Seven biotech companies climbing their way up in Colorado

Colorado is known for its landscapes of mountains, forests, and canyons. The U.S. state has witnessed the growth of biotech clusters in the cities of Denver and Boulder of late, and Denver has even been considered one of the leading life science hotspots in the country.

In this article, we take a look at seven biotech companies in Colorado that have managed to secure funding in recent years, to make headway with their pipeline candidates. 

Aytu BioPharma

Vascular Ehlers-Danlos syndrome (vEDS) is a genetic condition that affects the body’s connective tissues. Mutations in the gene COL3A1 cause the protein collagen III to be produced at lower amounts. As this protein is present in the arteries, hollow organs, skin, and lungs, these systems become more prone to tear, which makes it life-threatening. Aytu BioPharma is on a mission to combat the disease.

Its drug candidate AR101 (enzastaurin) is an oral PKCβ inhibitor that aims to prevent death from a spontaneous aortic rupture, which can occur in vEDS. The candidate is being studied in a phase 3 trial comprising 260 patients with vEDS caused by a COL3A1 mutation. 

The Colorado-based biotech company also has a portfolio of attention deficit hyperactivity disorder (ADHD) drugs and therapies for allergies in children. Its ADHD drug ADZENYS XR-ODT, contains amphetamine, which is the same active ingredient in Adderall. It is designed to help improve attention and reduce impulsivity and hyperactivity in patients with ADHD. 

Moreover, its drug Karbinal ER provides symptomatic relief to children with hay fever. Karbinal ER is an antihistamine in a liquid formulation. 

Last year, the pharmaceutical company closed a $4 million public offering.

BioLoomics

Based in Boulder, Colorado, BioLoomics is a biotech company that develops targeted antibody therapies. Late last year, it raised $8.7 million in a seed round to advance its antibody degrader programs. 

It develops antibodies that interact with the cellular machinery to improve target degradation. While its early-stage pipeline has been kept under wraps for now, the biotech has revealed that its preclinical portfolio focuses on cancer. It uses bispecific antibodies to overcome on-target off-tissue side effects.

It was launched by a team of researchers, one of whom was previously involved in the U.S. Defense Advanced Research Projects Agency (DARPA) Rapid Threat Assessment (RTA) program. The technology behind BioLoomics’ cancer program combines robotics, synthetic biology, and machine learning, to design antibodies.

Cerebral Therapeutics

Specializing in the fields of neuroscience and drug delivery, Cerebral Therapeutics is creating intracerebroventricular (ICV) therapies for people with neurological conditions. Its approach to targeted drug delivery is via the intracerebroventricular route. This means that the drug is meant to ultimately reach the cerebrospinal fluid in the brain.

At present, it is conducting a phase 2b trial of its valproate solution, CT-010, for the treatment of epilepsy. It is a randomized, placebo-controlled, double-blind study assessing the safety and tolerability of intracerebroventricular delivery of the candidate. The study comprises 70 patients and is being held in the U.S., Australia, and Israel. The first patient was enrolled back in 2020. 

Nearly two years ago, the biotech bagged $40 million in a series C funding round. The money is fueling the development of CT-010 in the clinic.

Crestone Pharma

Situated in Boulder in Colorado, Crestone Pharma’s goal is to bring its drugs to treat infectious diseases to the market.

Its phase 2 candidate, CRS3123, has been created to address infections caused by C. difficile, which causes gut-related issues. It is a MetRS inhibitor that blocks the growth, toxin production, and sporulation of the bacteria in the body. It has been found to be highly potent against all strains of C. difficile. 

The biotech also has CRS0540 in its roster. The candidate is a small molecule antibiotic targeting PolC, the replicative DNA polymerase in Gram-positive bacteria. This class of bacteria includes Staphylococcus aureus (MRSA), Streptococcus pneumoniae, Enterococci (VRE), and Bacillus anthracis (anthrax), among others. The candidate has shown low resistance rates in preclinical studies. It is an oral drug, which makes it easier for patients to be treated in their homes.

In the past, the biotech company has obtained funding from the National Institutes of Health (NIH), and a grant from the State of Colorado as part of its Advanced Industries Accelerator program.

Edgewise Therapeutics 

Driven by its mission to improve the lives of people with muscle disorders, Edgewise Therapeutics is developing precision medicines. 

Edgewise’s EDG-5506 treats muscular dystrophy. It is a small molecule designed to prevent muscular damage in Duchenne and Becker Muscular Dystrophy, which are associated with the absence of the dystrophin protein. The drug is in a phase 3 trial for treating Becker, and phase 2 trials for Duchenne – for which it received Fast Track Designation in February – and McArdle disease, a genetic muscular condition. 

Yesterday, it announced positive results from its phase 3 trial. The candidate was found to decrease levels of creatine kinase (CK) and fast skeletal muscle troponin I (TNNI2), both of which are biomarkers that are linked to the damage of skeletal muscles. It was also well-tolerated in all 12 patients who were part of the trial. The North Star Ambulatory Assessment (NSAA), which is a measure of functional motor abilities in patients with muscle disorders who are able to walk, remained stable. 

Besides EDG-5506, the Colorado-based biotech company also has EDG-7500, an oral, selective, cardiac sarcomere modulator for the treatment of hypertrophic cardiomyopathy, a disease in which the heart muscles become thicker, making it harder for the heart to pump blood. The candidate is currently being investigated in a phase 1 study. 

It was granted $240 million to assist the potential commercial launch of EDG-5506 for patients with Becker in the U.S., as well as make progress with its clinical candidates.

Enliven Therapeutics

Clinical-stage biotech Enliven Therapeutics is immersed in the field of precision medicine for cancer. It has two lead candidates ELVN-001 and ELVN-002.

ELVN-001 is a highly selective, small molecule kinase inhibitor designed to specifically target the BCR-ABL gene fusion – formed when pieces of chromosomes break off and trade places – in patients with chronic myeloid leukemia (CML). It is being evaluated in a phase 1 trial at the moment. The drug achieved a cumulative major molecular response (MMR) rate of 44% in 12 weeks, and elicited responses in patients who had previously been exposed to CML drug asciminib, according to a press release last week. MMR is a record of the amount of BCR-ABL gene in the blood of a patient with CML.

ELVN-002 is a highly selective, HER2 inhibitor that can penetrate through the central nervous system (CNS), and target HER2-positive cancers like breast cancer, non-small cell lung cancer (NSCLC), and colorectal cancer. While it blocks HER2 mutations, it is designed to spare the epidermal growth factor receptor (eGFR) and avoid toxicities associated with it. It is also being studied in a phase 1 trial.

Back in 2022, the Colorado company merged with American biotech ​​Imara. As part of the deal, the company was awarded $165 million to support its precision medicines pipeline. Earlier this year, it received $90 million in a private investment in public equity (PIPE) fundraising. 

OnKure Therapeutics

Notable in the field of precision medicine in the U.S., OnKure Therapeutics’ lead candidate is a PI3K inhibitor. PI3K is the most commonly mutated oncogene in cancer, particularly in estrogen receptor (ER)-positive breast cancer.

The candidate OKI-219 works by hindering the activity of the PI3K enzyme in breast cancer cells. It has shown strong activity at low doses in combination with drugs that target HER2, in preclinical trials. It is capable of penetrating through the CNS, and no toxicities have been reported in these models. In January, the biotech earned Investigational New Drug (IND) status for OKI-219. Now, the drug is in phase 1 in the clinic.

The Colorado-based biotech company has also teamed up with Pfizer to investigate bocodepsin, an oral class I histone deacetylase (HDAC) inhibitor, to fight blood cancers in a phase 2 trial. It is being assessed in combination with anti-cancer drug binimetinib in patients with NRAS-mutant melanoma.

Last year, it was raised $54 million in a series C financing round to move OKI-219 ahead in the clinic. 

Colorado’s Denver-Boulder biotech investment boom

The cities of Denver and Boulder in Colorado have been gaining ground in the nation’s life science industry. A surge in recent funding is proof of this. Real estate player BioMed Realty’s $625 million purchase of a massive complex in Boulder, has led to the area being converted to lab and tech spaces as the region’s healthcare and technology sectors expand. In 2021, annual funding for the industry almost hit $2.5 billion. Although it plummeted last year, funding managed to gather nearly $1.5 billion at a time when the industry at large was coping with a funding drought.