Proliposomal Intravesical Paclitaxel

MENLO PARK, Calif., May 6, 2021 /PRNewswire/ -- LIPAC Oncology LLC., a pharmaceutical company utilizing its liposome-bound nano-technology platform to provide precision targeted cancer drugs for the treatment of multiple tumor types, today announced the appointment of Josh Hamermesh as an independent board director. "Josh is a noted expert in driving and supporting the growth of innovative companies thanks to his two decades of leadership experience in the biotechnology industry," said Will Robberts, President of LIPAC Oncology. "We welcome Josh to the Board and look forward to his insights and contributions around both corporate and business development, strategy and commercialization as we continue to advance our oncology pipeline and build our business." Mr. Hamermesh currently serves as Chief Business Officer at Gamida Cell Ltd. Prior to joining Gamida Cell, he was Senior Vice President at Locust Walk Partners, Inc., a strategic partnering and financing transaction advisory firm, where he played an instrumental role in leading numerous transactions across an array of therapeutic areas and technologies. Prior to Locust Walk, Mr. Hamermesh served as Vice President, Business and Corporate Development at Infinity Pharmaceuticals, Inc., where he was responsible for the company's in-licensing, out-licensing and alliance management activities. Previously, he served as Senior Vice President, Strategy and Corporate Development at Pervasis Therapeutics, Inc., and has also held positions at Molecular Insight Pharmaceuticals, Inc., and Genzyme. Mr. Hamermesh currently serves as a member of the board of directors at Neurohealing Pharmaceuticals, Inc. He holds a B.S., magna cum laude, from Amherst College and an M.B.A from Harvard Business School. "I'm thrilled to join LIPAC Oncology and contribute to the team's efforts to advance their innovative liposome-bound nano-technology platform and address the unmet needs of patients suffering from intracavitary cancers," said Mr. Hamermesh. "This is an exciting time for the Company, as they build upon the momentum from a successful FDA Type B meeting and advance the program into a Phase 2b study of LiPax for the treatment of non-muscle invasive bladder cancer." About LiPax LiPax is a precision targeted, locally delivered taxane in Phase 2b development for intravesical instillation in the treatment of non-muscle invasive bladder cancer (NMIBC). Its liposome-bound nano-technology platform achieves targeted tissue penetration with no systemic exposure, toxicity or chemo-related side-effects. NMIBC is the lead program with additional orphan indications in upper tract urothelial cancer (UTUC), peritoneal and ovarian cancers, and thoracic cancers (mesothelioma and malignant pleural effusion). LiPax is designed to enhance the standard of care of outpatient endoscopic tumor removal followed by intravesical instillation using a standard urinary catheter. LIPAC Oncology completed a Phase 2a clinical trial in August 2020 and intends to initiate a Phase 2b study in the second half of 2021 to further investigate LiPax in the treatment of this condition. About LIPAC Oncology LLC LIPAC Oncology is a pharmaceutical company focused on advancing the development of new investigational therapies to treat intracavitary cancers. Its precision liposome-bound nano-technology platform targets local liposomal delivery of taxanes for the treatment of multiple tumor types. LiPax, its lead investigational candidate for the treatment of non-muscle invasive bladder cancer, is in Phase 2b development. The Company's pipeline includes multiple orphan indications based on the established LiPax formulation. For more information, visit lipaconcology.com. Investors: Sherri Spear, 212-600-1902 LIPAC@argotpartners.com Media: Leo Vartorella, 212-600-1902 LIPAC@argotpartners.com

MENLO PARK, Calif., April 29, 2021 /PRNewswire/ -- LIPAC Oncology LLC today announced the conclusion of a successful Type B meeting with the U.S. Food and Drug Administration (FDA) to discuss Phase 2b/3 clinical trials of LiPax in patients with low-grade highly recurrent non-muscle invasive bladder cancer (NMIBC). The feedback from the FDA provides a clear path for LIPAC Oncology to initiate the Phase 2b trial for LiPax in the second half of 2021. "We appreciate the thoughtful feedback and guidance from the FDA and acceptance of our proposed design for the Phase 2b/3 trial of LiPax," said Michael Oefelein, M.D., Chief Medical Officer of LIPAC Oncology. "Non-muscle invasive bladder cancer is difficult to treat and highly recurrent. With the lack of existing treatment options for low to intermediate risk NMIBC, the unmet medical need is very high." LIPAC Oncology recently announced the successful completion of a Phase 2a marker lesion clinical trial designed to predict long-term (two-year) recurrence free survival rates in patients with low-grade highly recurrent NMIBC treated with LiPax. In this study LiPax demonstrated a 63 percent marker lesion responder rate in highly recurrent and heavily pretreated patients. Based on these results, the FDA agreed that the Phase 2b trial will be a dose selection study with low dose (90 mg) and high dose (360 mg) arms and will enroll approximately 30 patients in each arm. The Phase 3 trial will be a randomized, double-blind, placebo-controlled trial in patients with low-grade recurrent NMIBC with a time to event primary endpoint after a one-year treatment phase. "LIPAC Oncology is pleased to reach this important point in the development of LiPax, bringing us one step closer to providing this therapeutic option to the patients who could benefit from a novel approach to treatment," said Will Robberts, President of LIPAC Oncology. "We have made significant progress with the program, including executing a successful Phase 1/2a trial, securing a strategic partner in South Korea and expanding the global intellectual property protection with formulation patents being granted in Europe, Japan, China and other territories." About NMIBC Non-muscle invasive bladder cancer (NMIBC) is a cancer found in the tissue that lines the inner surface of the bladder. Bladder cancer is the sixth most common cancer in the U.S., and 74% of all bladder cancer is non-muscle invasive. Approximately 90,000 patients are newly diagnosed with NMIBC per year in the U.S. alone with as many as 390,000 patients per year newly diagnosed with NMIBC worldwide. The disease is marked by a high recurrence with a five-year recurrence rate averaging 50%. Treatment of NMIBC is based on risk stratification. Patients are initially treated with a simple outpatient procedure involving transurethral resection of bladder tumor (TURBT) followed by a single, immediate instillation of intravesical chemotherapy to eliminate any residual tumor cells. Based on a patient's biopsy results obtained from TURBT, NMIBC is stratified into three risk categories: low, intermediate, and high risk. To reduce recurrence and prevent progression, the American Urological Association NMIBC guidelines recommend induction and maintenance intravesical therapy after TURBT for intermediate risk patients. The low to intermediate risk category targeted by LiPax is estimated to comprise 95,000 Americans per year, yet no intravesical agent is approved by the FDA for this disease. About LiPax LiPax is a precision targeted, locally delivered taxane in Phase 2b development for intravesical instillation in the treatment of NMIBC. Its liposome-bound technology achieves targeted tissue penetration with no systemic exposure and toxicity. NMIBC is the lead program with additional orphan indications in upper tract urothelial cancer (UTUC), peritoneal and ovarian cancers and thoracic cancers (mesothelioma and malignant pleural effusion). LIPAC Oncology's precision nano-technology platform provides targeted local liposomal delivery of taxanes (paclitaxel) to allow for deep tissue penetration in the bladder with no systemic exposure, dose-limiting toxicity or chemo-related side effects. LiPax is designed to enhance the standard of care of outpatient endoscopic tumor removal followed by intravesical instillation using a standard urinary catheter. LIPAC Oncology completed a Phase 2a clinical trial in August 2020 and intends to advance the program to a pivotal study to further investigate LiPax in the treatment of this condition. About LIPAC Oncology LLC LIPAC Oncology is a pharmaceutical company focused on advancing the development of new investigational therapies to treat intra-cavitary cancers. Its precision nano-technology platform targets local liposomal delivery of taxanes for the treatment of multiple tumor types. LiPax, its lead investigational candidate for the treatment of non-muscle invasive bladder cancer, is in Phase 2b development. The Company's pipeline includes multiple orphan indications based on the established LiPax formulation. For more information, visit lipaconcology.com. Investors: Sherri Spear, 212-600-1902 LIPAC@argotpartners.com Media: Leo Vartorella, 212-600-1902 LIPAC@argotpartners.com