On May 18, 2020 Blue Earth Diagnostics, a Bracco company focused on molecular imaging diagnostics, reported results from early clinical experience in Germany with positron emission tomography/computed tomography (PET/CT) imaging using rhPSMA-7.3 (18F), a radiohybrid Prostate Specific Membrane Antigen-targeted compound (Press release, Blue Earth Diagnostics, MAY 18, 2020, View Source [SID1234558228]). The results were presented by the Technical University of Munich (TUM) in an oral presentation at the American Urological Association’s AUA2020 Virtual Meeting on May 15, 2020. Results of the retrospective analysis of 56 patients with intermediate or high-risk prostate cancer indicated that rhPSMA-7.3 (18F) PET/CT demonstrated a patient-level sensitivity of 81%, specificity of 88% and diagnostic accuracy of 86%, when on-site image interpretations were compared to histopathological findings.

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Blue Earth Diagnostics is conducting two Phase 3 clinical trials of rhPSMA-7.3 (18F) PET imaging. The LIGHTHOUSE study (NCT04186819) will examine the potential use of rhPSMA-7.3 (18F) in newly diagnosed prostate cancer, and the SPOTLIGHT study (NCT04186845) is focused on its potential use in biochemical recurrent prostate cancer. Results from the early clinical experience by TUM, including with rhPSMA-7.3 (18F) PET, were included Blue Earth Diagnostics’ Investigational New Drug (IND) submission.

"We are very pleased that TUM is able to share the results of this early clinical experience with the prestigious urology community through the Virtual Science platform at AUA2020," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. "Blue Earth Diagnostics has rapidly advanced our rhPSMA-7.3 (18F) research program since acquiring exclusive rights to theranostic rhPSMA technology in 2018, in line with our strategy to expand and advance a world-leading prostate cancer radiopharmaceutical portfolio. Both rhPSMA-7.3 (18F) and approved, commercially available Axumin (fluciclovine F 18) have unique and complementary mechanisms of action, and we believe that each may ultimately allow physicians and their patients flexibility in selecting the diagnostic agent most appropriate to each specific clinical situation."

"The ability to effectively stage primary prostate cancer is important in determining appropriate management for these patients," said Tobias Maurer, MD, of the Martini-Klinik and Department of Urology, University of Hamburg-Eppendorf, Germany (previously in the Department of Urology at TUM), who presented the results at AUA2020. "This retrospective analysis is the first report investigating the potential efficacy of the single isomer product rhPSMA-7.3 (18F), in PET imaging for primary lymph node staging in patients with intermediate and high-risk prostate cancer. Our study results indicated that rhPSMA-7.3 (18F) PET demonstrated 86% accuracy in men with primary prostate cancer. These preliminary data are encouraging and we are pleased that further research is ongoing."

"TUM’s early experience with radiohybrid PSMA agents has allowed us to investigate the potential diagnostic performance of this new class of theranostic PSMA-targeting agents, which can be efficiently labeled with imaging radioisotopes such as 18F for PET imaging or with 177Lu for therapeutic use," said Matthias Eiber, attending physician, Department of Nuclear Medicine, Klinikum rechts der Isar, TUM. "PSMA-targeted imaging agents labeled with 18F offer potential advantages that are important considerations in detecting and localizing prostate cancer – broad availability, based on the radioisotope’s 110-minute half-life; consistent, centralized manufacturing with high batch production and high resolution PET scans."

Diagnostic efficacy of F-18-rhPSMA-7.3 PET Imaging for N-staging in Intermediate and High-Risk Prostate Cancer Patients Validated by Histopathology

The oral presentation detailed a 56-patient retrospective analysis investigating the efficacy of rhPSMA-7.3 (18F) PET/CT for primary lymph node staging in patients with intermediate and high-risk prostate cancer, spearheaded by Thomas Langbein, resident, Department of Nuclear Medicine, Klinikum rechts der Isar, TUM. Results from on-site reads were compared to morphological imaging and validated by histopathology. Patient-based analysis indicated that the sensitivity, specificity and diagnostic accuracy of rhPSMA-7.3 (18F) PETimaging were 81.3% (95% CI, 54.4–96.0%), 87.5 (95% CI, 73.2–95.8%) and 85.7% (95% CI, 73.8–93.6%), respectively. Those for morphological imaging were 33.3% (95% CI, 13.3–59.0%), 89.5% (95% CI, 75.2–97.1%) and 71.4% (95% CI, 57.8–82.7%), respectively. On template-based analysis, the sensitivity, specificity and accuracy of rhPSMA-7.3 (18F) PET were 63.6% (95% CI, 45.4-79.6%), 97.9% (95% CI, 95.5-99.2%) and 94.4% (95% CI, 91.2-96.6%), respectively, and those for morphological imaging were 15.2% (95% CI, 5.11-31.9%), 99.3%(95% CI, 97.5-99.9%) and 90.6% (95% CI, 86.9-93.6%), respectively. The mean PSA level of the patients in this primary prostate cancer study was 11.0 ng/mL.

About rhPSMA

rhPSMA-7.3 (18F) consists of a radiohybrid Prostate-Specific Membrane Antigen (PSMA)-targeted receptor ligand which attaches to and is internalized by prostate cancer cells, and is labeled with the 18F radioisotope for PET imaging. rhPSMA compounds can also be labeled with radioisotopes such as 177Lu and 225Ac for therapeutic use. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA imaging technology from Scintomics in 2018, with an option to therapeutic rights. rhPSMA originated from the Technical University of Munich, Germany, and has been utilized clinically under German legislation at the Department of Nuclear Medicine there for the diagnostic imaging of men with both primary and recurrent prostate cancer. rhPSMA compounds have not received regulatory approval.

NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

This press release is intended to provide information about Blue Earth Diagnostics’ business in the United States and Europe. Please be aware that the approval status and product label for Axumin varies by country worldwide. For EU Axumin product information refer to: View Source;mid=WC0b01ac058001d124.

U.S. Indication and Important Safety Information About Axumin

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

On May 18, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported the formation of the Independent Data Monitoring Committee (DMC) for its pivotal Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML) who have achieved complete remission after second-line anti-leukemic therapy (CR2) (Press release, Sellas Life Sciences, MAY 18, 2020, View Source [SID1234558226]).

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The DMC is comprised of an independent group of medical, scientific and biostatistics experts and is responsible for reviewing and evaluating patient safety and efficacy data for the Company’s Phase 3 REGAL clinical trial. The DMC will review study data at regular intervals in order to ensure the safety of all patients enrolled in the study. The Committee will also monitor the quality and overall conduct and ensure the validity, scientific and clinical merits of the study, including each site’s compliance with the requirements specified in the study protocol. The DMC is charged with assessing such actions in light of an acceptable benefit/risk profile for GPS and will also make applicable recommendations regarding the clinical trial to SELLAS.

"Our REGAL clinical trial is the only Phase 3 study focused on remission prolongation through maintenance post-CR2 therapy, a significant and growing unmet medical need. As such, it is critically important to maintain the highest levels of integrity for this pivotal study. With the formation of the DMC, comprised of highly regarded and experienced physicians and biostatisticians who will confer with the respected physicians on the Steering Committee recently announced, we believe that we have brought together world class experts to monitor and guide this critical study which has the potential to extend the life of AML patients in CR2," said Angelos Stergiou, MD, ScD h.c., President & Chief Executive Officer of SELLAS. "Furthermore, the DMC will be able, at its sole discretion, to directly and independently liaise with the U.S. Food and Drug Administration (FDA) in order to discuss potential early unblinding and discontinuation of the study in case of reliable evidence of safety and clinically significant positive efficacy of GPS. We believe that this further strengthens the integrity and conduct of our REGAL study."

The Data Monitoring Committee currently consists of four members:

Moshe Talpaz, M.D., Associate Director of Translational Research and Associate Chief of the Division of Hematology/Oncology at the University of Michigan Comprehensive Cancer Center and Chair of the REGAL Data Monitoring Committee
Thomas Fleming, Ph.D., Professor and former department chair of the University of Washington Department of Biostatistics, Member of the Fred Hutchinson Cancer Research Center, former Director of the Statistical Center for HIV/AIDS Prevention Trial Network, NIAID, Special Government Employee for the FDA, and for more than 25 years, a regular member of several FDA Advisory Committees
Miguel-Angel Perales, M.D., Chief, Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center (MSKCC)
Stephane de Botton, M.D., Head of the Hematology Department at the Gustave Roussy Cancer Campus in Paris, France
Dr. Moshe Talpaz, commented, "I look forward to working together with the other esteemed members of the Data Monitoring Committee on SELLAS’ important pivotal Phase 3 REGAL study. While significant progress has been made over the last few years in putting AML patients into a second remission, the survival benefit has not yet improved correspondingly. Because those patients are by definition in a remission, risk and benefit must be very carefully balanced and it is of great scientific interest to me to be a part of that process, as GPS may have the potential to prolong survival, as the Chair of the independent data monitoring committee for the study focused specifically on that patient population."

"It is a privilege to contribute to safeguarding the interests of study participants and to protecting the integrity of a trial of such importance in enhancing our understanding about the effects of interventions in AML patients in complete remission," added Dr. Fleming.

The Company previously reported initial data from the Phase 2a study of GPS in AML patients in CR2 at a median follow-up of 19.3 months, showing median overall survival (OS) in vaccine-treated patients of 16.3 months vs. 5.4 months in a patient cohort contemporaneously treated with best standard therapy (p = 0.0175). The final analysis, at a median follow-up of 30.8 months, showed a median OS of 21 months in the GPS-treated patient cohort. A second previous Phase 2 study of GPS in AML patients who achieved first complete remission (CR1) also met its primary endpoint with an OS rate at 3 years from first vaccination of 47%.

The REGAL study is an ongoing 1:1 randomized, open-label study comparing GPS monotherapy in the maintenance setting to investigators’ choice best available treatment in AML patients who have achieved hematologic complete remission, with or without thrombocytopenia (CR2/CR2p), after second-line antileukemic therapy and who are deemed ineligible for or unable to undergo allogeneic stem-cell transplantation. The primary endpoint is OS from the time of study entry. Secondary endpoints include leukemia-free survival, antigen-specific T-cell immune response dynamics, measurable residual disease by multigene array, and assessments of AML clonal evolution and inflammasome molecular signatures in the tumor microenvironment in bone marrow biopsy samples. The Company anticipates interim analysis for safety and futility in the fourth quarter of 2021.

On May 18, 2020 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, reported that Brian M. Culley, Chief Executive Officer, will be presenting at the 2020 Solebury Trout Virtual Investor Conference on May 26, 2020 at 2:30 pm Eastern Time (Press release, Lineage Cell Therapeutics, MAY 18, 2020, View Source [SID1234558225]). Interested investors can access the live presentation as part of the Solebury Trout Virtual Conference Series.

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The archived presentation will be posted on the Events and Presentations section of Lineage’s website the day following the event and will be available for 30 days. Additional videos are available on the Media page of the Lineage website, located at www.lineagecell.com/media/.

On May 18, 2020 VBL Therapeutics (Nasdaq: VBLT) reported that new data suggesting the potential of its proprietary bi-specific antibodies for immune-mediated targeting of solid tumors will be presented at the Annual American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, to be held June 22–24, 2020 (Press release, VBL Therapeutics, MAY 18, 2020, View Source [SID1234558223]). VBL’s data show that MOSPD2 bi-specific antibodies induce T-cell activation and significantly extend the survival of mice carrying established metastatic cervical cancer, with no evidence of toxicity.

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VBL’s research has identified MOSPD2 as a protein involved in cell motility, whose expression is highly elevated in various solid tumors. The proprietary bi-specific antibodies developed by VBL have two separate arms – one arm binds to MOSPD2 on tumor cells and the second recruits host T-cells that attack the tumor. The new data to be presented at AACR (Free AACR Whitepaper) highlight the potential of bi-specific mediated immuno-oncology investigational therapy for the treatment of various MOSPD2-expressing solid tumors.

Details for the AACR (Free AACR Whitepaper) 2020 Virtual Meeting II presentations are as follows :

Permanent Abstract Number: LB-086
Title: CD3 MOSPD2 bi-specific antibody significantly prolongs survival in a model of metastatic human cervical cancer without any evidence of toxicity
Authors: Yacov et al.
Session Type: Poster Session
Session Category: Immunology
Session Title: Late-Breaking Research: Immunology 1

Permanent Abstract Number: 5592
Title: MOSPD2 a novel target for bi-specific antibody mediated solid tumor cells immune death
Authors: Salem et al.
Session Type: Poster Session
Session Category: Immunology
Session Title: Inflammation, Immunity, and Cancer / Modifiers of the Tumor Microenvironment 2
VBL’s presentations will be available on the AACR (Free AACR Whitepaper) e-poster website on June 22, 2020.

About VBL’s VB-600 Platform
VBL is conducting two parallel drug development programs that are exploring the potential of MOSPD2 (motile sperm domain-containing protein 2), a protein that VBL has identified as a key regulator of cell motility, as a therapeutic target for inflammatory diseases and cancer. Our VB-600 platform comprises classical anti-MOSPD2 investigational monoclonal antibodies for inflammatory indications, as well as bi-specific antibody candidates for oncology.

On May 18, 2020 NuCana plc (NASDAQ: NCNA) reported it has re-commenced enrollment of new patients in multiple clinical studies following the temporary pause necessitated by the COVID-19 pandemic (Press release, Nucana BioPharmaceuticals, MAY 18, 2020, View Source [SID1234558222]). NuCana previously announced the re-opening of its global Phase III study of Acelarin plus cisplatin in patients with biliary tract cancer (NuTide:121) on May 5, 2020. NuCana has now also re-opened the Phase I and Phase Ib clinical studies of NUC-3373 and the Phase I clinical study of NUC-7738.

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"All of our clinical studies have now re-opened to new patient enrollment and we are pleased to be treating once again new patients who may benefit from our ProTides" said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "The COVID-19 pandemic has had a dramatic impact on the global healthcare delivery system and advancing clinical studies of potential new treatments for cancer patients is of critical importance to NuCana."

The following clinical studies have re-opened to new-patient enrollment:

NuTide:121, the Phase III study of Acelarin (NUC-1031) plus cisplatin in patients with biliary tract cancer. The re-opening of NuTide:121 has begun in certain geographies including Australia, Canada, South Korea, Taiwan, Ukraine and the United Kingdom.

NuTide:302, the Phase Ib study of NUC-3373 in combination with other agents typically combined with 5-fluorouacil (5-FU) in patients with advanced colorectal cancer. The re-opening of NuTide:302 has begun in the United Kingdom.

NuTide:301, the Phase I clinical study of NUC-3373 in patients with advanced solid tumors.

NuTide:701, the Phase I clinical study of NUC-7738 in patients with advanced solid tumors.