Bimiralisib

BASEL, Switzerland--(BUSINESS WIRE)--Torqur AG, subsidiary of Swiss Rockets incubator and a clinical-stage company advancing targeted therapies in oncodermatology and oncology, announced the results of the full Phase 2 proof-of-concept study results of topical bimiralisib gel (2%) for the treatment of actinic keratosis (AK) at the European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris, the largest dermatology conference in Europe. The randomized, multi-center study evaluated topical bimiralisib gel as a field-directed treatment for AK on the face, scalp, and/or back of hands. Results demonstrated substantial efficacy and a favorable safety profile, supporting further clinical development: Efficacy: 92% of complete or near complete response with Olsen grade 1 patients, and overall, 52% of patients in the 2-week period and 71% in the 4-week period achieved an Investigator’s Global Assessment (IGA) score of 0–1 (complete or partial clearance). All patients experienced some degree of lesion clearance after the initial treatment period. Clearance was seen in Olsen grade 1 and grade 2 AK lesions. Subanalysis showed that patients with Olsen grade 2 also had significant clearance with 48% complete or near complete response . Safety: Treatment was well tolerated , with related adverse events being generally local skin reactions with the vast majority being mild (only four grade 2 events), all resolving without intervention. Retreatment during the optional extension phase for up to 8 weeks was feasible without any significant or new safety concerns. Further improvements of lesions were noted with additional cases of complete clearance . The Phase 2 study enrolled 46 patients across two leading Swiss dermatology centers: University Hospital Basel (Prof. A. Navarini) and Lausanne University Hospital (Prof. O. Gaide). Dr. Vladimir Cmiljanovic, CEO of Torqur AG, said: “Presenting these Phase 2 results at Europe’s most prestigious dermatology congress is a tremendous milestone. The high rates of clearance and consistently favorable tolerability profile underscore bimiralisib’s potential to become a new standard for patients with actinic keratosis. We are now preparing for the pivotal Phase 3 clinical trials and discussing with potential partners to bring this therapy closer to patients worldwide.” Prof. Dr. Alexander Navarini, Chairman of Dermatology at University Hospital Basel and Lead Principal Investigator, commented: “These results show that bimiralisib gel 2% has both efficacy and safety across different grades of actinic keratosis. This represents a promising new non-invasive option for patients, addressing a significant unmet need in dermatology.” Prof. Dr. Olivier Gaide, Head of the Center of Excellence for Skin Cancer and Melanoma at Lausanne University Hospital and Principal Investigator, added: “With actinic keratosis being the most common precancerous skin condition, these data highlight the great potential of this targeted topical therapy to counter progression to squamous cell carcinoma.” Actinic keratosis affects more than 10% of Europeans and is considered the most common pre-cancerous dermatological condition driven by an overactive PI3K/mTOR pathway. Bimiralisib gel is a selective pan-PI3K/mTOR inhibitor and offers a new mechanism-based approach to treat early-stage skin lesions effectively and safely. About Torqur AG (www.torqur.com) Torqur AG is an innovative Swiss clinical-stage biotechnology company dedicated to advancing next-generation therapies in oncology and dermatology. Its lead product, bimiralisib, is a selective pan-PI3K/mTOR inhibitor with applications across cancer and dermatological indications. Torqur AG is a fully owned subsidiary of Swiss Rockets AG (www.swissrockets.com), the leading biotechnology incubator and accelerator of Switzerland, headquartered in Basel. Forward-Looking Statements This press release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding the clinical development, potential regulatory approval, and future commercialization of bimiralisib. Forward-looking statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially. Torqur AG undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

BASEL, Switzerland--(BUSINESS WIRE)--Torqur AG, an innovative clinical-stage biotechnology company dedicated to advancing treatments for oncology and dermatology, is delighted to announce the presentation of interim results from its ongoing Phase 2 clinical trial in Actinic keratosis at the American Academy of Dermatology (AAD) Annual Meeting, taking place in Orlando, Florida, from March 7–11, 2025. Actinic keratosis, the most common pre-cancerous dermatological condition, affects 58 million Americans each year.1 Primarily driven by an overactive PI3K pathway, early research suggests targeted therapy could hold promise for many patients. The study evaluates the safety and efficacy of topical gel bimiralisib, a selective pan-PI3K/mTOR inhibitor, in patients with Actinic keratosis. The interim results highlight strong potential, paving the way for further clinical advancement. Key interim findings include: Efficacy : Bimiralisib topical gel (2%) demonstrated strong efficacy with 60% of patients who completed the initial treatment and follow up visit showing either complete or partial clearance of their lesions. Notably, 70% in the 4-week treatment group (Arm B, 17 patients) and 50% in the 2-week treatment group (Arm A, 18 patients) showed significant improvement, reinforcing its potential as an effective targeted therapy for Actinic keratosis. Safety: The safety profile indicates that bimiralisib topical gel (2%) was well tolerated, with treatment-related adverse events primarily being mild (Grade 1) and resolving quickly after treatment completion. “These interim results mark a significant step forward in our commitment to bringing innovative therapeutic options to patients with Actinic keratosis,” said Dr. Vladimir Cmiljanovic, CEO at Torqur AG. “We are highly encouraged by the positive trends observed and remain focused on advancing the study toward the next phase of development.” Prof. Dr. David Fisher, Chair of the Dermatology Department at Massachusetts General Hospital (MGH) and Harvard Medical School, offered: “Most instances of cutaneous squamous cell carcinomas begin as Actinic keratosis. With more than 58 million Americans living with these lesions, new targeted, non-invasive treatments for early-stage growths could help to alleviate the burden of this disease for thousands of patients.” “The interim results from this Phase 2 trial are highly encouraging, showing strong potential for bimiralisib topical gel (2%) as an effective and well-tolerated treatment for Actinic keratosis,” said Prof. Dr. Alexander Navarini, lead Principal Investigator and Chairman of the Department of Dermatology and Allergy at the University Hospital Basel in Switzerland. “These encouraging interim findings further validate the need for effective, targeted therapies addressing the PI3K pathway in Actinic keratosis. We look forward to building on this momentum and further assessing bimiralisib’s clinical potential as the study progresses.” Prof. Dr. Olivier Gaide, Principal Investigator and Head of the Center of Excellence for Skin Cancer and Melanoma at the Lausanne University Hospital, Switzerland, added: “The interim results from this Phase 2 trial indicate promising efficacy and tolerability of bimiralisib topical gel (2%), reinforcing its potential as a valuable targeted therapy for Actinic keratosis.” The Phase 2 trial is enrolling patients across two renowned dermatology centers in Switzerland, Prof. Alexander Navarini in Basel and Prof. Olivier Gaide in Lausanne, with full results expected in June 2025. The complete interim analysis will be accessible to conference attendees through the AAD online viewing portal and on-site viewing stations starting at the beginning of the meeting. However, public access via the Journal of the American Academy of Dermatology supplement will occur later in the year. For more information on the trial, please visit www.clinicaltrials.gov, ID NCT06319794. About Torqur AG Torqur AG, a Swiss biotech pioneer, focuses on developing novel anti-cancer therapies targeting the metabolic PI3K/mTOR pathway. Leveraging the assets and intellectual property acquired from Piqur Therapeutics AG, Torqur AG is at the forefront of cancer research and therapy development. Founded by Dr. Vladimir Cmiljanovic and Dr. Natasa Cmiljanovic, Torqur AG operates under the auspices of Swiss Rockets AG, driving innovation in oncology and dermatology. DISCLAIMER Swiss Rockets AG and Torqur AG have prepared this press release to the best of its knowledge, based on the currently available preliminary data. The general background information about Torqur AG’s activities is current as of the date of this press release. This information is provided in summary form and does not claim to be exhaustive. The final results and outcomes of the study may materially differ from those projected in this slide deck. Torqur AG does not make any warranties, representations, or guarantees regarding the final results and outcomes of the study. The information contained in this press release does not constitute a solicitation or offer to buy, sell, or otherwise trade or engage in any similar transaction involving Swiss Rockets AG’s or Torqur AG’s shares. The information presented herein includes certain forward-looking statements and estimates. Such information is subject to significant scientific, economic, business, and financial uncertainties that cannot be predicted in advance. Therefore, actual results may materially differ from those projected. Neither Swiss Rockets AG nor its group companies make any warranties, representations, or guarantees regarding the data and information made available through this communication, including but not limited to their accuracy, timeliness, completeness, marketability, commercial usability, or suitability for any particular purpose and in particular with regard to forward-looking statements and does not make any warranties or gives any guarantees on the future course of development and success of any of its products, strategies or business activities. This disclaimer is governed by Swiss law. Any disputes arising from or in connection with this press release shall be subject to the exclusive jurisdiction of the competent courts of the Canton of Basel-Stadt, Switzerland. 1 https://my.clevelandclinic.org/health/diseases/14148-actinic-keratosis