CHM 1101 Program
Chimeric is currently conducting a Phase I study with its lead program, CHM 1101, which is a CAR T cell therapy that re-engineers a patient's own T-cells to carry the chlorotoxin peptide (derived from scorpion venom) that has a selective affinity for tumour cells. The Phase I study is applying the therapy for patients with recurrent or advanced glioblastoma.
Four patients were treated in the first cohort (44 million cells) with a direct injection into the brain tumour, with disease stability achieved in three of those four patients (for up to eight weeks). In the second cohort (given twice the dose (88 million cells into the tumour and into the CNS) two of the three patients achieved disease stability. The study is now enrolling patients into the third cohort who will receive four times the initial dose as Cohort 1 (220 million cells). The side effect profile so far has been good.
NK (Natural Killer) Cell Program
In December last year the company in-licensed an additional program around the use of the immune system's natural killer cells that is being trialled as an allogenic (off-the-shelf as opposed to using a patient's own cells) treatment.
A Phase I study in nine patients with a range of blood-based cancers and solid tumours started in May 2018 by Case Western University in Ohio. Earlier this month the results were released. It showed that in the patients with blood-based cancers, all three achieved stable disease at 28 days, with one of those patients remaining in remission after 15 months.
Of the six patients with solid tumours treated, two achieved disease control at 28 days and one of those maintained disease control at 100 days. No adverse immune response or rejection was observed. The program will be continued in blood-based cancers and the therapy will be modified to potentially include a CAR approach to better infiltrate the tumours as well as exploring higher doses.
CHM 2101 in Preclinical Development
The third program for Chimeric is a CAR T approach that targets CDH17. This is expected to move into Phase I studies this year in neuroendocrine and gastrointestinal tumours.
Summary
An appeal of the CAR T approach is that product approval has involved only around 50-100 patients in the registration study (excluding Breyanzi which involved 192 patients). A registration study for CHM 1101 is expected to start in around 18 months with preparation for manufacturing now underway. The company expects to have eight clinical studies underway by the end of next year.
Chimeric Therapeutics is capitalised at $59 million.
Bioshares recommendation: Speculative Buy Class B
The CEO of Chimeric Therapeutics, Dr Jennifer Chow, will be the Keynote Speaker at this year's Bioshares Biotech Summit to be held on 11-12 May in Albury. Dr Chow has been involved with the commercial development of four of the five CAR T products that have been approved by the FDA.
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