MAPK

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.

Immuneering Announces First Patient Dosed in its Phase 1/2a Trial of IMM-6-415 to Treat Advanced Solid Tumors with RAF or RAS Mutations

Retrieved on: 
Wednesday, March 27, 2024
Mutation, RAF, MAPK, Growth, Half-life, PD, Colorectal cancer, RAS, Patient, Neoplasm, Cancer, HRAS, DCI, Human, Binimetinib, AACR, NRAS, Safety, Cycle, Pharmacokinetics, Encorafenib, Pharmaceutical industry

CAMBRIDGE, Mass., March 27, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, today announced that the first patient has been dosed in its Phase 1/2a trial of IMM-6-415 to treat advanced solid tumors with RAF or RAS mutations.

Key Points: 
  • In animal studies, IMM-6-415 strongly inhibited the growth of tumors with RAF or RAS mutations, as both a monotherapy and in combinations.
  • “We are pleased to have dosed the first patient in our Phase 1/2a trial for IMM-6-415, our second product candidate to enter the clinic,” said Ben Zeskind, Chief Executive Officer, Immuneering Corporation.
  • We believe the shorter half-life of IMM-6-415 could provide a potential treatment option for a broad patient population with RAS or RAF mutations.
  • The trial will include solid tumor patients with any mutation in RAF, KRAS, NRAS, or HRAS who meet the enrollment criteria.

Element Biosciences Announces Availability of AVITI24, the First Benchtop Sequencer Capable of Direct Cell Profiling

Retrieved on: 
Friday, April 5, 2024
MAPK, Today, Science, SAN, DSM-IV codes, Neoplasm, Research, RNA, DNA, Element, Cancer, Neuroscience, Doctor of Philosophy, Protein, AACR, Drug development, Phosphoprotein, Annual general meeting, Vaccine

SAN DIEGO, April 5, 2024 /PRNewswire/ -- Element Biosciences, Inc., developer of pioneering technologies to empower science, has begun taking orders for AVITI24™ the first instrument to combine state-of-the-art sequencing and cyto-profiling (mapping cell characteristics) into a single integrated biology platform, the company announced at the Annual Meeting of the American Association for Cancer Research.

Key Points: 
  • AVITI24 revolutionizes research by enabling simultaneous examination of DNA, RNA, proteins, phosphoproteins, and cell structure within single cells.
  • Powered by Element's new Teton™ chemistry, AVITI24 expands on AVITI's best-in-class sequencing capabilities to offer new multi-omics functionality, simplifying results in one multi-omic read-out in less than 24 hours.
  • This technology is particularly relevant for cancer researchers, facilitating in-depth exploration of the links between the molecular makeup of cancer cells and how they function within complex tumors.
  • "Today, we are redefining what a sequencer can do by streamlining multiple conventional stages of discovery into a single powerful platform," said Molly He, PhD, CEO and co-founder of Element Biosciences.

Biotech/Oncology Stocks Targeting the Pancreatic Cancer Market - A Race Worth Winning

Retrieved on: 
Wednesday, March 6, 2024
Radiation, Doctor of Philosophy, Immunotherapy, News, FOLFIRINOX, Growth, CADL, PR, CXCR4, Lead, PRS, Multiple myeloma, Poster, Pancreatic cancer, Gemcitabine, Fast Track, Liver, Incidence, Cancer, City, HSC, Chung, TME, Overalls, FACP, Therapy, Sickle cell disease, Columbia University, MAPK, Immune system, SNF, G-CSF, Woman, AIO, SCD, AACR, PD-1, Conference, TILS, Tumor microenvironment, BioLineRx, Clinical trial, Survival, Oncology, Filgrastim, Collection, American Cancer Society, Caregiver, USD, SWI, MD, Blood, FDA, TSX, Biotechnology, Pancreatic Cancer Action Network, Stem cell, RAS, Valaciclovir, PDAC, Patient, Natalizumab, ONC, PEI, Pharmaceutical industry

Research Nester says , "The global pancreatic cancer market size is slated to expand at ~18% CAGR between 2024 and 2036.

Key Points: 
  • Research Nester says , "The global pancreatic cancer market size is slated to expand at ~18% CAGR between 2024 and 2036.
  • The American Cancer Society's estimates for pancreatic cancer in the United States for 2024 are: "About 66,440 people (34,530 men and 31,910 women) will be diagnosed with pancreatic cancer.
  • Pancreatic cancer accounts for about 3% of all cancers in the US and about 7% of all cancer deaths."
  • Biotech/oncology stocks targeting the growing global pancreatic cancer market have made headlines with recent developments and breakthroughs in treatments.

Immuneering Doses First Patient in Phase 2a Clinical Trial of IMM-1-104 in RAS-mutant Solid Tumors

Retrieved on: 
Monday, March 11, 2024
NSCLC, Lung cancer, Disease, MAPK, MEK, Patient, Cancer, Melanoma, Pharmaceutical industry

CAMBRIDGE, Mass., March 11, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, today announced that the first patient has been dosed in the Phase 2a portion of its Phase 1/2a clinical trial of IMM-1-104, its lead program. IMM-1-104 is designed to provide universal-RAS activity through deep cyclic inhibition of MEK in the MAPK pathway with once-daily oral dosing.

Key Points: 
  • - Phase 2a portion of Phase 1/2a clinical trial will evaluate IMM-1-104 as monotherapy in PDAC, non-small cell lung cancer (NSCLC) and melanoma, and as combination therapy in PDAC -
    CAMBRIDGE, Mass., March 11, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, today announced that the first patient has been dosed in the Phase 2a portion of its Phase 1/2a clinical trial of IMM-1-104, its lead program.
  • IMM-1-104 is designed to provide universal-RAS activity through deep cyclic inhibition of MEK in the MAPK pathway with once-daily oral dosing.
  • “The Phase 2a portion includes both monotherapy and combination arms, all in tumor types where we believe IMM-1-104 has the greatest potential to make a positive impact.
  • We look forward to sharing our topline Phase 1 data this month, and then reporting initial results from multiple arms of our Phase 2a later in 2024, which is shaping up to be a data-rich year for our company.”
    The Phase 2a portion of the Phase 1/2a clinical trial of IMM-1-104 is expected to include approximately 150 patients in five arms at our recommended Phase 2 dose of 320 mg once daily.

CervoMed Announces Presentation of Biomarker Data from the AscenD-LB Phase 2a Trial and Preclinical Data Supporting Potential of Neflamapimod in Tau-Mediated Disease at AD/PD ™ 2024

Retrieved on: 
Tuesday, March 5, 2024
Axonal transport, Tauopathy, Neuron, CRVO, Cell biology, DLB, Plasma, Medical laboratory, MB, Phosphorylation, Overalls, FTD, GS, Vrije Universiteit Amsterdam, Publication, MAPK, Glial fibrillary acidic protein, GFAP, Axon, Brain, CNR, IW, EM, SDL, UCL, RAF kinase, Alpha-synuclein, Conference, Biomarker, AG, Lewy body, GBA, MD, Neurochemistry, PDF, JC, CP, Patient, Dementia, Basal forebrain, JA, Medical imaging

BOSTON, March 05, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for degenerative diseases of the brain, today announced the presentation of biomarker data from the AscenD-LB Phase 2a trial of neflamapimod in patients with dementia with Lewy bodies (DLB), demonstrating that neflamapimod reduces plasma levels of glial fibrillary acidic protein (GFAP) compared placebo, and that the effects of neflamapimod on GFAP were inversely correlated to change in CDR-SB (reduction in GFAP associated with improvement in CDR-SB, and increase in GFAP associated with worsening in CDR-SB). These data will be featured in a poster presentation at the 18th International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™) 2024, being held both virtually and in Lisbon, Portugal from March 5–9, 2024. In addition, academic researchers from UCL will be presenting data in a separate poster at the meeting demonstrating that p38MAPK inhibition, including with neflamapimod specifically, improves tau-induced axonal transport defects both in vitro and in a tauopathy mouse model.

Key Points: 
  • These data will be featured in a poster presentation at the 18th International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™) 2024, being held both virtually and in Lisbon, Portugal from March 5–9, 2024.
  • “The effects on GFAP, particularly the association between GFAP response and clinical outcomes, further support that neflamapimod is clinically efficacious in patients with DLB,” said John Alam, MD, Chief Executive Officer of CervoMed.
  • A PDF copy of the GFAP poster presentation will be available on the “ Presentations and Publications ” section of the CervoMed website.
  • Title: NEW INSIGHTS IN THE DEVELOPMENT OF BIOMARKERS, IMAGING, AND THERAPY OF ALPHA-SYNUCLEIN, LRKK2, AND GBA PATHOLOGIES

Immuneering Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Friday, March 1, 2024
PD, Research, SRC, Melanoma, FDA, Research and development, Immunotherapy, Food, Binimetinib, AACR, Benchmarking, Cmax, RAS, Safety, RAF, Neoplasm, Pharmacokinetics, PDAC, Administration, Paclitaxel, Patient, Clinical trial, Lung cancer, Half-life, Circulating tumor DNA, MAPK, Pancreatic cancer, Cancer, Colorectal cancer, DNA, Pharmaceutical industry

“We look forward to sharing topline data from the Phase 1 portion of the Phase 1/2a trial of IMM-1-104 this month.

Key Points: 
  • “We look forward to sharing topline data from the Phase 1 portion of the Phase 1/2a trial of IMM-1-104 this month.
  • Presented preclinical data demonstrating encouraging anti-tumor activity for IMM-1-104 and IMM-6-415: In October 2023, Immuneering presented preclinical data at AACR-NCI-EORTC.
  • Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2023 were $11.9 million compared with $9.9 million for the fourth quarter of 2022.
  • General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2023 were $4.4 million compared with $4.1 million for the same period of 2022.

SpringWorks Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Business Updates

Retrieved on: 
Tuesday, February 27, 2024
Research, New Drug Application, Vomiting, Common, Rash, Multiple myeloma, Patient, Orange Book, Investigational New Drug, Neoplasm, Nausea, Panitumumab, BCMA, Therapy, European Medicines Agency, Food and Drug Administration, Plantar fibromatosis, MAPK, NDA, EGFR, Diarrhea, Patent, B-cell maturation antigen, IND, MEK, NRAS, Security, EMA, Aes, MAA, FDA, Research and development, Food, TEA, RAF, Medicare, NCCN, Administration, Cancer, Pharmaceutical industry

Launched OGSIVEO in the U.S. and achieved net product revenue of $5.4 million in the first partial quarter of the launch.

Key Points: 
  • Launched OGSIVEO in the U.S. and achieved net product revenue of $5.4 million in the first partial quarter of the launch.
  • Presented additional patient-reported outcome data from the Phase 3 DeFi trial at the 2023 Connective Tissue Oncology Society Annual Meeting.
  • Revenues: OGSIVEO net product revenues were $5.4 million in the fourth quarter of 2023, the first partial quarter of the U.S. launch.
  • Cash Position: Cash, cash equivalents and marketable securities were $662.6 million as of December 31, 2023.

Immuneering Receives FDA Fast Track Designation for IMM-1-104 in Pancreatic Cancer

Retrieved on: 
Tuesday, February 20, 2024
Fast Track, FDA, City, Food, U.S. FDA, FACP, RAS, Therapy, PDAC, Patient, Oncology, MAPK, Pancreatic cancer, Cancer, Pharmaceutical industry

CAMBRIDGE, Mass., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for its lead clinical-stage program, IMM-1-104, for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) who have failed one line of treatment. IMM-1-104 is designed to provide universal-RAS activity through deep cyclic inhibition of the MAPK pathway with once-daily oral dosing.

Key Points: 
  • IMM-1-104 is designed to provide universal-RAS activity through deep cyclic inhibition of the MAPK pathway with once-daily oral dosing.
  • “We welcome FDA’s decision to grant Fast Track designation for IMM-1-104.
  • Our Phase 1/2a study is designed to evaluate IMM-1-104 in pancreatic cancer, as well as a number of other tumor types associated with the RAS pathway.
  • City of Hope offers many clinical trials testing innovative treatments for people with pancreatic cancer," Chung said.

Pasithea Therapeutics Announces Opening of Enrollment in the U.S. for its Phase 1 Trial of PAS-004

Retrieved on: 
Tuesday, February 13, 2024
BRAF, SAN, Investigational New Drug, PD, FDA, Food, RAS, Safety, RAF, Human, KTTA, Pharmacokinetics, Solubility, Patient, Half-life, MAPK, NF1, Mutation, IND, MEK, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif. and MIAMI, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, today announced the activation of four clinical trial sites in the United States. These U.S. clinical trial sites in Texas and Virginia are now open and actively enrolling patients.

Key Points: 
  • These U.S. clinical trial sites in Texas and Virginia are now open and actively enrolling patients.
  • The Company's clinical development plan for PAS-004 following the Phase 1 study is to begin a Phase 2 clinical trial in NF1 pediatric and adult patients as soon as safety and PK are established.
  • There are also three other clinical trial sites in Eastern Europe that are expected to open in the coming months.
  • “Activating our four clinical trial sites in the U.S. is a significant milestone in Pasithea’s mission towards developing PAS-004 as a potential best-in-class next-generation MEK inhibitor.