Immunotherapy

EnGeneIC’s breakthrough Armed Nanocell Drug Conjugate (ANDC) treatment shows promising results in Pancreatic cancer patients who have run out of treatment options

Retrieved on: 
Monday, November 27, 2023
Drug resistance, McDiarmid, Quality of life, Immunotherapy, Survival, Heel, Immune system, Human body weight, Lead, Neoplasm, Clinical trial, Cancer, Rated R, EDV, Pancreatic cancer, Conditional sentence, PDAC, Toxicity, Weight gain, Optimism, Patient, Therapy, Pharmaceutical industry

The trial results highlight a significant advance in the treatment landscape for PDAC:

Key Points: 
  • The trial results highlight a significant advance in the treatment landscape for PDAC:
    Unprecedented Survival Rates.
  • The trial demonstrated a substantial increase in median overall survival for patients, with 88% of participants surpassing at least double the historical survival rates.
  • Remarkably, more than 80% of patients receiving the EDV treatment either maintained or experienced weight gain.
  • Joint-CEO and Director of EnGeneIC, Dr Jennifer MacDiarmid said, “We are very excited about the results of our Carolyn Trial.

Greenwich LifeSciences Extends Lock-up of Directors and Officers to End of 2024

Retrieved on: 
Tuesday, November 21, 2023
IPO, Immunotherapy, Patient, Breast cancer

STAFFORD, Texas, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced that its Board of Directors has extended the lock-up of the shares owned by the Company’s directors, officers, and existing pre-IPO investors to December 31, 2024 which is approximately 51 months from date of the Company’s IPO.

Key Points: 
  • STAFFORD, Texas, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced that its Board of Directors has extended the lock-up of the shares owned by the Company’s directors, officers, and existing pre-IPO investors to December 31, 2024 which is approximately 51 months from date of the Company’s IPO.
  • During this period, current officers, directors and certain shareholders will not be able to sell their shares of the Company's common stock unless otherwise modified by the Board of Directors.

SAB Biotherapeutics Appoints Katie Ellias to the Board of Directors

Retrieved on: 
Monday, November 20, 2023
Immunotherapy, McKinsey & Company, Health, Health care, SAB, Therapy, University, Medtronic, Growth, Investment, Sofinnova

With Ms. Ellias’ appointment, the SAB Biotherapeutics Board is composed of ten directors, eight of whom are independent.

Key Points: 
  • With Ms. Ellias’ appointment, the SAB Biotherapeutics Board is composed of ten directors, eight of whom are independent.
  • Ms. Ellias serves as a Managing Director at the JDRF T1D Fund LLC, a venture philanthropy fund with approximately $200 million in assets, including an investment in SAB.
  • “Katie’s exceptional experience and deep expertise in T1D are a natural fit for SAB’s Board of Directors,” said Samuel J. Reich, Executive Chairman of SAB.
  • I’m inspired by what the company is building and honored to join their Board of Directors.”

USA Solid Tumor Therapeutics Market Outlook to 2028 - Field of Oncology is Moving Towards more Personalized Treatment - ResearchAndMarkets.com

Retrieved on: 
Tuesday, December 26, 2023
Surgery, Medical Devices, Hospitals, Biotechnology, Radiology, Managed Care, Health, General Health, Oncology, Ipsen, Immunotherapy, Pfizer, Amgen, AstraZeneca, Breast cancer, Research, FDA, Lung, Breast, Colorectal cancer, Prevalence, Mortality, Tissue, Therapy, Cancer, Human services, Novartis, Neoplasm, Geography, Genetics, Prostate, Genomics, Traction, Growth, Patient, Gilead Sciences, Pharmaceutical industry

The "USA Solid Tumor Therapeutics Market Outlook to 2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "USA Solid Tumor Therapeutics Market Outlook to 2028" report has been added to ResearchAndMarkets.com's offering.
  • United States holds a significant share in the solid tumor therapeutics market.
  • Solid tumors are a significant healthcare concern in the United States, contributing to a significant portion of cancer cases & mortality.
  • The field of oncology is moving towards more personalized treatment approaches, where therapies are tailored to an individual patient's genetic & molecular profile.

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.

Natera Announces New Study Highlighting the Benefits of Signatera’s Unique Method of Quantifying ctDNA

Retrieved on: 
Thursday, December 21, 2023
Health, General Health, Women, Public Relations, Investor Relations, Oncology, Communications, Other Science, Research, Consumer, Science, Clinical Trials, NTRA, MTM, Plasma, Immunotherapy, Patient, Molecular oncology, Nucleic acid thermodynamics, Neoplasm, Circulating tumor DNA, Blood, DNA, MRD, Medical device

To date, mVAF and MTM/mL are the two main metrics that have been used to quantify ctDNA levels in the blood.

Key Points: 
  • To date, mVAF and MTM/mL are the two main metrics that have been used to quantify ctDNA levels in the blood.
  • The premise is that MTM/mL is therefore more representative of a patient’s true disease burden, a hypothesis that was validated in this study.
  • Among the 18,426 patients with longitudinal ctDNA measurements, 13.3% had discordant ctDNA trajectories (increase/decrease) when calculated using MTM/mL versus mVAF.
  • As the only MRD test that uses MTM/mL, this study supports the utility of Signatera for ctDNA quantification, to measure treatment response at critical time points and inform decisions on how patients are managed.”

NanOlogy Clinical and Preclinical Immune Data Presented at NACLC and SITC

Retrieved on: 
Tuesday, December 19, 2023
Research, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, Spleen, Immunotherapy, Conference, TME, LSAM, American Conference, Flow cytometry, Blood, Mouse, Paclitaxel, Immunomodulation, Society, Poster, Safety, Lung cancer, NK, NMIBC, SITC, Vaccine

NanOlogy LLC , a clinical-stage oncology company, reports data presented as posters during recent oncology conferences.

Key Points: 
  • NanOlogy LLC , a clinical-stage oncology company, reports data presented as posters during recent oncology conferences.
  • The poster was authored by clinical investigators Hiren Mehta , Abhishek Biswas , Sarah Wang , Jason Akulian , Christine Argento , et.al.
  • Summarizing presented data:
    The early phase lung cancer trial demonstrated safety and tolerability of intratumoral (IT) LSAM-PTX in combination with various concurrent therapies, including systemic immunotherapy.
  • Summarizing presented data:
    Immunophenotyping in 3 diverse tumor settings found commonalities in antitumor immunomodulation following local LSAM-DTX, including changes in T cells and MDSCs.

Gilead and Compugen Announce Exclusive License Agreement for Novel Pre-Clinical Immunotherapy Program

Retrieved on: 
Tuesday, December 19, 2023
Biotechnology, Hospitals, Health, Pharmaceutical, Oncology, Immunotherapy, Cytokine, Neoplasm, Tumor microenvironment, Multimedia, IND, Compugen, Science, Cancer, IPR, Patient, Gilead Sciences, EPS, Pharmaceutical industry

View the full release here: https://www.businesswire.com/news/home/20231218814564/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20231218814564/en/
    Compugen utilizes its broadly applicable predictive computational discovery capabilities to identify new drug targets and biological pathways for developing novel cancer immunotherapies.
  • Gilead will make Compugen an upfront payment of $60 million and $30 million in a near term milestone payment subject to IND clearance of COM503 expected in 2024.
  • Compugen will also be eligible to receive single-digit to low double-digit tiered royalties on worldwide net sales.
  • This transaction with Compugen is expected to reduce Gilead’s GAAP and non-GAAP 2023 EPS by approximately $0.03 - $0.05.

Innovent and Xuanzhu Enter into Clinical Trial Collaboration Investigating Combination Therapy of Sintilimab (PD-1 inhibitor) and A Novel ADC Candidate for Advanced Solid Tumors in China

Retrieved on: 
Thursday, December 28, 2023
Drug resistance, Immunotherapy, Intellectual property, HER2, IND, Autoimmunity, HKEX, PD-1, Eli Lilly, Clinical trial, Cancer, Sintilimab, Mutation, NMPA, Ophthalmology, NRDL, Patient, Safety, ADC, Endocytosis, Senior, Pharmaceutical industry

Under the agreement, Innovent will supply sintilimab for the collaborated clinical trial.

Key Points: 
  • Under the agreement, Innovent will supply sintilimab for the collaborated clinical trial.
  • Xuanzhu Biopharma will conduct a Phase 1b clinical study to evaluate the anti-tumor activity and safety of the combination therapy of sintilimab with KM-501 in Chinese patients with advanced solid tumors.
  • TYVYT® (sintilimab injection) is an innovative PD-1 inhibitor co-developed by Innovent and Eli Lilly and Company in China.
  • Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to collaborate with Xuanzhu Biopharma to explore the synergistic anti-tumor effects of the combination therapy of sintilimab and a novel ADC candidate.

Jemincare Announces 6 Approvals of Clinical Trials for its Innovative Drugs

Retrieved on: 
Tuesday, December 26, 2023
Hyperphosphatemia, Quality of life, Immunotherapy, Immune system, Klebsiella pneumoniae, FDA, PD-1, Renal cell carcinoma, Research, Bladder cancer, TKI, Cancer, Clinical trial, Pseudomonas aeruginosa, Acinetobacter baumannii, Chronic kidney disease, Phosphorus, Kidney disease, NMPA, BCG, Proteinuria, Escherichia coli, Kidney, Edema, National Medical Products Administration, Patient, Drug resistance, CKD, Dialysis, Gram-negative bacteria, Pharmaceutical industry

On December 20, NMPA has approved a clinical trial for JMKX003801 to treat serious infection caused by Gram-negative bacteria.

Key Points: 
  • On December 20, NMPA has approved a clinical trial for JMKX003801 to treat serious infection caused by Gram-negative bacteria.
  • Drug resistance of antibiotics, especially carbapenem resistance, in Escherichia coli, Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa has risen year by year.
  • On December 12, NMPA has approved a clinical trial for JMKX003142 to treat renal edema.
  • On December 12, FDA has approved a clinical trial for JMKX000197 to treat BCG-unresponsive non-muscle-invasive bladder cancer, and earlier on October 19, NMPA has approved the clinical trial.