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 […]
BriaCell Partners with New York Cancer & Blood Specialists (NYCBS) for Pivotal Phase 3 Study of Bria-IMT(TM) in Advanced Breast Cancer
“Cancer is complex. It takes a village to care for a cancer patient. At NYCBS, our mission is to offer cancer patients access to state-of-the-art treatments close to their homes, families, and support networks at convenient locations across Long Island, New York City, and Upstate New York,” stated Dr. Jeffrey Vacirca, CEO of NYCBS. “We […]
Ankyra Therapeutics and Merck to Evaluate ANK-101 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Advanced Solid Tumors
“ANK-101 has demonstrated therapeutic activity in several preclinical models and has been shown to strongly induce expression of PD-1 within the tumor microenvironment,” said Robert Tighe, CSO at Ankyra. “We have also seen significant improvement in tumor responses and abscopal activity in the preclinical models when murine ANK-101 is combined with PD-1 blockade without increased […]
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EXKIVITY® (mobocertinib) to be voluntary withdrawn from the U.S. for adult patients with EGFR Exon20 insertion+ mNSCLC whose disease has progressed on or after platinum-based chemotherapy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 […]
First Subjects dosed in Phase 2 Portion of Clinical Trial Evaluating Annamycin in Combination with Cytarabine (Ara-C) for the Treatment of AML
Walter Klemp, Chairman and Chief Executive Officer of Moleculin commented, “This milestone marks an important step in advancing the development of Annamycin for the treatment of AML. Based on the positive preliminary results demonstrated in the Phase 1B portion of this trial, we continue to believe that Annamycin has the potential to be a meaningful […]
First Patient dosed in Landmark STAR-LLD Lenalidomide Phase 1b Clinical Trial in Multiple Myeloma
“From its inception, Starton has been focused on execution. We are entering the development stage, in which we expect to achieve the safety and tolerability improvement profile as well signals of efficacy for our proprietary continuous delivery of lenalidomide. We will enable the patient outcomes and quality of life improvements for which we founded Starton,” […]
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 […]
Promising Readout from Phase 2a Trial Evaluating BPM 31510 IV for Pancreatic Cancer Announced
“We are extremely encouraged to observe that BPM 31510 has demonstrated an early indication of potential clinical benefit for patients with advanced refractory pancreatic cancer,” said Niven R. Narain, Ph.D., President and CEO of BPGbio. “Pancreatic cancer is the fourth leading cause of death of all cancers with only a 10% survival rate, we are […]
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 […]
FDA grants Orphan Drug Designation for BDC-1001 for Treatment of Gastric Cancers
“Receiving Orphan Drug Designation from the FDA is an important step forward in the development of BDC-1001 and reinforces the potential of BDC-1001 to address unmet needs for patients with gastric cancers,” said Edith A. Perez, M.D., Chief Medical Officer of Bolt Biotherapeutics. “Our Boltbody™ ISAC platform is the only one with emerging clinical validation, […]
US FDA grants Orphan Drug Designation for CRO-67
Noxopharm CEO Dr Gisela Mautner said: “For CRO-67 to achieve an ODD is a significant milestone in the development of the drug. In addition to financial benefits, the ODD will also strengthen our commercial position in a market that has seen very few new treatments over recent decades.
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 […]
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 […]
AbbVie is terminating its agreement with I-Mab to develop certain CD47 antibody compounds, including the programme’s lead drug lemzoparlimab
“AbbVie is terminating the license and collaboration agreement with I-Mab relating to certain CD47 antibody compounds and products. The termination of the Collaboration Agreement in its entirety by AbbVie is based on the previous program discontinuation and AbbVie’s strategic decision. The termination will take effect on November 20, 2023. As a result, the Company will […]
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 […]
Phase 1/2 Study of Azeliragon in Patients Refractory to First-Line Treatment of Metastatic Pancreatic Cancer initiated
“We are extremely pleased to announce the initiation and patient enrollment at Allegheny Health Network, a world-class provider of cancer treatment, of this important Phase 1/2 clinical study to evaluate the safety and efficacy of azeliragon in patients refractory to first-line treatment of metastatic pancreatic cancer,” said Stephen G. Marcus, M.D., Cantex’s Chief Executive Officer.
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 […]
Positive Clinical Data in Pancreatic Cancer and SCLC, including Single-Agent Activity from Onvansertib Monotherapy
“We are excited that the data released from these trials, in two challenging cancers with low survival rates, expands the opportunity for onvansertib beyond our lead program in RAS-mutated mCRC,” said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. “In pancreatic cancer, the strength of the data provides a clear rationale for a first-line […]
Updated Clinical Data for FasTCAR-T GC012F for High-Risk, Newly Diagnosed Multiple Myeloma, Demonstrating 100% Stringent CRR reported
“Patients with high-risk NDMM, including those who are transplant-eligible, typically face suboptimal outcomes with the current standard of care. Innovation is imperative to address the challenges faced by this group of hard-to-treat patients,” said Dr. Wendy Li, Chief Medical Officer at Gracell. “MRD- sCR is the deepest response possible in the treatment of multiple myeloma […]
Lutathera® demonstrated statistically significant and clinically meaningful PFS in first line advanced GEP-NETs
“These positive results for Lutathera are quite remarkable and they represent the potential for radioligand therapy to make a meaningful impact for newly diagnosed patients living with advanced GEP-NETs,” said Jeff Legos, Executive Vice President, Global Head of Oncology Development at Novartis. “Exploring the use of radioligand therapies in earlier lines of treatment for patients […]
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, […]
