Release Date: May 02, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Kura Oncology Inc (KURA, Financial) announced that the FDA granted Breakthrough Therapy Designation for their investigational treatment, which is a significant regulatory milestone.
- The company reported strong enrollment progress in their ongoing clinical trials, indicating robust interest and support from the medical community.
- Kura Oncology Inc (KURA) demonstrated a promising safety and tolerability profile for their drug combinations, with no major adverse effects reported in early trial data.
- The company is in a strong financial position, with sufficient funds to support operations into 2027, ensuring continued research and development efforts.
- Kura Oncology Inc (KURA) is expanding its pipeline with new investigational studies, including a focus on solid tumors, which could open new therapeutic areas and market opportunities.
Negative Points
- The net loss for Kura Oncology Inc (KURA) increased in Q1 2024 compared to Q1 2023, indicating higher expenses related to expanded clinical trials.
- Research and development expenses significantly increased, reflecting higher costs associated with advancing the clinical pipeline.
- While the company has promising preliminary data, the clinical efficacy and long-term outcomes of their treatments still need to be established in larger, pivotal trials.
- Kura Oncology Inc (KURA) faces intense competition in the oncology market, particularly from other firms developing similar menin inhibitors.
- Regulatory risks remain a challenge, as any future clinical trial setbacks or adverse findings could impact the drug approval timeline and market potential.
Q & A Highlights
Q: How should we be thinking about the implications of this domain of getting breakthrough therapy designation and the likelihood of success of commentaries are one and the timeline until approved?
A: The breakthrough therapy designation (BTD) for NPM1 mutant AML is a significant validation and derisking event for Kura Oncology. It not only acknowledges the unmet need but also enhances the drug's review process by the FDA, including potential for accelerated timelines through rolling review and priority review. The company is engaged with the FDA regularly, which supports the potential for a successful New Drug Application (NDA) submission.
Q: Can you provide any color on when we might see more this domain of clinical data over the course of the year?
A: Updates on clinical data from ongoing trials are expected to be shared at appropriate scientific or medical meetings throughout the year. The company remains open to using various platforms like corporate events or conferences like ASH to share data, aiming to provide updates that reinforce confidence in the drug's development direction.
Q: What happened with the four patients who were not on the trial, and what dose were they being treated with?
A: The patients not continuing in the trial were part of the initial 20 patient cohort treated at a 200 milligram dose. Their discontinuation was not due to progressive disease but rather clinical complications related to advanced leukemia, which is common in heavily pretreated patients.
Q: For the RP2D, you're about to declare that is in all of those four cohorts, first line and relapsed refractory in both Canada and the seven plus three. But your Phase Ib while or the Phase Ib expansion trial you plan to do only in first line managers is that?
A: The Phase Ib expansion trials will evaluate the safety and efficacy of the drug across different cohorts independently, including various combinations with venetoclax and azacitidine in both newly diagnosed and relapsed/refractory settings. This approach allows for a comprehensive assessment of the drug in various therapeutic contexts.
Q: Can you provide any color on whether the FDA has seen additional data for the breakthrough designation potentially from the ongoing pivotal study as well?
A: The FDA is very familiar with the data supporting the breakthrough designation for Kura's therapy. While specific details of the engagement with the FDA cannot be disclosed, the agency's familiarity with the data suggests a strong partnership and understanding of the drug's potential.
Q: What do you think the hurdles are for FDA approval of the isotope factor?
A: For FDA approval in the relapsed/refractory setting, the expected efficacy bar is a 20-30% complete response rate with a median duration of response of four to six months. Achieving this would likely support approval, with the breakthrough therapy designation providing additional regulatory advantages.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
