Protein kinase inhibitors

C-Raf Kinase Inhibitor Pipeline Insight Report 2020: HyNap-Sora, Sorafenib/MG 010, APL-102, & BAL 3833 - ResearchAndMarkets.com

Retrieved on: 
Friday, February 5, 2021

The "C-Raf Kinase Inhibitor - Pipeline Insight, 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "C-Raf Kinase Inhibitor - Pipeline Insight, 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This "C-Raf Kinase Inhibitor- Pipeline Insight, 2020," report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in C-Raf Kinase Inhibitor pipeline landscape.
  • This segment of the report provides insights about the different C-Raf Kinase Inhibitor drugs segregated based on following parameters that define the scope of the report, such as:
    There are approx.
  • C-Raf Kinase Inhibitor pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Pfizer Confirms U.S. Patent Term Extension for IBRANCE® (palbociclib) Until March 2027

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Friday, February 5, 2021

Pfizer Inc. (NYSE: PFE) today announced that the U.S. Patent and Trademark Office (USPTO) recently issued a U.S. Patent Term Extension (PTE) certificate for IBRANCE (palbociclib).

Key Points: 
  • Pfizer Inc. (NYSE: PFE) today announced that the U.S. Patent and Trademark Office (USPTO) recently issued a U.S. Patent Term Extension (PTE) certificate for IBRANCE (palbociclib).
  • The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984.
  • In PALOMA-2, Grade 3 (56%) or 4 (10%) decreased neutrophil counts were reported in patients receiving IBRANCE plus letrozole.
  • In PALOMA-3, Grade 3 (55%) or Grade 4 (11%) decreased neutrophil counts were reported in patients receiving IBRANCE plus fulvestrant.

InnoCare Announces First Subject Dosed in Clinical Trial of ICP-192 in the U.S.

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Thursday, February 4, 2021

InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, announced today the first subject dosed in clinical trial of pan-FGFR inhibitor ICP-192 in the United States.

Key Points: 
  • InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, announced today the first subject dosed in clinical trial of pan-FGFR inhibitor ICP-192 in the United States.
  • ICP-192 is a highly selective small-molecule pan-FGFR inhibitor for the treatment of various solid tumors with FGFR aberrations.
  • Currently it is in Phase I/II clinical studies in China and the United States.
  • The Phase II trial in China is a multi-center, open-label clinical trial designed to evaluate the safety and efficacy of ICP-192 in patients with advanced cholangiocarcinoma and urothelial cancer that have FGFR aberrations.

Asana BioSciences’ Gusacitinib Granted FDA Fast-Track Designation for Moderate-to-Severe Chronic Hand Eczema

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Wednesday, February 3, 2021

Asana BioSciences, a clinical stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast-Track designation to Asanas gusacitinib (ASN002), an investigational oral, dual inhibitor of Janus Kinase (JAK) and Spleen Tyrosine Kinase (SYK), for the treatment of moderate-to-severe Chronic Hand Eczema (CHE).

Key Points: 
  • Asana BioSciences, a clinical stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast-Track designation to Asanas gusacitinib (ASN002), an investigational oral, dual inhibitor of Janus Kinase (JAK) and Spleen Tyrosine Kinase (SYK), for the treatment of moderate-to-severe Chronic Hand Eczema (CHE).
  • Patients with CHE suffer greatly from this disease, which limits their ability to work and perform activities of daily living.
  • There are no approved treatments for patients suffering from CHE in the U.S. and in many other major markets.
  • We are pleased that the FDA has granted Fast-Track designation to gusacitinib.

Breast Cancer Index™ demonstrates its ability to predict preferential endocrine benefit irrespective of risk for HR+ early-stage breast cancer patients

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Thursday, December 17, 2020

San Diego, CA, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Evidence demonstrating the ability of Breast Cancer Index to predict preferential endocrine benefit irrespective of clinical risk for HR+ early-stage breast cancer patients was highlighted during a Spotlight session on December 9that this years San Antonio Breast Cancer Symposium.

Key Points: 
  • San Diego, CA, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Evidence demonstrating the ability of Breast Cancer Index to predict preferential endocrine benefit irrespective of clinical risk for HR+ early-stage breast cancer patients was highlighted during a Spotlight session on December 9that this years San Antonio Breast Cancer Symposium.
  • The Investigation on the Duration of Extended Adjuvant Letrozole (IDEAL) trial examined the Breast Cancer Index (BCI) HOXB13/IL17BR (H/I) ratio and its ability to predict benefit from extended endocrine therapy.
  • The Breast Cancer Index (BCI) allows us to sort out the patients who will benefit from extended endocrine therapy from those who will not (but who will suffer the harms).
  • Breast Cancer Index is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early stage, HR+ breast cancer.

BerGenBio (BGBIO): Progressing towards key inflection points

Retrieved on: 
Thursday, December 17, 2020

BerGenBio has presented two positive datasets for its lead asset bemcentinib in acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) at ASH 2020.

Key Points: 
  • BerGenBio has presented two positive datasets for its lead asset bemcentinib in acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) at ASH 2020.
  • We still forecast the NDA submission for this indication in 2023 (FDA fast-track has been granted).
  • We continue to value BerGenBio at NOK5.16bn or NOK59.1 per share based on a risk-adjusted NPV analysis.
  • The key drivers are bemcentinib in second-line NSCLC (peak sales $1.2bn, NOK40.7/share) and AML (peak sales $588m, NOK13.3/share) plus COVID-19 opportunity (NOK5.9/share).

AB Science issues a corrective press release regarding adverse events information from study AB09004 reported on December 16, 2020

Retrieved on: 
Thursday, December 17, 2020

AB Science SA (Euronext - FR0010557264 - AB) today announced that the press release issued on December 16, 2020 regarding the results from study AB09004, which evaluated masitinib in the treatment of Alzheimer disease, contained a material error in the adverse events information reported.

Key Points: 
  • AB Science SA (Euronext - FR0010557264 - AB) today announced that the press release issued on December 16, 2020 regarding the results from study AB09004, which evaluated masitinib in the treatment of Alzheimer disease, contained a material error in the adverse events information reported.
  • Masitinib is a new orally administered tyrosine kinase inhibitor that targets mast cells and macrophages, important cells for immunity, through inhibiting a limited number of kinases.
  • In oncology due to its immunotherapy effect, masitinib can have an effect on survival, alone or in combination with chemotherapy.
  • AB Science disclaims any obligationor undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq.

Rafael Pharmaceuticals Receives FDA Fast Track Designation for CPI-613® (devimistat) for the Treatment of Acute Myeloid Leukemia (AML)

Retrieved on: 
Tuesday, December 15, 2020

While one of the most common types of leukemia in adults, AML accounts for only 1% of all cancers .

Key Points: 
  • While one of the most common types of leukemia in adults, AML accounts for only 1% of all cancers .
  • This announcement comes on the heels of the Company receiving Fast Track designation for devimistat for the treatment of metastatic pancreatic cancer , in November.
  • The EMA has granted orphan drug designation to devimistat for pancreatic cancer and acute myeloid leukemia.
  • Devimistat has been granted orphan drug status by the FDA for the treatment of pancreatic cancer, acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and Burkitts,peripheral T-cell lymphomas and soft tissue sarcoma.

Arvinas Releases Interim Clinical Data Further Demonstrating the Powerful Potential of PROTAC® Protein Degraders ARV-471 and ARV-110

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Monday, December 14, 2020

In metastatic breast cancer, prior treatment with CDK4/6 inhibitors predicts high tumor ER-independence, rendering ER-targeting therapies ineffective.

Key Points: 
  • In metastatic breast cancer, prior treatment with CDK4/6 inhibitors predicts high tumor ER-independence, rendering ER-targeting therapies ineffective.
  • Arvinas also expects to initiate a Phase 1b cohort expansion of ARV-471 in combination with Ibrance (palbociclib) in December 2020.
  • Arvinas will host a conference call and webcast at 8:00 AM ET on Monday, December 14, 2020 to discuss these data.
  • ARV-110 is an investigational orally bioavailable PROTAC protein degrader designed to selectively target and degrade the androgen receptor (AR).

Everest Medicines Announces First Patient Dosed in Phase 3 Registration Asian Study of TrodelvyTM (sacituzumab govitecan) for Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

Retrieved on: 
Wednesday, December 9, 2020

The primary endpoint is progression free survival (PFS) per RECIST v1.1 by an Independent Review Committee.

Key Points: 
  • The primary endpoint is progression free survival (PFS) per RECIST v1.1 by an Independent Review Committee.
  • HR+/HER2- breast cancer is the most prevalent subtype of breast cancer and accounts for more than 60% of all breast cancer cases.
  • Hormone Receptor Positive, HER2 Negative (HR+/HER2-) breast cancer is the most common form of breast cancer in China, representing over 60% of all breast cancer cases.
  • This subtype of breast cancer grows in connection with estrogen or progesteroneand is likely to respond to hormone therapies initially, but almost all HR+/HER2- metastatic breast cancers becomerefractory over time.