On June 27, 2023 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported inter- and intra-reader reproducibility results from its Phase 3 LIGHTHOUSE trial of POSLUMA (flotufolastat F 18) injection (formerly referred to as 18F-rhPSMA-7.3) in newly diagnosed prostate cancer (Press release, Blue Earth Diagnostics, JUN 27, 2023, View Source [SID1234632945]). Results showed high inter-reader agreement across all 3 trained, blinded readers. The inter-reader agreement for POSLUMA PET/CT in 352 evaluable scans was ≥95% across pair-wise inter-reader comparisons. Overall intra-reader agreement was ≥96% for each reader. Recently approved by the U.S. FDA, POSLUMA is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. The results were reported in an oral presentation at the 2023 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting.

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"Up to 25% of patients with primary prostate cancer may have detectable regional pelvic lymph node metastases, which are correlated with a risk for recurrence and associated overall survival," said Phillip H. Kuo, MD, Ph.D., Departments of Medical Imaging, Medicine, and Biomedical Engineering. "Effective staging in primary disease − determining its presence and whether it may have metastasized − is critical to establishing optimal clinical management strategies for patients. Conventional imaging techniques are limited in the information they may provide, so the demonstrated performance of PSMA-PET imaging fits an important unmet need. As well, reliable and consistent interpretation of PET imaging is foundational to informed decision-making and has the potential to substantially impact patient care. These findings from the LIGHTHOUSE study showed high reader agreement in interpreting POSLUMA PET/CT scans among a patient population of men with unfavorable intermediate- to very high-risk prostate cancer prior to initial therapy. The high reproducibility of reader results across all regions is clinically valuable, with the potential to influence patient management prior to surgery for patients with newly diagnosed disease."

"We are pleased to present these reader interpretation results from the Phase 3 LIGHTHOUSE trial at SNMMI’s 2023 Annual Meeting," said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. "In designing the POSLUMA image interpretation training, we drew upon Blue Earth Diagnostics’ proven expertise and experience in designing PET image interpretation programs and training for our first commercialized product, Axumin (fluciclovine F 18). Newly FDA-approved POSLUMA represents a new class of purposely engineered, high-affinity PSMA-targeted PET radiopharmaceuticals based on novel radiohybrid technology. It is labeled with the radioisotope 18F to provide readily available patient access and leverage the high image quality of 18F-labeled PSMA PET imaging to facilitate detection of disease. In a post-hoc Phase 3 analysis, as well as in preclinical and Phase 1 studies, POSLUMA demonstrated low urinary bladder activity, providing the potential for enhanced image evaluation in the prostate and regions near the ureters for patients with prostate cancer."

The findings presented at SNMMI discussed inter- and intra-reader agreement for the interpretation of POSLUMA PET scans. Overall agreement between three blinded readers who received identical training was assessed for 352 evaluable PET scans; in addition, regional agreement was assessed for the prostate/prostate bed, pelvic lymph nodes, and other (extra-pelvic) sites (lymph nodes outside pelvis, soft tissue/parenchyma, and bones). Intra-reader agreement was based on a sample of 70 (20%) randomly selected scans and consisted of re-reads 4 weeks following the initial reads. The overall inter-reader agreement for POSLUMA PET/CT in 352 evaluable scans was ≥95% across pair-wise, inter-reader comparisons, with the highest agreement seen in the prostate/prostate bed region (also ≥95%). Overall intra-reader agreement was ≥96% for each reader. It should also be noted that the interpretation of POSLUMA PET in patients with suspected prostate cancer recurrence may differ depending on imaging readers, particularly in the prostate/prostate bed region.

The LIGHTHOUSE Phase 3 clinical trial (NC04186819) was a prospective, Phase 3, multi-center, single-arm, imaging study conducted in the United States and Europe to evaluate the safety and diagnostic performance of POSLUMA PET in men with newly diagnosed prostate cancer. Results for the co-primary endpoints of efficacy and safety for the LIGHTHOUSE trial were previously presented at the 23rd Annual Scientific Meeting in Urologic Oncology (SUO) in December 20221 and at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) in February 2023.2

The findings were discussed in an oral presentation at SNMMI 2023 on June 27, 2023, "Inter- and intra-reader reproducibility of 18F-rhPSMA-7.3 PET interpretation in patients with newly diagnosed prostate cancer: Results from a phase 3, prospective, multicenter study (LIGHTHOUSE)," by Phillip H. Kuo, MD, Ph.D., Departments of Medical Imaging, Medicine, and Biomedical Engineering, University of Arizona, Tucson, Ariz. Full session details and the abstract are available in the SNMMI online program here.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)
Radiohybrid Prostate-Specific Membrane Antigen (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 imaging isotopes for PET imaging, or with therapeutic isotopes for therapeutic use – providing the potential for creating a true theranostic technology. 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 sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics received U.S. Food and Drug Administration approval for its radiohybrid PET diagnostic imaging product for use in prostate cancer in 2023. rhPSMA compounds for potential therapeutic use are investigational and have not received regulatory approval.

About POSLUMA (flotufolastat F 18)
POSLUMA (flotufolastat F 18) injection (formerly referred to as 18F-rhPSMA-7.3) is an optimized, targeted radiohybrid diagnostic imaging agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Precision PET imaging with POSLUMA can help identify the location and extent of prostate cancer, providing clinically valuable information to guide patient management. POSLUMA represents a new class of high-affinity PSMA-targeted PET radiopharmaceuticals based on novel radiohybrid technology and is labeled with the radioisotope 18F to provide readily available patient access and leverage the high image quality of 18F-labeled PSMA PET imaging to facilitate effective detection of disease. POSLUMA was approved by the U.S. Food and Drug Administration in May 2023.

Indication and Important Safety Information About POSLUMA

INDICATION
POSLUMA (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer

with suspected metastasis who are candidates for initial definitive therapy
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.
Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline.
POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.
Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.
To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf.

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.

Full Axumin prescribing information is available at View Source

On June 27, 2023 Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") reported that it has successfully completed an underwritten public offering of 17,500,000 shares of its common stock to the public at a price of NT$75 per share (Press release, Foresee Pharmaceuticals, JUN 27, 2023, View Source [SID1234632944]). The aggregate gross proceeds to Foresee from the offering were NT$1,312.5 million (or US$42.3 million at FX=31).

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"We are pleased to announce the successful completion of the public offering. I would like to express my gratitude once again for shareholders’ full support and trust in us," said Dr. Ben Chien, Founder and Chairman of Foresee. "Moving forward, we are excited about the prospects and opportunities ahead of us."

The proceeds of the public offering will be used for general corporate purposes, including FP-001 (CAMCEVI), a ready-to-use 6-month leuprolide injectable, in a Phase 3 clinical trial for central precocious puberty (CPP), FP-045, an ALDH2 activator, in a Phase 1b/2 clinical trial for Fanconi Anemia, and FP-025, an MMP-12 inhibitor, in a Phase 2 POC study for respiratory disease.

On June 27, 2023 Mestag Therapeutics (‘Mestag’), an immunotherapy company focusing on fibroblast-immune interactions, and VIB, the leading life science research institute in Flanders, reported entering into an agreement under which Mestag obtains the exclusive worldwide rights to research, develop and commercialize a panel of single domain antibodies, also known as Nanobodies, to an undisclosed target that plays a central role in anti-cancer immunity (Press release, Mestag Therapeutics, JUN 27, 2023, View Source [SID1234632943]).

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Under the terms of the agreement, Mestag will be responsible for the research, development and commercialization of the antibodies, which are the outcome of many years of leading-edge research within VIB. In return, VIB will receive an upfront payment, future success-based milestones and royalty payments.

Susan Hill, PhD, Chief Executive Officer of Mestag Therapeutics, said, "We are delighted to partner with VIB, one of the premier research institutes in Europe and a leader in nanobody technology and cancer biology. This agreement further strengthens Mestag’s first-in-class pipeline and targets an exciting new area of fibroblast-immune cancer biology."

"We are thrilled to work with Mestag. Mestag brings together a unique expertise set in fibroblast-immune biology and a deep understanding of antibody engineering and development. The company is perfectly positioned to take this promising program forward," said Jérôme Van Biervliet, PhD, Managing Director of VIB.

On June 27, 2023 ImmunoGenesis, a clinical-stage biotechnology company developing science-driven immune therapies, and Cancer Focus Fund, LP, a unique investment fund established in collaboration with The University of Texas MD Anderson Cancer Center to provide funding and clinical expertise to advance promising cancer therapies, reported that Cancer Focus Fund plans to invest $4.5 million to support the Phase 1a/1b clinical trial of ImmunoGenesis’ lead candidate, IMGS-001 (Press release, ImmunoGenesis, JUN 27, 2023, View Source [SID1234632942]). IMGS-001 is a dual-specific PD-L1/PD-L2 antibody designed to treat immune-excluded tumors, which are resistant to existing immunotherapy. The investment will support the portion of the IMGS-001 Phase 1a/1b multi-site clinical trial being conducted at MD Anderson. It coincides with ImmunoGenesis’ Series A financing, which is expected to close in the third quarter.

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"Overcoming the widespread resistance to immunotherapy in immune-excluded tumors requires re-envisioning the starting point for treatment," said Dr. Michael A. Curran, Founder of ImmunoGenesis. "We are addressing this challenge by developing a novel, dual–specific PD–L1/PD–L2 inhibitor engineered to include tumor-killing effector function – essentially addressing tumor pathology at the roots. Based on the results of preclinical studies, we believe that IMGS–001 has the potential to significantly improve clinical response over currently approved checkpoint inhibitors for patients with immune-excluded tumors."

IMGS-001 is based on discoveries made by the laboratory of Dr. Curran, Associate Professor of Immunology at MD Anderson, and by the Oncology Research for Biologics & Immunotherapy Translation (ORBIT) platform, part of MD Anderson’s Therapeutics Discovery division. The technology was licensed to ImmunoGenesis in 2019.

"The Cancer Focus Fund Scientific Advisory Board is made up of expert scientists and clinicians and to be recommended for an investment by this group is an honor that we believe provides validation of the clinical potential for IMGS-001," said James Barlow, ImmunoGenesis President and CEO. "We believe that IMGS-001 has the potential to become the foundational treatment for immune-excluded tumors where there is both significant unmet need and tremendous market opportunity. This funding, combined with our upcoming Series A financing, will provide the opportunity to establish the initial proof of concept for this groundbreaking approach and bring hope, and potentially life-saving treatments, to the patients battling these difficult tumors."

"Cancer Focus Fund was founded with the goal of assuring that innovative early-stage cancer therapies had the opportunity to undergo the rigorous clinical testing needed for advancement," said Ross Barrett, a founder and Managing Partner of Cancer Focus Fund. "We are thrilled at the opportunity to invest in the exciting new approach to cancer immunotherapy pioneered by Dr. Curran – our first investment in a discovery made at MD Anderson and developed by a biotechnology company located here in Houston. Immune-excluded tumors are thought to represent more than half of all cancers and contribute to the high failure rates that limit the potential of cancer immunotherapy for too many patients. We welcome the opportunity to support ImmunoGenesis by investing in this promising candidate and look forward to the results of this important clinical trial."

About the IMGS-001 Phase 1a/1b Clinical Trial
This funding will support a Phase 1a/1b, first-in-human, open-label, dose-escalation and dose–expansion study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of IMGS-001. Phase 1a is a dose-escalation study that aims to determine the safety, tolerability, and maximum tolerated dose (MTD) of IMGS-001 in adult patients with locally advanced or metastatic solid tumors refractory to appropriate standard of care treatments. Phase 1b is an open-label, dose-expansion cohort study of patients with prespecified tumors intended to further assess the safety and preliminary antitumor activity of IMGS-001. Dr. David S. Hong, Professor of Investigational Cancer Therapeutics at MD Anderson, will serve as Principal Investigator of the trial.

About IMGS-001, a PD-L1/PD-L2 Dual-Specific Inhibitor
IMGS-001, the lead program at ImmunoGenesis, is a PD-L1/PD-L2 dual-specific inhibitor with engineered cytotoxic effector function. IMGS-001 is the first molecule to target PD-L2 in addition to PD-L1. This means that IMGS-001 has the potential to shut down the entire PD-1 pathway and provide a superior blockade compared to other PD-1 or PD-L1 inhibitors. The engineered effector function enables IMGS-001 to kill immunosuppressive PD-L1- and/or PD-L2-expressing cells present in the tumor microenvironment, which may enable it to overcome immune resistance in immune-excluded tumors. Preclinical data showed that IMGS-001 drove substantially higher response rates in head-to-head studies vs. currently available immunotherapies. With its innovative multi-tasking mechanism of superior blockade and killing function, IMGS-001 may provide a new foundation for combination therapies.

On June 27, 2023 CoImmune, Inc., a clinical stage immuno-oncology company working to redefine cancer treatment using best-in-class cellular immunotherapies, reported that it has exercised its option to obtain an exclusive license in the Delta-like Ligand 3 (DLL3)-targeted, allogeneic Chimeric Antigen Receptor-Cytokine Induced Killer (CAR-CIK) cell therapy field to interleukin-18 (IL-18) Armored CAR technology under a prior agreement with Memorial Sloan Kettering Cancer Center (MSK) (Press release, CoImmune, JUN 27, 2023, View Source [SID1234632941]). The company is coupling the technology with allogeneic CIK cells and launched a development program focused on solid tumors with initial trials planned in small cell lung cancer (SCLC).

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"Traditional CAR T cells have proven to be poorly effective against solid tumors due, in part, to the immunosuppressive tumor microenvironment, but we have demonstrated the potential for CAR-CIK cells to be effective in combination with additional technologies that may be able to improve proliferation, persistence and reverse immunosuppression," said Charles Nicolette, Ph.D., Chief Executive Officer of CoImmune. "IL-18 expression has the potential to greatly enhance the potency of DLL3-targeted therapy and we look forward to advancing our development of CMN-009, an IL-18 armored anti-DLL3 CAR-CIK therapeutic for SCLC."

CoImmune has the option to select up to three targets for IL-18 CAR products in the allogeneic cell therapy field under the agreement with MSK. In March 2023, the company announced it had selected CD19 as the first target to support the clinical development of CMN-008 (Armored CAR-CIK cells) in B-cell malignancies. CoImmune plans to file an Investigational New Drug (IND) application for CMN-008 to treat acute lymphoblastic leukemia (ALL) this year.

The DLL3 target has been identified as a tumor-specific cell surface marker on neuroendocrine cancers including SCLC. A paper recently published in Journal of Clinical Investigation, titled, "IL-18-secreting CAR T cells targeting DLL3 are highly effective in small cell lung cancer models," describes an effort by researchers including Renier J. Brentjens, M.D., Ph.D., Deputy Director and Chair of Medicine, Roswell Park Comprehensive Cancer Center, to develop a CAR against DLL3 that displays antitumor efficacy in xenograft and murine SCLC models. The data reported show IL-18 armored CAR-DLL3 T cells could eradicate disease at very low doses, especially when combined with a PD-1 checkpoint inhibitor.

"Our preclinical studies with a model of metastatic SCLC demonstrated that IL-18 production increased the activation of both CAR T cells and endogenous tumor-infiltrating lymphocytes," said Dr. Brentjens, who previously developed the IL-18 Armored CAR technology at MSK. "We also observed increased infiltration, repolarization and activation of antigen-presenting cells. Human IL-18-secreting anti-DLL3 CAR T cells were able to eradicate disease at dose levels where standard anti-DLL3 CAR-T cells were ineffective. We saw strong synergy with PD1 checkpoint inhibition, suggesting a potential for curative responses at lower, subtherapeutic administrations of IL-18 armored anti-DLL3 CAR T cells. These results define DLL3-targeting CAR T cells that produce IL-18 as a promising novel strategy against DLL3-expressing solid-tumor cancers."

CoImmune’s IL-18 armored CARCIK-DLL3 product prototype, CMN-009, will be studied in animal models throughout the remainder of 2023. Additional technologies licensed from MSK (e.g., SEAKER, SHIELD) will be tested in combination with CMN-009 to further enhance functionality. The Company expects to initiate IND-enabling studies in the first half of 2024.