Encorafenib

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

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Mittwoch, März 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.

EmeritusDX Announces Launch of FDA Approved Therascreen BRAF and KRAS Tests, Expanding Molecular Testing Capabilities

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Montag, April 8, 2024
Biopsy, Mutation, Colorectal cancer, Encorafenib, Cetuximab, Patient, Cancer, BRAF, Panitumumab, CRC, FDA, Physician, Health, Pharmaceutical industry

LAKE FOREST, Calif., April 8, 2024 /PRNewswire-PRWeb/ -- EmeritusDX, a leading cancer diagnostics and information company, is excited to announce the launch of the FDA-approved therascreen® BRAF and KRAS tests. These innovative products represent a significant advancement in the company's molecular testing menu and aligns perfectly with its strategy of enhancing patient care.

Key Points: 
  • LAKE FOREST, Calif., April 8, 2024 /PRNewswire-PRWeb/ -- EmeritusDX, a leading cancer diagnostics and information company, is excited to announce the launch of the FDA-approved therascreen® BRAF and KRAS tests.
  • These innovative products represent a significant advancement in the company's molecular testing menu and aligns perfectly with its strategy of enhancing patient care.
  • "The introduction of the therascreen® BRAF and KRAS portfolio is a testament to this commitment.
  • According to EmeritusDX's Chief Scientist, Dr. Vincent Funari, "The therascreen® BRAF and KRAS tests are a game-changer in personalized medicine for CRC patients.

Pfizer Oncology Hosts Innovation Day, Highlighting Fully Integrated Organization, Robust Portfolio, and Strategic Priorities to Drive Long-Term Sustainable Growth

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Donnerstag, Februar 29, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, NSCLC, Acquisition, Breast cancer, Head, Recurrence, Boshoff, CREST, MBC, Encorafenib, Growth, HR, Spacecraft, PFE, Prostate, Metastasis, Pembrolizumab, Lung, ADC, Monoclonal antibody, Webcast, Patient, Lymphoma, Multiple myeloma, Brentuximab vedotin, PD-L1, Cancer, Fine chemical

A replay of the webcast and related materials, including the presentations and a summary and transcript, will be made available on the Pfizer investor relations website at www.pfizer.com/investors .

Key Points: 
  • A replay of the webcast and related materials, including the presentations and a summary and transcript, will be made available on the Pfizer investor relations website at www.pfizer.com/investors .
  • “With the completion of the Seagen acquisition in 2023, Pfizer has significantly expanded its Oncology organization to amplify its efforts to advance new standards of care and improve outcomes for patients,” said Chris Boshoff, Chief Oncology Officer and Executive Vice President, Pfizer.
  • Pfizer’s Oncology portfolio is focused on three core scientific modalities: small molecules, antibody drug conjugates (ADCs), and bispecific antibodies, including other immuno-oncology biologics.
  • Please read full Prescribing Information , including BOXED WARNING, for ELREXFIOTM (elranatamab-bcmm).

Deciphera Pharmaceuticals Announces Planned 2024 Corporate Milestones Supporting Evolution to a Self-Sustaining, Multi-Product Company

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Montag, Januar 8, 2024
Research, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Oncology, Gastrointestinal stromal tumor, Food, Neoplasm, IND, INSIGHT, Autophagy, FDA, MAA, Cetuximab, European, Encorafenib, Public expenditure, KIT, NDA, Cancer, European Medicines Agency, Part, TGCT, MEK, Patient, GIST, Pharmaceutical industry

Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today highlighted its strategic outlook for 2024 and planned 2024 corporate milestones, and announced preliminary unaudited fourth quarter and full year 2023 revenue.

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today highlighted its strategic outlook for 2024 and planned 2024 corporate milestones, and announced preliminary unaudited fourth quarter and full year 2023 revenue.
  • Present updated data from the Phase 1/2 study of vimseltinib in TGCT in the second half of 2024.
  • Initiate a Phase 2 proof-of-concept study of vimseltinib for the treatment of cGVHD in the fourth quarter of 2024.
  • Initiate a Phase 1 study for DCC-3084, a potential best-in-class pan-RAF inhibitor, in the first half of 2024.

Immuneering Reports Third Quarter 2023 Financial Results and Provides Business Updates

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Donnerstag, November 9, 2023
Paclitaxel, Pancreatic cancer, Safety, DNA, Colorectal cancer, IND, RAS, Administration, Patient, China Bio-Immunity Corporation, Research, RAF, PDAC, Benchmarking, MAPK, Circulating tumor DNA, Binimetinib, Conference, Lung cancer, Melanoma, Cancer, Encorafenib, Toxic oil syndrome, R, Research and development, Immunotherapy, AACR, Pharmaceutical industry, Vaccine, Medical imaging, Cryptocurrency, Immune-related response criteria

CAMBRIDGE, Mass., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop medicines for broad populations of cancer patients with an initial aim to develop a universal-RAS therapy, today reported financial results for the third quarter ended September 30, 2023, and provided business updates.

Key Points: 
  • “Completing our Phase 1 dose escalation of IMM-1-104 with no observed dose-limiting toxicities was an important step in that direction.
  • The Phase 2a portion of the study will also include the addition of new sites and investigators focused on these cancer types.
  • Research and Development (R&D) Expenses: R&D expenses for the quarter ended September 30, 2023 were $10.1 million, compared with $9.4 million for the quarter ended September 30, 2022.
  • General and Administrative (G&A) Expenses: G&A expenses for the quarter ended September 30, 2023 were $3.9 million, compared with $3.8 million for the quarter ended September 30, 2022.

Foundation Medicine Announces Collaboration with Pierre Fabre Laboratories to Develop Companion Diagnostics in Non-Small Cell Lung Cancer

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Mittwoch, November 15, 2023
Biotechnology, Pharmaceutical, Oncology, General Health, Health, Medical Devices, Genetics, Other Health, Food and Drug Administration, Pfizer, Foundation Medicine, Food, European Medicines Agency, Union, Clinical trial, Patient, Liquid, Medicine, FDA, Lung cancer, BRAF, Cancer, Encorafenib, Physician, IVDR, NSCLC, Pharmaceutical industry, European

Foundation Medicine, Inc. , and Pierre Fabre Laboratories today announced a collaboration to develop Foundation Medicine’s high-quality genomic tests, FoundationOne®CDx and FoundationOne®Liquid CDx, as companion diagnostics for new targeted therapies to treat patients with non-small cell lung cancer (NSCLC).

Key Points: 
  • Foundation Medicine, Inc. , and Pierre Fabre Laboratories today announced a collaboration to develop Foundation Medicine’s high-quality genomic tests, FoundationOne®CDx and FoundationOne®Liquid CDx, as companion diagnostics for new targeted therapies to treat patients with non-small cell lung cancer (NSCLC).
  • The companies will work collaboratively to seek the regulatory approval for Foundation Medicine assays which detect mutations including BRAFV600E to identify patients for potential treatment with Pierre Fabre Laboratories’s BRAF/MEK inhibitor combination regimen, BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib), in the European Union.
  • And that’s why we are excited to work with Foundation Medicine,” said Núria Perez-Cullell, Head of Medical and Patient Consumer Department, Pierre Fabre Laboratories.
  • “We are excited to support Pierre Fabre Laboratories in offering more treatment options for cancer patients, and to increase access to precision therapies in the European Union.”
    Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.

Immuneering Presents Preclinical Data Demonstrating Encouraging Anti-Tumor Activity for IMM-1-104 and IMM-6-415 at AACR-NCI-EORTC Conference

Retrieved on: 
Donnerstag, Oktober 12, 2023
Lung cancer, RAF, KRAS, Female, China Bio-Immunity Corporation, 3D, AACR, BRAF, IND, Encorafenib, TGI, MEK, Benchmarking, Mutation, RAS, Binimetinib, Half-life, Cancer, Melanoma, Colorectal cancer, Paclitaxel, Mouse, Pancreatic cancer, MAPK, Conference, Patient, Combination therapy, Medical imaging, Cassette tape, Pharmaceutical industry, Vaccine, Short course immune induction therapy

Today’s findings add cytotoxic agents and RAF inhibitors to the list of promising combinations, building on our previously disclosed data supporting combinations with KRAS-G12C inhibitors and immuno-oncology agents.

Key Points: 
  • Today’s findings add cytotoxic agents and RAF inhibitors to the list of promising combinations, building on our previously disclosed data supporting combinations with KRAS-G12C inhibitors and immuno-oncology agents.
  • Pharmacogenomic data were used to generate a model predictive of response to IMM-1-104 and identify biomarker-aligned patient subpopulations.
  • IMM-1-104 was tested in combination with gemcitabine or paclitaxel in humanized 3D models of pancreatic cancer, demonstrating enhanced activity and combination therapy potential.
  • As monotherapy, IMM-6-415 demonstrated anti-tumor activity in over 50% (34 of 66) of the 3D-TGA models tested, including 30 BRAF mutant preclinical models in which 19 (63%) showed activity.

 U.S. Food and Drug Administration (FDA) Approves FoundationOne®Liquid CDx as a Companion Diagnostic for Pfizer’s BRAFTOVI® (encorafenib) in Combination With Cetuximab to Identify Patients With BRAF V600E Alterations in Metastatic Colorectal Cancer

Retrieved on: 
Freitag, Juni 9, 2023
Science, Biometrics, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, CGP, Encorafenib, BRAF, Woman, Large intestine, NSCLC, Lung cancer, Doctor of Philosophy, Cetuximab, Colorectal cancer, MD, Patient, Liquid, Foundation Medicine, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Colorectal Cancer Alliance, Food, Breast cancer, Pharmaceutical industry

This now makes FoundationOne Liquid CDx the only comprehensive genomic profiling (CGP) test FDA-approved to identify patients with BRAF V600E alterations in mCRC who may be appropriate for treatment with BRAFTOVI in combination with cetuximab.

Key Points: 
  • This now makes FoundationOne Liquid CDx the only comprehensive genomic profiling (CGP) test FDA-approved to identify patients with BRAF V600E alterations in mCRC who may be appropriate for treatment with BRAFTOVI in combination with cetuximab.
  • Colorectal cancer is one of the most common and deadly cancers globally.1BRAF V600E alterations are estimated to occur in approximately 8% of patients with metastatic CRC.2 Historically, there have been limited treatment options available, so patients with this condition generally face a poor prognosis.
  • The test has several companion diagnostic indications across non-small cell lung cancer (NSCLC), breast cancer, and colorectal cancer, plus a pan tumor indication specific to NTRK1/2/3 fusions.
  • “We’re encouraged by the ongoing progress happening in colorectal cancer care, and believe this approval is an important milestone in delivering broader access to more treatment options.”

Erasca Provides Update on Clinical Program for ERK Inhibitor ERAS-007 and Refines Pipeline

Retrieved on: 
Montag, Juni 5, 2023
KRAS, Communication, MYC, Probability, CRC, DCR, SOS1, Clinical trial, Encorafenib, DDI, Trae tha Truth, BRAF, Research, SHP2, CNS, Cetuximab, RAS, Patient, EGFR, Colorectal cancer, ERK, SAN, HNSCC, HPV, UPR, EC, CPRS, Resuscitation, Safety, Pharmaceutical industry

SAN DIEGO, June 05, 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 promising preliminary Phase 1b data for ERK inhibitor ERAS-007 in patients with metastatic BRAF V600E-mutated (BRAFm) colorectal cancer (CRC) and provided a portfolio update. Erasca will host a virtual investor event to discuss these updates today at 4:30 PM ET. To register for the event, please click here.

Key Points: 
  • Erasca will host a virtual investor event to discuss these updates today at 4:30 PM ET.
  • To register for the event, please click here .
  • “We are pleased that the early ERAS-007 clinical data continue to reinforce its potential to become a backbone for combination therapy,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder.
  • “Moreover, through our signal-seeking trials, we have tested three biological hypotheses: preventing in-pathway resistance, reversing in-pathway resistance, and targeting adjacent pathways.

Erasca to Present Promising Preliminary HERKULES-3 Phase 1b Data at the 2023 ASCO Annual Meeting

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Donnerstag, Mai 25, 2023
PDAC, KRAS, CRC, HER2, American Society of Clinical Oncology, Encorafenib, MAPK, Fulvestrant, BRAF, Cetuximab, ASCO, HIV disease progression rates, Patient, Colorectal cancer, Annual general meeting, Clutch (eggs), Poster, FDA, GI, EC, Society, Safety, Medical device, Pharmaceutical industry, Vaccine

SAN DIEGO, May 25, 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 preliminary Phase 1b data for ERAS-007 combinations in patients with GI malignancies from two poster presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. The posters will be available online at Erasca.com/science/presentations.

Key Points: 
  • “Early clinical data from HERKULES-3 continue to reinforce the potential to combine ERAS-007 with multiple agents and its potential as a backbone therapy to treat patients with GI malignancies.
  • “Our initial evaluation of the ERAS-007 + EC combination in patients with BRAF-mutated metastatic CRC will focus on EC-naïve patients based on the preliminary activity observed in HERKULES-3.
  • Based on these data, the combination of ERAS-007 and palbociclib will not be pursued further in this patient population.
  • While we will not pursue further development of this combination in this patient population, it has contributed to our understanding and characterization of ERAS-007.”