Trinity Delta Major milestone achieved, as first patient is treated with a CARMA product

Major milestone achieved, as first patient is treated with a CARMA product

Lighthouse | 10 October 2018

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The first patient has been treated in the Phase I trial with MCY-M11 (anti-mesothelin, CARMA-hMeso), the novel chimeric antigen receptor (CAR) cell therapy developed by MaxCyte.
The trial is a dose-escalation study (3+3 design) in c15 patients with ovarian cancer or peritoneal mesothelioma, who will receive three weekly doses of MCY-M11 delivered intraperitoneally, without any preconditioning treatment (eg. cyclophosphamide or fludarabine). The dosing of the initial cohort will be 1 x 10⁷ cells, which will be increased in subsequent cohorts to 5 x 10⁷, 1 x 10⁸ and 5 x 10⁸
The study is being conducted at National Cancer Institute, National Institutes of Health in Maryland, and Washington University in St. Louis in Missouri.
9 independent studies in over 20 patients have confirmed the potential of treating cancer, including solid tumours, with T-cells that only transiently express a CAR (unlike current CAR-T therapies) following transfection of mRNA into the cells using MaxCyte’s technology.
Initial data from the study is expected in early 2019, the primary endpoint is safety with efficacy and the analysis of biomarkers as secondary endpoints.
MaxCyte’s ability to manufacture the CARMA therapy in 1 day (compared to current approved CAR-T therapies of 1 to 2 weeks) has been validated during the treatment of the first patient.
The second CARMA therapy, an intravenous version of MCY-M11, should enter the clinic in H219.

Trinity Delta view: The CARMA technology platform is key asset of MaxCyte, internally developed and wholly-owned. CARMA products clearly have significant manufacturing advantages over the currently approved CAR-T therapies, Novartis’ Kymriah and Gilead’s Yescarta. This trial will indicate whether CARMA products have the better safety profile, with manageable on-target/off-tumour effects (a significant issue for the development of CAR-T therapies in solid tumours), while still having the expected anti-tumour activity.

The initial data from the trial is expected in Q119, but a better indication of the potential of MCY-M11 will probably become apparent later in the year, once patients have received the higher doses.

Our valuation of MaxCyte is currently £166m or 327p/share, which we will review in light of the company’s progress.

Lighthouse

10 October 2018


Price	237p
Market Cap	£122m
Primary exchange	AIM London
Sector	Healthcare
Company Code	MXCT / MXCR

Corporate client	Yes

Company description

MaxCyte uses its patented flow electroporation platform to transfect a wide array of cells. Revenues arise from sale and lease of equipment, disposables and licence fees; with an impressive client list. Additionally, a novel mRNA mediated CAR technology, known as CARMA, is being explored in various cancers, including solid tumours.

Analysts

Mick Cooper PhD
mcooper@trinitydelta.org
+44 (0) 20 3637 5042

Lala Gregorek
lgregorek@trinitydelta.org
+44 (0) 20 3637 5043

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