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NexImmune, Inc. (Nasdaq: NEXI) is an emerging biopharmaceutical company focused on advancing a new generation of immunotherapies using its proprietary Artificial Immune Modulation (AIM™) technology platform. Originally developed at Johns Hopkins University, AIM™ technology harnesses the body’s immune system to orchestrate a targeted T cell response against diseases.
The cornerstone of NexImmune’s innovation is the development of artificial antigen-presenting cells (aAPCs). These aAPCs present specific antigens to T cells, which in turn stimulate a highly targeted immune response. This approach can be rapidly customized to direct immune attacks toward various foreign substances or diseased cells within the patient's body. The company is currently working on therapies aimed at treating cancer and other serious immune-mediated conditions.
NexImmune has two key product candidates in clinical trials: NEXI-001, for treating acute myeloid leukemia (AML), and NEXI-002, for multiple myeloma (MM). These candidates leverage the curative potential of the body’s own T cells, engineered to target and destroy specific cancer cells.
Recent Highlights:
Clinical and Preclinical Updates: NexImmune announced significant progress in generating pre-clinical data supporting their multi-antigen-specific T cell-directing products. This includes validation from collaborators at leading institutions, underlining the transformative potential of their AIM technology.
Financial Highlights: The company recently reported select second-quarter 2023 financial results, showcasing a focus on core capabilities while managing operational flexibility through workforce adjustments.
Partnerships: NexImmune extended its research collaboration with Yale University and JDRF. This partnership aims to explore the use of NexImmune’s AIM nanoparticles combined with anti-CD3 mAb for potential type 1 diabetes treatments. The extension includes an additional $300,000 grant provided by JDRF.
In October 2023, NexImmune executed a 1-for-25 reverse stock split, reducing its outstanding shares and addressing compliance with Nasdaq’s minimum bid price requirement. The company remains dedicated to advancing its innovative therapeutic candidates and remains a significant player in the field of immuno-oncology and beyond.
For more information, visit www.neximmune.com.
NexImmune, Inc. (Nasdaq: NEXI), a biotechnology company focused on immunotherapy, has announced that clinical data from its Phase 1/2 dose escalation study of NEXI-001 will be presented at the ASCO 2023 Annual Meeting in Chicago from June 2 to June 6, 2023. The presentation will detail a first-in-human study of NEXI-001, targeting relapsed Acute Myeloid Leukemia (AML) post-allogeneic hematopoietic cell transplantation. Experts from various reputable medical institutions will author the study, reflective of collaborative efforts in advancing cancer treatment through innovative therapies. NexImmune leverages its proprietary AIM™ nanoparticle technology to enhance T-cell responses, aiming to deliver potent and long-lasting immune responses with reduced toxicity.
NexImmune, Inc. (Nasdaq: NEXI) has completed enrollment for its NEXI-001 study in relapsed refractory AML, with full dosing in final safety cohorts. The company reported a net loss of $62.5 million for 2022, with R&D expenses rising to $47.1 million. Cash reserves decreased to $34.6 million by year-end 2022, funding operations into Q4 2023. NexImmune has initiated pre-IND discussions with the FDA for NEXI-003, targeting HPV-related cancers. Executive leadership changes include Jerry Zeldis retiring and Bob Knight stepping down but continuing in advisory roles. The company remains focused on advancing its AIM INJ platform through further collaborations and research.
NexImmune, Inc. (Nasdaq: NEXI) announced promising preclinical findings regarding its AIM ACT CD8 T cells, presented at the 2023 Tandem Meetings. The study indicates that these T cells significantly enhance the efficacy of Bispecific T cell Engager (BiTE) therapy against multiple myeloma, outperforming traditional CD8 T cells. Following BiTE therapy withdrawal, patients with AIM ACT T cells maintained low tumor burdens or remained tumor-free, highlighting their potential for long-term remission. This data suggests that AIM ACT T cells may offer superior immunotherapy options compared to existing treatments, aligning with the company's goal of innovative cancer therapies.
NexImmune, Inc. (Nasdaq: NEXI) announced the publication of an article in Frontiers in Medicine detailing its AIM technology as a novel immunotherapy approach targeting viral diseases. The AIM platform utilizes nanoparticles to expand antigen-specific T cells effectively, showing significant cytotoxic activity against Epstein-Barr virus (EBV), human T-lymphotropic virus type 1 (HTLV-1), and human papillomavirus (HPV). Dr. Mathias Oelke emphasized the platform's potential to address unmet medical needs associated with chronic viral infections. By employing the body’s immune system, NexImmune aims to develop therapies adaptable for clinical evaluation in oncology, autoimmune disorders, and infectious diseases.
NexImmune announced a strategic shift to focus on its AIM Direct Injection (AIM INJ) platform aimed at oncology and autoimmune diseases. This involves reallocating resources to reduce operating costs and extend the cash runway through Q3 2023. The company will pause the NEXI-001 and NEXI-003 trials while exploring external collaborations for clinical development. As of September 30, 2022, NexImmune reported cash reserves of $45.9 million and a Q3 net loss of $14.7 million, with a loss per share of $0.60. The strategic realignment includes a 30% workforce reduction primarily in clinical and administrative roles.
NexImmune, Inc. (NEXI) announced a collaboration with the National Institute of Neurological Disorders and Stroke (NINDS) to explore immune responses related to Epstein-Barr virus (EBV) and Human T-cell Leukemia Virus type 1 (HTLV-1) in immunological diseases. The partnership aims to develop adoptive cell therapies targeting EBV-infected cells in multiple sclerosis and HTLV-1-infected cells in HTLV-1 associated myelopathy. With a focus on immune responses to viral infections, this collaboration enhances NexImmune's endeavor to create novel therapies for various diseases.
NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology firm, announced that CEO Kristi Jones will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 12 at 11:00 am ET. The presentation will be available via webcast on the company’s Investor Relations page, with a replay accessible for 30 days. NexImmune is pioneering a unique immunotherapy approach leveraging its AIM™ nanoparticle technology to promote targeted immune responses. Their lead candidates, NEXI-001, NEXI-002, and NEXI-003, are in Phase 1/2 trials for treating various cancers.
NexImmune Inc. has announced a service agreement with Selexis SA to develop cell lines targeting rare cancers and autoimmune diseases. This collaboration aims to advance two human leukocyte antigens (HLAs) using Selexis' SURE technology, which enhances efficiency in cell line development. The resulting cell lines will aid in manufacturing innovative therapeutic products designed to utilize T cell immunotherapy for patients.
This partnership signifies a continued commitment to improving treatment options for challenging diseases, highlighting NexImmune's long-term strategy in advancing its proprietary AIM injectable nanoparticles.
NexImmune received FDA clearance for its first solid tumor product candidate, NEXI-003, aimed at treating HPV-related cancers. The clinical-stage biotechnology firm plans to start the trial by the end of 2022. In the second quarter of 2022, NexImmune reported a net loss of $15.9 million, up from $12.2 million year-over-year, with R&D expenses rising to $11.8 million. The company is prioritizing resources to its lead candidates, NEXI-001 and NEXI-003, while pausing enrollment for NEXI-002 due to competitive pressures in the myeloma treatment landscape.
NexImmune has received IND clearance for NEXI-003, its first cellular therapy aimed at treating solid tumors in patients with relapsed or refractory HPV-related cancers. This marks a significant milestone for the company, as NEXI-003 utilizes a novel approach by directing T cells against multiple HPV tumor-associated antigens. The Phase 1 clinical trial will evaluate the safety and efficacy of NEXI-003 across various sites in the U.S., aiming to enroll 24 to 36 patients. Successful outcomes may pave the way for expanding its development to other HPV-related malignancies.
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