Nuvation Bio | MedPath

Promising Pipeline for Soft Tissue Sarcoma Treatment Expands with 130+ Therapies in Development

2 months ago

• Global soft tissue sarcoma pipeline constitutes 125+ companies developing 130+ treatment therapies, with significant progress in clinical trials across various stages of development. • FDA grants Orphan Drug Designation to Actuate Therapeutics' elraglusib for soft tissue sarcoma treatment, highlighting its potential to address unmet needs in this rare cancer. • Novel approaches include tumor-targeting antibody-cytokine fusion proteins, intratumoral administration techniques, and GSK-3β inhibition, offering hope for improved outcomes in this challenging disease.

Nuvation Bio Secures $250M Financing for US Launch of ROS1 Inhibitor Taletrectinib

3 months ago

• Nuvation Bio has successfully raised $250 million in financing to support the commercial launch of taletrectinib, a novel ROS1 inhibitor for advanced non-small cell lung cancer. • The financing package includes both equity and debt components, strengthening Nuvation Bio's position to advance taletrectinib through final development stages and commercial preparations. • This strategic funding will enable Nuvation Bio to establish its commercial infrastructure and prepare for the anticipated US market entry of taletrectinib as a targeted therapy option.

Nuvation Bio Secures $250M Financing Package to Launch Novel Lung Cancer Drug Taletrectinib

3 months ago

• Nuvation Bio has secured a $250 million non-dilutive financing deal with Sagard Healthcare Partners, including $150 million in royalty financing and up to $100 million in term loans. • The financing package is contingent on FDA approval of taletrectinib, a targeted therapy for ROS1-positive non-small cell lung cancer, expected in mid-2025. • The funding will fully support taletrectinib's U.S. commercial launch and ongoing clinical pipeline development without requiring additional capital raises.

FDA Approves Five Groundbreaking Treatments for Ultra-Rare Diseases in Recent Months

3 months ago

• The FDA has approved novel therapies for Duchenne Muscular Dystrophy, including ITF Therapeutics' Duvyzat (givinostat), which targets histone deacetylases to potentially slow muscle deterioration. • Breakthrough gene therapy Lenmeldy received approval for Metachromatic Leukodystrophy, offering the first targeted treatment option with significant survival benefits for pediatric patients. • Multiple rare diseases saw first-ever treatments, including Xolremdi for WHIM syndrome, dual approvals for Niemann-Pick Disease Type C, and Ctexli for Cerebrotendinous Xanthomatosis.

Arvinas Advances Vepdegestrant into Phase 3 Trials for Breast Cancer and Updates Pipeline Milestones

4 months ago

• Arvinas plans to initiate two Phase 3 trials in 2025 for vepdegestrant in ER+/HER2- metastatic breast cancer, one in the first-line setting with atirmociclib and another in the second-line setting with a CDK4/6 inhibitor. • Topline data from the Phase 3 VERITAC-2 monotherapy trial of vepdegestrant in second-line-plus ER+/HER2- metastatic breast cancer is anticipated in the first quarter of 2025. • Arvinas is set to present initial data from the Phase 1 trial of ARV-393 in B-cell lymphomas and file an IND application for a novel PROTAC KRAS G12D degrader in 2025. • Phase 1 trial with PROTAC LRRK2 degrader ARV-102 in patients with Parkinson’s disease has been initiated, with data expected to be presented in the first half of 2025.

Nuvation Bio's Taletrectinib Gains FDA Priority Review and Expanded Access Program for ROS1+ NSCLC

5 months ago

• The FDA granted priority review to Nuvation Bio's NDA for taletrectinib, a next-generation ROS1 inhibitor, for advanced ROS1+ non-small cell lung cancer, setting a PDUFA date of June 23, 2025. • Taletrectinib demonstrated promising efficacy and tolerability in the TRUST-I and TRUST-II trials, showing durable responses and prolonged progression-free survival in ROS1+ NSCLC patients. • Nuvation Bio has initiated an Expanded Access Program (EAP) in the U.S. for taletrectinib, offering access to eligible patients with advanced ROS1+ NSCLC outside of clinical trials. • The NDA is based on pooled data from the TRUST-I and TRUST-II studies, which included over 300 patients, representing the largest ROS1-positive NSCLC dataset supporting an NDA.

Innovent's Taletrectinib (DOVBLERON®) Receives Expanded Approval in China for ROS1-Positive NSCLC

5 months ago

• China's NMPA has approved Innovent's taletrectinib for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). • The approval was based on positive outcomes from the Phase II TRUST-I trial, which showed high and durable overall responses. • In TKI-naïve patients, taletrectinib achieved a confirmed objective response rate of 91% and intracranial cORR of 88%. • Taletrectinib is now approved for both first-line and previously treated ROS1-positive NSCLC patients in China.

Taletrectinib Approved in China for ROS1-Positive NSCLC, Showing Promise in TKI-Pretreated and Naive Patients

6 months ago

• China's NMPA has approved taletrectinib for treating adults with locally advanced or metastatic ROS1-positive NSCLC previously treated with ROS1 TKIs. • The approval was based on the phase 2 TRUST-I trial, which demonstrated a 51.5% ORR in patients pretreated with crizotinib, with a median DOR of 10.6 months. • Taletrectinib has also received priority review for first-line treatment of ROS1-positive NSCLC, supported by data showing a 90.6% ORR in TKI-naive patients. • Clinical trials show taletrectinib's efficacy in CNS penetration and activity against resistance mutations, offering a potential best-in-class safety profile.

Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025

7 months ago

• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD. • EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration. • Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option. • Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.

Taletrectinib Shows Promise in ROS1-Positive NSCLC: Nuvation Bio Announces Positive Phase 2 Data

8 months ago

• Taletrectinib demonstrated an 89% tumor shrinkage rate in TKI-naïve patients with ROS1-positive NSCLC, showcasing its high efficacy. • The drug achieved a median duration of response of 44 months and progression-free survival of 46 months in TKI-naïve patients. • Taletrectinib exhibited a favorable safety profile with a low incidence of neurologic treatment-emergent adverse events. • Nuvation Bio plans to submit an NDA to the FDA in Q4 2024, aiming for a U.S. launch in 2025.