Zenocutuzumab granted Breakthrough Therapy Designation by US FDA for the treatment of NRG1+ pancreatic cancer
“We believe the compelling clinical data for Zeno in NRG1+ cancer, and Breakthrough Therapy Designation, provide the opportunity to further engage with the FDA to expedite the review of a potential BLA submission,” said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. “Additionally, our intention to partner Zeno is a reflection of our strategy […]
NEOGAP acquires TCER Oncology AB, strengthening its position in personalised immunotherapy
“We are delighted to acquire the remaining shares in TCER Oncology and extend a warm welcome to Rolf Kiessling and Stina Wickström as valued shareholders in NEOGAP. This acquisition marks an important milestone, fortifying our standing in personalised immunotherapy. It allows us to expand our patent portfolio and pipeline of potential drug candidates while further […]
First Patient dosed in Ph 1 Study of Cancer Vaccine CVGBM for Surgically Resected Glioblastoma
“We are excited to enter the execution phase of our cancer vaccine development strategy with a study that is designed to establish proof-of-principle for our advanced second-generation mRNA backbone in oncology,” said Dr. Myriam Mendila, Chief Development Officer of CureVac. “We will use the study data to evaluate the ability of our second-generation mRNA backbone […]
First Patients Dosed in Ph 2 Liver Cancer Trial of TTI-101
“Enthusiasm for our HCC study continues to expand with recently presented clinical data demonstrating TTI-101 monotherapy has robust efficacy in heavily pretreated patients with HCC, published preclinical work highlighting TTI-101’s synergy with immunotherapy, and the FDA’s Fast-Track Designation for TTI-101 in HCC,” said Imran Alibhai, PhD, CEO of Tvardi Therapeutics. “This is the second of […]
Ongoing Double-Digit ORR observed for Single Agent Envafolimab in the ENVASARC Phase 2 Pivotal Trial
“We are pleased with the single agent activity of envafolimab that continues to generate a double-digit ORR, as well as the safety data showing envafolimab is well tolerated,” said James Freddo, M.D., TRACON’s Chief Medical Officer. “We believe the current response rate indicates that we remain on track to achieve the primary endpoint of the […]
FAILED TRIAL: Ph 3 KEYNOTE-585 Trial in GEJ Adenocarcinoma didn’t meet primary endpoint of EFS
“While a statistically significant improvement in pathological complete response was observed in this study, we are disappointed that the KEYTRUDA regimen did not significantly improve event-free survival, a result that underscores the challenges in treating locally advanced resectable gastric cancer,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. “Innovative research in […]
CHMP Positive Opinion for Trodelvy in Pre-Treated HR+/HER2- Metastatic Breast Cancer
“This positive opinion from the Committee confirms the clinical benefit and value of sacituzumab govitecan in pre-treated HR+/HER2- metastatic breast cancer and is a positive step toward bringing this treatment option to patients in Europe,” said Dr. Javier Cortes, Head of the International Breast Cancer Center, in Madrid and Barcelona, Spain. “Too many people living […]
FDA Orphan Drug Designation for ERAS-801 for the Treatment of Malignant Glioma
“GBM is an aggressive malignancy afflicting approximately 37,000 patients annually in the United States and Europe. Currently approved EGFR inhibitors are limited by insufficient CNS penetration to treat GBM and minimal activity against GBM-specific EGFR amplifications, mutations, and other molecular alterations, which contribute to high rates of relapse and a five-year survival rate below 10%,” […]
FDA Grants Full Approval For Blincyto To Treat MRD-Positive B-Cell Precursor Acute Lymphoblastic Leukemia
“We are pleased the FDA has granted full approval for BLINCYTO, the first FDA-approved CD19-directed CD3 T-cell engager BiTE® immunotherapy and the first to be FDA-approved for MRD in 2018,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “Today’s full approval underscores the clinical benefit of BLINCYTO for people […]
TALZENNA in Combination with XTANDI Receives U.S. FDA Approval for adult patients with HRR-mutated mCRPC
“Despite treatment advancement in metastatic castration-resistant prostate cancer, the disease can progress quickly, and many patients may only receive one line of therapy. Therefore, new first-line treatment options are needed to reduce the risk of disease progression or death. For patients with mCRPC harboring HRR genetic alterations, outcomes are even worse,” said Neeraj Agarwal, M.D., […]
Chronic oral dosage of HT-ALZ improves spatial memory in mouse model of Alzheimer’s disease
Hoth Therapeutics announced the pre-clinical results of its oral soluble film formulation, HT-ALZ, for the treatment of Alzheimer’s disease (AD) and associated symptoms (dementia). The study performed on an established AD mouse model (APP/PS1+/-) showed those receiving over 5 weeks of the oral treatment had significant improvement in spatial memory tests indicating a positive therapeutic potential of HT-ALZ […]
Astellas and Cullgen Enter into Strategic Collaboration and Option Agreement to Advance Innovative Targeted Protein Degraders
“Targeted Protein Degradation is one of the Primary Focuses of Astellas*1,” said Adam Pearson, Chief Strategy Officer at Astellas. “We hope this collaboration will bring synergies between the two companies’ cutting-edge research, and will ultimately lead to the expansion of Astellas’ portfolio and development of new therapeutics for patients with significant unmet medical needs.”
Coherus to Acquire Surface Oncology
“This transaction is well-timed, as it coincides with the accelerating growth of our biosimilar revenues driven by the launch of CIMERLI® and near-term launch of YUSIMRY®. With the agreement to acquire Surface and the expected near-term approval of toripalimab, Coherus is positioned to become one of the very few I-O companies with demonstrated commercial expertise, […]
First Patient Dosed in Investigator-Led Phase 2 IMpress Trial Evaluating Imetelstat in Patients with R/R AML or Higher Risk MDS
“This trial is based on multiple preclinical publications that describe the role of telomerase in AML, which have reported that inhibiting telomerase in both mouse and human AML models targets and potentially depletes leukemic stem cells and impairs their leukemic progression,” said Faye Feller, M.D., Executive Vice President, Chief Medical Officer of Geron. “We are […]
First Patient Randomized in Ph 3 TILVANCE-301 Trial in Frontline Advanced Melanoma
Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, “Our strategy is to offer TIL therapy across all lines of treatment for patients with advanced melanoma. Randomizing the first patient in TILVANCE-301, our first Phase 3 trial at Iovance, is an important milestone. The trial offers TIL therapy as part of an earlier treatment […]
Updated clinical data from KOMET-001, a Ph 1/2 clinical trial of ziftomenib, in patients with heavily pretreated and co-mutated R/R NPM1-mutant AML announced
“Our goal with our ziftomenib program is to transform the standard of care for patients with acute leukemias,” said Stephen Dale, M.D., Chief Medical Officer of Kura Oncology, “and we are delighted to share new clinical and preclinical data that we believe further demonstrate its potential best-in-class product profile. The emerging data for ziftomenib include: […]
KEYTRUDA + Trastuzumab and Chemotherapy Met Primary Endpoint of PFS as 1L Treatment in Patients With HER2-Positive Advanced GEJ Adenocarcinoma
“These new data from KEYNOTE-811, demonstrating a significant improvement in progression-free survival, are meaningful and build on the earlier insights from this study that supported the accelerated approval of this KEYTRUDA combination in the U.S. for certain patients with HER2-positive gastric or GEJ adenocarcinoma,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research […]
FDA accepts sNDA for Onivyde regimen in first-line metastatic pancreatic ductal adenocarcinoma
“PDAC is a devastating disease in need of additional treatment options. The FDA’s decision to accept the sNDA for this Onivyde-based regimen in treatment-naïve patients with metastatic disease represents an important milestone in the potential treatment of this complex form of cancer,” said Howard Mayer, Executive Vice President and Head of Research and Development at […]
FDA extends review period for momelotinib
GSK plc today announced that the US Food and Drug Administration (FDA) has extended the review period of the new drug application (NDA) for momelotinib by three months to provide time to review recently submitted data. The extended action date is 16 September 2023.
FDA Approves Columvi for People With R/R DLBCL
“People with diffuse large B-cell lymphoma who have gone through multiple lines of therapy have a poor prognosis and desperately need additional treatment options,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “As an off-the-shelf, fixed-duration treatment providing durable response rates, we believe Columvi could change the way this […]
mRNA-4157 (V940) + KEYTRUDA Combination Demonstrated a Statistically Significant DMFS Improvement in Patients with High-Risk Stage III/IV Melanoma Following Complete Resection Versus KEYTRUDA
“We are excited to be sharing these results with the oncology community and thrilled to see such an exceptional result in distant melanoma recurrence or death. Patients who experience metastases at distant sites typically have worse survival outcomes and a poor prognosis, thus these results showing a reduction in the risk of distant recurrence underscore […]
Enhertu demonstrated clinically meaningful and durable responses in patients across multiple HER2-expressing advanced solid tumours
Funda Meric-Bernstam, MD, Chair of the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, US and principal investigator for the trial, said: “The DESTINY-PanTumor02 data showed encouraging and durable response rates across a broad range of HER2-expressing solid tumours where there are currently no approved HER2-targeted treatments. Based on […]
sBLA accepted for priority review for Jemperli + chemo For The Treatment of dMMR/MSI-H Primary Advanced Or Recurrent Endometrial Cancer
Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK said: “We are excited about this initial filing for this potential new indication for dostarlimab in the patient population that demonstrated the strongest treatment effect in the phase III RUBY trial. Long-term outcomes for patients with primary advanced or recurrent endometrial cancer remain poor, […]
FDA Accepts Application for KEYTRUDA Plus Chemotherapy as Treatment for Advanced or Unresectable Biliary Tract Cancer
“Most biliary tract cancers go undetected until an advanced stage, at which point many patients are ineligible for surgery and have few treatment options,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. “We look forward to working with the FDA to bring a new option to patients with advanced or unresectable […]
FDA Approves FoundationOne®LiquidCDx as a Companion Diagnostic for BRAFTOVI + Cetuximab combo to Identify Patients With BRAF V600E Alterations in mCRC
“Companion diagnostics are high-quality, well-validated genomic tests that provide critical information to help oncologists make informed treatment decisions for their patients,” said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. “This new companion diagnostic indication for FoundationOne Liquid CDx provides oncologists with an important, non-invasive genomic testing option for metastatic patients with this […]
Bristol Myers Squibb Receives U.S. FDA Approval of New State-of-the-Art Cell Therapy Manufacturing Facility in Devens, Massachusetts
“The Devens facility integrates the latest state-of-the-art technology in the industry with top talent in the Boston area that will take us into the next phase of our cell therapy journey,” said Karin Shanahan, executive vice president, Global Product Development & Supply, Bristol Myers Squibb. “We are working diligently to increase our product capacity through […]
First Patient Dosed in Phase 1/2 Study of ROR1 targeting autologous CAR T, ONCT-808, in patients with relapsed or refractory aggressive B-cell lymphoma
“We are excited to announce the first patient, who had failed previous CD19 CAR T therapy, has been treated with ONCT-808,” said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. “We believe ONCT-808 has the potential to produce robust and durable responses for patients suffering from aggressive lymphoma. It builds on our extensive clinical experience […]
Impact Therapeutics Entered into Global Partnership with Eikon Therapeutics to Develop and Commercialize PARP1 Selective Inhibitors
“We are delighted to establish the global partnership with Eikon, whose leadership team has a well-documented track record of developing some of the world’s most therapeutically meaningful and commercially successful oncology medicines.” said Sui Xiong Cai, Ph.D., Chief Executive Officer of IMPACT Therapeutics. “As a company committed to develop innovative medicines globally, based on our […]
C4 Therapeutics and Betta Pharmaceuticals Announce Exclusive Licensing Agreement for the Development and Commercialization in Greater China of CFT8919
“We are excited to partner with Betta to develop CFT8919, an orally bioavailable allosteric EGFR L858R degrader, with the potential to treat NSCLC patients with EGFR L858R mutations in Greater China and beyond,” said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. “With their strong track record of developing and commercializing NSCLC therapies […]
Phase 2/3 Pivotal Study REFRaME-O1 to be initiated in Ovarian cancer patients
Anne Borgman, M.D., Sutro’s Chief Medical Officer said, “On the heels of these positive results, we are thrilled that REFRaME, our pivotal Phase 2/3 trial, is officially underway. From the clinical and nonclinical data gathered, we maintain our positive outlook that luvelta could potentially serve multiple additional indications where patients express FolRα.”
