Urethral Neoplasms

Before Infinity Pharmaceuticals shut down, eganelisib was fast-tracked by the FDA for potential use in triple-negative breast cancer in combination with other drugs. Just in time for a summer COVID wave to remind us that SARS-CoV-2 is here to stay, researchers at the University of California, San Diego (UCSD) have published new findings that show an experimental cancer drug developed by a now-bankrupt biotech can suppress the virus in lung tissue.  In a July 3 article in Science Translational Medicine, the UCSD team established that levels of damage-causing immune cells called myeloid cells are raised in the lungs of people with COVID-19 and other infections, like methicillin-resistant staphylococcus aureus (MRSA). Targeting an enzyme called phosphatidylinositol 3,4,5-kinase gamma (PI3Kγ) with the small molecule inhibitor eganelisib—a clinical-stage anti-cancer agent developed by Infinity Pharmaceuticals, which declared Chapter 11 bankruptcy in October 2023—reduced the number of myeloid cells in the lungs and improved the survival rate of mice infected with either COVID-19 or MRSA.  “Other drugs were tested early during the COVID-19 crisis for similar effects, with only modest success,” Judith Varner, Ph.D., the paper’s senior author who also studied eganelisib on behalf of Infinity, said in a press release. “Our work is significant because this is the first time this particular approach of targeting the myeloid cells specifically has been shown to be effective in COVID.”  Myeloid cells release immune pathway signaling proteins called cytokines and are thus an essential part of the immune system. But the inflammation they cause can go awry and lead to life-threatening lung damage, as happens in some patients with COVID-19 as well as those who are co-infected with flu and MRSA.  PI3Kγ is a key component of this process because it helps myeloid cells move into virus-infected organs. It does the same thing in cancerous tissues, which was the logic behind eganelisib’s mechanism of action. Stopping PI3Kγ’s activity stops myeloid cell migration, ameliorating tissue damage.  Before Infinity shut down, eganelisib was fast-tracked by the FDA for potential use in triple-negative breast cancer in combination with other drugs. A phase 1 study on that indication was completed in May 2024. Clinical trials for its use in urethral cancer, head and neck cancer and renal cell carcinoma were also underway.  Now, the team behind the research hopes that it will lead drug companies to develop compounds similar to eganelisib to treat COVID-19, MRSA and other diseases that cause myeloid-cell-driven organ damage. Varner also said in the release that she hopes the latest findings will lead to more funding for her team to continue their work in a range of disease settings.  Fierce has reached out to UCSD for comment.

MELBOURNE, Australia, Jan. 22, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces presentations featuring the Company’s theranostic programs at the upcoming American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU 2024) to be held in San Francisco, CA (US) from 25 – 27 January 2024. Dr David N. Cade, Telix Group Chief Medical Officer, said, “We are pleased to present updates on our late-stage therapeutic programs for prostate and kidney cancer at ASCO GU 2024, the leading specialised event for GU cancer care worldwide. “The ProstACT GLOBAL study of TLX591 (177Lu rosopatamab tetraxetan) will be presented, the first Phase III trial to evaluate TLX591, our lead radio-antibody drug conjugate (rADC) therapy candidate in patients with PSMA-positive metastatic castrate-resistant prostate cancer (mCRPC). “Data from the recently completed Phase I ProstACT SELECT study will also be showcased, confirming the clinical validity of Telix’s optimal fractionated dosing and product safety profile.1 Both ProstACT studies are exploring TLX591 administered together with real-world standard of care, differentiating this program from other PSMA studies and reflecting Telix’s continued innovation in prostate cancer care and commitment to patient outcomes. “Eric Jonasch MD, will present the STARLITE-1 investigator-initiated trial of Telix’s therapy candidate, TLX250 (177Lu girentuximab), in combination with immunotherapy in clear cell renal cell carcinoma, the most common and aggressive form of kidney cancer. “We look forward to seeing you at our booth to discuss Telix’s industry leading theranostic pipeline, our associated medical devices, and opportunities for collaboration.” ASCO GU 2024 presentation details are listed below: Track: Prostate Cancer- Advanced | Prostate Cancer- LocalizedType: Trials in Progress Poster SessionTitle: ProstACT SELECT: Safety, tolerability, and dosimetry of TLX591 with best standard of care in patients with PSMA-expressing metastatic castration-resistant prostate cancerClinicalTrials.gov ID: NCT04786847Location: Level 1, West Hall | On DemandDate and Time: January 25, 2024 | 11:30 AM – 1:00 PM (PT)Presenter: Nat Lenzo MD, GenesisCare, AUSTRALIA Abstract: TPS253Poster Bd: Q14 Track: Prostate Cancer- Advanced | Prostate Cancer- LocalizedType: Trials in Progress Poster SessionTitle: ProstACT GLOBAL: A Phase III study of best standard of care with and without TLX591 for patients with PSMA-expressing metastatic castration-resistant prostate cancer progressing despite prior treatment with a novel androgen axis drugClinicalTrials.gov ID: NCT04876651Location: Level 1, West Hall | On DemandDate and Time: January 25, 2024 | 11:30 AM – 1:00 PM (PT)Presenter: Brenda Cerqueira, Telix Pharmaceuticals, North Melbourne, AUSTRALIA Abstract: TPS256Poster Bd: Q17 Track: Renal Cell Cancer, Adrenal Cancer, Penile Cancer, Testicular Cancer, Urethral CancerType: Trials in Progress Poster SessionTitle: STARLITE-1: A Phase Ib/II study of combination 177Lu girentuximab plus cabozantinib and nivolumab in treatment naive patients with advanced clear cell RCCClinicalTrials.gov ID: NCT05663710Location: Level 1, West Hall | On DemandDate and Time: January 27, 2024 | 7:00 AM – 8:10 AM, 11:30 AM – 1:00 PM (PT) Presenter: Eric Jonasch MD, The University of Texas, MD Anderson Cancer Center, Houston, TXAbstract: TPS496Poster Bd: M17 About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn. Telix’s lead imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA),2 by the Australian Therapeutic Goods Administration (TGA),3 and by Health Canada.4 Telix Investor Relations Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com Legal Notices This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “outlook”, “forecast” and “guidance”, or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix’s preclinical and clinical studies, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix’s product candidates, if or when they have been approved; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward-looking statements. Past performance cannot be relied on as a guide to future performance. Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on our website. ©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved). _____________________________ 1 Telix ASX disclosure 19 October 2023.2 Telix ASX disclosure 20 December 2021.3 Telix ASX disclosure 2 November 2021.4 Telix ASX disclosure 14 October 2022.