RTOR

Kinnate Biopharma Inc. to Participate in the 2022 Piper Sandler Heartland Summit

Retrieved on: 
Thursday, September 15, 2022

SAN FRANCISCO and SAN DIEGO, Sept. 15, 2022 (GLOBE NEWSWIRE) -- Kinnate Biopharma Inc .

Key Points: 
  • SAN FRANCISCO and SAN DIEGO, Sept. 15, 2022 (GLOBE NEWSWIRE) -- Kinnate Biopharma Inc .
  • (Nasdaq: KNTE) (Kinnate), a clinical-stage precision oncology company, today announced that its chief executive officer, Nima Farzan , will participate in the Piper Sandler Heartland Summit as part of the panel Healthcare Politics: FDA Proposals from Optimus, to ORBIS to RTOR and CONFIRM How Might These Proposals Impact Oncology Drug Development and Implications?
  • Kinnate Biopharma Inc. is a clinical-stage precision oncology company focused on expanding on the promise of targeted therapies for those battling cancer.
  • Words such as believes, anticipates, plans, expects, intends, will, goal, potential and similar expressions are also intended to identify forward-looking statements.

SpringWorks Therapeutics Announces Data from Phase 3 DeFi Trial Evaluating Nirogacestat in Adult Patients with Progressing Desmoid Tumors at the European Society for Medical Oncology (ESMO) Congress 2022

Retrieved on: 
Saturday, September 10, 2022

STAMFORD, Conn., Sept. 10, 2022 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, announced that data from the Phase 3 DeFi trial of nirogacestat, an investigational oral gamma secretase inhibitor, in adult patients with progressing desmoid tumors, are being presented today as a late-breaking oral presentation during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2022.

Key Points: 
  • The median Kaplan-Meier estimate of PFS was not reached in the nirogacestat arm and was 15.1 months in the placebo arm.
  • Confirmed objective response rate (complete response + partial response) based on RECIST v1.1 was 41% with nirogacestat versus 8% with placebo (p
  • Nirogacestat demonstrated statistically significant and clinically meaningful improvements in patient-reported outcomes (PRO), which were key secondary endpoints of the study.
  • DeFi ( NCT03785964 ) is a global, randomized (1:1), double-blind, placebo-controlled Phase 3 trial evaluating the efficacy, safety and tolerability of nirogacestat in adult patients with progressing desmoid tumors.

U.S. FDA approves additional indication of darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC)

Retrieved on: 
Monday, August 8, 2022

Darolutamide in combination with docetaxel and ADT demonstrated a 32.5% reduction in the risk of death compared to docetaxel plus ADT.

Key Points: 
  • Darolutamide in combination with docetaxel and ADT demonstrated a 32.5% reduction in the risk of death compared to docetaxel plus ADT.
  • The compound is also being investigated in further studies across various stages of prostate cancer.
  • Ng, K., Smith, S., Shamash, J. Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): Advances and Treatment Strategies in the First-Line Setting.
  • Hahn AW, Higano CS, Taplin ME, Ryan CJ, Agarwal N. Metastatic Castration-Sensitive Prostate Cancer: Optimizing Patient Selection and Treatment.

SpringWorks Therapeutics to Present Progress Across the Company’s Targeted Oncology Portfolio at Virtual R&D Day

Retrieved on: 
Friday, June 10, 2022

-- BGB-3245 Monotherapy to Advance into Cohort Expansion Studies --

Key Points: 
  • SpringWorks is at an exciting juncture in terms of data generation, regulatory discussions, and launch preparations.
  • A replay will be available on the SpringWorks website for a limited period of time following the event.
  • SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for patients living with severe rare diseases and cancer.
  • New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties.

Jazz Pharmaceuticals Presents Positive Data from Phase 2/3 Trial of Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn) in Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma at the ASCO 2022 Annual Meeting

Retrieved on: 
Tuesday, June 7, 2022

DUBLIN, June 7, 2022 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced positive results from a Phase 2/3 trial, developed and conducted in close collaboration with the Children's Oncology Group (COG), evaluating the intramuscular (IM) administration of Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn) in adult and pediatric patients with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) who have developed hypersensitivity to an E. coli-derived asparaginase. These results will be presented as an oral presentation today at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting.

Key Points: 
  • Females of reproductive potential should use effective contraception (other than oral contraceptives) during treatment and for 3 months following the final dose.
  • Do not breastfeed while receiving RYLAZE and for 1 week after the final dose.
  • Tell your healthcare provider if there are any side effects that are bothersome or that do not go away.
  • We have a diverse portfolio of marketed medicines and novel product candidates, from early-to late-stage development, in neuroscience and oncology.

Jazz Pharmaceuticals Presents Positive Data from Phase 2/3 Trial of Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn) in Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma at the ASCO 2022 Annual Meeting

Retrieved on: 
Tuesday, June 7, 2022

DUBLIN, June 7, 2022 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced positive results from a Phase 2/3 trial, developed and conducted in close collaboration with the Children's Oncology Group (COG), evaluating the intramuscular (IM) administration of Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn) in adult and pediatric patients with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) who have developed hypersensitivity to an E. coli-derived asparaginase. These results will be presented as an oral presentation today at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting.

Key Points: 
  • Females of reproductive potential should use effective contraception (other than oral contraceptives) during treatment and for 3 months following the final dose.
  • Tell your healthcare provider if there are any side effects that are bothersome or that do not go away.
  • We have a diverse portfolio of marketed medicines and novel product candidates, from early-to late-stage development, in neuroscience and oncology.
  • Asparaginase activity levels and monitoring in patients with acute lymphoblastic leukemia.Leukemia & Lymphoma.

Mirati Therapeutics Submits Marketing Authorization Application to the European Medicines Agency for Investigational Adagrasib as a Treatment for Previously-Treated KRASG12C-mutated Non-Small Cell Lung Cancer

Retrieved on: 
Thursday, May 19, 2022

SAN DIEGO , May 19, 2022 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for adagrasib for the treatment of patients with non-small cell lung cancer (NSCLC) harboring the KRASG12C mutation who have received at least one prior systemic therapy. 

Key Points: 
  • We look forward to working with the EMA to potentially bring this therapy to patients.
  • We also thank the patients and investigators who make our work possible by participating in clinical trials."
  • Mirati has an Expanded Access Program (EAP) for investigationaladagrasibfor the treatment of eligible patients with KRASG12C-mutated cancers, regardless of tumor type, in the U.S.
  • This press release contains forward-looking statements regarding the business of Mirati Therapeutics, Inc. ("Mirati").

Mirati Therapeutics to Present New Research at the 2022 ASCO Annual Meeting Showcasing Clinical Advances of Treating KRASG12C-Mutated Lung Cancer with Investigational Adagrasib

Retrieved on: 
Wednesday, April 27, 2022

We believe adagrasib has the potential to transform the lives of those with KRAS-mutated cancers including lung, colorectal, pancreatic and other tumors that carry the KRASG12C mutation."

Key Points: 
  • We believe adagrasib has the potential to transform the lives of those with KRAS-mutated cancers including lung, colorectal, pancreatic and other tumors that carry the KRASG12C mutation."
  • Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.
  • For more information about Mirati, visit us at Mirati.com or follow us on Twitter , LinkedIn and Facebook .
  • This press release contains certain forward-looking statements regarding the business of Mirati Therapeutics, Inc. ("Mirati").

Moleculin Announces Appointment of Joy Yan, M.D., Ph.D. to Board of Directors

Retrieved on: 
Tuesday, March 1, 2022

"We are incredibly pleased to welcome Dr. Yan to our Board of Directors.

Key Points: 
  • "We are incredibly pleased to welcome Dr. Yan to our Board of Directors.
  • Dr. Yan added, "I am excited to join the Moleculin Board of Directors and provide guidance to help position the Company for continued growth.
  • I believe that Moleculin's pipeline and science will propel the Company to its next development phase and build value for stakeholders."
  • Joy Yan, M.D., Ph.D., currently serves as an Independent Board Director at Checkmate Pharmaceuticals.

U.S. Food and Drug Administration (FDA) Accepts Mirati Therapeutics' New Drug Application for Adagrasib as Treatment of Previously Treated KRASG12C-Mutated Non-Small Cell Lung Cancer

Retrieved on: 
Tuesday, February 15, 2022

Food and Drug Administration(FDA) accepted the New Drug Application (NDA) for adagrasib for the treatment of patients with non-small cell lung cancer (NSCLC) harboring the KRASG12C mutation who have received at least one prior systemic therapy.

Key Points: 
  • Food and Drug Administration(FDA) accepted the New Drug Application (NDA) for adagrasib for the treatment of patients with non-small cell lung cancer (NSCLC) harboring the KRASG12C mutation who have received at least one prior systemic therapy.
  • The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022.
  • The FDA's review of the adagrasib NDA marks important progress toward potentially providing a new, targeted option for those living with KRASG12C-mutated non-small cell lung cancer."
  • The Company has an ongoing confirmatory Phase 3 trial, KRYSTAL-12, evaluating adagrasib versus docetaxel in patients with second-line KRASG12C-mutated NSCLC.