Accessibility StatementSkip Navigation REDMOND, Wash. and PRINCETON, N.J., Oct. 17, 2025 /PRNewswire/ -- SystImmune Inc. (SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb (NYSE: BMY) today announced the oral presentation of the first disclosure of the safety and efficacy data from the global phase I US-Lung-101 study (NCT05983432) of iza-bren (BL-B01D1), a potentially first-in-class EGFR x HER3 bispecific antibody-drug conjugate (ADC), at the European Society for Medical Oncolo ...

Financial Data and Key Metrics Changes - For the first half of 2025, the company reported total revenue of $4.9 million, primarily driven by collaborations with AstraZeneca and Sanofi, as well as governmental funding for research expenditures [31] - Operating expenses reached $30.3 million, with R&D expenses at $20.5 million, reflecting a 29% decrease compared to the prior year, while G&A expenses remained stable at $9.8 million [31] - As of June 30, 2025, the company had $70.4 million in cash, cash equivalents, and financial assets, providing a cash runway until the end of the third quarter of 2026 [31][33] Business Line Data and Key Metrics Changes - The company is focusing investments on three high-value clinical assets: IPH4502, Lacutamab, and Monalizumab, which are expected to create meaningful value [6][33] - IPH4502 is currently in phase one development, with enrollment on track to complete by the end of Q1 2026 [13][15] - Lacutamab has received FDA breakthrough therapy designation and is preparing for a phase three trial, with a clear regulatory pathway for accelerated approval in Sézary syndrome [17][22] Market Data and Key Metrics Changes - The company identified approximately 1,000 Sézary syndrome patients in the U.S., with around 300 new cases each year, representing a significant market opportunity for Lacutamab [26] - The total agreement with AstraZeneca for Monalizumab is worth up to $1.275 billion, with $450 million already received in upfront and milestone payments [29] Company Strategy and Development Direction - The company has made a strategic decision to streamline its organization and focus on high-value clinical assets to drive forward programs that can make a significant difference [6][33] - The company is actively working to secure financing for Lacutamab's phase three trial and is exploring partnerships to maximize value for both patients and shareholders [22][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic refocus and the potential of the clinical pipeline to deliver value for patients and shareholders [33] - The company is committed to advancing its ADC pipeline and expects to report preliminary safety and activity data for IPH4502 in the first half of 2026 [15][33] Other Important Information - The Chief Scientific Officer, Eric Vivier, will transition to a full-time academic role but will continue to support the company as an advisor [7] - The company is exploring the potential of IPH4502 in various tumor types with significant medical needs beyond urothelial cancer [12][15] Q&A Session Summary Question: What should we take away on the potential of targeting NK cells now that ANKET® assets are not included in your prioritization today? - Management clarified that while NK cells are not the main priority, they are still working on NK cell programs and will base future decisions on clinical data [36] Question: Any commentary on where Sanofi is with the assets that they currently are developing? - Management indicated that Sanofi continues to progress the BCMA-targeted ANKET® and expects updates in the near future [40] Question: Should we still assume that unless you have a partner signed up ahead of the start of the study, it'll still be a wait and watch till you get a partner? - Management confirmed they are actively working with investors and partners to keep options open for moving forward with Lacutamab [41] Question: Based on the preclinical data that you have generated so far, what potential indications do you think IPH4502 will be effective? - Management highlighted a focus on urothelial cancer patients who became refractory to enfortumab vedotin, with potential for accelerated market approval [42] Question: How is enrollment progressing for IPH4502? - Management reported that enrollment is going extremely well, with plans to finish by Q1 2026 and a pool of data expected from 50-60 patients [48] Question: Does the new strategic focus mean the ANKET® assets will not be progressed irrespective of clinical data? - Management reiterated that decisions on ANKET® assets will be based on clinical data and market relevance [50]

Core Viewpoint - OBI Pharma has initiated a Phase 1/2 clinical trial for OBI-902, the first antibody-drug conjugate (ADC) utilizing its proprietary GlycOBI® technology, targeting TROP2, an antigen overexpressed in various tumors [1][2][3] Group 1: OBI-902 Overview - OBI-902 is a TROP2-targeted ADC that carries a potent topoisomerase I inhibitor payload with a drug-antibody ratio (DAR) of 4, making it suitable for treating solid tumors such as breast, biliary, ovarian, and gastric cancers [4][5] - The ADC is designed using OBI's GlycOBI platform, which enhances stability and hydrophilicity, demonstrating significant antitumor efficacy and improved pharmacokinetic characteristics in animal models [5][10] Group 2: Clinical Trial Details - The clinical trial aims to enroll patients with advanced solid tumors to assess the safety, pharmacokinetics, and preliminary efficacy of OBI-902 [2] - The lead investigator for the study is Dr. Apostolia M. Tsimberidou from MD Anderson Cancer Center [2] Group 3: Technology and Development - OBI's GlycOBI technology allows for site-specific conjugation of ADCs, compatible with various antibodies, linkers, and payloads, achieving a DAR of up to 16 [7] - The technology improves conjugation efficiency, reduces aggregation, and maintains the biophysical characteristics of the native antibody, leading to better antitumor activity and stability compared to traditional ADCs [7][10] Group 4: Company Background - OBI Pharma, established in 2002 and headquartered in Taiwan, focuses on developing novel therapeutic agents for patients with high unmet medical needs [8] - The company holds exclusive worldwide rights to OBI-902, except for rights pertaining to the antibody in China, which is licensed from Biosion, Inc. [6]