MIDATECH PHARMA
News | News Release
May 18, 2016
Midatech Pharma announces clinical pipeline update

Midatech Pharma (AIM: MTPH; Nasdaq: MTP), today announces an update on its clinical pipeline developments.
 
Midatech is working on eight internal research and development projects, including using its proprietary gold nanoparticle (GNP) and Q Chip technologies, in three distinct markets; oncology, immunology and CNS/ocular. It also has multiple partnerships across a further five development programmes, and is growing revenues from its marketed product portfolio in the United States.
 
Low bioavailability results from MTD101 Phase IIa trial
MTD101 (Midaform) failed to demonstrate the release profile seen in prior studies
 
MTD101 is a self-dissolving, oral, postage stamp-sized strip containing GNP conjugated insulin for transbuccal delivery. The oral delivery system used for this trial was a novel and unique application of Midatech’s GNP technology and is not used in the Company’s other GNP programs; all other GNP programs delivered via injection.
 
A recently completed Phase IIa study with 12 patients assessed the pharmacokinetics and pharmacodynamics of insulin delivered using a non-injected, oral, self-dissolving, transbuccal strip platform of Midatech’s GNP against sub-cutaneous insulin. The low bioavailability results vs sub-cutaneous insulin that were seen in the study will lead Midatech and its joint venture partner, MonoSol Rx, to begin the process of evaluating strategic options for this programme.

Midatech’s MTX110 oncology candidate for DIPG expands treatment on a compassionate basis
Increasing potential for fast tracked project to market for Midatech
 
Diffuse Intrinsic Pontine Glioma (DIPG) is an ultra-rare childhood tumour with between 300 to 1,000 recorded global cases per year with a current survival rate of almost zero. Midatech has used its expertise in drug development and nanotechnology to rapidly advance this programme approximately one year ahead of schedule.
 
Midatech today announces that a second patient has been dosed with the Company’s MTX110 treatment for DIPG and that the programme continues to show promising potential. A regulatory meeting has been held to explore a potential route to market in Europe and Midatech is on course to submit a Clinical Trial Application in 2016. Until then, Midatech is supplying the treatment on a named patient basis in the UK and is preparing for additional patient treatments.
 
Within the United States, interest in using the treatment at other centres is under evaluation with the FDA.

 
Preparation for commencement of dosing in Phase I immunotherapy trial
First immunotherapy study to be initiated by Midatech with applicability in oncology
 
Preparations are being made and the Company is on track to commence dosing in a first-in-human clinical trial for its collaborative innovative vaccine against type 1 diabetes, MTX102. With support from an EU Consortium grant, the study, running in the UK and Sweden, will commence in June as previously planned. Data updates from this trial are expected in the second half of 2016.
 
MTX102 makes use of Midatech’s primary platform technology, using GNPs, which are known to be both safe and inert in vivo. In this vaccine, which has applicability in oncology, GNPs are chemically bound to small antigens which generate a tolerogenic response when injected into the skin, turning down the immune response against the insulin producing cells, which causes type 1 diabetes. This is the first product of its type that mimics the natural process of insulin regulation. Discovery, pre-clinical and toxicology work has already been successfully conducted. Results from this study are expected in 2017.
 
Glioblastoma (MTR103) and Hepatocellular (MTR104) carcinoma candidate selection
IND enabling programs are scheduled to commence
 
Candidate selection is ongoing with a number of compounds for the treatment of glioblastoma (brain) and liver cancers and investigational new drug application (IND) enabling programs are scheduled to commence at the end of 2016. Midatech has a collaboration with Dana-Farber Cancer Institute, the principal teaching Institute of Harvard Medical School in Boston, MA and one of the premier cancer institutes in the US. Through these collaborations, the Company has gained access to a robust global network of clinical expertise which will help determine the best possible pathways for the application of Midatech’s leading GNP technology.
 
Q-Octreotide programme (MTD201) for the treatment of acromegaly and carcinoid syndrome
Pilot preclinical study confirmed the systemic release profile of Midatech’s Q-Octreotide compared favourably with the current market leader, Sandostatin® LAR Depot (Novartis).
 
MTD201, a sustained release version of Octreotide, is used to treat the incapacitating symptoms of metastatic carcinoid tumours, where it suppresses or inhibits the severe diarrhoea and flushing episodes associated with the disease, and to normalise the over-production of growth hormone in people suffering acromegaly who have had inadequate response to other therapies. Recent preclinical data has showed positive release profile data compared to Sandostatin LAR.  Midatech plans to submit its IND to the FDA and begin bio-equivalence studies in late 2016.
 
Commenting on the clinical pipeline developments, Dr. Jim Phillips, Chief Executive Officer of Midatech Pharma, said: “I am pleased with the progress we have made across our pipeline in oncology.  We are obviously disappointed by the results in the insulin MidaSol legacy program, however in the recent Q-Octreotide and OpsiSporin data we have made significant progress in 2016 validating the clinical platform and we look forward to now increasing our focus towards oncology, where our technology is better suited and where we have revenue generating products and have shown we can reach niche markets.”

News
News Release
May 18, 2016
Midatech Pharma announces clinical pipeline update

Midatech Pharma (AIM: MTPH; Nasdaq: MTP), today announces an update on its clinical pipeline developments.
 
Midatech is working on eight internal research and development projects, including using its proprietary gold nanoparticle (GNP) and Q Chip technologies, in three distinct markets; oncology, immunology and CNS/ocular. It also has multiple partnerships across a further five development programmes, and is growing revenues from its marketed product portfolio in the United States.
 
Low bioavailability results from MTD101 Phase IIa trial
MTD101 (Midaform) failed to demonstrate the release profile seen in prior studies
 
MTD101 is a self-dissolving, oral, postage stamp-sized strip containing GNP conjugated insulin for transbuccal delivery. The oral delivery system used for this trial was a novel and unique application of Midatech’s GNP technology and is not used in the Company’s other GNP programs; all other GNP programs delivered via injection.
 
A recently completed Phase IIa study with 12 patients assessed the pharmacokinetics and pharmacodynamics of insulin delivered using a non-injected, oral, self-dissolving, transbuccal strip platform of Midatech’s GNP against sub-cutaneous insulin. The low bioavailability results vs sub-cutaneous insulin that were seen in the study will lead Midatech and its joint venture partner, MonoSol Rx, to begin the process of evaluating strategic options for this programme.

Midatech’s MTX110 oncology candidate for DIPG expands treatment on a compassionate basis
Increasing potential for fast tracked project to market for Midatech
 
Diffuse Intrinsic Pontine Glioma (DIPG) is an ultra-rare childhood tumour with between 300 to 1,000 recorded global cases per year with a current survival rate of almost zero. Midatech has used its expertise in drug development and nanotechnology to rapidly advance this programme approximately one year ahead of schedule.
 
Midatech today announces that a second patient has been dosed with the Company’s MTX110 treatment for DIPG and that the programme continues to show promising potential. A regulatory meeting has been held to explore a potential route to market in Europe and Midatech is on course to submit a Clinical Trial Application in 2016. Until then, Midatech is supplying the treatment on a named patient basis in the UK and is preparing for additional patient treatments.
 
Within the United States, interest in using the treatment at other centres is under evaluation with the FDA.

 
Preparation for commencement of dosing in Phase I immunotherapy trial
First immunotherapy study to be initiated by Midatech with applicability in oncology
 
Preparations are being made and the Company is on track to commence dosing in a first-in-human clinical trial for its collaborative innovative vaccine against type 1 diabetes, MTX102. With support from an EU Consortium grant, the study, running in the UK and Sweden, will commence in June as previously planned. Data updates from this trial are expected in the second half of 2016.
 
MTX102 makes use of Midatech’s primary platform technology, using GNPs, which are known to be both safe and inert in vivo. In this vaccine, which has applicability in oncology, GNPs are chemically bound to small antigens which generate a tolerogenic response when injected into the skin, turning down the immune response against the insulin producing cells, which causes type 1 diabetes. This is the first product of its type that mimics the natural process of insulin regulation. Discovery, pre-clinical and toxicology work has already been successfully conducted. Results from this study are expected in 2017.
 
Glioblastoma (MTR103) and Hepatocellular (MTR104) carcinoma candidate selection
IND enabling programs are scheduled to commence
 
Candidate selection is ongoing with a number of compounds for the treatment of glioblastoma (brain) and liver cancers and investigational new drug application (IND) enabling programs are scheduled to commence at the end of 2016. Midatech has a collaboration with Dana-Farber Cancer Institute, the principal teaching Institute of Harvard Medical School in Boston, MA and one of the premier cancer institutes in the US. Through these collaborations, the Company has gained access to a robust global network of clinical expertise which will help determine the best possible pathways for the application of Midatech’s leading GNP technology.
 
Q-Octreotide programme (MTD201) for the treatment of acromegaly and carcinoid syndrome
Pilot preclinical study confirmed the systemic release profile of Midatech’s Q-Octreotide compared favourably with the current market leader, Sandostatin® LAR Depot (Novartis).
 
MTD201, a sustained release version of Octreotide, is used to treat the incapacitating symptoms of metastatic carcinoid tumours, where it suppresses or inhibits the severe diarrhoea and flushing episodes associated with the disease, and to normalise the over-production of growth hormone in people suffering acromegaly who have had inadequate response to other therapies. Recent preclinical data has showed positive release profile data compared to Sandostatin LAR.  Midatech plans to submit its IND to the FDA and begin bio-equivalence studies in late 2016.
 
Commenting on the clinical pipeline developments, Dr. Jim Phillips, Chief Executive Officer of Midatech Pharma, said: “I am pleased with the progress we have made across our pipeline in oncology.  We are obviously disappointed by the results in the insulin MidaSol legacy program, however in the recent Q-Octreotide and OpsiSporin data we have made significant progress in 2016 validating the clinical platform and we look forward to now increasing our focus towards oncology, where our technology is better suited and where we have revenue generating products and have shown we can reach niche markets.”

© Copyright 2017 Midatech Pharma PLC