MAPK

SpringWorks Therapeutics Reports First Quarter 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Wednesday, May 3, 2023
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STAMFORD, Conn., May 03, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today reported first quarter financial results for the period ended March 31, 2023 and provided an update on recent company developments.

Key Points: 
  • "In the first quarter of 2023 we continued to deliver strong results across our diversified oncology pipeline.
  • The application has been granted Priority Review and given a Prescription Drug User Fee Act (PDUFA) action date of August 27, 2023.
  • SpringWorks also expects to file a Marketing Authorization Application for nirogacestat with the European Medicines Agency in 2024.
  • Net Loss Attributable to Common Stockholders: SpringWorks reported a net loss of $73.4 million, or $1.18 per share, for the first quarter of 2023.

Day One Reports First Quarter 2023 Financial Results and Corporate Progress

Retrieved on: 
Monday, May 1, 2023
Rituximab, Bevacizumab, Society, Drug development, Capecitabine, New Drug Application, Roche, Neogene, Food and Drug Administration, Clinical trial, NDA, Cancer, MAPK, SNO, MBA, MEK, CMO, CCO, Doctor of Philosophy, ASCO, Research and development, Pakistan Society of Neuro-Oncology, Goldman Sachs, Development, American Society of Clinical Oncology, MD, Patient, Investment, Pediatrics, Roivant Sciences, Annual general meeting, Webcast, FDA, Conference, Day One, ASPHO, D, Pharmaceutical industry, Nursing, Medical imaging, Video game, Genentech, Research

BRISBANE, Calif., May 01, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced its first quarter 2023 financial results and highlighted recent corporate achievements.

Key Points: 
  • The company remains in position to initiate the submission of the NDA as early as the second quarter of 2023.
  • R&D Expenses: Research and development expenses were $27.8 million for the first quarter of 2023 compared to $15.0 million for the first quarter of 2022.
  • G&A Expenses: General and administrative expenses were $18.0 million for the first quarter of 2023 compared to $12.7 million for the first quarter of 2022.
  • Day One will present two posters at the 2023 American Society of Pediatric Oncology/Hematology (ASPHO) Conference May 10-13, 2023, focused on the pLGG burden of illness and healthcare utilization data.

Erasca Announces Two Poster Presentations at the 2023 ASCO Annual Meeting

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Wednesday, April 26, 2023
PDAC, Abstract, CRC, MAPK, BRAF, Cetuximab, ASCO, American Society of Clinical Oncology, Patient, SAN, Colorectal cancer, Annual general meeting, GI, EC, Society, Pharmaceutical industry, Vaccine

SAN DIEGO, April 26, 2023 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced the company will present two poster presentations at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, 2023, in Chicago, Illinois.

Key Points: 
  • SAN DIEGO, April 26, 2023 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced the company will present two poster presentations at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, 2023, in Chicago, Illinois.
  • The abstracts will be available on the ASCO meeting website.
  • The posters will be available online at Erasca.com/science/presentations following the presentations.
  • Abstract 3557- Preliminary results from ERAS-007 plus encorafenib and cetuximab (EC) in patients (pts) with metastatic BRAF V600E mutated colorectal cancer (CRC) in HERKULES-3 study: A phase 1b/2 study of agents targeting the mitogen-activated protein kinase (MAPK) pathway in pts with advanced gastrointestinal malignancies (GI cancers)
    Abstract 3558- Preliminary results from ERAS-007 plus palbociclib (palbo) in patients (pts) with KRAS/NRAS mutant (m) colorectal cancer (CRC) or KRASm pancreatic ductal adenocarcinoma (PDAC) in HERKULES-3 study: A phase 1b/2 study of agents targeting the mitogen-activated protein kinase (MAPK) pathway in pts with advanced gastrointestinal malignancies (GI cancers)

Immuneering Announces Positive Initial Phase 1 Pharmacokinetic, Pharmacodynamic and Safety Data for IMM-1-104 Universal-RAS Program; Accelerates Study Timeline

Retrieved on: 
Tuesday, April 18, 2023
PK, Pancreatic cancer, Human, AACR, PD, Half-life, 3D, Survival, MAPK, American Association for Cancer Research, Cancer, Mutation, Cell proliferation, MBA, Cmax, MEK, Lung, Șaeș, Plasma, RAS, Patient, Melanoma, ERK, China Bio-Immunity Corporation, Neoplasm, Infrared spectroscopy correlation table, IND, Protein, Safety, RAF, Pharmaceutical industry, Immune-related response criteria

It is the first time IMM-1-104 has shown the profile we believe is necessary for deep cyclic inhibition in humans.

Key Points: 
  • It is the first time IMM-1-104 has shown the profile we believe is necessary for deep cyclic inhibition in humans.
  • Prior therapies have often suffered from steep increases in drug half-life in humans when compared to preclinical models.
  • We now have an opportunity to assess potential preliminary efficacy earlier than anticipated.”
    “We are highly encouraged by the initial safety and tolerability data generated to date.
  • IMM-1-104 has been well tolerated with no DLTs or SAEs observed,” said Scott Barrett, M.D., Chief Medical Officer of Immuneering.

SpringWorks and BeiGene Present Clinical Data on Lifirafenib, in combination with Mirdametinib, in Patients with Advanced or Refractory Solid Tumors with MAPK Pathway Aberrations at the American Association for Cancer Research Annual Meeting 2023

Retrieved on: 
Monday, April 17, 2023
NRAS, KRAS, BGNE, AACR, MBBS, Diarrhea, Neoplasm, BeiGene, Platelet, Peter, MAPK, Pharmacokinetics, American Association for Cancer Research, BRAF, Mutation, Peter MacCallum Cancer Centre, NSCLC, MEK, Lung cancer, Doctor of Philosophy, Part, Incidence, Hair, SSE, Endometrial cancer, Patient, RAS, Public, Nausea, Toxic leukoencephalopathy, SWTX, Therapy, Safety, Fatigue, RAF, Pharmaceutical industry, FRACP

The data are being presented today in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place in Orlando, Florida.

Key Points: 
  • The data are being presented today in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place in Orlando, Florida.
  • “The lifirafenib plus mirdametinib combination represents a novel targeted approach to treat solid tumors driven by RAS/RAF mutations, and other MAPK pathway aberrations.
  • As of the data cut-off of January 20, 2023, 71 patients were treated across 9 dose levels evaluating different dosing regimens.
  • Of the 4 endometrial cancer patients treated, 2 (50%) had objective responses in tumors that harbor BRAF fusion mutation or KRAS mutation, respectively.

MapKure, SpringWorks and BeiGene Present Clinical Data on BGB-3245, a Selective Next-Generation B-RAF Inhibitor, in Adult Patients with Advanced or Refractory Solid Tumors at the American Association for Cancer Research Annual Meeting 2023

Retrieved on: 
Monday, April 17, 2023
NRAS, KRAS, BGNE, AACR, Senior, Neoplasm, BeiGene, Fever, Cancer, MAPK, Pharmacokinetics, American Association for Cancer Research, BRAF, MEK, BRAF V600, Assistant, SSE, Patient, SAN, Memorial Sloan Kettering Cancer Center, Public, SWTX, Safety, RAF, Pharmaceutical industry

The data are being presented today in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place in Orlando, Florida.

Key Points: 
  • The data are being presented today in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place in Orlando, Florida.
  • In particular, we are encouraged by the promising activity BGB-3245 is showing in patients with MAPK pathway aberrations,” said Saqib Islam, CEO of SpringWorks.
  • As of the data cut-off of September 1, 2022, 42 patients were treated across six dose levels (5-60 mg daily).
  • “These patients have very limited treatment options and I look forward to the further development of BGB-3245 as it continues to advance through the dose expansion cohorts.”

Kinnate Biopharma Inc. Adds Two New Drug Candidates to Its Growing Targeted Oncology Pipeline and Provides Cash Runway Guidance

Retrieved on: 
Monday, April 17, 2023
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(Nasdaq: KNTE) (Kinnate), a clinical-stage precision oncology company, today announced the addition of two new internally developed next generation development candidates to its targeted oncology pipeline – a brain penetrant mitogen-activated protein kinase (MEK) inhibitor and a highly selective mesenchymal-epithelial transition factor gene (c-MET) inhibitor.

Key Points: 
  • (Nasdaq: KNTE) (Kinnate), a clinical-stage precision oncology company, today announced the addition of two new internally developed next generation development candidates to its targeted oncology pipeline – a brain penetrant mitogen-activated protein kinase (MEK) inhibitor and a highly selective mesenchymal-epithelial transition factor gene (c-MET) inhibitor.
  • Targeted therapies have tremendous potential to help patients, but only about ten percent of patients with advanced or metastatic cancer are eligible for currently approved targeted therapies.
  • Kinnate expects to enter the clinic with KIN-7136 in the second half of 2023, pending U.S. Food and Drug Administration (FDA) clearance on its investigational new drug (IND) application.
  • Kinnate expects to enter the clinic with KIN-8741 in the first half of 2024, pending FDA clearance on its IND application.

Black Diamond Therapeutics Presents Trial in Progress Poster for BDTX-1535 and Preclinical Data on BDTX-1535 and BDTX-4933 at the 2023 American Association of Cancer Research Annual Meeting

Retrieved on: 
Monday, April 17, 2023
Diamond, MAP, Glioblastoma, Myenteric plexus, AACR, Central nervous system, Temozolomide, GBM, Phosphorylation, Drug discovery, Neoplasm, Cell proliferation, Cancer, Pharmacokinetics, MAPK, Black Diamond, BRAF, Mutation, Brain, NSCLC, Lung cancer, CNS, Trial of the century, II, M26 Modular Accessory Shotgun System, Phase 1, TMZ, RAS, Patient, EGFR, ERK, MET, Decompression (diving), Chemoradiotherapy, Assessment, III, Safety, Penetrance, RAF, Vaccine, Pharmaceutical industry, Medical imaging, Antibiotics, Medical device

Real world data in GBM demonstrates EGFR alterations often co-occur and persist throughout treatment with current standard of care therapy.

Key Points: 
  • Real world data in GBM demonstrates EGFR alterations often co-occur and persist throughout treatment with current standard of care therapy.
  • Black Diamond remains on track to provide a clinical update on BDTX-1535 in the second half of 2023.
  • Black Diamond expects to initiate a Phase 1 clinical trial of BDTX-4933 in patients with tumors harboring all-class BRAF or RAS mutations in the second quarter of 2023.
  • The posters from the AACR Annual Meeting are available on the “Scientific Presentations and Publications” section of the Black Diamond Therapeutics website.

BeiGene and SpringWorks Present Clinical Data on Lifirafenib, in Combination with Mirdametinib, in Patients with Advanced or Refractory Solid Tumors with MAPK Pathway Aberrations at the American Association for Cancer Research Annual Meeting 2023

Retrieved on: 
Monday, April 17, 2023
Research, FDA, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Oncology, NRAS, KRAS, BGNE, AACR, MBBS, Diarrhea, Neoplasm, Platelet, Peter, MAPK, Pharmacokinetics, American Association for Cancer Research, BRAF, Mutation, Peter MacCallum Cancer Centre, Multimedia, NSCLC, MEK, Lung cancer, Doctor of Philosophy, Part, Incidence, Hair, SSE, Endometrial cancer, Patient, RAS, Public, Nausea, Toxic leukoencephalopathy, SWTX, Safety, Fatigue, RAF, Pharmaceutical industry, FRACP, BeiGene

The data are being presented today in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place in Orlando, Florida.

Key Points: 
  • The data are being presented today in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place in Orlando, Florida.
  • View the full release here: https://www.businesswire.com/news/home/20230417005339/en/
    “The lifirafenib plus mirdametinib combination represents a novel targeted approach to treat solid tumors driven by RAS/RAF mutations, and other MAPK pathway aberrations.
  • As of the data cut-off of January 20, 2023, 71 patients were treated across 9 dose levels evaluating different dosing regimens.
  • Of 17 patients with LGSOC treated, 10 patients (59%) had objective responses, with median duration of treatment of approximately 26 months.

MapKure, BeiGene and SpringWorks Present Clinical Data on BGB-3245, a Selective Next-Generation B-RAF Inhibitor, in Adult Patients with Advanced or Refractory Solid Tumors at the American Association for Cancer Research Annual Meeting 2023

Retrieved on: 
Monday, April 17, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, NRAS, KRAS, BGNE, AACR, Senior, Neoplasm, BeiGene, Fever, Cancer, MAPK, Pharmacokinetics, American Association for Cancer Research, BRAF, Multimedia, MEK, BRAF V600, Assistant, SSE, Patient, Memorial Sloan Kettering Cancer Center, Public, SWTX, Safety, RAF, Pharmaceutical industry

The data are being presented today in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place in Orlando, Florida.

Key Points: 
  • The data are being presented today in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place in Orlando, Florida.
  • In particular, we are encouraged by the promising activity BGB-3245 is showing in patients with MAPK pathway aberrations,” said Saqib Islam, CEO of SpringWorks.
  • As of the data cut-off of September 1, 2022, 42 patients were treated across six dose levels (5-60 mg daily).
  • “These patients have very limited treatment options and I look forward to the further development of BGB-3245 as it continues to advance through the dose expansion cohorts.”