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MaxCyte gears up for first clinical trial after gaining regulatory green light

The US Food & Drug Administration has given the company investigational new drug clearance for MCY-M11, a chimeric antigen receptor that targets solid tumours
researcher filling a vial
The sign-off represents an "important milestone" for the company, according to CEO Doug Doerfler

MaxCyte Inc (LON:MXCT) shares rose on Monday after the firm said it had received the green light to embark on its first-ever clinical trial as it told investors the commercial arm of the business was trading in line with forecasts.

The US Food & Drug Administration has given the company investigational new drug clearance for MCY-M11, a chimeric antigen receptor that targets solid tumours.

READ: MaxCyte hails US National Institutes of Health tie-up to find treatment for sickle cell disease

The phase I clinical study will evaluate the safety of the potential treatment in people with relapsed, or difficult-to-treat ovarian cancer and peritoneal mesothelioma (a form of cancer that affects the abdomen).

MaxCyte used its CARMA platform to develop the cancer treatment. The technology incites the body’s own immune system to tackle the killer disease, which is a hot area at the moment.

New and innovative technology

What’s new and innovative, even for this very new and innovative strand of research, is that CARMA is being designed to grapple with solid tumours.

The breakthroughs in this field, such as CAR (chimeric antigen receptor) T-cell immuno-therapies, fight blood-borne illness, and yet 90% of cancers are solid tumours.

Chief executive Doug Doerfler said the regulatory sign-off marked an “important milestone” for the business.

“We are excited to advance MCY-M11, our first therapeutic candidate in solid tumours into the clinic and we hope that the upcoming study will serve as validation of our proprietary CARMA (CAR therapeutic) drug platform as a whole," he added.

MaxCyte isn’t the typical, binary, heads-you-win, tails-you-lose drug developer you find traditionally on AIM. It has a hybrid business. So, it sells and licenses its cell engineering technology to some of the world’s largest pharma and biotechnology companies.

Revenues up 27%

In the second of two announcements, MaxCyte told investors first-half revenues were US$6.9mln, up 11.6% on the year earlier and in line with market expectations.

It is partnered with commercial and academic cell therapy developers and revealed it now has more than 55 licensed programmes covering an increasingly diverse range of fields, including immuno-oncology, gene editing and regenerative medicine.

MaxCyte has increased the number of licences to partners covering clinical-stage programmes to more than 25 (up from 15 at the same point last year).

“This is a significant acceleration of the number of partners advancing towards commercialisation-stage with the goal of providing new therapies to individuals facing diseases such as triple-negative breast cancer, Hodgkins lymphoma, paediatric leukaemia and other blood cancers, HIV and sickle cell disease,” it added.

The shares were up 4% at 247.5p, valuing the business at £126mln.

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Article
October 10 2018

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