MaxCyte: Expanded prospects for CARMA
MaxCyte has confirmed that its CARMA Cell Therapies subsidiary will expand its phase I clinical trial of MCY-M11, its differentiated lead cell therapy candidate currently in first-in-human studies for advanced solid cancers. This is a natural progression based on promising preliminary data from the study presented at the virtual meeting of the American Society of Clinical Oncology (ASCO) in May. The expansion of the study will add a new parallel cohort, that will receive preconditioning treatment and this factor plus the extension of the trial to include multiple treatment cycles are factors that can potentially enhance the efficacy of MCY-M11. The addition of two new trial sites at Massachusetts General Hospital/Harvard Medical School and Hackensack University Medical Center, both renowned centres of excellence, can enable accelerated recruitment providing highly complementary expertise alongside existing leadership at the National Cancer Institute at the National Institutes of Health and Washington University in St Louis.
The ongoing phase I first-in-human study of lead CARMA candidate MCY-M11 evaluating the safety and preliminary efficacy of intraperitoneal infusions of MCY-M11 with treatment-resistant or relapsed advanced ovarian cancer or in advanced peritoneal mesothelioma is being expanded, almost doubling the eventual size of the study to 27 patients.The new parallel phase I cohort will evaluate MCY-M11 at escalating doses in new patients with the addition of preconditioning chemotherapy prior to MCY-M11 infusion. Preconditioning is a widely used strategy to increase the efficacy of CAR-T treatment or to reduce its side effects. The addition of preconditioning regime in a separate cohort also provides a comparator to the MCY-M11 used as a single agent and will progress independently from the ongoing evaluation of MCY-M11 in the existing phase I cohort, and which is anticipated to be completed during 2020.
The inclusion of multiple treatment cycles is a ground-breaking approach and a key feature of the CARMA technology which offers the potential to overcome life-threatening dose-limiting toxicity, enabling repeat dosing and potentially stimulating longer-term T-cell survival, which has been one of the challenges facing viral-based ‘first-gen’ treatments. The rationale in CARMA is that the infusions can be repeated to stimulate “controlled persistence” promoting T-cell survival with limited toxicity and leading to durable efficacy. Multiple treatment cycles will be introduced for eligible patients having already achieved stable disease, which in advanced cancers is, unfortunately, defined only in terms of months, targeting improved efficacy in both the original and parallel cohorts.
The expansion offers the opportunity for a broader evaluation of MXCT’s proprietary and differentiated cell therapy platform, CARMA, which offers a pioneering approach since it targets the successful treatment of solid as opposed to blood tumours that have so far eluded the field of cell therapy. The trial expansion highlights the potential for enhancing the breadth of data, efficacy and pace of recruitment into the phase I study of the lead CARMA candidate. This is central to the strategic planning for the CARMA Cell Therapies subsidiary, which is on track to secure independent funding in 2020. We reiterate that the current market capitalisation of MaxCyte is supported by its trading business alone, based on peer group comparison, plus potential for $800mln of risk-adjusted milestones, let alone an independent valuation of a differentiated cell therapy technology such as CARMA.