Nektar Therapeutics and Cellular Biomedicine Group to Evaluate NKTR-255 in Combination with C-TIL051 in Advanced NSCLC
“Early results have shown that NKTR-255 has the potential to emerge as a valuable adjuvant therapy for a range of cell therapy platforms,” said Mary Tagliaferri, M.D., Chief Medical Officer at Nektar Therapeutics. “We are excited to partner with CBMG, a leader in the development of the next generation of cell therapies, to evaluate this […]
AbbVie terminated agreement with Caribou Biosciences regarding development of next-generation, off-the-shelf CAR-T cell therapies
“AbbVie exercised its right to terminate the Agreement for convenience, and this decision was based on AbbVie’s strategic focus and was unrelated to Caribou’s performance under the Agreement or the data generated to date. Caribou was conducting certain preclinical research, development, and manufacturing activities for two AbbVie programs, each program comprising one or more collaboration […]
Enrollment of 120 Patients for Phase 3 Clinical Trial of Denifanstat Combined with Bevacizumab for Treatment of Recurrent Glioblastoma completed
“We congratulate Ascletis on achieving this important patient enrollment milestone in its Phase 3 clinical trial of denifanstat being conducted in China in patients with recurrent glioblastoma,” stated David Happel, Chief Executive Officer of Sagimet. “Sagimet looks forward to reporting biopsy results and other key endpoints from our Phase 2 FASCINATE-2 trial for denifanstat in […]
Phase III ENHANCE-2 study investigating magrolimab in patients with acute myeloid leukaemia (AML) with TP53 mutations discontinued
“Gilead Sciences has stopped its ENHANCE-2 study in acute myeloid leukemia (AML) with TP53 mutations. Based on an ad hoc analysis, and following review by an independent data monitoring committee, Gilead concluded that magrolimab is unlikely to demonstrate a survival benefit in AML with TP53 mutations compared to standard of care. There were no new […]
Ph 3 MARIPOSA Study Meets Primary Endpoint of PFS for RYBREVANT (amivantamab-vmjw) + Lazertinib vs Osimertinib in EGFR-Mutated NSCLC
“Positive topline results from the MARIPOSA study reinforce the potential of the RYBREVANT and lazertinib combination in frontline EGFR-mutated non-small cell lung cancer as a future standard of care,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “As a combination targeted regimen, RYBREVANT and lazertinib inhibit critical oncogenic […]
FAILED TRIAL: Phase 3 CANOVA Study of Venetoclax in Patients with RRMM failed to meet primary endpoint of PFS improvement
“While the CANOVA trial did not meet its primary endpoint, given the potential favorable trends seen in the study, we will discuss these data with health authorities in the near future,” said Mariana Cota Stirner, M.D., Ph.D., therapeutic area head oncology hematology, AbbVie. “We remain committed to elevating the standard of care for blood cancer […]
Odronextamab BLA for Treatment of R/R Follicular Lymphoma (FL) and Diffuse Large B-cell Lymphoma (DLBCL) Accepted for FDA Priority Review
“FDA has accepted for Priority Review the Biologics License Application (BLA) for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies. The target action date for the FDA decision is March 31, 2024. Odronextamab is an […]
FDA clears IND application for a phase 1 study of first-in-class CD3/EGFR bispecific antibody BC3448
“FDA cleared the Investigational New Drug (IND) application for a Phase 1 study of BC3448 (CD3/EGFR Bispecific antibody, BsAb). As a result, BioCity Biopharma will initiate a dose escalation/expansion study with BC3448, enrolling patients with advanced solid tumors in the United States. BC3448 is being developed in solid tumors with high EGFR expression, including NSCLC, […]
European Commission Approves Enrylaze for the Treatment of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
“Asparaginase is a core component of multi-agent chemotherapeutic regimens for the treatment of ALL, however, up to 30% of patients develop hypersensitivity to E. coli-derived asparaginase, resulting in a delay or disruption in treatment,” said Professor Carmelo Rizzari, Department of Pediatrics, University of Milano-Bicocca, Head of the Pediatric Hematology Oncology Unit, Foundation IRCCS San Gerardo […]
European Commission Approves TEPKINLY (epcoritamab) for Adults with R/R DLBCL
“With TEPKINLY, people in Europe living with relapsed or refractory diffuse large B-cell lymphoma who are in need of additional treatment options now have a readily available, innovative therapeutic option for this aggressive cancer,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “Today’s approval underscores our commitment to bringing our bispecific antibody […]
BeiGene Announces Positive Regulatory Updates in Europe and the U.S. After Recently Regaining Global Rights for TEVIMBRA®
“We are excited to announce the European Commission approval and the FDA filing acceptance for tislelizumab, having recently regained full global rights to this important medicine. These are significant milestones for people with advanced or metastatic ESCC, as tislelizumab has been shown to deliver clinically meaningful survival benefit as monotherapy and in combination with chemotherapy […]
1ST Biotherapeutics Announces Clinical Trial Collaboration and Supply Agreement with MSD to Evaluate FB849 in Combination With KEYTRUDA
“We are very pleased to mark the next stage of FB849’s development with this exciting collaboration. We are hopeful that combining FB849 with KEYTRUDA may induce an effective anti-tumor response and show an additive benefit for patients with advanced solid tumors,” said Jamie Jae Eun Kim, Ph.D., Founder and Chief Executive Officer of 1ST Biotherapeutics. […]
Phase 2 Study of Masofaniten (EPI-7386) + Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer initiated
“Initiation of the randomized Phase 2 portion of this study investigating the combination of masofaniten and enzalutamide (the “Combination”) is a significant milestone for ESSA and we look forward to reporting updated results from the Phase 1 dose equilibration portion of the study next month at ESMO 2023,” stated David Parkinson, M.D., President and CEO […]
First Patient Dosed in Phase I/IIa Clinical Study on HPV.DCVax in HPV-positive Oropharyngeal Cancer
Valérie Bouchara, Head of Clinical Operations at LinKinVax, commented: “This first administration is a major milestone in the development of our therapeutic cancer vaccine CD40HVac. Our teams are committed to uniting their efforts to bring significant innovations to patients with limited therapeutic options, particularly those with recurrent and/or metastatic HPV-positive cancers.”
FAILED TRIALS: Phase 3 trials, LEAP-006 and LEAP-008, of KEYTRUDA + LENVIMA in patients with certain types of mNSCLC did not meet primary endpoints of OS & PFS
“As a leader in lung cancer research, we continue to try to advance science for our patients by building upon the standard we set several years ago with KEYTRUDA,” said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, Merck Research Laboratories. “While these results are not what we hoped for, we are proud of the […]
PADCEV and KEYTRUDA Significantly Improve OS and PFS in Patients With Previously Untreated Advanced Bladder Cancer in Pivotal Phase 3 EV-302 Trial
Roger Dansey, M.D., President, Research and Development, Seagen, “This study has the potential to be practice changing and offer a new standard of care for first-line metastatic bladder cancer. We look forward to presenting the results at an upcoming medical conference and discussing with regulators in order to get this medicine to patients as soon […]
FDA Accepts for Priority Review sNDA for WELIREG® (belzutifan) in Certain Previously Treated Patients With Advanced RCC
“Patients with advanced RCC whose cancer progresses following immune checkpoint and anti-angiogenic therapies face a poorer prognosis, and for those patients, there is a crucial unmet need for new options with an alternative mechanism of action,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “The […]
IND Clearance from FDA for Phase 1 Initiation for LP-284 in NHL
“This is now our second novel drug candidate to receive IND clearance from the FDA in the past 100 days, further validating our approach of leveraging AI and machine learning to accelerate the development of our pipeline,” stated Panna Sharma, Lantern’s President and CEO. “LP-284 holds blockbuster potential, and we have been able to expedite […]
European Commission approved INAQOVI® (oral decitabine and cedazuridine) for the treatment of adults with newly diagnosed acute myeloid leukaemia
“The EC approval is based on the results from the Phase 3 ASCERTAIN clinical trial investigating the pharmacokinetic exposure equivalence of the novel oral fixed-dose combination versus intravenous (IV) decitabine in AML patients1. The ASCERTAIN study met its primary endpoint, with the orally administered decitabine and cedazuridine fixed-dose combination showing pharmacokinetic exposure equivalence to a […]
European Commission Approves ORSERDU in Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer with an Activating ESR1 Mutation
“We have long known that patients living with metastatic breast cancer need effective and tolerable options which treat their disease while enabling them to focus on the things that matter to them,” said Elcin Barker Ergun, CEO of the Menarini Group. “We are proud of delivering a new breast cancer treatment that offers efficacy in […]
Cancer early diagnosis and liquid biopsies: Are We There Yet?
The field of liquid biopsy-based cancer diagnostics stands at an inflection point, primed to enable earlier detection, precise monitoring, and tailored cancer management. Myriad companies, predominantly startups but also including seasoned diagnostics players, are steering rapid innovations through blood tests that analyse circulating tumor DNA, cells, and other cancer biomarkers. Central to this transformation is […]
Exelixis and Insilico Medicine Enter into Exclusive Global License Agreement for ISM3091
“ISM3091 represents a potentially best-in-class approach to inhibiting USP1, an important oncology target with broad applicability in BRCA-mutant tumors,” said Dana Aftab, Ph.D., Executive Vice President, Discovery and Translational Research and Chief Scientific Officer, Exelixis. “We believe preclinical data on ISM3091’s potent anti-tumor activity, tolerability, and pharmacokinetics set the compound apart from competing USP1 inhibitors […]
Ryvu Therapeutics’ Global Licensee Menarini to Expand Development of MEN1703 (SEL24) with a New Study in Advanced Diffuse Large B-Cell Lymphoma (DLBCL)
“We are excited to begin this Phase II study with our partner Menarini to address the critical unmet need in DLBCL,” said Pawel Przewiezlikowski, co-founder, largest shareholder, and CEO of Ryvu Therapeutics. “The extensive preclinical evidence of MEN1703 activity in multiple types of lymphomas sets a promising foundation for evaluating the molecule’s potential in DLBCL, […]
Patient Dosing with MT-302 initiated in Phase 1 Study for Advanced or Metastatic Epithelial Tumors
“Initiation of patient dosing with MT-302 is a major milestone for Myeloid in our effort to deliver better treatment options for patients living with solid tumors. We are leading the way with our proprietary approach to in vivo programming, including with many novel CAR constructs designed for selective expression in a wide range of immune […]
Clinical Hold Lift Plan of the HEMO-CAR-T IND is Accepted by FDA
Dr Vladislav Sandler, Chief Executive Officer, commented: “We are pleased that the FDA has agreed to our plan and preliminary test results to address their concerns regarding our HEMO-CAR-T IND application. We are now working hard to complete the schedule of work set out in the plan and to re-submit the IND as expeditiously as […]
Phase 2 EVOKE-02 Study Of Trodelvy + KEYTRUDA Demonstrates Promising Clinical Activity In 1L mNSCLC
“Patients with metastatic NSCLC continue to need novel treatment options. The data from the EVOKE-02 study gives us confidence in the clinical activity of sacituzumab govitecan in combination with pembrolizumab in first-line metastatic NSCLC patients,” said Byoung Chul Cho, MD, PhD, Professor in the Division of Medical Oncology at Yonsei Cancer Center, Yonsei University College […]
Datopotamab deruxtecan plus Imfinzi showed promising clinical activity in the 1L advanced NSCLC setting in TROPION-Lung04 Phase Ib trial
Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca, said: “Following the positive high-level results of TROPION-Lung01, these initial TROPION-Lung04 results in the first-line setting reinforce our confidence in datopotamab deruxtecan as a potential treatment option for patients with advanced non-small cell lung cancer. Through our robust clinical programme we are eager to […]
Quizartinib Recommended for Approval in EU by CHMP for Patients with Newly Diagnosed FLT3-ITD Positive AML
“Today’s positive CHMP opinion for quizartinib is an important step towards translating the clinical benefit observed in QuANTUM-First into an approved treatment option for patients in the EU with the difficult-totreat FLT3-ITD subtype of acute myeloid leukemia,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo. “If approved, quizartinib would be the first […]
Enhertu recommended for approval in the EU by CHMP for patients with HER2-mutant advanced NSCLC
Enhertu recommended for approval in the EU by CHMP for patients with HER2-mutant advanced NSCLC Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “HER2-mutant non-small cell lung cancer is an aggressive form of lung cancer that often affects younger patients and has a poor prognosis, with limited approved therapies. This milestone recognises the unmet […]
WaveBreak’s Small-Molecule Inhibits Toxic Oligomers of alpha synuclein in Pre-clinical study
WTX-A is a small-molecule oral drug developed by WaveBreak. In a recent pre-clinical study, it efficiently blocked α-synuclein oligomers and aggregates in both cell and mouse models of Parkinson’s disease (PD) in a dose-dependent manner. Oligomers are toxic intermediate forms of abnormally folded proteins directly responsible for neurotoxicity in PD, Alzheimer’s Disease, and Amyotrophic Lateral […]
