Toxicity

Eledon Pharmaceuticals Announces 12th Participant Enrolled in Phase 2 BESTOW Trial Evaluating Tegoprubart for the Prevention of Organ Rejection

Retrieved on: 
Monday, March 25, 2024
Toxicity, Nephrotoxicity, Transplant, Organ transplantation, Central nervous system, Risk, Patient, Kidney transplantation, Tacrolimus, Thumbay Hospital, Life, Kidney, Immune system, Tremor, Hypertension, Immunosuppressive drug

IRVINE, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the enrollment of the 12th participant on March 23, 2024, in the Company’s ongoing Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.

Key Points: 
  • IRVINE, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the enrollment of the 12th participant on March 23, 2024, in the Company’s ongoing Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.
  • In transplantation procedures, organ rejection is a major cause of graft failure, which can be a life-threatening condition.
  • Rejection occurs due to allorecognition, wherein the recipient's immune system identifies the transplanted organ as foreign tissue, triggering an immune response against the transplanted organ.
  • Calcineurin inhibitors (“CNIs”) are a critical component of most immunosuppressive regimens to prevent acute and long-term organ transplant rejection.

Synthekine Presents Positive Initial Results from Phase 1a/1b Clinical Trial of α/β Biased IL-2, STK-012, for Treatment of Advanced Solid Tumors

Retrieved on: 
Tuesday, April 9, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Arthralgia, Toxicity, Cell, NSCLC, RECIST, HNSCC, Patient, Diarrhea, Maculopapular rash, Lung cancer, Renal cell carcinoma, Injection site reaction, AACR, Nausea, Lymphocyte, Hypotension, RCC, Transaminase, Poster, Itch, CLS, Capillary leak syndrome, Fatigue, Vomiting, NK, Inc., Pharmaceutical industry

Synthekine Inc ., an engineered cytokine therapeutics company, today announced positive initial results from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, for the treatment of advanced solid tumors.

Key Points: 
  • Synthekine Inc ., an engineered cytokine therapeutics company, today announced positive initial results from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, for the treatment of advanced solid tumors.
  • The data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego.
  • In the results presented, which included 47 patients treated in Phase 1a dose escalation, STK-012 monotherapy demonstrated a favorable safety, efficacy, pharmacokinetic and pharmacodynamic profile.
  • The poster, titled “Initial results from a Phase 1a/1b study of STK-012, a first-in-class α/β IL-2 receptor biased partial agonist in advanced solid tumors (NCT05098132),” will be presented today at AACR from 9 am to 12:30 pm PT.

Obsidian Therapeutics Presents Positive 25-Week Median Study Follow-Up Safety and Efficacy Data from First-in-Human Study of OBX-115 in Advanced Melanoma at the American Association for Cancer Research Annual Meeting

Retrieved on: 
Tuesday, April 9, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, Toxicity, NSCLC, TIL, Disease, Patient, University, MD Anderson Cancer Center, AACR, IL2, ICI, Therapy, Safety, Poster, PFS, Capillary leak syndrome, Cytokine release syndrome, Pharmaceutical industry

, professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center and principal investigator of the study.

Key Points: 
  • , professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center and principal investigator of the study.
  • The single-center study ( NCT05470283 ) is evaluating the safety, tolerability, dosing, and efficacy of OBX-115 in patients with ICI-resistant metastatic melanoma.
  • All 6 patients had disease that was primary-resistant to anti–PD-1 therapy, with a median of 2.5 (range, 1–5) lines of prior therapy.
  • In addition to the first-in-human study, Obsidian is actively enrolling patients with metastatic melanoma and NSCLC at multiple sites in its ongoing Phase 1/2 multicenter study.

Syros Receives Fast Track Designation from the FDA for Tamibarotene for the Treatment of Newly Diagnosed Unfit AML with RARA gene overexpression

Retrieved on: 
Tuesday, April 9, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Toxicity, Aplastic anemia, Syros, Tamibarotene, AML, Patient, Fast Track, Venetoclax, Acute myeloid leukemia, Azacitidine, Prognosis, MDS, Bone marrow, RARA, Pharmaceutical industry

Tamibarotene, an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, is currently being evaluated in combination with venetoclax and azacitidine for the treatment of newly diagnosed AML patients with RARA gene overexpression.

Key Points: 
  • Tamibarotene, an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, is currently being evaluated in combination with venetoclax and azacitidine for the treatment of newly diagnosed AML patients with RARA gene overexpression.
  • “We are pleased to receive Fast Track designation for tamibarotene for the treatment of AML.
  • Syros is evaluating tamibarotene in combination with venetoclax and azacitidine in newly diagnosed, unfit AML patients with RARA overexpression in the ongoing SELECT-AML-1 Phase 2 trial.
  • In January 2023, the FDA granted Fast Track Designation to tamibarotene for the treatment of HR-MDS patients with RARA overexpression.

Blue Earth Therapeutics Announces Promising Results from Preclinical Evaluation of Synergistic Drug Combinations with Radiopharmaceutical 177Lu-rhPSMA-10.1 for Treatment of Prostate Cancer

Retrieved on: 
Monday, April 8, 2024
Health, Radiology, Pharmaceutical, Clinical Trials, Oncology, Toxicity, Therapy, Neoplasm, AACR, DNA, Prostate cancer, PSMA, MEK, Pharmaceutical industry

Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, today announced results from a series of preclinical analyses designed to identify synergistic combinations of known anticancer drugs with 177Lu-rhPSMA-10.1 radioligand therapy, and from a preclinical efficacy analysis of the lead novel drug combination for the treatment of prostate cancer.

Key Points: 
  • Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, today announced results from a series of preclinical analyses designed to identify synergistic combinations of known anticancer drugs with 177Lu-rhPSMA-10.1 radioligand therapy, and from a preclinical efficacy analysis of the lead novel drug combination for the treatment of prostate cancer.
  • “Combination approaches are of increasing interest among the medical community, as we know tumors are heterogeneous and some prostate cancer cells do not express PSMA.
  • Results from this preclinical study presented at AACR demonstrated a synergistic therapeutic effect between 177Lu-rhPSMA-10.1 and an MEK inhibitor.
  • This may be due to inhibition of the MEK-MAPK pathway during DNA damage response, resulting in radiosensitization of cancer cells to 177Lu-rhPSMA-10.1.

PanTher Therapeutics Presents Positive First-in-Human Data for PTM-101 in Pancreatic Cancer at AACR Annual Meeting

Retrieved on: 
Monday, April 8, 2024
Oncology, Health, Surgery, Clinical Trials, Pharmaceutical, Biotechnology, Toxicity, Infection, Associate, Patient, Cancer, Doctor of Philosophy, MD, Panther, AACR, Pancreatic cancer, Neoplasm, Clinical trial, Therapy, Paclitaxel, Pancreas, Pancreatitis, Safety, Monash University, Prognosis, Pharmaceutical industry

PTM-101 was placed directly onto the pancreas, overlying the location of the tumor using standard laparoscopic equipment as part of a disease staging assessment.

Key Points: 
  • PTM-101 was placed directly onto the pancreas, overlying the location of the tumor using standard laparoscopic equipment as part of a disease staging assessment.
  • Once in place over the tumor site, PTM-101 locally delivered a sustained dose of the chemotherapeutic agent over four weeks.
  • Approximately three weeks after placement of PTM-101, all participants began standard of care therapy, which included treatment with mFOLFIRINOX.
  • Results of the clinical trial demonstrated that PTM-101 reduced the size of pancreatic tumors in all three patients.

Three-Year Follow-up Data in BCG-Unresponsive NMIBC Show Durable Response to Treatment with ADSTILADRIN® (nadofaragene firadenovec-vncg) in Two Patient Cohorts

Retrieved on: 
Monday, April 8, 2024
Biotechnology, Pharmaceutical, Managed Care, Oncology, General Health, Health, FDA, Clinical Trials, NMIBC, BCG, Toxicity, HG, Physician, Congress, Nadofaragene firadenovec, Survival, PD, Cystectomy, Ferring Pharmaceuticals, Patient, Aes, EAU, MD Anderson Cancer Center, University, Month, Carcinoma in situ, Safety, Division, Probability, CIS, Food, Pharmaceutical industry

“Intravesical gene therapy represents an important innovative treatment option for these patients.

Key Points: 
  • “Intravesical gene therapy represents an important innovative treatment option for these patients.
  • The efficacy analysis included 103 and 48 patients in the CIS and PD cohorts, respectively, who met the protocol definition of BCG-unresponsive NMIBC.
  • In total, 12.1% (13/107) and 20.0% (10/50) of patients in the CIS and PD cohorts, respectively, received ADSTILADRIN at three years.
  • In the CIS cohort, about 53% achieved a complete response (CR) at Month 3 in the primary analysis.

AbCellera Presents Data on T-Cell Engagers Against Four Tumor Targets at AACR 2024

Retrieved on: 
Monday, April 8, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Toxicity, 5T4, Translational research, Autoimmunity, Risk, Trichloroethylene, SVP, Cancer, Protein, CD3, Translation, AACR, Doctor of Philosophy, MHC, ABCL, TCE, Safety, CD28, San Diego Convention Center, PSMA, Peptide, Pharmaceutical industry

Together, AbCellera’s data demonstrate that it is well-positioned to advance TCEs as a drug class by widening the therapeutic window, enhancing potency, and broadening the accessible target space.

Key Points: 
  • Together, AbCellera’s data demonstrate that it is well-positioned to advance TCEs as a drug class by widening the therapeutic window, enhancing potency, and broadening the accessible target space.
  • “Our data illustrate that we can repeatedly generate TCEs that maximize tumor-cell killing without inducing excessive cytokine release.
  • The data show that AbCellera’s IgG and heavy chain-only CD28-binding antibodies do not display superagonist activity — a property associated with toxicity.
  • “We look forward to advancing these programs with the aim of delivering powerful new medicines for patients.”

Affini-T Therapeutics Presents Preclinical Data from its Oncogenic Driver Programs Targeting KRAS G12D and p53 R175H at the American Association for Cancer Research (AACR) Annual Meeting 2024

Retrieved on: 
Sunday, April 7, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Toxicity, TP53, Patient, Lung, Arginine, AACR, Cholangiocarcinoma, Therapy, TRAC, Pancreas, CRISPR, TCR, Vaccine

Affini-T Therapeutics, Inc ., a precision immunotherapy company unlocking the power of T cells against oncogenic driver mutations, today announced that management is presenting data from the company’s oncogenic driver programs targeting HLA-A*11:01 KRAS G12D and HLA-A*02:01 p53 R175H at this year’s American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego.

Key Points: 
  • Affini-T Therapeutics, Inc ., a precision immunotherapy company unlocking the power of T cells against oncogenic driver mutations, today announced that management is presenting data from the company’s oncogenic driver programs targeting HLA-A*11:01 KRAS G12D and HLA-A*02:01 p53 R175H at this year’s American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego.
  • “We are also proud to present preclinical data from our cell therapy targeting KRAS G12D, which highlights the promising potential of our proprietary non-viral knock-in THRIVE™ platform.
  • The study supports the planned clinical investigation of the novel KRAS G12D mutant TCR-engineered CD4+ and CD8+ T cell therapy in 2024.
  • These data support the planned clinical development of a novel non-viral TRAC-knocked-in T cell therapy for the treatment of p53 R175H-mutant solid tumors.

Shasqi to Present Data on Novel Tumor-Targeted Drug Activation Technology at 2024 American Association for Cancer Research (AACR) Annual Meeting

Retrieved on: 
Friday, April 5, 2024
HER2, Toxicity, Therapeutic index, SAN, MMAE, Spacecraft, Abstract (summary), Nobel Prize, AACR, Neoplasm, Safety, Shasqi, Click chemistry, Pharmaceutical industry

SAN FRANCISCO, April 5, 2024 /PRNewswire/ -- Shasqi, Inc. ("Shasqi"), a biotech company whose mission is to make cancer drugs more effective with click chemistry, today announced it will present five posters on the company's novel tumor-targeted drug activation approach at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, April 5-10, 2024.

Key Points: 
  • SAN FRANCISCO, April 5, 2024 /PRNewswire/ -- Shasqi, Inc. ("Shasqi"), a biotech company whose mission is to make cancer drugs more effective with click chemistry, today announced it will present five posters on the company's novel tumor-targeted drug activation approach at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, April 5-10, 2024.
  • The posters will describe data generated with Shasqi's CAPAC® (Click Activated Protodrugs Against Cancer) approach.
  • Shasqi is advancing a pipeline of assets based on validated targets and payloads.
  • The posters presented at the AACR meeting will show preclinical efficacy and safety data for assets targeting HER2, TROP2, and NECTIN-4, each paired with either an MMAE or exatecan payload.