Colorado is known for its mountain, forest, and canyon landscapes. The state has recently seen the growth of biotech clusters in the cities of Denver and Boulder, and Denver is even considered one of the nation’s leading life sciences hotspots.
In this article, look at seven Colorado biotech companies that have secured funding to advance the development of their pipeline candidates in recent years.
Aytu BioPharma
Vascular Ehlers-Danlos Syndrome (vEDS) is a genetic disorder that affects the connective tissues of the body. Mutations in the COL3A1 gene result in decreased production of type III collagen protein. This protein is present in arteries, hollow organs, skin, and lungs, making these systems susceptible to rupture, which can be life-threatening. Aytu BioPharma is committed to fighting this disease.
Its drug candidate AR101 (Enzastaurin) is an oral PKCβ inhibitor aimed at preventing death from spontaneous aortic rupture that can occur in vEDS. This candidate is being studied in a phase 3 trial in 260 patients with vEDS caused by COL3A1 mutations.
The Colorado-based biotechnology company also has a portfolio of treatments for attention-deficit hyperactivity disorder (ADHD) and pediatric allergies. His ADHD medication ADZENYS XR-ODT contains amphetamines, the same active ingredient as Adderall. It is said to help improve alertness and reduce impulsivity and hyperactivity in ADHD patients.
Additionally, a drug called Karbinal ER reduces symptoms of hay fever in children. Karbinal ER is a liquid antihistamine.
Last year, the pharmaceutical company completed its $4 million initial public offering.
BioLoomics
Based in Boulder, Colorado, BioLoomics is a biotechnology company developing targeted antibody therapies. Late last year, the company raised $8.7 million in a seed round to advance its antibody mining program.
Develop antibodies that interact with cellular machinery to promote target degradation. While the early-stage pipeline is being kept under wraps for now, the company has revealed that its preclinical portfolio is focused on cancer. Use bispecific antibodies to overcome targeted side effects outside the tissue.
It was launched by a team of researchers, one of whom previously worked on the US Rapid Threat Assessment (RTA) program. The Defense Advanced Research Projects Agency (DARPA) was involved. The technology behind BioLoomics’ cancer program combines robotics, synthetic biology, and machine learning to develop antibodies.
Cerebral Therapeutics
Cerebral Therapeutics specializes in neuroscience and drug delivery, developing intracerebroventricular (ICV) therapies for people with neurological diseases. The targeted drug delivery approach is via the intracerebroventricular route. This means that the drug must eventually reach the cerebrospinal fluid in the brain.
The company is currently conducting a Phase 2b study of its valproate solution CT-010 for the treatment of epilepsy. This is a randomized, placebo-controlled, double-blind study to evaluate the safety and tolerability of intracerebroventricular administration of a candidate substance. The study involved 70 patients and was conducted in the United States, Australia, and Israel. The first patient was admitted in 2020.
About two years ago, this biotech company secured his $40 million Series C funding round. This funding will accelerate the development of his CT-010 in the clinic.
Crestone Pharma
Crestone Pharma, based in Boulder, Colorado, aims to bring to market medicines to treat infectious diseases.
Its Phase 2 candidate, CRS3123, is designed to fight infections caused by C. difficile, which causes intestinal problems. This is a MetRS inhibitor that blocks bacterial growth, toxin production, and sporulation in the body. It was found to be highly effective against all his C. strains. difficult.
The biotech company also adds CRS0540 to its product lineup. The candidate is a small molecule antibiotic that targets PolC, the replicative DNA polymerase of Gram-positive bacteria. This class of bacteria includes Staphylococcus aureus (MRSA), Streptococcus pneumoniae, Enterococcus enterococcus (VRE), and Bacillus anthracis (Bacillus anthracis). This candidate has been shown to have low resistance rates in preclinical studies. It is an oral medication that patients can easily treat at home.
In the past, the biotechnology company has received funding from the National Institutes of Health (NIH) as part of the Advanced Industries Accelerator Program and a grant from the State of Colorado.
Edgewise Therapeutics
Edgewise Therapeutics develops precision medicines with a mission to improve the lives of people with muscle diseases.
Edgewise’s EDG-5506 treats muscular dystrophy. It is a small molecule aimed at preventing muscle damage in Duchenne and Becker muscular dystrophies, which are associated with a deficiency of the protein dystrophin. The drug is in Phase 3 trials to treat Becker’s disease, and in February received Fast Track designation in Phase 2 trials for Duchenne disease and McArdle’s disease, an inherited muscle disease. It is being said.
Yesterday, the company announced positive results from its Phase 3 clinical trial. This candidate was found to reduce levels of creatine kinase (CK) and skeletal muscle fast-acting troponin I (TNNI2), biomarkers associated with skeletal muscle damage. It was also well tolerated by all 12 patients in this study. The North Star Ambulatory Assessment (NSAA), a measure of functional exercise capacity in outpatients with muscle disorders, remained stable.
In addition to EDG-5506, the Colorado-based biotech is developing EDG-5506, an oral selective cardiac sarcomere modulator for the treatment of hypertrophic cardiomyopathy, a disease in which the heart muscle thickens and makes it difficult for the heart to heal. 7500 is also being developed. pump out blood. This candidate is currently being investigated in Phase 1 trials.
$240 million was approved to support the potential commercial launch of EDG-5506 for Becker patients in the United States and advance its clinical candidate.
Enliven Therapeutics
Clinical Stage Biotechnology Enliven Therapeutics is active in the field of precision cancer medicine. Two potential candidates are ELVN-001 and ELVN-002.
ELVN-001 is a highly selective drug that specifically targets the BCR-ABL gene fusion in patients with chronic myeloid leukemia (CML), which occurs when parts of a chromosome are broken and swapped positions. A small molecule kinase inhibitor. It is currently being evaluated in a phase 1 trial. The drug achieved a cumulative major molecular response (MMR) rate of 44% within 12 weeks and produced responses in patients previously exposed to the CML drug asciminib, according to a news release last week. MMR is a record of the amount of the BCR-ABL gene in the blood of CML patients.
ELVN-002 is a highly selective HER2 inhibitor that penetrates the central nervous system (CNS) and targets HER2-positive cancers such as breast cancer, non-small cell lung cancer (NSCLC), and other colorectal cancers. It is designed to block HER2 mutations while bypassing epidermal growth factor receptor (eGFR) and avoiding associated toxicity. It is also being studied in phase 1 trials.
The Colorado company merged with American biotech company Imara in 2022. As part of the agreement, the company received $165 million to support its precision medicine pipeline. The company received $90 million in private equity investment (PIPE) earlier this year.
OnKure Therapeutics
OnKure Therapeutics’ leading candidate is his PI3K inhibitor, which is known in the US precision medicine field. PI3K is the most commonly mutated oncogene in cancer, especially estrogen receptor (ER)-positive breast cancer.
Candidate OKI-219 acts by inhibiting the activity of the PI3K enzyme in breast cancer cells. Preclinical studies have shown potent activity at low doses in combination with drugs that target HER2. It has the ability to penetrate the CNS and no toxicity has been reported in these models. In January, the biotech company received Investigational New Drug (IND) designation for OKI-219. This drug is currently in clinical phase 1.
The Colorado-based biotech company is also partnering with Pfizer to study vocodepsin, a class I oral histone deacetylase inhibitor (HDAC), to fight blood cancers in a Phase 2 trial. Its combination with the anticancer drug binimetinib is being studied in patients with NRAS-mutated melanoma.
Last year, the company raised $54 million in a Series C funding round to advance clinical development of OKI-219.
Colorado’s Denver-Boulder biotech investment boom
Colorado’s cities of Denver and Boulder have established themselves in the country’s life sciences industry. Evidence of this is the recent increase in funding. Real estate brokerage BioMed Realty has purchased a massive Boulder complex for $625 million that will transform the area into laboratory and engineering space as the region’s healthcare and technology sectors expand. I did. In 2021, the industry’s annual funding reached nearly $2.5 billion. Despite a significant drop in funding last year, the company managed to raise nearly $1.5 billion in one go at a time when the entire industry was facing a cash crunch.