MolMed’s Key Transplant Mortality Findings




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Video title: MolMed’s Key Transplant Mortality Findings
Released on: September 01, 2009. © PharmaVentures Ltd
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  • Summary
  • Transcript
  • Participants
  • Company
MolMed’s approach to cancer is based on an integrated strategy that provides both drugs effectively targeting the growing tumour mass in the acute stage, and highly selective therapies to eliminate residual disease.

Dr Fintan Walton talks to Holger Neecke, Director of Business Development and Investor Relations at MolMed, about:

• how the company’s business model changed when Roche acquired Boehringer Mannheim

• how the company’s cell therapy works and how it compares to that of competitors’

• the key phase II findings for the TK cell therapy in relation to transplant mortality

• plans for the future, including those for licensing in the USA and manufacturing in the UK
Company origin and its focus towards cancer therapeutics
Fintan Walton:
Hello and welcome to PharmaVentures business review here at Bio in Atlanta. On this show I have Holger Neecke who is the Director of Business Development and Investor Relations at a company called MolMed in Milano, Italy. Welcome to the show.
Holger Neecke:
Yeah thank you Fintan Walton for this opportunity.
Fintan Walton:
MolMed is a company that goes back to the Mid 1990's, 1997 when it actually started operating. So it's been around for nearly 12-years now and it's obviously focused in Italy. Could you tell us little bit about the story behind MolMed, how it originated and how it's become the company that is today?
Holger Neecke:
Yeah, MolMedwas originally founded as a joint venture between the German Boehringer Mannheim and San Raffaele Bio Medical Science park in Italy one of the largest research institutions in Italy and in Europe to provide a cell therapy service business to the hospital. When Boehringer Mannheim was acquired by Roche in [PharmaDeals ID = 3068]1998 the business model changed. Roche was not interested in cell therapies so the equity stake of by Roche was sold to an investment fund, with the entry of this investment fund we changed our business model from a service to a product company and started in-licensing products from the San Raffaele Institute.
Fintan Walton:
Today MolMed is focused on what therapy areas?
Holger Neecke:
So today MolMed is focused on oncology. We have two programs one is the cell therapy called TK which is -- helps to get access to bone marrow transplants to all patients even those who have not access to a fully matched donor. So this is our original cell therapy core competence and we complimented T cell therapy product with a vascular targeting agent which was in-licensed in 2001 from the San Raffaele institute.
Fintan Walton:
Okay. So a core part of the activities in MolMed is to in-license not just looking to develop drugs within your own organizations you are in-licensing and then applying them to your specific technology, technology base well would that be fairway of describing it?
Holger Neecke:
I don't think so, it was really in-licensed the early stage programs in 2001 from the San Raffaele Institute and we continued to them. We brought them into the clinic since then.
Fintan Walton:
Okay.
Holger Neecke:
In between we didn't in-license any further compounds.
Fintan Walton:
Okay.
Holger Neecke:
Yeah.
Fintan Walton:
So the current program that you've got which is the TK-cell-therapy based where about is that in its clinical development?
Holger Neecke:
that's right now in Phase III we started the Phase III program in Italy last year. Our plans are for the program is to extend it in Phase III in Europe this year and probably next year into United States.
Fintan Walton:
Okay. So are you doing that totally in your own or are you going to look for partners for that?
Holger Neecke:
So the initial idea was to do it totally on our own to build the manufacturing capability which we have now to do also do a commercial decision by ourselves but right now we are little bit more open we're also looking forward to enter into discussions in particular for the United States.
Fintan Walton:
Right.
Holger Neecke:
Yeah.
How does cell therapy work and the phase II clinical trials result
Fintan Walton:
Now for a treatment like that which is a cell based therapy what and what is the context? I mean obviously with such a therapy it has to it's a different way of doing things and could you tell us a little bit about how the cell-therapy actually works and what the treatment protocols actually are?
Holger Neecke:
Yeah. So of course it's a cell therapy. It's not really like a drug it's much more like an organ transplantation. it takes a long time to do genetic modification of the cells. It's a 10 day process so cells arrive up to MolMed's GP facility. We do the genetic modification, selection of genetically modified cells and expansion of cells and freeze them and check them back to the clinical centre. So this is the context how it works.
Fintan Walton:
And that would happen for every patient?
Holger Neecke:
That happens, it's patient specific.
Fintan Walton:
Right.
Holger Neecke:
It's prototype of patient's specific medicine, personalized medicine.
Fintan Walton:
Right, right.
Holger Neecke:
Yeah.
Fintan Walton:
And so how long is the therapy taken and what sort of results you are getting there?
Holger Neecke:
So the therapy -- what we do it's a little bit complex because we are talking about stem cell transplantation from a partially matched donor to patient. The risk is usually that the T cells of the donor may attack the patient and in particular it's only partially matched. So what we do compare to this is we take the stem cell transplant, transplant stem cells at day zero modify the T cells and implant them in at day 20. What we insert into the T cells is a TK-gene. That TK-genes allows to eliminate the cells in case they attack the patient.
Fintan Walton:
Sure.
Holger Neecke:
So contrary to compared to this we do not do any particular T cell depletion before the transplantation. we transplant a fully function immune system in the T -- immune system can fight infections, can fight leukemic cells and in case where we have the attack of the cells related to patient we can eliminate them by providing a product that gets Postulated the TK-gene and eliminates and those cells which are involved in the Graft versus Host reaction.
Fintan Walton:
Now that you are in Phase III what was, what were the results from the Phase II clinical trials?
Holger Neecke:
What we could show in Phase II is that we could really reduce transplant related mortality what is key in hematopoietic stem cell transplant is to reduce transplant related mortality which is due to infections. So probably really the ability to give patients a fully function immune system and that a very early immune reconstitution that's key.
Fintan Walton:
Right.
Holger Neecke:
And we would show that in those patients that we've treated with the TK-therapy and that could achieve the immune reconstitution that we could reduce transplant related mortality from around 50% down to 10%.
Fintan Walton:
Great that's it.
Holger Neecke:
Yeah.
The growing interest of pharmaceutical companies in cell therapy and the portfolio of products coming forward.
Fintan Walton:
So when you are here at Bio in Atlanta and you talk to pharmaceutical companies about this particular type of therapy. What's the interest?
Holger Neecke:
There is a growing interest in this kind of cell therapies in particular I think because it's a personalized medicine. It's a huge market but with a high added value since it's a very innovative approach and this also -- yeah a good value proposition. Of course companies are little bit reluctant because it's not a drug it's -- it's a cell therapy so there many questions about manufacturing, logistics, commercialization's but there is a growing interest definitely.
Fintan Walton:
Right, right. Well the companies are moving more, more towards new novel ways of therapy. So that's your-- obviously your lead program. What else is in your portfolio that's, that's coming through?
Holger Neecke:
Beside the cell therapy we have this huge muscular targeting agent program which is based on the(indiscernable) targeting peptide with cytokines . So lead candidate is TNF linked to an NGR-Peptide that compound is in Phase II and six different trials and in five different indications both as a single agent but also in combination with chemotherapy.
The next big thing to come out of MolMed.
Fintan Walton:
Okay and what are your plans going forward for MolMed you clearly got this-- this cell therapy in Phase III in Europe hoping to expand that beyond your what's gonna, what we going to see happen to MolMed over the next three to four-years?
Holger Neecke:
So of course the next big step is starting a Phase III trial and most likely we will start it in the Mesothelioma indication where we have the orphan drug designation does facilitate us from the EMEA and from the FDA . So the next big step is really starting the Phase III.
Fintan Walton:
Right and just in terms of manufacturing because...
Holger Neecke:
Yeah.
Fintan Walton:
As you mentioned that pharmaceutical companies look at that in particular. Are you confident that you have a manufacturing capability?
Holger Neecke:
Yeah.
Fintan Walton:
To match that cell therapy program that you described?
Holger Neecke:
So we will be collaborating with leading company in United Kingdom for the manufacturing of the product for Phase III and for commercialization.
Fintan Walton:
Excellent. Well thank you very much indeed Holger Neecke for coming on the show. Thank you very much indeed.
Holger Neecke:
Thank you Fintan Walton.
Holger Neecke
Director business development
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.
MolMed
MolMed S.p.A. is a medical biotechnology company focused on discovery, R&D, and clinical validation of innovative therapies for the treatment of cancerformed in 1997 as a joint venture between Boehringer Mannheim and San Raffaele Science Park to provide cell therapy to hospitals. MolMed is located in Milan, Italy, within the San Raffaele Science Park, which includes the renowned research hospital and scientific institute, along with several thriving biotechnology companies, and a private university.