MEK inhibitor

Kinnate Biopharma Inc. Announces Pipeline Updates, Strategic Reprioritization and Workforce Restructuring

Retrieved on: 
Monday, September 18, 2023
Perk, NRAS, Workforce, FGFR, DNA, Pancreatic cancer, DUSP6, PRS, Class II, Class, DCR, Clinical trial, DC, DL 2, Trae tha Truth, First grade, MEK inhibitor, BRAF, Research, Itch, MEK, RNA, Lung cancer, Completeness, Binimetinib, Rash, ORR, Vomiting, Investment, Patient, SAN, Melanoma, ERK, Weakness, Nausea, ALT, Neoplasm, CDK4, FDA, FGFR2, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, SD, KNTE, Food, PR, Safety, Fatigue, RAF, Pharmaceutical industry, Cryptocurrency, Medical imaging, Vaccine

(Nasdaq: KNTE) (“Kinnate” or “the Company”), a clinical-stage precision oncology company, today announced pipeline updates and a reprioritization plan, as well as a workforce restructuring, based on a strategic review of its business.

Key Points: 
  • (Nasdaq: KNTE) (“Kinnate” or “the Company”), a clinical-stage precision oncology company, today announced pipeline updates and a reprioritization plan, as well as a workforce restructuring, based on a strategic review of its business.
  • Additionally, Kinnate will pause development of KIN-7136 and explore strategic alternatives for exarafenib monotherapy and KIN-3248, as part of the reprioritization plan.
  • We believe that reprioritizing our programs is the most effective approach to unlock the full promise of our innovative therapies.”
    Farzan added, “The reprioritization plan unfortunately impacts our workforce.
  • Kinnate will implement a corporate restructuring by reducing the Company’s workforce by approximately 70%.

Pasithea Therapeutics Announces Completion of GMP Manufacturing for PAS-004

Retrieved on: 
Thursday, June 29, 2023
GMP, PK, Wuxi, Partnership, Central nervous system, PALO, CMC, API, MEK inhibitor, Research, Chemistry, KTTA, Investigational New Drug, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Safety, Pharmaceutical industry, Fine chemical, Pasithea (Charites)

GMP-compliant manufacturing of API was the final step needed to support the Investigational New Drug (“IND”) application that the Company expects to file with the U.S. Food and Drug Administration (“FDA”) in the second half of 2023.

Key Points: 
  • GMP-compliant manufacturing of API was the final step needed to support the Investigational New Drug (“IND”) application that the Company expects to file with the U.S. Food and Drug Administration (“FDA”) in the second half of 2023.
  • The Company intends to utilize this supply of PAS-004 for its upcoming Phase I clinical trial.
  • Dr. Tiago Reis Marques, Pasithea’s Chief Executive Officer, commented “We are pleased to have reached this milestone efficiently and on time.
  • We are grateful to WuXi STA for its expertise throughout the process, development and manufacturing of the API.

Pasithea Therapeutics Signs CMC Development and Manufacturing Agreement for the Production of PAS-004

Retrieved on: 
Wednesday, January 18, 2023
IND, API, Neurofibromatosis, Clinical trial, MEK inhibitor, CMC, CNS, MIAMI, NF1, FDA, Research, Central nervous system, Contract manufacturing organization, Wuxi, STA, Chemistry, KTTA, GMP, Pharmaceutical industry, Fine chemical

MIAMI BEACH, Fla., Jan. 18, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research and development of innovative treatments for Central Nervous System (CNS) disorders, today announced its contract with WuXi STA, a subsidiary of WuXi AppTec, to manufacture the active pharmaceutical ingredient (“API”) for Pasithea’s macrocyclic, next-generation MEK Inhibitor, PAS-004 (formerly CIP-137401).

Key Points: 
  • WuXi STA is recognized as an industry leader in “end-to-end” chemistry, manufacturing, and controls (CMC) services, for both API and finished dosage forms, with extensive expertise and track record for meeting global quality standards.
  • “​We are delighted to be working with WuXi STA, one of the largest and most well-respected Contract, Development, and Manufacturing Organizations (CDMOs) in the world.
  • We remain on track with PAS-004 development and look forward to our IND submission followed by the initiation of our Phase 1 clinical trial,” commented Pasithea CEO, Dr. Tiago Reis Marques.
  • “WuXi STA has a proven track record of manufacturing success to FDA standards and we believe that their high-quality capabilities will support progression of our drug candidate into the clinic.

Lutris Pharma Receives Notice of Allowance for Patent Covering the Use of B-Raf Inhibitors in MEK Inhibitor induced rash

Retrieved on: 
Wednesday, September 14, 2022
Treatment of cancer, Safety, Radiation, MEK inhibitor, Risk, TEL, Growth factor, Compliance, BRAF, Lutris, Patient, Breast cancer, Prognosis, USPTO, MEK, Quality of life, Patent, Pulmonary toxicity, MSK, Method, Skin, Memorial Sloan Kettering Cancer Center, Cancer, EGFR, Toxicity, Pharmaceutical industry, RD

TEL AVIV, Israel, Sept. 14, 2022 /PRNewswire/ -- Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing dose limiting side effects, today announced that the company, together with Memorial Sloan Kettering Cancer Center (MSK), has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for U.S. Patent Application No. 16/636,974, entitled, "Use of BRAF Inhibitors for Treating Cutaneous Reactions Caused by Treatment With a MEK Inhibitor." The company has licensed exclusive rights to the patent from MSK. When issued, Lutris will have a total of 24 issued national patents covering 18 countries, as well as 19 patents pending.

Key Points: 
  • 16/636,974, entitled, "Use of BRAF Inhibitors for Treating Cutaneous Reactions Caused by Treatment With a MEK Inhibitor."
  • When issued, Lutris will have a total of 24issued national patents covering 18 countries, as well as 19patents pending.
  • The USPTO issues a patent Notice of Allowance after it determines a patent should be granted upon completion of any outstanding administrative requirements.
  • The patent resulting from this application will have an expiration date of not earlier than August 8, 2038.

SpringWorks Therapeutics Announces Phase 1b/2a Clinical Trial of Mirdametinib in Patients with Advanced Solid Cancers Harboring MAPK-Activating Mutations

Retrieved on: 
Tuesday, August 3, 2021
Branches of biology, Clinical medicine, Organ systems, Neurofibroma, Neurofibromin 1, Antineoplastic drugs, Genodermatoses, MEK inhibitor, Targeted therapy, Neurofibromatosis type I

Hormonal therapies targeting ER, such as SERDs, can be effective in treating ER+ mBC, but over 90% of patients eventually develop resistance to ER-targeted therapy.

Key Points: 
  • Hormonal therapies targeting ER, such as SERDs, can be effective in treating ER+ mBC, but over 90% of patients eventually develop resistance to ER-targeted therapy.
  • We are committed to exploring the full potential of mirdametinib on behalf of patients with devastating cancers and look forward to collaborating with Dr. Rosen and his colleagues at MSK on this important trial.
  • In addition, mirdametinib is being evaluated in a Phase 1b/2 trial in combination with BeiGenes RAF dimer inhibitor, lifirafenib, in patients with advanced or refractory solid tumors harboring RAS mutations, RAF mutations, and other MAPK pathway aberrations.
  • NF106: A Neurofibromatosis Clinical Trials Consortium Phase II Trial of the MEK Inhibitor Mirdametinib (PD-0325901) in Adolescents and Adults With NF1-Related Plexiform Neurofibromas.

Verastem Oncology Announces Updated Phase 1/2 FRAME Study Data in Low Grade Serous Ovarian Cancer Selected for a Mini Oral Presentation at the European Society of Medical Oncology Congress 2021

Retrieved on: 
Tuesday, July 27, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Cancer, Health, KRAS, Clinical medicine, Gastrointestinal cancer, Uveal melanoma, Melanoma, Verastem Oncology, Pancreatic cancer, MEK inhibitor, the VS-6766/Defactinib Combination, Verastem Oncology, THE VS-6766/DEFACTINIB COMBINATION, VERASTEM ONCOLOGY

Patients with low-grade serous ovarian cancer urgently need better solutions due to low response rates and tolerability issues associated with other therapeutic approaches.

Key Points: 
  • Patients with low-grade serous ovarian cancer urgently need better solutions due to low response rates and tolerability issues associated with other therapeutic approaches.
  • The company-sponsored, registration-directed Phase 2 RAMP 201 study is well underway, with top-line results from the selection phase expected during the first half of 2022.
  • The FRAME study was expanded to include new cohorts in pancreatic cancer, KRAS mutant endometrioid cancer and KRAS-G12V NSCLC.
  • Verastem Oncology is also supporting an investigator-initiated Phase 2 trial evaluating VS-6766 with defactinib in patients with metastatic uveal melanoma.

MediWound Announces Initiation of U.S. Phase I/II Study of MW005 for the Treatment of Basal Cell Carcinoma

Retrieved on: 
Monday, July 26, 2021
Medicine, Cancer, Melanoma, Clinical medicine, Health, Skin cancer, Chemotherapy, Sulfonamides, MEK inhibitor, Wolfram Samlowski

YAVNE, Israel, July 26, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced initiation of its phase I/II study of MW005 for the treatment of low-risk Basal Cell Carcinoma (BCC). In parallel, an investigator-initiated phase II trial of MW005 in non-melanoma skin cancers is being conducted at the Soroka Medical Center in Israel. MediWound expects that data from both studies will be available by the end of 2021.

Key Points: 
  • In parallel, an investigator-initiated phase II trial of MW005 in non-melanoma skin cancers is being conducted at the Soroka Medical Center in Israel.
  • We are excited to initiate this U.S. phase I/II study of MW005, which is the first step in this important clinical development program.
  • MW005, a topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.
  • MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

Deciphera Announces First Patient Treated in Phase 1 Study of DCC-3116 in Patients with Advanced or Metastatic Tumors with a Mutant RAS or RAF Gene

Retrieved on: 
Wednesday, June 30, 2021
Oncology, Health, Other Health, General Health, Clinical trials, Pharmaceutical, Biotechnology, Branches of biology, Biology, Autophagy, Cell death, Immunology, Programmed cell death, Signal transduction, MEK inhibitor, MTOR, Ras GTPase

The ULK kinase initiates the autophagy pathway and provides a potential targeted approach to selectively inhibiting autophagy in cancers caused by RAS or RAF mutations.

Key Points: 
  • The ULK kinase initiates the autophagy pathway and provides a potential targeted approach to selectively inhibiting autophagy in cancers caused by RAS or RAF mutations.
  • In preclinical studies, DCC-3116 was observed to potently and durably inhibit autophagy in RAS and RAF mutant cancer cell lines through the inhibition of ULK kinase.
  • The Phase 1, multicenter, open-label, first-in-human study will evaluate DCC-3116 as a single agent and in combination with trametinib, an FDA-approved MEK inhibitor, in patients with advanced or metastatic tumors with a mutant RAS or RAF gene.
  • QINLOCK and the QINLOCK logo are registered trademarks, and Deciphera and the Deciphera logo are trademarks, of Deciphera Pharmaceuticals, LLC.

SpringWorks Therapeutics Announces Initiation of Phase 1/2 Clinical Trial of Mirdametinib in Children and Young Adults with Low-Grade Glioma

Retrieved on: 
Wednesday, June 16, 2021
Health sciences, Health, Branches of biology, Neurofibroma, Neurofibromin 1, MEK inhibitor, Clinical trial

The open-label, multi-center Phase 1/2 trial will evaluate the safety, tolerability and pharmacokinetics of mirdametinib in children, adolescents and young adults with LGG.

Key Points: 
  • The open-label, multi-center Phase 1/2 trial will evaluate the safety, tolerability and pharmacokinetics of mirdametinib in children, adolescents and young adults with LGG.
  • The primary objective of the Phase 1 portion of the trial will be to evaluate the safety, tolerability, and pharmacokinetics of mirdametinib.
  • The Phase 2 portion of the trial is designed to measure the objective response rate and duration of response to mirdametinib.
  • NF106: A Neurofibromatosis Clinical Trials Consortium Phase II Trial of the MEK Inhibitor Mirdametinib (PD-0325901) in Adolescents and Adults With NF1-Related Plexiform Neurofibromas.

Immunocore presents clinical data further characterizing the overall survival benefit of tebentafusp in metastatic uveal melanoma at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting

Retrieved on: 
Friday, June 4, 2021
Medicine, Clinical medicine, Cancer treatments, Virotherapy, Cancer immunotherapy, Cancer, Melanoma, Uveal melanoma, Immunotherapy, DecisionDx-UM, MEK inhibitor

At ASCO this year, we presented further analysis of the Phase 3 tebentafusp trial including an overall survival benefit from tebentafusp in patients with best response of progressive disease.

Key Points: 
  • At ASCO this year, we presented further analysis of the Phase 3 tebentafusp trial including an overall survival benefit from tebentafusp in patients with best response of progressive disease.
  • More than half of tebentafusp patients with best response PD were treated beyond initial progression and no new safety signals were observed.
  • Immunocores most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.
  • For more information about enrolling tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).