Company: TYRA
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0000950170-25-046124
Chunk: 20

Company: Tyra Biosciences, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 20
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.  Participants will be randomized initially to treatment with TYRA-300 at 50 mg QD (Cohort 1) or treatment with TYRA-300 at 60 mg QD (Cohort 2). Following a review of efficacy and safety, an additional dosing cohort may be evaluated. The primary endpoint is CR rate at three months.  Secondary endpoints include time to recurrence, the median duration of response, RFS, PFS, safety and tolerability. We expect to dose the first patient in this study in the second quarter of 2025. 

Our future plans may include potential combination studies with approved or novel agents across all stages of bladder cancer where the risk of overlapping toxicities may be diminished when combined with TYRA-300.  

Our FGFR3 Program for Skeletal Conditions

TYRA-300 for ACH and Skeletal Conditions

Mutations in FGFR3 are implicated in skeletal conditions due to its role in regulating bone and cartilage formation. We believe that there is a significant opportunity to develop TYRA-300 to potentially address the long-term complications associated with these skeletal conditions including ACH, hypochondroplasia (HCH), Short Stature Homeobox (SHOX) deficiency, other FGFR3-driven genetic syndromes and idiopathic short stature.

Disease background

FGFR3 is expressed in growth plate chondrocytes (cartilage cells) where it functions in signaling pathways to limit growth.  The G380R mutation in FGFR3, which causes an estimated 99% of ACH, as well as other activating mutations, increases FGFR3 activity, resulting in excessive limitation of growth in the long bones, vertebral bodies and skull base. In children with ACH, the most common form of dwarfism, these growth differences can result in life-long health complications such as sleep apnea, obesity, recurrent ear infections, and bowed legs. The most serious sequelae include spinal stenosis (narrowing of the spinal canal); up to 20% of infants require surgery to address narrowing at the base of the skull (foramen magnum stenosis), which can be life-threatening; in adults, spinal stenosis of the lower back results in chronic pain, necessitating surgery and long-term pain management.

ACH is an autosomal dominant condition that occurs in approximately 1 in 15,000 to 40,000 newborns worldwide, and it is estimated that there are approximately 3,000 affected individuals under the