Sonidegib Phosphate

Basal Cell Carcinoma CSR Highlights CX-4945 Monotherapy: Progression-free survival (PFS) exceeded 21 months in two patients. Optimal Treatment Response: Three patients achieved partial response (PR), while ten patients had stable disease (SD). Tolerability & Disease Control Rate: Shows potential superiority over current first- and second-line therapies. Unmet Medical Need: Enrolled patients with refractory or recurrent disease who had no remaining treatment options. TAIPEI and SAN DIEGO, April 2, 2025 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, today announced that the completion of Clinical Study Report (CSR) for Phase 1/Dose Expansion Trial of Silmitasertib (CX-4945) in the Treatment of Basal Cell Carcinoma(BCC), with positive data outcomes. The study included patients who had relapsed after standard therapies and had no other treatment options. Among them, three patients experienced over 30% tumor reduction (PR), and two patients had a progression-free survival (PFS) exceeding 21 months. CX-4945 significantly prolonged survival in advanced cancer patients, marking a major milestone for both the patients and Senhwa. Compared to current first- and second-line therapies, CX-4945 demonstrated superior tolerability and disease control potential. Therefore, Senhwa will actively pursue licensing possibilities while carefully evaluating CX-4945's potential as a monotherapy or in combination with the second-line immunotherapy Libtayo. The company aims to explore further indications and potential as a first-line treatment, offering better options for patients. Clinical Trial Overview The trial enrolled 25 patients with locally advanced BCC (laBCC, 20 patients) and metastatic BCC (mBCC, 5 patients). The primary objective was to determine the recommended Phase 2 dose (RP2D) and optimal dosing regimen for CX-4945. Among 22 patients eligible for efficacy analysis: Three laBCC patients achieved partial response (PR). Ten patients had stable disease (SD), including 2 mBCC and 8 laBCC patients. Disease control rates: mBCC patients: 80% (4 patients with complete/partial response or stable disease). laBCC patients: 65% (11 patients with complete/partial response or stable disease). Further data analysis showed that: Median progression-free survival (PFS): laBCC: 9.2 months mBCC: 3.7 months Median duration of disease control (DDC): laBCC: 10.3 months mBCC: 7.5 months CX-4945 exhibited promising anti-tumor efficacy and disease stabilization potential in this indication. Additionally, CX-4945 has a lower study drug discontinuation rate of 24% due to AEs, compared to first-line treatments including Vismodegib and Sonidegib, suggesting superior tolerability. Future Prospects This trial is particularly noteworthy as it evaluated CX-4945 monotherapy in patients who had already failed first-line HHIs. Notably, 27.3% (6 patients) had also failed second-line PD-1 inhibitors such as Libtayo or Keytruda. Among the enrolled patients, two advanced-stage patients achieved a progression-free survival (PFS) of over 21 months, lasting 653 days and 667 days, respectively. Notably, the primary lesion of the former patient was almost undetectable by visual inspection. Given the significant potential of CX-4945 as a monotherapy, Senhwa is now actively pursuing regional licensing to accelerate commercialization through strategic partnerships, ultimately benefiting more patients. SOURCE Senhwa Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BURLINGAME, Calif.--( BUSINESS WIRE )-- Genesis Therapeutics , a company pioneering artificial intelligence (AI) technologies to create breakthrough medicines for patients, today announced the appointments of three key members during 2024 to its senior leadership team and Board of Directors: Shifeng Pan, Ph.D., as Chief Scientific Officer; Alla Ivanova as Senior Vice President of Engineering; and Paul A. Friedman, M.D., as Chairman of the Board. “ We are thrilled to welcome to our team these exceptional leaders who share belief in our mission and approach to transforming drug discovery with groundbreaking predictive and generative AI technologies,” said Evan Feinberg, Ph.D., founder and CEO of Genesis. “ Their industrial expertise across technology and drug discovery will enable us to further advance our GEMS (Genesis Exploration of Molecular Space) AI platform, expand our therapeutic pipeline, and ultimately create breakthrough treatments for patients suffering from severe diseases.” Shifeng Pan, Ph.D., Chief Scientific Officer: Dr. Pan joined Genesis in April 2024 and oversees R&D activities for Genesis’ pipeline of AI-enabled therapeutics. He brings more than two decades of experience in medicinal chemistry and biopharmaceutical research, including a 22-year career at Novartis, where he served as Head of Discovery Chemistry at the Genomics Institute of the Novartis Research Foundation. At Novartis, he led the discovery of FDA-approved drugs ODOMZO ® , BRAFTOVI ® , and MAYZENT ® , as well as numerous other programs across several therapeutic areas. Dr. Pan joins Genesis from Odyssey Therapeutics, where he was Executive Vice President and Head of Discovery. He earned a doctorate in organic chemistry from New York University. “ Genesis’ AI capabilities enable the discovery of novel and breakthrough molecules, making its platform well-suited to address challenging or historically undruggable targets,” said Dr. Pan. “ It’s an exciting time for the field of AI-enabled drug discovery and our premier team of engineers, chemists, and biologists who are leveraging the GEMS platform to rapidly advance our broad therapeutic pipeline.” Alla Ivanova, Senior Vice President of Engineering: Ms. Ivanova joined Genesis in November 2024 and brings over 25 years of experience driving innovation in software development; spanning data center management, large-scale infrastructure, and high-traffic web applications to cutting-edge AI/ML solutions. She has held executive leadership roles at notable tech companies including Head of Looker Engineering at Google Cloud, VP of Cloud & Data Infrastructure at Atlassian, Head of Core Infrastructure at Uber, Senior Director of Data Platform at Groupon, and Software Engineering Manager at Netflix. Ms. Ivanova earned her master's degree in applied mathematics and computer science from Kazan Federal University. “ At a time when AI is redefining the boundaries of what’s possible in drug discovery, I’m honored to be joining the Genesis team,” said Ms. Ivanova. “ The company’s AI platform, GEMS, has the potential to unlock the promise of computational drug design and discover life-changing medicines for patients. I’m excited to continue advancing transformational AI work, not just for innovation’s sake but to make a meaningful difference in human health – a mission that resonates deeply with me and the future I envision for AI.” Paul A. Friedman, M.D., Chairman of the Board of Directors: Dr. Friedman has served as Chairman of the company’s Board of Directors since April 2024. With decades of experience in biotechnology and drug development, he has held senior leadership roles at notable pharmaceutical companies, including CEO of Madrigal Pharmaceuticals (2016–2023), CEO of Incyte (2001–2014), President of Research and Development at DuPont-Merck Pharmaceutical, President of DuPont Pharmaceuticals Research Laboratories, and Senior Vice President of Merck Research Laboratories. He has also served as a board member for several publicly held pharmaceutical companies, including Incyte and Alexion. A diplomate of the American Board of Internal Medicine and member of the American Society of Clinical Investigation, Dr. Friedman earned his medical degree from Harvard Medical School. " Genesis is in an exciting period of growth following an outstanding Series B fundraise last year and recent collaboration with Gilead, positioning the company well to advance and expand its AI-enabled pipeline to develop breakthrough therapies for patients,” said Dr. Friedman. This expansion of Genesis’ senior leadership team follows the company’s appointments of two industry veterans to its Board of Directors: Vijay Pande, Ph.D., Founding General Partner at Andreessen Horowitz’s (a16z) Bio + Health fund, joined as a Director in 2023, and Mohamed “Sid” Siddeek, Vice President and Head of NVentures, NVIDIA’s venture capital arm, joined as an observer in 2024. About Genesis Therapeutics Genesis Therapeutics is pioneering AI for biotechnology by leveraging its generative and predictive AI platform called GEMS (Genesis Exploration of Molecular Space) for small molecule drug discovery. GEMS synthesizes proprietary AI methods, including language models, diffusion models, and physical ML simulations, to generate and optimize molecules for complex targets. Genesis has raised over $300 million from leading life science, tech, and AI-focused investors, and is building a therapeutic pipeline for a variety of high-impact targets. Genesis is headquartered in Burlingame, CA, with a fully integrated laboratory in San Diego. For more information on Genesis, please visit the company’s website at www.genesistherapeutics.ai .