IMV, Inc. (NASDAQ:IMV) Q4 2019 Results Earnings Conference Call March 31, 2020 8:00 AM ET
Pierre Labbé – Chief Financial Officer
Frederic Ors – Chief Executive Officer
Joanne Schindler – Chief Medical Officer
Marianne Stanford – Vice President, Research and Development
Conference Call Participants
Kaveri Pohlman – BTIG
Edward Tenthoff – Piper Sandler
Joseph Pantginis – H.C. Wainwright & Co.
Jay Olson – Oppenheimer & Co. Inc.
Mayank Mamtani – B. Riley FBR
Archit Kshetrapal – Raymond James
Jim Birchenough – Wells Fargo Securities
Good morning, ladies and gentlemen. Thank you for standing by and welcome to the IMV, Inc. Announces its Fourth Quarter 2019 Financial Results and Provides Corporate Update Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions].
I would now like to turn the conference over to your speaker today, Pierre Labbé, Vice President and Chief Financial Officer. Please go ahead.
Thank you, Julie. Good morning, ladies and gentlemen. My name is Pierre Labbé. I’m CFO at IMV. First of all, I’ll start by saying that I hope that you are all safe and healthy and that it will stay like that.
I’m joined today by Fred Ors, our CEO. And we welcome you to our fourth quarter and year-end results and operational update conference call. Fred will begin with an overview of the company’s operational highlights and then I will provide some comments on our financials.
But before we begin, I would like to remind you that, except for historical information, this audio presentation contains forward-looking statements, which reflects IMV’s current expectations about future events.
These forward looking statements involve known and unknown risks and uncertainties that could cause IMV’s actual results to differ materially from these statements. These risks and uncertainties include, but are not limited to, our ability to access capital, successful and timely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly filings and annual information form.
The forward-looking statements made on this call are based on several assumptions which may prove incorrect and they represent views only as of the date of this call and are presented for the purpose of assisting potential investors in understanding IMV’s business and may not be appropriate for other purposes. IMV does not undertake to update forward-looking statements, whether written or oral, that may be made from time to time by, or on its behalf, except as required under applies securities legislation.
Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV’s continuous disclosure documents, including our current annual information form as well as our audited annual consolidated financial statements, which are available on SEDAR and also on EDGAR.
The press release, the MD&A and the consolidated financial statements are all posted on our website. If you wish to receive a copy of either of these documents, please do not hesitate to contact us.
Finally, take note that we will take questions only from certified analysts at the end of the call.
I will now turn the call over to Fred. Fred?
Thank you, Pierre. Welcome, everybody. Thank you all for joining us during this challenging time. We hope you and your loved ones are staying healthy and safe.
I also want to preface that Dr. Joanne Schindler, our Chief Medical Officer, and Dr. Marianne Stanford, our Vice President of Research, are also on the call and will be able to take your questions at the end.
Before jumping into a corporate update, I would like to make a few general comments about the COVID-19 situation and its impact on our work, both internally and with respect to our ongoing clinical studies.
In line with recommended public health interventions, we have taken all necessary measures to prioritize the health and safety of our employees, of patients, investigators and all others involved with our clinical research, while maintaining the continuity of our business.
Health Canada hygiene measures were enforced on premises. We suspended all corporate travel outside Canada and between our offices. Our IT infrastructure has been revised to support employees working from home. And additionally, we are further maximizing social distancing measures with essential leverage unit network, which remains ongoing.
As it was anticipated that COVID-19 is impacting ongoing clinical trial activity across the industry, we have been working closely with our clinical research organization and with each clinical site to establish a contingency plan that ensures patients are safely provided uninterrupted access to critical care and in a manner that preserves the integrity of our clinical data.
We continue to monitor updated institutional, regional and national guidance to fully comply with applicable guidelines as they are issued. Some clinical sites have paused or slowed enrollment, while other sites that are less impacted are continuing activities as planned.
Looking forward, the overall enrollment rate may decrease, but clinical activities are continuing and patients are encouraged to attend to comply with directives from public health officials, if possible, understand [ph] to attend visit as planned or to discuss alternatives with their physician.
The current activities performed at central labs to assess the eligibility of patients and the management of clinical sample is not impacted. And IMV is working with the vendors to ensure continuity of activities.
Drug supply is not expected to be impacted at this time. As added precaution, IMV is working in a contingency plan to ensure proper provisioning of drugs to all clinical sites in the event of future transportation or other constraints.
Despite these challenging conditions, we continued leveraging the breadth of our DPX technology to produce targeted immunotherapy that can program immune cells in vivo.
We believe DPX’s no-release mechanism offers the potential to produce a new and better class of immunotherapies that elicit a more rapid, robust and sustained immune response alongside an improved safety profile as observed across our clinical studies to date.
Each of our products is comprised of one or more immunologic agents, usually a B or T cell peptide encapsulated in nanoscale lipid particles, providing protection from degradation of the injection and targeted delivery into immune cells over a greatly extended period of time.
Throughout 2019 and into the new year, we have made significant progress in validating this approach, in advancing our clinical pipeline with our lead program, DPX-Survivac, which is targeted T cell immunotherapy harnessing the potential of this unique delivery technology to target survivin. Survivin is a tumor-associated-antigen that is overexpressed in more than 20 solid and hematologic cancers.
To date, our clinical work has centered around the growth potential of this program in oncology, where we are testing DPX-Survivac with intermittent low-dose cyclophosphamide, or CPA, used as an immune modulator to increase the level of survivin specific T cells, and also exploring combination with Merck’s Keytruda.
We view the potential of DPX-Survivac as a major value driver for IMV and believe its unique mechanism of action offers a differentiated and innovative approach for patients confronted with hard-to-treat cancers. And this view is supported by the encouraging clinical results presented thus far from our ongoing Phase II studies.
At the American Society for Hematology annual meeting in December, we provided an important clinical update from SPiReL an investigator-sponsored Phase II study of DPX-Survivac and intermittent low-dose CPA in combination with Merck’s Keytruda. This was in patients with persistent or relapsed refractory diffuse large B cell lymphoma.
We showed that seven out of nine, or 78%, of evaluable subjects exhibited clinical benefits, including three out of nine, or 33%, who achieved a complete response, in addition to two partial responses.
These results provided important validation, both that the results we observed in solid tumor extended to survivin expressing hematologic malignancies as well as that Survivac can work well in combination with checkpoint inhibitors, which expands our treatable population.
Moreover, such clinical benefits alongside the favorable safety profile offers meaningful differentiation versus more toxic chemotherapeutic treatments such as CAR-T and other immunotherapeutic approaches in development.
One key differentiating feature is the bridging chemotherapy and required [indiscernible] administered before CAR-T infusions. As a matter of fact, when considering the major differences between both approaches, ours and CAR-T’s, we believe ours is superior in terms of efficacy, safety and ease of care.
The treatment for the study is ongoing and is not expected to be materially impacted by COVID-19 crisis. As of last week, 19 patients were enrolled out of a maximum of 25 targeted in the study. However, considering the current COVID-19 situation and potential delays surrounding future scan, it is possible that our next update will only be in the second half of 2020.
On the heels of this very encouraging result in DLBCL, we also recently reported updated interim data from DeCidE1, our Phase II study in advanced ovarian cancer. The study achieved its primary objectives, showing DPX-Survivac plus intermittent low dose CPA was active, durable and well tolerated in this setting. Notably, this result presented DPX-Survivac as among the first in vivo T cell therapy demonstrating meaningful clinical activity in this extremely hard-to-treat solid tumor indication.
As of the data cut-off, 15 out of 19 evaluable patients, or 79%, demonstrated disease control, including 10 tumor regulations, which equates to 53% of evaluable subjects. 7 out of 19, or 37%, achieved clinical benefit with partial stable responses lasting more than six months. 4 out of 19, or 21%, of subjects reached partial responses on targeted lesions.
Finally, at the time of the data cut-off, 41% of patients remain on therapy, including three patients who achieved stable disease and one with tumor regression of minus 29.2%. This means there is a potential still to see deeper responses and/or additional conversion to partial regression as this data will mature.
The treatment was well tolerated, with the majority of adverse events being grade 1 or 2 reaction at the site of injection.
We view these results quite favorably for a number of reasons. As you know, patients with advanced ovarian cancer are people who are very sick and many have received several lines of prior therapy. Patients in our study were heavily pre-treated, but were nonetheless outlasting their prior lines of therapy. And we know that extending duration, while maintaining quality of life, is really the most important medical need for these patients.
Many advanced stage ovarian cancer patients are not responsive or eligible for high-dose single agent chemotherapy. Chemo is, of course, the standard of care in this indication, but only works in about 12% of patients for short duration and with a significant toxicity profile.
Even though we nearly doubled the response rate, and with potential for that measure to improve over time, like I just mentioned, we believe success in this indication goes beyond the objective response later on. It is about providing a safe and durable alternative to high dose chemo and to improve the quality of life of affected patients.
We believe that these results demonstrate DPX-Survivac potential to improve over the current standard of care across all three of these key measures.
This being said, based on this evaluation, we plan to take these results to the US Food and Drug Administration for a Type B meeting to align on the design of a Phase IIb study with potential to support registration under accelerated approval in this indication.
I will now provide an update on the Phase II basket study where we are evaluating DPX-Survivac with low-dose intermittent CPA used as an immune modulator in combination with Keytruda. And this is across five cohorts of patients with advanced and metastatic solid tumors.
Last fall, at the European Society for Medical Oncology Annual Meeting, we reported preliminary results from the study, which included a number of tumor regressions and partial responses, combined with an excellent toxicity and safety profile, consistent with our observations in DLBCL and advanced ovarian cancer.
With respect to recruitment, considering all cohorts, 19 clinical sites are currently activated and 82 patients are enrolled. Due to impact on the COVID-19 pandemic, we anticipate the pace of future enrollment to slow down. We still intend to provide an update at the end of Q2 at ASCO. For patients who are already enrolled, the trial is ongoing and we are committed to ensuring that they all have access to treatment.
Before turning the call back to Pierre, I want to provide additional color and details around our pipeline in immuno-oncology, including our current initiative on the COVID-19 pandemic.
Although our focus is on oncology, it is also part of our business plan to exploit the other multiple application of our DPX platform with partners. In collaboration with these partners, we have been advancing programs targeting infectious diseases, including our vaccine against respiratory syncytial virus, or RSV, and the vaccines against malaria. And our more recent work on COVID-19.
For COVID-19, we are developing the vaccine in collaboration with Dr. Joanne Langley and Dr. Scott Halperin of the Canadian Immunization Research Network, and this is perfectly in line with our strategy of exploiting the technology outside of oncology.
The CIRN network, the Canadian Immunization Research Network, was created by the Canadian government in 2009 to develop clinical capacity in Canada to evaluate pandemic vaccine in a situation like this.
The network is now representing over 100 investigators across 40 Canadian institutions, involving experts in vaccine-related evaluative research and clinical development. It serves as a primary source of capacity to provide clinical data to inform public health decision-making about immunization program in Canada.
Our clinical results so far have highlighted the unique ability of our platform to elicit sustained immune responses, particularly in sensitive populations such as older adults and those with preexisting conditions such as cancer, and those two population are both the most at risk for COVID-19 and generally also more difficult to achieve adequate immune response following vaccination.
Our decision on COVID-19 was based on clinical data, supporting a strong rationale for DPX-based vaccine candidates against COVID-19, as well as a sense of social responsibility to join the global effort.
So far, we have successfully used sequences of virus and immuno informatics to identify and predict several hundred epitopes on the virus, of which we have now selected 23 for their biological relevance and potential to generate neutralizing antibodies against the virus.
We’ve teamed up with Dr. Gary Kobinger, Director of the Research Centre on Infectious Diseases at the University Laval in Quebec City to perform pre-clinical assays to validate the safety and potency of the best vaccine candidate we will use for initiating the human clinical study.
At the same time, we have now completed the design of the study. It is a 48 healthy volunteer Phase I study which will be conducted at two clinical sites. We also have initiated discussions with Health Canada in preparation for clinical trial application and a meeting is set for on the week of April 20. And we anticipate moving ahead with the clinical study as soon as this summer.
As we recognize that COVID-19 is perhaps the most pressing unmet medical need, we and our partners are working as fast as we can to advance this program through these clinical studies.
Finally, going forward, we and our partners intend to provide regular update on our progress toward initiating this clinical study and this concludes my comments.
I will now turn the conference over to Pierre for a review of our financials. I will return later for some closing remarks before we take your questions. Pierre.
Thank you, Fred. I will start by reminding you that all the numbers I will be discussing are in Canadian dollars. And also, we’ll be referring to figures that relates to the full year only.
The net loss and comprehensive loss was CAD 27.4 million or CAD 0.55 per share for the year ended December 31, 2019, and it was CAD 5.4 million higher than the net loss and comprehensive loss for the year ended December 31, 2018.
R&D expenses increased by CAD 6 million for the year ended December 31, 2019 compared to 2018. These increases are mainly due to expenses related to the ongoing basket trial, the preclinical development of DPX-SurMAGE for bladder cancer and also salaries due to an increase in headcount. The increase is also attributable to manufacturing activities to support increased clinical activity, which included purchasing raw materials and CMO costs.
The G&A expenses increased by CAD 897,000 for the year compared to 2018. The increase is mainly due to salaries as a result of increased headcount, investor relation activities and a full-year of increased insurance premium and regulatory fees following the NASDAQ listing in mid-2018 and also a full year of increased rent, lease, interest accretion and utilities following the move to our new facility in Dartmouth in mid-2018.
As at December 31, 2019, the corporation had approximately CAD 16.6 million of existing and identified potential sources of cash, including cash and cash equivalents of CAD 14.1 million and also amounts receivable and investment tax credit for CAD 2.5 million.
Based on our current forecast and ongoing program, the management believes that its cash resources of CAD 14.1 million and its additional potential cash resources of CAD 2.5 million at the end of 2019 will be sufficient to fund operation at least until the end of the third quarter of 2020.
This estimate does not take into account any utilization of the ATM that we put in place on March 18, 2020 that will allow the corporation to offer its own common share from time to time up to an aggregate amount of US$30 million. As of March 30, 2020, 243,000 shares have been issued under the ATM for a total gross proceed of US$483,000 or approximately CAD 676,000.
And finally, as of March 30, 2020, the number of issued and outstanding common shares was CAD 61 million and we also had a total of 1.9 million stock options and deferred share units that were outstanding.
And please take note that our audited annual consolidated financial statement and the related MD&A are both available on SEDAR and EDGAR.
So, thank you very much for your attention and I will now turn the call back over to Fred for closing comments before the questions.
Thanks, Pierre. As you can see, we have made significant progress validating our platform and late clinical assets this past year. We announced promising translational and clinical data from ongoing studies of DPX-Survivac across multiple indications, which establish its ability to shrink solid and hematologic tumors with long-lasting responses and a highly differentiated safety profile.
This includes particularly meaningful Phase II results in hard-to-treat indications, relapsed refractory DLBCL and advanced ovarian cancer, providing important validation both of our platform’s novel mechanism and survivin relevance as a target antigen in cancer.
We entered into new calibrations, demonstrating the breadth of our proprietary delivery platform with opportunities to further expand our pipeline.
And with the support of leading voices in immunization and infectious diseases, we’ve launched an effort to develop a DPX-based vaccine candidate targeting novel epitopes from COVID-19. We believe this approach offers meaningful potential as a prophylactic vaccine to curb this global crisis.
Despite the ongoing crisis, however, we are really looking ahead of the remainder of 2020 with optimism. In the near term, we remain on track to report updated data from our Phase II studies in ovarian and including updated DLBCL as well as our top line data from our basket study in other solid tumor indications.
As these results emerge, we plan to engage with regulators on the design of potential pivotal trials in support of an accelerated pathway for the DPX-Survivac in advanced ovarian cancer and relapsed refractory DLBCL.
Together with our collaborators, we will work expeditiously to advance DPX-COVID-19 as fast as possible, beginning with a Phase I study launch expected this summer.
And we will pursue plans for pipeline expansion with DPX-SurMAGE advancing towards the clinic. And as we and our partner [indiscernible] DPX technology has additional targets of interest.
As we continue making progress in our quest to deliver improved outcomes for patients, we are grateful for the continued support of all stakeholders, partners, shareholders and employees. We look forward to working closely with them as we continue to deliver on this great opportunity for our 2020 and beyond.
Thank you for your attention. Operator, we are now ready to take questions.
Thank you. [Operator Instructions]. Your first question comes from the line of Tom Shrader with BTIG. Please go ahead.
Hi. This is Kaveri for Tom. Thanks for taking my question. I have a couple. Can you give us a sense on the number of patients for the basket trial that we might see later this year?
Joanne, you want to take one.
So, I think as Fred has said, we have accrued 82 patients as of this point. So, we would assume that this being the end of March, we’ll be able to have at least, let’s say, a couple months of data worth for patients.
That’s helpful. Thanks. And is DPX-SurMAGE Phase I trial for bladder cancer still on track for first half of 2020?
No. It’s a new trial. So, as you’re probably aware, for all clinical trials that are already started, you have ways to manage – continue the enrollment. But starting a new trial, currently, in the US and Canada is not something really possible. So, we cannot provide a precise date since we don’t know how long the crisis will go on. But most likely, we’re going to have to push in order – the start of the trial in the second part of the year.
Got it. Thank you and congrats on the quarter.
Your next question comes from the line of Ted Tenthoff with Piper Sandler. Please go ahead.
Great. Thank you very much. Thanks for the update. I’m glad to hear everyone’s being safe and healthy. And I appreciate the important work that you’re doing. What is the current thinking around ASCO reporting? I know that the conference has been announced. It’ll be virtual. But as a result of that, do you think that less presentations or fewer presentations would be made and what would be alternative sourcing for reporting data? And then, I have one quick follow-up on COVID-19.
Ted, thank you for joining us this morning. Like I said, we’re maintaining guidance on this. We believe that we’ll be able to present in a very different way this year on a virtual basis, but we’ll be able to provide clinical update as we said we would.
Awesome, excellent. I just want to make sure I understood that correctly. And then, when it comes to COVID-19, what are potential funding sources for clinical studies? And have you guys started to pursue some of those?
Thanks very much for the work you’re doing there.
Yes. It was, obviously, for us – given it’s not the focus of the company, but like I said, our business plan is similarly for anything that’s outside of oncology, application outside of oncology for DPX. We’ve always pursued a strategy of partnering and that’s what we have done here. The Canadian Immunization Research Network was created to deal with pandemic crises.
And we actually – in between pandemic crisis, what they do is that they run clinical studies of interest for immunization in Canada. And we already had a collaboration with them. The RSV vaccine, the DPX-RSV vaccine that was tested in Phase I clinical study was done in the CIRN network. And so, for us, it’s really following that same blueprint in the past that we had [indiscernible] where we are partnering from the get-go with the Canadian government, the clinical part of the Canadian government, we should say, for that.
Now, like for any country in the world, I think governments are struggling to put in patient very quickly funding for clinical development for vaccines. And Canada getting organized, they already gave some grants. And we’ve applied to different parts of the government at a provincial level and at the federal level to get some grants also to accelerate the clinical development. And, hopefully, on the basis that the clinical trial is going to be positive, be able to move into a much larger scale and clinical study and supplying the vaccine to Canada.
So, that’s really helpful. Thanks so much, Fred.
Your next question comes from the line of Joe Pantginis with H.C. Wainwright. Please go ahead.
Hey, everyone. Good morning and hope you’re all well, again, in these times. Your updates with regard to your clinical programs and your clinical data have been quite clear. So, I want to focus my question on COVID-19 as well, but more from the scientific rationale. And I guess I would ask it this way. Obviously, a lot of companies, I don’t include you in this category, but a lot of companies have come out of the woodworks and saying we’re going to be developing COVID-19 vaccines and jumping on the proverbial bandwagon. So, I guess, I would look to see, you had some of this in your prepared comments, but looking for more details, why the DPX platform is well suited for this, number one?
And number two, how you could really leverage your prior experience with regard to your RSV platform? Thanks, guys.
Thanks, Joe. I’ll start and certainly will ask Marianne to talk about how we have approached the development of targets for COVID-19.
So, the differentiation that we have, I think there’s two things important for us is, as you know, we have a lot of clinical data in the difficult-to-vaccinate population that is also, at the same time, the most at-risk population for COVID-19. And it’s really a challenge for making vaccine work in the elderly population. It’s been a challenge for flu and a lot of vaccines. So, we believe that any technology that has the potential to address this challenge should definitely be participating in the global effort, and that’s really what we’re doing. We have a very strong demonstration. We’ve made a very strong demonstration with that DPX-RSV in the older adult population. And we are really using it as a blueprint scientifically and clinically to develop COVID-19.
Marianne, if you could talk about our differentiation in terms of targeting epitopes versus using the entire spike protein and the potential risk and the benefits we may have by adding a targeted approach.
Sure. Thanks for the call. And I think I’ll build on what Fred said, is that we really wanted to build on what we did with RSV. And in RSV, we use a 23 amino acid synthetic epitope to direct very targeted immune response to that portion of the virus. And so, we are taking that same approach to COVID where we’re going to give a targeted component that we’ve used immunoinformatics to identify. Once we’ve down-selected those targets, we should be able to very clearly sort of guide the immune response.
And that’s important when we’re still generating information about the virus to be as targeted as possible because you really want to try to avoid some of the negative aspects of the immune response. So, we believe that targeting the immune response very specifically not only allows us to move rapidly, but it allows us to be very focused in what we’re asking the immune response to do.
Got it. Very helpful, guys. Stay well.
Your next question comes from the line of Jay Olson with Oppenheimer. Please go ahead.
Hi. Thanks for taking the questions and congrats on all the progress. Are there any additional details you can provide with regards to your plan to engage with the FDA for your end of Phase II meeting and the design of your registrational trials? And I’m guessing, at this point, those interactions will probably be done virtually and not as a face-to-face meeting. But is there any other color you can provide around that?
Joanne, you want to take this one?
Hi, thanks for the question. Yeah, I think what we’ll be doing is working with our investigators and outlining for ourselves the population that we need to address. I think we’ve already mentioned this to you before about the unmet medical need and where we believe we have an advantage. And so, we’ll take that together, provide that design, have those discussions with FDA and take it from there.
Okay. And any additional details on the timing of those potential interactions?
So, we’ve started them already in terms of our internal discussions and those with the investigators, so that I would anticipate this happening. I think we’re shooting for Q3. However, we also know that, as you’ve already mentioned, some of these meetings are going to be perhaps delayed due to COVID-19 and more likely to be virtual as well. So, we will do our best to keep this on track.
Okay, great. Thanks. And if I could ask one question about the COVID-19 vaccine, can you comment on your manufacturing capacity? Or is that something that would be done with a partner?
Thanks for asking the question because that’s really a significant element of what we’re bringing to the table in the fight against COVID-19. So, our technology is a fully scientific vaccine technology, like mRNA DNA technologies. So, all the advantages that we have that are associated with sensitive vaccine technology, we do have the same. The quantity of – just if I was to give you an example, there are suppliers in the world that can produce 20 kilograms of GMP peptide per week. If we were to use the same dose that we use in that DPX-RSV, which was 25 micrograms, this would represent 800 million doses of vaccines per week. Meaning that, providing that you have all the fill and finish capacity, which is always the limitation factor for production, but it shows that the technology like that could have the capacity to vaccinate billions of people, providing, again, that the fill-and-finish capacity, but it will be there.
But in terms of the production of the vaccine, that is a great advantage that we have in terms of production. I’m not saying that we’re going to do it alone. We’re working with partners and potential pharma partners. It’s something we’re considering down the road. But the technology is fully scalable. We are in Phase II/III in oncology. So, our GMP development stage is quite advanced also.
Great. Thank you for taking the questions.
Your next question comes from the line of Mayank Mamtani with B. Riley. Please go ahead.
Good morning, team. Thanks for taking my question. And again, best wishes for the important work you’re doing. Staying with COVID-19, could you maybe in specific terms talk to the prior data published or not, including in RSV, but also if any other coronaviruses you’ve worked on, SARS or MERS, that gave you this confidence in entering this space?
And a second part to that question, obviously, you have to, I think, work on these preclinical assays that you’re working on. At a high level, could you contrast what you may need to demonstrate there relative to the genetic immunization approaches like the mRNA and DNA? That would be helpful. Thank you.
Thanks. Thanks for the question, Mayank. We have not worked on MERS and SARS, but we’ve worked over the years in a number of infectious diseases including flu, malaria, Ebola, Zika. So, we have a substantial know-how in the company on how to make a successful epitope-based vaccine for infectious disease on top of all the knowledge that we have in cancer. That’s a different disease, but the concept is the same. You’re directing the immune system towards a target. And for oncology, you need reach a very high level of T cells. In the vaccine space, it’s more about neutralizing antibodies that you need to have in the blood to block the entry of the virus in human cells.
I think the world is pretty lucky in some way with COVID-19. I would say that – I’ve been in the vaccine business for a long time. And my view on COVID-19 is that it’s a – I don’t know if easy is the right word, but it’s kind of an easy virus to model, understand, what you have to target to develop a successful vaccine. It’s basically the spike protein on the outside. There was a number of neutralizing antibodies that have been described for MERS and SARS. Even though COVID-19 is a bit different, the biology is still the same. So, I think this is not the challenge. I think one of the challenge will be to make it work in the target population. This will probably require adjuvants for conventional vaccines and all that.
Another challenge will be the duration of the protection. We don’t know how long the duration is going to be and there are some expectation in the field that it could be short lived, which will be a problem to deal with the economic impact of COVID-19. And so, I believe that the approach we’re taking is really offering something unique versus the other approaches, in that we do have the experience and the know-how to it.
The second part of your question, sorry, I missed. I don’t remember if there was something else.
Yeah, the animal model.
The animal model.
Yeah. So, I believe we’re going to be doing more than some of the – what has been done with the early mRNA DNA vaccines both on potency and safety. And it’s really a decision that we’ve made to do that. So, what we want to see is, first of all, strong immunogenicity because, again, if you are going into the target population, you need to start with very strong immunogenicity to make it work in the elderly population. But more importantly, as we are developing a targeted approach, like Marianne was explaining, we really want to select the best neutralizing antibodies. So, the two things we’re going to be doing is basically immunogenicity and then neutralization assays to prove that the antibodies that we are – the epitopes that we are targeting are generating antibodies that are neutralizing the virus. So, those are the two validation points that will make us select the best epitopes. And as part of this, there’s going to be also a more traditional toxicity study before starting the Phase I study.
Great. And then, on DLBCL, very quickly, obviously, the data at ASH looked pretty good impressive relative to the more cumbersome approaches like CAR-Ts. But could you maybe talk to the response since then and particularly on enrollment? And is there a way you could maybe characterize – because it seems like the enrollment has remained the same since then. So, any color on what, again, in this current environment you could do to sort of enhance that?
Well, there were two additional patients enrolled actually from the last date, but I will repeat what we had said at that time when the data was released. It’s an investigator-sponsored trial. So, it’s not a trial that’s run by IMV. And the trial has a very simple primary objective. That is to evaluate the activity, the clinical activity, of the combination between our treatment regimen based on T cell therapy and Merck’s Keytruda.
And the simple answer the trial is trying to provide is, given Keytruda doesn’t have much activity in this indication, are we improving the level of activity of Keytruda and are we seeing a level of activity that is high enough to justify moving into a larger trial, and Japanese sponsored in this case, obviously.
And what we said in December is that we were very close to be able to make that conclusion. There was a setting in the investigator trial that was the number of responses that had to be reached to be able to make that conclusion. And we are very, very close to that. So, we remain confident that, even with some delays due to the COVID-19 pandemic, we should be able to get to know the conclusion of this trial on the primary objective. And then, like Joanne was talking about, for ovarian cancer, in the same way, request a meeting with FDA for a Phase IIb that fully would be able to support approval under an accelerated approval.
Great. Thanks for taking my questions. And be well and stay healthy, team.
Your next question comes from the line of David Novak with Raymond James. Please go ahead.
Hey. This is Archit on for David. Thanks for taking my question. I just have a quick one. On the funding for COVID-19, could you provide some additional color around how much capital you plan to allocate to this program? And perhaps what proportion of that do you expect to be funded by grants or other non-dilutive sources?
Pierre, you want to take this one? Okay, I’ll take it.
So, like I said earlier, our plan is to fund the vast majority of this project, and especially, everything that’s related to the clinical study and manufacturing through grants from different sources. The amount that the company is going to be spending is really not material. It’s very low. We’re always doing some work in the research part of the company on new targets. We are doing work on new targets for oncology, sometimes new targets for infectious diseases. For us, the work on COVID-19 is part of the ongoing recurrent work that R&D is doing with just – instead of working on an oncology target, we’re working on COVID-19. But that’s just for the preliminary work. And all the rest, our intention is to get it funded from grants.
Yeah, that’s helpful. Thanks very much.
And your last question comes from the line of Jim with Wells Fargo. Please go ahead.
Hi, guys. Thanks for taking the question. And like others, thanks for all the important work you’re doing. So, just maybe first on DPX-Survivac and into ASCO and the basket study, which cohorts should we focus on the most? I’m assuming ovarian, but what other cohorts? And could you remind me of what the target response rates are across the five different cohorts?
Joanne, can you do this one?
Yeah, sure. So, in terms of the targets, what we looked at was the past experience with pembro in each of the different indications. So, those were the targets that we were looking at, and to improve upon that. I think Fred has outlined that in the past about how we set up that trial with those sorts of indications where we might expect to see more response with pembro versus those that we didn’t.
So, in terms of the update, we were thinking that what we would be doing is separating out the different cohorts, so that we could look at those that perhaps have accrued a little bit faster. And so, that’s the way it will play out, is through the cohorts that has accrued faster, such that we can give some more significant updates at ASCO.
Great. And then, maybe on COVID-19 effort, could you maybe talk about any discussions that you might have beyond Health Canada? Do you plan to have discussions with other regulators or would this be a development program primarily focused on Canada?
Thanks for the question, Jim. We do have a presence in the US as well. We have two employees and we have a contract manufacturing organization based in the US. So, we can also be a potential relevant player in the US. You can fully understand that, when governments are looking at pandemic planning and vaccine supply, the presence of manufacturing capacity within the borders of the country is something absolutely key and important in any consideration. So, for us, the way we are seeing it is that there are really two countries where we could be a player. There is Canada and there is the US. And we’ve also had some interaction with BARDA in the US. It’s just at the beginning. So, I cannot really provide guidance how well this might go, but we do have submitted preliminary documents to BARDA for consideration.
And then, maybe just one final question and how this might differentiate from other approaches, but you have highlighted the validation of the DPX platform in generating immune responses in more compromised patients. Most vaccine trials focus on younger healthy volunteers. Is there any thought that you can include older healthy volunteers to show induced immunity in those patients that are harder?
Yeah, yeah. Great question. Thanks. So, we are. We are planning to do a trial in 18 to 64, which has been different from, I think, what is being done in the US and in some other trials. The 50 to 64 is a population that is considered as some type of surrogate for the elderly population. It’s difficult to do your first Phase I study safety, as you can imagine, indirectly into the elderly population and the compromised population. But what has been done in Canada, and the CIRN network has done a lot of studies this way, you can get a sense of what you can expect to see in the elderly population by studying that sub population between 50 to 64 where the immune system is already waning. And so, that’s what we’re going to be doing. We’re going to be looking at that subgroup and see if we can perform as well as we have with DPX-RSV subgroup as surrogates for the elderly.
And just one question, if you’ll allow me. Typically, in vaccine trials, the target is some fold increase in neutralizing antibody titers over base immunity in previously exposed patients. And so, do you expect to get some insights into what that level of neutralizing antibody titer in COVID-19 patients from Health Canada? Or how do you target an appropriate antibody titer in advance of knowing what the kind of base immunity is? And is that the right way to think about it?
Well, definitely. And, Joanne, you can jump in or correct me if I’m wrong. But we’ll definitely use some of the serological assays that are in development to get an understanding of what was the immune setting before getting vaccinated.
The difference that we have, Jim, is we are using a very targeted approach. So, we are targeting specific neutralizing antibodies with specific epitopes. So, it’s not like vaccinating with the entire virus or with the spike protein where you don’t really know what’s going to be immuno dominant epitopes, immuno dominant antibodies, and then you have to try to figure that out from the blood. For us, we exactly know the neutralizing antibodies that we are targeting. So, for us, part of the validation of the vaccine will be to evaluate the label of those neutralizing antibodies that we can generate in the patients and monitor those levels over time because I think duration is going to be a very important factor for this virus.
And finally, validate that those antibodies are functional, design the target and they can neutralize the virus. If you show safety, if you show high level of immunogenicity that’s sustained over time, you show that the antibodies that you are generating with your vaccine are all neutralizing, they’re all functional, I think you’re in a very good position to move into a large Phase II, with some expanded use for target population. And that’s really the goal of Phase I.
That’s great. Thanks for all the detail, Fred.
If there are further questions at this time, I will turn the call back over to the presenters for closing remarks.
I don’t have any closing remarks. Well, thank you very much for taking the time to listen to and the questions this morning.
This concludes today’s conference call. You may now disconnect.