PD-1

Elevar Therapeutics To Present Two Posters From Phase 3 CARES-310 Study at 2024 ASCO Gastrointestinal Cancers Symposium

Retrieved on: 
Thursday, January 18, 2024
CP, Patient, Therapy, Sorafenib, PD-1, ASCO, Survival, Society, Camrelizumab, Quality of life, Hepatocellular carcinoma, Food, DIH, Hepatotoxicity, FDA, PDUFA, TKI, Moscone Center

ASCO GI will be held Jan. 18-20, 2024, at the Moscone Convention Center (West) in San Francisco, and online.

Key Points: 
  • ASCO GI will be held Jan. 18-20, 2024, at the Moscone Convention Center (West) in San Francisco, and online.
  • Elevar’s poster presentations are:
    Abstract Title: Impact of baseline liver function on survival outcomes in patients with unresectable hepatocellular carcinoma (uHCC) treated with camrelizumab + rivoceranib vs sorafenib: A post hoc analysis of study CARES-310.
  • The results of this post-hoc analysis may have implications for selection of initial and subsequent therapies for uHCC patients.
  • The FDA assigned Prescription Drug User Fee Act (PDUFA) target action dates in May 2024.

Oxford BioTherapeutics Announces First Patient Dosed with OBT076 in Phase 1b Trial in Adenoid Cystic Carcinomas of the Head and Neck

Retrieved on: 
Thursday, January 18, 2024
Hope, OBT, Neoplasm, Patient, Radiation therapy, MD, ADC, Neck, PD-1, Radiation, Head, NSCLC, ACC, Doctor of Philosophy, Antigen, Ovarian cancer, Lausanne University Hospital, Lung, CPI, CD205, Pharmaceutical industry

OBT076 targets the CD205 receptor on tumor cells as well as certain immune suppressive cells in high-risk cancer patients.

Key Points: 
  • OBT076 targets the CD205 receptor on tumor cells as well as certain immune suppressive cells in high-risk cancer patients.
  • The CD205 receptor is highly overexpressed in solid and liquid tumors with high unmet need, including gastric, lung and ovarian cancer.
  • We look forward to demonstrating the potential value of OBT076, with the hope to provide meaningful benefit for ACC patients.
  • Trial arms are investigating OBT076 both as a monotherapy and in combination with a CPI in these tumors.

Immunotherapy for Pancreatic Cancer: Peptidic Targeting of a Tumor-Specific Glycan, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Wednesday, January 24, 2024
SRI International, PD-1, Mouse, MGS5, Cancer, Immunotherapy, Metastasis, CMAH, Food, Blood, Food and Drug Administration, Measles, MHC, FDA, Therapy, Glycosylation, Pancreatic cancer, Vaccine

TORONTO, Jan. 24, 2024 /PRNewswire-PRWeb/ -- Explore this webinar on a peptide ligand, called molecular guidance system 5 (MGS5), targeting N-glycolylneuraminic acid (Neu5Gc)-Sialyl LewisA in cancer, enhancing early detection and advancing liposome-based immunotherapy for pancreatic cancer.

Key Points: 
  • Attendees will learn about molecular guidance systems (MGSs) that can be identified for virtually any cell type.
  • The featured speaker will discuss a novel immunotherapy to use in combination with checkpoint inhibitors, and more.
  • TORONTO, Jan. 24, 2024 /PRNewswire-PRWeb/ -- Explore this webinar on a peptide ligand, called molecular guidance system 5 (MGS5), targeting N-glycolylneuraminic acid (Neu5Gc)-Sialyl LewisA in cancer, enhancing early detection and advancing liposome-based immunotherapy for pancreatic cancer.
  • Join Shelby Knoche PhD, SRI International , for the live webinar on Wednesday, January 31, 2024, at 2pm EST (11am PST).

U.S. Food and Drug Administration Grants Full Approval for BALVERSA® to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations

Retrieved on: 
Friday, January 19, 2024
Potassium, Death, Xerostomia, Patient, State, Overalls, Hyperphosphatemia, Shanda, OS, Bladder cancer, Stomatitis, PD-1, MUC, Survival, Fatigue, Sodium, Calcium, Cohort, Risk, FGFR, PD-L1, Xeroderma, Food, Constipation, Disease, Nail, Creatinine, Johnson & Johnson, Erdafitinib, Neoplasm, FDA, Confidence interval, Diarrhea, New Drug Application, FGFR3, Drug, Appetite, Pharmaceutical industry

RARITAN, N.J., Jan. 19, 2024 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for BALVERSA® (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This FDA action converts the April 2019 accelerated approval of BALVERSA® to a full approval based on the clinical and overall survival benefit observed in the Phase 3 THOR study. BALVERSA® is the first oral FGFR kinase inhibitor to be approved, and the first and only targeted treatment for patients with mUC and FGFR alterations.

Key Points: 
  • BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.
  • This FDA action converts the April 2019 accelerated approval of BALVERSA® to a full approval based on the clinical and overall survival benefit observed in the Phase 3 THOR study.
  • BALVERSA® is the first oral FGFR kinase inhibitor to be approved, and the first and only targeted treatment for patients with mUC and FGFR alterations.
  • This model is part of the Company's ongoing commitment to provide high-quality products, services, access, and support to healthcare professionals and patients.

ClearNote Health Announces New Proprietary Approach for Predicting Immunotherapy Treatment Response in Non-Small Cell Lung Cancer Using Only Blood

Retrieved on: 
Tuesday, January 16, 2024
Oncology, Health, Technology, Other Health, Artificial Intelligence, Biotechnology, Hope, Translational research, Translation, Prostate cancer, Patient, Biology, Research, SITC, DNA, Type 2 diabetes, PD-1, Nivolumab, Society, Cancer research, Nucleic acid thermodynamics, Immunotherapy, Risk, NSCLC, Plasma, Journal, Disease, Lung cancer, Biomarker, Pembrolizumab, Bayer, Pancreatic cancer, Pharmaceutical industry

The article, “ Plasma Cell-Free DNA Hydroxymethylation Profiling Reveals Anti-PD-1 Treatment Response and Resistance Biology in Non-Small Cell Lung Cancer ,” was published in the online issue of The Journal for ImmunoTherapy of Cancer, the official journal of the Society for Immunotherapy of Cancer (SITC) .

Key Points: 
  • The article, “ Plasma Cell-Free DNA Hydroxymethylation Profiling Reveals Anti-PD-1 Treatment Response and Resistance Biology in Non-Small Cell Lung Cancer ,” was published in the online issue of The Journal for ImmunoTherapy of Cancer, the official journal of the Society for Immunotherapy of Cancer (SITC) .
  • The comparison of plasma-derived cfDNA 5-hmC profiles revealed differences that distinguish patients responding to therapy from those not responding before and throughout treatment.
  • This underscores the value of 5hmC analysis for the measurement of treatment response biomarkers without the need for an invasive and potentially deadly tissue biopsy.
  • A recently published study in Cancer Research, “ The 5-Hydroxymethylcytosine Landscape of Prostate Cancer ,” showed the utility of ClearNote Health’s platform in marking epigenetic activation in prostate cancer and identifying hallmarks of prostate cancer progression.

Medicenna Commences Enrollment in the ABILITY-1 Study Combining MDNA11 with Pembrolizumab

Retrieved on: 
Tuesday, January 9, 2024
MSD, MDNA, Patient, Neoplasm, PD-1, Mouse, OTCQB, Cancer, TSX, Pembrolizumab, CPI, JITC, Pharmaceutical industry

“We are very pleased to announce initiation of the combination study of MDNA11 and the PD-1 inhibitor, pembrolizumab, the leading checkpoint inhibitor therapy,” said Fahar Merchant, Ph.D., President and CEO of Medicenna.

Key Points: 
  • “We are very pleased to announce initiation of the combination study of MDNA11 and the PD-1 inhibitor, pembrolizumab, the leading checkpoint inhibitor therapy,” said Fahar Merchant, Ph.D., President and CEO of Medicenna.
  • “Having established an appropriate dose for monotherapy as well as demonstrating its early clinical validation we believe MDNA11 may further enhance anti-tumor activity when combined with pembrolizumab in patients that do not respond or develop resistance to checkpoint therapy.
  • We look forward to reporting preliminary results from both the monotherapy expansion and combination escalation arms of the Phase 2 study in the first half of 2024.”
    In the Phase 1 monotherapy dose escalation and dose evaluation portions of the study, MDNA11 was well tolerated with promising single-agent activity.
  • MDNA11, with its uniquely differentiating ‘beta-enhanced not-alpha’ features, continues to be a potential best-in-class next-generation IL-2 super-agonist for treatment of advanced solid tumors.

Enhancing Leadership in Gynecology, Asieris Pharmaceuticals Appoints Sophia Cao to Lead the Newly-Established Women's Health Business Unit, Accelerating Strategic Expansion

Retrieved on: 
Tuesday, January 9, 2024
Action plan, E pluribus unum, Woman, Bladder cancer, Marketing, Health, Elimination, Society, Cancer, Cervical cancer, Infection, World Health Organization, Diagnosis, NMIBC, Comparison, Cervical weakness, Multimedia, Death, ASCO, Breast cancer, Eli Lilly, Tislelizumab, Prevalence, MIBC, Neoadjuvant therapy, HPV, Human papillomavirus infection, LSIL, New Drug Application, NMPA, National Health Commission, Central China, Kidney cancer, Women's health, National Cancer Center, PD-1, WHO, Mortality, HSIL, Conditional sentence, Internet, Weak topology, Patient, Senior, State Council, NDA, Incidence, Head, National Medical Products Administration, Miscarriage

This strategic move is designed to enhance the company's focus on genitourinary diseases and strengthen its position in women's health.

Key Points: 
  • This strategic move is designed to enhance the company's focus on genitourinary diseases and strengthen its position in women's health.
  • Asieris Pharmaceuticals will leverage both in-house discoveries and external partnerships to enrich its gynecological portfolio, thereby reinforcing its leadership in women's health.
  • In November 2020, the World Health Organization (WHO) released a Global Strategy to Accelerate the Elimination of Cervical Cancer.
  • To further deliver its strategic vision and commitment in the realm of women's health, Asieris Pharmaceuticals has announced the establishment of the Women's Health Business Unit.

Akeso to Present at the 42nd Annual J.P. Morgan Healthcare Conference and Share Its Corporate & Innovative Clinical Development Roadmap

Retrieved on: 
Monday, January 8, 2024
Monoclonal antibody, Immunotherapy, NPC, Atopic dermatitis, Hepatocellular carcinoma, Shanda, Cervical cancer, PD-1, EGFR, CDE, Anemia, NDA, HCC, Cohort, Death, Bevacizumab, NMPA, Ankylosing spondylitis, Summit, Patient, ADC, NSCLC, Hypercholesterolemia, PCSK9, Pembrolizumab, Pharmaceutical industry

Ivonescimab is expected to become the world's first bispecific drug combining immunotherapy and anti-angiogenesis.

Key Points: 
  • Ivonescimab is expected to become the world's first bispecific drug combining immunotherapy and anti-angiogenesis.
  • Potential initiation of a Phase III clinical trial for manfidokimab (IL-4R) for the treatment of moderate atopic dermatitis.
  • Over the next five years, Akeso has high expectations of launching around 10 internally developed blockbuster drugs, both in China and worldwide, thereby achieving successful commercialization.
  • Akeso has established and continuously advances its integrated and efficient system of discovery, development, production, and sales of its innovative drugs and pipeline candidates.

Compugen to Receive $10 Million Milestone Payment Following Dosing of First Patient in AstraZeneca Phase 3 Rilvegostomig Trial in Biliary Tract Cancer

Retrieved on: 
Monday, January 8, 2024
Compugen, PD-1, Immunotherapy, TIGIT, Cholangiocarcinoma, Pharmaceutical industry

HOLON, Israel, Jan. 8, 2024 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced that Compugen is entitled to receive a $10 million milestone payment from AstraZeneca (LSE/STO/Nasdaq: AZN), after the first patient was dosed in AstraZeneca's ARTEMIDE-Bil01 trial with rilvegostomig.

Key Points: 
  • HOLON, Israel, Jan. 8, 2024 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced that Compugen is entitled to receive a $10 million milestone payment from AstraZeneca (LSE/STO/Nasdaq: AZN), after the first patient was dosed in AstraZeneca's ARTEMIDE-Bil01 trial with rilvegostomig.
  • Rilvegostomig is a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical-stage anti-TIGIT antibody, COM902.
  • The ARTEMIDE-Bil01 trial is expected to recruit about 750 subjects in more than 20 countries with biliary tract cancer who will be randomized to receive rilvegostomig or placebo with investigator choice chemotherapy as adjuvant treatment after resection with curative intent.
  • "I am delighted to see the advancement of the rilvegostomig Phase 3 trial by AstraZeneca, a global leader in oncology, which has dosed the first patient triggering a $10 million milestone payment to Compugen," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen.

iTeos Announces 2024 Strategic Priorities and Anticipated Milestones

Retrieved on: 
Monday, January 8, 2024
IO, ENT1, Survival, Place of birth, PD-1, Therapy, GSK, Lymphocyte, HNSCC, Patient, TIGIT, NSCLC, Equilibrative nucleoside transporter 1, Pharmaceutical industry

WATERTOWN, Mass. and GOSSELIES, Belgium, Jan. 08, 2024 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, today outlined business updates and strategic priorities for 2024.

Key Points: 
  • and GOSSELIES, Belgium, Jan. 08, 2024 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, today outlined business updates and strategic priorities for 2024.
  • “Over the past twelve months, the TIGIT competitive landscape has substantially evolved, further positioning iTeos and GSK as a potential leader with our high-quality TIGIT:PD-1 doublet, belrestotug + dostarlimab.
  • The Company plans to integrate IO-001 biomarker knowledge into the development strategy of future inupadenant clinical trials.
  • The Company continues to expect its cash balance to provide runway through 2026, which includes the initiation of multiple Phase 3 registrational trials assessing the belrestotug + dostarlimab doublet.