Durable Responses of Botensilimab/Balstilimab Combination in Nine Different Treatment-Resistant Cancers announced
“This expanded dataset demonstrates the tremendous potential of botensilimab and balstilimab to treat a wide range of immunotherapy-resistant tumors,” said Steven O’Day, M.D., Chief Medical Officer of Agenus. “Importantly, the superior efficacy we observed in our MSS-CRC presentation at GI ESMO earlier this year has remained consistent across a larger dataset. Further, we are seeing […]
BLA Submission for Lifileucel in Advanced Melanoma delayed
Frederick Vogt, Ph.D., J.D., Iovance’s Interim President and Chief Executive Officer stated, “We continue to make substantial progress with our ongoing BLA submission and remain close to the finish line. The FDA has provided recent valuable feedback to the IND application and remains supportive during the rolling BLA submission process. Iovance is fully committed to […]
Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2-positive advanced gastric cancer
Ken Takeshita, Global Head, Oncology R&D, Daiichi Sankyo, Inc, said: “Enhertu is the first HER2-directed medicine to demonstrate a significant improvement in overall survival compared to chemotherapy in patients with gastric cancer following initial treatment with a HER2-directed medicine in the advanced or metastatic setting. The CHMP opinion recognises the high unmet need in this […]
Lynparza in combination with abiraterone recommended for approval in the EU by CHMP as 1st-line treatment for patients with mCRPC
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “With the incidence and mortality of prostate cancer set to double in the coming decades, it is more important than ever that we bring new treatment options to suitable patients at the earliest possible moment in their care. If approved, Lynparza in combination with abiraterone and […]
Imfinzi plus chemotherapy recommended for approval in the EU by CHMP as first immunotherapy regimen for advanced biliary tract cancer
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “If approved, Imfinzi plus chemotherapy will provide patients with advanced biliary tract cancer the first opportunity for treatment with an immunotherapy-based combination. This innovative regimen has been shown to significantly prolong patients’ lives, and we look forward to bringing this option to those in the European […]
FDA restricted 2L maintenance indication for Zejula (niraparib) to only the patient population with deleterious or suspected deleterious gBRCAmut
FDA grants Accelerated Approval of ELAHERE™ (mirvetuximab soravtansine-gynx) for the Treatment of Platinum-Resistant Ovarian Cancer
“The approval of ELAHERE is significant for patients with FRα-positive platinum-resistant ovarian cancer, which is characterized by limited treatment options and poor outcomes,” said Ursula Matulonis, MD, Chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute, Professor of Medicine at the Harvard Medical School, and SORAYA Co-Principal Investigator. “ELAHERE’s impressive anti-tumor activity, […]
EU approves BRUKINSA® (zanubrutinib) for the Treatment of Adults with Chronic Lymphocytic Leukemia (CLL)
“We’re pleased with the significant progress we’ve made to date bringing BRUKINSA to patients with hematological malignancies globally,” noted Gerwin Winter, Senior Vice President, Head of Europe at BeiGene. “With this notable approval, we welcome the opportunity to expand BeiGene’s presence in Europe and provide this innovative treatment option to CLL patients across the region.”
Exelixis and Catalent Enter into New License Agreement for Three Antibody-Drug Conjugate Programs with the Potential to Accelerate Exelixis’ Biologics Pipeline
“Exelixis is committed to building a robust biologics pipeline, and this agreement expands our portfolio to include three highly promising targets with broad potential in multiple solid tumor indications, including bladder, breast, lung, ovarian, pancreatic, and other cancers,” said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer, Exelixis. “We believe that […]
IO Biotech and Merck to Evaluate Neoadjuvant and Adjuvant IO102-IO103 With KEYTRUDA® (pembrolizumab) in a Ph 2 Trial in Patients with Resectable Tumors
“We are pleased to extend our collaboration with Merck into this new exploration of IO102-IO103 in combination with pembrolizumab in earlier, neoadjuvant and adjuvant settings,” said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech. “IO102-IO103 has shown promising early clinical activity with a positive safety profile in melanoma thus far and, as highlighted in […]
IGM Biosciences and ADC Therapeutics to Evaluate Imvotamab (IGM-2323) in Combination with ZYNLONTA® in Patients with R/R B Cell Non-Hodgkin’s Lymphoma
“Patients with B cell non-Hodgkin’s lymphoma are in need of efficacious and well-tolerated treatments,” said Chris Takimoto, M.D., Ph.D., F.A.C.P., Chief Medical Officer of IGM Biosciences. “We are excited to enter this collaboration with ADC Therapeutics that aims to provide a novel combination regimen targeting both CD19- and CD20-expressing cells for patients with relapsed/refractory B […]
Tessa Therapeutics, Baylor College of Medicine Execute Agreement For Global Commercial Rights to ‘Off-the-Shelf’ CAR-T Platform
“Allogeneic or ‘off-the-shelf’ CAR-T therapies have the potential to change the paradigm of cancer treatment, and we believe the allogeneic EBVST platform developed at the Center for Cell and Gene Therapy, at Baylor College of Medicine places Tessa at the forefront of a very substantial therapeutic and business opportunity,” said Thomas Willemsen, Tessa’s President and […]
Fate Therapeutics Announces Exercise by ONO Pharmaceutical of Option to HER2-targeted CAR T-Cell Product Candidate for Solid Tumors
“We are encouraged by the compelling preclinical data package generated for FT825/ONO-8250 under our collaboration, which combines the antigen binder that ONO provides and Fate’s industry-leading iPSC product platform to overcome the challenges in solid cancer treatment,” said Toichi Takino, Senior Executive Officer / Executive Director, Discovery & Research of ONO. “We look forward to […]
Geneos Therapeutics Announces Positive Clinical Data for Personalized Therapeutic Cancer Vaccines in Ongoing Liver Cancer Trial
“As a physician who has been managing patients with advanced liver cancer for more than two decades, I am thrilled by the response rate and immunologic activity we are seeing with this promising form of therapeutic cancer vaccination,” stated Dr. Gane, professor of medicine at the University of Auckland, New Zealand, hepatologist and deputy director […]
Incyte And Mirati Therapeutics Enter To Evaluate INCB99280 And Adagrasib In Patients With KRASG12C-Mutated Solid Tumors
“While monoclonal antibodies targeting PD‑L1 or PD-1 have transformed the treatment landscape in oncology, they are limited by their route of administration and long-half life and receptor occupancy which can affect the management of immune-related adverse events,” said Lance Leopold, M.D., Group Vice President, Clinical Development Hematology and Oncology, Incyte. “Incyte’s small molecule, oral PD-L1 […]
Portage Biotech announces clinical trial collaboration agreement with Merck
“We are pleased to collaborate with Merck, a long-established leader in cancer immunotherapy, to explore how our complementary mechanism with KEYTRUDA has the potential to further enhance long-term clinical benefit for people with cancer and also expand the eligible population to include those who do not currently receive anti-PD-1 therapy,” said Dr. Ian Walters, Chief […]
MGFB announces agreement with Mayo Clinic for development of novel therapeutic cancer vaccines
“We are very excited to collaborate with Mayo Clinic on this approach to treating solid tumors. Our objective is to develop the most therapeutically effective constructs with the hope of providing patients better therapeutic alternatives,” said Ajit Gill, CEO of MGFB.
Eucure Biopharma Announces Partnership with ISU ABXIS for the Development of Tri-specific Antibodies using YH003 Antibody Sequence
“Biocytogen utilized its unique evidence-based in vivo drug screening platform to obtain YH003, which has demonstrated a good preclinical safety and efficacy profile,” said Dr. Rong Chen, Vice President of Biocytogen and CEO/CMO of Eucure Biopharma. “Further, YH003’s phase I clinical trials indicate good tolerability and safety profiles, as well as encouraging antitumor activities against […]
Exelixis and Sairopa Establish Exclusive Clinical Development Collaboration and Option Agreement to Develop ADU-1805
“ADU-1805 is a promising antibody that has been carefully optimized to maximize the potential benefit of blocking the SIRPα – CD47 checkpoint, while minimizing potential toxicities and allowing for treatment of the broadest population of appropriate patients. We believe that ADU-1805 represents a differentiated and potentially best-in-class approach to this pathway,” said Peter Lamb, Ph.D., […]
Ph 3 trial of SYK inhibitor, entospletinib, for the treatment of newly diagnosed patients with NPM1-mutated AML to be discontinued
“Focusing on lanraplenib and KB-0742 will allow us to direct our resources to the highest value programs and deliver on our mission of bringing cancer drugs to the patients with the greatest need,” said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. “This is the right decision at the right time, and […]
First Patient Dosed in Ph 1/2 Clinical Trial Evaluating MRT-2359, a GSPT1-directed Molecular Glue Degrader, for Treatment of MYC-driven Tumors
“MYC transcription factors are well-defined drivers of human cancers, and disrupting protein translation has emerged as a promising path to address this highly prevalent disease pathway. Dosing the first patient is a significant milestone in developing MRT-2359 as a therapeutic option for MYC-driven cancers,” said Filip Janku, M.D., Ph.D., Chief Medical Officer of Monte Rosa. […]
First Patient Successfully Dosed in Ph 1 Study of Pindnarulex in Combination with Talazoparib for the Treatment of Prostate Cancer
“Pidnarulex, alone, has shown efficacy in tumor cells resistant to PARPi in the preclinical studies. Therefore, we think Pidnarulex demonstrates great potential as an alternative treatment for prostate cancer patients who have acquired resistance to PARPi or other chemotherapies,” said Dr. Jin-Ding Huang, Chief Executive Officer of Senhwa Biosciences.
Voluntary Pause of Enrollment in Ongoing in ITIL-168 and ITIL-306 Trials Related to Manufacturing
“We are committed to advancing TIL therapy for the treatment of patients with cancer,” said Bronson Crouch, Chief Executive Officer of Instil Bio. “This pause in enrollment provides us an opportunity to refine our processes and enable us to manufacture and deliver TIL therapies to patients with no other treatment options. We have assembled a […]
Enrollment into Ph 1 study of EPI-7386 with apalutamide/abiraterone acetate plus prednisone in mCRPC patients suspended due to operational recruitment challenges
“While we are disappointed that Janssen will not be completing this study, we thank Janssen for the conduct of the study to date and the patients who participated in the study. We are encouraged by the favorable safety, pharmacokinetic, and initial clinical activity in these patients as these data further support the data generated in […]
New Positive Data from Ongoing Ph 1 Trial of CUE-101 in Combination with KEYTRUDA(R) for Recurrent/Metastatic HPV+ Head and Neck Cancer presented
“We are very encouraged with the overall response rate observed in the trial so far with CUE-101, and its potential to improve standard of care for HPV+ head and neck cancer patients,” said Dr. Christine Chung, M.D., Chair, Department of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, and a principal investigator participating in the clinical […]
Additional efficacy analysis in Phase 2 study of VB10.16 in combination with atezolizumab in advanced cervical cancer announced
“This additional analysis confirms our belief in VB10.16’s competitive strength and its potential to improve outcomes in patients with advanced cervical cancer,” said Michael Engsig, Chief Executive Officer of Nykode. “Our C-02 trial enrolled heavily pre-treated patients with about one third having received three or more prior treatments. The additional analysis shows an increased response […]
Updated Overall Survival Results from GRANITE Phase 1/2 Study announced
“The follow-up data from our Phase 1/2 study in patients with MSS-CRC who have received at least two prior lines of therapy continue to demonstrate an association between molecular response and overall survival,” said Andrew Allen, M.D., Ph.D., Co-founder, President and Chief Executive Officer of Gritstone. “The median overall survival (MOS) in patients with MSS-CRC […]
Dose Escalation Data from transcendIT-101 Phase 1/2 Trial of TransCon™ TLR7/8 Agonist in Patients with Advanced Solid Tumors Presented
“We are very pleased to see intratumoral TransCon TLR7/8 Agonist administration working as designed to deliver prolonged, high local concentrations of resiquimod, steadily activating and intensifying the body’s innate and adaptive immune responses over weeks with a single injection,” said Stina Singel, Senior Vice President, Head of Clinical Development, Oncology at Ascendis Pharma. “With these […]
Onivyde® Regimen Demonstrated Statistically Significant Improvement In Overall Survival In Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
“The positive results from the NAPOLI 3 trial demonstrate that compared with the standard-of-care, the investigational Onivyde treatment regimen extended the lives of people living with metastatic pancreatic ductal adenocarcinoma who were previously untreated,” said Howard Mayer, Executive Vice President and Head of Research and Development for Ipsen. “The prognosis for people diagnosed with pancreatic […]
FAILED TRIAL: Ph 3 DREAMM-3 trial of Blenrep (belantamab mafodotin) in patients with RRMM did not meet primary endpoint of progression-free survival (PFS)
