On October 24, 2022 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported results from its Phase 3 SPOTLIGHT trial that evaluated the impact of various clinical factors, including baseline Prostate Specific Antigen (PSA) levels, PSA doubling time and Gleason score, on detection rates (DRs) for 18F-rhPSMA-7.3 in recurrent prostate cancer (Press release, Blue Earth Diagnostics, OCT 24, 2022, View Source [SID1234622314]). 18F-rhPSMA-7.3 is an investigational high affinity radiohybrid (rh) Prostate-Specific Membrane Antigen-targeted PET imaging agent. The results were reported in an oral presentation at the American Society for Radiation Oncology (ASTRO) 2022 Annual Meeting in San Antonio, Texas.

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"The ability to determine the extent and location of recurrent prostate cancer to inform appropriate clinical management for these men is key for physicians and their patients, because up to 40% of patients who undergo radical prostatectomy, and up to 50% of patients who undergo radiation therapy will develop local or distant recurrences within 10 years," said Benjamin Lowentritt, MD, Chesapeake Urology Research Associates, Towson, Md., on behalf of the SPOTLIGHT Study Group. "A rising PSA after radical prostatectomy usually precedes a clinically detectable recurrence by years, but cannot differentiate between local, regional, or systemic disease. The utility of conventional imaging for the localization of recurrence is limited, particularly in patients with low PSA levels. Relapse after curative-intent primary treatment remains a considerable clinical burden, and precise imaging techniques are required to identify areas of involvement to facilitate the delivery of optimized patient management. These findings from the SPOTLIGHT study showed high DRs by majority read for 18F-rhPSMA-7.3 PET over a wide range of baseline PSA levels."

"These results from the Phase 3 SPOTLIGHT trial in biochemically recurrent prostate cancer are included in our New Drug Application for 18F-rhPSMA-7.3 PET imaging currently under review by the U.S. Food and Drug Administration, and we are pleased that they are being presented to the radiation oncology community at ASTRO 2022," said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. "In line with our mission to help patients with cancer across the care continuum, Blue Earth Diagnostics continues to develop our comprehensive prostate cancer portfolio, which includes 18F-fluciclovine and investigational rhPSMA compounds for potential use in diagnostic PET imaging and targeted radiopharmaceutical therapy. 18F-rhPSMA-7.3 represents a new class of PSMA-targeted PET radiopharmaceuticals, with early studies 18F‐rhPSMA‐7.3 showing a high binding affinity for PSMA, together with biodistribution data suggesting the potential for low bladder activity."

The findings presented at ASTRO included analyses of clinical factors impacting DRs for 18F-rhPSMA-7.3 evaluated by three blinded central readers: DRs, including region-level analyses, stratified by baseline PSA levels, PSA doubling time, Gleason score and prior treatment (radical prostatectomy with or without radiotherapy, or radiotherapy only). For example, results showed that among the 389 patients in the Evaluable PET Scan Population, the patient-level DR of 18F-rhPSMA-7.3 PET by majority read was 83% (322/389). When stratified by PSA level, the DRs were: PSA <0.5 ng/mL: 64% (77/121); PSA ≥0.5 and <1 ng/mL: 76% (51/67); PSA ≥1 and <2 ng/mL: 93% (42/45); PSA ≥2 and <5 ng/mL: 98% (86/88); PSA ≥5 and <10 ng/mL: 94% (34/36); and PSA ≥10 ng/mL: 100% (32/32). As noted previously, no serious adverse reactions were attributed to 18F-rhPSMA-7.3 PET in the SPOTLIGHT study. Overall, 16 (4.1%) patients had at least one treatment-emergent adverse event that was considered possibly related/related to 18F-rhPSMA-7.3. The most frequently reported events were: hypertension: 1.8% (n=7); diarrhea: 1.0% (n=4); injection site reaction: 0.5% (n=2), and headache: 0.5% (n=2).

The SPOTLIGHT trial (NCT04186845) is a Phase 3, multi-center, single-arm imaging study conducted in the United States and Europe to evaluate the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. Key results for 18F-rhPSMA-7.3 PET were previously presented at ASCO (Free ASCO Whitepaper) GU in February 2022,1 with additional results announced at AUA in April 20222 and at SNMMI in June 2022.3

The findings were discussed in an oral presentation at ASTRO 2022 on October 24, 2022, "Impact of clinical factors on 18F-rhPSMA-7.3 detection rates in men with recurrent prostate cancer: Findings from the phase 3 SPOTLIGHT study," by Benjamin Lowentritt, MD, Chesapeake Urology Research Associates, Towson, Md., on behalf of the SPOTLIGHT Study Group. Full session details and the abstract are available in the ASTRO online program HERE.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

rhPSMA compounds consist of a radiohybrid ("rh") Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells and they may be radiolabeled with 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: ("SPOTLIGHT," NCT04186845), in men with recurrent disease and ("LIGHTHOUSE," NCT04186819), in men with newly diagnosed prostate cancer. Currently, rhPSMA compounds are investigational and have not received regulatory approval.

On October 24, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data from UTILISE (Clinical Utility and Health Outcomes Study), a prospective, multi-center, clinical utility study of DecisionDx-SCC, designed to capture the real-world impact of DecisionDx-SCC test results on the management of patients with cutaneous squamous cell carcinoma (cSCC) and one or more risk factors (Press release, Castle Biosciences, OCT 24, 2022, View Source [SID1234622313]). This first analysis showed that DecisionDx-SCC test results positively impacted patient management in over 80% of the patients enrolled in the study, consistent with previous clinical utility studies demonstrating that the test’s results can impact risk-appropriate changes in patient management plans, within established guidelines.

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"A true litmus test of any prognostic test is its ability to provide clinically actionable information that can drive positive change in the overall management of patients and more informed decisions than may be possible without the test’s results," said Matthew S. Goldberg, M.D., board-certified dermatologist and dermatopathologist and medical director at Castle Biosciences. "The initial data from our UTILISE study highlights the potential of DecisionDx-SCC test results to prompt risk-aligned changes in treatment plans for patients with high-risk cSCC, with clinical actionability rates comparable to the impact of molecular tests currently covered by Medicare for other disease states, such as breast, prostate and lung cancer."

This data from the UTILISE study was presented during the 2022 Fall Clinical Dermatology Conference through a poster titled, "A prospective clinical utility study demonstrates that physicians use the 40-gene expression profile (40-GEP) to guide clinical management decisions for Medicare-eligible patients with cutaneous squamous cell carcinoma (cSCC)." The poster can be viewed here.

In the study, clinician recommendations for patient management are recorded before and after DecisionDx-SCC testing using standard pre-test/post-test methodology, and any additional changes in management plans and patient outcomes are recorded every six months for three years. In this analysis of Medicare-eligible patients with high-risk cSCC (n=59), clinicians indicated that the DecisionDx-SCC test result was the most influential factor impacting their management plans for 42% of the patients. Additionally, DecisionDx-SCC test results positively impacted patient management in over 80% of patients in the cohort, with clinicians reporting increased confidence in the recommended treatment plan (59%) and risk-aligned management changes based on the tests’ results (24%). While additional analyses from UTILISE are forthcoming, the initial data from this real-world study support findings in previous clinical utility studies that DecisionDx-SCC provides valuable risk-stratification information that can guide patient management decisions and risk-appropriate treatment plan changes within established guidelines.

The following additional posters highlighting the performance of Castle’s suite of tests for skin cancer were also shared during the 2022 Fall Clinical Dermatology Conference:

DecisionDx-Melanoma

Poster titled, "Incorporating the 31-gene expression profile test stratifies survival outcomes and leads to improved survival compared to clinicopathologic factors alone: A Surveillance, Epidemiology, and End Results (SEER) Program collaboration," is available to view here.
Diagnostic GEP (MyPath Melanoma and DiffDx-Melanoma)

Poster titled, "A clinical impact study of dermatologists’ use of the 23- or 35-gene expression profile tests to guide surgical excision and enhance management plan confidence," is available to view here.
DecisionDx-SCC

Poster titled, "How Mohs surgeons utilize prognostic testing for high-risk cutaneous squamous cell carcinoma (SCC): a clinical impact study," is available to view here.
Poster titled, "Performance and clinical decision-making using the prognostic 40-gene expression profile (40-GEP) test in 1,018 patients with high-risk cutaneous squamous cell carcinoma (SCC)," is available to view here.
About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

About MyPath Melanoma and DiffDx-Melanoma

MyPath Melanoma and DiffDx-Melanoma are Castle’s two gene expression profile tests designed to provide an accurate, objective result to aid dermatopathologists and dermatologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately two million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. For these cases, the treatment plan can also be uncertain. Obtaining accurate, objective ancillary testing can mean the difference between a path of overtreatment or the risk of undertreatment. Interpreted in the context of other clinical, laboratory and histopathologic information, MyPath Melanoma and DiffDx-Melanoma are designed to reduce uncertainty and provide confidence for dermatopathologists and help dermatologists deliver more informed patient management plans.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a risk stratification gene expression profile test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 9,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 35 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through June 30, 2022, DecisionDx-Melanoma has been ordered 105,239 times for patients diagnosed with cutaneous melanoma.

On October 24, 2022 Scenic Biotech, a pioneer in the discovery of genetic modifiers developing therapeutics to treat severe diseases, reported the appointment of Jens Würthner, MD, PhD, as Chief Medical Officer (Press release, Scenic Biotech, OCT 24, 2022, View Source [SID1234622312]). Dr. Würthner brings Scenic Biotech 20 years of clinical development expertise. His track record includes the successful progression of drug candidates from Phase I initiation to regulatory submission, most recently during his tenure as Vice President, Head of Global Clinical Development at ADC Therapeutics. Dr. Würthner has also led clinical development programs at large pharmaceutical companies, namely Novartis, GlaxoSmithKline and AstraZeneca. As a member of the Scenic Biotech leadership team, he will be responsible for the clinical evaluation of the Company’s lead candidate targeting QPCTL, the druggable modifier of the CD47 innate immune checkpoint, as well as Scenic Biotech’s pipeline of genetic modifier-based small-molecule candidates to treat severe metabolic diseases.

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"Jens joins us at a pivotal time as we transition toward becoming a clinical development-stage company with a growing pipeline of proprietary and partnered programs," said Oscar Izeboud, CEO of Scenic Biotech. "His deep understanding of clinical strategy, trial execution and regulatory affairs as well as therapeutic expertise in oncology and rare diseases gained at leading international biopharmaceutical companies makes him an outstanding addition to our team."

"Scenic Biotech has established a robust technology platform to identify genetic modifiers and translate those discoveries into small molecule drug candidates to treat a range of severe diseases. I am excited to work alongside Oscar and everyone at Scenic Biotech as we advance a broad portfolio of disease-modifying therapeutics for the benefit of patients," added Dr. Jens Würthner, Chief Medical Officer of Scenic Biotech.

Dr. Würthner’s career spans the biotechnology and pharmaceutical industries as well as research institutes and academic hospitals. Prior to his role at Scenic Biotech, Dr. Würthner served as the Vice President, Head of Global Clinical Development at ADC Therapeutics, where he oversaw all aspects of clinical development including that of loncastuximab teserine (Zynlonta) among other successful development programs. Before that, he was Lead Clinical Program Leader at Novartis, where he was responsible for the advance of small molecule compounds and a monoclonal antibody through multiple clinical trials. Additionally, he held a seat on Novartis’ Integrated Safety Assessment Board, reviewing all therapeutic compounds moving into first-in-human studies. Prior to that, Dr. Würthner was Director and Indication Leader of Translational Pharmacology and Discovery Medicine at GlaxoSmithKline. He served as an Oncology Research Physician at AstraZeneca, where he was appointed Member of the Immunotoxicology Advisory Panel. Dr. Würthner has been a featured author on numerous publications and serves as visiting professor for Kings College, Faculty of Life Sciences & Medicine. He holds an MD and a PhD from the University of Hamburg and completed a postdoctoral fellowship at the Laboratory of Cell Regulation & Carcinogenesis, National Cancer Institute, National Institutes of Health in Bethesda, Maryland.

On October 24, 2022 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that it will host a research and development day, featuring key opinion leaders (KOL), with a focus on the Company’s CDK2/9 inhibitor, oral fadraciclib, and PLK1 inhibitor, oral CYC140, on Monday, October 31, 2022 at 10:00 am Eastern Time (Press release, Cyclacel, OCT 24, 2022, View Source [SID1234622311]).

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The R&D Day will feature renowned KOLs in oncology and program updates from senior management.

Jasmine Zain, MD, from City of Hope National Medical Center, will be providing an overview of the unmet medical needs in the treatment of T-cell lymphomas.
Do-Youn Oh, MD, PhD, from Seoul National University, will discuss unmet medical needs and current treatment options for hepatobiliary cancers.
The Cyclacel leadership team will then provide a program update on the company’s pipeline, highlighting patient data from the 065-101 oral fadraciclib Phase 1/2 study in solid tumors and lymphoma. In addition, an update will address progress with CYC140, Cyclacel’s oral PLK1 inhibitor, in a Phase 1/2 study as a potential treatment for solid tumors and lymphoma.

A live Q&A session will follow the formal presentations. To register for the event, please click here.

Dr. Zain is a professor in the Department of Hematology & Hematopoietic Cell Transplantation and Director of the T cell Lymphoma Program at the Toni Stephenson Lymphoma Center at City of Hope since 2014. She has led many clinical trials for T cell lymphomas and is a member of the NCCN Guidelines Committee for the treatment of T cell lymphomas.

Dr. Zain obtained her medical degree from Fatima Jinnah Medical College for Women in Lahore, Pakistan. She went on to complete an internship and residency at North Shore Hospital, Forest Hills, NY, followed by a hematology/oncology fellowship at New York University Medical Center. During her career she has worked at many institutions including Columbia University and NYU Medical Center. Her focus remains in developing novel therapies for T cell lymphomas.

Triple-board certified in hematology, oncology and internal medicine, Dr. Zain is an active member of several professional associations and has published more than 78 peer-reviewed publications, abstracts and book chapters. She has been invited to speak both nationally and internationally.

Dr. Oh is Professor, Division of Medical Oncology, Department of Internal Medicine at Seoul National University and Seoul National University College of Medicine.

Dr. Oh graduated from Seoul National University College of Medicine in 1997, and had residency training in Internal Medicine, and a fellowship in Hematology/Medical Oncology training at the Seoul National University Hospital. She received her PhD in the Department of Internal Medicine at the Seoul National University College of Medicine in 2005.

Her main research interests include gastric, pancreatic, and biliary tract cancer, with a particular interest in translational research and early new drug development. She has published over 250 peer-reviewed journal articles and has many committee memberships, including the Korean Cancer Association, Korean Association of Clinical Oncology, Korean Cancer Study Group, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), and American Association for Cancer Research (AACR) (Free AACR Whitepaper).

On October 24, 2022 Theriva Biologics (NYSE American: TOVX), ("Theriva" or the "Company"), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported a presentation of previously released data from a Phase 1 investigator-sponsored study evaluating VCN-01 in combination with durvalumab for patients with recurrent/ metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) (Press release, Theriva Biologics, OCT 24, 2022, View Source [SID1234622309]). Data will be featured in an oral presentation at the 14th International Oncolytic Virotherapy (IVOC) Conference, being held from in Karuizawa, Japan from October 23-26.

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Details on the presentation can be found below.

Title: VCN-01 changes tumor stroma when administered systemically in combination with Durvalumab (MEDI4736) in subjects with recurrent/ metastatic squamous cell carcinoma of the head and neck (R/M HNSCC): Biological data of a Phase I Study
Abstract: 0136
Presenter: Frank Tufaro, Ph.D., Chief Operating Officer of Theriva Biologics
Presentation Date and Time: Tuesday, October 25, 2022 at 11:20 a.m. JST/Monday, October 24, 2022 at 10:00 p.m. ET
Location: Karuizawa Prince Hotel West
A copy of the presentation will be accessible under the ‘Events’ section of the Theriva Biologics website.