On Thursday, Aura Biosciences, Inc. AURA revealed early data from an ongoing Phase 1 trial of bel-sar (AU-011) in patients with non-muscle-invasive bladder cancer (NMIBC).To date, the trial includes 13 patients, with the primary endpoints of evaluating the safety and feasibility of local administration of bel-sar alone (n=5) and bel-sar with light activation (n=8).Also Read: Aura Biosciences Touts Promising Data From Eye Cancer Candidate.The secondary endpoints are to evaluate biological activity and immune ...

Core Insights - Aura Biosciences announced positive early data from a Phase 1 clinical trial of bel-sar (AU-011) for non-muscle invasive bladder cancer (NMIBC), showing clinical complete responses in 4 out of 5 patients with low-grade disease [1][2][4] - The trial demonstrated a favorable safety profile, with less than 10% of patients experiencing Grade 1 drug-related adverse events and no serious adverse events reported [1][4] - The company plans to expand the ongoing Phase 1 trial and prepare for a Phase 2 trial to further evaluate the clinical activity and durability of response of bel-sar [2][3] Trial Design - The ongoing Phase 1 trial (NCT05483868) is a two-part, open-label study assessing the safety and feasibility of bel-sar as a monotherapy, with participants followed for safety monitoring over a 56-day period [3] - Part 1 of the trial is complete, involving 5 patients receiving a single bel-sar dose without light activation, while Part 2 is ongoing with 10 patients [3] - The study includes patients with a history of recurrent bladder cancer who have undergone multiple treatments prior to enrollment [3] Safety Data - As of the September 9, 2024 data cut-off, bel-sar was well-tolerated, with no Grade 2 or higher drug-related adverse events reported [4] - No significant differences were observed between the light-activated and non-light activated cohorts in terms of safety [4] Biological Activity - Clinical activity was detectable as soon as 7 days after a single low dose of bel-sar with light activation, evidenced by histopathological evaluations [4][5] - Among patients with low-grade disease, 4 out of 5 exhibited a clinical complete response, while 2 out of 3 patients with high-grade disease showed visual tumor shrinkage [5] - Immune activation was noted in all patients, indicating a potential bladder urothelial field effect beyond the target tumor [5] Upcoming Events - Aura will host a Virtual Urologic Oncology Investor Event featuring key opinion leaders to discuss the early Phase 1 data on October 17, 2024 [6]

Small-cap stocks faced a challenging environment for the last several years as inflation and high interest rates dampened lending opportunities. These companies—which are often in the early stages of development and lack stability—rely heavily on debt to fuel their growth.Fortunately for the small-cap space, the Federal Reserve's September rate cut of 50 basis points is a welcome relief that should make borrowing more accessible. The fact that the Fed has signaled that additional rate cuts are likely in the ...

I covered Aura Biosciences, Inc. (NASDAQ: AURA ) last year, and just last week, the company presented convincing phase 2 data for lead asset bel-sar as a first-line treatment in early-stage choroidal melanoma. AURA hasAbout the TPT serviceThanks for reading. At the Total Pharma Tracker, we offer the following:-Our Android app and website features a set of tools for DIY investors, including a work-in-progress software where you can enter any ticker and get extensive curated research material. For investors r ...

Shares of Aura Biosciences (AURA) gained 7.9% on Sept. 12 after the company announced encouraging data from a phase II study evaluating its lead candidate, bel-sar (AU-011), to treat early-stage choroidal melanoma (CM) in the first-line setting. Bel-sar is a novel investigational agent designed with a dual mechanism of action that includes targeted cytotoxicity and immune activation.CM is a type of cancer occurring in the choroid, a layer of blood vessels and connective tissue between the sclera (white of t ...

Thursday, Aura Biosciences, Inc. AURA revealed Phase 2 end-of-study results evaluating bel-sar (AU-011) for the first-line treatment of early-stage choroidal melanoma (CM), a vision and ocular cancer.The Phase 2 results demonstrated that bel-sar achieved an 80% tumor control rate (n=8/10) among Phase 3-eligible patients who received the therapeutic regimen, with complete cessation of growth following treatment among responders (post-treatment average growth rate of 0.011 mm/yr among responders compared to 0 ...

Bel-sar Demonstrated 80% Tumor Control Rate, 90% Visual Acuity Preservation, and a Highly Favorable Safety Profile Aura to Host a Virtual Ocular Oncology Investor Event Featuring Key Opinion Leaders Today at 8:00 am ET BOSTON, Sept. 12, 2024 (GLOBE NEWSWIRE) -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, today announced positive Phase 2 end of study results evaluating bel-sar (AU-011) for t ...

BOSTON, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies to treat a range of solid tumors designed to preserve organ function, today announced that it will host a virtual urologic oncology investor event on Thursday, October 17, 2024, at 4:30 PM ET. Aura also announced that Dr. Sabine Brookman-May is joining Aura as its Senior Vice President, Clinical Development Urologic Oncology in October 2024. Virtual investor ...

BOSTON, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies to treat a range of solid tumors designed to preserve organ function, today announced that members of its senior management team will participate in the following upcoming investor conferences: Morgan Stanley 22nd Annual Global Healthcare Conference on Wednesday, September 4, 2024. Members of Aura’s senior management team will participate in one-on-one invest ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |-------------------------------------------------------------------------------------|---------------------------------------------| | | | | For the transition period from _____ ...