Dosing advances to second cohort in CARMA Phase I

Lighthouse | 8 May 2019

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  • MaxCyte has completed the first dose cohort and initiated the second cohort in its first Phase I trial of MCY-M11, the first CARMA therapy in clinical development. No dose-limiting toxicities or safety concerns were observed in first patient cohort.
  • The Phase I is an open-label, dose-escalation study (3+3 design) evaluating safety and tolerability of intraperitoneal MCY-M11 in c. 15 patients with relapsed/refractory ovarian and peritoneal mesothelioma.
  • The MCY-M11 is a mesothelin-targeting CARMA therapy, which is an mRNA-based chimeric antigen receptor (CAR) therapy that is wholly owned by MaxCyte. Mesothelin is expressed at normal levels on mesothelial cells, but at high levels on various tumours, including ovarian cancer.
  • MaxCyte has also confirmed the feasibility of its streamlined, faster non-viral manufacturing process for CARMA. It uses MaxCyte’s proprietary flow electroporation technology to transfect mRNA into fresh, unexpanded peripheral blood mononuclear cells (PBMCs).

Trinity Delta view: In line with its guidance, MaxCyte has disclosed encouraging tolerability data for the first cohort of the MCY-M11 Phase I study, which in tandem has validated its manufacturing process.

A key goal of the Phase I study is to confirm the potential of CARMA therapies, particularly in solid tumours where there are currently limited treatment options. It is reassuring that there are no major tolerability issues associated with the initial dosing of the first CARMA therapy, although a better indication of MCY-M11’s potential should become apparent later this year, once safety and efficacy data from the higher dose cohorts becomes available. This trial will also provide the first indication in patients whether CARMA therapies can have a significant anti-tumour effect while avoiding severe on-target/off-tumour toxicities, which limits the potential protein targets of current CAR-T approaches.

Another key issue affecting the wider adoption of CAR-T therapies is manufacturing. The CARMA process can be carried out in the hospital and avoids the expansion step, so has cost and time advantages. The MCY-M11 Phase I trial has validated MaxCyte’s process and shown that it can be carried out in a single day, in comparison it takes one-to-two weeks for Novartis’ Kymriah and Kite’s Yescarta.

We expect further data from the MCY-M11 Phase I study later in 2019, and highlight that a second CARMA trial, with an intravenous formulation of MCY-M11, remains on track for initiation in H219.

We value MaxCyte at £195m or 341p per share.


8 May 2019

Market Cap£92m
Primary exchangeAIM London
Company CodeMXCT
Corporate clientYes

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.


Mick Cooper PhD
+44 (0) 20 3637 5042

Lala Gregorek
+44 (0) 20 3637 5043


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