Antisense Pharma unveils its corporate strategy for 2013
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Antisense Pharma unveils its corporate strategy for 2013
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* Trabedersen clinical development program update
* Advances in 'Next Generation' TGF-ß oligonucleotide program and expansion of
scientific advisory board
* Organization streamlined and senior management strengthened
* Strong, continued support from investors
Regensburg, February 26, 2013. The biopharmaceutical company Antisense Pharma
GmbH, today announced its revised corporate and development strategy, receiving
full support from its main investors.
The updated corporate strategy focuses on streamlining the organization to meet
its current business objectives and strengthen key senior management positions
in light of the new direction for trabedersen's clinical development program and
the advancement of Antisense Pharma's 'Next Generation' TGF-ß inhibitor
oligonucleotide program.
Revised development path for Trabedersen
The data analysis of "SAPPHIRE" (G005), trabedersen's early terminated phase III
study in glioma, is in progress. Due to a need for additional outcome data
collection, final results are now expected within the third quarter of 2013.
However, preliminary safety data analyses revealed that the benefit/risk ratio
might not be in favor of the trabedersen treatment arm due to serious adverse
events (SAE) associated with the local mode of administration of the drug in
this trial. The convention-enhanced delivery (CED) of trabedersen via intra-
cranial infusion with surgical catheter placement seemed to result in a
distinct, clinically relevant imbalance of SAEs observed. In light of this
finding, the company decided that the risk to the patient outweighs the
potential clinical benefits for this type of administration of the drug. As a
consequence, the company will no longer pursue further development of the local
administration of trabedersen in glioma.
Future clinical development of TGF-ß targeted drugs in glioma is still
considered for the 'Next Generation' TGF-ß oligonucleotide development program
based on the encouraging survival data for anaplastic astrocytoma from an
earlier glioma trial with trabedersen (G004).[1]
From now onwards, trabedersen's development path will only focus on the systemic
intravenous (IV) mode of administration.
This decision is further supported by the findings from the Phase I/II clinical
study (P001) presented at ASCO in June 2012.[2] The data demonstrated that the
systemic IV administration of trabedersen treatment is safe and well tolerated
by patients. First clinical signs of efficacy were observed in this study with
encouraging survival outcomes for patients suffering from pancreatic cancer or
malignant melanoma when compared to historical controls.
With this intent, Antisense Pharma is currently under way to launch a clinical
Phase II study to evaluate systemic, intravenous trabedersen treatment in
patients suffering from malignant melanoma, pancreatic cancer and other tumors
by the second half of 2013. This clinical trial will be conducted in two stages.
The first stage has a dose-confirmatory component and will further define the
pharmacodynamic (PD) activity of trabedersen in terms of TGF-ß2 target down-
regulation as a primary PD parameter and immunomodulation in the selected
patient populations. Upon successful completion of the first stage, the second
stage of the study is set to demonstrate a survival benefit over standard
chemotherapy for one or two key tumor indications in a larger patient
population.
Dr. Philippe Calais, Chief Executive Officer of Antisense Pharma commented: "Our
revised trabedersen clinical program takes into consideration all learnings from
the G005 and P001 studies. We move forward with the systemic intravenous
administration of trabedersen in a well-tailored, two stage clinical development
program aiming at further optimizing our chances of success in the regulatory
path leading to approval and market. This creative development approach
minimizes the risk and costs usually associated with larger, less tailored
programs. Indeed trabedersen holds a strong value for the company, as it is
supported by orphan drug designation for several indications in the US and
Europe as well as a fully validated manufacturing process. In parallel, we are
also exploring partnership opportunities to further accelerate trabedersen's
development path."
Progress of 'Next Generation' TGF-ß oligonucleotide program and expansion of the
scientific advisory board (SAB)
Since its foundation in 1998 Antisense Pharma has accumulated a vast amount of
expertise and intellectual property by focusing its research and development
efforts on the TGF-ß pathway and on oligonucleotides in high-medical-need
diseases in oncology. This expertise is unique in the world.
The company recently merged its indication-focused advisory boards into a single
corporate SAB comprised of 11 established academics, researchers and clinicians
who are worldwide leaders in fields of TFG-ß, oncology, and oligonucleotides.
Upon strategic considerations from the company's senior management team
supported by recommendations from the SAB, Antisense Pharma started a 'Next
Generation' TGF-ß inhibitor oligonucleotide program that provides the company
with a portfolio of additional assets, comprised of compounds specifically
designed to down regulate the TGF-ß pathway by targeting different TGF-ß
isoforms or combinations thereof, for the treatment of high unmet medical need
cancer indications. These potent compounds have meanwhile shown highly
impressive anti-TGF-ß activity in initial preclinical evaluations.
Antisense Pharma is committed to aggressively move forward a number of potential
lead candidates for further development and to explore development
collaborations at an early stage to further accelerate those highly promising
assets.
Dr. Michael Weller, Professor of Neurology and Chairman of the Department of
Neurology at Zurich University Hospital, and member of the Antisense Pharma SAB,
as well as having a strategic research collaboration with Antisense Pharma,
commented: "The cytokine TGF-ß has a critical role in several tumors. As a
soluble factor it travels through the body and hits immune cells which then are
shut off and don't recognize the tumor anymore. This is one of several ways how
TGF-ß promotes tumor growth and invasion. Antisense Pharma pursues an important
therapeutic approach to treat cancer by inhibiting TGF-ß. I am excited to test
their next generation antisense TGF-ß inhibitors in our animal models and
support their further clinical development."
Organization Streamlined and senior management strengthened
The revised corporate strategy necessitated an organizational streamlining to
better suit the current business objectives.
Refocusing Antisense Pharma's R&D efforts into lean and focused preclinical and
clinical development programs did impact the organization. Accordingly,
Antisense Pharma decided to outsource non-critical expertise and adjusted its
headcount, reducing its workforce by half on February 1(st), 2013. The company
furthermore announced the addition of new talents in several key senior
management positions. Added to the team are Eugen Leo, M.D. Ph.D. M.B.A., a
board certified hematologist and medical oncologist and Professor of Medicine
with a long-standing international targeted therapy clinical development
experience in both academia and industry, and Michel Janicot, Ph.D., a
biochemist, scientist and drug-developer with extensive global industry
expertise in preclinical development of targeted therapies for oncology.
Dr. Philippe Calais, CEO of Antisense Pharma commented further: "I am convinced
that the adaption of our development strategy and our refined corporate strategy
is the right way to secure a sustainable portfolio of clinical assets for
Antisense Pharma and at the same time reduces the risk for our investors. I am
committed to build on our great expertise in the area of TGF-ß and
oligonucleotide research. The strength of our refocused trabedersen development,
our well defined pipeline, as well as our renewed efforts to shape the
organization in a way to fit our new strategy will undoubtedly bring significant
opportunities for a bright future for Antisense Pharma."
The company's long term main investors are fully supportive of the new corporate
strategy of Antisense Pharma.
Dr. Matthias Kromayer of MIG commented: "We are fully supportive of the updated
strategy presented by Dr. Calais and his newly appointed team of development
experts. Considering the challenging environment, the entire Antisense Pharma
team is doing a great job in streamlining the organization and focusing
activities around Antisense Pharma's core capabilities - the vast experience and
skills in the area of TGF-ß, oncology, and oligonucleotide research. We are
especially encouraged by the recent US FDA approval of the first systemic
antisense drug,[3] which further validates the scientific rationale of this drug
technology platform. We are convinced that Antisense Pharma will be able to make
a significant contribution to the development of innovative oligonucleotide
therapies in oncology and expect management to deliver the promised development
and corporate milestones."
- END -
ADDITIONAL INFORMATION
About Antisense Technology
Antisense compounds are biological molecules which consist of fragments of 2 to
20 ribonucleic acid (RNA) or deoxyribonucleic acid (DNA) nucleotides
(oligonucleotides). They are designed to bind in a sequence-specific manner to a
matching messenger ribonucleic acid (mRNA) known to code for a defined protein.
The binding of an oligonucleotide to its matching mRNA sequence results in the
degradation of the mRNA through enzyme-mediated pathways or disruption of mRNA
function through binding alone. As a consequence the synthesis of a specific
protein, which affects the onset and progression of a certain disease, is
inhibited without altering the genome of the patient. Using antisense molecules
to inhibit the synthesis of pathogenic proteins is an innovative therapeutic
approach. It enables to treat the root of the disease and not merely its
symptoms.
About the target protein TGF-beta
The cytokine human transforming growth factor beta (TGF-ß) plays a key role in
the progression of various aggressive tumors.[4]-[6] Its overexpression induces
a profound state of cellular immunodeficiency and mediates the tumor's escape
from immunosurveillance. In addition, TGF-ß plays a significant role in invasive
tumor growth and the infiltration into non-affected tissue, in the promotion of
tumor angiogenesis, as well as tumor cell migration and metastasis.
About Trabedersen
The antisense molecule trabedersen consists of 18 DNA oligonucleotides and is
complementary to the human mRNA encoding for TGF-ß2. Trabedersen, specifically
designed to target the TGF-ß2 mRNA, is believed to reverse its immunosuppressive
effects, rendering the tumor visible to the patient's immune system and
resulting in priming and specific activation of the patient's anti-tumor immune
response. Trabedersen has been granted orphan designation for three tumor
indications: high grade glioma (US, EU), pancreatic cancer (US, EU) and
malignant melanoma (US). Trabedersen has been evaluated extensively in several
preclinical and clinical studies across selected oncological indications. The
compound has shown encouraging early signs of therapeutic activity in cancer
patients.
About Antisense Pharma
Antisense Pharma GmbH is a biopharmaceutical company based in Regensburg and
Munich, Germany, developing innovative therapies targeting the TGF-ß pathway to
treat tumor diseases with high unmet medical need. These therapies are highly
specific and antisense technology based as they aim at enabling the body's own
immune system to respond against tumor diseases with a potentially long-lasting
effect.
In addition, the company is expanding its pipeline through the development of a
"Next Generation" TGF-ß inhibitor oligonucleotide program identifying novel
proprietary compounds to target cancer.
The private company was founded in 1998 and funded mainly by renowned private
equity lead investor MIG and others such as S-Refit and Bayern Kapital.
For further information please visit www.antisense-pharma.com.
References
[1] Bogdahn U. et al. (2011): Targeted Therapy for High-Grade Glioma with the
TGF-beta2 Inhibitor Trabedersen: Results of a Randomized and Controlled Phase
IIb Study; Neuro-Oncology 13, doi: 10.1093/neuonc/noq142
[2] Oettle H. et al. (2012): Final results of a Phase I/II study in patients
with advanced pancreatic carcinoma, malignant melanoma, or colorectal carcinoma
with trabedersen; ASCO American Society of Clinical Oncology #4034, abstract and
poster presentation
[3] Press Release (Jan-29-2013): Genzyme and Isis Announce FDA Approval of
KYNAMRO(TM) (mipomersen sodium) Injection for the Treatment of Homozygous
Familial Hypercholesterolemia
[4] Akhurst R. J. & Hata A. (2012): Targeting the TGFß signalling pathway in
disease; Nature Reviews Drug Discovery 11: 790 - 811
[5] Massagué J. (2012): TGFß signalling in context; Nature Reviews Molecular
Cell Biology 13: 616 - 630
[6] Massagué J. (2008): TGFß in Cancer; Cell. 25; 134(2):215-30. doi:
10.1016/j.cell.2008.07.001
For further information please contact:
Antisense Pharma GmbH MC Services
Dr. Andrea Kottke Raimund Gabriel
Head of Medical Affairs & Communication raimund.gabriel(at)mc-services.eu
a.kottke(at)antisense-pharma.com T. +49-89-210228-30
T. +49-941-92013-106 Mareike Mohr
mareike.mohr(at)mc-services.eu
T. +49-89-210228-40
Press Release PDF:
http://hugin.info/156056/R/1680912/549330.pdf
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Source: Antisense Pharma GmbH via Thomson Reuters ONE
[HUG#1680912]
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Datum: 26.02.2013 - 10:00 Uhr
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