NexImmune, Inc. (Nasdaq: NEXI), a biotechnology company developing
a novel approach to immunotherapy designed to orchestrate a
targeted immune response by directing the function of
antigen-specific T cells for liquid and solid malignancies, today
announced results from its Phase 1/2 clinical trial of NEXI-001 in
patients with relapsed/refractory acute myeloid leukemia (AML)
post-allogeneic hemopoietic stem cell transplant (allo-HSCT). In
this clinical trial to date, NEXI-001 is well tolerated with a
favorable safety profile while eliciting an immune response to
target antigens and a clinical effect in some patients. The data
describing two patients from the dose escalation study of NEXI-001
are being presented in a poster session at the American Society of
Clinical Oncology (ASCO) 2023 Annual Meeting in Chicago on Monday,
June 5 at 8 AM in Hall A.
“We are pleased that NEXI-001, our donor derived
multi-antigen-specific T cell product candidate, is demonstrating
evidence of dose response and tolerability in the initial Phase 1
dose escalation portion of this clinical trial,” said Kristi Jones,
NexImmune’s Chief Executive Officer. “We have seen a
clinical response maintained for seven months, which is an
additional update from the data reported in our poster. These data
have established the ability of our AIM nanoparticles to expand
healthy, multi-antigen-specific T cells with anti-tumor activity.
The data also show these T cells persist and maintain their memory
phenotype at the site of tumor. We expect to provide an additional
update on Cohort 3 later this year with more details from the
patients in this study, and plan to apply learnings from this trial
to inform future trials for NexImmune products in cancer.
“We believe that NexImmune’s multi-antigen-specific product
candidates, alone or in combination with other immunotherapies,
offer the potential to benefit patients with challenging cancers
such as AML, for which treatment options with meaningful benefit
and tolerability has remained elusive. The safety profile of our
product candidate to date also presents the potential to
investigate trials in patients with lower burden disease where
significant unmet need remains,” added Ms. Jones.
Study Design
The goals of the NEXI-001 Phase 1 clinical trial are to evaluate
the safety, tolerability, immune response, and clinical activity of
the antigen-specific CD8+ NEXI-001 T cells, as well as to inform
the range of patient characteristics and to determine the
recommended Phase 2 dose. The dose escalation phase of the study
included patients who have relapsed acute myeloid leukemia (AML)
post allo-HSCT and are refractory to salvage therapy. All patients
in the study, except one, relapsed after, or were refractory to,
subsequent salvage therapies (one to three prior therapies). A
majority of patients had three-to-four adverse risk characteristics
linked to poor prognosis in addition to poor prognostic patients
with extramedullary disease.
Three dose-ascending cohorts of patients were enrolled in the
study, with potential doses ranging from a single dose of 50
million NEXI-001 T cells to multiple doses of up to a total of 1.2
billion NEXI-001 T cells. To date, the maximum dose evaluated has
been 600 million NEXI-001 T cells.
The study includes a lymphodepletion chemotherapy (Flu / Cy
30/300) following a baseline bone marrow biopsy. To date, 11
patients have completed the dose-limiting toxicity (DLT) period and
one patient is currently ongoing in the first month of protocol
treatment.
“I am very encouraged by the responses and the tolerability
profile observed in these difficult-to-treat refractory patients,”
said Dr. Monzr M. Al Malki, MD, Associate Professor of Hematology,
Director of BMT and Transplant, City of Hope and an investigator
for NEXI-001. “These patients are frequently fragile and lack
effective and tolerable options. Responses for these patients, if
any, are typically short-lived and there is an urgent need for
better options. As highlighted in the ASCO poster, achieving and
maintaining a durable clinical response in extramedullary disease
is clinically meaningful and supports the potential of NEXI-001 to
provide significant benefit to these patients.”
Key Data Highlights
- Through all dose levels to date, NEXI-001 maintains a favorable
tolerability profile with no grade 3 or greater treatment related
SAEs. Two patients experienced grade 2 CRS which resolved within 24
hours with tocilizumab therapy. No cases of ICANS have occurred as
of May 2023.
- Patients treated with NEXI-001 experienced rapid reconstitution
of both CD8+ and CD4+ T-cell subtypes after lymphodepletion
chemotherapy.
- Clinicians observed persistence of antigen-specific T cells in
both peripheral blood and bone marrow with evidence of clinical
activity including tumor burden reduction, increased chimerism and
improved ECOG scores.
- The antigen-specific T cells maintain less-differentiated
immunophenotypes, including stem-cell-like T cells (Tscm) over time
in both blood and bone marrow. Additionally, a marked increase in
the antigen specificity of CD8+ T cells in the bone marrow resulted
with increasing dose levels.
- Six of 11 patients across all dose levels experienced stable
disease for some period, including a stable clinical response
(MRD+) in one patient and one CR (MRD-) for up to 9 months in
cohort 2 (200 million NEXI-001 T cells, administered once), which
was reported in the ASCO poster. Data continue to support potential
dose response with 600 million total cells infused during Cycle 1
being the maximum dose evaluated as of May 2023. Additional cycles
or dose increases are anticipated to offer benefit in the designed
expansion phase of the study.
- One patient in Cohort 3 with a poor prognostic extramedullary
relapse of AML manifested by pericardial and bilateral pleural
effusions (cytology positive for AML blasts) resulting in symptoms
of moderate to severe dyspnea was enrolled in the highest dosing
cohort (200 million NEXI-001 T cells administered weekly for three
weeks). After one cycle of protocol therapy the patient became
asymptomatic and repeat PET/CT scans document that the effusions
regressed to minimal volumes. This extramedullary clinical response
has been maintained for up to 7 months and is updated from the 3
months described in the ASCO poster.
- These data indicating both immunologic and clinical dose
responses and observed durability in the patient at the higher dose
support further clinical study of NEXI-001.
Poster Presentation:
Title: An Analysis of a First-In-Human Study of
NEXI-001 Donor-Derived Antigen-Specific CD8+ T-Cell Treatment of
Relapsed AML after Allogeneic Hematopoietic Cell Transplantation
(HCT)
Abstract #: 7043 (Poster Board #173)
Session Title: Hematologic Malignancies –
Leukemia, Myelodysplastic Syndromes, and Allotransplant
Authors: Monzr M. Al Malki, MD1, Juan C. Varela
MD, PhD2, Sumithira Vasu, MBBS3, Dipenkumar Modi, MD4, Suzanne
Afonso-Smith, PhD5, Sojung Kim, PhD5, Emily Lu, PhD5, Robert D.
Knight, MD5, and Mathias Oelke, PhD5
(1)Hematology/Hematopoietic Cell Transplant, City of Hope
National Medical Center, Duarte, CA, (2)Advent Health Blood and
Marrow Transplant Program, Orlando, FL, (3)Division of Hematology,
Department of Internal Medicine, The Ohio State University,
Columbus Ohio, (4)Division of Oncology, Karmanos Cancer
Center/Wayne State University, Detroit, MI, (5)NexImmune, Inc.,
Gaithersburg, MD
About NexImmune
NexImmune is a clinical-stage biotechnology
company developing a novel approach to immunotherapy designed to
employ the body’s own T cells to generate a specific, potent, and
durable immune response. The backbone of NexImmune’s approach is a
proprietary Artificial Immune Modulation (AIM™) nanoparticle
technology platform. The AIM technology enables NexImmune to
construct nanoparticles that function as synthetic dendritic cells
capable of directing a specific T cell-mediated immune response.
AIM constructed nanoparticles employ natural biology to engage,
activate and expand endogenous T cells in ways that combine
anti-tumor attributes of antigen-specific precision, potency and
long-term persistence with reduced potential for off-target
toxicities. NexImmune is focused on developing injectable AIM
nanoparticle constructs and modalities for potential clinical
evaluation in oncology, autoimmune disorders and infectious
diseases.
For more information, visit www.neximmune.com.
Forward Looking Statements
This press release may contain “forward-looking”
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 that are based on the beliefs and assumptions
and on information currently available to management of NexImmune,
Inc. (the “Company”). All statements other than statements of
historical fact contained in this press release are forward-looking
statements, including statements concerning our clinical trials for
the Company’s product candidates, including NEXI-001; the
initiation, enrollment, timing, progress, release of data from and
results of those and other planned clinical trials and preclinical
studies; and the utility of prior preclinical and clinical data in
determining future clinical results. In some cases, you can
identify forward-looking statements by terminology such as “may,”
“will,” “should,” “expects,” “plans,” “anticipates,” “believes,”
“estimates,” “predicts,” “potential” or “continue” or the negative
of these terms or other comparable terminology. Forward-looking
statements involve known and unknown risks, uncertainties and other
factors that may cause the Company’s actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements. These risks and uncertainties include,
but are not limited to, the risks and uncertainties set forth in
the “Risk Factors” section of our Annual Report on Form 10-K for
the year ended December 31, 2022 filed with the Securities and
Exchange Commission (“SEC”) on March 28, 2023, and subsequent
reports that we file with the SEC. Forward-looking statements
represent the Company’s beliefs and assumptions only as of the date
of this press release. Although the Company believes that the
expectations reflected in the forward-looking statements are
reasonable, it cannot guarantee future results, levels of activity,
performance or achievements. Except as required by law, the Company
assumes no obligation to publicly update any forward-looking
statements for any reason after the date of this press release to
conform any of the forward-looking statements to actual results or
to changes in its expectations.
Contacts
Investors and Media:
Chad Rubin, SVP Corporate Affairs and Investor
RelationsNexImmune, Inc.crubin@neximmune.com
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