Pure Biologics

We are happy to share some exciting news from the ongoing phase 0 study of our anti-ROR1 drug candidate, PBA-0405. The data provided by the CRO, Presage Biosciences, Inc., included the results from first three patients who received intratumoral injections of PBA-0405. Early results indicate that in the two out of three patients, there was a significant increase in #tumor cell death near the PBA-0405 injection sites in comparison to control injections (vehicle).   Dr. John Weinberg, MD, MBA, CMO of Pure Biologics, commented on the early success: “Although it’s still too soon to draw definitive conclusions, data so far support that PBA-0405 can induce tumor cell killing in true cancer patient settings. We plan to continue enrolling additional patients, until we have clear picture of PBA-0405’s potential to treat ROR1-positive solid tumors.” Phase 0 is being conducted to test PBA-0405 ability to kill tumor cells in patients with specific solid tumors, including head & neck #cancer, soft tissue sarcoma, and triple-negative breast cancer. Three patients received direct injections of PBA-0405 into their tumors so far, followed by planned surgical removal of the tumors 24-48 hours later. No adverse effects were linked to the drug, and all three patients showed expression of ROR1, the key drug target, at a transcriptional level within their tumors. Even more promising, immune cells relevant to the drug’s mode of action were found in each tumor. In two out of three patients, there was a significant increase in tumor cell death near the PBA-0405 injection sites, as measured by cleaved caspase-3, a well-established marker of dying cells. This effect was notably stronger compared to areas treated with a placebo.   Filip Jelen, PhD, MBA, CEO and founder of Pure Biologics, said: While it's early days, these findings offer a strong first impression of PBA-0405's promise in solid tumor treatment. It’s a crucial step for Pure Biologics, validating science behind our flagship project. With these promising early results, PBA-0405 could be on its way to becoming a game-changer in the treatment of solid tumors.   About PBA-0405: PBA-0405 is a fully human monoclonal #antibody designed to treat solid tumors and B-cell malignancies by targeting ROR1, a protein expressed on many cancer cells but absent in healthy tissues. What sets PBA-0405 apart is its optimized ability to induce immune cell-mediated tumor cell death—an approach that has proven effective and safe in other therapeutic antibodies.

Pure Biologics is happy to announce that on July 15, 2024 the first patient was dosed with the #drug candidate PBA-0405 in a Phase 0 study. The patient, diagnosed with head and neck squamous cell #carcinoma [HNSCC], was recruited at the Louisiana State University Hospital in Shreveport. Intratumoral administration of PBA-0405 was followed by surgical resection of the #tumor the next day, from which tumor material was secured and prepared for immunohistochemical analysis. The planned immunohistochemical studies are expected to provide data on the pharmacodynamics of PBA-0405, and thus information on the expected #anticancer efficacy of the drug candidate. The analysis will focus on detecting the biomarkers of immune cell activation and tumor cell killing to confirm the therapeutic mode of action of PBA-0405 in the context of the human tumor microenvironment. This is important for the Company’s plans to obtain a strategic partner, which is currently a priority for the Company. The results of the study may be a key factor shaping the project valuation and influencing the decisions of potential pharmaceutical partners. This is a critical milestone for the Company's flagship project PB004. ‘We are extremely pleased to have dosed our first patient in this first-in-man study with PBA-0405, which promises to offer a novel approach to treating cancers. This is a pivotal step in the #development of PBA-0405.’ – says John Weinberg, MD, MBA, Chief Medical Officer at Pure Biologics. The Company expects to complete the study in the coming months and partial results will be monitored during the Study. Results from the first patient are expected within 8 weeks. The study is being conducted by Presage Biosciences, Inc. based in Seattle. #cancer #therapy #immunotherapy #drugcandidate #drugdevelopment #PureBiologics

Pure Biologics proudly announces that it has received approval from the United States Food and Drug Administration (#FDA) for an exploratory Investigational New Drug (eIND) for testing PBA-0111 in a Phase 0 clinical study in solid tumor #cancer patients. The Phase 0 study will be a multicenter, open-label #study conducted in the United States in up to 12 patients with head and neck #carcinoma, soft tissue #sarcoma and triple negative breast cancer. The Phase 0 study will focus on detection of early signs of pharmacodynamic activity of PBA-0111, after a single-dose injection directly in the #tumor, including #immune-cell activation and tumor cell killing, to confirm the PBA-0111 therapeutic mode of action in a real patient setting. Pure Biologics has partnered with Presage Biosciences, Inc. (Seattle, USA) to execute the studies. The Phase 0 study is expected to be completed in the end of 2024. Before then, the Company expects partial results as the study progresses. PBA-0111 is a fully human #antibody #drug candidate targeting GARP in the tumor micro-environment. PBA-0111 alleviates #immuno-suppression, a major obstacle in current immuno-therapy treatment, as well as directly initiates tumor killing by the immune system. The results of research under the PB003G project indicate, in the Company's opinion, clear advantages over drug candidates with promising results in the early stages of clinical development. PB003G is an attractive drug concept with a very strong competitive advantage in the context of commercialization on the cancer therapy market, with potential in the treatment of solid tumors. Studies performed in tumor-bearing humanized mice suggest that PBA-0111 holds great promise for solid tumor #treatment. The Phase 0 clinical study aims at front-load the acquisition of data on effectiveness of PBA-0111 in a human patient setting to further guide clinical development towards market authorization. Dr. Pieter Spee, Chief Scientific Officer of Pure Biologics said: 'The approval of PBA-0111 is a testimony to the dedicated team of researchers involved in PBA-011 development. We are very excited about starting the PBA-0111 Phase 0 study, as it allows us to obtain first proof of the effectiveness of PBA-0111 in human cancer patients two years faster in the PBA-0111 development path than we would be able to obtain in Phase I and II clinical trials.' Dr. Filip Jelen, PhD, MBA, PhD, MBA, co-founder and President of the Management Board of Pure Biologics said: 'These are exciting times for Pure Biologics! After FDA eIND approval for PBA-0405, we have now received FDA eIND approval for PBA-0111 a few months later. The outcome of the planned Phase 0 clinical study will lead to a significant increase in the value of the project. The Company's goal is to conduct a partnering transaction for at least one of the Company’s drug candidates, PBA-0405 and PBA-0111, in the coming year.'

We are happy to inform that we are heading to San Francisco for the Biotech Showcase event during J.P. Morgan Healthcare Week 2024 from January 8 to 11. Our CSO - Pieter Spee - will represent us there! We are looking forward to numerous meetings with international investors and pharma companies. #medtech #biotech #JPMorganHealthcareConference #JPMorganHealthcareWeek #PureBiologics #aptamers #antibodies

We are proud to announce that Pure Biologics has received approval from the U.S. Food and Drug Administration (FDA) for an exploratory Investigational New Drug (eIND) for testing PBA-0405 in a Phase 0 clinical study in solid tumour cancer patients.     About PBA-0405:  PBA-0405 is a fully human IgG1 antibody that targets ROR1, a drug-target found on many solid tumours and B cell malignancies, and rarely on healthy tissues. PBA-0405 has been designed to make tumor cells visible to the immune system. Through a process called afucosylation, PBA-0405 has been engineered to optimally induce tumor killing by so-called cytotoxic immune cells. PBA-0405 is the first ROR1-targeting compound with such mode of action to reach such an advanced stage of research. In preclinical studies, PBA-0405 has shown very promising anti-cancer activity, both in vitro and in vivo, both in a solid tumor model and in a B cell leukemia model.    Phase 0 Study Focus:  The Phase 0 study will focus on detection of early signs of pharmacodynamic activity of PBA-0405, after a single-dose injection directly in the tumor, including immune-cell activation and tumour cell killing, to confirm the PBA-0405 therapeutic mode of action in a real patient setting.    Study Detailes:  In the multi-centre, open label study, performed in the USA, patients with head and neck carcinoma, soft tissue sarcoma and triple negative breast cells cancer will receive a single intra-tumoral injection of PBA-0405. For this, Pure Biologics has partnered with Presage Biosciences, Inc. (Seattle, USA) as CRO to execute the studies. Company aims to complete the Phase 0 clinical study within six months after study initiation.      #ClinicalTrials #CancerResearch #InnovativeTherapies #PBA0405 #PureBiologics #Oncology 

At this special time of the upcoming Christmas and the approaching New Year 2024, the Pure Biologics Team would like to extend our warmest wishes for reflection, peace of mind, achieving what is most important to you in life and, above all, we wish you what you can't buy - HEALTH.   We are a company whose mission is to invent a new biological drug for cancer therefore thinking about health is deep in our DNA. We put our hearts into our projects because we know how important a topic we are working on.  That's why we wish you, and all the scientists in our field, positive breakthroughs in research. Merry Christmas and Happy New Year!

Pure Biologics is excited to share that our CSO Pieter Spee, will be participating in the Biotech Showcase 2024, January 8-10, 2024, in San Francisco. #BiotechShowcase2024 #Innovation #Biotechnology #Networking #SanFrancisco

Pure Biologics on tour: Damian Trojanowski gave a talk at PEGS Europe Conference!     Damian represented Pure Biologics S.A. at the PEGS Europe Conference held from November 14-16, 2023, in the beautiful city of Lisbon.   “Anti-GARP/TGFb1 Antibodies in a New Twist – Multifunctional Shapers of Anti-Tumor Immunity”   Key Highlights from Presentation:  Damian took the stage to present insights into one of our advanced Immunooncology projects, PB003G. Our lead molecule in this project is PBA-0111, a novel, fully human afucosylated antibody. This unique molecule is specifically designed to target the GARP/TGFβ1 complex, a key molecule inducing immunosuppression within the tumor microenvironment.     About PBA-0111:     PBA-0111 innovative design and mechanism of action make it a potent anti-cancer agent, offering new possibilities for enhancing tumor treatment. The fully human nature of this antibody and its precise targeting of the GARP/TGFβ1 complex underscore its potential as a game-changer in cancer therapy.     Stay Connected:     Follow us on LinkedIn for more updates and insights into our innovative projects. Pure Biologics S.A. remains committed to driving advancements in biopharmaceuticals and making a lasting impact on cancer research.     #PureBiologics #InnovationInBiopharma #Immunooncology #PEGSEuropeConference #CancerResearch #PBA0111 #Biopharmaceuticals #HealthcareInnovation #MeBetter 

Pure Biologics submits the first eIND application!   On November 21, 2023, Pure Biologics took a significant step forward by submitting an exploratory Investigational New Drug (eIND) application to the US Food and Drug Administration (FDA) to request approval for testing PBA-0405 in a Phase 0 clinical study in solid tumor cancer patients.   PBA-0405 is a fully human IgG1 antibody that targets ROR1, a drug-target found on many solid tumors and B cell malignancies. PBA-0405 has been designed to make tumor cells visible to the immune system. Through a process called afucosylation, PBA-0405 has been engineered to optimally induce tumor killing by so-called cytotoxic immune cells. PBA-0405 is the first ROR1-targeting compound with such mode of action to reach such an advanced stage of research.   PBA-0405 has displayed promising anti-cancer activity, both in vitro and in vivo, both in a solid tumor model and in a B cell leukemia model. Now, our focus turns to the Phase 0 clinical study. We aim to detect early signs of PBA-0405's pharmacodynamic activity, such as immune-cell activation and tumor cell destruction, validating its therapeutic potential in real patient scenarios.   The phase 0, multi-center, open-label study will take place in the USA, involving patients with head and neck carcinoma, soft tissue sarcoma, and triple-negative breast cancer. Each patient will receive a single intra-tumoral injection of PBA-0405. Once we secure FDA approval for our eIND application, we plan to wrap up the Phase 0 clinical study within six months after initiation.   At Pure Biologics, we are committed to pushing the boundaries of cancer treatment. We look forward to the next steps in the regulatory process and are hopeful that PBA-0405 will ultimately make a positive impact on the lives of patients.   #PureBiologics #CancerResearch #MedicalInnovation