SHANGHAI, Sept. 19, 2024 /PRNewswire/ -- Abbisko Therapeutics (HKEX: 02256) is excited to announce the receipt of the ESMO 2024 Best Poster Award on September 16, 2024. The award was received for the presentation titled "Updated Safety and Efficacy of Irpagratinib (ABSK011) in advanced hepatocellular carcinoma (aHCC) with FGF19 overexpression from a Phase 1 study". The update data from ABSK-011-101 study showed a tolerable safety profile and promising anti-tumor activity of Irpagratinib monotherapy in aHCC. Of note, in aHCC patients who were pretreated with both immune checkpoint inhibitor (ICI) and Tyrosine Kinase Inhibitor (TKI)—a population with high unmet need in the current treatment paradigm—the observed ORR and DCR was 44.8% and 79.3%, respectively, with a median duration of response (mDoR) of 7.4 months and median progression free survival (mPFS) of 5.5 months.
The poster, #983P, was presented at the Hepatocellular Carcinoma poster session on Sunday, September 16, 2024. The Best Poster Award was given at the conclusion of the Sunday Poster Session, with only one recipient being honored in HCC poster session.
As of September 5, 2024, 122 patients have been enrolled, including 74 in the BID cohort with doses consisting of 160mg BID, 220mg BID, and 300mg BID. 5.4% of patients were BCLC Stage B, and 89.2% BCLC Stage C, 64.9% had a Child-Pugh (CP) Score of 5, 27% CP Score of 6, and 6.8% CP Score of 7. 64.9% of patients received multiple lines of prior therapy, 85.1% of patients had previously been treated with ICIs, and 75.7% of patients had previously been treated with both ICIs and mTKIs.
The efficacy data show that forty pre-treated HCC patients with FGF19 overexpression were treated with irpagratinib 220 mg BID. Among the 38 evaluable patients, the response rate was 36.8% (14/38), and the disease control rate (DCR) was 78.9% (30/38). The response rate from the subset of patients who had previously received ICI and mTKI therapy was 44.8% (13/29). The longest observed DoR was 16.4 months and the mDoR was 7.4 months. DCR was 79.3% (23/29). mPFS was 5.5 months.
Safety data show one dose-limiting toxicity (DLT) was observed in the 300 mg BID cohort. The most common treatment-related adverse effects (TRAEs, >20%) were ALT elevation, diarrhea, AST elevation, hyperphosphatemia, bilirubin elevation, alkaline phosphatase elevation, platelet decrease, and total bile acid elevation. Grade 3-4 treatment-related adverse events (>5%) included AST elevation, ALT elevation, and diarrhea. No grade 5 adverse events occurred.
HCC is the main type of liver cancer, accounting for 85% to 90% of primary liver cancers. HCC is highly malignant, about 30% of which have abnormally high FGFR4 expression and a poor prognosis, and the existing treatment methods still cannot meet the long-term survival benefits. Currently, there is no approved standard of care for HCC patients who have progressed from first-line ICI-based therapies. The FGF19/FGFR4 signaling axis could be a novel therapeutic target for HCC. ABSK-011, a potent FGFR4 inhibitor, demonstrated a tolerable safety profile and promising anti-tumor activity as a single agent. Notably, the irpagratinib 220mg BID regimen exhibited a 44.8% ORR, 7.4 months mDoR and 5.5 months mPFS in heavily pre-treated HCC patients who had received both ICI and mTKI therapy, supporting further late-stage development of irpagratinib in such populations with substantial unmet medical need.
In addition, the design of the phase II study of pimicotinib in combination with chemotherapy and with/without toripalimab as first-line treatment for advanced pancreatic ductal adenocarcinoma (PDAC) has been presented.
About Irpagratinib (ABSK011)
Irpagratinib is a highly selective FGFR4 small molecule inhibitor intended for the treatment of advanced solid tumors that present with abnormalities in the FGF19/FGFR4 signaling pathway (e.g., ligand FGF19 amplification/overexpression, FGFR4 mutation/amplification/fusion), including advanced HCC, cholangiocarcinoma, breast cancer, among others. The FGFR4 signaling pathway is a recognized and promising target for treating HCC. Clinical data with irpagratinib have demonstrated improved potency and anti-tumor efficacy, among other favorable therapeutic properties, compared to competitors.
About Abbisko Therapeutics
Founded in April 2016, Abbisko Therapeutics Co., Ltd., a subsidiary of Abbisko Cayman Limited (Stock Code on the Hong Kong Stock Exchange: 2256.HK), is an oncology-focused biopharmaceutical company founded in Shanghai, dedicated to the discovery and development of innovative medicines that treat unmet medical needs in China and globally. The Company was established by a group of seasoned drug hunters with rich R&D and managerial expertise from top multinational pharmaceutical companies. Since its founding, Abbisko Therapeutics has built an extensive pipeline of 16 innovative small molecule programs focused on precision oncology and immuno-oncology. Please visit www.abbisko.com for more information.
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
Best Poster of ESMO 2024! Abbisko Announces Updated Clinical Data of Irpagratinib in HCC
DJI delivers action camera with industry-first professional features, including a groundbreaking 13.5-stop for both an exceptional high dynamic range and excellent low-light performance
SHENZHEN, China, Sept. 19, 2024 /PRNewswire/ -- DJI, the global leader in civilian drones and creative camera technology, today unveils the Osmo Action 5 Pro. The latest generation of DJI's popular Osmo action camera series delivers several industry-first features rivaling professional cameras. From the 13.5-stop dynamic range and 4-hour battery life to the built-in subject centering and tracking, the Osmo Action 5 Pro sets a new quality standard for action photography, capturing every adventure from the sea to the mountains, whether in the sun or the snow.
"By combining the image quality of a professional camera with the rugged durability of an action camera, we continue to innovate and set new standards for the industry," said Paul Pan, Senior Product Line Manager at DJI. "Creators have evolved, becoming more sophisticated in the stories they tell and the moments that they capture. Instead of making incremental improvements, we strive to push the entire action camera category forward and evolve with these creators."
13.5-stops of dynamic range deliver groundbreaking image quality
Osmo Action 5 Pro features a next-gen 1/1.3" sensor with a 2.4 μm pixel size and a high dynamic range of up to 13.5 stops, making it the first action camera with specs that rival professional cameras. Images can be captured in 10-bit D-Log M and support hybrid log-gamma (HLG) high-brightness displays. It can also shoot high-dynamic, low-light video at 4K/60fps, capturing intricate shadow details without overexposing highlights, thereby enhancing overall image quality. Additionally, SuperNight mode with AI noise reduction algorithms can overcome the darkness in extremely low-light environments to yield cleaner and clearer footage.
Extended 4-hour battery life for longer shoots
Osmo Action 5 Pro delivers up to 4 hours of continuous use with a single battery – a 50 percent improvement from its predecessor. This new innovation is made possible with a lower power consumption 4nm chip, a larger 1950mAh battery, and a proprietary DJI algorithm that optimizes for energy savings. Even in temperatures as low as -20° C (-4°F), the camera can reliably record video for up to 3.6 hours. The industry average for action camera battery life is approximately 2 hours. Moreover, the battery can deliver 2 hours of shooting from a 15-minute charge using the fast-charging DJI 30W USB-C Charger.
Industry's first built-in subject centering and tracking
Osmo Action 5 Pro is the first action camera to offer built-in subject centering and tracking, allowing creators to shoot without a gimbal. Powered with a high-performance 4nm chip and machine learning algorithms, the camera can intelligently detect a subject's position and dynamically adjust the composition to keep the subject centered in every frame.
Optimized for underwater photography
Osmo Action 5 Pro offers the industry's deepest waterproofing depth at 20m without a case. The built-in color temperature sensor captures true-to-life colors under the sea. The camera can also be set to start recording automatically while submerged and to stop after surfacing. It also has a built-in pressure gauge to record underwater depth, duration, and altitude data to ensure the user's safety. Certified with EN13319, it meets globally recognized standards for diving accessories.
Larger dual OLED high-brightness touchscreens
Osmo Action 5 Pro features larger front and rear tempered glass touchscreens upgraded with OLED high-brightness displays. With an impressive peak brightness of 1000 cd/㎡, daytime shooting becomes easier. In increasing the screen size and narrowing the bezels while retaining the camera body's size, the screen-to-body ratio increased by 16% from its predecessor.
Compatible with DJI OsmoAudioâ„¢ connectivity ecosystem
Osmo Action 5 Pro can connect directly to the DJI Mic 2 Transmitter via Bluetooth, enabling ultra-high-sampling-rate audio recording. This setup provides studio-quality sound while eliminating the need for a receiver. When Built-in Mic Audio Backup is enabled, ambient sounds can be recorded to add a richer layer of authenticity.
Other practical features for enhanced performance
Intelligent shooting and editing with Mimo app
Creators can quickly preview the camera view, adjust settings, and edit their footage by connecting the Osmo Action 5 Pro with the DJI Mimo app via Wi-Fi and Bluetooth. Some new Mimo features include taking live photos and capturing 4K high-resolution frame captures, reproducing D-Log M flat color profiles for more stylized adjustments, and exporting videos in 4K/120fps, 4:3 aspect ratio. Creators can also download photos and videos from their DJI camera in the background, allowing them to continue using their smartphones for other tasks.
Powerful accessories, reliable assistance
A range of dedicated accessories for every adventure can enhance the Osmo Action 5 Pro filming experience. Each is sold separately.
DJI Care Refresh
DJI Care Refresh, the comprehensive protection plan for DJI products, is now available for Osmo Action 5 Pro. Accidental damage is covered by the replacement service, including natural wear, collisions, and water damage. For a small additional charge, you can have your damaged product replaced if an accident occurs.
DJI Care Refresh (1-Year Plan) includes up to 2 replacements in 1 year. DJI Care Refresh (2-Year Plan) includes up to 4 replacements in 2 years. Other services of DJI Care Refresh include official warranty, international warranty service and free shipping. For a full list of details, please visit: www.dji.com/support/service/djicare-refresh
Price and Availability
Osmo Action 5 Pro is available today from store.dji.com and most authorized retail partners in several configurations.
For more information: www.dji.com/osmo-action-5-pro
About DJI
Since 2006, DJI has led the world with civilian drone innovations that have empowered individuals to take flight for the first time, visionaries to turn their imagination into reality, and professionals to transform their work entirely. Today, DJI serves to build a better world by continuously promoting human advancement. With a solution-oriented mindset and genuine curiosity, DJI has expanded its ambitions into areas such as agriculture, public safety, surveying and mapping, and infrastructure inspection. In every application, DJI products deliver experiences that add value to lives around the world in more profound ways than ever before.
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Website: www.dji.com
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** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
DJI Advances Action Camera Industry with Osmo Action 5 Pro's Revolutionary Image Quality
