Antisense Pharma Raises €13 Million
Antisense Pharma, a German developer of cancer therapeutics, has raised €13 million in new VC funding. Return backers included MIG Fonds and the Global Asset Fund.
The European Patent Office has granted the biopharmaceutical company Antisense Pharma additional patent protection for the use of its flagship product trabedersen. The company is a specialist in the development of targeted therapies for particularly aggressive cancers. This patent gives Antisense Pharma a comprehensive marketing exclusivity for the use of this drug within the settings of tumour-illnesses, illnesses of the central nervous system and immunosuppression, taking into consideration the effective dose.
Furthermore the company announced a recently completed round of financing. MIG Fonds and the Global Asset Fund have once again invested in Antisense Pharma and have confirmed their confidence in the enormous potential of their products. The company's management and private investors also took part in the investment of a total of 13 million Euros.
Trabedersen in clinical development Antisense Pharma has transformed itself from a pioneer into a trailblazer in the development of the so-called "gene silencing" drugs against cancer: The antisense-agent trabedersen selectively inhibits the production of the tumour-supporting protein TGF-? and so treats certain cancers at their "molecular roots". The company began its clinical program in 2000 with this drug, and have been able to attain promising results about the effectivity, safety and tolerability of trabedersen for the treatment of particularly aggressive tumours. Since the beginning of the clinical trials of trabedersen, it has been possible to obtain new data regarding the optimal dosage of the drug. This data forms the basis of the newly-granted patent protection. "The discovery that a low concentration of trabedersen is more effective than a higher concentration satisfies the requirements of patent authorities: It was new and innovative and thus surprising, even for experts" explained Dr. Karl-Hermann Schlingensiepen, founder and CEO of Antisense Pharma GmbH.
Less is more: A small concentration of trabedersen is more effective The discovery that, in the case of trabedersen, less seems to be more was made during the course of the Phase IIb study AP 12009-G004: This open-label, randomized, active-controlled study was designed to ascertain the efficacy, safety and correct dosage of trabedersen for patients with malignant brain tumours (high-grade glioma). In total, 134 patients took either 10 µM of trabedersen, 80 µM of trabedersen or standard chemotherapy as a control. Not only the efficacy data, but also the safety data showed that the concentration of 10 µM of trabedersen was superior to the 80 µM dose and thus confirmed the observations made in preclinical trials. The current data from studies shows: Patients with recurrent or refractory anaplastic astrocytoma who were treated with 10 µM of trabedersen had a median survival time of 39.1 months, whereas patients who had received 80 µM of trabedersen or standard chemotherapy had median survival times of 35.2 months and 21.7 months respectively. Similarly, the duration of response for the tumour is 29.1 months with 10 µM, 20.0 months with 80 µM and 8.0 months with standard chemotherapy. These results underscore the targeted nature of trabedersen because the optimal concentration of targeted therapies is not necessarily the maximum tolerated dose.
Patents secure value creation In no other field is the path from invention to marketing so long as it is in the pharmaceutical industries. "Because peoples health is on the line, the responsibility is extremely high at every stage and the requirements of the authorities particularly demanding" stressed Dr. Schlingensiepen. "A comprehensive patent protection and the marketing protection it brings are essential to generate the investment involved and to our long-term success." In addition to the existing patents, the market exclusivity for Antisense Pharma is protected in certain indications by the orphan drug status. Orphan drug status is awarded by the accreditation authorities for medicaments for treating relatively uncommon conditions which are life-threatening or very serious and for which other methods of therapy do not exist. It secures further advantages for the company such as the lowering of or freeing from fees, the provision of free regulatory advice and exclusive marketing rights for 7 years in the USA or 10 years in the EU following accreditation. Trabedersen was awarded orphan drug status from the European and American authorities for high grade glioma (brain tumours) in 2002 and for the treatment of pancreatic cancer (pancreatic carcinoma) in 2009.
Investors trust in Antisense Pharma Michael Motschmann, fund manager of MIG Fonds, remarked "Antisense Pharma has validated its antisense therapy approach with convincing results, above all for the indication of pancreatic cancer, malignant melanoma and colorectal cancer, and with this it has extended the scope of its potential continuing appreciation over the coming years. The reactions of the accreditation authorities are, like-wise, just as positive. With our investment, we view the road to the marketplace for Antisense as being as smooth as possible - which is good for both the patients and our investors." The lead investor of the now closed round of financing is the fund MIG 9 from MIG Verwaltungs AG, Munich, which has made 11 million Euros available. The Global Asset Fund from GA Global Asset Fund GmbH & Co. KG, Landshut, has contributed 1.5 million Euros. Both MIG Fonds and the Global Asset Fund had already participated in earlier financing rounds and have confirmed their confidence in the future of Antisense Pharma GmbH and the enormous potential of their products. The biopharmaceutical company is a specialist in the development of targeted therapies for particularly aggressive cancers. Their flagship product, trabedersen, is currently in Phase III of the clinical study for the indication of malignant brain tumours (WHO Grade III). Also, a Phase II/III Study into advanced pancreatic cancer is being prepared at the moment.
Pressing ahead with clinical research using fresh capital The capital which has just been raised is to be used particularly for the further clinical development of Antisense Pharma's flagship product, trabedersen. "With this new investment we are continuing a long-standing and very successful partnership with our investors, which further strengthens our position as an innovative biopharmaceutical company. This fresh equity will once again significantly accelerate the clinical development of trabedersen. This will bring the accreditation for the indication of the malignant brain tumour anaplastic astrocytoma tangibly close, and allow us to further our research into the effectivity of further indications, for example advanced pancreatic cancer and malignant melanoma" explained Dr. Karl-Hermann Schlingensiepen, Chief Executive Officer of Antisense Pharma.
Clinical phase III study SAPPHIRE in aggressive brain tumors Since the start of 2009, the company's flagship product has been in the third phase of clinical trials for the treatment of recurrent or refractory anaplastic astrocytoma, a type of recurring or therapy-resistant malignant brain tumour. The study is entitled "SAPPHIRE" and is being carried out in up to 100 clinics in Europe, America and Asia. The now closed financing round should enable a significant acceleration of the SAPPHIRE study. In addition to this, the capital will be used to start a comparative study based on the Phase I/II study with trabedersen for the indication of advanced pancreatic cancer (pancreatic carcinoma).
Information for those concerned Detailed information on Antisense Pharma's current studies can be found at www.anticancer.de. The company also offers free helplines relating to the SAPPHIRE study in Germany, Austria, UK, Russia and Poland (www.anticancer.de/sapphire/kontakt.html). Interested concerned parties and their families can obtain details of both the inclusion and exclusion criterion of the study as well as of the participating clinics within Germany.
Additional Information
About Antisense Pharma GmbH Antisense Pharma is a biopharmaceutical company located in Regensburg whose objective it is to develop and market novel antisense technology based drugs for the targeted treatment of cancers which are as yet incurable, and to market them worldwide. As targeted therapy, Antisense drugs specifically block the production of key proteins responsible for the onset and progression of diseases such as cancer.
Founded in 1998 by the family Schlingensiepen and Dr. Wolfgang Brysch, the company is now located in the BioPark in Regensburg, Bavaria. At the present time, the company is concentrating its efforts on some of the most aggressive of the known tumours for which there is a very high therapeutic need. These are, in particular, brain tumours (malignant glioma), pancreatic cancer and malignant melanoma. In the future the company's development program will be extended to include other forms of cancer and other as yet incurable diseases. The company's flagship product, trabedersen, is currently in the third phase of clinical trials. The drug has already been able to prove its effectivity during the earlier clinical studies, in which sustained tumour regression up to the complete disappearance of the tumour was observed.
In addition to the founding partners and private investors, there are a number of venture capital funds involved in Antisense Pharma. With the new investments, just under 80 million Euros of venture capital has been raised. Alongside the commitment from MIG Funds, the Global Chance Fond, the Global Asset Fond, the Technologie Beteiligungsgesellschaft mbH, the Technologie Beteiligungsfonds Bayern GmbH & Co. KG and the S-Refit AG have become involved. Finally, Antisense Pharma had, in November 2007, concluded a round of financing totalling 27 million Euros with the MIG Verwaltungs AG as investors.
The company has been honoured with the German Founder‘s Award and the Bavarian Innovation Award and in 2009 received the Innovation Prize TOP 100.
About MIG Fonds MIG Fonds invest in innovative, non-listed companies in the areas of life-sciences, biotechnology and high-technology. This company possesses a number of unique features and has the potential to set new standards within its industry. MIG Fonds are funds from the HMW Emissionshaus AG. MIG Verwaltungs AG is the exclusive fund manager and responsible for the choice and supervision of the MIG Fonds investments. MIG Fonds are the market leaders in the venture capital area for private investors within the German speaking world. Detailed information about their investment portfolio can be found on the internet page www.mig-fonds.de.