Paraparesis, Tropical Spastic

Approval is based on the Phase 3 MAGNITUDE study, a prospectively designed precision medicine study including the largest population of BRCA-positive patients in combination trials to date with metastatic castration-resistant prostate cancer (mCRPC) AKEEGA ™ plus prednisone significantly improved radiographic progression-free survival compared to abiraterone acetate plus prednisone (AAP) in patients with BRCA-positive mCRPC HORSHAM, Pa., Aug. 11, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food & Drug Administration (FDA) has approved AKEEGA ™ (niraparib and abiraterone acetate), the first-and-only dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive mCRPC, as detected by an FDA-approved test.1 "As a physician, identifying patients with a worse prognosis is a priority, especially those whose cancers have a BRCA mutation," said Kim Chi, M.D.*, Medical Oncologist at BC Cancer – Vancouver and principal investigator of the Phase 3 MAGNITUDE study. "We prospectively designed the MAGNITUDE study to identify the subset of patients most likely to benefit from targeted treatment with AKEEGA and to help us understand how we can potentially achieve better health outcomes for patients." Prostate cancer is one of the most common cancers in the U.S., with an estimated 288,300 new cases and nearly 35,000 deaths expected in 2023.2 Approximately 10 to 15 percent of patients with mCRPC have BRCA gene alterations. Patients with BRCA-positive mCRPC are more likely to have aggressive disease and may experience poor outcomes and a shorter survival time.3,4,5,6,7 "The approval of AKEEGA brings an important treatment option to patients with prostate cancer as they consider their road ahead, and it also highlights the importance of genetic testing and precision medicine for this disease," said Shelby Moneer, MS, CHES**, Vice President of Patient Programs and Education, ZERO Prostate Cancer. "All individuals diagnosed with prostate cancer should consider genetic testing, especially those from racial and ethnic minority groups who tend to have worse cancer outcomes. This is imperative to close the racial and ethnic disparities in prostate cancer health outcomes." The FDA approval is based on positive results from the randomized, double-blind, placebo-controlled multi-center Phase 3 MAGNITUDE study. In BRCA-positive patients treated with the combination AKEEGA ™ plus prednisone, a statistically significant 47 percent risk reduction was observed for radiographic progression-free survival (rPFS) (Hazard ratio [HR], 0.53; p=0.001). At the second interim analysis (IA2), with median follow-up at 24.8 months in the BRCA-positive subgroup, rPFS by central review demonstrated a consistent trend favoring AKEEGA ™ plus prednisone, with a median rPFS of 19.5 months compared with 10.9 months for placebo and AAP (HR, 0.55 [95 percent confidence interval (CI), 0.39-0.78]). Additionally, there was an observed improvement in the secondary endpoints of time to symptomatic progression (TSP) (HR, 0.54 [95 percent CI, 0.35-0.85]) and time to initiation of cytotoxic chemotherapy (TCC) (HR, 0.56 [95 percent CI, 0.35-0.90]) for AKEEGA ™ plus prednisone compared with AAP alone, supported by a trend towards improvement in overall survival (OS) (HR, 0.88 [95 percent CI, 0.58-1.34]). The observed safety profile of the combination of AKEEGA ™ plus prednisone was consistent with the known safety profile of each FDA-approved monotherapy. Of the patients in the MAGNITUDE study with a BRCA gene alteration, 41 percent who received AKEEGA ™ experienced a serious adverse event (AE). The most common AEs occurring in 20 percent or more of patients who received AKEEGA ™ plus prednisone versus patients who received placebo and AAP were musculoskeletal pain (44 percent vs. 42 percent, respectively), fatigue (43 percent vs. 30 percent), constipation (34 percent vs. 20 percent), hypertension (33 percent vs. 27 percent) and nausea (33 percent vs. 21 percent). Permanent discontinuation of any component of AKEEGA ™ due to an adverse reaction occurred in 15 percent of patients. "Janssen's legacy of advancing the science of prostate cancer has contributed to the evolution of transformational treatment approaches for more than a decade," said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. "This milestone, which marks the approval of Janssen's third prostate cancer treatment, highlights the importance of advancing precision medicine approaches and genetic testing for the treatment of patients with BRCA-positive mCRPC." About AKEEGA ™ AKEEGA ™ (niraparib and abiraterone acetate) is the first-and-only orally administered, once daily dual action tablet (DAT) of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, an androgen biosynthesis inhibitor. The novel DAT combination therapy targets two oncogenic drivers in patients with mCRPC and HRR gene alterations. AKEEGA ™ is indicated with prednisone for the treatment of adults with mCRPC and BRCA-positive mutations. The recommended starting dose is 200 mg niraparib/1,000 mg abiraterone acetate (two tablets). The 100 mg niraparib/1,000 mg abiraterone acetate dose option (two tablets) is available for dose reduction. In April 2016, Janssen Biotech, Inc. entered a worldwide (except Japan) collaboration and license agreement with TESARO, Inc. (acquired by GlaxoSmithKline [GSK] in 2019) for exclusive rights to niraparib in prostate cancer. About Metastatic Castration-Resistant Prostate Cancer Metastatic castration-resistant prostate cancer characterizes cancer that no longer responds to androgen deprivation therapy and has spread to other parts of the body. The most common metastatic sites are bones, followed by lungs and liver. Prostate cancer is the second most common cancer in men worldwide, behind lung cancer. More than one million patients around the world are diagnosed with prostate cancer each year. Patients with mCRPC and HRR gene alterations, of which BRCA mutations are the most common, are more likely to have aggressive disease, poor outcomes and a shorter survival time.2,3,4,5 About MAGNITUDE MAGNITUDE (NCT03748641) is a Phase 3, randomized, double-blind, placebo-controlled, multi-center clinical study evaluating the safety and efficacy of the combination of AKEEGA ™ plus prednisone for patients with mCRPC, with or without certain HRR gene alterations, and who have not received prior therapy for mCRPC except for up to four months of AAP. The study included patients with (HRR biomarker [BM] positive; ATM, BRCA1, BRCA2, BRIP1, CDK12, CHEK2, FANCA, HDAC2, PALB2) and without specified gene alterations (HRR BM negative), who were randomized 1:1 to receive niraparib 200 mg once daily plus AAP or placebo plus AAP.8 A total of 423 patients with HRR gene alterations were enrolled, 225 (53.2 percent) of whom had BRCA mutations.9,10,11 The primary endpoint of the MAGNITUDE trial was rPFS assessed by blinded independent central review.12 Secondary endpoints included TCC, TSP and OS. Analysis of the group of patients with BRCA alterations was alpha controlled for rPFS and prespecified for other endpoints. Access to AKEEGA ™ (niraparib and abiraterone acetate) Once a patient and their doctor have decided that AKEEGA™ is right for the patient, Janssen can help find the resources patients may need to get started and stay on therapy. Janssen offers support navigating the payer processes to assist patients in gaining access to AKEEGA™. We can provide information on insurance coverage and potential out-of-pocket costs and identify options that may help make AKEEGA™ more affordable. If patients have commercial or private health insurance and need help paying for AKEEGA™, the Janssen CarePath Savings Program may be able to help. To learn more about access and affordability support visit JanssenCarePath.com or call 1-877-CarePath (1-877-227-3728). We also offer personalized support for patients that provides one-on-one guidance, information, and educational resources, which includes helping them explore cost support options. Patients can get connected to dedicated support from our Care Navigators by calling Janssen Compass® directly at 844-628-1234 or by visiting JanssenCompass.com and requesting an introductory call. Janssen Compass® is limited to education for patients about their Janssen therapy, its administration, and/or their disease. It is intended to supplement a patient's understanding of their therapy and is not intended to provide medical advice, replace a treatment plan from the patient's doctor or nurse, provide case management services, or serve as a reason to prescribe a Janssen medication. IMPORTANT SAFETY INFORMATION FOR AKEEGA ™ WARNINGS AND PRECAUTIONS The safety population described in the WARNINGS and PRECAUTIONS reflect exposure to AKEEGA™ in combination with prednisone in BRCAm patients in Cohort 1 (N=113) of MAGNITUDE. Myelodysplastic Syndrome/Acute Myeloid Leukemia AKEEGA™ may cause myelodysplastic syndrome/acute myeloid leukemia (MDS/AML). MDS/AML, including cases with fatal outcome, has been observed in patients treated with niraparib, a component of AKEEGA™. All patients treated with niraparib who developed secondary MDS/cancer-therapy-related AML had received previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy. For suspected MDS/AML or prolonged hematological toxicities, refer the patient to a hematologist for further evaluation. Discontinue AKEEGA™ if MDS/AML is confirmed. Myelosuppression AKEEGA™ may cause myelosuppression (anemia, thrombocytopenia, or neutropenia). In MAGNITUDE Cohort 1, Grade 3-4 anemia, thrombocytopenia, and neutropenia were reported, respectively in 28%, 8%, and 7% of patients receiving AKEEGA™. Overall, 27% of patients required a red blood cell transfusion, including 11% who required multiple transfusions. Discontinuation due to anemia occurred in 3% of patients. Monitor complete blood counts weekly during the first month of AKEEGA™ treatment, every two weeks for the next two months, monthly for the remainder of the first year and then every other month, and as clinically indicated. Do not start AKEEGA™ until patients have adequately recovered from hematologic toxicity caused by previous therapy. If hematologic toxicities do not resolve within 28 days following interruption, discontinue AKEEGA™ and refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions AKEEGA™ may cause hypokalemia and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Clinical Pharmacology (12.1)]. In post-marketing experience, QT prolongation and Torsades de Pointes have been observed in patients who develop hypokalemia while taking abiraterone acetate, a component of AKEEGA™. Hypertension and hypertensive crisis have also been reported in patients treated with niraparib, a component of AKEEGA™. In MAGNITUDE Cohort 1, which used prednisone 10 mg daily in combination with AKEEGA™, Grades 3-4 hypokalemia was detected in 2.7% of patients on the AKEEGA™ arm and Grades 3-4 hypertension were observed in 14% of patients on the AKEEGA™ arm. The safety of AKEEGA™ in patients with New York Heart Association (NYHA) Class II to IV heart failure has not been established because these patients were excluded from MAGNITUDE. Monitor patients for hypertension, hypokalemia, and fluid retention at least weekly for the first two months, then once a month. Closely monitor patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia, or fluid retention, such as those with heart failure, recent myocardial infarction, cardiovascular disease, or ventricular arrhythmia. Control hypertension and correct hypokalemia before and during treatment with AKEEGA™. Discontinue AKEEGA™ in patients who develop hypertensive crisis or other severe cardiovascular adverse reactions. Hepatotoxicity AKEEGA™ may cause hepatotoxicity. Hepatotoxicity in patients receiving abiraterone acetate, a component of AKEEGA™, has been reported in clinical trials. In post-marketing experience, there have been abiraterone acetate-associated severe hepatic toxicity, including fulminant hepatitis, acute liver failure, and deaths. In MAGNITUDE Cohort 1, Grade 3-4 ALT or AST increases (at least 5 x ULN) were reported in 1.8% of patients. The safety of AKEEGA™ in patients with moderate or severe hepatic impairment has not been established as these patients were excluded from MAGNITUDE. Measure serum transaminases (ALT and AST) and bilirubin levels prior to starting treatment with AKEEGA™, every two weeks for the first three months of treatment and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient's baseline should prompt more frequent monitoring and may require dosage modifications. Permanently discontinue AKEEGA™ for patients who develop a concurrent elevation of ALT greater than 3 x ULN and total bilirubin greater than 2 x ULN in the absence of biliary obstruction or other causes responsible for the concurrent elevation, or in patients who develop ALT or AST ≥20 x ULN at any time after receiving AKEEGA™. Adrenocortical Insufficiency AKEEGA™ may cause adrenal insufficiency. Adrenocortical insufficiency has been reported in clinical trials in patients receiving abiraterone acetate, a component of AKEEGA™, in combination with prednisone, following interruption of daily steroids and/or with concurrent infection or stress. Monitor patients for symptoms and signs of adrenocortical insufficiency, particularly if patients are withdrawn from prednisone, have prednisone dose reductions, or experience unusual stress. Symptoms and signs of adrenocortical insufficiency may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with abiraterone acetate. If clinically indicated, perform appropriate tests to confirm the diagnosis of adrenocortical insufficiency. Increased doses of corticosteroids may be indicated before, during, and after stressful situations. Hypoglycemia AKEEGA™ may cause hypoglycemia in patients being treated with other medications for diabetes. Severe hypoglycemia has been reported when abiraterone acetate, a component of AKEEGA™, was administered to patients receiving medications containing thiazolidinediones (including pioglitazone) or repaglinide. Monitor blood glucose in patients with diabetes during and after discontinuation of treatment with AKEEGA™. Assess if antidiabetic drug dosage needs to be adjusted to minimize the risk of hypoglycemia. Increased Fractures and Mortality in Combination with Radium 223 Dichloride AKEEGA™ with prednisone is not recommended for use in combination with Ra-223 dichloride outside of clinical trials. The clinical efficacy and safety of concurrent initiation of abiraterone acetate plus prednisone/prednisolone and radium Ra 223 dichloride was assessed in a randomized, placebo-controlled multicenter study (ERA-223 trial) in 806 patients with asymptomatic or mildly symptomatic castration-resistant prostate cancer with bone metastases. The study was unblinded early based on an Independent Data Monitoring Committee recommendation. At the primary analysis, increased incidences of fractures (29% vs 11%) and deaths (39% vs 36%) have been observed in patients who received abiraterone acetate plus prednisone/prednisolone in combination with radium Ra 223 dichloride compared to patients who received placebo in combination with abiraterone acetate plus prednisone. It is recommended that subsequent treatment with Ra-223 not be initiated for at least five days after the last administration of AKEEGA™, in combination with prednisone. Posterior Reversible Encephalopathy Syndrome AKEEGA™ may cause Posterior Reversible Encephalopathy Syndrome (PRES). PRES has been observed in patients treated with niraparib as a single agent at higher than the recommended dose of niraparib included in AKEEGA™. Monitor all patients treated with AKEEGA™ for signs and symptoms of PRES. If PRES is suspected, promptly discontinue AKEEGA™ and administer appropriate treatment. The safety of reinitiating AKEEGA™ in patients previously experiencing PRES is not known. Embryo-Fetal Toxicity The safety and efficacy of AKEEGA™ have not been established in females. Based on animal reproductive studies and mechanism of action, AKEEGA™ can cause fetal harm and loss of pregnancy when administered to a pregnant female. Niraparib has the potential to cause teratogenicity and/or embryo-fetal death since niraparib is genotoxic and targets actively dividing cells in animals and patients (e.g., bone marrow). In animal reproduction studies, oral administration of abiraterone acetate to pregnant rats during organogenesis caused adverse developmental effects at maternal exposures approximately ≥ 0.03 times the human exposure (AUC) at the recommended dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose of AKEEGA™. Females who are or may become pregnant should handle AKEEGA™ with protection, e.g., gloves. Based on animal studies, AKEEGA™ may impair fertility in males of reproductive potential. ADVERSE REACTIONS The safety of AKEEGA™ in patients with BRCAm mCRPC was evaluated in Cohort 1 of MAGNITUDE. The most common adverse reactions (≥10%), including laboratory abnormalities, are decreased hemoglobin, decreased lymphocytes, decreased white blood cells, musculoskeletal pain, fatigue, decreased platelets, increased alkaline phosphatase, constipation, hypertension, nausea, decreased neutrophils, increased creatinine, increased potassium, decreased potassium, increased AST, increased ALT, edema, dyspnea, decreased appetite, vomiting, dizziness, COVID-19, headache, abdominal pain, hemorrhage, urinary tract infection, cough, insomnia, increased bilirubin, weight decreased, arrhythmia, fall, and pyrexia. Serious adverse reactions reported in >2% of patients included COVID-19 (7%), anemia (4.4%), pneumonia (3.5%), and hemorrhage (3.5%). Fatal adverse reactions occurred in 9% of patients who received AKEEGA™, including COVID-19 (5%), cardiopulmonary arrest (1%), dyspnea (1%), pneumonia (1%), and septic shock (1%). DRUG INTERACTIONS Effect of Other Drugs on AKEEGA™ Avoid coadministration with strong CYP3A4 inducers. Abiraterone is a substrate of CYP3A4. Strong CYP3A4 inducers may decrease abiraterone concentrations, which may reduce the effectiveness of abiraterone. Effects of AKEEGA™ on Other Drugs Avoid coadministration unless otherwise recommended in the Prescribing Information for CYP2D6 substrates for which minimal changes in concentration may lead to serious toxicities. If alternative treatments cannot be used, consider a dose reduction of the concomitant CYP2D6 substrate drug. Abiraterone is a CYP2D6 moderate inhibitor. AKEEGA™ increases the concentration of CYP2D6 substrates, which may increase the risk of adverse reactions related to these substrates. Monitor patients for signs of toxicity related to a CYP2C8 substrate for which a minimal change in plasma concentration may lead to serious or life-threatening adverse reactions. Abiraterone is a CYP2C8 inhibitor. AKEEGA™ increases the concentration of CYP2C8 substrates, which may increase the risk of adverse reactions related to these substrates. Please see the full Prescribing Information for AKEEGA ™. *Dr. Chi has been a paid consultant to Janssen; Dr. Chi has not been paid for any media work. **Ms. Moneer has not been paid for any media work. About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension. Learn more at . Follow us at @JanssenGlobal and @JanssenUS. Janssen Biotech, Inc. and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of AKEEGA ™. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC; Janssen Biotech, Inc., and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc., the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. 1 AKEEGA Prescribing Information. Horsham, PA: Janssen Biotech, Inc. 2 American Cancer Society. Cancer Facts & Figures 2023. Accessed May 11, 2023. 3 Scott RJ, Mehta A, Macedo GS, Borisov PS, Kanesvaran R, El Metnawy W. Genetic testing for homologous recombination repair (HRR) in metastatic castration-resistant prostate cancer (mCRPC): challenges and solutions. Oncotarget. 2021 Aug 3;12(16):1600-1614. doi: 10.18632/oncotarget.28015. PMID: 34381565; PMCID: PMC8351605. Available at: 4 Castro E, Romero-Laorden N, Del Pozo A, et al. PROREPAIR-B: A prospective cohort study of the impact of germline DNA repair mutations on the outcomes of patients with metastatic castration-resistant prostate cancer. J Clin Oncol. 2019;37(6):490-503. doi:10.1200/JCO.18.00358. 5 Cavanagh, H., & Rogers, K. M. (2015). The role of BRCA1 and BRCA2 mutations in prostate, pancreatic and stomach cancers. Hereditary cancer in clinical practice, 13(1), 16. 6 Messina, C., Cattrini, C., Soldato, D., et al (2020). BRCA mutations in prostate cancer: Prognostic and predictive Implications. J Oncol., 2020, 4986365. 7 Na, R., Zheng, S. L., Han, M., et al (2017). Germline mutations in ATM and BRCA1/2 distinguish risk for lethal and indolent prostate cancer and are associated with early age at death. European Urology, 71(5), 740–747. 8 Chi et al. Phase 3 MAGNITUDE study: First results of niraparib (NIRA) with abiraterone acetate and prednisone (AAP) as first-line therapy in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) with and without homologous recombination repair (HRR) gene alterations. Oral presentation, 2022 ASCO GU Annual Meeting. 9 AKEEGA ™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc. 10 Efstathiou E, et al. Niraparib With Abiraterone Acetate and Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer and Homologous Recombination Repair Gene Alterations: Second Interim Analysis of MAGNITUDE. Poster presentation, 2023 ASCO GU Annual Meeting. February 16, 2023. 11 AKEEGA ™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc. 12 AKEEGA ™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc. Media Contacts: Ania DiAntonio +1 215-620-9717 Suzanne Frost +1 416-317-0304 Investor Relations: Raychel Kruper [email protected] U.S. Medical Inquiries: +1 800-526-7736 SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson

NEXI-001 data presented at ASCO 2023 demonstrates proof-of-concept in patients with relapsed AML after allogeneic hematopoietic cell transplantation (HCT) and refractory to additional chemotherapy or salvage treatments; one patient continues to show no evidence of disease at nine months Preclinical data demonstrates superior potency and durability when combining T cell engager (TCE) bispecific agents with AIM-expanded multi-tumor-antigen-specific T cell at low doses NIH collaboration demonstrates AIM antigen-target functional validation capability and the potential of CD8+ T cell therapies as future treatments for EBV-related non-malignant diseases, such as multiple sclerosis (MS) and systemic lupus erythematosus (SLE) The oncology and autoimmune injectable nanoparticles demonstrate the ability to activate and expand or reduce and suppress targeted antigen specific T cells in vivo GAITHERSBURG, Md., Aug. 10, 2023 (GLOBE NEWSWIRE) -- 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 in oncology, autoimmune and infectious diseases, today reported financial results for the second quarter of 2023. “Our previously announced strategic prioritization of our injectable modality (AIM INJ) underscores our commitment to delivering on the significant potential of our artificial antigen-presenting cell (aAPC) nanoparticles to drive antigen-specific T cell function beyond cell therapy approaches and oncology. In our clinical trials with our adoptive cell therapy, we have demonstrated the ability to expand AML tumor-specific T cells with combined memory and effector functions and have observed clinical responses. Furthermore, our collaborations have generated preclinical data that highlights the potential to drive response in solid tumor indications, as well as non-malignant immunology diseases such as MS and SLE,” said Kristi Jones, NexImmune’s CEO. “Our cells exhibit potential superior potency and durability in preclinical models, combining a low dose of AIM multi-tumor expanded T cells with low doses of T-cell engaging bispecific agents, and showing synergistic tumor killing. We believe that these data support the importance of combining a “fit” multi-tumor specific T cell approach with other T cell immuno-oncology mechanisms and represent a unique opportunity to transform treatment paradigms, especially in solid tumors.” “We remain excited about advancing the injectable programs to the clinic and we are encouraged by initial dialogue with the FDA. We believe that the ability to bypass the host dendritic cell and directly engage T cells in the body provides the potential for greater specific T cell responses. Preclinical data to date has been consistent across modalities in the ability to selectively activate and expand important tumor specific T cells with cancer cell killing capacity. In autoimmune disease models, our injectable nanoparticles have been shown to selectively reduce and suppress the disease-causing T cells that reside in the lymph node and target organs in diseases such as T1D. Several manufacturing components have already been produced and process transfer plans are underway. We also continue to advance our Class II approach designed to address diseases like rheumatoid arthritis (RA) and celiac disease.” “We remain confident in the potential therapeutic benefit of our AIM platform-based product candidates and their ability to significantly impact the emerging, rapidly moving field of antigen specific immunotherapies and novel combinations and look forward to providing updates in the future.” Select Second Quarter 2023 Clinical and Business Highlights Clinical and Preclinical Updates AIM INJ, an injectable “Off-the-shelf” Antigen-Specific Immunotherapy, and Other Preclinical Research Initiated multiple preclinical studies to evaluate NEXI-100 as a monotherapy and in combination with other cancer immunotherapies to support the Company’s oncology program. 2023 FOCIS Annual Meeting poster presentation reported AIM nanoparticle expansion of EBV-specific T-cell from healthy donors and patients with MS revealed a functional defect in the EBV response of MS patients to select antigen peptide targets, which may be a contributing factor in the pathogenesis of MS as well as other EBV related non-malignant diseases such as SLE. In partnership with Yale University Professor Kevan Herold and the Juvenile Diabetes Research Fund (JDRF), evaluation of AIM injectable nanoparticles in type 1 diabetes (T1D) confirmed their ability to drive T cell function in vivo as evidenced by a significant delay in the onset of spontaneous T1D that is associated with a reduction in T1D inducing memory T cells in pancreatic lymph nodes and the pancreas. Future experiments will be conducted to test the addition of suppressive and apoptotic 2nd signals to the AIM nanoparticles in addition to therapeutic combination approaches with anti-CD3 agents. Continued to advance neo-antigen our melanoma research collaboration with NYU Langone’s Perlmutter Cancer Center. Continued to work in other areas of autoimmune diseases, including vitiligo, MS, HTLV-1-associated myelopathy and others. NEXI-001 Relapsed Refractory AML Post Allo-HSCT A marked increase in antigen-specific cells was observed with increasing dose levels, consistent with a dose response observation. The persistence of antigen-specific T-cells with phenotypes associated with anti-tumor effect and immunologic memory was consistently observed in blood and bone marrow. Phase 1 data reported at ASCO 2023 shows NEXI-001 is well tolerated with a favorable safety profile. An immunologic and clinical dose responses were observed. Since ASCO, the clinical response observed in the Cohort 3 patient with poor prognosis extramedullary disease who received the highest cell dose tested (200M x 3, Cycle 1 only) has now been maintained up to nine months. As of the most recent follow-up, the patient remains asymptomatic with no evidence of disease and continues to be monitored. Manufacturing and Regulatory: Transitioning the IND engine capability: Established ACT cell therapy and nanoparticle platform manufacturing to enable IND engine in blood and solid tumor indications. The Company is proactively transitioning this approach to the injectable program. Preparing to manufacture clinical material for the planned injectable IND: Completed clinical protein production, selected polymer vendor and the transfer activities to our CDMO are underway to support the planned submission of an IND for NEXI-101 (injectable) in 2H2024. Select Second Quarter 2023 Financial Highlights Cash and cash equivalents for the Company as of June 30, 2023 were $16.3 million compared to $34.6 million at December 31, 2022. Based upon current operating plans, NexImmune expects that its existing cash and cash equivalents will enable the Company to fund its operating and capital expenditure requirements into the fourth quarter of 2023. Research and development expenses were $4.9 million in the second quarter of 2023, compared to $11.8 million for the same period in the prior year. The decrease of $6.9 million was due primarily to the completion of preclinical manufacturing work, pausing of clinical trials, and reduction in personnel-related expenses resulting from terminations. General and administrative expenses were $2.9 million, compared to $4.1 million for the same period in the prior year. The decrease was primarily due to decreases in legal and other administrative fees expenses and in personnel-related expenses. Net loss, according to U.S. generally accepted accounting principles in the, or GAAP, was $7.6 million for the quarter, or a basic and diluted GAAP net loss per share of $0.29. This compares to a net loss of $15.9 million, or a basic and diluted GAAP net loss per share of $0.69, for the same period in the prior year. 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 . 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 results of operations for the three and six months ended June 30, 2023; the sufficiency of the Company’s current cash and cash equivalents to fund its planned operations into the fourth quarter of 2023; the enrollment, timing, progress, release of data from and results of the Company’s paused clinical trials and the expectations with respect to potential AIM INJ product candidates; the timing, progress and release of preclinical data from our AIM INJ platform programs and other preclinical research programs; the expectation of submitting an IND for NEXI-101 (injectable) in 2024; 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 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 Relations NexImmune, Inc. crubin@neximmune.com NEXIMMUNE, INC. BALANCE SHEETS June 30, 2023 December 31, 2022 (unaudited) ASSETS Current assets: Cash and cash equivalents $ 16,281,020 $ 34,642,340 Restricted cash 55,000 55,000 Prepaid expenses and other current assets 2,163,990 2,671,411 Total current assets 18,500,010 37,368,751 Property and equipment, net 3,970,516 4,459,071 Operating lease right-of-use assets 703,217 967,032 Other non-current assets 300,205 264,970 Total assets $ 23,473,948 $ 43,059,824 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 582,510 $ 2,377,374 Accrued expenses 5,139,784 7,357,153 Operating lease liabilities, current 545,285 599,047 Total current liabilities 6,267,579 10,333,574 Operating lease liabilities, net of current portion 203,887 425,766 Total liabilities 6,471,466 10,759,340 Commitments and contingencies Stockholders’ equity Common Stock, $0.0001 par value, 250,000,000 shares authorized as of June 30, 2023 and December 31, 2022; 26,078,451 shares issued and outstanding as of June 30, 2023 and December 31, 2022 2,608 2,608 Additional paid-in-capital 224,381,109 222,547,530 Accumulated deficit (207,381,235 ) (190,249,654 ) Total stockholders’ equity 17,002,482 32,300,484 Total liabilities and stockholders’ equity $ 23,473,948 $ 43,059,824 NEXIMMUNE, INC. STATEMENTS OF OPERATIONS (unaudited) Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Operating expenses: Research and development 4,880,338 11,837,519 11,004,382 22,286,362 General and administrative 2,904,321 4,088,445 6,605,686 8,693,124 Total operating expenses 7,784,659 15,925,964 17,610,068 30,979,486 Loss from operations (7,784,659 ) (15,925,964 ) (17,610,068 ) (30,979,486 ) Other income (expense): Interest income 223,321 84,221 498,059 117,314 Other expense (5,166 ) (19,046 ) (19,572 ) (21,622 ) Other income, net 218,155 65,175 478,487 95,692 Net Loss $ (7,566,504 ) $ (15,860,789 ) $ (17,131,581 ) $ (30,883,794 ) Basic and diluted net loss attributable to common stockholders per common share $ (0.29 ) $ (0.69 ) $ (0.66 ) $ (1.35 ) Basic and diluted weighted-average number of common shares outstanding 26,078,451 22,871,369 26,078,451 22,854,311 STATEMENTS OF COMPREHENSIVE LOSS (unaudited) Three Months Ended March 31, Six Months Ended June 30, 2023 2022 2023 2022 Net loss $ (7,566,504 ) $ (15,860,789 ) $ (17,131,581 ) $ (30,883,794 ) Other comprehensive loss: Unrealized gain (loss) on available-for-sale marketable securities, net of tax — 11,243 — (12,347 ) Comprehensive loss $ (7,566,504 ) $ (15,849,546 ) $ (17,131,581 ) $ (30,896,141 )

Company has initiated pre-IND discussions with the FDA for its first AIM INJ indicationNEXI-001 Phase I data to be presented at ASCO 2023 in June GAITHERSBURG, Md., May 15, 2023 (GLOBE NEWSWIRE) -- 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 in oncology, autoimmune and infectious diseases, today reported financial results for the first quarter 2023. “This is an exciting time for NexImmune, as we remain focused on progressing the development of novel approaches in the field of immunotherapy,” said Kristi Jones, NexImmune’s CEO. “Interest in antigen specific approaches for oncology, autoimmune disorders and infectious diseases has never been higher. We believe our AIM INJ direct injectable nanoparticle platform offers a unique and powerful solution to direct a multi-antigen specific T cell response in a scalable “off-the-shelf” approach across these disease areas. We continue to move our INJ “off-the-shelf” lead program forward in oncology and are encouraged by our conversations with the FDA.” “I am also pleased that our NEXI-001 Phase 1 clinical data in cell therapy has been accepted for presentation at ASCO and I look forward to reviewing this data, as well as the preclinical data across oncology, autoimmune and infectious disease areas for our “off-the-shelf” injectable this year.” “We remain confident in the potential therapeutic benefit of our AIM platform-based product candidates and their ability to significantly impact the emerging, rapidly moving field of antigen specific immuno-oncology therapies, novel IO/IO combinations, autoimmune disorders and virally-driven diseases.” Select First Quarter 2023 Clinical and Business Highlights Clinical and Preclinical Updates AIM INJ, Injectable “Off-the-shelf” Antigen-Specific Immunotherapy, and Other Preclinical Research Initiated multiple preclinical studies to evaluate as a monotherapy and in combination with a checkpoint inhibitor to support the Company’s oncology programContinue to evaluate AIM INJ nanoparticles as a therapeutic for type 1 diabetes as well as other autoimmune diseases with Yale University Professor Kevan Herold in partnership with JDRFPoster presented at 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR demonstrated evidence that AIM multi-antigen specific cells combined with a BCMA bispecific results in superior potency, enhanced persistence and durability in multiple myeloma modelsPublication in Frontiers in Medicine highlighted the potential ability of NexImmune’s AIM platform to treat viral diseasesAnnounced research collaboration with the National Institute of Neurological Disorders and Stroke of the National Institutes of Health, with an initial focus on multiple sclerosisAnnounced neo-antigen melanoma research collaboration with NYU Langone’s Perlmutter Cancer CenterContinued work in other areas of autoimmune diseases; including vitiligo, multiple sclerosis, pemphigus, HTLV-1-associated myelopathy and others NEXI-001 Relapsed Refractory AML Post Allo-HSCT Full enrollment and dosing of the final safety cohort of NEXI-001 completedPlan to announce data at ASCO 2023Continued to explore opportunities to advance NEXI-001 with potential collaborators and investigators NEXI-003 HPV-Related Cancers Continued to explore opportunities to develop this adoptive cell therapy with external partners and collaborators and develop a corporate HPV strategy that utilizes the AIM INJ modality Select First Quarter 2023 Financial Highlights Cash and cash equivalents for the Company as of March 31, 2023 were $22.3 million compared to $34.6 million at December 31, 2022. Based upon current operating plans, NexImmune expects that its existing cash and cash equivalents will enable the Company to fund its operating and capital expenditure requirements into the fourth quarter of 2023. Research and development expenses were $6.1 million in the first quarter of 2023, compared to $10.4 million for the same period in the prior year. The decrease of $4.3 million was due primarily to the completion of preclinical manufacturing work and the pausing of the clinical trials. General and administrative expenses were $3.7 million, compared to $4.6 million for the same period in the prior year. The decrease was primarily due to decreases in personnel-related expenses and in legal and other administrative expenses. Net loss, according to generally accepted accounting principles in the U.S. GAAP, was $9.6 million for the quarter, or a basic and diluted GAAP net loss per share of $0.37. This compares to a net loss of $15.0 million, or a basic and diluted GAAP net loss per share of $0.66, for the same period in the prior year. 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 results of operations for the three months ended March 31, 2023; the sufficiency of the Company’s current cash and cash equivalents to fund its planned operations into the fourth quarter of 2023; the enrollment, timing, progress, release of data from and results of the Company’s paused clinical trials and the expectations with respect to potential AIM INJ product candidates; the timing, progress and release of preclinical data from our AIM INJ platform programs and other preclinical research programs; 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. ContactsInvestors and Media:Chad Rubin, SVP Corporate Affairs and Investor RelationsNexImmune, Inc.crubin@neximmune.com NEXIMMUNE, INC. BALANCE SHEETS March 31,2023 December 31,2022 (unaudited) ASSETS Current assets: Cash and cash equivalents$22,315,215 $34,642,340 Restricted cash 55,000 55,000 Prepaid expenses and other current assets 3,034,485 2,671,411 Total current assets 25,404,700 37,368,751 Property and equipment, net 4,232,655 4,459,071 Operating lease right-of-use assets 836,292 967,032 Other non-current assets 190,583 264,970 Total assets$30,664,230 $43,059,824 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable$650,568 $2,377,374 Accrued expenses 5,547,648 7,357,153 Operating lease liabilities, current 587,944 599,047 Total current liabilities 6,786,160 10,333,574 Operating lease liabilities, net of current portion 300,217 425,766 Total liabilities 7,086,377 10,759,340 Commitments and contingencies Stockholders’ equity Common Stock, $0.0001 par value, 250,000,000 shares authorized as of March 31, 2023 and December 31, 2022; 26,078,451 shares issued and outstanding as of March 31, 2023 and December 31, 2022 2,608 2,608 Additional paid-in-capital 223,389,976 222,547,530 Accumulated deficit (199,814,731) (190,249,654)Total stockholders’ equity 23,577,853 32,300,484 Total liabilities and stockholders’ equity$30,664,230 $43,059,824 NEXIMMUNE, INC. STATEMENTS OF OPERATIONS(unaudited) Three Months Ended March 31, 2023 2022 Operating expenses: Research and development 6,124,044 10,448,843 General and administrative 3,701,365 4,604,679 Total operating expenses 9,825,409 15,053,522 Loss from operations (9,825,409) (15,053,522)Other income (expense): Interest income 274,738 33,093 Other expense (14,406) (2,576)Other income, net 260,332 30,517 Net Loss$(9,565,077) $(15,023,005)Basic and diluted net loss attributable to common stockholders per common share$(0.37) $(0.66)Basic and diluted weighted-average number of common shares outstanding 26,078,451 22,836,781 STATEMENTS OF COMPREHENSIVE LOSS(unaudited) Three Months Ended March 31, 2023 2022 Net loss$(9,565,077) $(15,023,005)Other comprehensive loss: Unrealized gain (loss) on available-for-sale marketable securities, net of tax — (23,590)Comprehensive loss$(9,565,077) $(15,046,595)