Positive Clinical Data from Dose Escalation of CB-010 ANTLER Phase 1 Trial in r/r B-NHL reported
“I am excited to see the initial and durable response rates for patients following a single dose of CB-010 in the ANTLER Phase 1 clinical trial. The data are promising and may offer a clinical advantage as an off-the-shelf option compared with approved autologous CAR-T cell therapies,” said Loretta J. Nastoupil, MD, deputy chair and […]
FDA granted Fast Track Designation for REQORSA® Immunogene Therapy for patients with extensive-stage small cell lung cancer (ES-SCLC)
“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 […]
sNDA submitted to FDA for BRUKINSA in combination with obinutuzumab as a treatment for relapsed or refractory follicular lymphoma
“Follicular lymphoma is the most common slow-growing non-Hodgkin lymphoma, but there are limited treatment options for patients whose condition has progressed after two lines of therapy. We are therefore pleased that BRUKINSA is the first Bruton’s tyrosine kinase inhibitor to demonstrate efficacy in follicular lymphoma and plan to continue worldwide regulatory submissions based on the […]
FDA Clearance of Investigational New Drug Application for P-CD19CD20-ALLO1, an Allogeneic Dual CAR-T Cell Therapy for B-Cell Malignancies
“We are pleased to receive IND clearance for P-CD19CD20-ALLO1, our third fully allogeneic CAR-T cell product candidate and the second therapy in our partnership with Roche for hematological malignancies that will enter the clinic. We believe this represents the FDA’s first known IND clearance of an allogeneic dual CAR-T therapy targeting CD19 and CD20,” said […]
FDA clears FDA INDA for CFT8919, an Orally Bioavailable BiDAC™ Degrader Targeting EGFR L858R for Non-Small Cell Lung Cancer
“This milestone marks C4T’s fourth IND clearance from its proprietary TORPEDO® platform. In May 2023, C4T and Betta Pharmaceuticals entered into an exclusive licensing agreement for the development and commercialization of CFT8919 in Greater China, including Hong Kong SAR, Macau SAR and Taiwan. In China, approximately 693,000 patients were diagnosed with NSCLC in 2020 and […]
FDA Clears SP-3164 Investigational New Drug Application to Begin a Phase 1 Clinical Trial in Relapsed/Refractory Non-Hodgkin Lymphoma Patients
“FDA clearance of the SP-3164 IND marks another significant milestone for Salarius and demonstrates our continued focus and commitment to bringing new therapies to patients in need of new treatment options,” said David Arthur, president and chief executive officer of Salarius, ”We now plan to enroll NHL patients in the dose-escalation portion of the clinical […]
FDA Orphan Drug Designation for Padeliporfin VTP in Pancreatic Cancer
Barak Palatchi, CEO of ImPact Biotech, said, “We are delighted to receive Orphan Drug Designation for Padeliporfin VTP in Pancreatic Cancer, further validating ImPact’s technology and the potential benefits our product could bring to patients with locally advanced Pancreatic Cancer. We continue to believe and follow our strategy, refocusing Padeliporfin VTP treatment on patients with […]
Registrational Pivotal Phase III Study of Olverembatinib for the First-Line Treatment of Patients with Ph+ ALL Approved by the CDE in China
“This approval for the pivotal Phase III study in newly diagnosed patients with Ph+ ALL marks a major milestone for the development of olverembatinib,” said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “TKIs combined with chemotherapy is a widely recognized standard treatment strategy for patients with Ph+ ALL, but no TKI has been […]
Orphan Drug Designation for First-In-Class Trispecific Antibody, ISB 2001
“The FDA’s decision to grant orphan drug designation to ISB 2001 – our third clinical-stage asset to receive that designation in five years – underscores the importance of the work our team is doing to develop potentially curative therapies for the treatment of multiple myeloma,” said Cyril Konto, M.D., President and Chief Executive Officer of […]
Regulatory and Clinical Updates for TIL Therapy in Advanced NSCLC provided; positive FDA Feedback Supports IOV-LUN-202 Trial Design for Accelerated Approval of TIL Therapy in Post-Anti-PD-1 Advanced NSCLC
“At a Type B Pre-Phase 3 meeting held between Iovance and the U.S. Food and Drug Administration (FDA), the FDA provided positive regulatory feedback that the design of the IOV-LUN-202 trial may be acceptable for accelerated approval of LN-145 TIL therapy for patients who have progressed on or after chemotherapy and anti-PD-1 therapy for advanced […]
Full FDA Review for HEMO-CAR-T IND Announced
Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: “We are confident that we will be able to address the FDA’s questions and concerns regarding the IND. AML has poor survival rates and we are eager to resolve this hold and continue down the treatment development pathway toward saving lives.”
European Commission approves fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma
“As pioneers in the development of innovative T-cell-engaging bispecific antibodies, we are delighted that we can now offer Columvi as the first approved treatment of its kind to people in Europe,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are confident that thanks to its off-the-shelf availability, […]
Enhertu approved in China as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer
Binghe Xu, MD, Director of the National Clinical Research Center for New Anticancer Drugs, Tenured Professor and Former Director, Department of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College, said: “Historically, breast cancer tumours with low levels of HER2 expression have been classified as HER2-negative and have not been […]
European Commission Grants Conditional Marketing Authorization for Taiho’s 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.”
Caribou Biosciences Announces $25 Million Equity Investment from Pfizer
“We believe Pfizer’s investment in Caribou highlights the potential of our clinical programs and we are excited to establish this partnership with one of the world’s premier biopharmaceutical companies,” said Rachel Haurwitz, PhD, Caribou’s president and chief executive officer. “We are actively advancing our allogeneic CAR-T cell therapy pipeline and look forward to providing updates […]
F-star Announces Strategic Collaboration and Licence Agreement with Takeda to Discover and Develop Next-Generation Multi-Specific Antibodies
Neil Brewis, Ph.D., Head of F-star Therapeutics and Chief Scientific Officer said: “We are delighted to expand our relationship with Takeda who shares our vision of developing pioneering multi-specific immunotherapies so more people with cancer can live longer with improved lives. This strategic collaboration leverages the capabilities of both companies by combining F-star’s clinically validated […]
Pheon Therapeutics enters into license agreement with Biocytogen Pharmaceuticals
Bertrand Damour, Chief Executive Officer of Pheon Therapeutics, said: “This license agreement represents a significant expansion of Pheon’s pipeline, and it enhances our ability to successfully develop the next generation of ADCs. Biocytogen is a fantastic partner with groundbreaking technology that is well suited to our needs. We look forward to working with them and […]
Shorla Oncology Announces Licensing Agreement and Strategic Partnership for Rights to Market Chemotherapy Drug, PIP-101, in the United States
“We are excited to partner with and leverage the developer’s oral oncology liquid manufacturing expertise,” said Sharon Cunningham, CEO and Co-founder of Shorla Oncology. “This commercial partnership is a strong endorsement of our commitment to bring to market differentiated oncology treatments to address key areas of unmet needs for patients.”
FDA Removes Partial Clinical Hold on TakeAim Leukemia Study RP2D Established at 300 mg BID
“We are pleased to announce that FDA has removed the partial clinical hold on the TakeAim Leukemia study and that we are proceeding with 300 mg BID as our RP2D. We are working with our clinical sites to enroll targeted patients with AML (patients with a FLT3 or spliceosome mutation who have received ≤ 2 […]
New Positive Interim Ph 3 Data Demonstrating RenovoGem™ Delays Cancer Progression by Eight Months in Locally Advanced Pancreatic Cancer Announced
“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 […]
Datopotamab Deruxtecan Met Dual Primary Endpoint Of PFS In Patients With Advanced NSCLC in TROPION-Lung01 Phase 3 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 […]
Botensilimab/Balstilimab Combination Achieves Unprecedented Survival in Advanced Colorectal Cancer
“The data from our expanded cohort demonstrate remarkable median overall survival and sustained responses in heavily pre-treated patients that historically haven’t responded to immunotherapy. These findings provide evidence of the benefit of botensilimab/balstilimab in metastatic colorectal cancer, the second leading cause of cancer death in the U.S.,” said Dr. Steven O’Day, Chief Medical Officer at […]
NEJM Publishes BRUIN Ph 1/2 Trial Data for Pirtobrutinib in BTK Inhibitor Pre-Treated Adult Patients with CLL/SLL
“Patients with relapsed or refractory CLL or SLL following treatment with a covalent BTK inhibitor represent a population with limited treatment options,” said the study’s co-lead author Jennifer A. Woyach, M.D., professor and hematologist-oncologist at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. “These […]
Positive final KappaMab Ph2b study results in in kappa-type R/R multiple myeloma patients announced
“This study validates KMA as a highly specific target, and the ability to safely deliver KappaMab in combination with a mainstay treatment for multiple myeloma,” HaemaLogiX CEO, Bryce Carmine, said.
Paxalisib Receives Fast Track Designation From FDA For Treatment Of Solid Tumor Brain Mets Harboring PI3K Pathway Mutations In Combination With Radiation Therapy
“Brain metastases are rapidly emerging as a key pillar of paxalisib’s clinical development,” said Dr. John Friend, Chief Executive Officer of Kazia. “We have seen a high level of interest from clinicians in the emerging data from this patient population, and it is exciting to now have that interest complemented by FDA’s award of Fast […]
FDA Grants Priority Review for Zolbetuximab Biologics License Application
“Astellas is committed to bringing innovative therapies to patients with hard-to-treat cancers, including gastric cancer. While rare in the U.S., gastric cancer can be deadly when diagnosed in the late stages,” said Moitreyee Chatterjee-Kishore, PhD, MBA, Senior Vice President and Head of Immuno-Oncology Development, Astellas. “The FDA’s acceptance of the Biologics License Application filing and […]
Positive guidance from US FDA on Cu-64 SAR-bisPSMA Phase III trial in prostate cancer
Clarity’s Executive Chairperson, Dr Alan Taylor, commented, “We are very excited to progress our Phase III trial and are appreciative of the time and valuable guidance the FDA has provided in relation to our 64Cu SAR-bisPSMA program during the end of phase meeting. The initiation of the CLARIFY trial is supported by compelling preclinical and […]
FDA Clears Investigational New Drug Application for CFT8919 Targeting EGFR L858R for Non-Small Cell Lung Cancer
C4 Therapeutics announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug (IND) application for CFT8919, an orally bioavailable BiDAC™ degrader designed to be potent and selective against EGFR L858R for non-small cell lung cancer (NSCLC) patients. This milestone marks C4T’s fourth IND clearance from its proprietary TORPEDO® platform.
FDA Clears Investigational New Drug Application for P-CD19CD20-ALLO1 Dual CAR-T Cell Therapy for B-Cell Malignancies
“We are pleased to receive IND clearance for P-CD19CD20-ALLO1, our third fully allogeneic CAR-T cell product candidate and the second therapy in our partnership with Roche for hematological malignancies that will enter the clinic. We believe this represents the FDA’s first known IND clearance of an allogeneic dual CAR-T therapy targeting CD19 and CD20,” said […]
Design for Confirmatory Trial of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer Announced
“We are pleased to partner with GOG and ENGOT and announce the final study design for RAMP 301, another important milestone in advancing our avutometinib and defactinib program and bringing us closer to addressing the unmet needs of patients living with LGSOC,” said Brian Stuglik, Chief Executive Officer, Verastem Oncology. “This trial builds on the […]
