On December 1, 2022 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported topline results from its Phase 3 LIGHTHOUSE trial that evaluated the diagnostic performance and safety of 18F-rhPSMA-7.3 in newly diagnosed prostate cancer (Press release, Blue Earth Diagnostics, DEC 1, 2022, View Source [SID1234624716]). 18F-rhPSMA-7.3 is an investigational high affinity radiohybrid (rh) Prostate-Specific Membrane Antigen-targeted PET imaging agent. The results were reported in a presentation at the 23rd Annual Scientific Meeting in Urologic Oncology (SUO), in San Diego, Calif.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Effective staging of primary prostate cancer − determining its presence and whether it may have metastasized − is critical in assessing a patient’s prognosis and informing individual clinical management strategies," said Brian F. Chapin, MD, Associate Professor, Department of Urology, Division of Surgery, The University of Texas MD Anderson Cancer Center, and Coordinating Investigator of the LIGHTHOUSE study. "Up to 25% of patients with primary prostate cancer may have detectable pelvic lymph node metastases, which are correlated with a risk for recurrence and associated overall survival. Conventional imaging techniques, such as MRI and CT, are limited in the information they may provide. Pelvic lymph node dissection (PLND), or pelvic lymphadenectomy, is considered the gold standard in assessing pelvic node lesions, but its use is limited to the planned surgical area. An ideal staging technique for detecting metastatic prostate cancer should include both pelvic nodes as well as more distant soft tissue and skeletal findings. The Phase 3 LIGHTHOUSE clinical study investigated the diagnostic performance of 18F-rhPSMA-7.3 PET imaging as a decision-making aid in assessing newly diagnosed prostate cancer in patients with unfavorable intermediate-, high- or very high-risk disease."

"We are pleased to share these key Phase 3 LIGHTHOUSE study results with the urologic oncology community at SUO 2022, which 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," said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. "LIGHTHOUSE is the second of Blue Earth’s diagnostic imaging trials to report results based on novel radiohybrid technology PSMA technology, which offers potential theranostic utility in both diagnostic PET imaging and therapy. 18F-rhPSMA-7.3 represents a new class of PSMA-targeted PET radiopharmaceuticals, with early studies of 18F‐rhPSMA‐7.3 potentially showing a high binding affinity for PSMA, together with biodistribution data suggesting the potential for low bladder activity. Blue Earth Diagnostics is committed to helping men with prostate cancer across the care continuum, and we especially would like to thank the patients and clinical teams who participated in the LIGHTHOUSE study."

The findings presented at SUO reported on the first results of the Phase 3 LIGHTHOUSE trial on the diagnostic performance and safety of 18F-rhPSMA-7.3 in men with newly diagnosed prostate cancer planned to undergo radical prostatectomy (RP). Co-primary endpoints were patient-level sensitivity and specificity of 18F-rhPSMA-7.3 PET for the detection of pelvic lymph node (PLN) metastases using histopathology as the standard of truth. The endpoints were evaluated for the Efficacy Analysis Population (EAP) of 296 patients who underwent 18F-rhPSMA-7.3 PET and had subsequent RP and PLN dissection. Based on the majority read from the three blinded, independent PET readers, the overall specificity of 18F-rhPSMA-7.3 PET/CT in the LIGHTHOUSE study was 96% (217/226). By majority read, the specificity was 95% (139/146) for high-risk or very high-risk, and 98% (78/80) for unfavorable intermediate-risk patients. The overall sensitivity of 18F-rhPSMA-7.3 PET/CT in the LIGHTHOUSE study was 24% (17/70) by majority read, which is consistent with reports to date of sensitivity within the class of PSMA-targeted diagnostic imaging radiopharmaceuticals. By majority read, the sensitivity was 27% (14/51) for high-risk or very high-risk, and 16% (3/19) for unfavorable intermediate-risk patients. No serious adverse events were observed in the LIGHTHOUSE study. Overall, 28 of the 356 (7.9%) patients in the Safety Population had at least one treatment-emergent adverse event that was considered possibly related to 18F-rhPSMA-7.3. The most frequently reported adverse event for patients in the Phase 3 LIGHTHOUSE study was injection site pain among 0.8% (3/356) of patients.

The LIGHTHOUSE Phase 3 clinical trial was a prospective, Phase 3, multi-center, single-arm, imaging study investigating the safety and diagnostic performance of 18F-rhPSMA-7.3 Positron Emission Tomography (PET) in men with newly diagnosed prostate cancer. The study enrolled 356 patients at clinical sites in the United States and Europe. Additional information about the Phase 3 LIGHTHOUSE trial is available at www.clinicaltrials.gov (NC04186819).

The findings, "Diagnostic Performance and Safety of 18F-rhPSMA-7.3 PET in Patients with Newly Diagnosed Prostate Cancer: Results from a Phase 3, Prospective, Multicenter Study (LIGHTHOUSE)," were presented at SUO 2022 on December 1, 2022, by Brian F. Chapin, MD, Associate Professor, Department of Urology, Division of Surgery, The University of Texas MD Anderson Cancer Center, on behalf of the LIGHTHOUSE Study Group. Full session details and the abstract are available in the SUO 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 Decemebr 1, 2022 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases , reported that their first in class new drug Pidnarulex (CX-5461) , has been successfully selected to the anticancer pipeline of NIH-sponsored NExT Program (NCI Experimental Therapeutics Program), which will foster the exploration of its therapeutic potential in unmet medical needs and advancement to market (Press release, Senhwa Biosciences, DEC 1, 2022, View Source [SID1234624712]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The mission of the NExT Program is to advance clinical practice and bring improved therapies to patients with cancers by supporting the most promising new drug discovery and development projects. "The NExT Program does not directly fund but guide the project to its success ; applications with exceptional science cannot be accepted unless a clear path to the clinical practice or potential benefit to patients is identified. Senhwa is honored and will partner with the NCI to facilitate the milestone-driven progression of Pidnarulex (CX-5461) towards clinical evaluation and registration," said Dr. Jin-Ding Huang, the Chief Executive Officer of Senhwa Biosciences,.

Although Awardees will not necessarily receive direct funding; rather, the NCI may allocate various collaborations and grant resources toward the implementation and development of the awarded projects. NCI operates the program very much like a small pharmaceutical or biotechnology company by working with external investigators and top scientific experts to advance promising or novel therapies from the earliest stages of research to human clinical trials.

About Pidnarulex (CX-5461)

Specific mutations within the HR pathway may be exploited by Pidnarulex through a "synthetic lethality" approach by targeting the DNA repair defects in HR Deficient tumors. Specifically, Pidnarulex is designed to stabilize DNA G-quadruplexes of cancer cells, which leads to disruption of the cell’s replication fork. While acting in concert with HR pathway deficiencies, such as BRCA1/2 mutations, replication forks stall and cause DNA breaks, ultimately resulting in cancer cell death. On the other hand, PMCC postulates a different mechanism of action. Specifically, it is thought that Pidanrulex acts as a RNA Pol I Inhibitor.

On December 1, 2022 Protagonist Therapeutics, Inc. (Nasdaq: PTGX) ("Protagonist" or "the Company") reported that Dinesh V. Patel, Ph.D., President and Chief Executive Officer, will participate in a fireside chat presentation and host one-on-one meetings with investors at the JMP Securities Hematology and Oncology Summit, a virtual investor event taking place December 6-7, 2022 (Press release, Protagonist, DEC 1, 2022, View Source [SID1234624711]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presentation Details:
Date: December 6, 2022
Time: 11:40 a.m. ET / 8:40 a.m. PT

A webcast of the event will be available for 90 days on the Investors section of the Protagonist Therapeutics website at View Source

On December 1, 2022 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, reported that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Biologics License Application (BLA) for denileukin diftitox ("I/ONTAK" or "E7777"), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL) (Press release, Citius Pharmaceuticals, DEC 1, 2022, View Source [SID1234624710]). I/ONTAK is a purified and more bioactive formulation of previously FDA-approved ONTAK. The PDUFA target action date is September 28, 2023. The BLA is supported by a pivotal Phase 3 study (NCT01871727).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The acceptance of the previously announced BLA submission for I/ONTAK is another important regulatory milestone for our oncology program. With an anticipated PDUFA date of September 28, 2023, we look forward to the potential approval of this therapeutic for patients with persistent or recurrent cutaneous T-cell lymphoma, a rare disease for which patients with advanced disease have limited treatment options," stated Leonard Mazur, Chairman and CEO of Citius.

About I/ONTAK

I/ONTAK is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. I/ONTAK, a purified version of denileukin diftitox, is a reformulation of previously FDA-approved oncology treatment ONTAK. ONTAK was marketed in the U.S. from 1999 to 2014, when it was voluntarily withdrawn from the market. Manufacturing improvements resulted in a new formulation which maintains the same amino acid sequence but features improved purity and bioactivity. The new formulation received regulatory approval in Japan in 2021 for the treatment of CTCL and peripheral T-cell lymphoma (PTCL). In 2011 and 2013, the FDA granted orphan drug designation to I/ONTAK for the treatment of PTCL and CTCL, respectively.

About Cutaneous T-cell Lymphoma

Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and Sézary Syndrome (SS) comprise the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to upwards of ten to potentially reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and can spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle through multiple agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no curative therapy for advanced CTCL.

On December 1, 2022 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it intends to offer and sell, subject to market and other conditions American Depositary Shares ("ADSs") (or pre-funded warrants in lieu thereof) and warrants to purchase ADSs (the "Warrants") in an underwritten public offering (Press release, RedHill Biopharma, DEC 1, 2022, View Source [SID1234624709]). Each ADS represents 10 of our ordinary shares, par value NIS 0.01 per share. The Company expects to grant the underwriter a 30-day option to purchase additional ADSs and/or Warrants at the public offering price, less the underwriting discounts and commissions. All of the securities to be sold in the offering are to be offered by RedHill.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Aegis Capital Corp. is acting as sole book-running manager for the proposed public offering.

The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

RedHill intends to use the net proceeds of the offering for working capital, acquisitions and general corporate purposes.

The securities described above will be offered by RedHill pursuant to a shelf registration statement on Form F-3 (No. 333-258259) declared effective by the Securities and Exchange Commission (the "SEC") on August 9, 2021.

The securities will be offered only by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the preliminary prospectus supplement, when available, and the accompanying prospectus relating to the offering may be obtained from Aegis Capital Corp., Attention: Syndicate Department, 1345 Avenue of the Americas, 27th floor, New York, NY 10105, by email at [email protected], or by telephone at (212) 813-1010.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.