Olema Oncology Announces Expansion of Collaboration Agreement with Novartis
“The amendment announced today significantly increases the size of our ongoing Phase 1/2 clinical study testing palazestrant in combination with ribociclib, in collaboration with Novartis,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “With the Phase 1b dose escalation portion now successfully completed, we are currently in Phase 2 […]
MediLink Therapeutics Announces Strategic Collaboration And Worldwide License Agreement With BioNTech To Develop Next-Gen Anti-Cancer ADCs
“Under the terms of the agreement, MediLink will grant BioNTech exclusive global rights for the development, manufacturing, and commercialization of one of MediLink’s ADC assets excluding Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region. In exchange, BioNTech will provide MediLink with an upfront payment totaling of $70 million and additional development, […]
Enrollment ex-China in Phase 3 REGAL Clinical Trial for Galinpepimut-S in AML Expected to be Completed in November 2023
“We are pleased to be so close to achieving this most important milestone – the completion of enrollment in the REGAL study – and, at the same time, it is important to note that we already have a sufficient number of patients enrolled for the pre-specified analyses,” said Angelos Stergiou, MD, ScD h.c., President and […]
Clinical trials of nanrilkefusp alfa as monotherapy and in combinations with pembrolizumab and cetuximab to be discontinued
“While we are disappointed with this outcome, we will continue to gather and analyze the full body of data from these studies to inform our future development plans for nanrilkefusp alfa, especially its potential utility in combination with other cancer immunotherapies,” said Richard Sachse, M.D., Ph.D., chief medical officer of SOTIO. “We are grateful to […]
AbbVie acquires Mitokinin in its Neuroscience pipeline
Earlier this month, AbbVie acquired Mitokinin, a discovery-stage biotechnology company developing a disease modifying treatment for Parkinson’s Disease (PD). PD is a neurodegenerative movement disorder where dopaminergic neurons of the brain that control movement are preferentially lost, causing slowness in movement, rigidity of limbs and trunk, tremors, and postural instability. It affects over 10 million […]
New Data Demonstrating Superiority of TPST-1120 Arm Across Multiple Study Endpoints in Randomized 1L HCC Study presented
“This comprehensive analysis of more mature clinical data shows an even greater benefit than the earlier interim analysis of the TPST-1120 triplet therapy over standard of care alone, both for the entire study population and in subpopulations of patients, the latter of which was predicted by TPST-1120’s proposed mechanism of action,” said Stephen Brady, president […]
Pivotal KEYNOTE-671 Trial Meets Dual Primary Endpoint of OS in Resectable Stage II, IIIA or IIIB NSCLC
“This is a significant milestone in the treatment of resectable non-small cell lung cancer, as it represents the first Phase 3 study to show a statistically significant overall survival benefit for these patients with stage II, IIIA or IIIB (T3-4N2) non-small cell lung cancer. These results build upon the previously reported event-free survival data, and […]
FDA Orphan Drug Designation for SLS009 for Treatment of AML
“We are honored to receive the ODD from the FDA. This designation underscores the potential of SLS009 to address a significant unmet medical need for patients with AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “SLS009 is a novel and highly selective CDK9 inhibitor that has already shown a […]
Positive EU CHMP Opinion for KEYTRUDA + Chemo as 1L Treatment for HER2-Negative Advanced GEJ Adenocarcinoma Expressing PD-L1 (CPS ≥1)
“This positive CHMP opinion builds on our efforts to treat advanced gastric and gastroesophageal junction cancer in Europe, including in patients with HER2-negative disease, which accounts for the vast majority of gastric cancer cases,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “We look forward […]
FDA Approves Pfizer’s BRAFTOVI + MEKTOVI for BRAF V600E-Mutant mNSCLC
“Today’s approval builds on our long-standing commitment to deliver innovative, personalized medicines to patients with lung cancer. By pursuing precision medicines that target a patient’s specific type of cancer, we are leveraging our deep understanding of tumor biology to help address the underlying cause of disease,” said Chris Boshoff, M.D., Ph.D., Chief Oncology Research and […]
Lilly to Acquire POINT Biopharma to Expand Oncology Capabilities into Next-Gen Radioligand Therapies
Joe McCann, Ph.D., CEO of POINT added: “The combination of POINT’s team, infrastructure and capabilities with Lilly’s global resources and experience could significantly accelerate the discovery, development and global access to radiopharmaceuticals. I look forward to a future where patients all over the world can benefit from the new cancer treatment options made possible by […]
Bristol Myers Squibb to acquire Mirati Therapeutics
“We are excited to add these assets to our portfolio and to accelerate their development as we seek to deliver more treatments for cancer patients,” said Giovanni Caforio, Chief Executive Officer and Board Chair, Bristol Myers Squibb. “With a strong strategic fit, great science and clear value creation opportunities for our shareholders, the Mirati transaction […]
US FDA places lacutamab IND on partial clinical hold for new patient enrollment following one unexpected severe adverse reaction
“Patient safety is of paramount importance to us, and we are currently undertaking efforts to address the FDA requests, which include incorporation of risk mitigation and management strategies for hemophagocytic lymphohistiocytosis in ongoing lacutamab studies.” said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. “Additionally, with all patients recruited into the Phase 2 TELLOMAK study, […]
EXKIVITY® (mobocertinib) to be voluntary withdrawn from the U.S. for adult patients with EGFR Exon20 insertion+ mNSCLC whose disease has progressed on or after platinum-based chemotherapy
“Our steadfast commitment to pursue solutions for people with high unmet needs led us to develop and launch EXKIVITY as the first oral therapy designed for patients with EGFR Exon20 insertion+ metastatic NSCLC,” said Awny Farajallah, MD, head of Global Medical Affairs Oncology at Takeda. “We have been fortunate to witness the impact EXKIVITY has […]
Positive Interim Phase 2 ASPEN-06 Clinical Trial Results of Evorpacept for the Treatment of Advanced HER2-Positive Gastric Cancer Reported
“The ASPEN-06 clinical trial validates the potential of evorpacept both in solid tumors and in combination with anti-cancer antibodies and these data highlight the drug’s potential as a first-in-class foundational immunotherapy,” said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. “We are highly encouraged by these initial randomized efficacy and safety results in gastric […]
KEYTRUDA® Met Primary Endpoint of DFS in Certain Patients With Muscle-Invasive Urothelial Carcinoma (MIUC) After Surgery
“Up to half of patients with bladder cancer who undergo surgery will experience recurrence within a year, underscoring the need for new treatment options in the adjuvant setting,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “These positive results highlight the potential of KEYTRUDA to […]
U.S. FDA Fast Track Designation for KT-333 for the Treatment of R/R Cutaneous T-Cell Lymphoma and R/R Peripheral T-Cell Lymphoma
“The KT-333 Fast Track designation highlights the promise of degrading STAT3, a protein that has historically been undruggable, for the treatment of patients with CTCL and PTCL,” said Jared Gollob, MD, Chief Medical Officer, Kymera Therapeutics. “We look forward to providing an update on the KT-333 Phase 1 clinical trial later this year, including initial […]
FDA Grants Priority Review to KEYTRUDA + Concurrent ChemoRT as Treatment for Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer
“The standard of care for patients with locally advanced cervical cancer has not changed in more than two decades, and the majority of patients will experience recurrence or progression of their disease,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “If approved, KEYTRUDA will be the first immunotherapy available for patients […]
NeuroSense receives patent approval for ALS candidate drug, PrimeC from multiple countries
After the U.S., Canada, and Australia, it was turn for Europe, Israel and Japan to approve NeuroSense Therapeutic’s patent application on “Compositions comprising an anti-inflammatory drug and a dicer activator for use in treatment of neuronal diseases.” The patents relate to the formulation of two known FDA (US Food and Drug Administration) approved drugs viz. Ciprofloxacin and […]
Guardant Health in liquid biopsy cancer diagnosis
Cancer treatment experienced a seismic shift in the 2010s with the rise of personalized precision medicine. Cofounded in Silicon Valley by entrepreneur Helmy Eltoukhy with fellow Stanford and Illumina alum AmirAli Talasaz in 2012, Guardant Health has been at the forefront of developing liquid biopsy technology for cancer diagnosis. Guardant aimed to provide non-invasive approaches […]
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 […]
