Molmed: Holger Neecke. How their TK cell-based therapy could offer a potential solution to patients unable to find a fully matched bone marrow donor




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Video title: Molmed: Holger Neecke. How their TK cell-based therapy could offer a potential solution to patients unable to find a fully matched bone marrow donor
Released on: December 07, 2011. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, Fintan Walton talks to Holger Neecke, Director Business Development & Investor Relations of Molmed.
MolMed's areas of specialisation and strengths
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at BIO-Europe, in Duesseldorf Germany in 2011. On this show I have Holger Neecke, who is the Director of Business Development & Investor Relations at an Italian company called MolMed, which is based in Milan and it's also listed on the Milan's Stock Exchange, welcome.
Holger Neecke:
Yes thank you for this opportunity.
Fintan Walton:
So Holger, could you tell us a little bit about the origins of MolMed?
Holger Neecke:
Yes, MolMed was founded in 1996 as a cell therapy company basic cell therapy services to do the closely associated hospital the San Raffaele hospital.
Fintan Walton:
Okay, so it was founded as a specialized science based company, what was its strength? What was it actual doing?
Holger Neecke:
So at that time was founded as a joint venture between the German Boehringer Mannheim and the Scientific Institute San Raffaele in Milano really to build a network of cell therapy companies around the world and the strengths of the company was really the provision of genetically modified stem cells for patients.
Fintan Walton:
Right, so that ultimately then presumably Roche ended up having a stake in the company at one stage?
Holger Neecke:
Yes at a certain stage that had stake in the company and as they grew more interest in the pharma business they sold their equity stake to a Swiss Investment Fund.
Fintan Walton:
Okay, so since the foundation of the company it's obviously evolved could you tell us a little bit about that history, how has the company evolved and it's areas of specialization?
Holger Neecke:
So the major transformation was around in 1999 - 2000 when the company decided to become a product company the in-license products at that time that were in preclinical stage and are today in Phase III development, at that time we were a private company in 2000, 30 people, today we are public company 94 employees with two products in Phase III.
Products and therapy approach
Fintan Walton:
Okay, so now tell us a little bit about those products?
Holger Neecke:
Two completely different products, one is a cell therapy an adjunctive therapy to stem cell transplantation bone marrow transplantation and the other one is a selective vascular targeting agent.
Fintan Walton:
Okay, so both are in Phase III clinical trials, so going back to the first one in the cell based therapy tell us little bit more about that particular approach?
Holger Neecke:
Yes, so in high risk leukemia patients are transplanted the bone marrow transplantation the challenge is to find the fully matched donor this is unavailable for around 50% of patients with our therapy it's possible to transplant all patients including those who do not find a fully match donor so in that case we can use a half matched half-identical donor.
Fintan Walton:
So Holger could you tell us a little bit about the cell based therapy and what that particular approach you've adopted?
Holger Neecke:
So the TK cell therapy is an adjunctive cell therapy for patients who cannot find a fully matched donor in bone marrow transplantation. The stem cells the separate stem cells from T lymphocytes and stem cells are infused at day zero in the mean time we process T lymphocytes insert a TK gene into these cells select a purely genetically modified cell population and infuse them back into the patient at day 20.
Data from Phase 11 clinical trials
Fintan Walton:
Okay, and obviously you are in Phase III clinical trials, tell us a little bit about the outcome of the Phase II clinical trials, what sort of data have you've been able to release?
Holger Neecke:
Yes, it's the Phase II data what we could show on 28 patients that were treated with TK that around 75% 22 of these patients got an early immune reconstitution and that's critical for bone marrow transplant patients, they have to fight infections, they have to fight leukemia and so a rapid reconstitution of the immune system is important and the most important data I believe is really the over the survival after four-years, so around 40% of patients are disease free at that time.
Fintan Walton:
Right, so it's those clinical trials where done how long ago?
Holger Neecke:
They were done, they were completed in 2008.
Fintan Walton:
2008.
Holger Neecke:
Yes.
MolMed's business model
Fintan Walton:
So you obviously going to follow those that patient population to see what that come from those patients are, so in terms of taking a this sort of cell based therapy approach what challenges do you have from a regulatory point of view but also acceptance from the pharmaceutical industry and I suppose that relates back to for MolMed what is your business model for that particular therapy going forward?
Holger Neecke:
Yes, so for that specific therapy there we have lets say the production expertise and where the product is addressing specialized clinical centres, we intend to build our own industrial and capabilities and commercialization capabilities to distribute the therapy. The challenge is of course the manufacturing of genetically modified cells ex vivo and here the key to manufacturing is really automation get away from manual production system to an automated system where we need less skilled operators there we need a less sort of container class of the facility that at the end will reduce the investment into the production facility.
Fintan Walton:
So from a commercialization point of view what's the approach that MolMed is taking for the cell based therapy this Phase III?
Holger Neecke:
Yes, so this is of course it's patient specific medicine it's niche indication it's a relatively small number of patients with a high unmet medical need and the company has a strong manufacturing know-how the therapy is addressing specialized clinical centres, so here we believe that here we can build of our own industrial and commercialization capabilities.
Fintan Walton:
Okay, so you go to go on out on your own, is there difference between the approaches you have to take for Europe versus the United States?
Holger Neecke:
Not really for the time being we intend to go ahead on our own, but of course if there might be an interested partner we will consider that opportunity too.
Agreement with GSK
Fintan Walton:
Okay, sure. Now you also recently announced an agreement with GSK for manufacturing, could you tell us a little bit about that?
Holger Neecke:
Yes, this regards a therapy that has been developed by an Italian charity Fondazione Telethon Foundation and in-licensed by Glaxo in 2010 [PharmaDeals ID = 37830] it's addressing patients who have a severe combined immunodeficiency it's a single gene defect in for that specific project product we are developing and manufacturing a (indiscernable) and we are producing the genetically modified stem cells for this patient.
Fintan Walton:
Right, okay and that's presumably a long-term agreement that will, for total manufacturing for the life cycle of the product?
Holger Neecke:
So right now it's just a development agreement. We hope that we will be able in the future to enter into a commercial agreement.
NGR-hTNF program and clinical trials
Fintan Walton:
Okay. So back to the other product that you've got in Phase III clinical trials could you tell us a little bit more about that?
Holger Neecke:
Yes, so NGR-hTNF is a vascular targeting agent, TNF is already used in the clinics, what we do we add this specific peptide that binds to an aminopeptidase that is present on a newly formed tumour blood vessels therefore we can concentrate TNF at the tumour site and induce the destruction of tumour blood vessels that feed the tumour, so this is of course a completely different program it's a recombinant protein.
Fintan Walton:
Right and obviously specifically targeted to cancer cells themselves?
Holger Neecke:
Yes, to tumor blood vessel cells.
Fintan Walton:
Yes, so you say that's in Phase III clinical trials?
Holger Neecke:
Yes.
Fintan Walton:
When do you expect those clinical trials to come to an end?
Holger Neecke:
So it's in Phase III clinical development, recruitment is in track so far we last week reported inclusion of the first patient in the United States, we expect to have the data in 2013.
Fintan Walton:
Okay, and then in terms of partnering that particular program are you looking for a partner?
Holger Neecke:
Yes certainly we are discussing with pharma companies that's clear, we met many of the companies once or even two, three times this year. We really believe that the next step is when we have overall survival data on a randomized Phase II trial that is currently running in non-small cell lung cancer .
Future plans
Fintan Walton:
Okay, and in terms of going forward into the future for the company you've obviously got these two programs both on Phase III are you presumably you got some other products coming through in earlier stages, what's the plan for continue to build your pipeline?
Holger Neecke:
So of course key today is to push these Phase III products versus the market and for early programs we have an option right on intellectual property from the San Raffaele Institute, this is a leading research institution in Italy and we have the option right in the field of oncology to access with a first right of (indiscernable) all products that are in development and we of course we updated on certain programs and we carefully look at them and thus have interesting opportunities.
Fintan Walton:
Good. Well Holger, thank you very much indeed for coming on the show.
Holger Neecke:
Thank you.
Fintan Walton
Dr Fintan Walton is the Founder and CEO of PharmaVentures . After completing his doctoral research on the genetics of cell proliferation at the University of Michigan(US)and Trinity College (Dublin, Ireland), Dr Walton gained broad commercial experience in biotechnology in management positions at Bass and Celltech plc (1982-1992).
Holger Neecke
Director
At the time of this PTV interview Holger Neecke serves as Director Business Development & Investor Relations of MolMed. Holger Neecke joined MolMed in October 2001. Before, he worked at Biopolo Scrl, one of the leading biotechnology transfer agencies in Italy, where he developed and evaluated business plans for start-up companies. At MolMed, he has acquired a broad expertise in biotech business development, particularly by structuring, negotiating and finalizing important license agreements with pharma and biotech companies and institutions in Europe, Japan and the U.S. Holger Neecke holds a degree in Molecular Biology from the University of Basel, Switzerland, a PhD in Genetics from the University of Milan, and a MBA from SDA Bocconi Business School, Milan.
PharmaVentures
PharmaVentures is a corporate finance and transactions advisory firm that has served hundreds of clients worldwide in relation to their strategic deal making in the pharmaceutical, life science and healthcare sectors. Our key offerings include: Transactions / deal negotiations; Product / technology valuations; Deal term advice; Due diligence & expert reports; Strategy formulation; Alliance management; and Expert opinion for litigation/arbitration cases. PharmaVentures provides the global expertise to ensure our clients generate the highest possible return on investment from all their deal making activities. We have experience of all therapeutic areas and can offer advice on both product and technology commercialisation.
MolMed
MolMed is a medical biotechnology company focused on discovery, R&D, and clinical validation of innovative therapies for the treatment of cancer. MolMed's approach to cancer is based on an integrated strategy that provides both drugs effectively targeting the growing tumormass in the acute stage, and highly selective therapies to eliminate residual disease. Since year 2000, MolMed has evolved into a biotechnology drug-developing company, with a primary focus on novel cancer therapies. Today, MolMed is a mature company covering all functions, from discovery to proof of clinical activity. MolMed is located in Milan, Italy, within the San Raffaele Biomedical Science Park, which includes the renowned research hospital and scientific institute, along with several thriving biotechnology companies, and a private university. This location offers crucial advantages, allowing MolMed to complement its own R&D resources with the cutting-edge technological and clinical resources of its host institution, also because of its option right on research results of the Scientific Institute. The San Raffaele Scientific Institute counts over 500 scientists, and the hospital is the largest Italian private clinical centre, with over 1400 beds and more than 100 clinical studies running each year.