This morning, TCRT reported clinical study results of the first two patients treated by KRAS G12D/HLA-A*11:01 and HLA-A*02:01 TCR-T cells, respectively, at the CRI-ENCI-AACR (CICON22) meeting. This is the first formal clinical report of the SB TCR-T in solid tumor Phase I/II study.
· Details. For the first patient, the data reported at the meeting is overall similar to that announced at the abstract earlier. Specifically, she is a young (34-year-old) patient with r/r KRAS G12D/HLA-A*11:01 NSCLC, including refractory to CPI (durvalumab) therapy. Her PD-L1 expression on tumor is ~10%. She received 9 bn TCR-T cells with 95% purity. She has shown a PR with 51.2% target lesions regression at week 12 (46.3% of week six). TCR-T cell presence persisted at week 12 with 134/mL, which accounts for 22.5% of patient’s total circulating CD3+ cells. Consistent with the TCR-T cell presence is the expression of serum INF-g. The safety profile of the treatment is acceptable and well-tolerated. The patient did experience a transient Grade II CRS during first four day of treatment, which resolved satisfactorily. The second patient is a 54-year-old female with KRAS G12D/HLA-A*02:01 mCRC that progressed after one prior line of therapy (Avastin). She received 64 bn TCR-T cells, and experienced SD with reduction of 15.2% and 22% in weeks 6 and 12, respectively. Disease progressed in week 12 with new lesions in liver and lung and the patient dropped out of the study. She also experienced a transient Grade III CRS during early of treatment which resolved satisfactorily. Data were presented by Dr. Marcelo V. Negrao, of MD Anderson.
· Implications. Overall, we view the initial readouts promising as the hot spot mutation TCR-T treatment is effective and safe, especially in the context that includes three other retroviral driven TCR-T treated cases. We anticipate additional data from more patients and longer treatment duration could further solidify the potency of TCR-T modality. In our discussions the company indicated plans to provide more clinical updates throughout 2023, mainly via medical conferences, on new and more matured existing patient results given exogenic T cells could potentially persist for a year. TCRT contemplates prophylactic measures, such as anti-IL-6 treatment, to further mitigate CRS. Action. We are reiterating our Buy rating and our target price of $7.50 to reflect our bullish view on the two clinical products advancing. Our valuation is based on probability adjusted DCF, peer comparable, and sum-of-the-parts analyses.