The European Commission Grants Orphan Drug Designation to Temferon™ for Treatment of Glioma
“European Medicine Agency’s Committee reviewed Genenta’s ODD application for Temferon and agreed on the potential significant benefit that Temferon could contribute to patients suffering from GBM if approved. The ODD designation supports and facilitates the development of our cell therapy-based technology platform for solid tumors,” said Pierluigi Paracchi, Chief Executive Officer at Genenta. “The EMA […]
NMPA Approves FUCASO, the First Fully-human BCMA CAR-T Therapy, for the Treatment of Relapsed or Refractory Multiple Myeloma in China
Dr. Hui Zhou, Senior Vice President of Innovent Biologics, stated, “Multiple myeloma is a common hematology malignant disease with high incidence rate, and relapse and refractory are almost inevitable after current treatments. There’s an urgent unmet need of a treatment with well-tolerated and long persistence for RRMM patients in China. FUCASO®, as an innovative fully-human […]
European Commission Grants Conditional Marketing Authorization for LYTGOBI Tablets for the Treatment of Adults With Cholangiocarcinoma
“Today is an important day for current and future patients with CCA as well as the healthcare providers who treat them,” said Peter Foertig, MD, Vice President, Medical Affairs, Taiho Oncology Europe. “LYTGOBI is an oral molecularly targeted medication that may provide clinically meaningful outcomes for patients undergoing treatment for CCA.”
Mestag Therapeutics and VIB enter into an exclusive partnership in oncology
Susan Hill, PhD, Chief Executive Officer of Mestag Therapeutics, said, “We are delighted to partner with VIB, one of the premier research institutes in Europe and a leader in nanobody technology and cancer biology. This agreement further strengthens Mestag’s first-in-class pipeline and targets an exciting new area of fibroblast-immune cancer biology.”
K36 Therapeutics Announces $70 Million Series B Financing to Fund Clinical Proof of Concept of KTX-1001 for Treatment of Multiple Myeloma Patients with Genetic Translocation (4;14)
“We are committed to developing KTX-1001 for t(4;14) multiple myeloma patients, a large patient population with chronic disease who are relatively unresponsive to existing and emerging therapeutics,” said Terry Connolly, Ph.D., Chief Executive Officer of K36 Therapeutics. “We welcome our new investors who bring extensive expertise in cancer drug development as well as company building, […]
Prime Medicine and Cimeio Therapeutics Announce Research Collaboration to Develop Prime Edited Shielded-Cell & Immunotherapy Pairs for Genetic Diseases, AML and MDS
“We believe Prime Editing is an incredibly powerful technology that could impact the care and treatment of a wide range of diseases. To fully exploit the potential of our technology, we are committed to collaborating with partners who can meaningfully expand our reach, accelerating our efforts to deliver important new medicines to patients worldwide,” said […]
Innovent and RemeGen Enter into Clinical Trial Collaboration Investigating Combination Therapy of TYVYT® and Novel ADC Candidates for Advanced Solid Tumors in China
Dr. Hui Zhou, Senior Vice President of Innovent, stated: “We are pleased to collaborate with RemeGen to further explore the combination therapy potential of sintilimab injection and novel ADC candidates. Preclinical studies has suggested the synergistic anti-tumor effects, which supports the investigation of combining ADCs with an anti-PD-1 monoclonal antibody to improve patient outcomes and […]
ImmunoGenesis and Cancer Focus Fund Announce $4.5 Million Investment to Support First-in-Human Trial of IMGS-001 for R/R Advanced Solid Tumors
“Overcoming the widespread resistance to immunotherapy in immune-excluded tumors requires re-envisioning the starting point for treatment,” said Dr. Michael A. Curran, Founder of ImmunoGenesis. “We are addressing this challenge by developing a novel, dualspecific PDL1/PDL2 inhibitor engineered to include tumor-killing effector function – essentially addressing tumor pathology at the roots. Based on the results of […]
LegoChemBio signs a license agreement to acquire a first-in-class antibody from Elthera
“We are very pleased to enter into this license agreement with LegoChemBio, a global ADC company with industry-leading ADC technology,” said Anne Schmidt, CEO of Elthera. “This agreement is the result of a fruitful collaboration with LegoChemBio, demonstrating the outstanding quality and therapeutic potential of our antibody. The combination with LegoChemBio’s ConjuAll technology generates a […]
First patient dosed in Ph 2 MATISSE study in combination with durvalumab and chemotherapy in treatment-naïve patients with resectable early stage NSCLC
Joyson Karakunnel, MD, MSc, FACP, Chief Medical Officer at Innate Pharma “We are pleased to announce the dosing of a first patient in this Phase 2 study conducted in collaboration with our partner AstraZeneca. The study aims to assess the potential of combining our IPH5201 drug candidate with durvalumab as neoadjuvant treatment with chemotherapy and […]
Phase 3 Study of Tifcemalimab plus Toripalimab for Treatment of Limited-stage Small Cell Lung Cancer initiated
“In recent years, immune-oncology (I-O) therapy has made rapid advancements, particularly in the field of lung cancer, where it has emerged as the standard of care for first-line treatment of advanced NSCLC,” said Dr. Jianjun ZOU, the Global Research and Development President of Junshi Biosciences. “Regarding more aggressive SCLC, however, the progress in I-O therapy […]
Enrollment completed in Pivotal Phase 3 TiNivo-2 Study of FOTIVDA® (tivozanib) in Combination with OPDIVO® (nivolumab) in Advanced Renal Cell Carcinoma
“The TiNivo-2 study will provide us with a robust Phase 3 dataset to answer the outstanding question of whether adding a PD-1 Inhibitor (nivolumab) to a VEGF TKI (tivozanib), provides additional efficacy and acceptable safety over a single agent VEGF TKI following prior immunotherapy,” said Toni Choueiri, M.D., Director, Lank Center for Genitourinary Oncology; Director, […]
Pivotal Ph 3 Study of Selinexor and Ruxolitinib in JAKi-Naïve Myelofibrosis initiated
“Selinexor and ruxolitinib appear to work synergistically, resulting in meaningful improvements in spleen response and total symptom score for patients with myelofibrosis,” said Reshma Rangwala, MD, PhD, Chief Medical Officer of Karyopharm. “We believe that an opportunity exists to expand upon the initial response, depth, and duration of JAK inhibitors to ultimately improve patient outcomes. […]
Pivotal Phase 3 Trial of BNT316/ONC-392 Program in mNSCLC initiated
“We believe this investigational treatment has the potential to become a new option for patients with late-stage NSCLC who have an otherwise poor prognosis. Given its specific mode of action, this treatment approach may also be applicable in a synergistic combination with other immunotherapeutic modalities to provide benefit to further patient populations,” said Prof. Özlem […]
FDA clears Roche’s Elecsys CSF diagnosis assays for Alzheimer’s disease
Roche’s Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF (tTau) assays received FDA’s 510(k) clearance (also called pre-market notification) for early and accurate diagnosis of Alzheimer’s disease (AD). This assay pair measures the ratio of two biomarkers of AD viz., tau (tTau) and beta-amyloid (Abeta42). It will hit the market in Q4 of 2023 […]
Imfinzi + Imjudo demonstrated sustained OS benefit in advanced liver cancer with an unprecedented one in four patients alive at four years in HIMALAYA Ph 3 trial
Bruno Sangro, MD, PhD, Director of the Liver Unit and Professor of Internal Medicine at Clínica Universidad de Navarra, Pamplona, Spain and a lead investigator in the trial, said: “Historically, only seven per cent of patients with advanced liver cancer have survived five years, making the HIMALAYA long-term survival data especially meaningful. One in four […]
Datopotamab deruxtecan met dual primary endpoint of PFS in patients with advanced NSCLC in TROPION-Lung01 Phase III trial
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “With TROPION-Lung01, we met the dual primary endpoint of progression-free survival, challenging the entrenched standard of care in a previously treated and unselected patient population that has long deserved an alternative to chemotherapy. These first Phase III trial results from the datopotamab deruxtecan clinical programme provide […]
Positive updated data announced from Phase 1 study of NKX101 to treat patients with R/R AML
“Patients with relapsed or refractory AML have few treatment options, and novel approaches are urgently needed. Traditional chemotherapy is often unable to drive deep remissions in this setting, and many patients cannot tolerate it,” said Carlos Bachier, M.D., Medical Director of Research and Cellular Therapy, Sarah Cannon Transplant & Cellular Therapy Program at Methodist Hospital […]
Pivotal NAVAL-1 Trial Achieves Efficacy Threshold for Expansion in Relapsed or Refractory EBV-positive Peripheral T-Cell Lymphoma (R/R EBV+ PTCL)
“Initial data from the PTCL cohort in NAVAL-1 show a strong signal of efficacy that is in-line with our promising Phase 1b/2 data and sufficient to advance to Stage 2. We now look forward to completing enrollment in Stage 1 and are taking steps to further accelerate enrollment through Stage 2,” said Mark Rothera, President […]
Positive Second Interim Efficacy Analysis from Mitazalimab OPTIMIZE-1 Ph 2 Study in 1st Line Pancreatic Cancer Announced
“Our OPTIMIZE-1 Phase 2 study has produced another set of very encouraging data to add to the growing body of compelling clinical evidence supporting our lead drug candidate mitazalimab in pancreatic cancer. Especially, we are excited to see that tumor responses continue to develop suggesting a longer benefit for the patients, and we are looking […]
Clinical Data from Ph 1 Study of FHD-286 in Metastatic Uveal Melanoma announced
“The clinical data further support the safety and tolerability of FHD-286 and build on the previously disclosed AML/MDS data. In the study, nine patients had stable disease and one patient had a durable partial response,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. “However, Foghorn does not plan to pursue this indication on […]
Positive 15-month Survival Data From GLORIA Expansion Arm Evaluating NOX-A12 in Combination With Radiotherapy and Avastin in GBM Announced
“Reaching the 15-month survival point with this expansion arm is a significant milestone in our development of NOX-A12 in glioblastoma, and to do so with more than 80 percent of patients still on study represents a fantastic achievement,” said Aram Mangasarian, CEO of TME Pharma. “This latest set of survival data further underlines the clinically […]
Positive Topline Results from Ph 1/2 EPCORE™ NHL-1 Trial of Epcoritamab in Patients with Relapsed/Refractory Follicular Lymphoma (FL) announced
“These topline results are encouraging for relapsed or refractory follicular lymphoma patients who are in need of new therapeutic options,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “With our partner AbbVie, we are committed to evaluating epcoritamab as a potential core therapy across B-cell malignancies. We look forward to sharing the […]
RenovoGem™ Delays Cancer Progression by Eight Months in Locally Advanced Pancreatic Cancer
“Clinical practice has been waiting decades for a meaningful advancement in the standard of care for pancreatic cancer treatment, with less toxicity and better outcomes. The new data from the TIGeR-PaC interim results support that RenovoGem has the potential to more than double progression-free survival compared to systemic chemotherapy alone in this difficult-to-treat cancer, which […]
U.S. FDA grants Fast Track Designation to REQORSA® in Combination with Tecentriq® for the Treatment of Small Cell Lung Cancer
“We are very pleased to receive a third Fast Track Designation from the FDA for REQORSA, this time for patients with ES-SCLC in combination with the checkpoint inhibitor Tecentriq,” said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex. “This is another exciting achievement in our REQORSA development program, which further validates REQORSA’s potential […]
Zenocutuzumab granted Breakthrough Therapy Designation by US FDA for the treatment of NRG1+ pancreatic cancer
“We believe the compelling clinical data for Zeno in NRG1+ cancer, and Breakthrough Therapy Designation, provide the opportunity to further engage with the FDA to expedite the review of a potential BLA submission,” said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. “Additionally, our intention to partner Zeno is a reflection of our strategy […]
FDA OKays Proceeding with Phase 1/2 Trials of NEO212 for Primary Brain Tumors and for Brain Metastasis in Combination with Standard of Care Therapy
“We believe receiving this authorization from the FDA will enable us to advance NEO212 into the clinic where we believe it can have a positive effect on treatment outcomes,” stated NeOnc CEO, Thomas Chen, MD, Ph.D. “Based on pre-clinical testing, we believe NEO212 may be effectively delivered to the brain to treat primary brain tumors.”
GAVRETO® (pralsetinib) sNDA approval by China NMPA for first-line treatment of patients with locally advanced or metastatic RET fusion-positive NSCLC
Dr. Jason Yang, CEO of CStone, said, “We are delighted to see the approval of GAVRETO for the first-line treatment of RET-fusion positive NSCLC in China, broadening its indications to cover both first-line and second-line settings, as well as first-line RET-altered thyroid cancer. GAVRETO has treated thousands of patients since being marketed in China. As […]
U.S. Expanded Access Protocol for Imetelstat in Lower Risk MDS announced
“We have heard physicians in both academic and community settings express the need for new treatment options for their lower risk MDS patients, and they will now have an option to access imetelstat through the EAP,” said Faye Feller, M.D., Executive Vice President, Chief Medical Officer of Geron. “With positive IMerge Phase 3 results submitted […]
NEOGAP acquires TCER Oncology AB, strengthening its position in personalised immunotherapy
“We are delighted to acquire the remaining shares in TCER Oncology and extend a warm welcome to Rolf Kiessling and Stina Wickström as valued shareholders in NEOGAP. This acquisition marks an important milestone, fortifying our standing in personalised immunotherapy. It allows us to expand our patent portfolio and pipeline of potential drug candidates while further […]
