Presage Biosciences, Inc.

SEATTLE, July 25, 2024 /PRNewswire/ -- Presage Biosciences, a biotechnology company that directly measures activity of oncology drugs within human tumors, announced the Phase 0 dosing of the first cancer patient with Pure Biologics' PBA-0405, an antibody that targets ROR1. PBA-0405 has been engineered to induce tumor cell killing by cytotoxic immune cells. This exploratory study is designed to study the biological effects of PBA-0405 within the human tumor microenvironment. In January, Presage and Pure Biologics announced the U.S. Food and Drug Administration issued a Study May Proceed notification for Phase 0 testing of a pre-GMP first-in-human drug candidate with Presage's Comparative In Vivo Oncology (CIVO®) platform. CIVO enables microdosing directly in a human tumor that is planned for surgical removal. Extensive molecular profiling technologies determine drug effectiveness in the tumor microenvironment by analysis of the expression of thousands of genes. "With the dosing of the first patient in our exploratory Phase 0 study, PBA-0405 is the first ROR1-targeting compound with a unique mode of action to enter studies in patients. We're encouraged by the preclinical data we've seen so far and are eager to evaluate its pharmacodynamic activity in human studies", said Dr. John Weinberg, Chief Medical Officer of Pure Biologics. ROR1 is a tumor-associated antigen expressed on many solid tumors and B cell malignancies. "We are very excited to partner with Pure Biologics to evaluate their pre-GMP oncology drug in a first-in-human Phase 0 CIVO study" said Dr. Patrick Gray, Presage CEO. "Testing of pre-GMP compounds in human tumors in situ simplifies and speeds up the drug development process. Our Phase 0 studies can determine tumor killing activity, synergism with approved or investigational drugs, and immuno-oncology activity." About CIVO Comparative In Vivo Oncology (CIVO) is Presage's patented platform that enables multiplexed intratumoral microdosing and generation of detailed tumor profiling. The CIVO device can deliver up to eight different drugs or drug combinations simultaneously into trackable drug columns. Presage's CIVO technology and analysis capabilities are unparalleled at providing insight into drug-exposed areas of the intact tumor microenvironment. Presage is pairing the use of CIVO with immunohistochemistry, in situ hybridization, and molecular profiling technologies in both preclinical and Phase 0 trials to inform and de-risk oncology drug development. About Presage Presage Biosciences is a translational oncology company dedicated to understanding the complexity of drug response in the tumor microenvironment. Presage partners with oncology-focused pharmaceutical companies through strategic alliances along with other innovators who are at the forefront of spatial biology and oncology drug development. Presage is privately held and based in Seattle. For more information, visit . For more information: [email protected] SOURCE Presage Biosciences Inc

SEATTLE, Nov. 30, 2023 /PRNewswire/ -- Presage Biosciences, a pioneering translational oncology company whose mission is to use CIVO and spatial molecular profiling to understand the complexity of drug response in the tumor microenvironment (TME), has entered into an agreement with AstraZeneca (LSE/STO/Nasdaq: AZN), a global biopharmaceutical company. According to the agreement, Presage's platform will be used by AstraZeneca in translational analysis to evaluate several investigational bispecific antibody combinations in samples taken from head and neck cancer patients. The work will contribute to advancing AstraZeneca's growing portfolio of immuno-oncology agents looking to harness the immune system against cancer. Rich Klinghoffer, PhD, Chief Executive Officer of Presage, said: "Prior studies have demonstrated that the CIVO platform provides accurate guidance about the therapeutic potential of novel agents in the only context that matters: Fully intact patient tumors. We are very pleased to be working with an innovator like AstraZeneca and supporting their quest to discover, develop, and deliver transformative medicines to patients." Earlier this month, Presage presented results from a completed Phase 0 study evaluating Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) alone and in combination with other immune-oncology agents at the Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting. The study enrolled patients across six US-based cancer centers in both soft tissue sarcoma and head and neck cancer. Study data highlight the importance of evaluating novel therapies in patient tumors and revealed a contradiction between results from in-vivo animal studies versus results in the intact TME. "For too long, we have put our trust in laboratory models of cancer that do not capture the complexity of the intact TME," said Klinghoffer. "The CIVO technology was developed to address this fundamental issue in cancer drug development and the results from this study demonstrate the true power of our platform - the ability to know, early in development, how a drug impacts patient tumors." KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About CIVO Clinical In Vivo Oncology (CIVO) is Presage's patented platform that enables multiplexed intratumoral microdosing and generation of deep spatial biology insights. The platform enables evaluation of up to eight distinct and trackable drugs and drug combinations simultaneously. Presage's CIVO technology and analysis capabilities are unparalleled at providing insight into drug-exposed areas of the intact tumor microenvironment. Presage is pairing the use of CIVO with molecular profiling technologies in Phase 0 trials in order to inform and de-risk drug development. About Presage Presage Biosciences is a translational oncology company dedicated to understanding the complexity of drug response in the tumor microenvironment. Presage partners with oncology-focused pharmaceutical companies through strategic alliances along with other innovators who are at the forefront of spatial biology and oncology drug development. Presage is privately held and based in Seattle. For more information, visit . SOURCE Presage Biosciences Inc

SEATTLE, April 17, 2023 /PRNewswire/ -- Presage Biosciences, a pioneer in translational oncology whose mission is understanding the complexity of drug response in the tumor microenvironment (TME), will present at the Immunology, TME Minisymposium at the American Association for Cancer Research (AACR) 2023 Annual Meeting. In an independent study, Presage's innovative multiplexed trackable microdosing platform (CIVO®) was used to introduce an investigational ubiquitin inhibitor (TAK-243) alone and in combination with anti-PD1. The resulting data demonstrated that TAK-243 has potential to increase anti-tumor immunogenicity and prime tumors for response to immune checkpoint inhibition. The Session (MS.IM01.03 – Immune Checkpoints at Tumor Beds, #3476) is titled "TAK-243 increases tumor immunogenicity enhancing systemic anti-tumor immune response and tumor regression in combination with immune checkpoint inhibition in a syngeneic model of lymphoma" and will be presented live on April 17, 2023 from 3:52pm-4:07pm EST. "We are excited to showcase these novel findings on the TME and how we have paired CIVO with sophisticated spatial profiling to translate preclinical findings to human disease" said Richard Klinghoffer, Presage's Chief Executive Officer. "We continue our work with fellow innovators in oncology to deliver key translational data early in the clinical development process." After AACR 2023, Presage Biosciences' CIVO technology will be further showcased at two events: The 4th Annual International Phase-0/Microdosing Stakeholder Meeting in Boston, MA on April 24th. Presage is featured speaker, panel moderator and sponsor at this year's event; Life Science Innovation Northwest (LSINW) in Seattle, WA on April 25. LSINW is the Pacific Northwest's largest annual life science conference. About CIVO Comparative In Vivo Oncology (CIVO) is Presage's patented platform that enables multiplexed intratumoral microdosing and generation of deep spatial biology insights. Presage's CIVO technology and analysis capabilities are unparalleled at providing insight into drug-exposed areas of the intact tumor microenvironment. Presage is pairing the use of CIVO with molecular profiling technologies in both preclinical and Phase 0 trials in order to inform and de-risk oncology drug development. About Presage Presage Biosciences is a translational oncology company dedicated to understanding the complexity of drug response in the tumor microenvironment. Presage partners with oncology-focused pharmaceutical companies through strategic alliances along with other innovators who are at the forefront of spatial biology and oncology drug development. Presage is privately held and based in Seattle. For more information, visit . Media Contact: Julie Rathbun Rathbun Communications (206) 769-9219 [email protected] SOURCE Presage Biosciences