Sonnet BioTherapeutics Announces a Collaboration with Roche for the Clinical Evaluation of SON-1010 with atezolizumab in Ovarian Cancer
“As this is Sonnet’s first combination clinical study and an opportunity to use our lead FHAB-derived candidate, SON-1010, with atezolizumab, it is a very important milestone for the company. We believe that the combination of our best-in-class IL12-FHAB immune-enhancer candidate with atezolizumab could enable the next generation of cancer treatment.” said Pankaj Mohan, Ph.D., Sonnet’s […]
Kronos Bio Announces Discovery Collaboration with Genentech to Advance Novel Therapies Against Transcriptional Targets in Oncology
“This, our first collaboration, brings together expertise from both companies with the goal of answering fundamental scientific questions about the biology of cancer that we hope will one day lead to the advancement of new clinical candidates,” said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. “We are pleased to be able […]
AbbVie and Anima Biotech Announce Collaboration for the Discovery and Development of mRNA Biology Modulators against Oncology & Immunology Targets
“This collaboration will give AbbVie access to Anima’s leading technology platform and deep expertise in mRNA biology and will help further strengthen AbbVie’s world class capabilities in discovering and developing drugs to make a difference in patient’s lives,” said Jonathon Sedgwick, Ph.D., vice president and global head of discovery research, AbbVie. “Modulating mRNA biology with […]
Foundation Medicine Announces Collaboration with Karyopharm Therapeutics to Develop FoundationOne®CDx as a Companion Diagnostic for XPOVIO® (selinexor)
“We’re looking forward to partnering with Karyopharm as they work to advance this exciting new treatment option for patients living with advanced endometrial cancer,” said Sanket Agrawal, Chief Biopharma Business Officer, Foundation Medicine. “Our deep understanding of cancer biology and global regulatory expertise, combined with their innovative approach to developing cancer therapies puts us in […]
Syneos Health Announces Partnership with Fosun Pharma USA to Launch Serplulimab
“This partnership showcases our ability to provide fit-for-purpose solutions that encompass the entire product development continuum. Our ability to strategize and execute across multiple service lines, including medical affairs and commercial, makes us the premier partner for Fosun Pharma USA,” said Lee Taurman, EVP, Global Head, Syneos One, Syneos Health. “We are strategically supporting the […]
Lurbinectedin “Named Patient Program” for Small-Cell Lung Cancer launched in Hong Kong
PharmaMar announced today that its partner in China, Luye Pharma Group, has launched the Named Patient Program (NPP), a compassionate use program, in Hong Kong, providing eligible local patients immediate access to the new anti-cancer therapy Zepzelca® (lurbinectedin).
Randomization in PNT2002’s Ph 3 SPLASH Trial Completed
“We are proud to have reached this important milestone for the PNT2002 program,” said Jessica Jensen, Executive Vice President, Clinical Development of POINT Biopharma. “Our incredibly talented cross-functional team collaborated tirelessly to ensure that, despite the extraordinary circumstances of a pandemic, POINT’s first phase 3 global trial remained on track. Our success is a testament […]
First patient dosed with B4t2-001 CAR-T targeting solid tumors
“This first-in-human study marks the initial therapeutic to be evaluated from Bio4t2’s technology,” said Dr. Laurence Cooper MD-PhD, Executive Chairman of the board. “PrismCore is capable of rapidly generating CAR-T to safely target self-antigens, opening a new frontier to delivering CAR-T to treat many types of solid tumors. This clinical trial is at the cutting […]
Additional Patients dosed in Ongoing Ph 1b/2a IMX-110 Monotherapy Clinical Trial
“We are delighted with continued robust IMX-110 clinical trial enrollment,” said Ilya Rachman, MD PhD, CEO of ImmixBio. “We continue to accumulate valuable clinical data for first-in-class IMX-110 therapy. In Q1 2023 we plan to share clinical data from our IMX-110 monotherapy and IMX-110 combination trial with Beigene/Novartis’ anti-PD-1 Tislelizumab.”
Enrollment in Ph 1 Clinical Trial of ADXS-504 for the Treatment of Early Prostate completed
“We have completed evaluation of the dose-limiting-toxicity period for three patients at the second dose level for this Phase 1 trial of ADXS-504. At both the first and at this higher dose level, patients have experienced mild and short-lived flu-like symptoms after the infusion of ADXS-504,” said Dr. Runcie. “The safety of ADX-504 and encouraging […]
Enrollment in Ph 2 Clinical Trial MN-166 (ibudilast) trial in Recurrent and Newly Diagnosed Glioblastoma patients completed
Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented, “We have completed enrollment and are actively treating the remaining patients in Part 2 of the trial. We look forward to reporting the interesting findings from tumor tissue analysis and clinical outcomes at the 20th Annual World Congress of SBMT, including potential predictors […]
Results of the First Post-Commercial Utilization Review of JELMYTO® Provide New Evidence that Reinforces its Efficacy and Safety in Patients with Low-Grade Upper Tract Urothelial Cancer
“This study provides valuable insights into how physicians are utilizing JELMYTO in the real-world and reinforces the genuine clinical value of this therapy for patients with LG-UTUC,” said Mark Schoenberg, M.D., Chief Medical Officer, UroGen. “We look forward to additional analyses from this retrospective study as well as prospective and retrospective data from the uTRACT […]
Promising Top-Line Results from Ph 2 Trial of BXCL701 in small cell neuroendocrine metastatic castration-resistant prostate cancer (SCNC) patients announced
“We are pleased that BXCL701 in combination with pembrolizumab has demonstrated an encouraging response rate in this difficult-to-treat cancer with no currently approved FDA therapies,” said Vincent J. O’Neill, M.D., Chief R&D Officer, OnkosXcel Therapeutics, a wholly owned subsidiary of BioXcel Therapeutics. “BXCL701’s promising profile as an oral innate immune activator with a large safety […]
Topline Data from Pivotal Phase 2 FIREFLY-1 Trial Demonstrated Meaningful Responses with Tovorafenib (DAY101) in Pediatric Low-Grade Glioma
“The responses we’ve observed in the FIREFLY-1 study with weekly monotherapy tovorafenib in children with recurrent or progressive low-grade gliomas are very encouraging,” said Samuel Blackman, M.D., Ph.D., co-founder and chief medical officer of Day One. “As tovorafenib progresses in the clinic, we want to thank the patients, their families, the clinical investigators, and the […]
Upcoming 2023 Readouts from Phase 2 and Pivotal Phase 3 Clinical Trials of Trilaciclib announced
“Cytotoxic therapy remains the backbone of treatment for many metastatic tumors, either alone or in combination with targeted therapies,” said Raj Malik, M.D., G1’s Chief Medical Officer. “But the high toxicity of these cytotoxic agents poses a risk of serious adverse events that can compromise patient well-being and patient outcomes. Trilaciclib represents a novel approach […]
Results from Ph 1 dose-expansion study of STRO-002 (luvelta) in patients with advanced ovarian cancer announced
“Today, patients with this form of heavily pre-treated ovarian cancer have extremely limited treatment options available to them, and unfortunately, experience poor outcomes,” said Dr. R. Wendel Naumann, Professor and Director of Gynecologic Oncology Research and Associate Medical Director of Clinical Trials at the Levine Cancer Institute, Atrium Health in Charlotte, North Carolina, and a […]
Leukemia Drug Lumoxiti to be withdrawn From US Market
Fast Track Designation Granted by the FDA to CFI-402257 for the Treatment of ER+/HER2- Breast Cancer
“There is an urgent need for new, safe and efficacious therapies to treat ER+/HER2- breast cancer, particularly when standard of care regimens fail,” said Dr. Mark Bray, Treadwell CSO and Co-founder. “CFI-402257 has shown early signs of durable activity with a manageable safety profile, as a monotherapy and in combination with fulvestrant in ER+/HER2- breast […]
IND approved for MUC1*-CAR-1XX with Increased Persistence and Ability to Kill Low Antigen Expressing Cells for Treatment of Solid Tumor Cancers
“These 1XX mutations solve the two hurdles that have thus far stood in the way of an effective CAR T treatment for solid tumor cancers: 1) CAR T cell exhaustion; and 2) failure to kill the low antigen expressing cells,” said Minerva’s CEO Dr. Cynthia Bamdad, “Together with our MUC1* antibodies that recognize an epitope […]
Orphan Drug Designation in Europe for Duvelisib for the Treatment of Patients with Peripheral T-cell Lymphoma
“Secura Bio is dedicated to developing duvelisib for the treatment of patients with difficult-to-treat cancers, which includes relapsed/refractory PTCL. We are investing significant corporate resources in this endeavor and hope to see new treatment options brought to the market which may benefit patients, such as those with relapse/refractory PTCL.” Said Joseph M. Limber, President and […]
Orphan Drug Designation granted to QN-302 for the Intended Indication of Pancreatic Cancer
“Receiving Orphan Drug Designation for our lead cancer therapeutic, QN-302, for treating pancreatic cancer, is an important accomplishment as we prepare to submit our IND application in the first half of 2023 for our Phase I clinical trial. It is a testament of Qualigen’s commitment to developing treatments for devastating, rare cancers with unmet medical […]
Triumvira Immunologics and Merck to Evaluate TAC01-HER2 Cell Therapy + KEYTRUDA® in Patients with HER2-positive Solid Tumors
“We believe the addition of an immune checkpoint inhibitor, such as KEYTRUDA, to TAC01-HER2 will effectively release inhibitory PD-L1/PD1 signaling in T cells, potentially leading to improved and durable therapeutic responses, said Paul Lammers, M.D., M.Sc., Chief Executive Officer of Triumvira. We are pleased to work collaboratively with Merck to explore the potential of this […]
Nouscom and MSD to Evaluate NOUS-209 + KEYTRUDA® in a Ph 2 Randomized Trials in dMMR/MSI-High Metastatic Colorectal Cancer
Dr Marina Udier, Chief Executive Officer of Nouscom, added: “We are thrilled to collaborate with MSD, a global leader in immuno-oncology, and to work with their highly experienced and talented clinical development team, allowing us to accelerate the ongoing US and EU Phase 2 trial with NOUS-209. Based on our published and presented Phase 1 […]
AbbVie and Immunome Announce Strategic Collaboration to Discover Multiple Novel Oncology Targets
“Partnering with Immunome represents AbbVie’s commitment to developing and commercializing novel treatment approaches for solid tumors,” said Steve Davidsen, Ph.D., vice president, oncology discovery research, AbbVie. “Immunome’s approach has the potential to unlock novel cancer biology and yield multiple therapeutic candidates. We look forward to utilizing their Discovery Engine to enhance our existing oncology pipeline.”
Enrollment Completed in the Global Registrational Ph 3 AXLerate-OC Trial for Platinum-Resistant Ovarian Cancer
“Completing enrollment of this pivotal study brings us closer to the day when batiraxcept potentially is available to patients,” said Scott Dove, Ph.D., Chief Operating Officer of Aravive. “Public reporting of topline data remains on track for mid-2023 and, if successful, are expected to support a Biologics License Application for PROC at the end of […]
50% Enrollment completed in Randomised Ph IIb TACTI-003 Trial for 1L Head & Neck Cancer
Marc Voigt, CEO of Immutep stated: “We are pleased to reach this important milestone and extend our sincere appreciation to our investigators, clinical team, partners, and most importantly patients, that have participated in this study. As clinical evidence showing the compelling benefits of combining efti with immune checkpoint therapies such as pembrolizumab continues to grow, […]
First Patient Dosed in PRESERVE-004, a Ph 2 Clinical Trial of ONC-392 in Combination with KEYTRUDA® in Patients with Platinum-Resistant Ovarian Cancer
“It is an exciting time for immunotherapy clinical trial research. I am incredibly grateful for the opportunity to serve as the Co-PI on this Phase 2 trial with Dr. Bradley Monk. We are thrilled to dose the first patient at our institution with this innovative immunotherapy combination, which hopes to address the unmet need in […]
First Patient Dosed in the Ph 2 U.S. Study of CTX-009 in Patients with mCRC
“We are very pleased to begin dosing patients with colorectal cancer in the United States. We have previously seen 2 confirmed responses among 6 patients dosed at the projected efficacious doses in a Phase 1 monotherapy study” said Thomas Schuetz, M.D., Ph.D., Chief Executive Officer and Scientific Founder of Compass. “Colorectal cancer patients in whom […]
Positive Top-line Results from Pivotal Ph 3 Trial of TAVT-45 for the Treatment of Metastatic Prostate Cancer Announced
“The positive results from the TAVT45C02 trial demonstrate that TAVT-45 may provide an easy-to-swallow alternative to Zytiga®, benefitting many patients with dysphagia or difficulty swallowing large tablets,” said Andreas Maetzel, M.D. Ph.D., chief medical officer of Tavanta Therapeutics. “Approximately 20 to 30 percent of cancer patients, including many patients with prostate cancer, have difficulty swallowing […]
Pivotal LUNAR Study of TTFields + SoC in NSCLC Met Primary Overall Survival Endpoint
“We are pleased with the positive readout of the LUNAR study. Prior to LUNAR, the last phase 3 trial to lead to significant improvement in overall survival in late-stage, platinum-resistant non-small cell lung cancer was six years ago, underlining the difficulty in treating this disease,” said William Doyle, Novocure’s Executive Chairman. “We are also pleased […]
