Immunomedics Inc. (NASDAQ:IMMU) F4Q12 Earnings Call August 24, 2012 10:00 AM ET
Gerard Gorman - SVP, Finance & CFO
Cynthia Sullivan - President & CEO
David Goldenberg - Chairman, CSO & CMO
Boris Peaker - Oppenheimer
Ryan Martin - Lazard Capital Markets
Ling Wang - Summer Street
Welcome to Immunomedics Incorporated fourth quarter and fiscal year 2012 financial results conference call. And as a reminder, this call is being recorded. Today is Friday, August 24, 2012. With us on the call this morning are Dr. David M. Goldenberg, Chairman, Chief Scientific Officer and Chief Medical Officer; Cynthia Sullivan, President and CEO; Gerard Gorman, Senior Vice President of Finance and CFO.
I would now like to turn the conference over to Gerard Gorman, Chief Financial Officer of Immunomedics. Please go ahead.
Thank you and good morning and welcome to our first earnings conference call. I am Gerard Gorman, Senior Vice President of Finance and CFO and I thank you for participating in today’s call. I will begin with a brief summary of our current financial condition. Cynthia Sullivan, our President and CEO will follow with an overview of developments in our business and some updates on clinical programs. Finally, Dr. Goldenberg will describe our major clinical programs and research plans before we open up the call for questions and answers.
Before we begin, I would like to remind everyone that during this call, we would be making forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995.
Such statements may involve significant risks and uncertainties and actual results could differ materially from those expressed or implied in the call. For factors that could cause such differences, please refer to our regulatory filings with the SEC, most recently our annual report for the year-ended June 30, 2012.
Now let me start with the financials. I hope everyone had a chance to review the financial results we released yesterday afternoon. The earnings report is available on our company website at www.immunomedics.com.
We reported total revenues of $1 million for the fourth quarter of fiscal year 2012, which ended June 30 2012 as compared to revenues of $11.1 million for the same quarter last fiscal year.
The decrease in revenues was primarily due to a $10 million milestone payment received in the fourth quarter of 2011 under the terms of the Nycomed agreement. The lower revenue in fiscal 2012 was the primary reason for the net loss attributable to our stockholders of $7.5 million or $0.10 a share for the current quarter as compared to net income attributable to our stockholders of $2.3 million or $0.03 a share for the same period last year.
For the entire 2012 fiscal year we were successful on implementing our non-dilutive financing strategies to support our robust R&D program. Total revenues for the fiscal year 2012 amounted to $32.7 million as compared to $14.7 million for fiscal year 2011. The increase of $18 million as compared to the prior fiscal year was primarily the result of $18.3 million in higher license fee revenue in 2012 fiscal year due to the $28.4 million in license fee revenue that the company received in 2012 in connection with an amendment to the licensing agreement with UCB which was partially offset by lower revenue from Nycomed in fiscal year 2012 as a result of the non-recurring $10 million Nycomed milestone payment we received in 2011.
Net income attributable to our stockholders for the fiscal year ended June 30, 2012 was $800,000 or $0.01 per share as compared to a net loss attributable to our stockholders of $15.1 million or $0.20 a share in the fiscal year 2011.
The improvement in profitability this fiscal year was primarily due to the increase in license fee revenue and reduction in operating expenses of $1.9 million offset in part by a non-recurring grant of $2.9 million from the federal government’s Qualifying Therapeutic Discovery Project program in fiscal 2011.
The company has no long-term debt and as of June 30, 2012 cash and cash equivalents totaled $32.8 million. In fiscal 2013, expenditures are expected to be $24 million to $26 million due to increased spending for research and development including the further clinical development of Clivatuzumab in patients with pancreatic cancer.
This summarizes our financial results for the fourth quarter and for the full year 2012. I will now turn the call over to Cindy.
Thank you, Gerry and good morning everyone. I am pleased to have this opportunity to give you an overview of developments in our business and provide updates on our key clinical programs during this past year. On the business side in December 2011, we announced that we amended our licensing agreement with UCB to permit the sub licensing of Epratuzumab in certain territories.
As a recap for this amendment we received from UCB a non-refundable cash payment totaling $30 million in January 2012 and we issued a five-year warrant to UCB to purchase 1 million shares of our stock at an exercise price of $8 per share. The amendment also included the return to us of UCB's right to buy-in option for Epratuzumab in oncology.
Discussions with potential sub-licensing partners continue to progress. As we previously stated we believe the addition of a sub-licensing partner could add value to the development of Epratuzumab in Lupus and in other indications. As discussed if this sub license agreement is consummated, we expect to receive a second non-refundable cash payment and will likely be eligible to receive new regulatory and sales milestones payments.
Other business developments are progressing with regard to out licensing of certain product candidates including Epratuzumab and Veltuzumab in the cancer indication in certain territories and technologies such as our Fluorine-18 labeling and our dock-and-lock platforms.
At this time I cannot comment further on these activities. With regard to our clinical developments, our major focus is on Clivatuzumab as a potential therapy for patients with advanced pancreatic cancer. This antibody recognizes an antigen in the mucin produced by pancreatic cancer cells. The antibody by itself has no cancer activity. So in this case we are using it to selectively deliver a potent dose of radiation to the tumor by attaching Yttrium-90 to the antibody.
As reported by our clinical investigators, recently at ASCO and at the Society of Nuclear Medicine Meeting as well as in an online publication in the Journal of Cancer, repeat administration of yttrium-90 labeled clivatuzumab in combination with gemcitabine resulted in very encouraging survival data in patients with previously untreated advanced pancreatic cancer.
We discussed plans for further development of clivatuzumab in this patient population with key opinion leaders and with FDA this past year. In response to the feedback from these meeting, our yttrium-90 labeled clivatuzumab is now in a Phase Ib trial enrolling patients who have received at least two prior therapies for their disease. We are also evaluating the benefit of adding low dose gemcitabine to the labeled antibody.
Specifically, this Phase Ib trial is a limited dose finding study which will enroll 50 patients; 25 patients will receive fractionated doses of the labeled antibody by itself and 25 patients will receive fractionated doses of the labeled antibody in combination with low dose gemcitabine. This trial will provide results on the potential benefit of low dose gemcitabine added to the antibody versus the antibody by itself.
Recognizing the benefit of repeated dosing cycle demonstrated in the front-line study, we want to make sure patients in this study are able to receive at least two cycles of therapy. Safety is the primary endpoint, but we will also be looking for early signs of efficacy and monitoring overall survival.
We believe positioning clivatuzumab in patients who received at least two prior therapies may offer a quicker pathway to approval. This strategic shift was made after consulting with key opinion leaders in the field of pancreatic cancer therapy. There is a high unmet medical need for patients with pancreatic cancer who have received prior therapies, since there are almost no treatment options available for them.
Therefore, we are optimistic that patient approval will be rapid not only for the current Phase Ib trial, but also for future registration trials in the setting. We expect to complete the Phase Ib study in the first half of calendar year 2013 and have already begun protocol design and identification of a clinical research organization for the global Phase III clinical trial which will begin immediately after the Phase Ib has been completed, assuming of course the positive out come and available funding. Pursuit of this indication does not mean that we will now also explore clivatuzumab in the front-line setting in untreated pancreatic cancer patient.
Let me now move on to epratuzumab our CD22 antibody which is in two Phase III registration trials in patients with lupus. These clinical trials are being conducted our partner UCB and are expected to enroll about 800 patients into each of the two trials; patient enrollment in ongoing in these studies with topline results expected in the first half of calendar year 2014.
The results of our ALLEVIATE trials initiated before the product was licensed to UCB are being prepared for publication and the long-term safety and durability results from this trial as well as UCB’s completed Phase IIb trial are also being prepared for presentation and publication. In a few minutes, you will hear future development plans for epratuzumab in the oncology setting from Dr. Goldenberg.
With regard to the development of veltuzumab, our humanized CD20 antibody, I am sure you are aware that we licensed the subcutaneous formulation to Nycomed for all non-cancer indications worldwide. Nycomed has since been acquired by Takeda Pharmaceutical Company. During fiscal year 2012, Takeda-Nycomed reviewed the future development plans for this antibody as a therapy for patients with rheumatoid arthritis or RA. A Phase II clinical trial is ongoing; modifications to the protocol design and the RA patient population for enrollments are being considered. As soon as we have more information on the trial, we will share it with you. In the oncology setting, grant supported clinical trials in patients with non-Hodgkin’s lymphoma are ongoing.
In addition to these three lead product candidates, we also have an active antibody drug conjugate or ADC program that’s producing a number of interesting new agents. You will be hearing more details on these early stage programs in a few minutes, but briefly we have we have two clinical programs ongoing and a third ADC trial will begin in the next six months. Two of these three clinical trials will focus on the therapy of advanced solid cancers where there is a high unmeant medical need.
These early stage clinical trials are often conducted in a few sites and are focused on dose finding objective. They require fewer patients for enrollment and therefore are manageable within our clinical budget. In addition, we have been successful in securing competitive funding from the small business innovation research program of the National Institutes of Health for these early stage trials. Currently, we are supported by two multiyear grants totaling more than $6 million from the National Cancer Institute. We are pleased that we faired so well in to peer-review of our science.
Finally, in October of this year, we plan to file an IND for a new agent called IMMU-114 as a potential therapy for patients with blood cancers. We are very excited about this novel antibody which Dr. Goldenberg will address.
So on that note, let me turn further discussion over to David.
Thank you Cindy, and good morning. It is my charge to briefly describe our major clinical programs and research plans. I believe it is not an overstatement that we have a very robust research program involving naked or unconjugated antibodies for the therapy of cancer and autoimmune diseases, antibody drug conjugates or ADCs as well as radio labeled antibodies. The Clivatuzumab antibody is an example of the latter in developments of pancreatic cancer therapy.
We also have published studies on our radio labeled anti-CD22 antibody Epratuzumab in the therapy of non-Hodgkin's lymphoma. In fact we continue to study this agent in combination with our unconjugated anti-CD20 antibody Veltuzumab in a multi-center Phase I2 clinical program of patients with relapse, aggressive non-Hodgkin's lymphoma supported by a grant from The National Cancer Institute.
We hope to present our intermittent findings at a the future medical conference. Epratuzumab which is our lead product in Phase III trials for the therapy of patients with Lupus as discussed already, continues to be of interest in the therapy of hematological tumors.
We’re pleased to report that a consortium of pediatric leukemia centers across Europe has received funding from the European Union to conduct a randomized Phase III trial of Epratuzumab added to chemotherapy in children with relapse, acute lymphoblastic leukemia at over 20 or more centers in approximately 19 countries, coordinated by the Charite University of Medical Center in Berlin.
We’re actively involved and we’ll be supplying Epratuzumab. Our European office in Darmstadt Germany will serve as a distribution center for this global clinical effort in addition to managing the sales of our LeukoScan product in Europe and else where.
This study in acute lymphoblastic leukemia will be the largest trial conducted in this orphan disease approaching over 800 patients and so we will require a number of years for completion. Acute lymphoblastic leukemia is of interest because these cells express CD22 in a larger proportion than CD20 the target of Rituximab and our Veltuzumab.
It is also of interest in acute lymphoblastic leukemia in adults and we expect that the promising trial results of Epratuzumab given in combination with two other drugs in relapse, refractory acute lymphoblastic leukemia in adults conducted by the (inaudible) study group of the National Cancer Institute will be presented at a future medical conference.
Hence we are very pleased that epratuzumab continues to be of interest in oncology and is showing promising activity in adult and pediatric acute lymphoblastic leukemia. Beside its contribution to the therapy of the aggressive lymphoma when combined with Rituximab CHOP as reported in the past by the North Central Cancer Treatment Group of the National Cancer Institute.
In our antibody drug conjugated or ADC development program, we have two agents now in clinical trials and a third soon to enter clinical studies. The first is Doxorubicin conjugated to our anti-CD74 antibody Milatuzumab which is being studied in patients with advance relapse multiple myeloma and which is still in dose escalation trial to determine optimal dosing and safety.
This trial is now being extended to patient with relapse non-Hodgkin's lymphoma and a chronic lymphocytic leukemia. Our second ADC clinical program involves a humanized anti carcinoembryonic antigen antibody Labetuzumab conjugated with the irinotecan metabolite SN38. This is a dose escalation trial in patients with advanced colorectal cancer at the Memorial Sloan-Kettering Cancer Center.
The same agent will soon enter another trial with a different dosing schedule at other cancer centers. Finally the third ADC compound involves an antibody against a different marker, TROP-2 which is expressed on a large number of cancer types and again conjugated with SN38.
This has not commenced yet but we have FDA approval to begin this trial and we will study it in a variety of cancer types including gastrointestinal, breast, lung, ovarian and prostate cancers.
Turning back to unconjugated or naked antibodies, our next product to enter clinical trials for the therapy of relapsed non-Hodgkin's lymphoma and chronic lymphocytic leukemia is IMMU-114 which targets a human leukocyte transplantation antigen, HLA-DR expressed by a large number of blood cancers. This is planned to enter a Phase I study at the Ohio State University Cancer Center during this fiscal year.
The clinical enthusiasm is based on preclinical evidence published in the prestigious journal Blood, showing very broad and potent activity against a large number of blood cancer types. In the area of preclinical research, we continue to focus on our novel proprietary dock-and-lock methods while making fusion proteins particularly by specific antibodies.
These involve a number of targets such as CD22, CD20 and CD 74 which we believe may have potential for improved therapies of both hematological tumors and a variety of autoimmune diseases. We believe that next generation antibodies will be multi-targeting agents such as by specific antibodies as acknowledged by most pharma companies who are now developing such strategies.
In fact I was privileged to lead a special session on this subject at 2012 BIO International Convention this past June. Immunomedics has been engaged in this kind of research for over ten years. So we have an extensive patent portfolio and a number of candidate products in developments. We also use this technology to make three-armed antibodies using our pre-targeting strategy in collaboration with our subsidiary IBC Pharmaceuticals.
This technology is now in clinical trials and is intended to show an improved delivery of diagnostic and therapeutic radionuclides to various cancers. Trials are in progress in Europe on the local research grants and patients with colorectal and small cell lung cancers. This work stimulated us to develop a better positron emission or PET imaging agent using Fluorine 18 which is now being extensively patented and adopted by other research groups because of its ease of use and rapid labeling.
Efforts to license this to other companies interested in companion PET diagnostics are underway. I am proud that our patents covering this technology received the Edison Award in Medical Imaging from the Research and Development Council of New Jersey this past year. We have been able to pursue these various important product developments because of our success of gaining competitive external funding from the National Cancer Institute, our work with National Cancer Institute study groups as well as our collaborations with research groups that have enabled to secure competitive funding in their own countries. As a result, about 25 to 30 articles per year are published by us and our collaborators on Immunomedics agents or technology in very prestigious medical journals.
In closing, we thank you for joining us today and we’ll now take your questions. Conference operator, please begin the Q&A session.
Thank you, sir. (Operator Instructions) And our first question comes from the line of Boris Peaker from Oppenheimer.
Boris Peaker - Oppenheimer
I have several questions; I guess, maybe I'll start with veltuzumab. I am just curious in terms of the Takeda’s work on the RA trial changes; have they commented on the timeline of when an updated trial design maybe announced or is it still just a work-in-progress?
At this moment, no decision has been made with regard to patient population or dosing schedule. So it is a work-in-progress and you know, if changes are indeed implemented, we will share them with everyone as soon as possible.
Boris Peaker - Oppenheimer
And can you comment in terms of the changes, are they, I guess on the standards are they more targeted towards maybe FDA requirement and just the regulatory element of getting a drug approved versus towards making the study data more commercially fitting into rapidly evolving RA treatment landscape?
I think the changes are designed to actually address both of those items. They do want to have obviously with the subcu formulation and appropriate dosing schedule as well as dose finding study and you are correct to point out the landscape is changing, so therefore patient population choices maybe appropriate.
Boris Peaker - Oppenheimer
And I have two questions on epratuzumab; from the enrollment perspective, I am just curious, how many sites are active and what update should we expect from the lupus program enrollment?
With regard to the lupus enrollment, although UCB hasn't provided information on the status as to where they are, the clinical trials at gov site list a total of 261 active sites for these two studies. So the only guidance today provided by UCB is with regard to topline results becoming available in the first half of 2014.
Boris Peaker - Oppenheimer
And my last question in terms of epratuzumab I guess your move to RA the lupus market has had some changes in recent several years and there is a wide range of drugs just in general being used in lupus patients off label as I am sure you know. So what I would like to understand as well that the study itself is somewhat restricted to very specific patients and treatment paradigms. From your market research of real world practice how combinable is epratuzumab with established treatment modalities?
Well, although we don’t have specific with regard to epratuzumab combination in the lupus indication, we certainly have multiple studies that have been published in the cancer indication. So we also, we are talking about epratuzumab plus Rituxan and epratuzumab in combination with chemotherapies there and we are experiencing of course in lupus they have the combination of corticosteroids and background medications other than corticosteroids that are being used in combination. Epratuzumab is interesting in terms of its safety profile; in fact the backbone to that antibody is most often used when we are CDR-grafting other antibodies because of the safety benefit.
Perhaps I can answer that the use of epratuzumab with a number of drugs has been very well received and tolerated in pediatric ALL from the children’s oncology group studies and the studies that were completed with the North Central treatment group workshop and Rituximab when combine with epratuzumab. So in all of these settings and there are I mentioned that there will be SWOG data coming out soon where epratuzumab was combined with two other drugs it’s still different from any of these I mentioned in adult ALL and it was tolerated well and I look forward to SWOG their data results which are very promising in my view.
Thank you. And our next question comes from the line of Ryan Martin from Lazard Capital Markets.
Ryan Martin - Lazard Capital Markets
Just start off with on clivatuzumab; can you talk about the rational for why they have been better responses with the low dose of gemcitabine versus the higher doses?
Well, first of all, even when the high doses were given, they weren’t given under the standard therapy with Gem which goes over many months; these were just four doses at the 600 milligram or 1000 milligrams, so these were as I was saying not yet really the most highest doses that are standard for Gem.
The questions is really, do we need Gem combined with yttrium-90 or PAM-4, the 200 milligrams per meter squared combined with PAM-4 showed encouraging results, but naturally after seeing that and stepping back a little bit and thinking about our very first Phase I trial where we gave a small number of patients dose escalation of PAM-4 yttrium without gemcitabine, even in that trial we showed partial responses in a few patients and they only had one injection of PAM-4, not repeated.
So with that background and the results showing that low dose was no different or we didn’t see an approval with high dose Gem, the question naturally came up from our opinion leaders and FDA, do you even need Gem in this trial for which reason we are doing this Phase Ib. I can just say that contrary to the clinical data, the preclinical animal results show that the combination was better than either alone, but that’s if you rely on results in mice. That’s why we started the original large trial in untreated patients with the combination because of the pre-clinical work. But it's very important before we embrace a large Phase III trial to finally decide, do we need 200 milligrams per meter squared of Gem given four times in each cycle or not.
Ryan Martin - Lazard Capital Markets
Thanks for clarifying that David and you know, that kind of takes me to the next thing, I wanted to ask on clivatuzumab which is in your prepared remarks, I think you all went over on the possibility of obviously doing a front line trial as a registration study. I mean seriously what you may be looking for from the Phase IB either on the combination arm or the clivatuzumab alone arm in order to go ahead and make that decision and could we see potentially two patient populations being studied or you will make a decision on either front line or third line at some point?
Well, a lot depends of course on the results of this trial. One of the other areas of interest is what's the right dosing in heavily pretreated population in order to achieve repeated cycles. Because our experiences from the former trial that the more repeated cycles, the better results. We saw a durability of 11.8 months in 13 patients, like our repeated cycles in the upfront trial and that was done a little bit to 9.8 when we studied the 31 patients in follow up.
So I think it's very important for us to assess if we are going to have repeated cycles, what's the optimal dosing and that’s what we’re looking at here. Once we know that, we can ask the question, how can we push this to frontline also because in frontline it may very well be that we combine PAM4 at these more modest radiation doses within other range in comparison to whatever other standard therapy is available at a time.
So it's hard to predict how we would design to say through our untreated patients front line before we get the information we need out of this phase Ib trial which I must say is very well received. There is a lot of enthusiasm and we are moving quickly in our enrollment in this trial.
I can just get a little more specific there with regard to enrollment into the phase Ib. The trial is only been opened about two months and so far we have eight sites that are open. Eight patients have been enrolled and three of the eight patients have either received or shortly plan to receive a second cycle of therapy.
So over the next couple of months we plan to open 20 to 30 sites and total enrollment of course as I mentioned is plan to be around 50 patients.
Ryan Martin - Lazard Capital Markets
And maybe just following up on that is you know is that a realistic number of cycles of therapy that you think these third line patients could be eligible to receive with the drug on the combination?
Well, the reason we think we are going to be able to give at least and so far with the first few patients coming in, we very encouraged is because we've drop the dose of yttrium-90. We started in the original Phase I going up to size  so we reach the meter squared given three times and the dose we are addressing now is 6.5 millicuries per meter squared and the reason for that is when we did the dose escalation in the first large trial, the first patients received the lower dose and in those we saw multiple cycles tolerated and they had responses that went out over a year in terms of survival. So we think a lower dose fractionated of the yttrium-90 PAM4 maybe very effective and yet allow repeated cycles or someday even combination therapies with other agents.
Ryan Martin - Lazard Capital Markets
May be one final question more from a broader perspective, can you talk about the linkers you are using for your ADCs. Clearly that seems to be the main component in terms of ADCs and how these may compare to some of your competitors linkers out there?
Well we have different kinds of linkers depending upon the drug and we have protected them. They are not I would say so different than much in the literature but they are very important for the nature of the drug we are using. We attached the lysine groups. So we attached SH groups or other parts of the antibodies.
But I think the important consideration is that A, we are using what I think are very novel antibodies. The one with doxorubicin is one of the most rapidly internalizing antibodies that were studied which means it gets into the cancer cell and pulls the drug in there very rapidly and in all preclinical studies it’s been very potent in many different tumors that express CD74 which is I think a target that is also unique to Immunomedics. The SN-38 is of course a well known drug because it’s the active principle of irinotecan and we put it on antibodies where we have in once case clinical experience Labetuzumab has been in several hundred patients either as a naked antibody or as an isotope conjugated antibody.
So we know it is targeting and we know its safety and we know its ability to really target colorectal and another CA expressing tumors very well. The next antibody is an exciting opportunity because I think we are the only company working on the TROP2 antibody and we have been doing it for a number of years and this has a selectivity for cancer over the normal tissues and it has a very broad specificity for most of the solid tumors.
And that's why in the Phase I trial, we are not limiting it to colorectal or one of the others. We are looking at five or six tumor types so we can get a better idea in the Phase II developments should it be successful in the Phase I. Where we should focus personally I would love it see it working in triple negative breast cancer and in possibly gastric cancer, in prostrate cancer and in ovarian cancer, all cancers where there is a great need because of not having a very successful alternative therapeutics.
And our next question comes from the line of Ling Wang from Summer Street.
Ling Wang - Summer Street
A couple of questions. First for the Clivatuzumab in the pancreatic cancer program, can you talk about the potential trial design for the phase III trials especially with regard to any specific requirement for the front line and second line therapy for the patients.
Well I think the patients should have either a Fluoropyrimidine or gemcitabine containing regimen when they come in to a trial in second or third line. So that’s one requirement. Secondly, we think we will be able to randomize our PAM4 yttrium even with or without gem in our case to the best available therapy because this would be patients with a regional therapy that's standard. So I think whatever the investigator in the randomized drug chooses as their best available or supportive therapy would be what we would see in the control arm. So it’s a very simple study actually and I am hoping it will not need a large number of patients to show a benefit over what is available which is whatever is the physician’s choice.
Ling Wang - Summer Street
So, it doesn’t matter that patients receive gem in the frontline or second line?
No, I think we hope they will have received Fluoropyrimidine or Gem or Folfirinox trial and then are in condition to come in to and they've benefited from that obviously, so that they’re able to come in to a trial in this late setting. More and more patients are actually doing well with these various combination therapies in front line and second line.
So we’re encouraged from the interest of our investigators, the screening that's going on to enroll patients that there are quite a few patients that fit into the setting that we've set for this trial.
Ling Wang - Summer Street
And secondly for the Epratuzumab in Lupus, Cindy mentioned that you are preparing for the prior Phase II trials for publication or data presentation. Can you give us more detailed timeline for that matter?
Immunomedics’ ALLEVIATE trials which you know we terminate prematurely did have some interesting data in the patients that were enrolled and these data have been summarized and they are in the process of being published, I can't say what, when it will come out or what the status is, but the manuscripts have been written, the authors have renewed everything and we're working on that publication.
Interesting thing is in that trial we also had patients that long-term follow-up, long-term treatment and so that information will be also included into quality of life and the reduction if that's the case which we’ll have to wait for the paper with corticosteroids.
The Phase IIb trial from UCB, it’s their responsibility, but they are presenting data at the rheumatology meetings on a regular basis and I know we will be presenting further information in the future and so its not going to be a long time after that, that I am sure the publications will be completed and then be published of course.
So I think there is a very robust publications program and I am personally very excited and encourages, because the data are very important for us to communicate.
Ling Wang - Summer Street
And lastly, can you share with us your thoughts on potential too out-licensing some of your non-core assets and especially with regards to Epratuzumab and veltuzumab and oncology; what is your plan on licensing them, do you want to do like separate (inaudible) or perhaps combine?
Well, we certainly could combine them because we are doing studies, and we have done studies in the past combining epratuzumab with CD20 and that is a very interesting prospect that we are quite aware of. I will make some general statements, first it was only about eight months ago that we got back the right to go forward with epratuzumab in oncology in terms of our UCB deal. And secondly, epratuzumab has been around a long time; it was one of the antibodies that went in after Rituximab into the oncology arena and we have been disappointed that it’s taken so long for it to be commercialized and yet in all these time it’s not died and the reason for that is, there is a lot of interest and it actually works.
So when you look at the trial results that we see all the time whether it be in pediatric ALL, in non-Hodgkin’s lymphoma in combination with others and very soon you will all see in adult ALL, is it reaffirms, so that this is an active antibody and we now need to pursue a little bit more aggressively since we got it back in our arrangement with UCB to bring it to commercialization.
Having said that, veltuzumab is an even more interesting subject; everything we published on veltuzumab in preclinical or even clinical studies shows it to be among the best and in my view the best anit-CD20 antibody that I have seen. The clinical results with veltuzumab and relaxed on non-Hodgkin’s lymphoma patient showed complete response rates of 25% to 27% which I have not seen within the antibody in CD20 including Rituximab in similar populations.
But as soon as it’s compared head-on-head to any other CD20 antibody, this is a very difficult test to say how much different or better it is. The fact that it has low doses that show activity similar to double or triple the doses with other CD20 antibodies, reassures to me that this is very potent and important molecule.
However, we are dealing with a very big market opportunity which means many pharma companies are developing biosimilars; Roche is developing second generation CD20 and so we need to find a partner that has the interest and courage to go ahead in a major program to develop this, to compete not only with Rituximab, but the second generation Roche and the many biosimilars, because they are coming on the market.
But if you look at the data, which I encourage everyone to look, on the preclinical results when we compare it to Rituximab, head-on-head we’ll show better efficacy; when we look at the clinical results in many patients published in Journal of Clinical Oncology, and we get the survival, complete response rates of 25% to 27% which was confirmed, when we repeated the study with the subcutaneous formulation, I am very encouraged that veltuzumab stands alone in terms of its distinguishing from many other CD20 antibodies that had been published or that we have data for on.
In terms of other assets, you asked about other assets, there is certainly a lot of activity going on with the fluorine-18 labeling method and we do have a research relationship with General Electric on that; we see other parties interested in it and most importantly is our very novel dock-and-lock method where we make many different fusion proteins. Some of them called immunocytokine, some of them by specific antibodies and we are in discussions with many different parties on those and of course that takes a long time.
And finally, what we did mentioned today and which I think is very important because of the limited time, we couldn’t discuss everything and if they let me talk about science, you’ll never go back to work today, but we have the clivatuzumab antibody as a part of an assay for the detection of pancreatic cancer and monitoring by simply doing a blood test and this is just published online in the Journal of Cancer; when we compared to the standard test CA-99 and we showed its actually more specific than CA-99 which is a commercial assay for pancreatic cancer monitoring and diagnosis.
And in combination, both assays are very much better than either alone and more importantly, PAM-4 enables us based upon these published results to actually pickup to diagnose patients with early disease, with pancreatic cancer is less than 2 centimeters in diameter and even some pancreatic cancer are precursor lesions which evidently make PAM-4, so this is the antigen that PAM-4 recognizes, not PAM-4.
So this is a very exciting additional aspect which in the area of personalize medicine becomes very important, because I can envision that we’re going to be testing patients with high risk for pancreatic cancer patients who have been diagnosed, patients who are being treated with our PAM-4 blood assay and using this in conjunction with our radio-immunotherapeutic or possibly one of our drug conjugates that also targets pancreatic cancer. So for us, this is one of the best examples of personalized medicine applied to a very dismal disease.
Thank you. And that is all the time we have for questions-and-answers today. At this time, I would like to hand the conference back over to Cynthia Sullivan for her closing remarks.
Once again, we would like to thank you all very much for joining us this morning. And on behalf of the entire management team, I would like to thank you for your continued support and interest in Immunomedics.
That does conclude today’s conference call. You may now disconnect. Thank you and have a good day.
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