Chimeric Therapeutics (CHM: $0.003) has released updated data from its open label Phase Ib study with its CAR-T CDH17 program.
So far, eight patients have been treated in the first two cohorts with data available from the first five patients.
The most impressive outcome to date has been in a woman with colorectal cancer (CRC), who has been stable for more than nine months now. CEO Rebecca McQualter believes that without the cell treatment, that patient would have died (the patient's life expectancy was just three months prior to treatment). That patient had previously received chemotherapy, radiotherapy, and undergone tumour resection.
Patients being recruited have either CRC or neuroendocrine tumours (NETs). Of interest is the cytokine release syndrome (CRS) reactions in two patients with NETs, one being a Grade 1 and the second a Grade 3. McQualter said this is a sign that the therapy is taking effect, as well as fevers in the patients.
In the patient on the lower dose with a Grade 1 CRS (who received 50 million cells), stable disease was achieved out to 90 days before disease progression recurred. In the patient with a Grade 3 CRS (who received 150 million cells), the first data (at day 28) has yet to be released.
In CRC, the Chimeric team believes that a higher dose may be required. The next two patients - who have NETs - are due to be treated, possibly at the same dose (150 million cells). And a further two patients with CRC may be recruited with a higher dose (450 million cells). Cohort 1 trialed 50 million cells, and Cohort 2 received 150 million cells.
One patient in Cohort 2 with CRC has achieved stable disease for three months, with 12% tumour shrinkage.
McQualter said there is no shortage of patients for this trial, with regular requests from hospitals to be involved in the study. However, the treatment is costly to manufacture, which limits patient numbers at this point.
Chimeric is likely to treat 12 patients with its current funding, however, the trial is structured for up to 15 patients. One of the aims for this study is to identify the effective dose to progress into Phase II.
Chimeric Therapeutics is capitalized at $6 million with $5.8 million in cash at the end of June. The company will need to raise additional funding to progress to Phase II. More advanced data, if positive, will support additional funding for the novel and much needed therapy.
Bioshares recommendation: Speculative Buy Class B
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