Orphan Drug Designation Granted by the U.S. FDA to Nana-val for the Treatment of Nasopharyngeal Carcinoma
“This orphan drug designation highlights the urgent need for new targeted treatment options for patients with rare diseases such as nasopharyngeal carcinoma, which is highly associated with EBV,” said Mark Rothera, President and Chief Executive Officer of Viracta. “We are encouraged by the interim data from the Phase 1b/2 study of Nana-val in patients with […]
FDA grants priority review for tarlatamab in SCLC
“The FDA’s Priority Review designation for this application underscores the urgency to provide new treatment options for patients with advanced SCLC who have progressed following treatment with platinum-based chemotherapy,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “While first-line treatments often show strong responses, patients can experience aggressive recurrences […]
FDA Approves WELIREG® (belzutifan) for the Treatment of Patients With Advanced Renal Cell Carcinoma (RCC) Following a PD-1 or PD-L1 Inhibitor and a VEGF-TKI
“Despite recent progress in the treatment of advanced RCC, there is yet to be an option specifically approved for patients whose disease progresses following a PD-1 or PD-L1 inhibitor and a TKI therapy,” said Dr. Toni K. Choueiri, LITESPARK-005 study chair, director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Jerome and Nancy Kohlberg […]
FDA Approves Expanded Indication for KEYTRUDA Plus Padcev for 1L Treatment of Adult Patients With Locally Advanced or Metastatic Urothelial Cancer
“Advanced bladder cancer is a common cause of cancer-related death,” said Dr. Thomas Powles, primary investigator of KEYNOTE-A39, professor of Genitourinary Oncology and director, Barts Cancer Center. “The overall survival benefit seen in the KEYNOTE-A39 trial demonstrates the potential for KEYTRUDA in combination with enfortumab vedotin to impact the first-line treatment of patients with locally […]
Foundation Medicine
Foundation Medicine stands as an early innovator, harnessing genomics technologies for scalable, high-throughput cancer gene mutation profiling-based diagnoses. Established in 2010 in Cambridge, Massachusetts, the company’s first product, FoundationOne, was launched in 2012 as a tissue-based test. This was followed by FoundationOne Heme in 2013, an NGS based comprehensive genome profiling test catering to hematologic […]
IDEAYA Announces Clinical Study Collaboration with Gilead Sciences to Evaluate Trodelvy® and IDE397 Combination in MTAP-Deletion Bladder Cancer
“We are delighted to enter into this clinical collaboration with Gilead that advances our multi-pronged strategy designed to deliver maximal benefit to MTAP-deletion solid tumor patients. We believe the strong mechanistic rationale of this combination, and the monotherapy efficacy observed by both agents in MTAP-deletion bladder cancer, may enable this combination to be differentiated and […]
Exelixis and Arcus Biosciences Announce Clinical Trial Collaboration to Evaluate Zanzalintinib in Combination with AB521 in Patients with Advanced RCC
“We are excited to learn more about the potential effects of zanzalintinib plus Arcus’ HIF-2⍺ inhibitor, as these two molecules approach the inhibition of cancer cell proliferation and tumor angiogenesis from differing angles, and combination therapy may provide better outcomes than either therapy alone,” said Amy Peterson, M.D., Executive Vice President, Product Development & Medical […]
HiberCell and Merck to Evaluate HC-7366 in Combination with WELIREG (belzutifan) in a Phase 1b Study of Patients with Clear Cell Renal Cell Carcinoma (ccRCC)
“We are excited to collaborate with Merck to evaluate HC-7366 in combination with belzutifan,” said Jonathan Lanfear, President & CEO of HiberCell. “We are also excited to announce that one of the scientific leaders within the RCC space, Dr. Robert Motzer, will be our lead PI for this important trial. We expect this study to […]
ONK Therapeutics and NAYA Biosciences Announce Research Partnership to Advance Combination Therapy of Optimally Engineered Off-the-Shelf Natural Killer Cell Therapies and FLEX-NK Bispecific Antibodies
“We are impressed with the data ONK has generated using its differentiated editing of NK cells, which may further enhance the efficacy of our FLEX-NK™ bispecific antibodies,” commented NAYA’s CEO Dr. Daniel Teper. “The future development of this combination therapy alongside our monotherapy clinical trials will help expand patient options and narrow the gap towards […]
NiKang Therapeutics Enters into Clinical Trial Collaboration and Supply Agreement to Evaluate NKT2152 in Combination with Standard-of-Care in 1L Advanced HCC
“We are thrilled to enter this collaboration with Roche, which allows us to explore the broader potential of our HIF2α inhibitor NKT2152 in treating solid tumors beyond clear cell Renal Cell Carcinoma (ccRCC),” said Zhenhai Gao, Ph.D., co-founder, president, and CEO of NiKang. “Based on the compelling scientific rationale and supporting preclinical studies, we have […]
Kite and Arcellx Announce Expansion in Strategic Partnership
“We are pleased to see the momentum with the CART-ddBCMA multiple myeloma program, enabling Kite to enter an area of high unmet need and bring a new, potentially best-in-class cell therapy to patients,” said Cindy Perettie, Executive Vice President of Kite. “Given this, we are deepening our relationship with Arcellx to further support advancement of […]
Myricx Bio Enters into an Exclusive Antibody License Agreement with WuXi Biologics
Myricx CEO Dr Robin Carr said, “We are delighted to have reached this agreement with WuXi Bio, one of the top biologics CRDMOs globally. We believe that combining this leading antibody with our novel NMTi-based payload will create an ADC with significant clinical differentiation in solid tumours. Based on our positive preclinical data we believe […]
Boehringer Ingelheim expands immuno-oncology portfolio with the acquisition of bacterial cancer therapy specialist T3 Pharma
“The acquisition of T3 Pharma will significantly expand our immuno-oncology pipeline portfolio and is synergistic with many of our existing R&D programs. This will bring us closer to achieving our vision of driving a paradigm shift in cancer care treatments,” said Michel Pairet, Member of the Board of Managing Directors at Boehringer Ingelheim with responsibility […]
AbbVie to Acquire ImmunoGen, including its Flagship Cancer Therapy ELAHERE® (mirvetuximab soravtansine-gynx), Expanding Solid Tumor Portfolio
“The acquisition of ImmunoGen demonstrates our commitment to deliver on our long-term growth strategy and enables AbbVie to further diversify our oncology pipeline across solid tumors and hematologic malignancies,” said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. “Together, AbbVie and ImmunoGen have the potential to transform the standard of care for people living […]
Ionetix to provide Bayer with Therapeutic Radioisotope Actinium-225 (Ac-225)
“We recognized the emerging demand and made the early investment to develop a commercial-scale production solution for Ac-225 using our expertise in cyclotron accelerator and target technology,” said David Eve, VP of Medical Affairs for Ionetix Corporation. Located in Lansing, Michigan, Ionetix has established a new isotope production facility that is dedicated to manufacturing alpha-emitters. […]
Ankyra Therapeutics Announces Clinical Trial Supply Agreement with Regeneron to Evaluate ANK-101 in Combination with Libtayo® (cemiplimab) in Patients with Cutaneous Squamous Cell Carcinoma
“We are excited to expand our clinical collaborations to evaluate the combination of ANK-101 with cemiplimab in cutaneous squamous cell carcinoma (CSCC),” said Dr. Joe Elassal, Chief Medical Officer at Ankyra. “Cemiplimab has been a major step forward for patients with advanced CSCC and we believe that this is a tumor where combination therapeutic effects […]
Myricx Bio Enters into an Exclusive Antibody License Agreement with WuXi Biologics
Myricx CEO Dr Robin Carr said, “We are delighted to have reached this agreement with WuXi Bio, one of the top biologics CRDMOs globally. We believe that combining this leading antibody with our novel NMTi-based payload will create an ADC with significant clinical differentiation in solid tumours. Based on our positive preclinical data we believe […]
Evotec and Dewpoint Therapeutics Enter Strategic Partnership in Oncology
Dr. Matthias Evers, Chief Business Officer of Evotec, commented, “We are excited to enter this strategic development partnership with Dewpoint. Their innovative approach is based on a holistic understanding, which can significantly expand the target space across indications. By combining our complementary expertise, Evotec’s development platform will serve as the capital-efficient IND engine for this […]
Jazz Pharmaceuticals and MD Anderson Announce Five-Year Collaboration to Evaluate Zanidatamab in HER2-Expressing Cancers
“Current data indicates that zanidatamab has anti-tumor activity in multiple HER2-positive solid tumors, including positive results from a pivotal clinical trial for patients with HER2-amplified biliary tract cancers,” said Funda Meric-Bernstam, M.D., chair of Investigational Cancer Therapeutics at MD Anderson. “We are pleased to extend our research efforts with Jazz through this new collaboration, which […]
Menarini Group and SciClone Pharmaceuticals Announce Exclusive Sub-Licensing Collaboration to Develop and Commercialize ORSERDU® (Elacestrant) in China to Address Advanced or Metastatic Breast Cancer
“China accounts for 20% of breast cancer prevalence worldwide,¹ and we know that these patients need new therapeutic options, particularly in the metastatic setting,” said Zhao Hong, Executive Director, President and CEO of SciClone. “We believe that this agreement will enable us to work toward providing oncologists with an important option in the treatment armamentarium […]
Orum Therapeutics Announces Acquisition of ORM-6151 Program by Bristol Myers Squibb
“We believe this agreement with Bristol Myers Squibb, a global leader in cancer with a strong legacy in protein degradation, validates Orum’s unique Dual-Precision Targeted Protein Degradation approach, which we pioneered to improve the therapeutic window and realize the full potential of targeted protein degraders through precision delivery to cancer cells via antibody drug conjugates,” […]
Kite And Arcellx Announce Expansion In Strategic Partnership
“We are pleased to see the momentum with the CART-ddBCMA multiple myeloma program, enabling Kite to enter an area of high unmet need and bring a new, potentially best-in-class cell therapy to patients,” said Cindy Perettie, Executive Vice President of Kite. “Given this, we are deepening our relationship with Arcellx to further support advancement of […]
Astellas to Acquire Propella Therapeutics
Naoki Okamura, President and CEO, Astellas said “The acquisition fits with Astellas’ strategy to provide patients with therapeutic options for diseases with high unmet medical needs. Propella has a promising program, PRL-02, targeting prostate cancer. We believe that the synergy with Astellas’ global development and commercialization capabilities in the cancer and urology fields will accelerate […]
BeiGene and Ensem Therapeutics Announce Partnership to Advance Differentiated CDK2 Inhibitor
“We are committed to developing novel molecules with the potential to transform the therapeutic landscape for cancer patients, and this partnership fits well with our strategic focus on breast cancer as an area with tremendous unmet need for innovative treatment options,” said Lai Wang, Ph.D., Global Head of R&D at BeiGene. “This CDK2 inhibitor from […]
First Patient Enrolled in Phase 2 Clinical Study Evaluating BDC-1001 in Patients with HER2-Positive Breast Cancer Previously Treated with Enhertu
“The dosing of the first patient in this trial is a significant achievement in our efforts to find new treatment options for patients with HER2-positive breast cancer that continues to progress after treatment,” said Kang, a principal investigator on the study. “Despite the numerous HER2-targeted therapeutics approved for treating advanced or metastatic HER2-positive breast cancer, […]
STELLAR-305 Phase 2/3 Pivotal Trial of Zanzalintinib + Pembrolizumab in Patients with Previously Untreated Recurrent or Metastatic Head and Neck Cancer announced
“We are excited to progress zanzalintinib, our next-generation multi-targeted tyrosine kinase inhibitor, into this population of patients who otherwise are relegated to immunotherapy plus chemotherapy, but may benefit from a chemo-free option,” said Amy Peterson, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. “This study is based on encouraging […]
Application submitted to the EMA for RYBREVANT + Chemo for the Treatment of Adult Patients with Advanced EGFR-Mutated NSCLC After Failure of Prior Therapy
“Patients with EGFR-mutated advanced non-small-cell lung cancer treated with osimertinib inevitably develop resistance mechanisms and are faced with poor outcomes on platinumbased chemotherapy alone,” said Catherine Taylor, Vice President, EMEA Medical Affairs, Therapy Area Strategy, Janssen-Cilag AG. “Amivantamab is active against a wide range of EGFR and MET alterations, which are key mechanisms of resistance […]
Registrational Phase III CLARIFY trial in prostate cancer commences
Clarity’s Executive Chairman, Dr Alan Taylor, commented, “The prostate cancer market is a key focus area for Clarity as there is a high unmet need for diagnostics and therapy, and we believe our theranostic SAR-bisPSMA product has the potential to improve diagnosis, therapy and ultimately change patients’ lives. We look forward to progressing this trial […]
Patient Enrollment of Phase 3 ECLIPSE Trial Ahead of Schedule Completed
Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium said: “We are proud to announce the completion of enrollment in the ECLIPSE trial, and would like to thank the patients, trial investigators, clinical research partners, and our Curium cross-functional teams for their dedication and commitment. We are looking forward to delivering the study results once […]
First Patient Dosed in the Phase 1a Clinical Trial of QN-302 for Treatment of Advanced or Metastatic Solid Tumors
“The initiation of the QN-302 Phase 1a clinical trial represents a significant milestone for Qualigen and further progress toward our goal to offer patients new treatment options for devastating diseases, such as pancreatic cancer and other advanced solid tumors,” commented Tariq Arshad, M.D., M.B.A., Qualigen’s Chief Medical Officer. “We are grateful for the support of […]
