On May 18, 2020 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and artificial intelligence to find, fight and follow cancer, reported that the results from the Phase 3 CONDOR trial evaluating the diagnostic performance and clinical impact of PyLTM (18F-DCFPyL) in men with biochemical recurrence of prostate cancer will be presented in an oral session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program (Press release, Progenics Pharmaceuticals, MAY 18, 2020, View Source [SID1234558231]). PyL is the Company’s PSMA-targeted small molecule positron emission tomography (PET) imaging agent designed to visualize prostate cancer.

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"The vast majority of men dying of prostate cancer, the second most common cause of cancer-related death in men, succumb to metastatic disease. Due to the limitations of conventional imaging, early detection and accurate localization of metastatic lesions in patients with biochemical recurrence of prostate cancer represents an important medical need," said Peter R. Carroll, M.D., M.P.H., Distinguished Professor, Department of Urology, University of California, San Francisco. "New imaging agents, such as PyL, that enable early identification of metastatic disease, both at initial staging and at any point after definitive therapy, could have the potential to impact patient outcomes."

The Phase 3 CONDOR trial is a prospective, multi-center, open label pivotal trial in which 208 patients with biochemical recurrence of prostate cancer and uninformative baseline imaging based on conventional modalities, including Axumin, Choline PET, CT/MR and/or bone scan, were dosed and imaged with PyL at 14 sites in the United States and Canada. The trial achieved its primary endpoint, with a correct localization rate (CLR) of 84.8% to 87.0% among the three blinded independent readers (the lower bound of the 95% confidence intervals ranging from 77.8% to 80.4%). CLR is based on positive predictive value (PPV), defined as the percentage of patients with a one-to-one correspondence between localization of at least one lesion identified on PyL and a composite truth standard comprised of histopathology, conventional imaging and/or a ≥ 50% decline in PSA levels following radiation therapy. Median CLR in patients with baseline PSA <0.5 ng/mL, 0.5 to <1.0 ng/mL, and 1.0 to <2.0 ng/mL were 73.3%, 75.0%, and 83.3%, respectively, which are promising results in a patient population with non-informative baseline findings based on available approved imaging modalities.

63.9% of patients in the CONDOR trial had a change in intended disease management plans due to PyL imaging results, a key secondary endpoint of the trial. The most frequent changes to treatment management plans due to the PyL results included salvage local therapy to systemic therapy, observation to initiating therapy, noncurative systemic therapy to salvage local therapy, and planned treatment to observation.

"In addition to the robust diagnostic performance, the clinician’s high change in management rate based on PyL scans is a particularly significant finding of CONDOR. The subjects in this study represent a true clinical dilemma as there is residual disease present as demonstrated by the detectable PSA, but standard scans are uninformative. CONDOR demonstrates that clinicians trust the information on the PyL scan and use it." said Michael J. Morris, M.D., Clinical Director, Genitourinary Medical Oncology Service & Prostate Cancer Section Head, Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center, and lead author of the ASCO (Free ASCO Whitepaper) presentation. "These positive results further underscore the diagnostic potential for PSMA targeted imaging and open up future opportunities to examine how the results of PyL imaging can be used to deliver new, improved patterns of care."

Progenics ASCO (Free ASCO Whitepaper) Data Release Page 2

Consistent with the Phase 2 OSPREY trial results, safety results showed that PyL was well tolerated. There was one serious adverse event of hypersensitivity reported as related to the study drug in a patient with significant allergic history.

"The full positive results of our Phase 3 CONDOR trial continue to validate our beliefs in PyL to potentially alter the way physicians treat prostate cancer. The CONDOR results, together with previously presented data from OSPREY, collectively demonstrated strong diagnostic performance of PyL in multiple stages of the prostate cancer disease continuum," said David Mims, Interim Chief Executive Officer of Progenics. "We remain on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PyL early in the third quarter of 2020."

Details for the ASCO (Free ASCO Whitepaper) 2020 Virtual Scientific Program presentation are as follows:

Title: Impact of PSMA-targeted imaging with 18F-DCFPyL-PET/CT on clinical management of patients (pts) with biochemically recurrent (BCR) prostate cancer (PCa): Results from a phase III, prospective, multicenter study (CONDOR)

Presenter: Michael J. Morris, M.D., Clinical Director, Genitourinary Medical Oncology Service & Prostate Cancer Section Head, Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center

Abstract #: 5501

Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Date and Time: May 29, 2020 at 8 AM ET on an "on demand" basis

About PyL for PET Imaging of Prostate Cancer

PyL (also known as 18F-DCFPyL) is a fluorinated PSMA-targeted positron emission tomography (PET) imaging agent that enables visualization of both bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in nine men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 174,650 new cases of prostate cancer will be diagnosed and about 31,620 men will die of the disease. Approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.

On May 18, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that pending the receipt of additional information from the Company, Nasdaq has halted the trading in the Company’s common stock (Press release, Moleculin, MAY 18, 2020, View Source [SID1234558230]). The Company is actively working with the staff of Nasdaq to provide it with all requested information, and hopes to begin trading as soon as possible.

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The May 1st, 2020 temporary suspension by the Securities and Exchange Commission in the trading of Moleculin securities expired at 11:59 p.m. ET on May 15th, 2020.

On May 18, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, autoimmune, metabolic and other major diseases, and The University of Texas MD Anderson Cancer Center reported a strategic collaboration agreement to co-develop TYVYT (sintilimab injection), Innovent’s anti-PD-1 monoclonal antibody, in rare cancers in the U. S. (Press release, Innovent Biologics, MAY 18, 2020, View Source [SID1234558229]).

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The joint development will focus on advancing sintilimab as an effective immune checkpoint inhibitor for patients with rare cancer types. This research will be enabled by MD Anderson’s experience in conducting clinical trials for even the rarest cancers not often seen by other centers. These studies will provide opportunities for Innovent to pursue approval of sintilimab by the U.S. Food and Drug Administration for multiple rare cancer indications in addition to larger cancer indications for sintilimab that Innovent is independently pursuing for approval as well.

"TYVYT (sintilimab injection) was approved in 2018 by the National Medical Products Association (NMPA) in China for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after second-line or later systemic chemotherapy, where it is currently being evaluated in additional clinical trials for solid tumors" said Dr. Michael Yu, Founder, Chairman and CEO of Innovent. "We believe TYVYT has great potential in various tumor types, both as a single agent and in combination with other inhibiting agents, and currently we are conducting more than 20 related clinical trials including over 10 registration clinical trials. Through this new co-development collaboration, we will work to advance TYVYT into rare tumors, where we hope it will continue to demonstrate its efficacy across multiple tumor types."

"We look forward to working with Innovent and utilizing our unique expertise in treating rare cancers to advance sintilimab toward potential FDA approval," said Ferran Prat, Ph.D., J.D., senior vice president for Research Administration and Industry Relations at MD Anderson. "The introduction of sintilimab to the U.S. would broaden the treatment options available to patients with rare cancer types, many of whom do not currently have an effective standard of care available."

Under the agreement, Innovent and MD Anderson will co-fund the development activities for sintilimab, which may include multiple clinical research studies to be conducted by MD Anderson. MD Anderson plans to develop an approach, upon commercialization in rare diseases, to allow royalty payments it receives on sales of the product in the U.S. to be used to fund care for uninsured patients.

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection), an innovative drug developed with global quality standards jointly developed by Innovent and Lilly in China, has been granted marketing approval by the NMPA for relapsed or refractory classic Hodgkin’s lymphoma after second-line or later systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL), in November 2019. In April 2020, the NMPA accepted the supplemental new drug application for TYVYT in combination with ALIMTA (pemetrexed) and platinum as first-line therapy in non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT combined with Gemzar (gemcitabine for injection) and platinum chemotherapy met the predefined primary endpoint in the Phase 3 ORIENT-12 study as first-line therapy in patients with locally advanced or metastatic squamous NSCLC, TYVYT monotherapy met the primary endpoint in the ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma as well.

TYVYT is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registration or pivotal clinical trials.

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.