October 3, 2024 - 🧬 [nGram] Today’s Oncology Scoop: UGN-103 Trial, Gilead's HIV Initiative, Enara Bio Funding

1. First patient dosed in phase 3 trial of UGN-103 for bladder cancer

   • UroGen Pharma has dosed the first patient in a Phase 3 trial for UGN-103, targeting low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
   • The UTOPIA study is a single-arm, multicenter trial aiming to enroll 87 patients, assessing efficacy and safety with a focus on complete response rate at three months.
   • UGN-103 uses UroGen’s RTGel technology, a sustained-release hydrogel, to enhance drug exposure and treatment efficacy.
   • The trial follows the potential FDA approval of UGN-102, with UGN-103 expected to advance post-approval.
   Read more
   
   

2. Arcus Biosciences announces collaboration with AstraZeneca for renal cell carcinoma trial

   • Arcus Biosciences partners with AstraZeneca to evaluate casdatifan and volrustomig combination in advanced ccRCC.
   • AstraZeneca will sponsor and manage the study focusing on safety and early efficacy.
   • This is the second collaboration between the two companies, following a 2020 agreement for a lung cancer study.
   • Gilead has the option to join the development and commercialization of casdatifan post data package delivery.
   Read more
   
   

3. TerSera presents real-world evidence on treatment patterns of goserelin in women with breast cancer

   • TerSera Therapeutics presented new real-world analyses on goserelin treatment patterns at the 2024 ASCO Quality Care Symposium.
   • The study analyzed data from 3,620 women with breast cancer treated with goserelin between 2017 and 2022.
   • Findings highlighted treatment adherence and healthcare resource utilization among patients.
   • The study used data from the TriNetX global healthcare research network.
   Read more
   
   

4. Enara Bio secures $32.5 million to advance TCR-based immunotherapies

   • Enara Bio raised $32.5 million in Series B financing, co-led by Pfizer Ventures and M Ventures.
   • The funds will advance Enara's pipeline of TCR-based immunotherapies targeting novel Dark Antigens for solid tumors.
   • Dark Antigens are cancer-specific targets derived from genomic regions previously considered non-coding.
   • The financing will help Enara move these therapies towards clinical trials.
   Read more
   
   

5. Gilead signs licensing agreements for lenacapavir access

   • Gilead has signed royalty-free licensing agreements with six manufacturers for generic lenacapavir in 120 countries.
   • The agreements aim to increase access to lenacapavir for HIV prevention and treatment in resource-limited countries.
   • Gilead plans to begin regulatory filings for lenacapavir for PrEP by the end of 2024, following successful Phase 3 trials.
   • The company is prioritizing registration in 18 high-incidence countries to provide lenacapavir until generics are available.
   Read more
   
   

6. Reneo Pharmaceuticals announces stockholder approval of merger with OnKure

   • Reneo Pharmaceuticals' stockholders approved the merger with OnKure, Inc.
   • The combined company will trade on Nasdaq under the ticker 'OKUR'.
   • A 1-for-10 reverse stock split of Reneo's common stock will occur before the merger.
   • The merger is expected to close around October 4, 2024, with trading commencing on October 7, 2024.
   Read more
   
   

7. Orum Therapeutics submits registration statement for KOSDAQ listing

   • Orum Therapeutics has filed a registration statement with the Financial Supervisory Service to list on the KOSDAQ market.
   • The company specializes in degrader-antibody conjugates (DACs) using its TPD2 approach for targeted protein degradation.
   • Orum plans to offer 3 million new shares with a price range of 30,000 to 36,000 won per share, aiming to raise approximately KRW 90 billion.
   • A demand forecast for institutional investors will occur from October 24–30, 2024, with public subscription from November 5-6, 2024.
   Read more