Pembrolizumab

NextCure Provides Year-End Clinical Pipeline Updates

Retrieved on: 
Thursday, December 14, 2023
Cancer, Journal of Clinical Investigation, GMP, Patient, Acute myeloid leukemia, ADC, Pembrolizumab, Environment

BELTSVILLE, Md., Dec. 14, 2023 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today provided an update on its clinical pipeline.

Key Points: 
  • BELTSVILLE, Md., Dec. 14, 2023 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today provided an update on its clinical pipeline.
  • Given evidence of clinical activity to date, additional patients are being added to the 100 mg cohort of patients with microsatellite stable / microsatellite instable-low immune checkpoint inhibitor naïve colorectal cancer without active liver metastasis.
  • Clinical data, including results from additional patients, are expected in the first half of 2024.
  • Data defining the mechanism of action were published in Journal of Clinical Investigation in November.

Kineta Publishes Preclinical Data Demonstrating the Potential of Anti-VISTA Antibody KVA12123 as an Immunomodulatory Therapy for Cancer

Retrieved on: 
Wednesday, December 13, 2023
Immunotherapy, Tumor microenvironment, Arm, Cancer, Kineta, Pembrolizumab, VISTA, Patient, Safety, Immunoglobulin G, Vaccine

SEATTLE, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, announced today the peer-reviewed publication in Frontiers in Immunology of preclinical data highlighting the potential of KVA12123 as a new immunotherapy against poorly immunogenic tumors. The publication titled “A Highly Potent Anti-VISTA Antibody KVA12123 - A New Immune Checkpoint Inhibitor and a Promising Therapy Against Poorly Immunogenic Tumors”, reports on the development of KVA12123.

Key Points: 
  • The publication titled “ A Highly Potent Anti-VISTA Antibody KVA12123 - A New Immune Checkpoint Inhibitor and a Promising Therapy Against Poorly Immunogenic Tumors ”, reports on the development of KVA12123.
  • “This scientific article summarizes the extensive characterization and selection of our clinical candidate KVA12123 that targets VISTA, a strong driver of immune suppression in the tumor microenvironment,” said Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta.
  • “The publication highlights the differentiating potency and safety characteristics of KVA12123 that guided its advancement into clinical development.
  • Additional clinical efficacy data in the monotherapy arm and initial combination data with pembrolizumab are anticipated in Q2 2024.

Coherus Presents Phase 1/2 Clinical Data on Casdozokitug, a First-in-Class IL-27-Targeted Antibody, at the 2023 ESMO Immuno-Oncology Congress

Retrieved on: 
Wednesday, December 6, 2023
DCR, Lung cancer, ESMO, Neoplasm, IL-27, CHRS, RECIST, Immunohistochemistry, Medicare, Antibody, PRS, PD-1, Dor, Adenocarcinoma, Blood, Macrophage, HCC, RCC, HC, Biomarker, Carcinoma, Patient, Safety, Pembrolizumab, PD-L1, Pharmaceutical industry

REDWOOD CITY, Calif., Dec. 06, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today announced data from the ongoing Phase 1b/2 clinical trial of casdozokitug (casdozo), a first-in-class IL-27-targeting antibody, being presented at the 2023 ESMO Immuno-Oncology Congress taking place December 6 – 8, 2023 at Palexpo Exhibition Centre in Geneva, Switzerland. The presentation includes updated data for casdozo monotherapy dose escalation and expansion cohorts and a cohort evaluating treatment with casdozo in combination with the anti-PD-1 antibody pembrolizumab (pembro) in patients with non-small cell lung cancer (NSCLC) who have progressed after 2-4 prior lines of therapy, including chemotherapy and anti-PD-1 agents. Interleukin (IL)-27 is an immunoregulatory cytokine involved in suppressing anti-tumor immune responses and an important new target for cancer treatment. Casdozo is a first-in-class antibody, and the only clinical stage immunomodulatory cytokine antagonist targeting IL-27.

Key Points: 
  • Interleukin (IL)-27 is an immunoregulatory cytokine involved in suppressing anti-tumor immune responses and an important new target for cancer treatment.
  • Casdozo is a first-in-class antibody, and the only clinical stage immunomodulatory cytokine antagonist targeting IL-27.
  • The overall response rate (ORR) in the subset of patients with squamous NSCLC (n=2/9) was 22% in this data cut.
  • Casdozo continues to demonstrate an acceptable safety profile as monotherapy or in combination with a PD-1 inhibitor (pembro).

Valo Therapeutics Announces Regulatory Approval to Expand Phase I Immuno-oncology Trial into Sarcoma

Retrieved on: 
Wednesday, November 29, 2023
NY-ESO-1, Lung cancer, Neoplasm, Antigen, Tumor microenvironment, Immune system, Research, Sarcoma, American Cancer Society, Melanoma, Cancer, Swelling, Abdomen, Paul Ehrlich Institute, MAGE-A3, Patient, Pembrolizumab, Medical imaging

PeptiCRAd-1 is made up of ValoTx’s proprietary oncolytic virus, VALO-D102, coated with MAGE-A3 and NY-ESO-1 peptides.

Key Points: 
  • PeptiCRAd-1 is made up of ValoTx’s proprietary oncolytic virus, VALO-D102, coated with MAGE-A3 and NY-ESO-1 peptides.
  • ValoTx’s Phase I, first-in-human trial of PeptiCRAd-1 is currently in three tumor types: melanoma, triple negative breast cancer and non-small cell lung cancer.
  • These sub-types of sarcoma are particularly interesting as they have very high expression levels of our two target antigens.
  • If you are a cancer patient interested in participating in the study, please see the “For Patients” section on valotx.com for more information.

Immutep Announces Site Expansion for INSIGHT-003 Phase I Trial

Retrieved on: 
Wednesday, November 22, 2023
Lung cancer, ASX, ESMO, Autoimmune disease, IMM, Cancer, TPS, Patient, NSCLC, Pembrolizumab, Pharmaceutical industry

This site expansion will support faster enrolment in this cost-efficient, investigator-initiated study evaluating eftilagimod alpha (efti) in combination with the anti-PD-1 therapy KEYTRUDA® (pembrolizumab) and doublet chemotherapy for first line treatment of non-squamous non-small cell lung cancer (NSCLC).

Key Points: 
  • This site expansion will support faster enrolment in this cost-efficient, investigator-initiated study evaluating eftilagimod alpha (efti) in combination with the anti-PD-1 therapy KEYTRUDA® (pembrolizumab) and doublet chemotherapy for first line treatment of non-squamous non-small cell lung cancer (NSCLC).
  • The strength of the early clinical data in this first-in-man triple combination study led to its increase to 50 patients.
  • The extension opened in mid-2023 and 29 patients have been enrolled to date.
  • With the addition of the new sites, the trial is expected to complete recruitment in 1H CY2024.

CEL-SCI Reports Fiscal 2023 Financial Results and Clinical & Corporate Developments

Retrieved on: 
Friday, December 22, 2023
FDA, Health, Pharmaceutical, Clinical Trials, Oncology, Marketing, Pembrolizumab, Neck, Policy, Immunotherapy, ESMO, Food, Survival, Risk, Physician, Plasma protein binding, Research, Radiation, EMA, SCCHN, Medication, Neoadjuvant therapy, Congress, Bank statement, Head, Patent, Condition, Neoplasm, European Medicines Agency, Health Canada, NIHR, Patient, Diagnosis, PD-L1, BLA, Pharmaceutical industry

CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2023, as well as key clinical and corporate developments.

Key Points: 
  • CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2023, as well as key clinical and corporate developments.
  • CEL-SCI identified the target head and neck cancer patient population for Multikine that will be the basis for the Company’s regulatory filings for marketing clearance.
  • General and administrative expenses in fiscal 2023 were $9 million, a decrease of approximately $1.7 million, or 16%, compared to the year ended September 30, 2022.
  • Net loss narrowed by $4.5 million, or 12%, to approximately $32.2 million for the twelve months ended September 30, 2023 from $36.7 million in fiscal 2022.

Mural Oncology Launches to Advance Pipeline of Novel Engineered Cytokine Immunotherapies

Retrieved on: 
Wednesday, November 15, 2023
Rubius, IL-2, Mural, Cytokine, Research, General counsel, Alexion, Therapy, Head, Arbutus Biopharma, Jazz Pharmaceuticals, Patient, Doctor of Philosophy, Protein engineering, Bristol Myers Squibb, Pembrolizumab, IL-12, Alkermes (company), Halozyme, AbbVie, MBA, YM Biosciences, El Rubius, Nivolumab, Ipilimumab, ImClone Systems, Mirati Therapeutics, BMS, Financial toxicity, Mucosal melanoma, FRCP, The Celator, Cancer, PROC, GSK plc, Pharmaceutical industry, Vaccine, Management, Exelixis, Merck, Immunogen

DUBLIN, Ireland, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Mural Oncology plc (Nasdaq: MURA) today launched as an independent, publicly traded, clinical-stage immuno-oncology company leveraging its core competencies in immune cell modulation and protein engineering to develop novel, investigational engineered cytokine therapies designed to address areas of unmet need for patients with a variety of cancers. Mural’s ordinary shares will begin trading on the Nasdaq Global Market tomorrow, November 16th, under the ticker symbol “MURA”.

Key Points: 
  • “Immunotherapies have made a tremendous impact on the treatment of cancers over the past decade,” said Caroline Loew, Ph.D., the Company’s chief executive officer.
  • We believe Mural Oncology can lead the future of immunotherapies for patients.
  • Our protein engineering expertise allows us to reimagine the development of pro-inflammatory cytokine-based therapeutics that could address the key limitations with current cancer immunotherapies.
  • Goodwin Procter LLP and Arthur Cox LLP are serving as legal counsel to Mural Oncology.

Provectus Biopharmaceuticals Provides Updated Data on Cancer Immunotherapy PV-10 for Advanced Cutaneous Melanoma

Retrieved on: 
Wednesday, November 15, 2023
AJCC, Safety, OTCQB, PRN, Progression-free survival, RECIST, Patient, PFS, Pembrolizumab, CRS, CB, ORR, Metastasis, Birth control, Pension fund

KNOXVILLE, TN, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today provided updated data from an ongoing Phase 1b/2 clinical trial of investigational cancer immunotherapy PV-10 (rose bengal sodium) in combination with standard of care immune checkpoint blockade (CB) for the treatment of advanced cutaneous melanoma ( NCT02557321 ).

Key Points: 
  • KNOXVILLE, TN, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today provided updated data from an ongoing Phase 1b/2 clinical trial of investigational cancer immunotherapy PV-10 (rose bengal sodium) in combination with standard of care immune checkpoint blockade (CB) for the treatment of advanced cutaneous melanoma ( NCT02557321 ).
  • Initial results from CB-naïve patients in the main study cohort illustrated potential clinical benefit across all stages of metastasis.
  • Longer-term follow-up of an expanded patient population has been assessed.
  • Participants must have had at least 1 injectable lesion and at least 1 measurable target lesion and been a candidate for pembrolizumab.

AIM ImmunoTech Announces Publication of Data from Roswell Park Comprehensive Cancer Center Phase 1 Study Evaluating Ampligen® as a Component of a Chemokine-Modulating (CKM) Regimen in Metastatic Triple-Negative Breast Cancer

Retrieved on: 
Tuesday, November 14, 2023
CTL, AIM, Safety, NYSE, Senior, Breast cancer, Celecoxib, Roswell Park, Rintatolimod, Paper, Patient, TLR3, Journal, Immunology, CKM, Pembrolizumab, AIM ImmunoTech, Science of team science, Immunotherapy, Doctor of Philosophy, Manuscript, Pharmaceutical industry, Management, Cancer, MD

OCALA, Fla., Nov. 14, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the publication of results from the Phase 1 study at Roswell Park Comprehensive Cancer Center in patients with metastatic triple-negative breast cancer using chemokine modulation therapy, including AIM ImmunoTech Inc.’s drug candidate Ampligen® (also known as rintatolimod), interferon α-2b and celecoxib, followed by pembrolizumab.

Key Points: 
  • OCALA, Fla., Nov. 14, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the publication of results from the Phase 1 study at Roswell Park Comprehensive Cancer Center in patients with metastatic triple-negative breast cancer using chemokine modulation therapy, including AIM ImmunoTech Inc.’s drug candidate Ampligen® (also known as rintatolimod), interferon α-2b and celecoxib, followed by pembrolizumab.
  • The data were published in a manuscript titled, “ Systemic Infusion of TLR3-Ligand and IFNα in Breast Cancer Patients Reprograms Local Tumor Microenvironment for Selective CTL Influx ,” in The Journal for ImmunoTherapy of Cancer.
  • The pilot study evaluated the safety of systemic CKM composed of intravenous rintatolimod (Ampligen; selective TLR3 ligand), interferon α-2b and celecoxib, and the combination’s ability to promote local CTL influx to mTNBC lesions.
  • For more information about the study, please visit ClinicalTrials.gov: NCT03599453 .

Medicenna Therapeutics Reports Second Quarter Fiscal 2024 Financial Results and Operational Highlights

Retrieved on: 
Tuesday, November 14, 2023
Doctor of Philosophy, Bispecific monoclonal antibody, Pancreatic cancer, MSI, Brain, Research, Annual general meeting, Glioblastoma, Metalloproteinase, Toronto Stock Exchange, Patient, MDNA, Pakistan Society of Neuro-Oncology, Intellectual property, Pembrolizumab, OTC Markets Group, Neuro-Oncology (journal), Conference, Standard of care, Melanoma, SITC, Survival, Partnership, Cancer, Neoplasm, Bifunctional, TSX, SNO, Microsatellite instability, Decompression (diving), Society, MMR, Patent, Pharmaceutical industry, Cryptocurrency, Immunotherapy

TORONTO and HOUSTON, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA; OTC: MDNAF), a clinical-stage company focused on the design and development of novel evolutionary superkines to create revolutionary immunotherapies, today announced financial results and corporate highlights for the second quarter of fiscal 2024, ended September 30, 2023.

Key Points: 
  • We look forward to reporting initial Phase 2 dose expansion data from both the monotherapy and combination arms during the first half of 2024,” concluded Dr.
  • Clinical update from the ABILITY study’s MDNA11 plus pembrolizumab Phase 2 combination arm expected in the first half of 2024.
  • Research and development expenses of $3.1 million were incurred during the quarter ended September 30, 2023, compared with $2.4 million incurred in the quarter ended September 30, 2022.
  • General and administrative expenses of $2.3 million were incurred during the quarter ended September 30, 2023, compared with $2.4 million during the quarter ended September 30, 2022.