Full Press Release Details
PRIMA BIOMED DISCUSSES Q1 OF FISCAL YEAR 2014 RESULTS AND CVAC PROGRAM UPDATE EARNINGS CALL TRANSCRIPT
Matthew Lehman, Chief Executive Officer
Marc Voigt, Chief Financial Officer
Sharron Gargosky, Chief
Anton Uvarov, RM Capital
Robin Davidson, Edison Investment Research
Bernardino, MLV & Co.
Kallos, Edison Investment Research
Prima BioMed (ASX: PRR; NASDAQ: PBMD; Deutsche B rse:YP1B.F) Q1 of Fiscal Year 2014 Results Earning Call and CVac
Program Update Discussion 7th November 2013 9:00am AEST
Good day ladies and gentlemen and welcome to the Prima BioMed Limited quarterly conference call for the quarter ended September 30th 2013. My name is Nikki and I will be your moderator for today. At this time all participants are in a listen only mode. We will conduct a question and answer session towards the end of the
conference at which time if you wish to ask a question you will need to press * followed by the number 1 on your telephone keypad. I will now like to turn the call over to Mr. James Moses, Prima s investor relations representative.
Mr. Moses please proceed.
James Moses, Investor Relations Representative:
Good morning everyone, I m pleased that you could join us today for Prima BioMed s quarterly conference call covering the first quarter of the
company s financial year for 2014. With me is Mr. Matthew Lehman our Chief Executive Officer, Mr. Marc Voigt our Chief Financial Officer and Dr.
Sharron Gargosky Prima BioMed s Chief Technical Officer. Before we begin I d like to remind you that during this call we will be making forward looking statements that are subject to
risks and uncertainties that may cause actual results to differ from the results discussed in the forward looking statement. Reference to these risks and uncertainties are disclosed in detail in our public announcements to the ASX and our disclosure
filings with the US Securities and Exchange Commission. After some prepared remarks by the management team, we will open the lines for questions. Please note that to ask a question you will need to press * followed by the 1 key. I ll now hand
the call over to Matt Lehman, Prima BioMed s CEO.
Matthew Lehman, Chief Executive Officer:
Thank you James and hello everyone, thanks for joining us today. A lot has happened at Prima BioMed in the past quarter and we do have a lot to look forward to
as well. Before jumping into a detailed discussion of our CVac clinical development program with Dr. Sharron Gargosky, I would like to briefly address a few other important operational, recent operational activities as well. So first I m
happy to report that as of October 2nd this year, we and Oncothyreon Inc, which had previously been known as Biomira Inc if you look at some of our old agreements, had agreed to terminate a
licence and development agreement that was originally signed in 2004 which was also subsequently amended a few times. That agreement, and the amendments, related to a purported licence of mucin 1 technology for us in CVac. So now that we have a
termination, we ve agreed to terminate, this clarifies that we do not have ongoing obligations to Oncothyreon. The old agreements could have been construed as requiring Prima to pay up to US$ 8.5 million in research milestones and more in
continued royalties on commercial sales of CVac. And those are now clearly not the case.
I do want to point out that in the event that CVac would be
approved for sale in the US, United States, prior to 2018, which is when some of the patents related to mucin 1 that are controlled by Oncothyreon expire, Prima we may need to obtain, on some commercially reasonable terms, a licence from Oncothyreon
related to the use of mucin 1 patents until that expiration in 2018. I should also point out however that these relevant mucin 1 patents are basically expired in all other countries in the world except for Canada and in Canada they expire in 2014.
So, second, and this occurred just recently and after the end of our reporting quarter, I would like to confirm
that we have entered into a binding term sheet for the licence of CVac rights in Israel and Palestine to a company called the Neopharm Group. We re very excited, we believe this is a very exciting milestone for us and this is the first
corporate partnership for CVac. We think it represents a nice vote of confidence in our development program. We believe Neopharm is a good licensing partner for us, they are the second largest life sciences company in Israel with extensive reach in
the hospitals throughout the country, a very strong logistics and distribution support which we think are critical for the success of cell based products like CVac. The economics of this deal are significantly weighted to a profit sharing
arrangement on commercial sales with some minor development milestone payments. Basically Prima will be reimbursed first for our cost of manufacturing and then there would be a 50/50 profit split on net profits - the net profit split would be based
on profit after sales and marketing expenses.
So moving on to our CVac development program, as most of you know on September 18th we reported top line analysis of our CAN003 phase two trial. This data was presented in more detail at the European Cancer Congress by Dr. Jeffrey Goh on October 1st and Prima s management team also delivered a presentation via a conference call and web cast on October 2nd. We will have further
updated data from that CAN003 trial that will be presented at a poster session on November 8, 2013, so in a few days, at the Society for Immunotherapy of Cancers 28th annual meeting. The
title of that poster is called Study of Autologous Dendritic Cell Therapy Targeting Mucin 1 as a Treatment for the Maintenance of Ovarian Cancer Patients in Remission . The poster will be presented by Prima s Chief Technical Officer
Dr. Sharron Gargosky on behalf of the trial investigators and the study team.
So just before we continue, as a brief refresher, the CAN003 trial is
phase 2 trial enrolled 63 women after having achieved a complete remission after first or second line treatment. Prior to joining that trial, all women underwent cytoreductive, or also called debulking, surgery to remove as much of the cancer as
possible and then completed conventional chemotherapy. Patients were allowed to enrol on this trial within 12 weeks of having achieved remission. The first seven patients on the study were not randomised and were assigned to receive CVac. This part
of the trial was intended to assess manufacturing comparability between Australia and the US manufacturing sites, which was successfully achieved. After
the first seven patients, 56 patients were then randomised to either receive CVac or they were assigned to a control group. Of the randomised patients, 20 of those women were in second remission,
10 each were assigned the CVac and to the observation only control one. The trial specified monitoring patients until disease progression or for two years. There were two primary clinical objectives of the trial. One was to assess the safety profile
of CVac and to assess CVac s impact on progression free survival. The two secondary clinical objectives of the trial were one to assess CVac s impact on overall survival of the patient and to evaluate immunologic responses to CVac
In summary and again if you re interested or did not see some of our earlier presentations, you can find these filings online via the ASX
or via SEC websites, but we are able to make the following conclusions from the CAN003 trial data to date. On the safety objective, CVac was well tolerated and non-toxic. In terms of immune activity, CVac induced some mucin 1 specific T cell
response and CVac did not induce an antibody response to mucin 1. On the PFS objective, the combined group of both the first and second remission patients, there was no observed difference in PFS. We did however observe distinct and divergent trends
when we look at the first and second remission groups separately. And Dr. Gargosky will review this in a bit more detail momentarily. And regarding overall survival, eight patients have been confirmed as deceased to date and we will continue
monitoring to evaluate the OS or overall survival signals in the CAN003 trial. As we previously advised, we will continue to monitor these patients for an extended period of time and is expected that this data will be mature enough for further
evaluation approximately by the end of calendar year 2014, so about a year from now.
I should also mention there is further detailed analysis of the
immune monitoring that is also ongoing. And with that I will now turn over to Dr. Gargosky to give a more detailed update on our clinical development plans. Sharron.
Sharon Gargosky, Chief Technical Officer:
Matt, thanks for that great background and hello to everyone on the call. Well as we have continued our extensive review and assessment of the CAN-003 data with our clinical and scientific advisers and as we have approached the final database lock
on the PFS progression free survival data, it is apparent, as Matt has mentioned, that CVac is clearly well tolerated in these patients and that CVac has the
expected immunological mechanism of action in the subjects that were treated with the product. Notably there is a particularly favourable progression free survival signal in patients with second
line remission and interestingly as we ve presented previously, this is not the same type of efficacy signal that we would see in the first line remission patient population.
So on this Kaplan-Meier estimate we are looking at now, it s somewhat updated from the last presentation we made a few weeks ago, it is now as all the
data has been entered into the database and been compiled. And as we can see, there s quite a separation in the progression free survival curves in the populations who achieved remission after second line therapy. Interestingly here you see
CVac has conferred nearly a 50% increase in the median progression free survival of PFS and strikingly this has resulted in a hazard ratio that is 0.41 with a P value of 0.09. Of course we would strongly caution that these results are based on a
relatively small number of patients. We are only looking at 20 patients here, but this type of PFS signal in the second line remission patients is really quite striking. We have gone back with our physicians to analyse these patients on an
individual basis and looked at thousands of pages of data to ensure that there really is nothing anomalous in the data and what we are looking at here with regards to these patients, medical, surgical, chemotherapy prior histories. And after that
review we really do not see anything unusual about the prior treatments or the demographics of the patients in this population. It s interesting that when we review this positive T cell activity associated with CVac in conjunction with the
strong PFS signal that we re seeing in the second line remission patients, it s clear to us that there is some kind of story or message here and that we really should be continuing our development of CVac in the second line patient cohort.
In addition to our CAN-003 trial, there have obviously been a number of other cancer immunotherapies that have been reported data in the past few years.
And I think Matt referenced this for everyone during the last presentation we gave several weeks ago. And based on the available data in the field, commercially approved cancer immunotherapy products and based on our correspondence with key
regulators, all suggest that it is important for us to be following overall survival or OS as a primary end point for our future CVac trials. It s a very clear non-subjective end point and very clearly the indicator that shows the best outcome
for immunotherapy products.
So moving forward we will be making several significant changes to the CAN-004 or CANVAS clinical trial program.
To start with we will not enrol additional first remission ovarian cancer patients. Patients who are currently enrolled in the trial will be permitted to continue through the protocol. The primary efficacy end point of the CAN-004 trial will be
changed to overall survival and we will also continue to monitor progression free survival, immune responses and of course safety through adverse events. We may expect that of the currently 76 randomised patients that are involved in the trial, that
we would anticipate that 50 to 60 of them will continue through the dosing stage of the trial and be evaluable for end points. Given the expected survival prognosis for these patients, these first line remission patients, we may expect an evaluable
trend in the overall survival from this group in approximately 2018. Additionally we will be opening the CAN-004 clinical program to a new cohort of ovarian cancer patients, those who are in complete remission after second line treatment. This
cohort really represents the patient group in which we re seeing that really strong striking PFS signal in the CAN-003 data. And just to give a rough outline of the planned protocol amendment or adjustment that we are putting in place, we
intend to enrol 210 patients who are in complete remission after second line chemotherapy. They will be randomised into the trial in a classical one-to-one fashion to either receive the CVac treatment or to be observed as according to current
standards of care. And as we ve said above, the primary end point for this trial will be overall survival.
You know this type of trial would give us
approximately an 80% power to detect the hazard ratio of 0.67 with a P value of 0.1 and so we ve set this trial up so that we believe that it will be sufficient to meet a robust standard proof of concept of clinical outcomes for CVac in these
second line patients. We expect to complete the CAN-004 protocol amendments and to make the regulatory submissions to each authority before the end of this calendar year, such that all going well, patient recruitment should start in early 2014. We
will conduct our annual interim evaluations with our data safety monitoring board, who will review both the efficacy data along with their regular review of safety and adverse events.
So we re really quite excited about this expansion of the epithelial ovarian cancer program and really what we ve learnt from the CAN-003 trial to
give us guidance and direction in our CVac development program. We will also plan to move forward with our pilot trial in resected pancreatic cancer, although this will be
under a slightly different design than we previously advised. The resected pancreatic cancer trial design will include 40 resected pancreatic patients treated singly with CVac. We will review the
safety and key immune responses and overall survival outcomes in these patients in this protocol. Our goal really is just to add value to the CVac franchise by potentially expanding the clinical application of CVac and to help us be able to make key
go/no go decisions on further CVac clinical trials in pancreatic cancer. So this will be a 40 patient smaller proof of concept trial with a single arm of CVac treatment.
With the clear direction to overall survival as our primary efficacy endpoint to CVac development, and given the longer expected overall survival outcomes for
the patients in triple negative breast cancer or in colorectal cancer, we believe it is best for us not to start phase 2 trials in those indications as we had previously planned.
So, operationally we will conduct the pancreatic pilot trial and the new second line remission cohort trial of CAN-004 in Europe. The Saxony Development Bank
in Germany provides significant non-dilutive grant funding that supports our manufacturing and clinical costs associated with the program. And we believe that focusing the trial in Europe will allow us to maximise our grant resources that are
available to us and to reduce Prima s trial costs.
So we re really excited and looking forward to our upcoming CVac clinical development
program in this expansion of ovarian cancer and in pancreatic cancer. And so with that I would like to turn over our call to our CFO Marc.
Chief Financial Officer:
Thank you very much Sharron and good morning to everyone. As usual I would like to start with a few comments about our
finances. So in line with the Australian regulations Prima reports financials according to Australian accounting standards or AASB which is consistent with IFIS or the international financial reporting standards, all numbers are in Australian
dollars and our financial year runs from July 1st through June 30th. I will be briefly speaking about our quarterly report, the
appendix 4C for the first quarter of our financial year 2014 so for the period from July to September 2013. The 4C is primarily a statement of cash flows for the company and is not an income statement.