FGFR2

Kinnate Biopharma Inc. Receives Fast Track Designation from the U.S. Food and Drug Administration for KIN-3248, an Investigational Pan-FGFR Inhibitor

Retrieved on: 
Tuesday, February 14, 2023
CCA, Cholangiocarcinoma, ICC, Priority review, Patient, Food, FGFR2, Cell proliferation, FGFR, Survival, FDA, SAN, Research, Neoplasm, Accelerated approval (FDA), Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Fast Track, KNTE, Pharmaceutical industry

SAN FRANCISCO and SAN DIEGO, Feb. 14, 2023 (GLOBE NEWSWIRE) -- Kinnate Biopharma Inc .

Key Points: 
  • SAN FRANCISCO and SAN DIEGO, Feb. 14, 2023 (GLOBE NEWSWIRE) -- Kinnate Biopharma Inc .
  • Cholangiocarcinoma, also known as bile duct cancer, is a rare condition, often diagnosed when it is advanced.
  • Fast Track is a process designed by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need.
  • A therapeutic candidate that receives Fast Track designation is eligible for more frequent interactions with the FDA to discuss the candidate’s development plan, and if relevant criteria are met, for Accelerated Approval and Priority Review.

Lytgobi® (futibatinib) Now Available from Onco360 for the Treatment of Adult Patients with Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma Harboring FGFR2 Gene Fusions or Other Rearrangements

Retrieved on: 
Monday, February 13, 2023
FDA, Pharmaceutical, Health, Oncology, OS, Specialty pharmacy, Patient, Clinical trial, Cholangiocarcinoma, ACS, FGFR2, United, American Cancer Society, ORR, Phase, Pharmaceutical industry, Futibatinib

This indication is approved under accelerated approval based on overall response rate and duration of response.

Key Points: 
  • This indication is approved under accelerated approval based on overall response rate and duration of response.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • “Onco360 is honored to partner with Taiho Oncology and become a specialty pharmacy provider for Lytgobi patients,” said Benito Fernandez, Chief Commercial Officer, Onco360.
  • The FDA approval of Lytgobi comes as a result of the Phase I/II, open-label, single-arm TAS-120-101 (NCT02052778) clinical trial which evaluated the use of Lytgobi in previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma patients.

Latest Clinical Data of InnoCare’s Gunagratinib Presented at 2023 ASCO GI

Retrieved on: 
Thursday, January 26, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, SSE, Cancer, Tongji University, Patient, Hospital, Estonia, FGFR2, Male, FGFR, ORR, DCR, Shanghai East Hospital, Society, HKEX, Cholangiocarcinoma, ASCO, Pharmaceutical industry

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the development of therapies for cancer and autoimmune diseases, announced today that the latest clinical result of FGFR inhibitor gunagratinib (ICP-192) for the treatment of cholangiocarcinoma was presented at 2023 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium.

Key Points: 
  • InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the development of therapies for cancer and autoimmune diseases, announced today that the latest clinical result of FGFR inhibitor gunagratinib (ICP-192) for the treatment of cholangiocarcinoma was presented at 2023 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium.
  • The study was presented in a poster entitled “Gunagratinib, a highly selective irreversible FGFR inhibitor, in patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR pathway alterations: A phase IIa dose-expansion study”.
  • As of September 5, 2022, 18 cholangiocarcinoma patients were treated orally with gunagratinib 20 mg QD.
  • Gunagratinib is a promising second-generation FGFR inhibitor with potential for the treatment of multiple indications with FGF/FGFR pathway abnormalities.”
    More information can be found at ASCO official website.

Kinnate Biopharma Inc. to Present Trials in Progress Poster for its Pan-FGFR Inhibitor, KIN-3248, at the 2023 ASCO Gastrointestinal Cancers Symposium and ASCO Genitourinary Cancers Symposium

Retrieved on: 
Tuesday, January 17, 2023
Pancreas, Cancer, ASCO, Neoplasm, FGFR2, Part, Next, Pharmacokinetics, Safety, American Society of Clinical Oncology, Progress, Squamous cell carcinoma, Irreversible, Patient, ICC, Cholangiocarcinoma, FGFR3, KNTE, SAN, Society, UC, Pharmaceutical industry, FGFR

SAN FRANCISCO and SAN DIEGO, Jan. 17, 2023 (GLOBE NEWSWIRE) -- Kinnate Biopharma Inc .

Key Points: 
  • SAN FRANCISCO and SAN DIEGO, Jan. 17, 2023 (GLOBE NEWSWIRE) -- Kinnate Biopharma Inc .
  • In preclinical studies, KIN-3248 demonstrated inhibitory activity across a wide range of clinically relevant mutations that drive primary disease and acquired resistance to other FGFR inhibitors.
  • Dose escalation (Part A) will determine the recommended dose and schedule of KIN-3248 for further evaluation in patients with FGFR2 and/or FGFR3 gene alteration-driven cancers.
  • This trial is currently enrolling across multiple sites in the U.S. and Taiwan, with initial dose escalation data anticipated in the second half of 2023.

Cogent Biosciences Announces Positive Updated Clinical Data from Ongoing Phase 2 APEX Trial Evaluating Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)

Retrieved on: 
Sunday, December 11, 2022
Division, PPR, Patient, Mast cell leukemia, Clinical trial, FGFR2, TKI, BID, B cell, CRH, HER2/neu, Edema, Intracranial hemorrhage, Dana–Farber Cancer Institute, APEX, Safety, Webcast, Part Two, CoGeNT, ASH, GIST, CR, ORR, Neutropenia, Thrombocytopenia, Risk, ASM, Government budget balance, Society, MCL, Mutation, PEAK, Social media, CI, Anemia, KIT, PR, Medical imaging, Pharmaceutical industry, Health insurance, Leukemia, Cogent

WALTHAM, Mass. and BOULDER, Colo., Dec. 11, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced positive updated clinical data from its ongoing Phase 2 APEX clinical trial evaluating the selective KIT D816V inhibitor bezuclastinib in patients with advanced systemic mastocytosis (AdvSM). The data are being presented in an oral presentation at the 64th American Society of Hematology (ASH) Annual Meeting in New Orleans, LA. 

Key Points: 
  • and BOULDER, Colo., Dec. 11, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced positive updated clinical data from its ongoing Phase 2 APEX clinical trial evaluating the selective KIT D816V inhibitor bezuclastinib in patients with advanced systemic mastocytosis (AdvSM).
  • Patients were enrolled with the following sub-types: three patients with aggressive systemic mastocytosis (ASM), 12 patients with systemic mastocytosis with associated hematologic neo-plasm (SM-AHN), and one patient with mast cell leukemia (MCL).
  • In addition, Cogent continues to actively enroll patients in SUMMIT, a Phase 2 clinical trial with bezuclastinib for patients with non-advanced systemic mastocytosis (NonAdvSM), and PEAK, a registrational randomized, open-label, global, Phase 3 clinical trial in patients with imatinib-resistant Gastrointestinal Stromal Tumors (GIST).
  • ET (7:00 a.m. CT) to discuss today’s updated clinical data from the ongoing APEX trial.

Cogent Biosciences to Host Investor Webcast to Discuss Updated Clinical Data at ASH from the Ongoing Phase 2 APEX Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis

Retrieved on: 
Monday, December 5, 2022
Question answering, B cell, HER2/neu, APEX, Dana–Farber Cancer Institute, Webcast, ASH, GIST, Question, Society, Mutation, Social media, Division, Patient, KIT, FGFR2, Pharmaceutical industry, Leukemia, Cogent

ET (7:00 a.m. CT) to discuss updated clinical data from its on-going Phase 2 APEX trial evaluating bezuclastinib in patients with Advanced Systemic Mastocytosis being presented at the 64th American Society of Hematology (ASH) Annual Meeting.

Key Points: 
  • ET (7:00 a.m. CT) to discuss updated clinical data from its on-going Phase 2 APEX trial evaluating bezuclastinib in patients with Advanced Systemic Mastocytosis being presented at the 64th American Society of Hematology (ASH) Annual Meeting.
  • The live webcast of the event can be accessed on the Investors and Media page of Cogent’s website at investors.cogentbio.com .
  • KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells.
  • Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com.

Cogent Biosciences Appoints Rachael Easton, MD, Ph.D., VP, Head of Clinical Development

Retrieved on: 
Monday, November 28, 2022
Growth, GSK, KIT, HER2/neu, University, Mutation, Doctor of Philosophy, Knowledge, Employment, George Washington University School of Medicine & Health Sciences, FGFR2, CO, Degenerative disease, Patient, Financial compensation, Waltham, Easton, Immunocore, Research, Molecular and Cellular Biology, Lee University, Washington University School of Medicine, GIST, B cell, Metabolism, Pharmaceutical industry, Cogent, Chemistry, Sanofi, MD, Medicine

and BOULDER, Colo., Nov. 28, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the appointment of Rachael Easton, MD, Ph.D., Vice President, Head of Clinical Development.

Key Points: 
  • and BOULDER, Colo., Nov. 28, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the appointment of Rachael Easton, MD, Ph.D., Vice President, Head of Clinical Development.
  • Easton is an accomplished physician-scientist who brings a wealth of experience in both early and late-stage clinical development across multiple therapeutic areas.
  • Prior to joining Cogent, Dr. Easton was Group Senior MedicalDirector, Oncology Clinical Development at GSK.
  • Prior to GSK, she held clinical development roles of increasing responsibility at Immunocore and Sanofi.

Cogent Biosciences Reports Recent Business Highlights and Third Quarter 2022 Financial Results

Retrieved on: 
Monday, November 14, 2022
ASM, Clinical trial, EGFR, Tablet, Gastrointestinal stromal tumor, Cogent, EORTC, KIT, Mutation, Patent, B cell, Patient, HER2/neu, PEAK, G&A, Social media, ASH, APEX, Safety, Society, Research, D, IND, Sunitinib, GIST, FGFR1, ENA, Novel, FGFR2, Pharmaceutical industry, Generic drug, Vaccine, Lithium, Lease, Apex

WALTHAM, Mass. and BOULDER, Colo., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported financial results for the third quarter ended September 30, 2022.“We are excited to announce the initiation of our Phase 3 PEAK trial in imatinib-resistant, second line GIST patients and look forward to presenting an update from our Phase 2 APEX trial in ASM patients in an oral presentation at ASH 2022,” said Andrew Robbins, President and CEO of Cogent Biosciences. “Our team has made tremendous progress this year, advancing our three bezuclastinib clinical trials, PEAK, APEX, and SUMMIT, recently presenting new data on our novel FGFR2 and ErbB2 selective programs, and delivering an optimized formulation of bezuclastinib which will significantly improve the patient experience.”

Key Points: 
  • and BOULDER, Colo., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported financial results for the third quarter endedSeptember 30, 2022.
  • Cogent will host an investor webcast on December 12, 2022 at 8:00 am ET to discuss these data.
  • R&D expenses include non-cash stock compensation expense of $2.1 million for the third quarter of 2022 compared to $1.4 million for the third quarter of 2021.
  • G&A expenses include non-cash stock compensation expense of $2.6 million for the third quarter of 2022 compared to $2.0 million for the third quarter of 2021.

LianBio Reports Third Quarter 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, November 10, 2022
GLOBE, NBTXR3, Head, Forward-looking statement, Leadership, Cardiomyopathy, Food, Inflammation, Education, Department, New Drug Application, Diagnosis, LIBRA, Ophthalmology, Large-cell lung carcinoma, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Hypertrophic cardiomyopathy, SEC, Department of Health and Social Care, U.S. Securities and Exchange Commission, PDUFA, Company, Disease, Program, Research, FGFR, Awareness, Patient, Biotechnology, Pivotal, Growth, Oxford Handbook of Clinical Medicine, Chinese Journal, HCM, FGFR2, NDA, FDA, Pharmaceutical industry, Medical device, Heart

In September 2022, LianBio collaborated with Beijing Lisheng Cardiovascular Health Foundation to launch Joy from Heart, a hypertrophic cardiomyopathy (HCM) disease awareness campaign in China.

Key Points: 
  • In September 2022, LianBio collaborated with Beijing Lisheng Cardiovascular Health Foundation to launch Joy from Heart, a hypertrophic cardiomyopathy (HCM) disease awareness campaign in China.
  • In September 2022, mavacamten was added as a Class Ib recommended drug in the 2022 Chinese Guidelines on Hypertrophic Cardiomyopathy published in the Chinese Journal of Heart Failure and Cardiomyopathy.
  • In November 2022, LianBio announced the initiation of the Phase 3 LIBRA clinical trial of TP-03 in Demodex blepharitis.
  • LianBio expects to report topline data from the Phase 3 LIBRA trial in the fourth quarter of 2023.

Cogent Biosciences Announces Participation at Upcoming Investor Conferences

Retrieved on: 
Wednesday, November 9, 2022
Investor, GLOBE, Waltham, GIST, CO, HER2/neu, Mutation, B cell, Nasdaq, KIT, Conference, Patient, FGFR2, Pharmaceutical industry

and BOULDER, Colo., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that management will participate in the following upcoming investor conferences:

Key Points: 
  • and BOULDER, Colo., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that management will participate in the following upcoming investor conferences:
    Jefferies London Healthcare Conference - Wednesday, November 16, 2022 at 11:30 a.m. GMT (6:30 a.m.
  • ET
    A live webcast of each event can be accessed on the Investors & Media page of Cogents website at https://investors.cogentbio.com/events.
  • Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases.
  • Cogent Biosciences is based inWaltham, MAandBoulder, CO.