Azenosertib

Robust Pipeline of 200+ Therapies Targets Colorectal Cancer Treatment Landscape

2 months ago

• DelveInsight's latest report reveals a robust pipeline with over 195 companies developing 200+ therapies for colorectal cancer, highlighting significant innovation in targeted treatments and immunotherapies. • Key drug candidates include XL092 (Exelixis), Adagrasib (Mirati Therapeutics), Olaparib (Merck/AstraZeneca), and novel approaches like LYL845, an autologous tumor-infiltrating lymphocyte therapy from Lyell Immunopharma. • The metastatic colorectal cancer segment shows particular promise with 150+ companies advancing 180+ pipeline therapies, including innovative treatments targeting specific mutations and immune pathways.

Schrödinger Unveils Promising Preclinical Data for Novel Cancer Therapeutics at AACR 2025

2 months ago

• Schrödinger presented preclinical data for SGR-3515, a Wee1/Myt1 co-inhibitor showing superior anti-tumor activity compared to monotherapy inhibitors, with optimized dosing schedules that preserve efficacy while minimizing side effects. • The company revealed first characterization data for SGR-4174, a selective SOS1 inhibitor targeting KRAS-driven cancers, demonstrating potent tumor growth inhibition both as monotherapy and in combination with MEK or KRAS inhibitors. • Initial Phase 1 clinical trial data for SGR-3515 in patients with advanced solid tumors is expected in the second half of 2025, highlighting Schrödinger's progress in translating its computational drug discovery platform into clinical candidates.

Verastem Oncology to Present New LGSOC Treatment Data at SGO 2025 Annual Meeting

3 months ago

• Verastem Oncology will present additional analyses from the Phase 2 RAMP 201 trial evaluating avutometinib plus defactinib in recurrent low-grade serous ovarian cancer at SGO 2025, building on their FDA Priority Review submission. • The presentations include new subgroup analyses by KRAS mutational status, supporting the company's ongoing efforts to advance treatment options for RAS/MAPK pathway-driven cancers. • The company's NDA for the avutometinib-defactinib combination therapy has received Priority Review from the FDA with a PDUFA date of June 30, 2025, for KRAS mutant LGSOC patients.

Zentalis Pharmaceuticals Restructures to Advance Azenosertib in Gynecological Cancers

4 months ago

• Zentalis Pharmaceuticals is restructuring to prioritize the late-stage development of azenosertib, a WEE1 inhibitor, for gynecological malignancies. • The restructuring includes a workforce reduction of approximately 40% to extend the company's cash runway into late 2027. • Azenosertib has shown a 5.5-month median duration of response with no new safety signals in mid-trial data from the MAMMOTH and DENALI studies. • Zentalis plans to present updated clinical data and regulatory plans for azenosertib at a corporate event on January 29, 2025.

Azenosertib Shows Promise in Cyclin E1+ Platinum-Resistant Ovarian Cancer

4 months ago

• Zentalis Pharmaceuticals presented updated clinical data on azenosertib, highlighting its potential in treating Cyclin E1+ platinum-resistant ovarian cancer (PROC). • In the DENALI trial, azenosertib monotherapy demonstrated an objective response rate (ORR) of approximately 35% in heavily pretreated patients with Cyclin E1+ PROC. • The FDA has granted Fast Track Designation to azenosertib for Cyclin E1+ PROC, potentially expediting its development and regulatory review. • Zentalis plans to initiate enrollment for DENALI Part 2 in the first half of 2025, with topline data expected by the end of 2026, aiming for accelerated approval.

Aprea Therapeutics Advances WEE1 and ATR Inhibitors in Clinical Trials

6 months ago

• Aprea Therapeutics is progressing its Phase 1 ACESOT-1051 trial of APR-1051, a WEE1 inhibitor, showing promising tolerability in treating cancers with Cyclin E over-expression. • The company's Phase 1/2a ABOYA-119 study is evaluating ATRN-119, an ATR inhibitor, for patients with DDR-related gene mutations, addressing a significant unmet medical need. • Aprea Therapeutics reported $26.2 million in cash reserves, ensuring funding for at least the next twelve months, and appointed Dr. Philippe Pultar as a senior medical advisor.

FDA Lifts Clinical Hold on Zentalis' Azenosertib Trials, Boosting Cancer Research

8 months ago

• The FDA has lifted the partial clinical hold on Zentalis Pharmaceuticals' azenosertib studies, allowing for the resumption of patient enrollment in ongoing trials. • The decision follows a comprehensive safety assessment review by the FDA, reinforcing confidence in azenosertib's therapeutic potential, especially for gynecologic malignancies. • Azenosertib, an orally bioavailable WEE1 inhibitor, is being evaluated as both a monotherapy and in combination to treat ovarian cancer and other tumor types. • Zentalis plans to present monotherapy data on azenosertib later in 2024, providing updates on clinical development timelines and data presentation.

FDA Lifts Partial Clinical Hold on Azenosertib Trials in Advanced Solid Tumors

8 months ago

• The FDA has lifted the partial clinical hold on trials evaluating azenosertib, a WEE1 inhibitor, in patients with advanced solid tumors, allowing studies to resume enrollment. • The hold was initiated in June 2024 due to two deaths from presumed sepsis in the DENALI trial, but the FDA has now reviewed and approved Zentalis Pharmaceuticals' response package. • Azenosertib is being investigated as a monotherapy and in combination for platinum-resistant ovarian cancer and uterine serous carcinoma, with additional data expected in Q4 2024.

FDA Lifts Partial Clinical Hold on Zentalis' Azenosertib Studies

8 months ago

• The FDA has lifted the partial clinical hold on Zentalis Pharmaceuticals' azenosertib studies, allowing the company to resume enrollment in ongoing clinical trials. • Zentalis plans to present azenosertib monotherapy data and provide updates on clinical development at a corporate event later this year. • The company remains confident in azenosertib's therapeutic potential for addressing unmet needs in gynecologic malignancies. • Zentalis is on track to meet all previously disclosed data guidance for 2024, including key clinical study results expected in Q4.

Drug Development Updates