Coretag, Inc. is a new publicly trading company based in Boston, USA which recently acquired all shares of Coretag Therapeutics AG (hereinafter together mentioned as “Coretag”). Coretag is an oncology biotechnology company, founded in 2019 in Basel, Switzerland by serial life science entrepreneurs. At Coretag our focus is developing innovative targeted radioligands via our proprietary, extensively patented “Tumor Necrosis Targeting Platform®” based on the discovery of a family of cyanine dyes which specifically bind to necrotic cells and tissues. In cancer, Coretag’s novel radiopharmaceutical ligands (RPL’s) are being developed to serve as a First-In-Class “theranostics” modality which includes Diagnosis, Therapy and Treatment Response Monitoring.
The preclinical in vitro and in vivo proof of Principle (PoP), meaning highly specific Tumor Necrosis binding based on the Coretag’s Tumor Necrosis Targeting Platform®, has been achieved in a consistent manner with reproducible results in the period of 2015 to 2022, at the academic centers in Netherlands i.e.; Leiden Medical University (LUMC) and Erasmus Medical University (Erasmus MC) at Prof. Clemens Löwik’s medical imaging laboratories. In addition, the IND-enabling studies for requesting starting the First In Human (FIH) trial in solid tumors from the respective health authorities in North America and Europe, have been completed or planned. We are aiming at meeting Coretag’s next major milestone i.e.; starting the FIH study, in Q1 2026.

Our science
Coretag is embarking on the proven power of radiopharmaceutical ligand class (RPLs) of anti-cancer modalities, with using Coretag’s Tumor Necrosis Targeting Platform®. We use a distinct group of cyanines (small molecules) with preclinically proven specific binding to necrotic tissues and favorable safety profile for guiding the tumor-eradicating radioisotopes to reach specifically to the tumor necrotic zones and necrotic cores.
What is Tumor Necrosis?
Necrosis is a common feature of solid tumors, either prior to cancer therapy or followed by common cancer treatments such as chemo or radiotherapy. Tumor necrosis shouldn’t get confused with another well-known and programmed cell death, Apoptosis. Apoptosis occurs regularly at healthy body and has been subject of drug development research for decades. On the contrary the research around Tumor Necrosis (Necroptosis), still is at the novelty stage. As tumor necrosis is absent from normal healthy tissues, we could consider targeting tumor necrosis as a tumor agnostic biomarker.
Necrosis is thought to be independent of the activity of caspases and is characterized by cellular swelling, organelle dysfunction, extensive mitochondrial damage, and plasma membrane rupture. Because necrotic cells release their cell contents into tumor microenvironment (TME) territory, including proteins and nucleic acids, necrosis is much more inflammatory compared to apoptosis.
Why target Tumor Necrosis?
- Tumor necrosis is a common pathological phenomenon in solid tumors.
- Tumor necrosis is not occurring at healthy human tissues and organs; therefore, this phenomenon could serve as a specific biomarker for targeting radioligand therapy, irrespective of tumor type. The cut off quantification of ratio of necrosis to non-necrotic cells, still need to be investigated and clinically validated. A high proportion of tumor necrosis (≥ 10 %) had a negative prognostic value in patients with surgically resected Extensive stage neuro-endocrine tumors (HGNEC).
- Dead zones of tumors have leaky blood vessels, hypoxia or low levels of oxygen and the recruitment of immune cells, some of which have been shown to help cancer cells spread. Recent research shows that these dead zones harbor some surviving tumor cells that help the cancer disseminate in the body.
- Peri-necrotic tumor regions have been found to be a source of cancer stem cells a group of self-renewing, multi-potential cells, (CSC), important in tumor primary resistance and post remission recurrence.
- In addition to therapeutic value of targeting tumor necrosis, precision molecular radio-imaging of necrotic zones and necrotic cores might enable capability to assess early response to prior commonly used anti-tumor therapies.
- Preclinical studies have suggested a significant correlation between the expression imbalance of necroptosis-related molecules and suggests necroptosis plays an important role in modeling the tumor microenvironment (TME). Following tumor necrosis, and cell membrane rupture, the cell contents spill out into TME, creating another opportunity for targeting tumor necrotic area, to address hard to treat tumor microenvironment.
Coretag novel targeted radio-ligands have reached proof of principle of specific and stable binding to tumor necrotic territory in vitro and in vivo
Coretag’s small molecules CyanTag® (based on cyanine IRDye 800CW), CyanCore® (based on cyanine IRDye 800CW-IBA), and cyanines HQ5® and HQ4®, have been preclinically investigated extensively for their necrosis avidity, at the academic medical imagine laboratories of Prof. Clemens Löwik at Leiden Medical University (LUMC) and Erasmus Medical University (EMC), Netherlands. The results have been published so far at the peer reviewed scientific journals, from 2015 to 2022. Additional preclinical studies are either completed or planned, in anticipation of our First in Human clinical trial, which is planned for Q1 2016.
References
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Corporate strategy
The interest in radioligand therapies (RLTs) has been growing increasingly in the recent years among the oncology community and cancer drug developer companies. This is due to the increasing number of patients who are being diagnosed with cancer, and yet with high unmet medical needs improving treatment outcomes, the growing awareness of prospects of safer and more precise radioligand therapies, and recent marketing approvals of targeted RPL’s, in the context of theranostics approaches, with proven efficacy of labeled tumor receptor targets carriers with therapeutics Beta-emitter radioisotopes, for example in prostate cancer and in neuroendocrine tumors. (Novartis introduced Lutathera® (Advanced Accelerator Applications) and Pluvicto® (Endocyte) approved by FDA, for GEP-neuroendocrine tumor in 2018 and in prostate cancer in 2022, respectively).
At Coretag we strive to address the critical unmet medical needs of tumor primary resistance or post treatment recurrence in solid tumors, with harnessing the power of next generation novel radiopharmaceutical ligands (RPLs), that might have the utility in all tumor types irrespective of disease location or stage of malignancy, using Coretag’s proprietary Necrotic Cell Scan (NC-Scan®), followed by the CyanCore Therapy® with our therapeutic radiolabeled lead candidates cyanines, to the approved tumor-eradicating radioisotopes such as Lutetium-177.
Our operational model is designed to make our safe and effective novel tumor agnostic lead candidates getting available to patients with solid tumors, at the shortest time possible, but with the highest level of scientific and clinical quality and regulatory compliance excellence! To that end, we are operating within a lean and highly efficient corporate infra-structure:
- We are currently at an advanced preclinical stage with our 2 clinical candidates CyanTag® and CyanCore®.
- In-licensing promising Cyanine class RP-ligands @ discovery or @early preclinical stage;
- Developing selected lead candidates all way, from preclinical POC, to IND-enabling studies (dosimetry, biodistributions, CMC, Toxicology, etc), to an early clinical proof of concept ( POCP clinical Phase II);
- Out licensing the lead clinical candidate which successfully obtained a predefined POCP, or embarking on a M&A strategy,
- Our resourcing is based on a lean approach for internal hire;
- Manufacturing and RPL Kits developments, are/will be outsourced to external vendors and CMOs, with track records in industry;
- Operational execution of preclinical in vitro, efficacy in vivo, nonclinical dosimetry and toxicology, are/will be outsourced to specialized CROs with track records in industry;
- A highly skilled C-suite, with track record in industry, is responsible for leadership of Coretag, ensuring meeting excellence at all stages of drug development, from design and planning, to clinical execution;
- An international highly acknowledged Scientific and Clinical Advisory Board (SAB) regularly provides guidance to Coretag scientific and clinical strategy, pressure tests the study plans and reviews the study results;
- A Supervisory Board will be formed in near future, who will monitor Coretag’s performance, milestones and obligations.
Explore more
Meet the visionaries behind our mission
Our leadership team blends unmatched expertise with a passion for oncology, guiding Coretag to groundbreaking achievements in cancer care.
Discover our scientific research journey
Delve into the current stages of our research, where innovative discoveries are shaping the future of cancer treatment.