Primary tumor

Beyond Air® Affiliate Beyond Cancer™ Doses Initial Patient in First-in-Human Phase 1 Study of Ultra-High Concentration Nitric Oxide Therapy at Tel Aviv Sourasky Medical Center (Ichilov)

Retrieved on: 
Tuesday, August 23, 2022
COVID-19, CEO, Technology, Safety, MTD, NTM, Toxicity, Ultra, Nitric oxide, GLOBE, Company, Radiation, Urinary tract infection, Adult, Patient, Spleen, Diagnosis, Cancer, Survival, Time, Death, Medical school, Incidence, SEC, FDA, Primary tumor, UNO, Metastasis, NASDAQ, Pulmonary hypertension, Head, Respiratory distress syndrome, Hypoxemia, Pulmonology, Immunotherapy, Treatment, HIV disease progression rates, Policy, Wilms' tumor, Tel Aviv Sourasky Medical Center, Faculty, Index (publishing), Atmosphere of Earth, NO, Annual report, Nontuberculous mycobacteria, Forward-looking statement, Pharmaceutical industry, Medical imaging, Vaccine, Oncology, Medicine, Tel Aviv University

Jedidiah Monson, M.D., Chief Medical Officer of Beyond Cancer, added, This open-label, first-in-human, single administration, Phase I study is a promising advancement as a new approach towards treating solid tumors with nitric oxide.

Key Points: 
  • Jedidiah Monson, M.D., Chief Medical Officer of Beyond Cancer, added, This open-label, first-in-human, single administration, Phase I study is a promising advancement as a new approach towards treating solid tumors with nitric oxide.
  • "Once again the Beyond Air team executes, this time in collaboration with our Beyond Cancer colleagues.
  • We will continue our rapid development to determine what role UNO therapy may play in the fight against solid tumors.
  • Ultra-high concentration Nitric Oxide (UNO) therapy is a completely new approach to preventing relapse or metastatic disease.

Sheba Medical Center and Enlivex Announce Dosing of the First Patient in Phase I/II Trial Evaluating Allocetra Combined with Chemotherapy in Patients with Peritoneal Metastases Arising from Solid Cancers

Retrieved on: 
Wednesday, July 6, 2022
American Society of Clinical Oncology, Decision-making, Patient, Research, Macrophage, GLOBE, Marketing, General officer, Progression-free survival, Phase, U.S. Securities and Exchange Commission, Tel Aviv University, Immune system, Animal, Oncology, Primary tumor, International Society, ASCO, Therapy, Security (finance), MFD, Department, FDA, Tuba City Regional Health Care Corporation, Annual general meeting, Tissue, TEL, Sheba Medical Center, Population, Risk, Newsweek, Immunotherapy, Sepsis, ORR, Cell, Technology, Private Securities Litigation Reform Act, Survival, Nasdaq, SOC, City, Ascites, Annual report, Abdomen, Surgical oncology, Metastasis, Cancer, Principal, Intraperitoneal injection, Human, Gene, Tumor microenvironment, Safety, Peritoneum, Society, Hope, Pharmaceutical industry, Medical imaging, Medical device

Patients with peritoneal metastases are in urgent need of novel treatment options, as standard-of-care (SOC) chemotherapy currently provides only modest survival benefits.

Key Points: 
  • Patients with peritoneal metastases are in urgent need of novel treatment options, as standard-of-care (SOC) chemotherapy currently provides only modest survival benefits.
  • We are eager to test this new combination with the hope of changing the lives of patients with peritoneal metastases.
  • We are excited to test this combination as a new hope for patients with peritoneal cancers.
  • It is designed to evaluate the safety and potential preliminary efficacy of Allocetra combined with SOC chemotherapy in patients with peritoneal metastases arising from solid cancer.

Junshi Biosciences and Coherus Announce FDA Acceptance of Resubmission of BLA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma

Retrieved on: 
Wednesday, July 6, 2022
Patient, Nose, Biosimilar, GLOBE, Marketing, COVID-19, Biologics license application, Pharynx, PD-L2, Ranibizumab, Drug development, EUA, Primary tumor, Severe acute respiratory syndrome coronavirus 2, National Medical Products Administration, FDA, Bamlanivimab, Infection, Journal of Clinical Oncology, Skull, NMPA, Breakthrough therapy, Agency, Immunotherapy, Travel, Autoimmunity, SSE, CEO, Blas, NPC, Orphan drug, American Society of Clinical Oncology, Lilly, Nasopharyngeal carcinoma, Private Securities Litigation Reform Act, Social responsibility, HKEX, Review, Journal, Cisplatin, Bamlanivimab/etesevimab, Ligand, HIV disease progression rates, Nature Medicine, PD-1, U.S. Securities and Exchange Commission, United, PD-L1, Risk, Cancer, Radiation, PDUFA, Society, BLA, Medical device, Pharmaceutical industry, Science

SHANGHAI, China and REDWOOD CITY, Calif., July 06, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”) announced today that the United States Food and Drug Administration ("FDA") has accepted for review the Biologics License Application (“BLA”) resubmission for toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

Key Points: 
  • Over the next several months, we will work closely with the FDA to facilitate the review of this novel drug.
  • Toripalimab would address a critical unmet medical need for patients with nasopharyngeal carcinoma, an aggressive cancer for which there are currently no FDA-approved immunotherapy treatments.
  • We collaborated closely with our partner, Junshi Biosciences, to complete the quality process changes requested by the FDA and facilitate the rapid resubmission of the toripalimab BLA, said Dr. Theresa LaVallee, Chief Development Officer of Coherus.
  • The resubmission of the BLA for toripalimab for the treatment of NPC was accepted by the FDA in July 2022.

Coherus and Junshi Biosciences Announce FDA Acceptance of Resubmission of BLA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma

Retrieved on: 
Wednesday, July 6, 2022
Patient, Nose, Biosimilar, GLOBE, Marketing, COVID-19, Biologics license application, Pharynx, PD-L2, Ranibizumab, Drug development, EUA, Primary tumor, Severe acute respiratory syndrome coronavirus 2, National Medical Products Administration, FDA, Bamlanivimab, Infection, Journal of Clinical Oncology, Skull, NMPA, Breakthrough therapy, Agency, Immunotherapy, CHRS, Travel, Autoimmunity, SSE, CEO, Blas, NPC, Orphan drug, American Society of Clinical Oncology, Lilly, Nasopharyngeal carcinoma, Private Securities Litigation Reform Act, Social responsibility, HKEX, Review, Journal, Cisplatin, Bamlanivimab/etesevimab, Ligand, HIV disease progression rates, Nature Medicine, PD-1, U.S. Securities and Exchange Commission, United, PD-L1, Risk, Cancer, Radiation, PDUFA, Society, BLA, Medical device, Pharmaceutical industry, Science

REDWOOD CITY, Calif., and SHANGHAI, China, July 06, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) announced today that the United States Food and Drug Administration ("FDA") has accepted for review the Biologics License Application (“BLA”) resubmission for toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

Key Points: 
  • Toripalimab would address a critical unmet medical need for patients with nasopharyngeal carcinoma, an aggressive cancer for which there are currently no FDA-approved immunotherapy treatments.
  • We collaborated closely with our partner, Junshi Biosciences, to complete the quality process changes requested by the FDA and facilitate the rapid resubmission of the toripalimab BLA, said Dr. Theresa LaVallee, Chief Development Officer of Coherus.
  • Over the next several months, we will work closely with the FDA to facilitate the review of this novel drug.
  • The resubmission of the BLA for toripalimab for the treatment of NPC was accepted by the FDA in July 2022.

Enlivex Receives Israeli Ministry of Health Authorization for the Initiation of a Phase I/II Trial Evaluating Allocetra Combined with Chemotherapy in Patients with Peritoneal Metastases Arising from Solid Cancers

Retrieved on: 
Monday, June 6, 2022
Human, MFD, Immunotherapy, Macrophage, Company, Society, Marketing, Gene, Tams, Survival, Safety, Neoplasm, Decision-making, ORR, Progression-free survival, Animal, Metastasis, Annual report, Security (finance), International Society, Cancer, U.S. Securities and Exchange Commission, MOH, Cell, Nasdaq, Ovarian cancer, Medicine, Ministry, Peritoneum, FDA, Therapy, GLOBE, Patient, Primary tumor, Private Securities Litigation Reform Act, Sepsis, Intraperitoneal injection, Trial of the century, Ascites, Risk, Immune system, Phase, Immunosuppression, Population, SOC, Tissue, Mission statement, Pharmaceutical industry, Medical imaging, Medical device

Nes-Ziona, Israel, June 06, 2022 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis and solid tumors, today announced that the Israeli Ministry of Health (MOH) authorized the initiation of a company-sponsored Phase I/II clinical trial evaluating Allocetra™ combined with chemotherapy in patients with peritoneal metastases arising from solid cancer.

Key Points: 
  • Patients with peritoneal metastases are in urgent need of novel treatment options, as standard-of-care (SOC) chemotherapy provides only modest survival benefits.
  • It is designed to evaluate the safety and potential preliminary efficacy of Allocetra combined with SOC chemotherapy in patients with peritoneal metastases arising from solid cancer.
  • Intraperitoneally delivered Allocetra and SOC chemotherapy administered via PIPAC will be given to patients every six weeks.
  • Enlivex plans to initiate the Phase I/II trial evaluating Allocetra in combination with chemotherapy in patients with peritoneal metastases arising from solid cancer in Q3 2022.

Aura Biosciences Announces Publication of Preclinical Data of the Combination of VDCs with Immune Checkpoint Inhibitors at the 2022 ASCO Annual Meeting

Retrieved on: 
Thursday, May 26, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Cancer, Risk, VDC, Annual general meeting, Private Securities Litigation Reform Act, U.S. Securities and Exchange Commission, Survival, Â, Leiden University Medical Center, Patient, Goal, Leiden University, NASDAQ, Review, Primary tumor, University Medical Center, Radiation, Wilms' tumor, Clinical trial, Society, COVID-19, Aura, American Society of Clinical Oncology, Intention, ASCO, NMIBC, Acral lentiginous melanoma, LinkedIn, Immune system, Twitter, SEC, Pharmaceutical industry, Ophthalmology

Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the publication of preclinical data on AU-011, its first VDC product candidate, in combination with immune checkpoint inhibitors.

Key Points: 
  • Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the publication of preclinical data on AU-011, its first VDC product candidate, in combination with immune checkpoint inhibitors.
  • The abstract has been published online as part of the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 3-7, 2022, in Chicago, IL.
  • AU-011 selectively targets and destroys cancer cells and activates the immune system with the potential to create long-lasting anti-tumor immunity.
  • Aura plans to develop AU-011 across its ocular oncology franchise including for the treatment of patients with choroidal metastases.

Oxford BioTherapeutics Announces Collaboration with Agenus to Support the Clinical Development of OBT's Antibody Drug Conjugate OBT076 in combination with Agenus' CPI Balstilimab

Retrieved on: 
Wednesday, May 25, 2022
Cancer, Company, BMS, Neoplasm, CPI, Infection, CD205, GMP, ImmunoGen, Doctor of Philosophy, Kite Pharma, Antibody-drug conjugate, Patient, Wuxi, ADC, PD-1, OXFORD, Primary tumor, Therapy, Clinical trial, Mink, Research, SAN, Partnership, Ovarian cancer, Boehringer Ingelheim, Lung, CMO, Twitter, Immune system, Amgen, OBT, MD, CA, CEO, Pharmaceutical industry, Medical imaging, Vaccine, IO

OBT plans to evaluate the clinical efficacy of OBT076 in combination with Agenus proprietary CPI, balstilimab.

Key Points: 
  • OBT plans to evaluate the clinical efficacy of OBT076 in combination with Agenus proprietary CPI, balstilimab.
  • Balstilimab is an PD-1 blocking antibody currently in clinical development in several solid tumor indications.
  • "I am very excited about our new partnership with Agenus, which will allow us to progress the clinical development of OBT076 in combination with balstilimab," said Christian Rohlff, PhD, Chief Executive Officer (CEO) of Oxford BioTherapeutics.
  • "We look forward to collaborating with Oxford BioTherapeutics to bring this novel combination to patients," said Steven O'Day, MD, Chief Medical Officer of Agenus.

Oxford BioTherapeutics Announces Collaboration with Agenus to Support the Clinical Development of OBT's Antibody Drug Conjugate OBT076 in combination with Agenus' CPI Balstilimab

Retrieved on: 
Wednesday, May 25, 2022
Cancer, Company, BMS, Neoplasm, CPI, Infection, CD205, GMP, ImmunoGen, Doctor of Philosophy, Kite Pharma, Antibody-drug conjugate, Patient, Wuxi, ADC, PD-1, OXFORD, Primary tumor, Therapy, Clinical trial, Mink, Research, SAN, Partnership, Ovarian cancer, Boehringer Ingelheim, Lung, CMO, Twitter, Immune system, Amgen, OBT, MD, CA, CEO, Pharmaceutical industry, Medical imaging, Vaccine, IO

OBT plans to evaluate the clinical efficacy of OBT076 in combination with Agenus proprietary CPI, balstilimab.

Key Points: 
  • OBT plans to evaluate the clinical efficacy of OBT076 in combination with Agenus proprietary CPI, balstilimab.
  • Balstilimab is an PD-1 blocking antibody currently in clinical development in several solid tumor indications.
  • "I am very excited about our new partnership with Agenus, which will allow us to progress the clinical development of OBT076 in combination with balstilimab," said Christian Rohlff, PhD, Chief Executive Officer (CEO) of Oxford BioTherapeutics.
  • "We look forward to collaborating with Oxford BioTherapeutics to bring this novel combination to patients," said Steven O'Day, MD, Chief Medical Officer of Agenus.

Lantheus Announces First Patient Dosed in Phase 2 Clinical Trial of NM-01 to Monitor PD-L1 Expression in Non-Small Cell Lung Cancer (NSCLC) Patients

Retrieved on: 
Friday, May 13, 2022
Company, Wilms' tumor, Neoplasm, Private Securities Litigation Reform Act, U.S. Securities and Exchange Commission, CSO, Patient, NASDAQ, Solution, Decision-making, Primary tumor, Immunohistochemistry, Artificial intelligence, Bausch Health, NSCLC, PD-L1, Technetium, Securities Act of 1933, Securities Exchange Act of 1934, Opioid, Forward-looking statement, LNTH, Large-cell lung carcinoma, Drug Quality and Security Act, Prognosis, Therapy, Security (finance), Intelligence, PSMA, Risk, Interim, GLOBE, Medical imaging, MD

The PELICAN trial (NCT04992715) is an open-label, single-arm trial in non-small cell lung cancer (NSCLC) patients.

Key Points: 
  • The PELICAN trial (NCT04992715) is an open-label, single-arm trial in non-small cell lung cancer (NSCLC) patients.
  • The primary endpoint is the assessment of PD-L1 expression in primary tumor and metastatic lesions by NM-01 compared to immunohistochemistry.
  • Other objectives will look at quantifying intra- and inter-tumoral heterogeneity of PD-L1 expression by NM-01, as well as establishing correlation with other diagnostic procedures.
  • The trial is being conducted by Lantheus partner NanoMab Technology Limited (NanoMab) at Kings College London.

NexImmune Announces Preclinical Research Collaboration with Columbia University Irving Medical Center’s Herbert Irving Comprehensive Cancer Center

Retrieved on: 
Tuesday, April 26, 2022
ACT, Head, Neck, Columbia, PDO, Nakagawa, U.S. Securities and Exchange Commission, Security (finance), DRS, Research, Annual report, MD, Immunotherapy, R, Columbia University Irving Medical Center, Private Securities Litigation Reform Act, Degenerative disease, Associate, GLOBE, Columbia University, Patient, Terminology, Infection, Toxic shock syndrome, Multiple myeloma, Technology, Nasdaq, Company, Nanoparticle, AML, SEC, Forward-looking statement, AIM, Assistant, NCI, Cancer, NEXI, Primary tumor, Medical imaging, Vaccine, Medicine

Columbia scientists Hiroshi Nakagawa, MD, Associate Professor of Medicine, and Brian Henick, MD, Assistant Professor of Medicine, will lead the research.

Key Points: 
  • Columbia scientists Hiroshi Nakagawa, MD, Associate Professor of Medicine, and Brian Henick, MD, Assistant Professor of Medicine, will lead the research.
  • HICCC is an NCI designated cancer center that is at the forefront of discovery science, translational medicine, clinical trials, clinical care and community outreach.
  • HPV-associated cancers remain an area with a large unmet medical need, said Dr. Jerry Zeldis, Executive Vice President, R&D of NexImmune.
  • Our collaboration with Columbia University Irving Medical Center will continue to help us develop new therapies for those patients that are not adequately treated and cured with existing standard of care.