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Aura Biosciences, Inc. (symbol: AURA) is a clinical-stage biotechnology company revolutionizing cancer treatment through the development of precision immunotherapies. The company's pioneering approach, known as molecular surgery, targets and destroys cancer cells selectively while sparing the surrounding healthy tissue. This method holds promise in treating various cancers, particularly those that are challenging to manage with current therapies.
Aura Biosciences' lead program focuses on ocular melanoma (OM), also known as choroidal or uveal melanoma. This innovative therapy aims to eliminate cancer cells in the eye as a first-line treatment, with the potential to preserve patients' vision. By addressing the cancer early, Aura Biosciences seeks to prevent the disease from progressing and metastasizing to other organs such as the liver, where it often becomes fatal.
In addition to OM, the company's lead candidate, bel-sar, is in early-stage clinical development for bladder cancer and other ocular oncology indications. This first-in-class, non-radioactive treatment offers a novel approach to precisely target and eradicate cancer cells.
Aura Biosciences is also exploring treatments for cancers of the ocular surface, affecting approximately 35,000 patients in the United States and Europe annually. Positive preclinical data for bel-sar in this indication were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting.
Recently, the company strengthened its leadership team with the appointment of Conor Kilroy as General Counsel and Secretary, further solidifying its strategic vision and operational capabilities.
Operating exclusively in the United States, Aura Biosciences is committed to advancing its clinical programs and bringing transformative cancer therapies to patients worldwide.
Aura Biosciences (NASDAQ: AURA) has announced its participation in the 7th Annual Evercore ISI HealthCONx Conference. CEO Elisabet de los Pinos will engage in a fireside chat on December 3, 2024, at 2:35 p.m. ET. The clinical-stage biotechnology company, which focuses on developing precision therapies for solid tumors, will make the presentation available via live webcast on their investor relations website. A replay will be accessible for 90 days after the event.
Aura Biosciences (NASDAQ: AURA) reported Q3 2024 financial results and clinical progress. The company presented positive Phase 2 end-of-study data for bel-sar in early-stage choroidal melanoma, showing 80% tumor control rate and 90% visual acuity preservation. In the Phase 1 trial for bladder cancer, 4 out of 5 patients with low-grade disease achieved complete response. The company's cash position of $174.4 million is expected to fund operations into 2H 2026. Q3 net loss increased to $21.0 million from $18.5 million year-over-year, with R&D expenses at $17.0 million and G&A expenses at $6.2 million.
Aura Biosciences (NASDAQ: AURA) announced positive early data from an ongoing Phase 1 clinical trial of bel-sar (AU-011) in patients with Non-Muscle-Invasive Bladder Cancer (NMIBC). The trial includes 13 patients, evaluating safety and feasibility of local administration of bel-sar alone and with light activation. Key findings include:
- 4 out of 5 patients with low grade disease demonstrated a clinical complete response
- 2 out of 3 patients with high grade disease showed visual tumor shrinkage
- Favorable safety profile with only Grade 1 drug-related adverse events reported in less than 10% of patients
- Evidence of bladder urothelial field effect in non-target tumors
Bel-sar, a virus-like drug conjugate, shows potential as a transformative cancer treatment with rapid tumor response and immune oncology effect. Aura is preparing for a Phase 2 trial to further evaluate bel-sar's clinical activity and durability of response.
Aura Biosciences (NASDAQ: AURA) reported positive Phase 2 end of study results for bel-sar (AU-011) in treating early-stage choroidal melanoma (CM). The study showed an 80% tumor control rate and 90% visual acuity preservation among Phase 3-eligible patients. Bel-sar demonstrated a highly favorable safety profile with no treatment-related serious adverse events. The drug achieved complete cessation of growth in responders, with a post-treatment average growth rate of 0.011 mm/yr compared to 0.351 mm/yr prior to study entry (p<0.0001). Notably, 80% of patients were at high risk for vision loss due to tumor proximity to critical eye structures. These results are significant given the poor prognosis associated with CM and the lack of approved vision-preserving therapies. Aura is currently enrolling patients in the global Phase 3 CoMpass trial for bel-sar.
Aura Biosciences (NASDAQ: AURA) announced a virtual urologic oncology investor event on October 17, 2024, to present early Non-Muscle Invasive Bladder Cancer (NMIBC) data from its ongoing Phase 1 trial. The event will feature key opinion leaders discussing the trial data, unmet medical needs, and current NMIBC treatment landscape. The Phase 1 trial is evaluating bel-sar (AU-011), a novel virus-like drug conjugate, as a monotherapy prior to standard care.
Additionally, Aura announced that Dr. Sabine Brookman-May will join as Senior Vice President, Clinical Development Urologic Oncology in October 2024. Dr. Brookman-May brings over 20 years of experience in urology and will lead Aura's urologic oncology therapeutic area, focusing on developing bel-sar for bladder cancer treatment.
Aura Biosciences (NASDAQ: AURA), a clinical-stage biotech company developing precision therapies for solid tumors, has announced its participation in two upcoming investor conferences. The company will attend the Morgan Stanley 22nd Annual Global Healthcare Conference on September 4, 2024, where senior management will engage in one-on-one investor meetings. Additionally, Aura will participate in the H.C. Wainwright 26th Annual Global Investment Conference on September 9, 2024, featuring both investor meetings and a virtual presentation by CEO Elisabet de los Pinos, PhD.
The virtual presentation at the H.C. Wainwright conference will be available at 7:00 am ET on September 9, 2024, accessible via the company's website and the conference platform. This presentation will remain archived on Aura's website for 90 days following the event, providing extended access for interested parties.
Aura Biosciences (NASDAQ: AURA) announced the upcoming presentation of Phase 2 end of study data for bel-sar, a treatment for early-stage choroidal melanoma, at The Retina Society Annual Meeting in Lisbon, Portugal. The presentation, titled 'Final Results of a Phase 2 Trial of Suprachoroidal Administration of Belzupacap Sarotalocan (bel-sar, AU-011) for Choroidal Melanoma', will be given by Dr. Ivana Kim on September 12, 2024.
Additionally, Aura will host a virtual ocular oncology investor event on the same day, featuring Dr. Kim and Dr. Prithvi Mruthyunjaya, to discuss the Phase 2 data. The event will include a live Q&A session and will be available for replay on Aura's website for 90 days.
Aura Biosciences (NASDAQ: AURA) reported Q2 2024 financial results and business highlights. Key points include:
1. Early Non-muscle Invasive Bladder Cancer (NMIBC) data from ongoing Phase 1 trial to be presented in October 2024.
2. Phase 2 end of study data for choroidal melanoma treatment to be presented in September 2024.
3. Strong cash position of $187.4 million, expected to fund operations into second half of 2026.
4. Q2 2024 financial results: R&D expenses increased to $16.9 million, G&A expenses rose to $5.9 million, net loss was $20.3 million.
5. Ongoing clinical trials in ocular and urologic oncology, with potential for new treatment options.
Aura Biosciences (NASDAQ: AURA), a clinical-stage biotechnology company focused on developing precision immunotherapies for solid tumors, announced participation in the Jefferies Global Healthcare Conference. CEO Elisabet de los Pinos will present on June 6, 2024, at 12:30 p.m. ET. The presentation will be webcast live and available on Aura Biosciences' website, with a replay accessible for 90 days post-event.
Aura Biosciences will host a virtual KOL event titled “Pioneering a New Standard of Care In Ocular Oncology” on May 29, 2024, at 2:00 PM ET.
Experts including Dr. Carol Shields, Dr. Hakan Demirci, and Dr. Mandeep Sagoo will discuss the unmet medical needs and current treatments for ocular cancers like primary uveal melanoma and metastases to the choroid. The event will spotlight Aura's lead candidate, bel-sar, which is in a Phase 3 trial for early-stage uveal melanoma.
The event will feature a panel discussion moderated by Chris Howerton and will include a live Q&A session. The webcast will be available on Aura's website and archived for 90 days.
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