. PCLX-001 is currently being studied in non-Hodgkin lymphoma (NHL) and solid tumor cancer patients at 4 sites in Canada. Pacylex has filed an IND to study PCLX-001 in the U.S. in AML patients.

Dr. Michael Weickert, Pacylex’s President and CEO commented, "The 5-year survival rate for AML patients 20 and older is only 27%. Patients relapse despite existing therapies. We are developing a first-in-class therapy that tackles AML in a new way that has been very effective in disease models and may be synergistic with other approaches. Our trial will offer relapsed patients another option. This Orphan Drug Designation for PCLX-001 recognizes the importance of this potential new therapy for these patients."

The planned US study will be the first time an NMT inhibitor is tested in AML patients. The U.S. Department of Defense recently awarded a grant of $1.4 million to treat AML patients with PCLX-001. "Our ongoing clinical trial in people with NHL and solid tumors showed PCLX-001 was well-tolerated and achieved drug exposures likely to benefit AML patients," said Dr. John Mackey, CMO of Pacylex. "We look forward to treating AML patients with PCLX-001 in the near future."

In animal models of AML, PCLX-001 monotherapy produced complete remissions in subcutaneous AML cell line derived xenografts (CDXs). In tail-vein injected AML patient derived xenografts (PDXs), PCLX-001 treatment resulted in up to 95% reduction of human peripheral blood and bone marrow CD45+ cells, which include the malignant stem cell population responsible for disease relapse.

The ongoing clinical PCLX-001 trial in NHL and solid tumor patients is registered at ClinicalTrials.gov Identifier: NCT04836195.

The U.S. FDA Orphan Drug Designation is only granted to investigational therapies addressing medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug designation provides several benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity.

PCLX-001
PCLX-001 (aka DDD86481) is a first-in-class, small molecule NMT inhibitor originally developed by the University of Dundee Drug Discovery Unit as part of a program to treat African sleeping sickness, funded by Welcome Trust. Pacylex is developing PCLX-001 in the form of a once-a-day pill initially to treat leukemia and lymphoma. PCLX-001 has also been shown to inhibit the growth of lung and breast cancer tumors in animal models. In leukemia, lymphoma and breast cancer patients, the levels of NMT2 is correlated with survival, suggesting an important biological role in these cancers. In tests using cultured cancer cells in vitro, PCLX-001 is at least ten times as potent as ibrutinib (Imbruvica) and dasatinib (Sprycel), two clinically approved drugs currently used to treat hematologic malignancies.

Genor Biopharma officially launched the Phase I/II Clinical Trial of GB263T in China

On October 14, 2022 Genor Biopharma (Stock code: 6998.HK) reported that the first patient has been successfully dosed in a Phase I/II clinical trial of GB263T, a novel EGFR/cMET/cMET trispecific therapeutic antibody, in China for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC) and other solid tumors (Press release, Genor Biopharma, OCT 14, 2022, View Source [SID1234629909]).

Previously, the first patient has been successfully dosed in this GB263T FIH study in Australia.

About GB263T（EGFR/cMET/cMET）

GB263T is the world’s first EGFR/cMET/cMET tri-specific antibody targeting EGFR and two different epitopes of cMET and has been designed with the goal of improving safety and efficacy. Thus, GB263T is a highly differentiated tri-specific antibody that exhibits multiple mechanisms of action to inhibit primary and secondary EGFR mutations and cMET signaling pathway simultaneously. The unique sequential binding feature whereby c-MET VHH2 binding depends on c-MET VHH1 binding expands the safety and efficacy window.

Preclinical studies showed that GB263T potently blocked ligand-induced phosphorylation of EGFR and cMET, and demonstrated better dual inhibition of EGFR and cMET signaling pathways compared to the JNJ-372 analogue. GB263T effectively induced enhanced internalization of EGFR and cMET, and downregulated the expression levels of both EGFR and cMET proteins. The in vivo anti-cancer efficacy of GB263T was demonstrated in several different tumor models, such as those with EGFR exon 20 insertion, EGFR exon 19 deletion, including C797S mutation, and various cMET alteration models. In all the models studied, GB263T demonstrated significant and dose-dependent tumor inhibition. In addition, GB263T did not show any major toxicities in monkeys, even at a high dose given for four weeks in a GLP tox study.

Pacylex Announces Orphan Drug Designation Granted to PCLX-001 for the Treatment of Acute Myeloid Leukemia

On October 14, 2022 Pacylex reported that the U.S. Food and Drug Administration (FDA) granted PCLX-001 Orphan Drug Designation for "treatment of patients with acute myeloid leukemia (Press release, Greenfire, OCT 14, 2022, View Source [SID1234624500])." PCLX-001 is a first-in-class N-myristoylation inhibitor in clinical development by Pacylex. PCLX-001 is currently being studied in non-Hodgkin lymphoma (NHL) and solid tumor cancer patients at 4 sites in Canada. Pacylex has filed an IND to study PCLX-001 in the U.S. in AML patients.

The ongoing clinical PCLX-001 trial in NHL and solid tumor patients is registered at ClinicalTrials.gov Identifier: NCT04836195.

BMF-219 Enters the Clinic for KRAS Solid Tumors

On October 14, 2022 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared Biomea’s IND application to begin a Phase I/Ib trial of BMF-219, a selective, covalent menin inhibitor in patients with unresectable, locally advanced, or metastatic NSCLC, CRC, and PDAC with an activating KRAS mutation (Press release, Biomea Fusion, OCT 14, 2022, View Source [SID1234622111]).

"We are very excited to open this particular IND as we now look to validate the preclinical potential of BMF-219 in patients across several solid tumor types who have a KRAS mutation, which currently is associated with a very poor survival prognosis," said Thomas Butler, Biomea’s CEO and Chairman of the Board. "In January 2022, we mapped out perhaps one of the more aggressive clinical development plans among peer companies to initiate clinical studies of BMF-219 in up to seven tumor types by the end of 2022. I am so incredibly proud of our team’s extraordinary efforts to deliver on this plan, motivated by the persistent and significant unmet needs of numerous cancer patients."

Mr. Butler continued, "I would like to thank the FDA for their extraordinary effort clearing our IND on-time, and also our contract research organizations, our consultants, our investors, and of course TEAM FUSION for their commitment, guidance, and support in generating another broad and promising IND package for BMF-219."

KRAS is the most frequently mutated isoform amongst RAS oncogenes in human solid tumors, with high prevalence in NSCLC, CRC, and pancreatic cancer. With only one approved therapy targeting KRAS G12C for locally advanced or metastatic NSCLC, KRAS-driven tumors continue to represent a significant unmet medical need. A targeted pan-KRAS inhibitor has the potential to treat 25-35% of NSCLC, 35-45% of CRC, and approximately 90% of PDAC patients.

Menin is a scaffold protein and a required co-factor of oncogenic transcriptional proteins with functional interactions that are critical for the development of various cancers. As previously reported by Biomea Fusion, KRAS-mutant NSCLC, CRC, and PDAC cell lines and ex vivo preclinical models were highly sensitive to BMF-219. In preclinical models, high potency of BMF-219 was observed amongst various KRAS-mutant solid tumor cell lines, but not KRAS wild type, suggesting that BMF-219 broadly inhibited mutant KRAS in these tumor models. As a covalent menin inhibitor, BMF-219 has manifested advantages over the commercially KRAS-targeted inhibitor LUMIKRAS in multiple pre-clinical studies due to the independence of KRAS’ phosphorylation state within G12C tumors, and more broadly the ability to target multiple activating KRAS mutations.

About COVALENT–102

COVALENT-102 is an open-label, multi-cohort, multicenter, Phase I/Ib dose finding study evaluating the safety, tolerability, and clinical activity of escalating doses of oral BMF-219 administered to patients with unresectable, locally advanced, or metastatic NSCLC, CRC, and PDAC with a KRAS mutation.

About Non-Small Cell Lung Cancer (NSCLC)

NSCLC is the most common form of lung cancer, representing approximately 82% of all lung cancer cases or approximately 200,000 cases in the U.S. each year (Source: NCI SEER Data). Additionally, the five-year survival rate of NSCLC is approximately 25%. While lung cancer is the third most common form of cancer in the U.S. based on incidence, it contributes to the highest number of annual cancer deaths in the U.S. KRAS is the most frequently mutated oncogene in NSCLC, occurring in approximately 30% of patients. There remains a great unmet need for targeted therapies to address all KRAS driver mutations and avoid known mechanisms of resistance.

About Colorectal Cancer (CRC)

CRC is the fourth most common form of cancer and the second leading cause of cancer death in the U.S., representing approximately 150,000 cases in the U.S. each year (Source: NCI SEER Data). These cancers start in the rectum or the colon and can be diagnosed/identified early, even potentially as noncancerous polyps. The five-year survival rate of CRC is approximately 65%. Among other mutations, KRAS mutations occur in approximately 40% of patients with CRC. These mutations can not only help predict the absence of response to anti-EGFR therapy, but also result in poorer overall survival. Therefore, there’s a growing unmet need for personalized therapies for patients with KRAS-mutant colorectal cancer.

About Pancreatic Cancer (PDAC)

Pancreatic cancer is a relatively rare form of cancer in the U.S., representing approximately 60,000 cases in the U.S. each year (Source: NCI SEER Data). Pancreatic cancer is an aggressive cancer with a very low five-year survival rate of approximately 11%, indicating that there is a large unmet need. 80% of patients are diagnosed at an advanced stage, contributing to the low survival rate. KRAS mutations are found in nearly all pancreatic cancer patients and are considered as a driver of the malignant process in most of those patients.