On April 7, 2025, Colossal Biosciences announced the birth of three genetically engineered wolf pups, claiming them as the first dire wolves in over 12,000 years.
Dire wolves are extinct canine species native in North America during the Late Pleistocene period. In order to bring back “dire wolves” back from extinction, Colossal used fossilized DNA and implanted a modified ovum into a common dog as a surrogate mother. Three puppies were successfully bred through this method and these puppies exhibit dense, pale coats not seen in grey wolves and are larger than their modern counterparts.
Colossal is a genetic engineering startup and claims to be the “first and only de-extinction company”. Apart from dire wolves, the Texas-based biotech is working to bring back species such as the woolly mammoth, the thylacine (Tasmanian wolf or tiger), the northern white rhinoceros, and the dodo – all part of its goal to achieve de-extinction.
In this article, we take a closer look at Colossal Bioscience’s patents.
Patentability: ‘De-extinction’ vs ‘Genetically Modified’
There are various arguments regarding Colossal Biosciences’ claim of ‘de-extinction’. Some experts claim that the ‘dire-wolves’ produced are technically genetically modified gray wolves. True dire-wolves are genetically distinct species from modern day wolves.
According to Colossal, they are veering away from the textbook definition of de-extinction, as they are not seeking to simply copy or clone extinct creatures. They are bringing forth the concept of “functional de-extinction” which aims to bring back lost species through key traits while also enhancing their survivability in the modern environment of today’s climate change.
In an interview with CNN, Colossal’s chief science officer Beth Shapiro claimed that their goal is not to bring back species that are 100% genetically identical to their extinct counterparts. She adds “Our goal with de-extinction is to always create functional copies of these extinct species. We were focusing on identifying variants that we knew would lead to one of these key traits.”
Is it patentable?
Genetically modified organisms (GMOs) are patentable if they are proven to be non-naturally occurring in nature. Organisms created through the current de-extinction process of Colossal Biosciences are not only artificial creations, but neither are they exact genetic copies of either prehistoric dire-wolves or modern gray wolves. These modern dire-wolves are hybrids that do not occur naturally by nature, and are legally patentable entities.
Colossal Biosciences: Patent Portfolio
Colossal Biosciences was founded in 2021 and, as of current writing, has six active patent applications: 2 U.S.-based patent applications and 4 PCT applications. None of these patent applications deal specifically with their latest achievement on dire-wolves for now. Their current portfolio consists of various bio-engineering patent applications, which are an indication of their capabilities in continuing their de-extinction efforts.
| Patent Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| WO2024081614A1 | Three-dimensional co-culture system for embryos cultured in vitro and uses thereof | 2022-10-10 | 2023-10-10 |
| US20240254508A1 | Multi-Genome Editor Construct and Uses Thereof | 2023-01-27 | 2024-01-29 |
| WO2024211655A1 | Woolly mammoth specific gene variants and compositions comprising same | 2023-04-06 | 2024-04-05 |
| WO2024258838A1 | Laser-assisted in vitro fertilization | 2023-06-12 | 2024-06-11 |
| WO2025019671A1 | Cryopreservation formulations | 2023-07-18 | 2024-07-18 |
| US20250066438A1 | Methods and compositions for preventing or treating cancer | 2023-08-23 | 2024-08-23 |
Woolly Mouse
Even before their success with dire-wolves, Colossal Biosciences has successfully engineered a laboratory mouse to exhibit traits of a woolly mammoth. Using gene-editing techniques, they introduced mammoth-specific features such as woolly hair and enhanced fat metabolism into a common mouse model.
The mechanism of “woolly mouse” is described in WO2024211655A1 titled “Woolly mammoth specific gene variants and compositions comprising same”. The publication deals with isolated nucleic acids, vectors, recombinant cells, and transgenic animals capable of expressing at least one or more woolly mammoth genes. This patent discusses the procedure to edit genes of an elephant to produce a woolly mammoth variant.
The publication was filed on April 5, 2024 and was published on October 10, 2024. The patents list the following Colossal Biosciences scientists: Eriona Hysolli, Devon Fitzpatrick, Austin Bow, Michael Abrams, and includes Ben Lamm, the current CEO of Colossal Biosciences.
In vitro embryo culture
The dire-wolves were created by editing genes of gray wolf isolated endothelial progenitor cells (EPCs) to resemble that of dire wolf’s which are then inserted into an ovum. The ovum was then allowed to develop into an embryo before inserting into surrogate mothers.
A method of culturing embryos is described in WO2024081614A1 titled “Three-dimensional co-culture system for embryos cultured in vitro and uses thereof”. This patent publication describes a process for developing an embryo in vitro using a three-dimensional structure to provide a culture system closer to an in vivo environment. Such an environment results in better embryo viability and development. The three-dimensional structure can be a scaffold-based structure composed of a gel-like material such as a hydrogel, an agarose, a basement membrane extract, or an extracellular matrix.
The patent publication was filed on October 10, 2023 and was published on April 18, 2024. The patents list the following inventors: Li Leyi, Eriona Hysolli, Beard Cassidy, and Ouyang Jie.
Cancer treatment and prevention
While Colossal Bioscience’s primary research focus is on de-extinction, their investigations into woolly mammoths have produced valuable insights into the health sciences. Specifically, their woolly mammoth research required the development of “Asian elephant induced pluripotent stem cells,” which was achieved through the regulation and suppression of the P53 protein. In U.S. Pat. App. No. 2025/0066438 titled, “Methods and compositions for preventing or treating cancer”, genetic material that contain instructions to produce the elephant P53 protein are delivered to a patient as a way to treat cancer. Moreover, the genetic material can further include instructions to produce Elephant LIF proteins.
Cancer cells are produced when cells uncontrollably reproduce and avoid proper cell death, due to damaged DNA in the cell’s nuclei. Elephant LIF proteins are known to detect damaged DNA in cells, and quickly triggers cell death to prevent them from multiplying. The patent discusses compositions of p53 and Elephant LIF proteins, and methods to deliver the proteins for human use.
The patent application was filed on August 23, 2024 and was published on February 27, 2025. The patent application lists the following inventors: Eriona Hysolli, Evan Appleton, and Ben Lamm.
These applications were handled by agents from Ice Miller who include Andrew Baraniak, Amy Berg, Siddharth Bose, Troy Cole, and Holiday Banta.
Note: The image of wolves used in this article is for illustrative purposes only and does not depict the actual dire wolves being developed by Colossal Biosciences.
