Gothenburg, 21 February 2025
Simsen Diagnostics Partners with Buzzard Pharmaceuticals for Isunakinra Colorectal Cancer Trial
Simsen Diagnostics, a leader in ultrasensitive analysis of nucleic acids, is please to announce a collaboration with Buzzard Pharmaceuticals, a Swedish pharmaceutical company, for their Phase IIa, non-randomized, open-label dose expansion trial. The trial will evaluate isunakinra, an IL-1 inhibitor, in combination with pembrolizumab in patients with metastatic or unresectable, locally advanced colorectal cancer.
Buzzard Pharmaceuticals has chosen Simsen Diagnostics as its partner for ultrasensitive ctDNA analysis. Leveraging its proprietary SiMSen-Seq platform, Simsen will deploy its highly sensitive Simsen® Personal solution to monitor circulating tumor DNA (ctDNA) throughout the trial. By enabling personalized tracking of tumor-specific genetic variations through simple blood draws, Simsen® Personal offers the potential to detect minimal residual disease, assess treatment response, identify relapse earlier, and enhance the understanding of disease progression.
The primary objectives of the trial are:
- To determine the safety and tolerability of isunakinra as monotherapy at the RP2D (50mg/day) and in combination therapy with pembrolizumab by evaluating the incidence and severity of adverse events and safety laboratory
- To evaluate the evidence of clinical benefit in subjects treated with isunakinra including radiological changes and tumor biomarkers at the RP2D
In addition, Buzzard wants to explore changes in ctDNA as predictor of response in isunakinra treated patients.
The precise and reliable data provided by Simsen® Personal will play a crucial role in guiding these processes and advancing the understanding of isunakinra’s therapeutic potential.
“We are honored to partner with Buzzard Pharmaceuticals in this important trial,” said Pontus Rehn, CEO of Simsen Diagnostics. “The application of isunakinra in oncology holds tremendous promise as a potent IL-1 inhibitor, and we are excited to contribute valuable insights that will support Buzzard’s groundbreaking research.”
Maarten de Château, CEO of Buzzard Pharmaceutical, says “We are delighted to work with Simsen on characterising ctDNA as a marker of therapeutic effect of isunakinra in our trial. We have found the support given by Simsen in developing the biomarker part of our trial as well as discussions around practical issues to be very constructive and helpful”
About Simsen Diagnostics:
Simsen Diagnostics is a biotech company that is specialized in ultrasensitive analysis of nucleic acids. Simsen® Personal, the flagship solution, is based on an ultrasensitive sequencing technology capable of detecting minimal residual disease, cancer recurrences, and treatment efficacy, earlier than with any standard-of-care methods. Founded in 2020, Simsen Diagnostics has experienced steady growth, gaining increased recognition from the pharmaceutical industry, CRO’s, researchers and clinics alike. Based in Gothenburg, Sweden, the company is at the forefront of providing innovative services in cancer management and monitoring. Personalized assays. Personalized services. https://simsendiagnostics.com/
About Buzzard Pharmaceuticals:
Founded in 2016 and based in Stockholm, Sweden, Buzzard Pharmaceuticals specializes in developing innovative oncology treatments. The company’s lead asset, isunakinra, is a potent IL-1 inhibitor re-positioned for cancer indications. Acquired from Eleven Biotherapeutics in 2017, isunakinra is being evaluated in clinical trials for its ability to inhibit IL-1 signaling with high potency. Buzzard was co-founded by Urban Paulsson and Maarten de Château, both experienced leaders in biotech innovation, and is driven by a mission to address unmet needs in cancer care. https://www.buzzardpharma.com
Contact:
Pontus Rehn
CEO, Simsen Diagnostics
pontus.rehn@simsendiagnostics.com
