FDA grants Fast Track designation for KIN-3248 for the treatment of patients with metastatic cholangiocarcinoma
“U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Kinnate’s investigational pan-FGFR inhibitor, KIN-3248, for the treatment of patients with unresectable, locally advanced or metastatic cholangiocarcinoma (CCA) harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other alterations, who have received at least one prior systemic therapy.”
Regulatory update provided on the clinical development plan of Tedopi® in Ph 3 in monotherapy in advanced or mNSCLC after checkpoint inhibitor failure
Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “We are pleased with the positive outcomes from the US Food & Drug Administration (FDA) Type C Meeting following the supportive European Medicines Agency (EMA) advice, as we are actively preparing a confirmatory phase 3 trial to support the regulatory registration of Tedopi®. Leveraging on the […]
China NMPA Clears IND Application for Ph 1/2 Clinical Trial of FasTCAR-T GC012F for Treatment of Relapsed/Refractory Multiple Myeloma
“This milestone marks successful regulatory clearances to commence key clinical trials for Gracell’s lead asset, GC012F, in both China and the United States,” said Dr. William (Wei) Cao, founder, Chairman, and CEO of Gracell. “We believe GC012F has vast potential to meaningfully improve cancer care, including the faster delivery to patients enabled by Gracell’s FasTCAR […]
FDA grants Orphan Drug Designation for the PRMT5 inhibitor JBI-778 for the treatment of Glioblastoma Multiforme (GBM)
“JBI-778 is our highly differentiated, substrate competitive PRMT5 inhibitor in development for both systemic and brain tumors with certain genetic signatures. It is the second clinical stage oral drug candidate that has emerged from the TIBEO discovery engine,” said Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc. He further added, “JBI-778’s differentiated profile compared to […]
Refusal to File Letter issued from U.S. FDA for HyBryte™ New Drug Application in the Treatment of Cutaneous T-Cell Lymphoma
“We are fully determined to work with the FDA staff as quickly as possible to better understand the open issues and clarify the potential path to successfully resubmitting our application,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “We remain focused on advancing HyBryte™ as a potential new first-in-class treatment option […]
FDA Clears IND Application for Ph 1b/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of R/R Multiple Myeloma
“Advancing our lead therapeutic candidate into a U.S. clinical trial is major milestone for Gracell, and further validates our GC012F program, proprietary FasTCAR next-day manufacturing platform and novel dual-targeting approach,” said Dr. William (Wei) Cao, founder, Chairman, and CEO of Gracell. “Having demonstrated deep responses and a favorable safety profile across indications, GC012F continues showing […]
Orphan Drug Designation Granted to Adze-1.17-CD40L for the treatment of Malignant Glioma
“This important designation is a milestone in the development of our Adze-1.17 oncolytic immunotherapy platform and highlights the need for potential new treatment options for patients with Malignant Gliomas and other difficult to treat cancers,” said Sidney Hopps, Chief Executive Officer of Adze Biotechnology. “The novel Adze-1.17 oncolytic immunotherapy platform is designed for both systemic […]
US FDA Advisory Committee votes in support of trials designed to evaluate Jemperli as a potential treatment for MMR-D/MSI-high locally advanced rectal cancer
Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK, said: “The Committee’s positive vote in favour of our proposed clinical trial programme for dostarlimab reinforces our plans to generate data in support of a future US regulatory submission for the potential treatment of patients with dMMR/MSI-H locally advanced rectal cancer, a patient population […]
US FDA grants regular approval for Jemperli for the treatment of patients with recurrent or advanced mismatch repair-deficient endometrial cancer
Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK, said: “This US regulatory action confirms our confidence in Jemperli as an important treatment option for patients with dMMR recurrent or advanced endometrial cancer. We continue to unlock the potential of Jemperli as the backbone for our immuno-oncology development programmes to address the unmet […]
Kite And Arcellx Close Agreement To Co-Develop And Co-Commercialize Late-Stage Clinical CART-DdBCMA In Multiple Myeloma
Currently being investigated in a Phase 2 pivotal trial, CART-ddBCMA is Arcellx’s T-cell therapy utilizing the company’s novel synthetic binder, the D-Domain. Kite and Arcellx will jointly advance and commercialize the CART-ddBCMA asset in the U.S., and Kite will commercialize the product outside the U.S.
CARsgen Announces Collaboration Agreement to Evaluate AB011 in Combination with Atezolizumab to Treat Gastric Cancer
“We are glad to work with Roche, a global leader in oncology, to explore the potential of AB011 in combination with atezolizumab and chemotherapy for the treatment of gastric cancer,” said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen, “Gastric cancer is one of the most […]
Hillstream BioPharma Signs an Exclusive Option Agreement to Advance Next-Generation Anti-MUC1-C Agents for Drug Resistant Cancers
“We look forward to this unique opportunity to work with Dr. Kufe and Dana-Farber,” said Randy Milby, CEO of Hillstream. “This agreement allows Hillstream to leverage our Quatramer platform to advance anti-MUC1-C agents targeting CSCs for the treatment of highly aggressive tumors, which represents a major unmet need for patients.”
Ratio Therapeutics Announces $20M Series A Financing to Advance Targeted Radiotherapies for Cancer Treatment
“We are grateful for the support and honored by the confidence of our investors, who have witnessed our tremendous progress in the past year and recognize the potential of our technology and the strength of our team,” commented Dr. Hoppin, Ratio’s Chairman and Chief Executive Officer. “This financing extends our cash runway into 2024 and […]
Guardant Health and AnHeart Therapeutics to Develop Guardant360 CDx and Guardant360 TissueNext™ as Companion Diagnostics for Taletrectinib in ROS1-Positive mNSCLC
“We are very excited to partner with Guardant Health, a global leader in oncology companion diagnostics, to identify NSCLC patients with ROS1 fusion mutations who may benefit from taletrectinib. There is a critical need to improve access to high quality diagnostics to help guide treatment decisions for patients,” said Junyuan (Jerry) Wang, Ph.D., chief executive […]
TROPION-Lung07 Ph 3 Trial Initiated to Evaluate Datopotamab Deruxtecan in Combination with Pembrolizumab in 1L mNSCLC Patients
“Metastatic non-squamous non-small cell lung cancer remains a challenge because the majority of patients experience disease progression following their initial treatment, underscoring the need for more effective treatment optionsin the first-line setting,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo. “The TROPION-Lung07 trial will assess the potential of the combination of datopotamab […]
First Patient Dosed in NMIBC Substudy of the LUMINOS-103 Basket Trial Evaluating Lerapolturev Monotherapy
“We know that NMIBC tissue expresses the poliovirus receptor, CD155 and is responsive to immunotherapy, providing the rationale for intravesicular lerapolturev for patients with low to intermediate risk BCG-naïve NMIBC,” said W. Garrett Nichols, MD, MS, Chief Medical Officer at Istari Oncology. “Approximately 60,000 patients with low to intermediate risk NIMBC are identified each year […]
Dosing of Tuspetinib Initiated in APTIVATE Expansion Trial in AML Patients
“We are pleased to have dosing underway in our APTIVATE clinical trial of tuspetinib in a very ill R/R AML population,” said William G. Rice, Ph.D., Chairman, President, and Chief Executive Officer. “Tuspetinib has demonstrated noteworthy safety and mutation agnostic potency across a spectrum of AML patients with a diversity of adverse mutations, further distinguishing […]
Expansion Portion of UPGRADE-A Combination Clinical Trial in Platinum-Sensitive Ovarian Cancer Initiated
“While the combination of carboplatin and paclitaxel has historically served as the standard of care in early lines of therapy for platinum-sensitive ovarian cancer, it is limited by distinct tolerability and side effect challenges that can include severe neutropenia, peripheral neuropathy and alopecia,” said Dr. Arvin Yang, Senior Vice President and Chief Medical Officer of […]
Avutometinib + Defactinib Combination Advancing in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) Based on Positive Data from Planned Interim Analysis of Part A of RAMP 201 Trial
“Building on the Breakthrough Therapy designation for the combination of avutometinib with defactinib in recurrent LGSOC and the positive results from the interim analysis of Part A of the RAMP 201 trial, we are working rapidly to bring forward the first U.S. Food and Drug Administration (FDA)-approved therapy for these patients who deserve better options,” […]
NRG-GY018 Study Demonstrates Significantly Improved PFS Outcomes for Women with Endometrial Cancer with the Addition of Pembrolizumab to Chemotherapy
“Patients with advanced stage or recurrent endometrial cancer, the most common type of gynecologic cancer in the U.S., face a poor prognosis with limited treatment options. This is particularly notable in patients who progress after prior platinum-based adjuvant therapy with disease not amenable to curative surgery or radiation,” stated Ramez Eskander, MD, of the University […]
KEYTRUDA + Chemo Met Primary Endpoint of PFS as First-Line Therapy for Advanced or Recurrent Endometrial Carcinoma
“Patients with advanced stage or recurrent endometrial cancer, the most common type of gynecologic cancer in the U.S., face a poor prognosis with limited treatment options. This is particularly notable in patients who progress after prior platinum-based adjuvant therapy with disease not amenable to curative surgery or radiation,” said Dr. Ramez Eskander, principal investigator and […]
FDA Orphan Drug Designation for ezurpimtrostat to treat HCC
“FDA Orphan Drug Designation is a significant milestone for both Genoscience and for our product, ezurpimtrostat. It recognizes that our treatment has the potential to improve the lives of individuals living with HCC,” said Professor Philippe Halfon, CEO of Genoscience Pharma. “We have recently launched our phase 2b clinical trial using ezurpimtrostat in conjunction with […]
FDA Approval of IND Application for EP0042 for AML Patients Announced
Dr Rajan Jethwa, Chief Executive Officer & Founder of Ellipses, commented “This FDA approval of EP0042’s Investigational New Drug application allows us to open additional trial sites in the world’s foremost pharmaceutical market. This will help us in achieving our strategic goal of bringing potential new treatment options to patients in need at unprecedented speed, […]
FDA Approves Jaypirca™ (pirtobrutinib) for Adult Patients with R/R Mantle Cell Lymphoma After at Least Two Lines of Systemic Therapy, Including a BTK Inhibitor
“The approval of Jaypirca represents an important advance for patients with relapsed or refractory MCL, who currently have limited options and historically have had a poor prognosis following discontinuation of treatment with a covalent BTK inhibitor,” said Michael Wang, M.D., Puddin Clarke Endowed Professor of Lymphoma and Myeloma at The University of Texas MD Anderson […]
U.S. FDA Approves Trodelvy In Pre-Treated HR+/HER2- Metastatic Breast Cancer
“Despite decades of advances, people living with pre-treated HR+/HER2- metastatic breast cancer need new treatment options. Nearly all people with this type of breast cancer will eventually develop resistance to endocrine-based therapies and progress on available chemotherapies,” said Hope S. Rugo, MD, Professor of Medicine and Director, Breast Oncology and Clinical Trials Education at the […]
FDA approves Orserdu (elacestrant) for postmenopausal women or adult men with ER+ve, HER2-neg, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy
“The FDA approval of ORSERDU marks the first ever therapy for ER+, HER2- advanced or metastatic breast cancer patients with ESR1 mutations and we are very proud to offer a targeted therapy addressing this huge unmet need,” commented Elcin Barker Ergun, Chief Executive Officer of the Menarini Group. “We are grateful to the patients, investigators […]
Teon Therapeutics Announces Clinical Trial Collaboration With Merck to Evaluate TT-81 in Combination with KEYTRUDA
“We are fortunate to have the opportunity to collaborate with Merck for this Phase 1/2 trial. The collaboration of the combination arm of our TT-816 clinical trial represents an important advancement in our comprehensive development program and further supports our mission to invent new hope for patients by potentially providing meaningful treatments to those with […]
Takeda To Acquire Exclusive Worldwide (ex-China) License of HUTCHMED’s Fruquintinib
“Fruquintinib has the potential to change the treatment landscape for patients with refractory metastatic CRC who are in need of additional treatment options. We look forward to utilizing our development and commercial capabilities to expand the potential of this innovative medicine to patients beyond China,” said Teresa Bitetti, President of the Global Oncology Business Unit […]
TC BioPharm and The University of Texas MD Anderson Cancer Center Announce Strategic Collaboration to Advance Gamma Delta T Cells in Oncology
“We are enthusiastic about working with MD Anderson to further our knowledge of gamma delta T cells in order to help TC Biopharm develop future trials and treatments using our platform therapy OmnImmune,” said Bryan Kobel, CEO of TC BioPharm. “This collaboration reinforces our mutual commitment to accelerating the discovery and development of cell therapies, […]
Elicio Therapeutics and Angion Enter into Definitive Merger Agreement
“The merger with Angion comes at an ideal time with ELI-002 now completing the dose escalation portion of Phase 1 clinical studies in patients. We believe Elicio is at the forefront of changing the tide regarding how cancers with these mutations, which account for 25% of human solid tumors, are treated,” said Robert Connelly, Chief […]
