Telormedix: Johanna Holldack. Focusing on targeted immunity in the treatment of cancer and other diseases




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Video title: Telormedix: Johanna Holldack. Focusing on targeted immunity in the treatment of cancer and other diseases
Released on: May 15, 2013. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, filmed at BioEurope Spring 2013, in Barcelona, Spain, Fintan Walton talks to Johanna Holldack, CEO at Telormedix.
Origin and basis of Telormedix business
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at BioEurope Spring, in Barcelona, in 2013. On this show I have Johanna Holldack, who is the CEO of a company called Telormedix, based in Switzerland, welcome.
Johanna Holldack:
Thank you very much, it&s a pleasure to be here.
Fintan Walton:
Johanna, you are the CEO of Telormedix, your company has a specific approach to dealing with cancer, it&s largely immunity based approach, could you tell us first of all just a little bit about the origins of the company, who your backers are, and the reason for your focus?
Johanna Holldack:
Okay, the company is a spin-off of the University in San Diego, so that is a far spin-off from San California to Switzerland and because of that we have US based investors, Proquest Venture, and then we have our Aravis Venture, a Swiss firm that supports us, very supportive investors.
Fintan Walton:
Okay, and so you said the origins come from San Diego, what was the underlying elements of that business?
Johanna Holldack:
Well the research, the basic research and the patents that the company is based on were filed and the inventions were made in Dennis Cason&s lab and he was the Director of the Moores Cancer Center in San Diego and they were all around TLR7, compounds binding to TLR7, activating and inhibiting TLR7.
Fintan Walton:
Right, so what is the importance of TLR7 in relation to it as a suitable target?
Johanna Holldack:
Well TLR7 is part of the innate immune system, and the innate immune system is a first line defense of the human body, very old in evolution 400, 500 million years old and in contrast to the acquired immune system it doesn&t have a memory, so it really a first line defense against viral bacteria infection and against cancer, and most recently there is a growing body of data showing that when you have a tumor that tumor develops mechanisms that locally suppress the body&s own immune system and when you stimulate cells surrounding the tumor with our compound by binding to TLR7 and stimulating the TLR7 you can overcome that local inhibitory effect and therefore you can support the anti-cancer effect, and when you think about cancer the patients who are transplant recipients, elderly people who have any kind of immunosuppressive therapy, they have a higher incidence of tumors, so therefore the body&s own immune system plays a key role in the defense against tumors.
Telormedix&s TLR7 program and clinical developments
Fintan Walton:
Right, and so the evidence you&ve got a, you&ve obviously developed some compounds that can stimulate TLR7 and therefore obviously this innate immune system, what evidence do you have that that is going to be successful?
Johanna Holldack:
Well when you think about it the first compounds that stimulate the immune system like BCG in bladder cancer, and the Imiquimod in skin cancer have been on the market for many years, in other words their target is validated, now we come with Imiquimod in a formulation that allows it, allows us to administrate into the bladder and stimulate the local immune defense in the bladder.
Fintan Walton:
Okay, so obviously that&s just your strategy is to obviously bladder cancer?
Johanna Holldack:
There our first indication is bladder cancer, we have second generation compounds and that, well we have established proof-of-concept in skin cancer and bladder cancer and in some other settings and they are in comparison to Imiquimod the new generation TLR7 agonists and those, that&s at least what we are hoping for can be administered systemically and can be developed for other cancers as well. We have cooperation with other companies and we have demonstrated that as a vaccine adjuvant in an oncology setting with tumor antigens it is very strong as well, so I think we have a broad range of approaches to treat cancer, and the TLR7 plays a key role in this.
Fintan Walton:
And would it play a role on its own or you seeing this in combination with other therapies?
Johanna Holldack:
Well we see effects on its own actually, pretty strong effects, I think that cancer therapy is always a combination and there are data supporting the assumption that a combination with radiotherapy, with kinase inhibitors, with antibodies might be useful to do, so first you need to establish the efficacy on its own, but in the long run in these complex oncology and treatment schedules I think it will be a combination therapy.
Fintan Walton:
Okay, and with your own compound that&s TMX-100?
Johanna Holldack:
TMX-101.
Fintan Walton:
101, and that compound has just it&s gone into Phase II clinical trial, you&ve just today put out a press release on the first patient recruitment?
Johanna Holldack:
Yes, We have the first safety part completed and control that we have a nice immune response and that the compound is safe, patients had much fewer side effects than I personally expected, and now we are opening a new trial, we opened a second clinical trial in CIS meaning carcinoma in situ patients, because it has been demonstrated with BCG and other immunotherapeutic approaches that these subset of bladder cancer respond really well to immunotherapy and these are desperate patients, and there is a high medical need and we though that it would be a good opportunity to explore that, and in addition of course for us as a very small company it was important to file IND and get FDA approval for a new trial.
Novel approaches in target identification
Fintan Walton:
Sure, and obviously taking this approach is it, in terms of risk associated with your approach, how would you place your risk profile against other approaches?
Johanna Holldack:
Well I think you know biotech compounds are always risky, right, I mean that&s what the game is, but here we are talking about compounds that bind to a validated target and we have the safety already established, I would think that in by comparison it has a very low risk.
Fintan Walton:
Okay, now you&ve obviously targeted the bladder cancer and CIS, is that correct?
Johanna Holldack:
Yes.
Fintan Walton:
So, I mean what other applications, how far can you go with this sort of approach in terms of other therapeutic targets?
Johanna Holldack:
Well as I said our new generation compounds TMX-202 which is more specific and has an improved PK/PD profile a lower concentration in circulation and so on, I think there is at least a hope that we will be able to administer it systemically meaning that you could treat melanoma, you could treat colon carcinoma, you could treat breast cancer, I think that would be a good indication and many other tumors.
Fintan Walton:
Right, so you still have the same target which is different molecules will do, will have different performance in different therapeutic settings?
Johanna Holldack:
Absolutely.
Fintan Walton:
And why is that, why is there differential?
Johanna Holldack:
These second generation compounds are phospholipids, so they are, they have a pharmacofore, a chemical structure and then there is a phospholipid attached to it.
Fintan Walton:
Okay.
Johanna Holldack:
And this compound or the phospholipid causes that is like forming a little depot, it is rapidly in the cell up taken and then it forms a little depot, in other words the concentration that is in circulation in the body and causes side effects is much lower, but the local concentration is much higher, so the pharmacokinetic patent is improved and therefore you can overcome some of the side effects that the first generation compounds had.
Fintan Walton:
Right, so you&re basically engineering the molecule for its specificity and reduced toxicity?
Johanna Holldack:
Yes and it only binds to TLR7. We have looked at other targets, if you look at the first generation compounds they bind to lots of off targets and these new molecules they bind to TLR7 and almost nothing else.
Partnering and deal making strategies
Fintan Walton:
Right, and you are obviously here at a partnering event, you are presumably looking at partners at some point, what is your strategy, what&s your partnering strategy?
Johanna Holldack:
Well the TMX-101 is we&ll establish proof-of-concept hopefully in July, August and then of course we are seeking for a partner, because then you have to go into Phase IIb and III trials and that is something we are not able to perform, so definitely we are looking for partnering opportunity at that point.
Fintan Walton:
I mean at this stage what sort of level of interest do you from pharma companies, I mean obviously they&ve been following you?
Johanna Holldack:
Yes, there is lots of interest and we have a whole list of companies that are interested, I mean clinical programs are of interest at this point of time where everybody has a need to fill the pipelines, clinical compounds are of interest and lots of companies are in that the urogenital area active, so yes there is interest.
Fintan Walton:
And would you take, if a company came along and said &look we are prepared to take an option on your molecule, on your TMX-101&, would you take an option or would you like to hold out until you can actually do a proper license deal?
Johanna Holldack:
Well I think we would consider an option absolutely, yes.
Fintan Walton:
Right, okay. Do you think that the industry has changed in the way it looks at doing deals with companies like yours, or they still the same?
Johanna Holldack:
Well if you look over the last 10-years or so definitely has changed, I mean there is, I personally think and I&ve looked at some of the numbers of funding, there is definitely a lack in funding for small molecules or biotechnology compounds in early stage.
Fintan Walton:
Right.
Johanna Holldack:
Clinical stage I think there is still a lot of interest, but to get early stage compounds funded is more difficult than it used to be.
Fintan Walton:
Yes, but you are in a safe place?
Johanna Holldack:
We are, we have extremely supportive investors.
Fintan Walton:
VCs?
Johanna Holldack:
Yes, we are in a good spot right now, yes.
Fintan Walton:
Johanna, thank you very much indeed for coming on the show.
Johanna Holldack:
It has been a pleasure. 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).
Johanna Holldack
CEO
At the time of this PTV interview Johanna Holldack, serves as CEO of Telormedix. Dr. Holldackhas worked in the pharmaceutical industry for more than 20 years, where she has held key positions in both start-up and large pharma companies. Her experience includes management and executive positions at Behringwerke, Chiron, MediGene and Borean Pharma. Dr. Holldackhas a medical degree from Georg-August-University in Gottingen, Germany and is a Board Certified pediatrician. In addition, she has held positions as an assistant professor at the University of Essen, research fellow for the Deutsche Krebshilfe and a research associate at Harvard Medical School.
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 commercialization.
Telormedix
Telormedix (www.telormedix.com), founded in October 2007, is a biopharmaceutical company focused on targeted immunity and modulation of the innate immune system for treating cancer and autoimmune diseases. The Company&s lead product, TMX-101, recently entered a Phase I/II clinical trial for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC) . In addition, Telormedix is developing novel TLR7-targeted agonists. One of these molecules, TMX-202, has recently been selected for preclinical study for the topical treatment of skin cancers and other indications. Telormedix also has a pipeline of programs for inflammatory and autoimmune diseases, which includes TMX-302, a TLR7-binding small molecule showing anti-inflammatory properties in vivo. Located in Switzerland, Telormedix is led by a highly experienced management team and backed by an international consortium of venture capitalists including Aravis Venture (Basel, Switzerland) and Proquest Investments (Princeton-San Diego, USA).