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SAN DIEGO, April 29, 2025 /PRNewswire/ -- NEUVOGEN, Inc. ("NEUVOGEN THERAPEUTICS" or "NEUVOGEN"), a San Diego based biotechnology company, will present data that its next generation whole tumor cell vaccine (NGEN-143) activates T cells that recognize a diverse antigen repertoire. "These findings support that NGEN-143 can deliver an unprecedented breadth of targets and activate cytotoxic T cells, as compared to other currently available cancer vaccines, making NGEN-143 a better potential option for patients" said Todd Binder, Chief Executive Officer of NEUVOGEN. "Our dedicated team is eager to bring this new cancer vaccine forward to treat patients with non-small cell lung cancer (NSCLC)." Key Findings: In a fully human in vitro system, NGEN-143 expands effector T cells against a broad repertoire of both tumor-associated antigens and common shared neo-antigens across a wide range of HLA types. NGEN-143 activates polyfunctional, cytotoxic T cells; the response is dominated by CD8+ cells without any evidence of antigenic competition. CD4+ T cell responses are skewed toward CD4+ Th1 cells over CD4+ Th2 cells. NGEN-143 activated T cells efficiently kill human tumor cells in a caspase-3 dependent manner. In the 'immune warm' CT26 mouse tumor model, vaccine abrogates or slows tumor growth – durable protection against rechallenge supports efficient induction of immune memory; vaccine + αPD1 improved survival over αPD1 monotherapy. In the 'immune cold' B16F10 mouse tumor model, our vaccine approach inhibits tumor growth and prolongs survival; vaccine + αPD1 improved survival. Bernadette Ferraro, Ph.D., NEUVOGEN's Vice President, Immuno-oncology, is scheduled to present "An optimized off-the-shelf whole tumor cell vaccine activates T cells that recognize a diverse antigen repertoire with potential to provide meaningful clinical benefit to patients with NSCLC," at AACR on Tuesday, April 29 from 2:00 – 5:00 PM CT. A copy of the poster will be made available for download at neuvogen.com/our-science after the meeting concludes. About NEUVOGEN NEUVOGEN, Inc. is a San-Diego based biotechnology company focused on developing whole cell cancer vaccine therapies. NEUVOGEN believes its cancer vaccines have the broadest combination of tumor associated antigens and tumor specific antigens delivered in a cancer vaccine. As a result, these next-generation cancer vaccines can directly target a greater percentage of cancer cells in a solid tumor than any previous cancer vaccine. NEUVOGEN's goal is to develop therapeutic cancer vaccines that activate the body's immune system to treat primary tumors, micrometastases, and metastases. In turn, these agents can delay and prevent relapses in early and late-stage disease and meaningfully extend the lives of patients with minimal side effects. About NGEN-143 NGEN-143 is NEUVOGEN's lead product candidate engineered for use in patients with non-small cell lung cancer. NGEN-143 is comprised of six allogeneic tumor cell lines genetically modified to include NEUVOGEN's proprietary activation technology and to increase the breadth of available tumor antigens. NGEN-143 is an off-the-shelf product enabling access to a broader range of patients. To learn more, visit . Media Contact [email protected] SOURCE NEUVOGEN, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

HOUSTON, April 9, 2025 /PRNewswire/ -- Diakonos Oncology, a clinical-stage biotechnology company developing innovative immunotherapies for difficult-to-treat cancers, today announced the successful presentation of an abstract at the 2025 American Academy of Neurology (AAN) Annual Meeting, which took place April 5-9, 2025, in San Diego, California. The abstract presentation, titled "Phase I Analysis of DOC1021, a Cell-Based Vaccination Platform for Adjuvant Therapy of Glioblastoma", featured promising data from an open-label Phase I trial evaluating the safety, immunogenicity, and early efficacy signals of DOC1021. "We were honored to present our latest research at the American Academy of Neurology Annual Meeting," said Jay Hartenbach, President and Chief Operating Officer of Diakonos Oncology. "Glioblastoma remains one of the most aggressive and challenging cancers to treat, and we are committed to advancing novel immunotherapy approaches that have the potential to make a meaningful impact for patients. The results of this Phase I analysis are highly encouraging and reinforce the potential of DOC1021 as a novel immunotherapy for glioblastoma." Abstract Presentation Details: Title: Phase I Analysis of DOC1021, a Cell-Based Vaccination Platform for Adjuvant Therapy of Glioblastoma Authors: Zhu J-J, Esquenazi-Levy Y, Hsu S, Zvavanjanja RC, Vu M, Schumann EH, Trivedi A, Liu W, Namekar M, Hofferek CJ, Ernste K, Mossop C, Clay CM, Amin S, Ravi V, Kemnade JO, Aguilar LK, Turtz A, Tandon N, Konduri V, Georges JF, Decker WK Session: S29 - Neuro-oncology Date and Time: Tuesday, April 8, from 4:06-4:18 p.m. PT Location: San Diego Convention Center, 25C Key Highlights: DOC1021 vaccines were administered to 16 newly diagnosed glioblastoma patients, with 94% (15/16) being MGMT unmethylated. No adverse events greater than Grade 2 attributable to the investigational regimen and no dose-limiting toxicities (DLTs) were observed. CD4+ (13/13) and CD8+ (11/13) central memory T-cell compartments expanded post-vaccination (p<0.002 and p<0.05, respectively), indicating robust immune activation. CD8+CD127+ memory precursor effector cells (MPECs) expanded in 12/13 patients (p<0.001), suggesting enhanced immune memory potential. Spatial transcriptomics analysis of three patients showed intense CD25+ foci overlapping effector memory T-cell and migratory microglial markers post-vaccination. One-year overall survival (OS) rate in the 15/16 unmethylated cohort was 88%, compared to 53% in an age-matched control cohort (p<0.002), highlighting a potential survival benefit. "In the Phase I trial, the dendritic vaccine injections at the lymph nodes were well tolerated, with no significant side effects observed in any participants," said Dr. Jay-Jiguang Zhu, Principal Investigator of the study and Professor and Director of Neuro-oncology at UTHealth Houston. "We are looking forward to assessing this dendritic cell-based vaccine therapy in the upcoming Phase II trial." About DOC1021 DOC1021 is an autologous dendritic cell vaccine (DCV) that initiates a complete cytotoxic TH1 immune response against a patient's cancer through the company's proprietary double loading technology. The vaccines are made with a patient's dendritic cells combined with mRNA and proteins prepared from freshly obtained patients' tumor specimens. This unique approach unlocks a synergistic tumor killing TH1 response driven by dual protein and RNA antigen sourcing, and it allows targeting of the complete cancer antigen pool. Moreover, the approach does not require any molecular modification of the patient's immune cells for manufacturing, and does not require preconditioning of bone marrow or high dose IL-2 for administration. In addition to the lead GBM study, a clinical trial of another Diakonos dendritic cell vaccine is ongoing for the treatment of pancreatic cancer. Diakonos has received Fast Track designations from the FDA for both the GBM and pancreatic cancer programs. The company has also received Orphan Drug Designation for the GBM program. About Diakonos Oncology Corp. Based out of Houston, TX, Diakonos Oncology is a clinical-stage biotechnology company dedicated to revolutionizing cancer immunotherapy and focusing on difficult-to-treat indications, including glioblastoma. A variant of the DOC1021 treatment platform also is in early-stage clinical testing in pancreatic ductal adenocarcinoma (PDAC). For more information visit: . SOURCE Diakonos Oncology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

March 20, 2025 -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that additional data from the Company’s Phase 1/1b clinical trial of soquelitinib for the treatment of patients with T cell lymphoma (TCL) is being presented at the 16th Annual T-Cell Lymphoma Forum taking place March 20-22, 2025 in San Diego, CA. “The data from the Phase 1/1b clinical trial of soquelitinib in patients with T cell lymphoma continues to demonstrate strong indications of anti-tumor activity in a significant number of patients,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “We are encouraged by the high complete response, prolonged median progression free survival and high rate of 18-month progression free survival, which all appear superior to standard of care agents such as belinostat and pralatrexate. In addition, analysis of patient blood samples at baseline and on treatment show that soquelitinib reduces T cell exhaustion, which may allow for improved T cell function and anti-tumor immunity. Supported by this data, our registrational Phase 3 trial of soquelitinib is enrolling patients with relapsed peripheral T cell lymphoma at multiple sites in the U.S., Canada and Australia, along with our Phase 1 trial in atopic dermatitis that is anticipated to deliver data in the second quarter 2025.” The soquelitinib data from the Phase 1/1b clinical trial of soquelitinib for TCL will be presented by John Reneau, MD, PhD, Assistant Professor in the College of Medicine and The Ohio State University Comprehensive Cancer Center. Dr. Reneau is a hematologist who specializes in treating patients with lymphoma and an investigator in the trial. The details of Dr. Reneau’s presentations are as follows: Oral Presentation Title: Selective ITK Inhibition for Treatment of PTCL Time: 4:50 – 5:10 pm PT on March 20, 2025 Poster Presentation Abstract Title: Soquelitinib, a Selective ITK Inhibitor for Treatment of T Cell Lymphomas: Results of Ph1 trial Reveal Novel Mechanisms of Action A total of 25 patients were enrolled in the Phase 1/1b trial at the optimum 200 mg two-times a day dose and would have met the eligibility criteria for the ongoing registrational Phase 3 clinical trial based on ≥1 and ≤3 prior therapies, including 23 evaluable patients. For the 23 evaluable patients: Objective responses (complete response, CR, plus partial response, PR) were seen in nine patients (39%), including six CRs (26%) and three PRs. The median duration of response (DOR) for the nine patients with objective response by Lugano criteria was 17.2 months. Three patients continue on therapy at 25+ months, 18+ months and 14+ months. Kaplan Meier estimated median progression free survival (PFS) was 6.2 months. At 18-month follow-up, the PFS rate was 30%, which compares favorably to 18-month PFS of 1 2 Peripheral blood samples were collected from patients both prior to the initiation of soquelitinib therapy and during the course of treatment. These samples were analyzed for markers of T cell exhaustion in normal T cells. The results indicated that the majority of patients exhibited a reduction in T cell exhaustion markers on both CD4+ and CD8+ cells after 21 days of treatment. T cell exhaustion is a state in which T cells exhibit diminished functionality due to prolonged exposure to antigens. Soquelitinib was well-tolerated, with no new safety signals, drug interruptions or dose reductions. Based on the results from the Phase 1/1b trial, Corvus is enrolling patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed Peripheral T cell lymphoma (PTCL) at multiple sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate. The primary endpoint of the trial is PFS. There are no FDA fully approved agents for the treatment of relapsed PTCL and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least 2 lines of systemic therapy. Peripheral T cell lymphoma (PTCL) is a heterogeneous group of malignancies accounting for about 10% of non-Hodgkin’s lymphomas (NHL) in western populations, reaching 20% to 25% of NHL in some parts of Asia and South America. The most common subtypes are PTCL-not otherwise specified (PTCL-NOS) and T follicular helper cell lymphoma. Initial therapy for these diseases is typically combination chemotherapy; however, approximately 75% of patients either do not respond or relapse within the first two years. Patients in relapse are treated with various chemotherapy agents but have poor overall outcomes with median progression-free survival in the 3 to 4 month range and overall median survival of 6 to 12 months. There are no approved drugs in relapsed PTCL based on randomized trials. PTCL is a disease of mature helper T cells that express ITK (interleukin-2-inducible T cell kinase), often containing numerous genetic mutations and frequently associated with viral infection. Most often the malignant cells of PTCL express a Th2 phenotype. Soquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. Soquelitinib has been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases. Recent studies have demonstrated that ITK controls a switch between the differentiation of Th17 proinflammatory cells and T regulatory suppressor cells. Inhibition of ITK leads to a shift toward T regulatory cell differentiation which has the potential to suppress autoimmune and inflammatory reactions. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company is conducting a registrational Phase 3 clinical trial (NCT06561048) of soquelitinib in patients with relapsed PTCL. Soquelitinib is also being investigated in a randomized placebo-controlled Phase 1 clinical trial in patients with atopic dermatitis and a Phase 2 clinical trial in patients with autoimmune lymphoproliferative syndrome (ALPS), a rare genetic disease. A recent publication describing the chemistry, enzymology and biology of soquelitinib appeared in NPJ Drug Discovery in December 2024 and is available online at the Nature website and on the Publications and Presentations page of the Corvus website. Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancers and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com. 1 O’Connor O. et. al. J. Clin Onc 33:2492, 2015 2 O’Connor O. et. al. J. Clin Onc 29:1182, 2011 The content above comes from the network. if any infringement, please contact us to modify.