Biodexa Pharmaceuticals
PLC(“Biodexa” or the “Company”)
Biodexa CEO Issues Shareholder Letter
Highlighting Progress in 2023 and Expected
Milestones in 2024
CARDIFF, United Kingdom, Jan. 22, 2024 (GLOBE
NEWSWIRE) – Biodexa Pharmaceuticals PLC (Nasdaq: BDRX), a clinical
stage biopharmaceutical company developing a pipeline of innovative
products for the treatment of diseases with unmet medical needs
including Type 1 diabetes and rare / orphan brain cancers, today
announced that Stephen Stamp, CEO and CFO of Biodexa, has issued a
Shareholder Letter highlighting the Company’s progress in 2023 and
expected milestones in 2024. The full text of the letter
follows:
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 Midatech Pharma with a single clinical asset and we
finished the year as a NASDAQ-listed, multi-asset therapeutics
company re-named Biodexa Pharmaceuticals. In December 2023, we
completed an in-licensing of a new, potentially disease modifying,
orally delivered clinical stage molecule for Type I diabetes, an
unmet medical disease. Outside of the recent FDA approval of
Tzield®, developed by Provention Pharma and subsequently acquired
by Sanofi (NASDAQ: SNY) for $2.9 billion, there have been limited
options for the treatment of Type 1 diabetes other than exogenous
insulin. Tzield® has a different, but potentially complementary,
mode of action to tolimidone.
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 Columbia
University was completed in mid-2023. We expect publication
of results at a major conference around the end of the first
quarter of 2024. Based on the combined results of the two
Phase I studies, we will evaluate the potential for an IND for what
could prove a pivotal Phase II study towards the end of the
year.
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 $6.0 million we raised in
December 2023, we have the resources to deliver two sets of
preclinical data and three sets of clinical data in 2024. Our
development pipeline now includes five programs, of which four are
at clinical stage. With the pipeline stronger than it has ever
been, we are enthusiastic about the potential for our Company in
2024 and beyond.
Sincerely,
/s/ Stephen Stamp
CEO, CFO
Forward Looking Statements
Certain statements in this shareholder letter
may constitute “forward-looking statements” within the meaning of
legislation in the United Kingdom and/or United States. Such
statements are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995 and are based on
management’s belief or interpretation. All statements
contained in this announcement that do not relate to matters of
historical fact should be considered forward-looking statements. In
certain cases, forward-looking statements can be identified by the
use of words such as “plans”, “expects” or “does not anticipate”,
or “believes”, or variations of such words and phrases or
statements that certain actions, events or results “may”, “could”,
“would”, “might” or “will be taken”, “occur” or “be
achieved.” Examples of forward-looking statements include,
among others, statements we make regarding our pre-clinical
data and clinical trials. Forward-looking statements and
information are subject to various known and unknown risks and
uncertainties, many of which are beyond the ability of the Company
to control or predict, that may cause their actual results,
performance or achievements to be materially different from those
expressed or implied thereby, and are developed based on
assumptions about such risks, uncertainties and other factors set
out herein.
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 United States Securities and Exchange
Commission, which contain and identify other important factors that
could cause actual results to differ materially from those
contained in any projections or forward-looking statements.
These forward-looking statements speak only as of the date of this
announcement. All subsequent written and oral forward-looking
statements by or concerning the Company are expressly qualified in
their entirety by the cautionary statements above. Except as
may be required under relevant laws in the United States, the
Company does not undertake any obligation to publicly update or
revise any forward-looking statements because of new information,
future events or events otherwise arising.
- 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:
Biodexa Pharmaceuticals PLC |
Stephen Stamp, CEO, CFO |
Tel: +44 (0)29 20480 180 |
www.biodexapharma.com |
Edison Group (US Investor Relations) |
Laine Yonker |
Tel: +1 (610) 716
2868 |
Email:
lyonker@edisongroup.com |
About Biodexa Pharmaceuticals PLC
Biodexa Pharmaceuticals PLC (listed on NASDAQ:
BDRX) is a clinical stage biopharmaceutical company developing a
pipeline of innovative products for the treatment of diseases with
unmet medical needs. The Company’s lead development programmes
include tolimidone, under development as a novel agent for the
treatment of type 1 diabetes and MTX110, which is being studied in
aggressive rare/orphan brain cancer indications, and
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 Cardiff, UK. For more information visit
www.biodexapharma.com.
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