Full Press Release Details
Presentation Transcript
Lis (Executive Chairman and Chief Executive Officer of Jasper Therapeutics, Inc.):
and thank you for joining today's webcast. My name is Bill Lis, I'm the executive chairman and CEO of Jasper. We are really
pleased today to announce the proposed merger of Jasper Therapeutics and Amplitude Healthcare Acquisition Corporation. We expect the
combined capital raised by PIPE and by Amplitude will be approximately $180 million in cash at the closing of the transaction, this is
assuming no redemptions. We're really excited, this will significantly bolster Jasper's balance sheet and provide an estimated
24 months of cash runway from the time of close through key value creating milestones. These include the potential registration enabling
data for our lead program, and for an IND for our second pipeline program. We expect the merger transaction to close in the third quarter
of 2021, with the combined company operating as Jasper Therapeutics and listed on the Nasdaq under the symbol "JSPR."
is a review of the safe harbor.
slide 3 I highlight the vision for Jasper Therapeutics. The vision is straightforward. It is to become the leading biotech company focused
on hematopoietic stem cell transplant therapies. We have a deep expertise in the science, and we've defined the biology to target
the stem cell and to advance two innovative programs. First is our lead program, which we refer to as JSP191, it's a first-in-class
anti-CD117 monoclonal antibody conditioning agent. We have promising initial safety and efficacy data for JSP191 across multiple indications
in transplant patients, with multiple upcoming data read outs in acute myeloid leukemias and monogenic diseases such as severe combined
immunodeficiency and sickle cell disease, and these are over the next 12 to 18 months. These initial indications serve as the foundation
to expand JSP191 as a potential standard of care conditioning agent across additional allogeneic indications such as autoimmune diseases
and for autologous gene therapy indications. Our second program is a groundbreaking hematopoietic stem cell engineering platform. It's
designed to increase cure rates of donor grafts, it has multiple potential upcoming milestones as well. In addition, we have announced
a number of academic and corporate partnerships specifically for JSP191 that provide further validation of its potential. We expect to
announce additional partnerships in the coming months. We have an experienced management team with a strong track record of success in
both drug discovery and development and through commercialization. And overall, Jasper is well positioned as a leader in field for both
stem cell conditioning and stem cell engineering, these two areas of high unmet need that have seen little innovation over the past few
on the next slide, I'm going to highlight our management team and the scientific advisory board. I can summarize both by stating
that the management team and the scientific advisory board have a really nice combination of world leading experts in the fields of blood
and bone marrow transplantation, and stem cell and gene therapy, and hematologic cancers, as well as success as industry drug developers
and company builders.
to the next slide. Hematopoietic stem cell transplant is known as the most powerful form of disease cure but it's woefully underutilized
due to significant limitations. Our goal at Jasper is to target the two largest areas on unmet medical need in the field. First on the
host, or what we call the patient side, there are significant limitations because the standard of care to prepare a bone marrow for transplant
is genotoxic agents. These conditioning agents are associated with risk of mortality and other major toxicities, including treatment
related cancer, veno-occlusive disease, bacteremia, pulmonary fibrosis and infertility. On the donor or transplant graft side the limitations
are also significant. Current allogeneic and autologous grafts are associated clinical relapse and failed engraftment and in allogeneic
transplants are associated with graft versus host disease and the need for long term immune-suppression.
on slide six I'll review how Jasper's innovative science is focused on the stem cell, and this is because the stem cells
play the central role in hematopoietic cellular therapy cures. I'll review at a high level the mechanism of action of both programs
and why were excited about their potential. First on the host side, or the patient side, the goal is to deplete healthy and diseased
stem cells to make room in the bone marrow for donor cells to engraft and to produce lineage of curative cells. The stem cell
survival signal is through stem cell factor, so by blocking its receptor, CD117 or cKIT, JSP191 turns off the signal, the survival signal,
and depletes healthy and diseased cells creating the space in the bone marrow and enabling engraftment. What's important is that
it does this without toxicity. This is depicted on the left-hand side of the slide. On the right-hand side of the slide we now switch
to the mechanism of action of the engineered stem cell program. Here we are focused on addressing the limitations of the donor graft.
We use the same understanding of the biology for the engineered donor stem cells, which produce the curative cells for both allogeneic
and autologous gene edited hematopoietic stem cell grafts. Here you are simply using the same biology that you did with JSP191 for conditioning,
but now you turn the coin over and instead of turning off the stem cell survival signal, you're turning it on to proliferate curative
cells. We've innovated a way to engineer stem cells transiently with RNA to give them this competitive or proliferative advantage
and they also give all other incoming grafted cells the same competitive advantage over the host or patient cells, again, to increase
engraftment rates and cure rates.
slide seven we review how this looks like from a pipeline standpoint. On the upper part of the slide in red is everything related to
JSP 191. The first three indications are what we call our sponsored indications, and that we'll be running the clinical trials.
That's in AML and MDS, that's in the SCID indication, and upcoming this year, now a pilot study in autoimmune disease. In
addition to the sponsored clinical trials, we have partnerships now, that'll let us expand the indications and the pipeline for
JSP191. They include investigator sponsored trials at Stanford for Fanconi's anemia, include investigator sponsored trial at NIH
for sickle cell disease, and then the corporate partnerships with our gene therapy partners across a number of monogenic diseases. What's
important is that the three partnered indications to date, these are with existing protocols, they come with funding from our partners,
but they allow us to keep 100% of the commercial rights. On the lower part of the slide in blue represents the preclinical work in areas
that we're focused on from a preclinical standpoint, these include the monogenic diseases and autoimmune diseases. As with JSP191
there is an expansive number of indications that we can pursue as this program advances. The one final point I'll make that's
really important on this slide is there is really significant leverage across these two programs that drive what will be two unique and
potential revenue streams. What we're doing is we are leveraging the same underlying biology, the same validated translational
models and the same clinical trials sites and commercial platform for both programs. So everything that we've done with JSP191,
we'll be using that same model to move the engineered stem cell program forward. What's also important is that if we're
successful we'll replace old standard of care transplants agents and then we can expand hematopoietic stem cell transplant far
beyond what's currently done today. Today there's about 20,000 hematopoietic stem cell transplants that are done annually.
If we're successful with JSP191 we can expand that to somewhere greater than 40,000 transplants annually in the G7, and if we're
successful with both JSP191 and the engineered stem cell program, that number could approach 100,000 hematopoietic stem cell transplants,
just within the next decade annually in the G7.
is a highly differentiated, first-in-class, anti-CD117 antibody for transplant conditioning. It has unique properties compared to all
the other antibodies in its class. First, it's only anti-CD117 antibody designed to bind with high affinity to CD117 and block
stem cell factor signaling directly. For this reason it's the only naked antibody that's demonstrated both in vitro and in
vivo stem cell depletion. This is a property that also allows it to sensitize stem cells so that 191 can synergize in combination with
other standard agents, and this allows the increase efficacy. That's with either radiation, other antibodies that target CD47,
or 5 azacytidine. Also, it's the only aglycosylated anti-CD1117 antibody. This removes effector function and mast cell activation.
What this does is it has the potential to give JSP191 a safety advantage related to mast cells and potential for adverse events such
the next few slides I'll review top line data from our ongoing phase 1/2 clinical trials. JSP191 has demonstrated preliminary single
agent conditioning safety and efficacy in the first ongoing Phase 1 trial in patients with severe combined immunodeficiency undergoing
transplant. Severe combined immunodeficiency is a lethal genetic immune disorder. Hematopoietic stem cell transplant is the only proven
cure for these infants, who will die before the age of two without a transplant. The data to date are encouraging and we show the following
on this slide. We've enrolled 12 patients who received a second transplant after a prior failed transplant and two newly diagnosed
infants who received a first transplant. We have seen no treatment related severe adverse events and no myelosuppression has been reported
in any of the subjects. Based on this the FDA allowed an amendment to administer JSP191 on an outpatient basis, and this in of itself
is a major advance for patients. Initial efficacy is shown on the lower part of the slide in what we call one representative patient.
It shows positive reconstitution of the immune system as measured by an increase in both naive T-cells and naive B-cells.
addition, a good representation of JSP191's efficacy is shown here on this slide. This is a comparison of na ve T-cell reconstitution
in the first 6 re-transplant SCID patients conditioned with JSP191 and compared to a matched cohort of historical re-transplant patients
who also did not receive conditioning. Hematopoietic stem cell transplant without conditioning is standard in many institutions because
clinicians will not re-challenge patients undergoing a second transplant with genotoxic agents. So on the left-hand side what you see
is a matched cohort of patients not receiving conditioning and you see none of the patients here had a meaningful increase in measurable
naive T-cell production, and these are patients at least two years after follow up. Whereas on the right-hand side, in the graph, what
this depicts is JSP191, and here we see four of six patients conditioned with JSP191 reached naive T-cell production above a threshold
that we believe represents clinical benefit. These are all patients with at least 2 year follow up. In these patients we have seen an
example of immune reconstitution such as resolution of chronic infection, reduction of supportive therapies or antibody production after
vaccine challenge. Additionally, we continue to collect data on these patients at earlier timepoints and are actively enrolling patients
across the United States.
the next slide we show data from our preliminary Phase 1 study of JSP191 in combination with standard total body irradiation and fludarabine.
This in the first six patients, in patients with myelodysplastic syndrome and acute myeloid leukemia. Of note, these are elderly patients
who are in complete response but have minimal residual disease status at baseline prior to JSP191 conditioning and transplantation. The
data demonstrates that JSP191 conditioning leads to successful engraftment as measured by full donor chimerism of greater than 95% in
five of the six patients transplanted to date. What is impressive is that five of six patients with baseline minimal residual disease
converted to MRD negative status at day 90 after transplant. These data are encouraging as the literature shows that both full donor