Moves to Second Dose in CDH17 Program
The company recently announced that its primary internal program, CHM CDH17, a CAR-T cell therapy for the treatment of colorectal and intestinal tumors (NETs), has moved to the second dose of 150 million cells per patient, up from 50 million cells in the first cohort. Seven patients in total have now been enrolled. CEO Rebecca McQualter said the company is not facing any recruitment constraints.
In the first cohort of four patients, one patient with a very aggressive NET achieved stable disease for five months. This was impressive given the tumour increased from 4 cm in diameter to 10 cm in the two weeks before therapy, and five months after treatment the tumour had almost no change in size, with evidence of necrosis inside the tumour. Another patient with colorectal cancer has been stable out to four months. It's believed that tumours further down the intestinal tract may require higher doses.
Whilst not in the trial protocol, there is the potential for patients to receive additional doses outside of the study (from previously processed cells, if recommended by their physician), particularly given the benign safety profile of the treatment. Grade 1 level of cytokine release syndrome was observed in one of the patients at day 10 which is not a concern. McQualter said that the slight fever is a positive indication of the therapy being active in the body.
The first patient in the second cohort is expected to receive treatment shortly. After 28 days, if the safety profile remains acceptable, the next two patients can be dosed, one week apart.
Fourth Complete Response in CORE-NK Study
In the company’s study with its CORE-NK therapy, the first complete response with the technology continues from a patient with Acute Myeloid Dysplastic Syndrome (a form of AML) treated five years earlier, before it was in-licensed by Chimeric. A second complete response, also in AMDS, was reported in November last year from Chimeric's Phase Ib study, treated at Case Western Reserve University.
In December the company announced that it would be moving from patients with refractory or recurrent AML to those newly diagnosed with AML who are unable to undergo a bone marrow transplant. Of the three patients treated before chemotherapy, two have achieved a complete response with a third achieving stable disease at the MD Anderson Cancer Center. This brings the total to four complete responses achieved to date with the therapy.
McQualter believes this is the first time that patients are receiving a cell therapy as a frontline treatment. The main factor to monitor here according to McQualter is durability of response, with the cells known to be active for around 60 days in the body. CAR-T cell therapies have been approved for AML. However, the allogeneic CORE-NK therapy is less aggressive and considerably less expensive, with one donor sample providing treatment for 200 patients.
Summary
For Chimeric the main program is its CDH17 technology, for which the company will seek to transact once sufficient levels of positive data can be obtained. The company is capitalized at $7.4 million. Following completion of the placement, the company's market value will be $14 million. At the end of March Chimeric had $6 million in cash, including $1 million raised from a rights issue last month.
