Eterna Therapeutics Acquires Allogeneic Immuno-Oncology Platform from Exacis Biotherapeutics
Gregory Fiore, M.D., President and CEO of Exacis, and member of Eterna’s Board of Directors, commented, “Exacis was started with the goals of improving patient outcomes and experiences as well as increasing access to life-saving treatments. Today’s announcement marks a key milestone on the path to achieving these goals. The Eterna Board and leadership are […]
Convergent Therapeutics Announces $90 Million Series A Financing to Advance the Clinical Development of Radiopharmaceuticals for the Treatment of Prostate Cancer and Other Solid Tumors
“While considerable progress has been made in the search for effective treatments for prostate cancer, it continues to be the second leading cause of cancer death in men1, representing a significant unmet need,” said Dr. Kantoff. “This financing is an important milestone for Convergent and accelerated development of novel radioantibodies, beginning with CONV01-α. We view […]
Janssen Enters Worldwide Collaboration and License Agreement with Cellular Biomedicine Group to Develop Next Generation CAR-T Therapies
“We are committed to advancing the science and treatment of B-cell malignancies, especially in DLBCL where deeper responses and long-term remissions represent a persistent unmet need,” said Sen Zhuang, M.D., Ph.D., Vice President, Clinical Research and Development, Janssen Research & Development, LLC. “A tenet to our continued innovation is a focus on accelerating the development […]
FibroGen Enters into Exclusive License for FOR46 with Fortis Therapeutics
“The agreement with Fortis Therapeutics bolsters FibroGen’s clinical pipeline in a capital-efficient manner, providing a product candidate with the potential to address a significant unmet medical need in oncology,” said Enrique Conterno, Chief Executive Officer, FibroGen. “FOR46 is a natural fit with our R&D capabilities and expertise. The flexibility of the agreement gives us the […]
ALX Oncology Announces Clinical Trial Collaboration with Sanofi to Evaluate Evorpacept + SARCLISA (isatuximab-irfc) in Patients with Multiple Myeloma
“We are thrilled to enter this collaboration with Sanofi that has the potential to advance a new combination therapy for patients with relapsed multiple myeloma who would benefit from novel effective treatment options,” said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. “The combination of blocking both CD47 and CD38 has […]
Algok Bio Enters into Exclusive Worldwide License Agreement with BTG to Develop and Commercialize Idetrexed, a Clinical-Stage Folate Receptor-Targeted Oncology Drug
Dr. Sung Chul Kim, President and Founder of Algok Bio, commented, “As the only small molecule drug with a unique mechanism of action currently targeting FRα, the efficacy and safety profiles in early clinical studies were highly promising and competitive with other antibody-drug conjugate drugs. We are thrilled to be a part of this development […]
Mirati Therapeutics & SCRI announce strategic, community site focused partnership
“The opportunity to partner with SCRI enables Mirati to advance diversity in our clinical studies, which is a key pillar of our Diversity, Equity, and Inclusion efforts. We are excited about the opportunity to leverage the expertise and scale of SCRI as we collaborate on a range of initiatives aimed at improving health outcomes for […]
First Patient Dosed in Ph 1/2 Clinical Trial of STX-478, Its Mutant-Selective PI3Kα Inhibitor for the Treatment of Breast Cancer and Other Solid Tumors
“We are excited to begin clinical evaluation of STX-478, our mutant-selective PI3Kα inhibitor with a potentially best-in-class profile, for the treatment of HR+/HER2- breast cancer and a wide array of other solid tumors,” said Axel Hoos, M.D., Ph.D, Chief Executive Officer of Scorpion. “The initiation of this clinical trial in just three years after our […]
ELAHERE® Demonstrates OS Benefit in the Ph 3 MIRASOL Trial in Patients with FRα-Positive Platinum-Resistant Ovarian Cancer
“I believe the data from the confirmatory MIRASOL trial are practice-changing. They demonstrate ELAHERE’s superiority to chemotherapy based on all efficacy endpoints, in particular overall survival, and build on the clinical benefit of ELAHERE previously reported in the SORAYA trial,” said Kathleen Moore, Associate Director of Clinical Research and Director of the Oklahoma TSET/Sarah Cannon […]
Updated Results from ORIENT-31 Study of Sintilimab + Chemo +/- Bevacizumab in Patients with EGFR-TKI failed EGFR-mutated nsqNSCLC announced
Dr. Hui Zhou, Senior Vice President of Innovent, stated, “the ORIENT-31 study is the first Phase 3 study that met primary endpoints in the world evaluating efficacy of PD-1 inhibitor and chemotherapy with or without bevacizumab in patients with EGFR mutated non-squamous NSCLC that progressed on prior EGFR-TKI therapy. The results of first and second […]
TRANSCEND FL and TRANSCEND NHL 001 Studies of Breyanzi (lisocabtagene maraleucel) in R/R FL and MCL Meet Primary Endpoint of ORR
“For people living with relapsed or refractory follicular lymphoma or mantle cell lymphoma, there are limited treatment options that provide deep and durable responses, especially for patients with high-risk disease,” said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb. “These continued unmet needs coupled with our deep understanding of lymphoma […]
First Results from Ph 2 SunRISe-1 Study of TAR-200 and Cetrelimab in Patients with BCG-Unresponsive NMIBC announced
“We continue to see significant unmet need among high-risk patients with non-muscle invasive bladder cancer, who often experience negative outcomes and poor quality of life with existing standard of care treatments, such as radical cystectomy,” said Siamak Daneshmand* , M.D., Professor of Urology, Director of Urologic Oncology at the Norris Comprehensive Cancer Center, Keck School […]
Interim Clinical Data from Ongoing Phase 1b Cohort A Monotherapy with ACTengine® IMA203 TCR-T Targeting PRAME announced
“The treatment of solid cancer patients who have exhausted all available standard of care options remains a significant challenge. These patients typically show fast progressing disease with very poor prognosis,” said Martin Wermke, MD, Coordinating Investigator of the ACTengine® IMA203 TCR-T trial. “It is therefore very encouraging to see that IMA203 is able to provide […]
Early Positive IMX-110 Interim Data Demonstrating 100% Tumor Shrinkage in Advanced mCRC at the Lowest Dose of IMX-110 + Tislelizumab announced
“We are excited to see 100% tumor shrinkage in the very first cohort at the lowest dose of IMX-110 in combination with anti-PD-1 antibody tislelizumab in our ongoing IMMINENT-01 dose escalation trial, especially in patients with advanced colorectal cancer, who have limited treatment options,” said Ilya Rachman, MD PhD, CEO of ImmixBio. “These initial results […]
Positive Early Results from Global Randomized Ph 1b/2 Combination Study of TPST-1120 in 1L HCC announced
“These randomized data in first-line HCC are exciting and support the promise of TPST-1120 as an active small molecule for patients,” said Stephen Brady, chief executive officer of Tempest. “HCC is a common and aggressive cancer where significant unmet need remains to improve care in the first line and beyond. We believe the improvements shown […]
Positive Preliminary Data announced from ADVANCED-1 Ph 1a Dose Escalation Trial of TARA-002 in NMIBC Supporting Advancement into Ph 2 Clinical Development
“These promising results suggest TARA-002 may provide meaningful benefit to patients with NMIBC, who currently have limited treatment options,” said Neal Shore, M.D., Medical Director, Carolina Urologic Research Center, Chief Medical Officer, GenesisCare US, and study investigator. “These data show favorable tolerability and initial evidence of anti-tumor activity, thus serving as an impetus to advance […]
Positive Pivotal Ph 3 SIERRA Trial Results of Iomab-B Announced
Dr. Avinash Desai, Actinium’s Chief Medical Officer, commented, “Throughout the SIERRA trial, Actinium had a great partnership approach with BMT clinical trial sites, which has provided us with valuable insights for the potential commercial adoption and utilization of Iomab-B. Through our education efforts and shielding solutions, we have optimized administration of Iomab-B across a wide […]
CHMP recommends EU approval of Roche’s fixed-duration Columvi (glofitamab) for people with R/R DLBCL
“New therapeutic options that are readily and broadly available are urgently needed for people with relapsing diffuse large B-cell lymphoma, which can become fatal without immediate treatment,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The CHMP’s recommendation for Columvi brings us closer to providing a new, fixed-duration […]
POINT Biopharma Announce FDA Grants Fast Track Designation for 177Lu-PNT2002 for the Treatment of mCRPC
“Fast track designation by the FDA is an important milestone and recognizes the potential for 177Lu-PNT2002 to address the significant unmet need for mCRPC patients,” said Jean-Claude Provost, M.D., Chief Medical Officer at Lantheus. “We are encouraged by the FDA’s decision as it reflects the need for FDA approved and widely available treatments for these […]
FDA grants Orphan Drug Designation for INB-400/410 for the Treatment of Newly Diagnosed Glioblastoma
“Our goal is to achieve our Mission of Cancer Zero by eradicating cancer cells and improving patient outcomes,” said IN8bio CEO and co-founder, William Ho. “Our novel approach combines engineered, chemo-resistant gamma-delta T cells with standard-of-care treatments to amplify immune signals, maximize tumor killing, and eliminate more cancer cells. We eagerly anticipate enrolling our first […]
Type A Meeting Request submitted to FDA to Review Proposed Study Design for a Second Ph 3 Study Evaluating HyBryte™ in the Treatment of Cutaneous T-Cell Lymphoma
“During the Type A meeting in April, FDA expressed its understanding of the need for additional therapies in CTCL and its willingness to work with Soligenix. FDA provided significant insights into its thoughts on a clinical study design allowing our team to prepare a comprehensive proposal expeditiously,” stated Christopher J. Schaber, PhD, President and Chief […]
Positive Interim Ph 2 Data for Darovasertib + Crizotinib Combination and Successful FDA Type C Meeting on Registrational Trial Design for Accelerated Approval in First-Line Metastatic Uveal Melanoma announced
“The observed efficacy in first-line metastatic uveal melanoma patients – including confirmed ORR of 45% and median PFS of ~ 7 months – is clinically significant and represents a potential paradigm shift for treating MUM patients. The interim data for the darovasertib and crizotinib combination treatment in MUM suggests a compelling clinical efficacy and tolerability […]
EMA Validates MAA for Jemperli (dostarlimab) + Chemo for the Treatment of dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer
Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK said: “New treatment options are urgently needed for patients with primary advanced or recurrent endometrial cancer. With this initial filing, we are accelerating the submission of a potential new indication for dostarlimab in the patient population that demonstrated the strongest treatment effect in the […]
Update on FDA Advisory Committee vote on Lynparza plus abiraterone for mCRPC
Neal Shore, Chief Medical Officer of Urology and Surgical Oncology for Genesis Care, US and PROpel trial investigator, said: “Today’s recommendation by the ODAC is disappointing news for clinicians and prostate cancer patients alike. Preventing or delaying radiographic progression is an important clinical endpoint in assessing oncologic treatment and is very relevant to patients, their […]
EU approves Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy
“With Breyanzi, people in Europe living with relapsed or refractory DLBCL now have a differentiated CAR T cell therapy option earlier in the treatment paradigm that provides long-term clinical benefit,” said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb. “This marks the approval of our third indication in Europe for […]
BRUKINSA approved for first-line treatment for CLL/SLL and WM in China
“CLL/SLL and WM patients are predominantly populated in the elderly, and there are increasing needs for improved efficacy and safety in CLL/SLL and WM treatments,” said Professor Ma Jun, Director of the Harbin Institute of Hematology & Oncology, Chief Supervisor of Supervisory Committee at the Chinese Society of Clinical Oncology. “BRUKINSA has been recommended as […]
European Commission granted approval to AKEEGA® (Niraparib & Abiraterone Dual Action Tablet) for the Treatment of Patients with mCRPC with BRCA1/2 Mutations
“Metastatic castration-resistant prostate cancer remains a lethal disease, with high unmet needs in terms of treatment options, particularly for patients with BRCA1/2 gene mutations,” said Professor Gerhardt Attard, Oncologist, University College London (UCL), London, UK*. “We’ve seen that in these patients, niraparib combined with abiraterone acetate and predniso(lo)ne (AAP) significantly reduced the risk of disease […]
CONFERENCE COVERAGE: American Association for Cancer Research (AACR) Annual Meeting 2023
Coeptis Therapeutics Signs Agreement to Acquire Allogeneic Immuno-Oncology NK Platform in Phase 1 Clinical Trials from Deverra Therapeutics
“This transaction would greatly expand Coeptis’ technology portfolio by incorporation of a cutting-edge allogeneic cell therapy platform with extensive safety and clinical data and align itself with leading experts in the field of cell and gene therapy,” said Dave Mehalick, President and CEO of Coeptis Therapeutics. Mr. Mehalick continued, “The addition of these clinical and […]
Tubulis Announces Strategic License Agreement with Bristol Myers Squibb to Develop Next Generation ADCs for the Treatment of Cancer Patients
“This strategic agreement with Bristol Myers Squibb is an important validation of the potential of our approach in developing next-generation ADC-based therapeutics and our cutting-edge ADC conjugation technologies that accommodate advanced ADC design to tackle tumors with high-unmet medical need,” said Dominik Schumacher, PhD, CEO and co-founder of Tubulis. “We are committed to transforming oncology […]
