On October 18, 2022 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported the signing of a data-sharing agreement with Siemens Healthineers and the University Hospital of the Technical University of Munich (TUM) for anonymized 18F-rhPSMA-7.3 clinical data and images (Press release, Blue Earth Diagnostics, OCT 18, 2022, View Source [SID1234622145]). Siemens Healthineers plans to evaluate the data to enhance its analytics and artificial intelligence (AI)-based algorithms for prostate cancer across its advanced PET/CT imaging software. 18F-rhPSMA-7.3 is an investigational radiohybrid (rh) Prostate-Specific Membrane Antigen-targeted PET imaging agent in development by Blue Earth Diagnostics for diagnostic imaging of newly diagnosed and biochemically recurrent prostate cancer.

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"Blue Earth Diagnostics is committed to helping men with prostate cancer across the care continuum, and we recognize the importance of AI in advancing healthcare," said David Gauden, D.Phil., Chief Executive Officer, Blue Earth Diagnostics. "AI-based algorithms have the potential to streamline the PET/CT analytical workflow for hospitals and imaging centers, by efficiently providing physicians with information critical to patient management and care, and freeing them to spend more time with patients. Blue Earth has a long-standing relationship with Siemens Healthineers, a leading medical technology company pioneering breakthroughs in healthcare. We are excited to collaborate on this project to facilitate provision of anonymized 18F-rhPSMA-7.3 data from TUM which will be used to enhance the analytical workflows for the Siemens Healthineers Biograph and syngo.via platforms. The project includes evaluation of diagnostic analytical techniques for 18F-rhPSMA-7.3 data as well as exploring their theranostic potential in radiopharmaceutical therapy. Looking forward, we also plan to make analytical data from Blue Earth Diagnostics’ Phase 3 clinical trials for 18F-rhPSMA-7.3 available, which includes robust histopathology data as the gold Standard of Truth."

The agreement covers use of anonymized 18F-rhPSMA-7.3 PET/CT data from TUM by Siemens Healthineers to evaluate workflow improvements for image acquisition and interpretation; dose optimization; detection of small metastases and recurrent tumors; evaluation of patients in earlier stages of disease progression and stratification by low PSA levels; and, together with histopathology, assessment of the sensitivity of results. The data will also be used to define and optimize 18F-rhPSMA-7.3 workflow prior to PSMA-targeted radioligand therapy in prostate cancer, to assess its theranostic potential in therapeutic dose planning and the likelihood of treatment success.

"The TUM experience with rhPSMA has allowed us to investigate the potential performance of a new class of theranostic PSMA-targeting agents that enable efficient labelling with radioisotopes such as 18F for PET imaging or 177Lu for therapeutic use," said Matthias Eiber, MD, PhD, Department of Nuclear Medicine, Klinikum rechts der Isar, TUM. "We are happy that 18F-rhPSMA-7.3 PET/CT imaging scans performed at TUM as part of routine patient care in prostate cancer can be part of this project to inform AI-based algorithms for improved PET/CT workflows. The use of AI has the potential to markedly improve the quality of PET/CT as well as enhance the ability to interpret the scans and follow lesions over time. This will hopefully lead to expanded clinical use cases for this valuable technology, leading to better patient care."

"We are pleased to collaborate with Blue Earth Diagnostics and TUM on this data-sharing agreement for 18F-rhPSMA-7.3," said Bruce Spottiswoode, Director, Clinical Applications Research, Siemens Healthineers. "These data will help us optimize the acquisition and processing of 18F-based PSMA imaging and therapeutic radiopharmaceuticals across our family of PET/CT scanners and reading solutions."

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

rhPSMA compounds are referred to as radiohybrid ("rh"), as each molecule possesses three distinct domains. The first consists of a Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells. It is attached to two labelling moieties which may be radiolabeled with either 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. They may play an important role in patient management in the future, and offer the potential for precision medicine for men with prostate cancer. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics has completed two Phase 3 clinical studies evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in prostate cancer: ("LIGHTHOUSE," NCT04186819), in men with newly diagnosed prostate cancer, and "SPOTLIGHT," NCT04186845), in men with recurrent disease. Currently, rhPSMA compounds have not received regulatory approval.

On October 18, 2022 McKesson reported that it will play a major role in the upcoming 2022 Association for Value-Based Cancer Care (AVBCC) Summit, speaking on a wide range of topics that showcase their extensive knowledge of the changing healthcare landscape and oncology’s transformation to value-based care (Press release, McKesson, OCT 18, 2022, View Source [SID1234622144]). The Summit, to be held Oct. 19-21, 2022, in New York City, is an invitational forum that provides invaluable access to more than 200 diverse experts representing every stakeholder of the cancer care ecosystem.

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"Staying ahead of the rapidly evolving landscape is challenging, and events like this greatly help, bringing together some of the best practices and ideas we can share to improve practice sustainability, clinical research and cancer care," said Lalan Wilfong, MD, vice president, Payer Relations & Practice Transformation, The US Oncology Network. "We are committed to being at the forefront of value-based care and are excited to have the opportunity to collaborate with other thought leaders at this important meeting."

Summit participants will gain insights from a diverse range of practitioners, pharmacists, payers, policymakers and other key stakeholders who are nationally recognized in their fields. Attendees will learn strategies on how to stay competitive in the ever-changing field of oncology, explore cutting-edge methodologies enabling value-based care that can rapidly be implemented, and gain access to timely and accurate information from reliable sources to empower good decision-making. It facilitates achievable change by providing a forum for payers, providers and the entire oncology team to network and evaluate value in terms of quality, cost and impact on patient care and outcomes.

McKesson is represented at the Summit by several of its experts, speaking on a diverse array of topics including value-based agreements, oncology drug trends, pathways and decision support models. Summit sessions featuring affiliated speakers as panelists are:

Headwinds and Tailwinds Ahead for Value-Based Agreements (Oct. 19, 8:30 a.m.-9:30 a.m.)
Lalan Wilfong, MD, vice president, Payer Relations & Practice Transformation, The US Oncology Network
Succeeding in Value-Based Payment Arrangements: ASCO (Free ASCO Whitepaper)’s Patient Centered Cancer Care Certification Pilot (Oct. 19, 10:30 a.m.-11:30 a.m.)
Matthew Skelton, MD, oncologist and physician champion for value-based care, Blue Ridge Cancer Care, a practice in The US Oncology Network
Legal and Regulatory Issues Surrounding Value-Based Agreements (Oct. 19, 2:15 p.m.-3:15 p.m.)
Ben Jones, vice president, Government Relations & Public Policy, The US Oncology Network
Lessons Learned from OCM That Should Be Incorporated into EOM and Future Cancer Care Models (Oct. 20, 9:45 a.m.-10:45 a.m.)
Marcus Neubauer, MD, chief medical officer, The US Oncology Network
How Long is the Last Mile? Real-World Evidence’s Vast Potential and Challenges in Oncology (Oct. 20, 3:15 p.m.-4 p.m.)
Viraj Narayanan, chief commercial officer, Ontada
Utilization of Pathways in Precision Medicine to Impact Patient Care (Oct. 21, 8 a.m.-9 a.m.)
Ira Zackon, MD, senior medical director, Ontada
The Impact Pathways Have on Outcomes and Value (Oct. 21, 10 a.m.-11 a.m.)
Lalan Wilfong, MD, vice president, Payer Relations & Practice Transformation, The US Oncology Network, and Marcus Neubauer, MD, chief medical officer, The US Oncology Network
Oncology Drug Supply Channels and the Move to Smart Networks and Supporting Value-Based Agreements (Oct. 21, 10 a.m.-11 a.m.)
Heather Morel, PhD, president, Provider Solutions, McKesson
Practice Transformation Through Value-Based Analytics (Oct. 21, 11 a.m.-12 p.m.)
Lalan Wilfong, MD, vice president, Payer Relations & Practice Transformation, The US Oncology Network
Payer and Provider Innovative Value-Based Agreement (Oct. 21, 2 p.m.-2:45 p.m.)
Rhonda Henschel, senior director, Payer Solutions, The US Oncology Network, and Jay Scott, director, Managed Care, Minnesota Oncology, a practice in The US Oncology Network
AI and ML Decision Support Models (Oct. 21, 2 p.m.-2:45 p.m.)
Ira Zackon, MD, senior medical director, Ontada
The live event is invitation-only, limiting the number of guests to adhere to COVID-19 safety guidelines; however, there will be a virtual simulcast of the entire Summit for those who cannot attend in person.

On October 18, 2022 Abalos Therapeutics reported the appointment of Thomas Bogenrieder, MD, PhD, as Chief Medical Officer (Press release, Abalos Therapeutics, OCT 18, 2022, View Source [SID1234622143]). Dr. Bogenrieder will contribute more than 17 years of international clinical development experience including successfully guiding cancer immunotherapies through the clinical evaluation process. His expertise in the clinical development of cancer virotherapies will further strengthen the company’s leadership position and guide the design and implementation of clinical and regulatory strategies for the company’s product candidates. Abalos has developed a platform of arenavirus-based variants that have optimized anti-tumoral properties to trigger a highly precise and directed immune response against primary tumors and their metastases.

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"Thomas’ extensive experience in the clinical development of immuno-oncology drug candidates coupled with his track-record of successfully navigating interactions with regulatory bodies will be invaluable as we begin ramping up our medical and clinical operations," said Marcus Kostka, CEO of Abalos. "I am excited to welcome him to the Abalos team and look forward to working with him as we build the clinical development plan for our first arenavirus-based immuno-virotherapeutics product candidate and advance it towards clinical evaluation in solid tumor indications."

"Abalos has pioneered a unique approach that utilizes the arenavirus to achieve precise and directed immune responses to reach distant metastases and provide long-term disease control. I value the opportunity to join a great team focused on meeting the needs of cancer patients with a scientifically distinct approach that has the potential to change the treatment paradigm in solid tumors," commented Thomas Bogenrieder, Chief Medical Officer of Abalos.

Prior to his role at Abalos, Dr. Bogenrieder served as Chief Clinical Officer for AMAL Therapeutics, where he oversaw the clinical development of cancer vaccine candidates in combination with an oncolytic virus. Before AMAL, he served as Chief Medical Officer at Evaxion Biotech, a public company creating AI-driven, neoepitope-targeting personalized cancer immunotherapies and vaccines against infectious diseases. Over the course of his career, Dr. Bogenrieder has held several leadership roles in oncology and medical affairs at Boehringer Ingelheim and GlaxoSmithKline. Dr. Bogenrieder holds an MD from the Albert-Ludwigs-University, Medical School in Freiburg and a PhD from the University of Utrecht and completed a postdoctoral fellowship at the Memorial Sloan-Kettering Cancer Center in New York City.

On October 18, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that two abstracts highlighting the clinical value of the company’s Envisia Genomic Classifier and Percepta Nasal Swab tests in interstitial lung disease (ILD) and lung cancer, respectively, were presented as posters today at the American College of Chest Physicians (CHEST) Annual Meeting 2022, taking place in Nashville, Tenn., October 16-19 (Press release, Veracyte, OCT 18, 2022, View Source [SID1234622142]).

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The first poster provides further evidence that the Envisia Genomic Classifier can help identify patients with ILD, including idiopathic pulmonary fibrosis (IPF), who are likely to have progressive disease. The Envisia test identifies a genomic pattern of usual interstitial pneumonia (UIP) in lung tissue samples obtained by transbronchial biopsy.

In a study of 135 patients with undiagnosed ILD, researchers found that those who had an Envisia-positive result for UIP had a lower baseline lung function, as measured by forced vital capacity (FVC) testing, compared to patients with an Envisia-negative result for UIP (66.9% vs. 73.4%; p=0.034). They also had a significantly lower FVC when measured approximately one year later (63.2% vs. 73.3%; p=0.002). Further, Envisia-positive patients had a significantly greater absolute decline in FVC compared to Envisia-negative patients (-3.7% vs. 0.1%; p=0.03) and findings were similar independent of pathology results.

"Our findings suggest that a positive Envisia test result may serve as a biomarker for FVC decline by identifying the genomic signature of UIP in patients whose CT scans do not reveal definitive UIP." said Lisa Lancaster, M.D., professor of Medicine at Vanderbilt University Medical Center, who presented the findings at the CHEST meeting. "Importantly, the Envisia test may help identify patients with progressive pulmonary fibrosis who could potentially benefit from earlier therapy before they might experience significant, irreversible loss of lung function."

Researchers also presented new preliminary study findings for use of the Percepta Nasal Swab test on potentially cancerous lung nodules found on CT scans. Veracyte developed the novel, noninvasive Percepta Nasal Swab test to help physicians more accurately, quickly and confidently determine which patients with lung nodules are low-risk for cancer and can be safely directed to routine monitoring, and which are high-risk for cancer and should proceed to further diagnostic work-up and treatment as needed.

The new data suggest that the Percepta Nasal Swab test may categorize more lung nodule patients as low-risk or high-risk for cancer, as compared to the standard-of-care (SOC) approach, which consists of a physician’s own assessment of clinical factors along with CT imaging. Previous data have demonstrated that the Percepta Nasal Swab test is highly accurate when it identifies patients as low- or high-risk for cancer.

"The data presented at the CHEST 2022 meeting reinforce our commitment to driving innovation that can help physicians make better care decisions for their patients," said Bill Bulman, M.D., medical director, Pulmonology, at Veracyte. "These findings suggest that, beyond helping to diagnose IPF, our Envisia test may also help to identify progressive disease in patients with other forms of ILD. Additionally, early results suggest that our Percepta Nasal Swab test may be able to change risk stratification so that patients with suspicious lung nodules may receive more-appropriate care."

On October 18, 2022 Syncromune, Inc., a clinical stage biopharmaceutical company focused on the development of combination intratumoral immunotherapy reported that the Company has signed an exclusive worldwide license agreement for YH002 (OX40 antibody) and two other active ingredients with Eucure (Beijing) Biopharma Co., Ltd. ("Eucure"), a wholly owned subsidiary of Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen") (Press release, Syncromune, OCT 18, 2022, View Source [SID1234622141]).

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Under the terms of the agreement, Syncromune will acquire global rights of development and commercialization of the intratumoral combination therapy containing Eucure’s YH002 and two other active ingredients as part of the Syncrovax therapy. Pursuant to the agreement, Eucure has the potential to receive hundreds of millions of US dollars, including an upfront cash payment that reflects the projected clinical value of the molecules, significant development and regulatory milestone payments, as well as royalties and other incentives based on the long-term commercial value of the Syncrovax combination therapy. Eucure will be responsible for drug manufacturing and supply, and Syncromune will be responsible for clinical development and commercialization.

The Syncrovax platform is a next-generation personalized cancer therapy being developed to optimize intratumoral immunotherapy for the treatment of metastatic solid tumor cancers. The technology aims to generate a personalized autologous cancer vaccine using a patient’s own cancer antigens. This new approach to fighting cancer is designed to generate a robust anti-cancer response by overcoming the immunosuppressive characteristics of metastatic cancers and addressing the limitations of current systemic immunotherapies. Syncromune intends to initially develop combination therapies for metastatic breast, prostate, and lung cancer, with a robust pipeline aimed at six additional target cancers.

"We are excited to enter into an exclusive licensing agreement with Eucure/Biocytogen," said Eamonn Hobbs, President and Chief Executive Officer of Syncromune. "This license agreement is an important step in the development of our proprietary Syncrovax platform and further supports Syncromune’s strategy to maximize our platform to build a sustainable cancer therapeutics company."

"We believe the antibodies developed with Biocytogen’s unique platform may provide competitive advantages," said Charles Link, M.D., Executive Chairman and Chief Medical Officer of Syncromune. "The preclinical data suggests that these second-generation molecules might have best-in-class potential."

"YH002 is a co-stimulating molecule for the OX40 target which has shown favorable safety and promising anti-tumor activity against solid tumors, " said Rong Chen, M.D., Ph.D., Chief Executive Officer and Chief Medical Officer of Eucure, and Vice President of Biocytogen. "We are excited to collaborate with Syncromune to realize the potential in intratumoral immunotherapy."

About Syncrovax

The Syncrovax platform therapy utilizes a combination approach of tumor activation and targeted delivery, aiming to synchronize the timing and location of tumor antigen release with the functional activation of immune cells. To achieve tumor activation, a portion of a target tumor is lysed to generate immunogenic cell death and the release of Damage Associated Molecular Patterns (DAMPs) and tumor antigens, changing the tumor microenvironment by creating an in situ vaccine. The second component of the platform, targeted delivery, involves the intratumoral infusion of a proprietary fixed-dose combination drug with 4 active ingredients into the lysed portion of the tumor. This is designed to provide immunostimulatory effects in the tumor microenvironment and draining lymph nodes, mitigate the cancer’s ability to block immune responses, and contribute to the activation of antigen presenting cells and cytotoxic T cells. The immune responses triggered by the in situ personalized vaccine enable the patient to vaccinate against multiple autologous antigens at the same time. The anti-cancer responses are expected to act at the site of the treated tumor as well as in metastases throughout the body.

About YH002

YH002 is a recombinant anti-OX40 humanized IgG1 agonistic antibody. The specificity, safety, and anti-cancer efficacy of YH002 have been demonstrated in a comprehensive panel of pre-clinical studies. The totality of pre-clinical data supports progression of YH002 combination therapy into clinical studies in adult subjects with locally advanced or metastatic solid tumors. A first-in-human (FIH), multicenter, open-label, Phase I dose-escalation study is currently underway in Australia to evaluate the safety, tolerability, and pharmacokinetics and determine the MTD/RP2D of YH002 in subjects with advanced solid malignancies.