(“Biodexa” or the “Company”)
Biodexa CEO Issues Shareholder Letter Highlighting Progress in 2023
and Expected Milestones in 2024
Dear Shareholders,
I thought now would be a good time to review our Company’s progress in 2023 and our plans and expected milestones for 2024, the latter being set out in the following graphic:
Last year proved to be a year of transition for our Company. We started the year as dual-listed drug delivery company called
Looking at our programs one by one ….
TOLIMIDONE
We were delighted to finish the year with the in-licensing of tolimidone, a Phase II ready asset which we plan to develop for Type 1 diabetes, a genetically-driven disease where an autoimmune reaction destroys the pancreatic β-cells which produce the insulin that regulates plasma glucose levels. Originally discovered by Pfizer, it comes with an extensive preclinical and toxicology data package and has been exposed to over 700 patients, including in Type 2 diabetes. Tolimidone is an activator of lyn kinase which has been shown to play a significant role in cell proliferation, differentiation, apoptosis, migration and metabolism. We have already commissioned experiments at a CRO and expect to announce data from an in vitro study of β-cell survival and proliferation in a validated model in the first quarter of 2024.
We are also in the process of setting up a Phase IIa study of tolimidone in approximately 16 patients with Type 1 diabetes. The study will be open-label with three tolimidone doses tested in parallel. The study will include measurement of C-peptide (a marker of insulin), HbA1c (a measure of plasma glucose levels) and number of hyperglycemic events. We expect to be able to announce preliminary data before the end of 2024.
MTX110
Recurrent Glioblastoma Multiforme
Our unique formulation of panobinostat in combination with Convection Enhanced Delivery direct to the tumor continued to advance in the clinic. Because we saw no drug-related adverse events during dose escalation, we were able to recruit the minimum number in the first cohort of patients in our Phase I study (called the MAGIC-G1 study) in recurrent glioblastoma multiforme, or GBM. GBM is the most common form of adult brain cancer with incidence of 3 -4 per 100,0001 and overall survival of 13 to 30 months depending on numerous factors, including MGMT methylation2. GBM universally recurs and, once recurred, median overall survival is approximately 6.5 months3. We expect to announce Progression Free Survival data on the first cohort of patients in mid-2024.
Diffuse Midline Glioma (formerly categorized as Diffuse Intrinsic Pontine Glioma, or DIPG)
Diffuse Midline Glioma, or DMG, is a fatal pediatric brain cancer with approximately 1,100 diagnoses per annum globally4 and overall survival of 8 to 10 months5. Building on our first Phase I study in DMG, which showed median overall survival of 26 months, recruitment of a second Phase I study at
MTD217
When under stress from chemotherapy, to generate energy, cancer cells often switch from aerobic glycolysis pathway to an alternative oxidative phosphorylation, or OXPHOS, pathway. In 2023 we initiated a preclinical program to explore the simultaneous inhibition of both aerobic and OXPHOS pathways and we have already been able to demonstrate up to a six-fold synergistic effect of co-administering MTX110 with an OXPHOS inhibitor in three patient-derived cells lines. We have also established new patent positions to protect these combinations. Our initial target for MTD217 is leptomeningeal disease, or LMD, a lethal complication in which metastatic cancer cells, most commonly from breast and lung tumors, invade the cerebrospinal fluid and central nervous system. Approximately 5% of all cancer patients develop LMD6 and, with no effective treatments currently available, median overall survival is just three to six months post- diagnosis6. In the fourth quarter of 2023 we set up and validated a mouse LMD model. We expect to report data from the in vivo LMD efficacy model by the end of the first quarter of 2024. If positive, we aim to open an IND before year end 2024 and start a first clinical study by the end of the first quarter of 2025.
OUTLOOK
Including the
Sincerely,
/s/
CEO, CFO
Forward Looking Statements
Certain statements in this shareholder letter may constitute “forward-looking statements” within the meaning of legislation in the
Reference should be made to those documents that the Company shall file from time to time or announcements that may be made by the Company in accordance with the rules and regulations promulgated by the
- Cancers | Free Full-Text | Epidemiology of Glioblastoma Multiforme; Literature Review (mdpi.com)
- Radke et al (2019). Predictive MGMT status in a homogeneous cohort of IDH wildtype glioblastoma patients.
Acta Neuropathologica Communications 1:89 - J Neurooncol. 2017; 135(1): 183–192
- DIPG International Registry
- DIPG.org/facts/dipg-survival-rate-and-prognosis
- https://my.clevelandclinic.org/health/diseases/22737-leptomeningeal-disease
For more information, please contact:
Tel: +44 (0)29 20480 180 |
www.biodexapharma.com |
Tel: +1 (610) 716 2868 |
Email: lyonker@edisongroup.com |
About
Tolimidone is an orally delivered, potent and selective inhibitor of lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent.
MTX110 is a solubilised formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the tumour, by-passing the blood-brain barrier and potentially avoiding systemic toxicity.
Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-distribution of medicines. Biodexa’s headquarters and R&D facility is in
Source:
2024 GlobeNewswire, Inc., source