On October 17, 2023 Nucleus RadioPharma, the world’s first fully integrated development, manufacturing, and supply chain organization for radiopharmaceuticals reported an oversubscribed $56 million Series A funding round led by Eclipse and GE HealthCare with participation from Echo Global, Fox Chase Cancer Center, Granger Management, Mayo Clinic, Mercy Health, and University of Missouri (Press release, Nucleus RadioPharma, OCT 17, 2023, View Source [SID1234636096]). With this round of funding, Nucleus RadioPharma will establish multiple new manufacturing facilities around the country, including Rochester, Minnesota, near Mayo Clinic, and build novel technology for the development, manufacturing, and distribution of radiopharmaceuticals.

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Radiopharmaceuticals offer a highly targeted approach to a wide variety of cancer types and stages. "Conceivably, many cancers have the potential to be treated with a properly designed radiopharmaceutical and yet, very few patients with cancer are receiving this kind of treatment," said Geoff Johnson, M.D., Ph.D., Chair of Nuclear Medicine, Mayo Clinic, and Chief Scientific Officer of Nucleus RadioPharma. Despite their promise, only a small fraction of patients are able to obtain these drugs due to limited production capacity and an outdated, fragmented supply chain. Nucleus RadioPharma was founded and built to ensure cancer patients can access potentially lifesaving radiopharmaceuticals by developing technologies to modernize the clinical development, manufacturing, and supply chain of these promising new therapies.

"Theranostic radiopharmaceuticals are offering promise for millions who currently have limited treatment options," said Charles S. Conroy, CEO of Nucleus RadioPharma. "As truly targeted therapies, these drugs are proving not only to be highly effective but also to maintain a superior safety profile. This funding advances the reach and impact of these life-saving agents, allowing for therapies that can be mass-produced, and offers hope to those with few alternatives."

In addition to its manufacturing capabilities, Nucleus RadioPharma will shape the development of a new supply chain network designed to move, track, and deliver materials to patients faster and more efficiently. This network will cover the entire process, from identifying target molecules and testing treatments to supporting regulatory approvals and delivering patient-ready medication. Nucleus will bring life-saving treatments to an even broader patient base with the completion of multiple large regional sites. To enable global logistics and distribution of these therapies, the company is developing novel software and hardware technologies.

"We co-founded Nucleus RadioPharma, and are leading their Series A, to propel the radiopharmaceutical industry forward," said Justin Butler, Partner at Eclipse. "Nucleus RadioPharma distinguishes itself as the first to offer an accelerated development platform, full-scale commercial manufacturing, and enhanced distribution through streamlined patient delivery systems. The company sets new standards for innovation in the industry, uniquely positioning Nucleus RadioPharma to unlock the full potential of the radiopharmaceutical sector."

Nucleus RadioPharma is positioned to expedite the availability of targeted radiopharmaceutical therapies through several ongoing partnerships and collaborations. These will enable rapid initiation of clinical trials, full support for formulation, analytical method development, regulatory guidance, and commercial manufacturing.

"Radiopharmaceuticals are a powerful tool in the fight against cancer," said Kevin O’Neill, President & CEO of GE HealthCare’s Pharmaceutical Diagnostics (PDx) segment. "Nucleus RadioPharma has made tremendous progress in the field in a short period of time. We are excited to partner with them to expand development, supply, and commercial manufacturing capabilities to make targeted radiotherapies and theranostics more accessible to patients globally."

On October 17, 2023 Diakonos Oncology Corporation ("Diakonos"), a clinical stage immuno-oncology company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s unique dendritic cell vaccine, DOC1021 (Press release, Diakonos Oncology, OCT 17, 2023, View Source [SID1234636095]). The designation was based on positive preliminary safety and efficacy data from a Phase 1 clinical trial enrolling patients with glioblastoma multiforme (GBM).

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FDA Fast Track designation is intended to speed development and review of drugs that show early clinical promise in treating severe or life-threatening conditions. This pivotal designation can help propel Diakonos closer to delivering DOC1021 to GBM patients, of which only 7% survive more than five years.

"The FDA’s decision acknowledges the potential of this new treatment approach for a very challenging disease," said Mike Wicks, Chief Executive Officer of Diakonos, "Our protocol represents a first for cancer immunotherapy and could be viable for many types of cancers beyond GBM."

Developed at the Texas Medical Center in Houston, DOC1021 represents a novel approach to fighting cancer that harnesses the body’s natural anti-viral immune response. By mimicking a viral infection with the patient’s cancer markers, DOC1021 leverages the body’s innate ability to detect and eliminate infected cells.

At the core of DOC1021 is Diakonos’ proprietary "double-loading" technique, which stimulates a previously undiscovered pathway for viral recognition and response. Using a patient’s dendritic cells, a type of white blood cell that detects threats, the unique cancer markers are loaded both internally and externally into the immune cells, which would simultaneously occur in a viral infection. Once the patient’s individualized treatment is prepared, it is administered through three precise injections targeting the deep cervical lymph node chains. This approach results in immune responses that directly target the central nervous system.

This revolutionary approach has shown remarkable outcomes, as the earliest patients have all exceeded survival expectations. DOC1021 also maintains an impressive safety profile. As the treatment enters the final stages of the clinical trial, no serious adverse events have been linked to it. In addition, without the need of genetic modification or artificial stimulation, DOC1021 further stands apart from other cancer immunotherapies.

"Because Phase I clinical trials are generally not statistically powered to demonstrate efficacy, detection of a statistically significant efficacy signal is very promising," said William Decker, Associate Professor of Immunology at Baylor College of Medicine and inventor of the DOC1021 technology.

Dr. Joseph Georges, FDA Sponsor-Investigator of the DOC1021 phase 1 clinical trial and Assistant Professor of Neurosurgery at the University of Arizona College of Medicine-Phoenix, said, "Historically, glioblastoma outcomes have been notoriously challenging to improve upon. From a clinical and scientific standpoint, the results we are observing with DOC1021 are encouraging. The vaccine’s mechanism of action and its unique route of administration showcase the potential of harnessing the body’s immune system to combat glioblastoma."

The Phase 1 open-label trial of DOC1021 (NCT04552886) is underway at the MD Anderson Cancer Center at Cooper University Health Care in Camden, NJ, and at the University of Texas Health Science Center in Houston. The trial is expected to complete this year.

GBM is the most common and lethal malignant brain tumor with an annual incidence of 3.19 per 100,000 persons in the U.S. About 61% of patients have the unmethylated subtype, which has demonstrated median survival of 15 months compared to 21.7 months for methylated GBM patients when treated with the standard of care.

On October 17, 2023 BostonGene, a leading provider of AI-based molecular and immune profiling solutions, reported that it will present three abstracts at ESMO (Free ESMO Whitepaper) Congress 2023 (Press release, BostonGene, OCT 17, 2023, View Source [SID1234636094]). This highly influential oncology event brings together clinicians, researchers, patient advocates, journalists and healthcare industry representatives from around the world to exchange and debate translational cancer science, present potentially practice-changing data and stimulate multidisciplinary discussions to improve treatment options for our patients. The event will be held on October 20 – 24, 2023, in Madrid, Spain, at the IFEMA MADRID. BostonGene will also exhibit in Hall 5, booth 550.

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BostonGene session details are below:

Abstract: 1215P
Title: Comparative analysis of cfDNA liquid biopsy and tumor-based next-generation sequencing (NGS) approaches
Date: Sunday, October 22
Presenter: Chris Davitt, PhD, BostonGene

This study compared the utility of cell-free DNA (cfDNA) liquid biopsy with tumor-based next-generation sequencing approaches, revealing a 66.2% and 31.4% increase in the detection of single nucleotide variants and insertions and deletions, respectively, in clinically actionable gene panels using cfDNA.

Abstract: 1963P
Title: Comprehensive profiling of chordoma reveals tumor microenvironment subtypes and unique molecular findings
Date: Monday, October 23
Presenter: Alexander Bagaev, PhD, BostonGene

Whole exome and whole transcriptome sequencing of chordoma patients identified distinct tumor microenvironment (TME) subtypes. In total, 89% of patients had immune-enriched (IE and IE/F) TMEs, highlighting potential avenues for targeted therapies, particularly immune checkpoint inhibitors, in the management of advanced chordomas.

Abstract: 1982P
Title: Transcriptomic analysis and tumor microenvironment (TME) classification reveals unique immune biology in HIV patients with Kaposi Sarcoma (KS)
Date: Monday, October 23
Presenter: Krystle Nomie, PhD, BostonGene

Transcriptomic analysis of HIV-positive and HIV-negative Kaposi Sarcoma (KS) patients revealed unique tumor microenvironment (TME) characteristics related to treatment response, suggesting potential avenues for novel therapeutic strategies in KS and emphasizing the importance of understanding the interplay between immune status and the TME.

To learn more or to schedule a meeting with BostonGene during the event, please contact Maria Proia at [email protected].

For more information, please visit the ESMO (Free ESMO Whitepaper) Congress 2023 website.

On October 17, 2023 Radionetics Oncology, Inc., a clinical stage radiopharmaceutical company focused on the discovery and development of novel agents for the treatment of a wide range of oncology indications, reported that the first subject has been dosed in its Phase 1 study of 68Ga-R8760 (Press release, Radionetics Oncology, OCT 17, 2023, View Source [SID1234636093]).

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Study R8760-101 (NCT05999292) is evaluating the safety and dosimetry of 68Ga-R8760, a first-in-class small molecule radioligand imaging agent being developed for patients diagnosed with adrenocortical carcinoma. 68Ga-R8760 was discovered by Radionetics Oncology for identifying melanocortin 2 receptor (MC2R)-expressing adrenocortical cancer lesions to select patients who may benefit from MC2R-directed radioconjugate therapy. The multi-center study is being conducted in the United States in collaboration with global leaders in the treatment of adrenocortical carcinoma.

"Adrenocortical carcinoma is a disease with a desperate need for new agents, as the last drug approved by the FDA was in 1970. MC2R is highly expressed on adrenocortical carcinoma tumors with limited expression in healthy tissue outside of the adrenal gland itself. Theranostic targeting of MC2R may provide a new approach for identifying and treating adrenocortical carcinoma," said Dr. Gary Hammer, M.D., Ph.D., the Millie Schembechler Professor of Adrenal Cancer at the University of Michigan Rogel Cancer Center and scientific advisor to Radionetics Oncology.

"Starting this exciting clinical study is an important milestone and was achieved within two years of the founding of Radionetics Oncology," said Brett Ewald, Chief Operating Officer. "Our team has a deep understanding of G-protein coupled receptors (GPCRs), leading to the identification of novel and compelling first-in-class imaging and therapeutic targets for oncology, such as MC2R. This coupled with our company’s chemistry, biology, and clinical expertise allows us to rapidly develop potent and selective radiopharmaceutical agents for clinical evaluation." Radionetics Oncology is developing a pipeline of new radiopharmaceuticals against novel targets and plans to have three clinical programs by 2024.

About 68Ga-R8760

68Ga-R8760 is a gallium-68-labeled small molecule radioligand conjugate that selectively binds with high affinity to MC2R, a highly expressed target on adrenocortical carcinoma. It is the first imaging agent developed to localize and identify MC2R-expressing tumors and is being developed to identify patients with adrenocortical carcinoma who may benefit from a MC2R-directed therapeutic agent that is also being developed by Radionetics Oncology. Adrenocortical carcinoma is a rare cancer of the adrenal cortex with limited treatment options, especially in the recurrent or metastatic setting. Despite significant research efforts, the median survival of patients with metastatic disease is less than 15 months.

On October 17, 2023 Eucure Biopharma, a wholly owned subsidiary of Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315), reported that it will attend and present a poster at the ESMO (Free ESMO Whitepaper) Congress 2023, taking place in Madrid, Spain from October 20-24, 2023 (Press release, Biocytogen, OCT 17, 2023, View Source [SID1234636092]). The poster will summarize data from a completed phase I study of YH003, an independently developed anti-CD40 monoclonal antibody (mAb).

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Poster title: Phase I open-label, dose escalation and expansion study of YH003, an anti-CD40 agonist monoclonal antibody in combination with toripalimab in patients (pts) with advanced solid tumours.
Presenting author: Dr. Ben Markman
Clinical Trial #: NCT04481009
Final publication number (FPN): 1041P
Category: Investigational immunotherapy
Presentation date: Monday 23 October

Clinical data indicates that YH003 has favorable pharmacokinetics, and is well tolerated when used in combination with the anti-PD-1 mAb Toripalimab. The combination therapy has also shown encouraging anti-tumor activity in patients with advanced solid tumors.

About YH003

YH003 is a humanized IgG2 agonistic anti-CD40 monoclonal antibody. Whether used as a single agent or in combination with anti-PD-1 monoclonal antibody drugs, YH003 demonstrated strong anti-tumor effects in multiple tumor models in Biocytogen’s humanized CD40 mice, without exhibiting hepatotoxicity or other toxicities. Pharmacodynamic studies in mice indicates that YH003 significantly increased the infiltration of anti-tumor T cells into tumors. Currently, YH003 is undergoing phase II multi-regional clinical trials (MRCTs) for the treatment of patients with unresectable/metastatic pancreatic ductal adenocarcinoma (PDAC) and melanoma.