A Phase 1 Open-Label Dose-Escalation Study of the Safety of Adoptively Transferred Autologous CD8+ T Lymphocytes Targeting HPV-16 E6/E7, HPV-18 E6/E7 and Survivin in Patients With Relapsed or Refractory HPV-related Oropharyngeal Cancers

This is a multicenter, open-label, Phase I, first-in-human trial to characterize the safety and clinical activity of an antigen-specific CD8+ T-cell product in patients with relapsed or refractory locally advanced or metastatic HPV-related oropharyngeal cancers. Patients must have received at least one prior standard treatment regimen consisting of systemic immunotherapy and/or chemotherapy. The investigative agent is an autologous adoptive T-cell product derived from the patient's endogenous cytolytic T cells that are directed toward HPV-16 E6/E7, HPV-18 E6/E7 antigens, and a tumor-associated antigen (Survivin) by ex vivo exposure to an artificial antigen presenting cell to which HLA-A2 antigen-peptides have been fit within the pocket of an MHC class 1 molecule. Patients must express HLA-A*0201.

Start Date31 Mar 2025

Sponsor / Collaborator

NexImmune, Inc.

NCT04505813 / SuspendedPhase 1/2

A Phase 1 / 2 Study to Evaluate the Safety and Tolerability of Adoptively Transferred Autologous T Cells in Patients With Relapsed Refractory Multiple Myeloma

This Research study is being done to characterize the safety, tolerability, and preliminary antitumor activity of the NEXI-002 T cell product (a new experimental therapy), which contains populations of CD8+ T cells targeting multiple Myeloma associated antigen peptides in patients with relapsed refractory multiple myeloma (MM).
The study will enroll patients with MM who have relapsed or are refractory to standard lines of treatment.
The enrolled patients will undergo bridging therapy for the purposes of disease control while the NEXI-002 T cell product is being manufactured. Choice of bridging therapy administered will be per the Investigator's discretion, but is limited to acceptable agents as specified in the protocol. Bridging therapy will be administered prior to lymphodepleting (LD) therapy, with the last dose of the bridging therapy administered ≥ 14 days prior to initiation of LD therapy. Within 72 hours after completing LD therapy, patients will receive a single IV infusion of the NEXI-002 T cell product.

Start Date17 Aug 2020

Sponsor / Collaborator

NexImmune, Inc.

NCT04284228 / Active, not recruitingPhase 1/2

A Phase 1 / 2 Study to Evaluate the Safety, Tolerability and Initial Anti-Tumor Activity of Adoptively Transferred T Lymphocytes Targeting WT1, PRAME and Cyclin A1 AML or MDS Patients With Relapsed Disease After Matched Allogeneic HCT

This Research study is being done to characterize the safety, tolerability, and preliminary antitumor activity of the NEXI-001 T cell product (a new experimental therapy), which contains populations of CD8+ T cells targeting multiple leukemia associated antigen peptides in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who have relapsed disease after an allogeneic hematopoietic cell transplant (HCT).
The study will enroll AML or MDS patients who have either Minimal Residual Disease (MRD) or relapsed disease after a human leukocyte antigen (HLA)-matched allogeneic HCT. Patients who have had an HLA-mismatched or haploidentical allogeneic HCT will not be eligible to participate in this study. Eligible patients for this study must also have ≥ 50% T-cell chimerism from the original donor at the time study entry.
The enrolled patients will undergo bridging therapy for the purposes of disease control while the NEXI-001 T cell product is being manufactured. Choice of bridging therapy administered will be per the Investigator's discretion, but is limited to acceptable agents as specified in the protocol. Bridging therapy will be administered prior to lymphodepleting (LD) therapy, with the last dose of the bridging therapy administered ≥ 14 days prior to initiation of LD therapy. Within 72 hours after completing LD therapy, patients will receive a single IV infusion of the NEXI-001 T cell product.

Start Date20 Feb 2020

Sponsor / Collaborator

NexImmune, Inc.

100 Clinical Results associated with NexImmune, Inc.

0 Patents (Medical) associated with NexImmune, Inc.

Literatures (Medical) associated with NexImmune, Inc.

01 Jun 2023·Journal of Clinical Oncology

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).

Author: Oelke, Mathias ; Afonso-Smith, Suzanne D ; Marcucci, Guido ; Lu, Emily ; Kim, Sojung ; Varela, Juan Carlos ; Vasu, Sumithira ; Modi, Dipenkumar ; Al Malki, Monzr M. ; Knight, Robert D.

7043 Background: NEXI-001 is a non-genetically engineered donor-derived cellular therapy product consisting of > 90% CD3+/CD4- T cells that includes significant numbers of CD8+ T cells that are of early memory subtypes and target 5 specific HLA 02.01-restricted peptides from the WT1, PRAME, and Cyclin A1 antigens that are commonly expressed on AML blasts and leukemic stem cells. Methods: AML patients who relapse after allogeneic HCT have a high unmet medical need. These patients have a poor prognosis (2-year survival rate < 10%) and few treatment options. Currently 11 patients have completed the 4-week dose-limiting toxicity (DLT) period in the 3+3 design of the dose-escalation stage of this NEXI-001 phase I trial. The following doses of NEXI-001 T cells were administered during the DLT period: Cohort 1, 4 patients received an infusion of 50M (million) to 100M T cells; Cohort 2, 4 patients received an infusion of 200M T cells; and Cohort 3, 3 patients received infusions of 200M T cells on Days 1, 8, and 15. Results: The NEXI-001 antigen-specific T cells were found to persist and expand in peripheral blood, traffic to bone marrow, and maintain a less differentiated immunophenotype in blood and bone marrow for ≥3 months. No DLTs have occurred. NEXI-001-related adverse events have included grade 2 cytokine release syndrome (2), grade 1 diarrhea (2), grade 2 orthostatic hypotension (1), and a grade 3 GvHD of the gut in week 3 of the first NEXI-001 cycle that resolved within 72 hours with corticosteroid treatment. Clinical activity consisting of the following have occurred in patients within each cohort; neutrophil and platelet count recovery resulting in decreased transfusions and decreases in blasts in peripheral blood and bone marrow. A patient who achieved an MRD- remission following bridging therapy and then was administered a single infusion of 200M NEXI-001 T cells has continued to remain in CR at 6 months of follow-up. A patient in Cohort 3 who relapsed after alloHCT with extramedullary disease manifested by a pleural effusion has achieved a 45% decrease of the symptomatic moderate effusion at baseline to an asymptomatic small effusion after the administration of three 200M NEXI-001 T cells on Days 1, 8, and 15 of the first 4-week cycle. The patient remains asymptomatic at 3 months of follow-up with no detectable AML blasts in peripheral blood or bone marrow and a stable small effusion. A PET scan of the chest showed no areas of increased uptake. Conclusions: Early results indicate that the antigen-specific NEXI-001 T cells have the potential to enhance GvL effects and is tolerated with easily manageable side effects. Greater clinical activity has been observed with increased doses of the NEXI-001 T cells. The trial remains ongoing, and the data support an Expansion Cohort of the study that will allow for a more complete assessment of clinical activity. Clinical trial information: NCT04284228 .

01 May 2023·C68. TOPICS IN AIRWAY AND ALVEOLAR EPITHELIAL CELL BIOLOGY

Interactions Between SCGB1A1 Protein and LPS

Author: Winn, M.E. ; Pilon, A.L.

01 May 2023·C68. TOPICS IN AIRWAY AND ALVEOLAR EPITHELIAL CELL BIOLOGY

Enhancement of rhCC10-mediated Anti-inflammatory Activity in Airway Epithelial and Vascular Endothelial Cells Through ROS- and RNS-mediated Modification

Author: Lee, Y.L. ; Clayton, R.S. ; James, M.C. ; Tian, C. ; Stewart, T.J. ; Winn, M.E. ; Pilon, A.L.

News (Medical) associated with NexImmune, Inc.

23 Oct 2024

·www.prnewswire.com

Anti-CD38 mAb Market to Accelerate Substantially During the Study Period (2020-2034) Owing to a Strong Uptake of DARZALEX in Multiple Myeloma and Expected Entry of anti-CD38 mAbs in Autoimmune Diseases | DelveInsight

The anti-CD38 mAb market is projected to experience substantial growth in the coming years owing to strong uptake of DARZALEX (along with DARZALEX FASPRO), the expected entry of subcutaneous formulation of SARCLISA in Multiple Myeloma. This growth is also driven by a rising number of cancer and autoimmune disorder diagnoses, as well as an increasing number of Anti-CD38 mAbs undergoing clinical trials and seeking approval. LAS VEGAS, Oct. 23, 2024 /PRNewswire/ -- DelveInsight's Anti-CD38 mAb Market Insights report includes a comprehensive understanding of current treatment practices, emerging anti-CD38 mAb, market share of individual therapies, and current and forecasted anti-CD38 mAb market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Anti-CD38 mAb Market Report As per DelveInsight's analysis, the total market size of anti-CD38 mAb in the 7MM is expected to surge significantly by 2034. Multiple Myeloma is the only indication for which anti-CD38 therapies, Johnson&Johnson's (J&J) DARZALEX and Sanofi's SARCLISA have been approved until now. Around 50% of DARZALEX usage comes from second-line treatment in Multiple Myeloma. Additionally, in the frontline multiple myeloma clinical trials, DARZALEX has emerged triumphant, surpassing all expectations and solidifying its position as the gold standard of therapy. Its unparalleled effectiveness and exceptional safety profile have exceeded rivals' predictions and soon positioned DARZALEX to dominate the multiple myeloma market. The filing submission of SARCLISA subcutaneous in 3L R/R MM (IRAKLIA) is anticipated in 2025 and beyond. Somehow, SARCLISA is way behind DARZALEX in terms of market expansion, and DARZALEX has also got an early mover advantage of over 4 years. Multiple Myeloma is the leading indication, other emerging indications with commercial opportunity include Systemic Lupus Erythematosus (SLE), Chronic Kidney Disease (CKD), and IgA Nephropathy Leading emerging anti-CD38 mAb companies such as Takeda Pharmaceuticals, HI-Bio, Genmab, CASI Pharmaceuticals, and others are developing novel anti-CD38 mAb that can be available in the market in the coming years. Some of the key anti-CD38 mAb in the pipeline include Mezagitamab (TAK-079), Felzartamab, GEN3014, CID-103 , and others. In June 2024, data from the IMROZ Phase III study by Sanofi demonstrated that SARCLISA is the first anti-CD38 to significantly improve progression-free survival in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed transplant-ineligible multiple myeloma. In May 2024, Biogen and Human Immunology Biosciences (HI-Bio), announced the companies have entered into a definitive agreement under which Biogen has agreed to acquire HI-Bio for USD 1.15 billion upfront and up to USD 650 million in potential milestone payments. Discover which therapies are expected to grab the anti-CD38 mAb market share @ Anti-CD38 mAb Market Report Anti-CD38 mAb Market Dynamics The market for anti-CD38 mAbs has undergone significant growth and transformation in recent years, driven primarily by the increasing prevalence of multiple myeloma and the d emand for more effective treatment options. The market dynamics are further influenced by ongoing research into the broader application of anti-CD38 mAbs beyond multiple myeloma. There is growing interest in exploring their efficacy in other CD38-expressing malignancies, such as chronic lymphocytic leukemia and certain solid tumors. Additionally, research into combination therapies, where anti-CD38 mAbs are paired with immune checkpoint inhibitors, CAR-T cells, or other novel agents, is expanding the horizon for these treatments. Such advancements are likely to further propel the market, attracting substantial investment and fueling innovation. However, challenges such as biosimilar competition, pricing pressures, and the need for differentiation in a crowded market pose potential hurdles. The entrance of biosimilars could reduce costs but also threaten market share for existing products. Companies must navigate these challenges through strategic pricing, market access strategies, and continuous innovation to maintain their competitive edge. The anti-CD38 mAb market is poised for continued expansion, with a promising pipeline of new therapies and combinations on the horizon, making it a dynamic and evolving sector within oncology. Anti-CD38 mAb Treatment Market Monoclonal antibodies targeting CD38 are crucial in the treatment of newly diagnosed and refractory multiple myeloma. Currently, DARZALEX and SARCLISA are the two approved anti-CD38 therapies. SARCLISA is a prescription medication used to treat multiple myeloma in adults. It is administered alongside pomalidomide and dexamethasone for patients who have undergone at least two previous treatments, including lenalidomide and a proteasome inhibitor. Additionally, SARCLISA is used with carfilzomib and dexamethasone for patients who have received one to three prior therapies that were either ineffective or have stopped working. In March 2020, the US FDA approved SARCLISA in combination with pomalidomide and dexamethasone for multiple myeloma patients who had at least two prior therapies, including lenalidomide and a proteasome inhibitor. Later, in May 2020, the European Commission approved SARCLISA. By March 2021, the US FDA also approved SARCLISA with carfilzomib and dexamethasone for those with relapsed or refractory multiple myeloma who had received one to three previous treatments. DARZALEX is an innovative monoclonal antibody that the US FDA approved for treating multiple myeloma in patients with at least one prior treatment. It works by inducing tumor cell death through several mechanisms, including antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity, and antibody-dependent cellular phagocytosis. In November 2015, the FDA granted DARZALEX accelerated approval as a monotherapy for multiple myeloma patients who had undergone at least three prior treatments. By November 2016, it was also approved for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for patients who had received at least one prior therapy. From 2015 to 2021, DARZALEX gained further approvals for use in various drug combinations. Their effectiveness in managing multiple myeloma and plasma cell disorders has been confirmed by numerous Phase III clinical trials. Moreover, CD38-targeted therapies are being explored for other conditions such as primary immune thrombocytopenia, IgA nephropathy, antibody-mediated transplant rejection, lupus nephritis, and various hematologic cancers. Learn more about the FDA-approved anti-CD38 mAb @ Anti-CD38 mAb Drugs Key Emerging Anti-CD38 mAb and Companies Several key players, including Takeda Pharmaceuticals, HI-Bio, CASI Pharmaceuticals, and others, are involved in developing drugs for Anti-CD38 mAb for various indications such as multiple myeloma, myasthenia gravis, and others. Mezagitamab is a fully human IgG1 monoclonal antibody that targets CD38 and is being developed by Takeda for the treatment of multiple myeloma, myasthenia gravis, and primary immune thrombocytopenia. On March 14, 2024, the FDA granted Fast Track designation and Orphan Drug status to mezagitamab for idiopathic thrombocytopenic purpura (ITP). Takeda also revealed plans to begin a global Phase III trial for mezagitamab in ITP later in 2024. The drug is currently in Phase II of clinical development. HI-Bio's leading candidate, felzartamab, is a fully human anti-CD38 monoclonal antibody. Clinical studies have demonstrated its ability to selectively target and deplete CD38+ cells, including plasma cells and NK cells, potentially enabling broader therapeutic applications and enhanced clinical outcomes across various immune-mediated diseases. Felzartamab has been granted Breakthrough Therapy and Orphan Drug Designations by the FDA for primary membranous nephropathy and also received Orphan Drug Designation for treating antibody-mediated kidney transplant recipients. Phase II trials have been completed for primary membranous nephropathy and antibody-mediated transplant rejection, with ongoing studies in IgA nephropathy. HI-Bio intends to progress each of these indications to Phase III. The anticipated launch of these emerging therapies are poised to transform the anti-CD38 mAb market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the anti-CD38 mAb market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about anti-CD38 mAb clinical trials, visit @ Anti-CD38 mAb Treatment Drugs Anti-CD38 mAb Overview Anti-CD38 monoclonal antibodies (mAbs) are a class of therapeutic agents that target CD38, a surface protein widely expressed on plasma cells, including malignant ones in multiple myeloma. By binding to CD38, these mAbs can induce direct cytotoxicity, promote antibody-dependent cellular cytotoxicity (ADCC), and facilitate complement-dependent cytotoxicity (CDC) to destroy the targeted cells. Beyond their role in multiple myeloma, anti-CD38 mAbs are being explored for their potential in treating other hematologic malignancies and autoimmune diseases. CD38 is not only a marker for plasma cells but also involved in processes like calcium signaling and NAD+ metabolism, which are crucial for cell survival and proliferation. By targeting CD38, these antibodies can modulate the immune microenvironment, making them a promising tool for both oncology and immunology. The ongoing research is focused on optimizing their efficacy, managing resistance, and exploring their use in combination with other immunotherapies to enhance patient outcomes. Anti-CD38 mAb Epidemiology Segmentation Epidemiology assessed for multiple myeloma showed that the United States, in 2023, accounted for 36,800 incident cases of multiple myeloma. The anti-CD38 mAb market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Incident Cases of Selected Indication for Anti-CD38 mAb Total Eligible Patient Pool for Anti-CD38 mAb in Selected Indication Total Treatable Cases of Selected Indications for Anti-CD38 mAb Scope of the Anti-CD38 mAb Market Report Anti-CD38 mAb Therapeutic Assessment: Anti-CD38 mAb current marketed and emerging therapies Anti-CD38 mAb Market Dynamics: Conjoint Analysis of Emerging Anti-CD38 mAb Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Anti-CD38 mAb Market Access and Reimbursement Discover more about anti-CD38 mAb in development @ Anti-CD38 mAb Clinical Trials Table of Contents Related Reports Multiple Myeloma Market Multiple Myeloma Market Insight, Epidemiology and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Johnson & Johnson (Janssen), Pfizer, AbbVie and Roche (Genentech), Regeneron Pharmaceuticals, Bristol-Myers Squibb, Celgene, Roche (Genentech), Arcellx, Novartis, Regeneron Pharmaceuticals, BeiGene, CARsgen Therapeutics, Cartesian Therapeutics, C4 Therapeutics, Heidelberg Pharma, Bristol-Myers Squibb, RAPA Therapeutics, AbbVie (TeneoOne), Takeda , among others. Multiple Myeloma Pipeline Multiple Myeloma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key multiple myeloma companies, including Janssen, Pharmacyclics, Novartis, Incyte Corporation, Gracell Biotechnology, SpringWorks Therapeutics, Sana Biotechnology, Cytovia Therapeutics, Pfizer, MorphoSys, Biokine Therapeutics, Arcellx, Rapa Therapeutics, iTeos Therapeutics, Sorrento Therapeutics, CARsgen, Ascentage Pharma, Cartesian Therapeutics, Bristol-Myers Squibb, Juno Therapeutics, Nanjing IASO Biotherapeutics, Arch Oncology, Oncoceutics, TeneoBio, Nerviano Medical Sciences, among others. Relapse/Refractory Multiple Myeloma Market Relapse/Refractory Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key R/R multiple myeloma companies, including NexImmune, Amgen, AbbVie, Allogene Therapeutics, Precision Biosciences, Takeda Oncology, ORIC Pharmaceuticals, Ionis Pharmaceuticals, Cellectis S.A., YZY Biopharma, Janssen Research & Development, Bristol Myers Squibb, Lava Therapeutics, Prelude Therapeutics, among others. Relapse/Refractory Multiple Myeloma Pipeline Relapse/Refractory Multiple Myeloma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key R/R multiple myeloma companies, including Bristol-Myers Squibb, I-MAB Biopharma, Pfizer, Arcellx, Gilead Sciences, Novartis, Array Biopharma, Hrain Biotechnology Co., Ltd., Cartesian Therapeutics, Xencor, Takeda, Sorrento Therapeutics, Heidelberg Pharma AG, Ichnos Sciences, Allogene Therapeutics, Harpoon Therapeutics, Cellectis, Poseida Therapeutics, Regeneron Pharmaceuticals, ONK Therapeutics, TeneoOne, iTeos Therapeutics, Oricell Therapeutics, Anaveon AG, Luminary Therapeutics, Seagen Inc., Trillium Therapeutics Inc., Virtuoso BINco, Inc., Seagen Inc., Trillium Therapeutics Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalOrphan DrugFast TrackPhase 3Immunotherapy

02 Oct 2024

·www.pharmaceutical-technology.com

Shattuck Labs stock craters following pipeline and job cuts

Following the restructuring news, Shattuck’s stock was down by 44.99% at market close on 1 October, compared to market close on the previous day. Shutterstock: paper cut design / Shutterstock. Shattuck Labs has dropped by nearly 45% after it announced plans to reduce its headcount and discontinue its lead cancer therapy programme, SL-172154. The restructuring decision was made after interim data from a Phase Ib trial (NCT05275439) showed a lack of a definitive overall survival (OS) benefit in patients receiving SL-172154. The company added that the ‘modest’ improvements in the OS seen in Phase I would likely erode in larger late-stage studies. Following the announcement, Shattuck’s stock was down by 44.99% at market close on 1 October, compared to market close on the previous day. The company’s market cap currently stands at $81.6m. SL-172154 is a cluster of differentiation 47 (CD47) inhibitors, which were investigated as a treatment for myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML). In February, Shattuck licensed out multiple potential drug candidates, including SL-172154, to Ono Pharmaceuticals in a deal worth more than $227m. As part of the restructuring, the companies have mutually terminated the agreement and Shattuck is “no longer required to satisfy any remaining performance obligations and will not receive any future research activity reimbursements or upfront, milestone, or royalty payments from Ono”. See Also: ImmunoPrecise and Biotheus partner on bispecific antibodies to treat cancer Novaliq and Laboratoires Théa announce EC approval for dry eye disease therapy The cost-saving measures also cull 40% of the workforce by the end of the year and will cost between $1.5m and $1.75m. Shattuck reported cash reserves of $105.3m as of 30 June, as per the latest SEC filing by the company. The company plans to funnel its remaining resources into developing its antibody therapy, SL-325. The DR3 antagonist acts by modulating adaptive immunity, as DR3 is expressed on the cell surface of various immune cells. Shattuck is developing SL-325 as a treatment for inflammatory autoimmune diseases, including inflammatory bowel disease (IBD). The company plans to file an investigational new drug application (IND) for SL-325 in Q3 2025. Shattuck noted that it has sufficient funds to finance beyond its planned Phase I clinical trial of SL-325 and into 2027. Following the recent round of lay-offs, Shattuck joins the list of pharmaceutical companies, including Atreca , Candel Therapeutics , Cidara Therapeutics , Kinnate Bio , and NexImmune , which have cut their workforces to reallocate funds into their clinical development pipelines in the last few months.

Phase 1ImmunotherapyLicense out/inIND

13 Sep 2024

·www.pharmaceutical-technology.com

Cidara axes 30% of staff to focus on flu prevention drug

Cidara reacquired the rights to the therapy from J&J for $85m in April. Image credit: gguy / Shutterstock. Cidara Therapeutics is axing nearly a third of its workforce to find funds to continue advancing clinical development of its reacquired flu candidate. The US-based biotech plans to lay off approximately 30% of its workforce, amounting to 20 positions, as per the company’s recent SEC filing. The reduction is expected to cost the company $1.2m in severance and benefit payments and will conclude by 1 November 2024. Cidara plans to focus its resources on advancing its influenza prevention therapy, CD388. The company also announced it plans to start a Phase IIb trial of CD388 for the prevention of influenza A and B in Q3 this year during the Northern Hemisphere’s flu season. After originally selling the rights to the drug to Johnson & Johnson (J&J) in 2021, the company reacquired the rights to the therapy for $85m in April after the pharma giant announced plans to deprioritise the development of the drug. Despite Cidara now being responsible for all development and marketing costs for CD388, J&J is eligible to receive additional milestone-based payments. CD388 received fast track designation by the US Food and Drug Administration (FDA) in June 2023. The drug has been evaluated in two Phase I studies (NCT05285137 and NCT05619536) and one Phase IIa (NCT05523089) trial. See Also: Bavarian Nordic promises two million mpox vaccines for Africa by end of 2024 IBA venture PanTera gains €134m in funding to scale up actinium-225 production In the Phase IIa data, despite a numerical decrease in influenza virus replication after a single dose of CD388, the reduction was not statistically significant. The CD388 treatment group also reported reduced influenza incidence rates compared to the placebo arm but again this was not statistically significant. Cidara also has cancer therapeutics as part of its pipeline, its most advanced candidate in the indication is CBO421. In July 2024, the company received investigational new drug application (IND) clearance to start a Phase I trial for evaluating CBO421 in solid tumours. However, Cidara’s SEC filing noted that it “does not currently plan to initiate clinical trials for any other product candidate”. The company has started multiple strategic measures to raise capital this year, including the sale of its rezafungin programme to Mundipharma and a $240m private investment in a public equity financing deal. Both efforts were expected to fund the Phase IIb trial of CD388. Following the recent round of lay-offs, Cidara joins a list of pharmaceutical companies, including Atreca , Candel Therapeutics , Kinnate Bio , and NexImmune , that have fired workers to funnel more money into their clinical development pipelines.

Phase 1Phase 2Fast TrackVaccineIND

100 Deals associated with NexImmune, Inc.

100 Translational Medicine associated with NexImmune, Inc.

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Drug(Targets)	Indications	Global Highest Phase

NEXI-003 ( HPV E6 )	Solid tumor More	Phase 1
NEXI-004	Epstein-Barr Virus Infections More	Preclinical
NEXI-200	Autoimmune Diseases More	Preclinical
NEXI-100	Solid tumor More	Preclinical
NEXI-300	Infectious Diseases More	Preclinical

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