On January 3, 2025 DiaCarta Inc., a precision molecular diagnostic company, reported the publication of its prospective clinical trial data on its blood-based test for triaging FIT (fecal immunochemical test)-positive patients in colorectal cancer (CRC) screening (Press release, DiaCarta, JAN 3, 2025, View Source [SID1234649408]).The study data was published in the Journal of Molecular Pathology on December 13, 2024. The findings reveal that in triaging FIT-positive patients in CRC screening, the QuantiDNA test from patients’ plasma reduces the need for colonoscopy examinations by 33% and is non-inferior to the standard of care in detecting significant colorectal lesions.

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The prospective clinical trial was designed for the Triage of FIT+ Patients Enrolled in a Colorectal Cancer Screening Program. During the period 2019–2022, 711 individuals of both genders, aged 50–74, participating in a CRC screening program organized by the ASL NA 3 SUD, a public healthcare company operating in the district of Naples (Italy), were enrolled in a cross-sectional study aimed at investigating the possible role of the plasma-based test. According to the study protocol, all participants with a FIT+ (or FOBT+) test, willing to sign an informed consent and eligible for the study, received both the blood-based test and a colonoscopy. Data analysis strategy ensured a comparison between the standard of care and the alternative approach. The study was approved by the Ethical Committee in December 2018. Statistical analysis was conducted internally and independently validated by TechnoSTAT Clinical Services (Bnei Brak, Israel). The database was provided and held by Mednet, Inc. (Minnetonka, MN, USA).

"In Europe, all patients diagnosed as FIT positive are referred for colonoscopy, but, according to data collected from within the screening programs, 75% of them turn out to be negative afterward," said Dr. Mauro Scimia, DiaCarta’s Medical Director and Senior Business Director in Italy, as well as one of the senior authors of this paper. "We utilized the straightforward, non-invasive, and well-tolerated blood-based test to triage FIT+ patients, significantly reducing the number of patients who truly require colonoscopy. This approach helps alleviate the burden on healthcare providers and reduces patients’ anxiety while they wait for long colonoscopy queues."

"We are very pleased with the clinical trial results. The clinical performance of the simple blood-based test in triaging CRC screening aligns perfectly with our mission to advance cancer testing through liquid biopsy," Dr. Adam (Aiguo) Zhang, President and CEO of DiaCarta, added. "This clinical trial represents a major milestone in "bringing the test into clinical practice."

On January 3, 2025 Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation (nano-PFA or nsPFA) technology, reported plans to present at the upcoming 43rd Annual J.P. Morgan Healthcare Conference in San Francisco (Press release, Pulse Biosciences, JAN 3, 2025, View Source [SID1234649407]).

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Pulse Biosciences’ Management is scheduled to present on Wednesday, January 15, 2025, at 3:45 pm PT. A live and recorded webcast of the presentation will be available on the "Events Calendar and Presentations" page of the company’s investor website at View Source

On January 3, 2025 Imugene Limited (ASX:IMU), a clinical-stage immuno-oncology company, reported that the first Australian patient has been dosed in the Phase 1b clinical trial of its allogeneic CAR T-cell therapy azer-cel (azercabtagene zapreleucel), at the Royal Prince Alfred Hospital (RPAH) in Sydney (Press release, Imugene, JAN 3, 2025, View Source [SID1234649406]). The trial is focused on patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), one of the most challenging and aggressive forms of non-Hodgkin’s lymphoma.

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Azer-cel is one of the few allogeneic CAR T-cell therapies currently being evaluated in Australia. Azer-cel offers an off-the-shelf alternative to traditional autologous CAR Tcell therapies, which require lengthy manufacturing processes involving a patient’s own cells. By utilising pre-manufactured donor T-cells, azer-cel has the potential to significantly shorten treatment timelines and expand accessibility for patients with limited options.

Imugene recently reported promising data from its US trial sites (see ASX announcement 2 September 2024), demonstrating the potential of azer-cel to deliver meaningful clinical outcomes. In the US cohorts, three patients achieved complete responses (CR) despite having relapsed following multiple prior treatments, including autologous CAR T therapies. Notably, patients treated in Cohort B – which includes lymphodepletion chemotherapy and interleukin-2 (IL-2) – have shown particularly robust and durable responses, with responses extending beyond 90 and 120 days.

Leslie Chong, Managing Director and CEO of Imugene, said: "Achieving first patient dosed for azer-cel in Australia represents a significant milestone for Imugene and for Australian patients battling this devastating disease. The trial’s opening at RPAH in Sydney reflects our commitment to accelerating the development of innovative, offthe-shelf immunotherapies that have the potential to improve outcomes for patients with relapsed or refractory DLBCL. We are proud to bring this trial to Australia and look forward to expanding recruitment across multiple sites."

On January 3, 2025 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, reported that Saqib Islam, Chief Executive Officer, reported that it will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 11:15 a.m. PT (Press release, SpringWorks Therapeutics, JAN 3, 2025, View Source [SID1234649405]).

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To access the live webcast, please visit the Events & Presentations page within the Investors & Media section of the company’s website at View Source A replay of the webcast will be available on SpringWorks’ website for a limited time following the conference.

On January 3, 2025 Rakovina Therapeutics, Inc. (TSX: RKV), a biopharmaceutical company focused on the development of new cancer therapies based on novel DNA-damage response technologies, reported its participation in events and meetings being held alongside the 43rd Annual J.P. Morgan Healthcare Conference, taking place January 13-16, 2025, in San Francisco (Press release, Rakovina Therapeutics, JAN 3, 2025, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-to-connect-with-industry-leaders-during-43rd-annual-j-p-morgan-healthcare-conference-week [SID1234649404]).

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Showcasing Innovation on a Global Stage

As the premier healthcare investment symposium, the J.P. Morgan Healthcare Conference attracts thousands of global leaders, investors, and innovators from the biopharmaceutical and healthcare sectors. Rakovina Therapeutics will leverage this opportunity to highlight its progress in AI-driven drug discovery and the transformative potential of its advancements in cancer treatment.

Rakovina will engage in meetings held outside the main conference with interested parties, including industry leaders, potential collaborators, and members of the investment community. These meetings aim to foster partnerships and explore new opportunities to advance the company’s mission.

"The conference and surrounding engagements serve as valuable platforms to showcase Rakovina Therapeutics’ progress in AI-driven drug discovery and its transformative potential for cancer treatment," said Jeffrey Bacha, Executive Chairman of Rakovina Therapeutics. "It is an opportunity to engage with industry leaders, partners, and the investment community as we continue to drive innovation in the DNA-damage response space."

2025: Accelerating Progress and Innovation

The upcoming year holds significant promise for Rakovina Therapeutics as it strives to make key advancements in its mission to develop innovative cancer treatments. The company plans to progress its AI-identified drug candidates through preclinical validation, preparing them for entry into clinical trials, marking a crucial step forward. Concurrently, it aims to enhance its AI-driven platforms, streamlining the drug discovery process to accelerate the development of novel therapies.

Strategic partnerships will remain a cornerstone of the company’s strategy, facilitating the swift development and delivery of innovative cancer treatments to patients. These initiatives exemplify Rakovina’s commitment to leveraging cutting-edge technology, fostering collaboration, and transforming the landscape of cancer care.

Stock Option Grant

The Company also announces that its board of directors approved the grant of 4,330,00 stock options ("Options") to certain officers and directors of the Company pursuant to the Company’s Long Term Incentive Plan. The Options are exercisable at $0.185 per share for five years from the grant date and will vest in equal parts every six months over the next three years.