Protein kinase inhibitor

Eisai to Present Abstracts on Lenvatinib at 2021 Gastrointestinal Cancers Symposium

Tuesday, January 12, 2021 - 3:37am

TOKYO, Jan 12, 2021 - (JCN Newswire) - Eisai Co., Ltd. has announced that presentations on a series of abstracts highlighting updates on its in-house discovered lenvatinib mesylate (product name: LENVIMA, the orally available kinase inhibitor, "lenvatinib") will be given at the Gastrointestinal Cancers Symposium Virtual Meeting, from January 15 to 17, 2021.

Key Points: 
  • TOKYO, Jan 12, 2021 - (JCN Newswire) - Eisai Co., Ltd. has announced that presentations on a series of abstracts highlighting updates on its in-house discovered lenvatinib mesylate (product name: LENVIMA, the orally available kinase inhibitor, "lenvatinib") will be given at the Gastrointestinal Cancers Symposium Virtual Meeting, from January 15 to 17, 2021.
  • In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.
  • Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer.
  • Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these Ricchi, with the aim of contributing to the cure of cancers.

Onconova Therapeutics Announces FDA Permission for Study to Proceed Under its Investigational New Drug Application for Multi-kinase CDK4/6 Inhibitor ON 123300

Monday, December 21, 2020 - 1:00pm

We are grateful to receive this timely, favorable response from the FDA to initiate a Phase 1 trial with ON 123300, said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova.

Key Points: 
  • We are grateful to receive this timely, favorable response from the FDA to initiate a Phase 1 trial with ON 123300, said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova.
  • Additional patient cohorts are under consideration, including but not limited to patients diagnosed with advanced colorectal cancer, and non-Hodgkins lymphoma, in particular mantle cell lymphoma.
  • Onconovas lead pipeline compound is the novel small molecule ON 123300, a proprietary, first-in-class multi-kinase inhibitor targeting tumor-driving kinases including CDK4/6 and ARK5.
  • Onconova Therapeutics is a biopharmaceutical company focused on discovering and developing novel products to treat cancer.

Turning Point Therapeutics Granted FDA Breakthrough Therapy Designation for Repotrectinib Treatment in Patients with ROS1-Positive Metastatic Non-Small Cell Lung Cancer Who Have Not Been Treated with a ROS1 Tyrosine Kinase Inhibitor

Tuesday, December 8, 2020 - 1:30pm

Turning Point plans to present updated TRIDENT-1 Phase 2 study data from patients with TKI-naive ROS1-positive NSCLC during a mini-oral presentation at the World Conference on Lung Cancer on Jan. 31, 2021.

Key Points: 
  • Turning Point plans to present updated TRIDENT-1 Phase 2 study data from patients with TKI-naive ROS1-positive NSCLC during a mini-oral presentation at the World Conference on Lung Cancer on Jan. 31, 2021.
  • Breakthrough therapy designation is granted by the FDA to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition.
  • The companys lead drug candidate, repotrectinib, is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors.
  • The company is driven to develop therapies that mark a turning point for patients in their cancer treatment.

Kinnate Biopharma Announces Closing of Initial Public Offering and Exercise in Full of the Underwriters’ Option to Purchase Additional Shares

Monday, December 7, 2020 - 9:05pm

Including the option exercise, the aggregate gross proceeds from the offering were $276.0 million, before deducting underwriting discounts and commissions and estimated offering expenses.

Key Points: 
  • Including the option exercise, the aggregate gross proceeds from the offering were $276.0 million, before deducting underwriting discounts and commissions and estimated offering expenses.
  • The shares began trading on The Nasdaq Global Select Market on December 3, 2020, under the symbol KNTE.
  • Goldman Sachs & Co. LLC, SVB Leerink LLC and Piper Sandler & Co. acted as joint book-running managers for the offering.
  • Kinnate Biopharma is focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers.

Rilzabrutinib granted FDA Fast Track Designation for treatment of immune thrombocytopenia

Wednesday, November 18, 2020 - 6:15am

Phase 3 trial initiated to evaluate rilzabrutinib, the potential first BTK inhibitor (Brutons tyrosine kinase inhibitor) for the treatment of immune thrombocytopenia

Key Points: 
  • Phase 3 trial initiated to evaluate rilzabrutinib, the potential first BTK inhibitor (Brutons tyrosine kinase inhibitor) for the treatment of immune thrombocytopenia
    PARIS November 18, 2020 The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the oral investigational Brutons tyrosine kinase (BTK) inhibitor, rilzabrutinib, which has the potential to be the first BTK inhibitor for the treatment of immune thrombocytopenia (ITP).
  • Rilzabrutinib received orphan drug designation from the FDA for the treatment of ITP in October 2018.
  • "By awarding Fast Track Designation to rilzabrutinib, an investigational candidate for the treatment of ITP, the FDA has recognized rilzabrutinib's potential to meaningfully improve outcomes for patients with this debilitating disease.
  • Rilzabrutinib is an oral, reversible covalent, Brutons tyrosine kinase (BTK) inhibitor being investigated for the treatment of immune mediated diseases.

Apollomics, Inc. Receives China Investigational New Drug Approval for APL-102 to Initiate a Phase 1 Study

Thursday, November 12, 2020 - 12:10pm

Dr. Guoliang Yu, the companys Co-Founder, Chairman and CEO said that: APL-102 is a small molecule multi-kinase inhibitor developed by us.

Key Points: 
  • Dr. Guoliang Yu, the companys Co-Founder, Chairman and CEO said that: APL-102 is a small molecule multi-kinase inhibitor developed by us.
  • APL-102 may not only be used as a single agent to treat patients, but also has a potential of being co-administered with immunotherapy and other treatments as a combination therapy.
  • APL-102 is an oral, multi kinase inhibitor (mKi) targeting several key oncogenic drivers.
  • Apollomics owns the global clinical development, production and commercial sales rights of APL-102.

Puma Biotechnology Announces Interim Results from the Phase II SUMMIT Trial of Neratinib for EGFR Exon 18 Mutated, Metastatic Non-Small Cell Lung Cancer

Thursday, November 5, 2020 - 9:07pm

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced interim results from the ongoing SUMMIT trial of neratinib in the cohort of metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor (EGFR) exon 18 mutations that has been previously treated with an EGFR targeted tyrosine kinase inhibitor (TKI).

Key Points: 
  • Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced interim results from the ongoing SUMMIT trial of neratinib in the cohort of metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor (EGFR) exon 18 mutations that has been previously treated with an EGFR targeted tyrosine kinase inhibitor (TKI).
  • The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating EGFR exon 18 or HER2 mutations.
  • In the EGFR exon 18 mutation cohort, patients with lung cancer with single or complex EGFR exon 18 mutations, who were EGFR TKI nave or were previously exposed to EGFR TKI, were enrolled into this study and received 240 mg of neratinib daily as a single agent.
  • Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care.

Exelixis to Present the Preclinical Profile and Initial Clinical Pharmacokinetics of XL092, Its Next-Generation Oral Tyrosine Kinase Inhibitor

Friday, October 9, 2020 - 8:01am

XL092 is a next-generation oral tyrosine kinase inhibitor that targets VEGF receptors, MET, AXL, MER, and other kinases implicated in cancers growth and spread.

Key Points: 
  • XL092 is a next-generation oral tyrosine kinase inhibitor that targets VEGF receptors, MET, AXL, MER, and other kinases implicated in cancers growth and spread.
  • In designing XL092, Exelixis sought to build upon the experience and target profile of cabozantinib, the companys flagship medicine, while improving key characteristics, including clinical half-life.
  • Exelixis is a member of the Standard & Poors (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies.
  • For more information about Exelixis, please visit www.exelixis.com , follow @ ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.

Blueprint Medicines Announces European Commission Approval of AYVAKYT® (avapritinib) for the Treatment of Adults with Unresectable or Metastatic PDGFRA D842V Mutant Gastrointestinal Stromal Tumors

Friday, September 25, 2020 - 4:46pm

AYVAKYT demonstrated deep and durable clinical activity and was generally well-tolerated in patients with PDGFRA D842V mutant GIST with or without prior therapy.

Key Points: 
  • AYVAKYT demonstrated deep and durable clinical activity and was generally well-tolerated in patients with PDGFRA D842V mutant GIST with or without prior therapy.
  • GIST is a genomically driven sarcoma of the gastrointestinal (GI) tract, with PDGFRA D842V mutations implicated in a rare subset of patients.
  • As part of the conditional marketing authorization, Blueprint Medicines plans to conduct an observational, long-term study in patients with PDGFRA D842V mutant GIST treated with AYVAKYT.
  • AYVAKYT (avapritinib) is a kinase inhibitor approved in the EU for the treatment of adults with unresectable or metastatic GIST harboring the PDGFRA D842V mutation.

ESMO 2020: Cabometyx® (cabozantinib) in Combination With Opdivo® (nivolumab) Demonstrates Significant Survival Benefits in Patients With Advanced Renal Cell Carcinoma in Pivotal Phase III CheckMate -9ER Trial

Saturday, September 19, 2020 - 5:30pm

Cabometyx in combination with Opdivo was associated with a longer duration of response than sunitinib, with a median duration of 20.2 months versus 11.5 months.

Key Points: 
  • Cabometyx in combination with Opdivo was associated with a longer duration of response than sunitinib, with a median duration of 20.2 months versus 11.5 months.
  • All these key efficacy results were consistent across the pre-specified International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk and PD-L1 subgroups.
  • The CheckMate -9ER data demonstrate meaningful efficacy benefits with nivolumab plus cabozantinib, which significantly improved overall survival and doubled progression-free survival and objective response rate with consistent effects observed across pre-specified subgroups.
  • Cabometyx in combination with Opdivo was well tolerated and reflected the known safety profiles of the immunotherapy and tyrosine kinase inhibitor components in previously untreated advanced RCC.