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 […]
Clinical Hold Announced for iMMagine-1 Ph 2 Clinical Program
“The safety and well-being of patients enrolled in our studies is our top priority,” said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer.” In coordination with our investigators, data safety monitoring board (DSMB), and our partners at Kite Pharma, we are working with FDA to address the clinical hold. The expansion of bridging therapy regimens is consistent […]
First Patient Dosed in Ph 2a Clinical Trial of GFH009 in AML
“We are excited to advance GFH009 to the next phase of clinical development, which we believe holds great promise for patients who continue to suffer with advanced and difficult to treat AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “As far as we know, GFH009 is the only CDK9 […]
First Patient Dosed in Ph 1 Trial of Briquilimab in Lower-Risk MDS
“The initiation of this trial in LR-MDS represents a significant milestone in our briquilimab development program,” said Ronald Martell, President and Chief Executive Officer of Jasper. “To date, the potential of briquilimab has been clinically assessed across five transplant indications and we are excited to explore its potential as a treatment option for a chronic […]
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 […]
Ph 3 Trial of ADCETRIS (brentuximab vedotin) with Modified Chemo Regimen Shows Non-Inferiority with Unprecedented 3-Year PFS of 94.9% vs Less Tolerable SoC in cHL
“Our mission in Hodgkin lymphoma is to cure patients with a first-line treatment that reduces the risk of cancer returning as much as possible so patients can go on with their lives,” said Professor Dr. med. Peter Borchmann, Assistant Medical Director, Department of Hematology and Oncology at the University Hospital of Cologne, Germany and Head […]
3-Year Update from Phase I Study in Malignant Melanoma: Results Confirm Strong Overall Survival in Patients Treated with UV1 Cancer Vaccine
“We are very encouraged to observe a 67% overall survival rate at 3-year follow-up in this Phase I study, which treats the same patient population as our UV1 Phase II study, INITIUM. These data further strengthen the previously reported results from the study, including good safety for UV1 and remarkable 33% complete response rate in […]
ICML 2023: Breyanzi (lisocabtagene maraleucel) Delivers Deep and Durable Responses in R/R FL and MCL in TRANSCEND Clinical Trials
“With Breyanzi, we’re dedicated to delivering a CAR T cell therapy with a differentiated profile to transform outcomes for some of the most difficult-to-treat lymphomas,” said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb. “Based on results from TRANSCEND FL and TRANSCEND NHL 001, Breyanzi continues to demonstrate the ability […]
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 Orphan Drug Designation for KT-253 for the Treatment of AML
“This orphan drug designation reinforces the potential of KT-253 to advance the treatment of AML by targeting MDM2, a protein that has been challenging to effectively drug with conventional medicines,” said Nello Mainolfi, Founder, President and CEO, Kymera Therapeutics. “We have a significant opportunity to deliver an important new medicine that acts on this common […]
Epcoritamab Added to NCCN Guidelines for ‘B-Cell Lymphomas’
“The NCCN Guidelines are a resource for treating various types of cancer and providing healthcare providers with information for making informed treatment decisions,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “We are pleased that the NCCN has updated its Guidelines to include epcoritamab in a speedy manner.”
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 […]
225 patients randomized in Phase 3 clinical trial for IO102-IO103, in combination with KEYTRUDA in patients with advanced melanoma
“I am very proud to announce today that we have hit this critical enrollment milestone in our global Phase 3 clinical trial as planned,” said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech. “The enthusiasm for this trial in cancer care centers in Europe, Australia, South Africa, Israel, and the United States is a […]
Clinical Study Pause of PLAT-08 Trial of SC-DARIC33 in AML Announced
“Importantly, I’d like to offer that our thoughts are with the family during this time. The safety of every patient who participates in our studies or is treated with our therapies is the utmost priority for us, and we are in communication with FDA while we assess the data surrounding this SAE, and the potential […]
Expansion of NX-2127 Phase 1b Trial in Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma Indications initiated
“The significant preclinical activity demonstrated in an aggressive, patient-derived CNS lymphoma model conducted in the laboratory of Dr. James Rubenstein at UCSF provides strong support for the inclusion of primary CNS lymphoma patients in our ongoing NX-5948 clinical trial,” said Gwenn Hansen, chief scientific officer of Nurix. “We remain enthusiastic about NX-5948’s differentiated profile, including […]
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 […]
Updated Results from Waldenstrom Macroglobulinemia Cohort of Ongoing Phase 1/2 Clinical Trial of MB-106, CD20-Targeted Autologous CAR T Therapy
“As we continue to evaluate MB-106 in this single-institution study, we’re encouraged by its potential to become an outpatient treatment option for WM and other B-cell malignancies, including indolent and aggressive non-Hodgkin lymphomas,” said Dr. Shadman. “We have observed ongoing responses to MB-106 with improvements in the quality of response over time, along with a […]
Efficacy Threshold achieved in Stage 2 of the VERSATILE-002 Trial Evaluating PDS0101 and KEYTRUDA® in Head and Neck Cancer
“We are highly encouraged by the growing set of PDS0101 efficacy and safety data being generated in multiple independent trials by leading experts in the field,” stated Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. “The consistency in PDS0101 induced HPV16-specific immune responses, the response rates and survival benefit observed in multiple […]
FDA Clears Addition of Time-based Final Analysis to Pivotal Phase 3 Study of Uproleselan in R/R AML
“We are pleased the FDA cleared the addition of a time-based pathway to final analysis as it provides the opportunity to evaluate the effect of uproleselan on R/R AML based on a clinically mature database with more than three years median follow-up,” said Harout Semerjian, Chief Executive Officer of GlycoMimetics. “This approach is consistent with […]
VENCLYXTO®/VENCLEXTA® (venetoclax) Continues to Show Sustained PFS in CLL Patients
“Results from the CLL14 and MURANO studies demonstrate the long-term benefits of fixed-duration venetoclax combinations for patients living with CLL,” said Mariana Cota Stirner, M.D., Ph.D., vice president, hematology, AbbVie. “These results underscore our commitment to transform how blood cancers are treated today and show that venetoclax can give patients lasting results with time off […]
