• A JDRF funded grant will be used to explore the combination of NexImmune’s antigen specific nanoparticles and an anti-CD3 mAb for prevention and treatment of type 1 diabetes

NexImmune, Inc. (Nasdaq: NEXI), Yale and JDRF have begun a two-year project to explore the use of NexImmune’s AIM nanoparticles in combination with an anti-CD3 mAb to tolerize, deplete or modulate diabetes antigen-specific T cells. The $600,000 grant, funded by JDRF to Yale, is a part of its Cures research portfolio, which includes therapies for the prevention of type 1 diabetes (T1D).

“We are pleased to partner with visionary institutions such as JDRF and Yale to investigate our technology in combination with a murine surrogate of teplizumab, a T cell-specific mAb candidate,” said Dr. Jack Ragheb, Senior Vice President of Translational Sciences and Medicine at NexImmune. “NexImmune’s technology has the potential to modulate autoimmune diseases through the presentation of disease-specific antigens that send a signal to tolerize or kill autoantigen specific self-reactive CD8+ T cells. Together with teplizumab, we believe this combination has the potential to delay or prevent T1D.”

“Combining teplizumab with a technology that can directly target autoreactive T cells that are known to be a mediator of pancreatic beta cell destruction can potentially be a transformative therapy for patients suffering with autoimmune diabetes. We are excited to work with NexImmune and JDRF to find a way to improve treatments for this life-long and difficult to control disease,” stated Dr. Kevan Herold, Deputy Director of Yale Center for Clinical Investigation, Co-Director of the Yale Diabetes Center, and C.N.H. Long Professor of Immunobiology and of Medicine (Endocrinology) at Yale School of Medicine.

The JDRF award will fund efforts to investigate the use of NexImmune’s AIM nanoparticles in combination with a murine surrogate of teplizumab. Clinically, teplizumab can modulate the pathogenic immune response acutely and will be combined with NexImmune’s therapy, which can target antigen-specific T cells and potentially maintain their non-responsiveness. The investigation will test this hypothesis in a preclinical model by combining anti-CD3 mAb treatment with T1D antigen-specific nanoparticles to modulate residual diabetogenic T cells.

“The identification of combination therapies for T1D is a critical piece of the JDRF strategy for accelerating the advancement of cures. Dr. Herold’s work builds on decades of support by JDRF for the development of teplizumab, and we’re thrilled to continue that partnership and fund this exciting new study aiming to enhance and prolong efficacy by combining teplizumab with NexImmune’s AIM nanoparticle technology,” said Joshua Vieth, JDRF Director, Research.

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’s two lead programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to at least three prior lines of therapy, respectively. NexImmune is also developing new AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology and in disease areas outside of oncology, including autoimmune disorders and infectious disease.

For more information, visit www.neximmune.com.

About JDRF

JDRF’s mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our five international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter (@JDRF), Facebook (@myjdrf), and Instagram (@jdrfhq).

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 planned and ongoing clinical studies for the Company’s product candidates, including NEXI-001 and NEXI-002; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical 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, 2021 filed with the Securities and Exchange Commission (“SEC”) on March 9, 2022, 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:

NexImmune:
Chad Rubin, SVP Corporate Affairs
NexImmune, Inc.
646.319.3261
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