FGFR2

Basilea reports updated interim results for iCCA patients with FGFR2 mutations and amplifications from phase 2 study FIDES-01 at ASCO GI Cancers Symposium

Retrieved on: 
Monday, January 24, 2022
Survival, Isavuconazonium, Patient, Research, Human, Cell proliferation, FGFR, Mycosis, SIX Swiss Exchange, DCR, Acral lentiginous melanoma, FGFR2, Neoplasm, Fibroblast, Squamous cell carcinoma, Toxic leukoencephalopathy, Safety, Epithelium, Paclitaxel, Infection, Merck, Society, Roche, CSF1R, Cancer, FGFR1, Progression-free survival, Basilea Pharmaceutica, American Society of Clinical Oncology, PFS, Prognosis, ICCA, Merck & Co., Communication, ASCO, PD-L1, Breast, Maintenance, Stomatitis, Pharmaceutical industry, Vaccine, EU, Cholangiocarcinoma

Dr. Marc Engelhardt, Chief Medical Officer, said: The updated interim results in iCCA patients with FGFR2 mutations and amplifications remain encouraging and support the therapeutic relevance of derazantinib in this group of patients where there has been limited clinical evidence of successful treatment with other FGFR inhibitors.

Key Points: 
  • Dr. Marc Engelhardt, Chief Medical Officer, said: The updated interim results in iCCA patients with FGFR2 mutations and amplifications remain encouraging and support the therapeutic relevance of derazantinib in this group of patients where there has been limited clinical evidence of successful treatment with other FGFR inhibitors.
  • Derazantinib has demonstrated clinically meaningful efficacy across all types of FGFR2 genetic aberrations, which confirms the broad potential of derazantinib as a monotherapy for the treatment of iCCA patients.
  • Efficacy of derazantinib in intrahepatic cholangiocarcinoma patients with FGFR2 mutations or amplifications: Interim results from the phase 2 study FIDES-01.
  • The first study, FIDES-01, is a phase 2 study in patients with inoperable or advanced iCCA.

Kinnate Biopharma Inc. to Present Preclinical Data on its FGFR Inhibitor Candidate at the ASCO Gastrointestinal Cancers Symposium

Retrieved on: 
Wednesday, January 19, 2022
IC50, Patient, KNTE, MBBS, Gastrointestinal cancer, SAN, FGFR, Clinical trial, Cholangiocarcinoma, SEC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, COVID-19, FGFR2, Growth, EC50, HIV disease progression rates, Poster, GLOBE, Â, Cancer, FGFR1, Translational medicine, U.S. Securities and Exchange Commission, Nasdaq, Industry, Program, FGFR3, Therapy, Food, Immortalised cell line, ASCO, Investigational New Drug, FGFR4, Security (finance), Fibroblast growth factor receptor, Risk, ICC, Pharmaceutical industry

These findings will be presented during a poster session at the ASCO Gastrointestinal Cancers Symposium taking place in San Francisco, January 20-22, 2022.

Key Points: 
  • These findings will be presented during a poster session at the ASCO Gastrointestinal Cancers Symposium taking place in San Francisco, January 20-22, 2022.
  • Oncogenic FGFR (FGFR1, FGFR2, FGFR3, and FGFR4) gene alterations are observed in approximately 7% of all human cancers.
  • KIN-3248 has been evaluated across wild-type FGFR family members and clinically relevant fusions and kinase domain resistance mutations in vitro.
  • Additional information on the ASCO GI Cancers Symposium is available through the conference website at: https://conferences.asco.org/gi .

Kinnate Biopharma Inc. Announces FDA Clearance of Investigational Drug Application for KIN-3248

Retrieved on: 
Tuesday, January 18, 2022
Patient, KNTE, Gastrointestinal cancer, SAN, Clinical trial, Cholangiocarcinoma, UC, SEC, COVID-19, FGFR2, Safety, Adult, Growth, HIV disease progression rates, GLOBE, Part, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Â, Cancer, FGFR1, U.S. Securities and Exchange Commission, Nasdaq, Industry, FGFR3, Pharmacokinetics, Therapy, Squamous cell carcinoma, FDA, Investigational New Drug, FGFR4, Security (finance), Risk, ICC, Pharmaceutical industry, Vaccine, FGFR

In preclinical studies, KIN-3248 demonstrated inhibitory activity across a wide range of clinically relevant mutations that drive primary disease and acquired resistance.

Key Points: 
  • In preclinical studies, KIN-3248 demonstrated inhibitory activity across a wide range of clinically relevant mutations that drive primary disease and acquired resistance.
  • Kinnate is focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers.
  • Kinnate utilizes its deep expertise in structure-based drug discovery, translational research, and patient-driven precision medicine, which it refers to as the Kinnate Discovery Engine, to develop targeted therapies.
  • Based in San Francisco and San Diego, California, the Kinnate team is composed of drug discovery experts supported by a distinguished group of scientific advisors.

Helsinn Launches Fully Integrated Targeted Therapy (FITT) Strategy and Announces Leadership and Structural Changes

Retrieved on: 
Thursday, January 13, 2022
Research, Applied science, FGFR2, ETH, FITT, CCA, Therapy, Environment, Health, Cancer, Respect, Corporation, P&G, Executive, The arts, Founder, Heart, Doctor of Philosophy, Director, Patient, CMC, Group, GPX4, Growth, Swiss Federal Institute of Aquatic Science and Technology, Health care, Master, City University, City, University of London, FGFR, CEO, Swiss Federal Institute of Technology, Business, University of Applied Sciences and Arts of Western Switzerland, RET, Vomiting, University, Board, Management, Fine chemical, Pharmaceutical industry, Novartis, Chemistry, EU

Gabriele Braglia, current Chairman and Founder, named Honorary Chairman

Key Points: 
  • Gabriele Braglia, current Chairman and Founder, named Honorary Chairman
    Lugano, Switzerland, January 13, 2021 - Helsinn Group (Helsinn), a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track-record of commercial execution, today announces the launch of its Fully Integrated Targeted Therapy (FITT) Strategy and Board and management changes.
  • Helsinns FITT strategy will focus on developing a differentiated pipeline of highly innovative oncology assets addressing unmet needs, transforming Helsinn from a leading cancer supportive care company to a fully integrated targeted therapy company.
  • A RET tyrosine kinase inhibitor currently in a Phase I/II trial that Helsinn believes has the potential for fast-track approval.
  • These combined changes will enable Helsinn to be fully focused on building out its targeted oncology pipeline.

Black Diamond Therapeutics Announces Strategic Priorities and Expected Milestones for 2022

Retrieved on: 
Monday, January 10, 2022
Diamond, Large-cell lung carcinoma, FGFR, II, Safety, US Foods, Black Diamond, FGFR1, FGFR2, HER2, FGFR3, Drug resistance, Drug discovery, MAP, Mutation, Cancer, Investment, Patient, IND, BRAF, GBM, Annual report, CNS, Survival, Program, Partnership, III, Food, Glioblastoma, U.S. Securities and Exchange Commission, Private Securities Litigation Reform Act, EGFR, Nasdaq, Pharmacology, COVID-19, FDA, Neoplasm, GLOBE, OpenEye Scientific Software, Population, NEW, Pharmaceutical industry, Medical device, Vaccine, Medical imaging, EU, NSCLC, M26 Modular Accessory Shotgun System, Company

and NEW YORK, Jan. 10, 2022 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, today announced a strategic pipeline update and outlined its expected upcoming milestones.

Key Points: 
  • and NEW YORK, Jan. 10, 2022 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, today announced a strategic pipeline update and outlined its expected upcoming milestones.
  • Black Diamond is developing a CNS-penetrant BRAF inhibitor against a family of Class I, II, III canonical and non-canonical mutations.
  • Black Diamond anticipates the initiation of IND-enabling studies for the BRAF program in 2022.
  • Black Diamond Therapeutics is a precision oncology medicine company pioneering the development of novel MasterKey therapies.

Basilea reports on portfolio progress made in 2021

Retrieved on: 
Thursday, January 6, 2022
ESMO, Radiation, Mucormycosis, Safety, Food, Program, Infection, FGFR2, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, DXR, Growth, SIX Swiss Exchange, Research, Communication, Patient, Cancer, Adult, IND, Cryptococcosis, CHF, TTK, Investigational New Drug, ICCA, FGFR, Pfizer, Mycosis, Survival, Financial toxicity, MCI, USD, Marketing, FDA, File, Population, ASCO, New Drug Application, Glioma, Human, Glioblastoma, Cholangiocarcinoma, Gram-negative bacteria, Congress, Eurasian Economic Union, Aspergillosis, Basilea Pharmaceutica, Economic union, NDA, Pharmaceutical industry, Medical imaging, Animal, EU, Isavuconazonium, Basel

In December 2021, Basileas partner Pfizer received a Drug Approval License for the oral formulation of Cresemba in China for the treatment of adult patients with invasive mucormycosis.

Key Points: 
  • In December 2021, Basileas partner Pfizer received a Drug Approval License for the oral formulation of Cresemba in China for the treatment of adult patients with invasive mucormycosis.
  • The filing is based on a phase 3 study completed in early 2021.3 It triggered a CHF 5 million milestone payment to Basilea.
  • In May 2021, Basilea was awarded a grant of up to USD 2.7 million from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) for the development of selective inhibitors of the bacterial enzyme DXR.
  • The continued strong commercial performance of Cresemba throughout 2021 triggered several sales milestone payments by its partners to Basilea.

Relay Therapeutics Announces Dosing of First Patient in First-in-Human Trial of RLY-2608 and Initiation of Expansion Cohorts for First-In-Human Trial of RLY-4008

Retrieved on: 
Tuesday, January 4, 2022
Twitter, Safety, COVID-19, Private Securities Litigation Reform Act, Head, Risk, Diarrhea, U.S. Securities and Exchange Commission, Cholangiocarcinoma, Toxicity, Protein, Stomach, WT, Fulvestrant, Therapeutic index, Woman, PIK3CA, HR, Hyperphosphatemia, Family, FGFR4, GLOBE, Pharmacokinetics, Annual report, FGFR, Therapy, FGFR2, Breast cancer, Cervical cancer, Patient, Man, Toxic leukoencephalopathy, Nasdaq, PI3K, Interim, Security (finance), Endometrial cancer, Cancer, ICC, FGFR1, Compte rendu, Mutation, Pharmaceutical industry, Medical imaging

CAMBRIDGE, Mass., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, today provided an update for two of its ongoing first-in-human trials, RLY-2608, the first known allosteric, pan-mutant and isoform-selective PI3Kα inhibitor in clinical development, and RLY-4008, a highly selective, irreversible and oral small molecule inhibitor of FGFR2.

Key Points: 
  • For RLY-2608, Relay Therapeutics dosed the first patient in a first-in-human trial for patients with advanced solid tumors with a PIK3CA (PI3K) mutation.
  • The first-in-human trial for RLY-2608 is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity, and will consist of two separate arms.
  • Relay Therapeutics initiated expansion cohorts last month for the first-in-human trial for RLY-4008 in patients with FGFR2-altered cholangiocarcinoma, breast cancer and other solid tumors.
  • Relay Therapeutics will continue to monitor the dose escalation data and expansion cohorts to determine if other doses or schedules should be evaluated.

LianBio Announces Infigratinib Approved Under Special Named Patient Program for the Treatment of Cholangiocarcinoma in the Pilot Zone of Hainan Province in China

Retrieved on: 
Tuesday, December 21, 2021
Squamous cell carcinoma, GLOBE, Therapy, Physician, Bladder cancer, Inflammation, Lists of diseases, FGFR2, PRC, Bile, Cholangiocarcinoma, Neoplasm, National Medical Products Administration, Cancer, Osteochondrodysplasia, Liver, Achondroplasia, Strategic alliance, Ophthalmology, FGFR, Drug development, Biotechnology, Safety, MD, Disease, Forward-looking statement, NPP, MAPK, SHP2, U.S. Securities and Exchange Commission, National Health Commission, SEC, Population, Patient, Achievement, State Council, Chinese Academy of Engineering, Pharmaceutical industry, Medical imaging, Fine chemical, Engineering

The first cholangiocarcinoma patient in China was prescribed and treated with infigratinib at Boao Super Hospital in Mainland China, marking the first prescription of infigratinib outside of North America.

Key Points: 
  • The first cholangiocarcinoma patient in China was prescribed and treated with infigratinib at Boao Super Hospital in Mainland China, marking the first prescription of infigratinib outside of North America.
  • LianBio is committed to bringing transformative medicines to patients and physicians in China, said Yizhe Wang, Ph.D., Chief Executive of LianBio.
  • We are proud to enable early commercial access to infigratinib in Hainan Province approximately six months after the drugs first global approval.
  • LianBio in-licensed rights from BridgeBio Pharma in 2020 for infigratinib for development and commercialization in Mainland China, Hong Kong and Macau.

Helsinn Group Announces European Medicines Agency’s (EMA) Acceptance for review of the Marketing Authorization Application (MAA) for Infigratinib for Patients with Cholangiocarcinoma with Fibroblast Growth Factor Receptor 2 Fusions or Rearr

Retrieved on: 
Tuesday, December 21, 2021
EMA, MAA, Review, Incidence, Therapy, Environment, Union, Structured Product Labeling, Health authority, Bladder cancer, Diagnosis, FGFR2, Bile, Cancer, Achondroplasia, FGFR, Osteochondrodysplasia, Disease, Cholangiocarcinoma, Dubai Health Authority, Heart, Corporation, European Medicines Agency, Respect, Patient, Growth, CCA, Pharmaceutical industry, Medical imaging

The EMAs acceptance for review of the MAA confirms that the submission is complete and the formal review process can begin.

Key Points: 
  • The EMAs acceptance for review of the MAA confirms that the submission is complete and the formal review process can begin.
  • Sergio Cantoreggi, Helsinn Group Chief Scientific Officer and Global Head of R&D, commented: The acceptance for review of our MAA is a significant step towards bringing infigratinib to patients in the European Union.
  • There is a great need for new therapies in bile duct cancer for patients who have relapsed after first-line therapy and need further targeted treatment.
  • Infigratinib is a potent orally administered, selective, ATPcompetitive, kinase inhibitor of FGFRs, with highest affinity for FGFR 1, 2, and 3.

Helsinn and Xediton sign exclusive license and distribution agreement for TRUSELTIQ™ (infigratinib) in Canada

Retrieved on: 
Monday, December 20, 2021
Orbis, Cancer, Food, Condition, FGFR2, CCA, Health Canada, Greater Toronto Area, Bile, FGFR, Physician, Infection, Diagnosis, Respect, Growth, Environment, Incidence, ORR, Compliance, Review, GI, International healthcare accreditation, CEO, Corporation, Patient, Disease, CV, Cholangiocarcinoma, Policy, Dor, Precision medicine, Health, Heart, Pharmaceutical industry, Oncology, Pain, Ophthalmology

Under the terms of the license and distribution agreement, Helsinn Healthcare SA grants Xediton an exclusive license to distribute, promote, market, and sell TRUSELTIQ in Canada and Helsinn will supply TRUSELTIQ for commercialization in Canada.

Key Points: 
  • Under the terms of the license and distribution agreement, Helsinn Healthcare SA grants Xediton an exclusive license to distribute, promote, market, and sell TRUSELTIQ in Canada and Helsinn will supply TRUSELTIQ for commercialization in Canada.
  • Riccardo Braglia, Helsinn Group Vice Chairman and CEO commented, We are very pleased to have signed this agreement with Xediton for the distribution of TRUSELTIQ in Canada.
  • George Gafrey, President of XEDITON Pharmaceuticals Inc., commented: We are very pleased to partner with Helsinn Group to bring to Canadian patients TRUSELTIQ.
  • Xediton Pharmaceuticals is committed to developing, partnering and making available new and established medicines to promote the health of Canadians.