HairClone Interview With Paul Kemp: Part 1

Happy Holidays to all of the readers of Follicle Thought. I’m pleased to be bringing you all an exclusive interview with the UK-based startup HairClone, I hope you enjoy it with your celebrations this year.

As many of you know, HairClone has recently launched a crowdfunding campaign in order to advance its R&D and setup a deep-freeze follicle banking service. Many readers have had interest in exactly how HairClone is planning to develop and roll out its treatment.

To further explain the work HairClone is currently engaged in, Paul Kemp has agreed to do a series of interviews for you here on Follicle Thought. If you have questions you’d like to see addressed in the next interview please comment below. Enjoy.

Q&A With Paul Kemp PhD of HairClone

FT: Can you please tell us the background of HairClone’s founders and scientific board in relation to hair growth research?

PK:  One of the aspects that makes me most excited about HairClone is the huge amount of experience the founders and scientific board have in all the areas required to meet our goal of making hair loss history. Equally important, we have worked together in previous companies and we like and trust each other which is critical in setting up a new company. Bessam, Nilofer, Jeff and myself all worked together at Intercytex where we carried out the world’s first clinical trial using human follicle cells for hair growth (Jeff and I were both also patients!) Vern and Jeff worked together at Aderan’s Research Institute and were both heavily involved in their clinical trials. Claire obtained her PhD in Colin Jahoda’s lab and then went on to do important post-doctoral work in Angela Cristiano’s lab in the US before joining our scientific advisory board. Bessam and Nilofer are two of the best known and respected hair transplant surgeons in the world and as well as their clinical practice are also heavily involved in working with many senior hair research scientists. Vincent, Eric, Jeff and myself have all worked in a variety of cell therapy companies in the US, Europe and Asia and this is critical to successfully navigating a path through the heavily regulated process from academic research to clinical treatment. 

The cell products that we have helped develop (in skin and other tissues rather than hair) have reached routine clinical use in the US and have treated around a million people. Between our team we have designed and built GMP facilities for cell culture, and taken a variety of cellular products through the complex regulatory process and into over 20 clinical trials in the US, Europe and around the world. In the commercial areas, Eric and myself have also founded and grown Biotech Companies, raised many tens of millions of dollars from venture capital and public markets, taken companies public and sold others. I am not aware of any other cell therapy company with such breadth of experience in such a small team.

FT: What prompted you to start HairClone?

PK: Four things came together to inspire us to start HairClone.  Firstly, it was the Higgins et all PNAS paper that used cutting edge transcriptomic techniques and showed that the gene expression of dermal papilla cells changed rapidly and virtually completely when cultured. They ceased, in effect, to be functional dermal papilla cells which probably explained why hair induction to regenerate brand new hairs wasn’t very effective in previous clinical trials we’ve seen. When we were at Intercytex, the only way to show a DP cell was still inductive was to inject it and see if it regenerated hairs, with this new approach from the Higgins research there were rapid & sensitive analytical techniques.  More importantly, this change in cells wasn’t permanent and if the cells were then put into a 3D environment their gene expression reverted back to some degree to a more DP type and these cells were able to induce hairs. It was great that Claire Higgins was interested in our plans and became the first member of our scientific advisory board.

The second inspiration came from our experiences in classic development of new treatments. The scientists come up with a proposed treatment, test it in animal models and and then clinicians see whether it works in humans in classic clinical trials. The problem with this method is the protocol and patient populations are fixed when applying for permission to run the trial and are, to be honest, mainly just educated guesses. Trials with large patient populations (usually in the hundreds) are designed and money is raised in the millions of dollars. Then the trial is run and it can be years before the outcomes are clear. If the result is promising but not great then it is virtually impossible to raise the money to carry out an improved version of the clinical trail. This is what happened to Intercytex and then Aderans Research Institute and we wanted to come up with a different, improved way that utilised flexibilities in the regulatory frameworks which were put into place to allow clinicians and patients to have early access to treatments. This is why we are planning to provide our cell expansion service to clinicians in 2019.

The idea of HairClone is to create a unique biotechnology company, one that is focused completely on one disease. This is why we called ourselves HairClone rather than a generic cell therapy company name. We aim to utilise flexibilities that the regulators have built into their systems in order to allow patient access as soon as possible. This will allow clinicians to use their skills to develop the best treatment system which we can then repeat in clinical trials in order to obtain the marketing licenses needed to advertise the treatment. We also want the people with a vested interest in the outcome of these treatments to help fund their development so that together we can create a successful solution to hair loss.

FT: Why crowdfunding instead of the usual venture capital route?

PK: Crowdfunding is part of our financing plan and is the third inspiration that came from our experiences in the funding of biotechnology companies.  As I mentioned above, the classic clinical development process is slow, extremely expensive, and “one time only”. This funding is usually from venture capitalists or big investment funds (people who don’t have a vested interest in the treatment but see it merely as a financial vehicle and often push treatments into the clinic as fast as possible for this one-shot-deal).  During this process the treatment is only available to clinical trial participants and the general public are not aware of progress. Only if this whole clinical trial process is successful and a marketing license is granted, then the treatment can be advertised.  At HairClone, we wanted to create a “community of scientists, clinicians and patients” who would work together to develop the treatment and provide funds, their time, expertise and follicles and would then benefit in various ways when the treatment was a success.

Crowdfunding allows anyone to take part in the early stage of the development of the company. There are risks involved and Capital Cell ensures potential investors are aware of this, but through crowdfunding a shareholder could invest as little as £100 and own shares of HairClone. To own the same percentage of a company like Shiseido would cost almost 3/4 of a million pounds! The current hair transplant market is around £4 billion. If cell therapy revenues for a hair loss treatment were even a tenth of that amount then HairClone would be hugely valuable and the share price would be expected to increase proportionately. However, an increase in £400 million in sales for a Company like Shiseido would be less than a 6% increase on their total sales.

Visit HairClone’s Crowdfunding Campaign on Capital Cell Here

FT: Can you explain the difference between rejuvenating hair follicles and regeneration? What evidence supports this theory so far?

PK: Hair regeneration is the formation of brand new hair follicles.  The idea was born from work carried out by Colin Jahoda’s lab in the 1980’s that showed that dermal papilla cells could induce epithelial cells to change their function and become hair follicle epithelial cells which produced a hair shaft, which is an amazing ability when you think about it. However Jahoda also found that the these dermal papilla cells lost this hair induction ability when cultured so there wasn’t an increase in the total number of hairs produced.  In hindsight that isn’t a surprise as you are now asking these dermal papilla cells to make more cells rather than induce hair follicle growth. Work is continuing in this area to understand how to create new hair follicles and all groups, including HairClone, are realising that with human cells, 3D constructs containing dermal papilla and epithelial cells together is probably the way to go. This is an extremely challenging project. I do not doubt that one of the groups will be clinically successful and it will be the first example of the regeneration of a human organ, albeit a small one which will be a huge watershed moment for medicine.

Hair rejuvenation is a totally different process and focuses on the process of hair loss which should really be called hair miniaturisation. We know from numerous labs that this miniaturisation coincides with (and is probably directed by) the loss of DHT sensitive dermal papilla cells in progressive hair cycles. Hair rejuvenation aims to replace these lost dermal papilla cells and restore the follicle, and hence the hair shaft, to their original dimensions.

There are various pieces of evidence to support this from both animal studies that shows that DP cells can restore the dimension of chemically miniaturised follicles, or that DP cells from large follicles can migrate to the dermal papilla niche in smaller follicles and increase the diameter and length of the hair shaft, to clinical studies aimed at hair regeneration that showed hair shaft improvements in newly balding regions. If we are right and we can provide cellular replacement to miniaturising follicles then a patient could have their follicles rejuvenated as soon as they noticed hair loss beginning and their hair loss would be reversed. We think from the animal and clinical data that only miniaturising follicles would be affected so as the wave of miniaturisation occurred then we could rejuvenate newly miniaturing follicles and provide a wave of rejuvenation. This is the basis of our decision to use follicle banking so that multiple treatments could be produced from one surgical procedure, it also allows us to harvest different cell populations for rejuvenation and later the regeneration of hair follicles.

Thank you Paul for answering these questions. I hope all the readers have enjoyed this interview and learned more about the HairClone company.
Stay tuned for part 2 of this interview series coming soon.