IND

Quanta Presents Preclinical Data for QTX3544, a Potent and Selective G12V-preferring Multi-KRAS Inhibitor, in Late-Breaking Session at Annual AACR Meeting 2024

Retrieved on: 
Monday, April 8, 2024
Discovery, MAPK, Patient, Lung, Doctor of Philosophy, MD, IND, AACR, Therapy, Stomach

RADNOR, Pa. & SOUTH SAN FRANCISCO, Calif., April 08, 2024 (GLOBE NEWSWIRE) -- Quanta Therapeutics, a privately-held biopharmaceutical company leading innovative development of direct, oral therapeutics for RAS-driven cancers, announced the presentation of QTX3544, a multi-KRAS inhibitor with G12V-preferring activity (G12V+ multi-KRAS), in a late-breaking poster presentation session at the American Association of Cancer Research (AACR) Annual Meeting.

Key Points: 
  • QTX3544 demonstrated a favorable preclinical profile, including high selectivity and potent activity against multiple KRAS mutations with preference for the G12V mutation.
  • Additionally, QTX3544 significantly inhibited KRASG12V tumor growth in preclinical animal models and exhibited promising oral bioavailability and pharmacokinetic properties.
  • “We continue to advance our pipeline of candidates against KRAS-driven cancer mutations focusing on the most prevalent drivers, G12D and G12V,” said Perry Nisen, MD, PhD, Chief Executive Officer of Quanta.
  • We look forward to completing IND-enabling studies for QTX3544 this year to support future clinical studies in patients with G12V-mutated solid tumors, a population without targeted treatment options.”
    Data from the presentation are summarized below.

Medigene Presents Favorable Safety Profile of TCR-T Cells with Costimulatory Switch Protein at AACR Annual Meeting 2024

Retrieved on: 
Monday, April 8, 2024
TME, Toxicity, Ovarian cancer, Sarcoma, Tissue, Synovial sarcoma, IND, AACR, Safety, Immune system, Melanoma, TCR, Poster, CSP, Stomach, PD-L1, Vaccine

Impaired T cell functionality and T cell exhaustion are driven by several factors within the hostile solid tumor microenvironment (TME).

Key Points: 
  • Impaired T cell functionality and T cell exhaustion are driven by several factors within the hostile solid tumor microenvironment (TME).
  • This is one major factor that allows cancer cells to proliferate and metastasize without being recognized by the host immune system.
  • Enhanced, gated T cell functionality of CSP-armored rTCR-T cells increased secretion of interferon-γ (IFNγ) only when tumor cells simultaneously expressed the pHLA target antigen and PD-L1.
  • Rapid and sustained killing of 3D tumor cell-derived spheroids only occurred when PD-L1-positive tumor cells simultaneously expressed the specific pHLA target antigen.

IND HEMP Earns Prestigious B Corp™ Certification

Retrieved on: 
Friday, April 5, 2024
Certification, B Lab, Farmer, HEMP, Environment, Recycling, Agriculture, Goodness, Climate, Food, LCA, Professional corporation, IND, Carbon

Fort Benton, Montana, April 05, 2024 (GLOBE NEWSWIRE) -- IND HEMP, a leading environmental and agricultural company, has earned B Corp™ Certification .

Key Points: 
  • Fort Benton, Montana, April 05, 2024 (GLOBE NEWSWIRE) -- IND HEMP, a leading environmental and agricultural company, has earned B Corp™ Certification .
  • IND HEMP joins over 8,000 certified B Corps™ to date from across 96 countries and 162 industries that employ more than 750,000 workers.
  • IND HEMP attained this certification on its first attempt, which is rare, and will hold B Corps™ certification for three years before submitting to a renewal process.
  • IND HEMP joins a prestigious roster of B Corp™ companies including: Arbonne, Athleta, Ben & Jerry's, ButcherBox, C.F.

Caribou Biosciences Expands Clinical Development of CB-010 with FDA Clearance of IND in Lupus

Retrieved on: 
Thursday, April 4, 2024
Logic, LN, Transplant, Medical College of Wisconsin, Rachel Haurwitz, Infection, Lupus, Risk, Medical college, Patient, Inflammation, Tissue, Autoimmune disease, Standard of care, Doctor of Philosophy, MD, Autoantibody, IND, Congress, HLA, Reindeer, Antibody, CRISPR, Safety, Immune system, Fatigue, FDA, Lupus nephritis, Autoimmunity, Bone marrow, ERL, Medicine, CD19, Food, PD-1, Pharmaceutical industry

BERKELEY, Calif., April 04, 2024 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced that it received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout (KO), for the treatment of lupus nephritis (LN) and extrarenal lupus (ERL). The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024.

Key Points: 
  • The Phase 1, multicenter, open label GALLOP clinical trial of CB-010 in patients with LN and ERL is expected to initiate by year-end 2024.
  • CB-010 targets CD19, a protein on the surface of B cells, and has a PD-1 knockout (KO) that reduces CAR-T cell exhaustion.
  • CB-010 holds the potential for deep depletion of disease-causing B cells which could reset the immune system, leading to sustained drug-free remission.
  • Instead, the chRDNA technology allows for precise insertion of the CAR at an intended location within the T cell genome.

Outpace Bio Announces Multiple Presentations at the 2024 American Association of Cancer Research (AACR) Annual Meeting

Retrieved on: 
Thursday, April 4, 2024
Cell, MSLN, Synthetic biology, Doctor of Philosophy, IND, AACR, Lentivirus, Safety, OP1, Poster, NK

“T cell therapies have so far demonstrated modest efficacy against solid tumors, limited in part by poor expansion and functional persistence,” said Outpace CSO Aaron Foster, PhD .

Key Points: 
  • “T cell therapies have so far demonstrated modest efficacy against solid tumors, limited in part by poor expansion and functional persistence,” said Outpace CSO Aaron Foster, PhD .
  • “Our lead program OPB-101 incorporates multiple Outpace technologies that together drive durable responses in stringent preclinical models at very low treatment doses.
  • These attributes could potentially address the key barriers to efficacy and safety observed in previous solid tumor clinical studies.”
    Details of the poster presentations during the AACR annual meeting are below.
  • OPB-101 is the company’s lead pipeline program and is on track for an IND submission in Q4 2024.

TransCode Therapeutics Reports 2023 Results; Provides Business Update

Retrieved on: 
Wednesday, April 3, 2024
Research, Transcoding, Brain, Survival, CFO, TTX, Patient, Operating cost, RNA, Sale, CMC, Cancer, OTS, IND, AACR, Glioblastoma, Pancreatic cancer, Therapy, Genomics, CRISPR, Breast cancer, Melanoma, Debiopharm, FDA, Liver, IRB, Pharmaceutical industry

BOSTON, April 03, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today reported financial results for 2023 and recent business progress.

Key Points: 
  • BOSTON, April 03, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today reported financial results for 2023 and recent business progress.
  • “We believe 2023 was extremely productive and pivotal for TransCode.
  • The year was highlighted by preliminary clinical results from our Phase 0 clinical trial with radiolabeled TTX-MC138,” said Tom Fitzgerald, interim CEO and CFO of TransCode.
  • We also continued to achieve other important milestones, with the ultimate objective of fulfilling the promise of RNA therapeutics for oncology applications.

BetterLife Announces Closing of $1.168 Million Convertible Debentures to Further Advance IND-enabling Studies of its Non-hallucinogenic LSD-based Drug Candidate BETR-001

Retrieved on: 
Wednesday, April 3, 2024
GAD, Metabolism, MDD, LSD, Patient, Research, Lysergic acid diethylamide, DSM-IV codes, IND, Hallucination, Safety, GLP, Multilateral, Medical device

The IND-enabling cardio-pulmonary GLP studies have been completed, and the metabolism and genotoxicity GLP studies are to be initiated shortly.

Key Points: 
  • The IND-enabling cardio-pulmonary GLP studies have been completed, and the metabolism and genotoxicity GLP studies are to be initiated shortly.
  • Dr. Ahmad Doroudian, CEO of BetterLife, commented, “We are very encouraged with FDA’s recent decision to grant breakthrough therapy designation to LSD for generalized anxiety disorder (GAD) patients.
  • In simple words, we believe BETR-001 will deliver all the therapeutic benefits of LSD without its side effects.”
    BetterLife issued a total of $1.168 million 10% convertible debentures (the “Convertible Debentures”).
  • $800,000 of the Convertible Debentures mature on March 27, 2026 and $368,000 mature on April 1, 2026.

Inhibikase Therapeutics Announces Pre-IND Meeting with the FDA for IkT-001Pro in Pulmonary Arterial Hypertension

Retrieved on: 
Wednesday, April 3, 2024
Ventricular septal defect, DCN, Disease, HIV, Patient, CTD, Connective tissue disease, Death, Parkinson's disease, Imatinib, IND, Pulmonary hypertension, Woman, Therapy, Heart, Safety, Division, WHO, HIV/AIDS, Stomach, PAH, FDA, Blood, Food, Pharmaceutical industry

The meeting will be held on April 5, 2024, with meeting results to be reported following receipt of the formal meeting minutes.

Key Points: 
  • The meeting will be held on April 5, 2024, with meeting results to be reported following receipt of the formal meeting minutes.
  • “Following our pre-NDA discussion with the FDA related to the path to approval for IkT-001Pro in up to 11 blood and stomach cancers in January, we requested an additional FDA meeting with the Division of Cardiology and Nephrology to discuss Pro as a treatment for Pulmonary Arterial Hypertension,” said Dr. Milton Werner, President and Chief Executive Officer of Inhibikase.
  • “PAH is a rare condition that primarily afflicts women between the ages of 30 and 60 and can lead to premature heart failure and death.
  • We believe that Pro may be a be a safer and better tolerated therapeutic option for imatinib treatment in PAH.

Verve Therapeutics Announces Updates on its PCSK9 Program

Retrieved on: 
Tuesday, April 2, 2024
LDLR, Cardiovascular disease, Gene editing, PCSK9, ALT, Patient, RNA, Health care, Health Canada, IND, N-Acetylgalactosamine, MHRA, Asialoglycoprotein receptor, Clinical trial, CTAS, Therapy, Bleeding, Safety, Moyamoya disease, DSMB, FDA, Liver, ASCVD, LNP, Medsafe, Hypercholesterolemia, Food, Pharmaceutical industry

BOSTON, April 02, 2024 (GLOBE NEWSWIRE) -- Verve Therapeutics, a clinical-stage biotechnology company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced updates from the Heart-1 Phase 1b clinical trial of VERVE-101 and clearance of its Clinical Trial Applications (CTAs) by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada for VERVE-102, with the Heart-2 Phase 1b clinical trial expected to initiate in the second quarter of this year.

Key Points: 
  • Six participants have been dosed at 0.45 mg/kg of VERVE-101, with a total of 13 participants dosed in the study.
  • Verve is conducting an investigation into the laboratory abnormalities and based on those results, expects to work with regulatory authorities to define a path forward for VERVE-101.
  • Verve is now prioritizing the development of VERVE-102 and the initiation of the Heart-2 clinical trial.
  • VERVE-102 uses the same base editor and guide RNA for PCSK9 but a different lipid nanoparticle (LNP) delivery system than VERVE-101.

Bio-Path Holdings Provides 2024 Clinical and Operational Update

Retrieved on: 
Tuesday, April 2, 2024
Toxicity, Obesity, Drug discovery, Chronic lymphocytic leukemia, Survival, CLL, AML, Fast track (FDA), Insulin, Patient, New York Medical College, Biomarker, Cancer, Leukemia, IND, University, Lymphoma, Pancreatic cancer, Clinical trial, Paclitaxel, Potential, Breast cancer, Safety, RNA interference, GRB2, Holding, Leptin, Probability, FDA, STAT3, Stage 4, Food, Pharmaceutical industry

HOUSTON, April 02, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today provides a clinical development and operational update for 2024.

Key Points: 
  • HOUSTON, April 02, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today provides a clinical development and operational update for 2024.
  • Prexigebersen Phase 2 Clinical Trial – Bio-Path’s Phase 2 clinical trial is treating Acute Myeloid Leukemia (AML) patients.
  • Phase 1/1b Clinical Trial in BP1002 in Relapsed/Refractory AML – A Phase 1/1b clinical trial for BP1002 to treat relapsed/refractory AML patients, including venetoclax-resistant patients, is ongoing.
  • In January 2024, Bio-Path announced successful completion of the first dose cohort in the Phase 1 clinical trial.