Update provided on US Regulatory Review of LYNPARZA + Abiraterone in mCRPC patients
“FDA will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss the supplemental new drug application (sNDA) for use of LYNPARZA in combination with abiraterone and prednisone or prednisolone (abi/pred) for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). The ODAC provides the FDA with independent, expert advice and […]
Nubeqa™ (darolutamide) receives EU approval in mHSPC based on Ph 3 ARASENS trial data
“Today’s approval of Nubeqa represents a significant milestone in addressing unmet medical needs for people living with metastatic hormone-sensitive prostate cancer in Europe,” said Christine Roth, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of the Oncology Strategic Business Unit. “We are committed to improving prostate cancer care across all stages of […]
AstraZeneca enters license agreement with KYM Biosciences for CMG901, a Claudin-18.2 antibody drug conjugate
Puja Sapra, Senior Vice President, Biologics Engineering & Oncology Targeted Delivery, Oncology R&D, AstraZeneca, said, “We are excited by the opportunity to accelerate the development of CMG901, a potential new medicine for patients with Claudin18.2-expressing cancers. CMG901 strengthens our growing pipeline of antibody drug conjugates and supports our ambition to expand treatment options and transform […]
Blueprint Medicines to Regain Global Rights to GAVRETO® (pralsetinib) from Roche
“At Blueprint Medicines, we are dedicated to driving innovation and changing outcomes for patients with lung cancer. GAVRETO is an important treatment option for patients with RET fusion-positive lung cancer and other RET-altered cancers, and we are committed to ensuring that patients being treated with GAVRETO in the commercial and clinical trial settings continue to […]
MEI Pharma and Infinity Pharmaceuticals Announce Definitive Merger Agreement to Advance Three Promising Clinical Oncology Candidates
“We are very excited to enter into this agreement with Infinity given the strength of a combined organization that builds on each company’s potential. The combined organization will have three differentiated clinical-stage oncology assets, expected funding into mid-2025 to reach clinical data in all three programs, and a team with extensive oncology clinical development expertise. […]
Kite Completes Acquisition Of Tmunity
“Kite announced the completion of the previously announced transaction to acquire Tmunity Therapeutics (Tmunity), a clinical-stage, private biotech company focused on next-generation CAR T-therapies and technologies. The acquisition of Tmunity complements Kite’s existing in-house cell therapy research capabilities by adding additional pipeline assets, platform capabilities, and a strategic research and licensing agreement with the University […]
Kinnate Biopharma Inc. Announces Acquisition of Ownership Stake from Series A Investors of the China Joint Venture, Kinnjiu Biopharma Inc., and Initiation of Phase 1 Clinical Trial for Exarafenib (KIN-2787) in People’s Republic of China
Nima Farzan, chief executive officer, Kinnate Biopharma Inc., commented, “We believe retaining the Kinnjiu structure will enable Kinnate to continue to invest in innovation and clinical development of its kinase inhibitors in the People’s Republic of China, Hong Kong, Macau and Taiwan. We are pleased with the progress to date across our programs, including initiating […]
First Patient dosed in Ph 2 Neoadjuvant Clinical Study of (Z)-Endoxifen in Premenopausal Women with ER+/HER2- Breast Cancer
“We are excited to kick-off this important trial, a significant achievement in our development strategy,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “Approximately 78% of breast cancers are ER+ / HER2- and premenopausal women diagnosed with this disease need more effective and tolerable treatment options; specifically new treatments that do not require […]
Updated survival data from Ph 2 trial of Bria-IMT™ + retifanlimab combo in advanced metastatic breast cancer patients announced
“This is working, and it’s working well. We had high hopes going into this clinical read-out, and the survival numbers have even exceeded our expectations. With 9 of 11 women still alive, this has a material impact for the patients and their loved ones, especially since some patients may have had only weeks or months […]
Positive Full Data Results From the Pivotal Ph 3 SIERRA Trial in Patients with Active, R/R AML announced
Dr. Sergio Giralt, Deputy Head, Division of Hematologic Malignancies, Attending Physician, Adult BMT Service at Memorial Sloan Kettering Cancer Center, stated, “The SIERRA trial results are an exciting advancement for older patients with active r/r AML and will be practice changing in how we treat these patients. I am thrilled to see a high percentage […]
ESMO 2023: Ad hoc interim OS study results of ZEJULA® (niraparib) from the NORA Ph 3 study and a post hoc analysis from the Ph 3 PRIME trial of niraparib maintenance therapy to be presented
“Our data presentations at this ESMO Gynaecological Cancers Congress continue to support the clinical profile of ZEJULA ® as a maintenance monotherapy for patients in China for both first-line and recurrent ovarian cancer regardless of biomarker status,” said Rafael Amado, MD, President, Head of Global Oncology Research and Development, Zai Lab. “We remain committed to […]
Elranatamab Receives FDA and EMA Filing Acceptance with Submissions based on favorable MagnetisMM-3 trial results in patients with R/R multiple myeloma
“Today, multiple myeloma is a fatal hematologic malignancy, with a median survival of just over five years. As an off-the-shelf treatment, BCMA bispecific antibodies are heralding a new treatment paradigm that can greatly impact the lives of people with this disease.” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global […]
mRNA-4157/V940 + KEYTRUDA® combo Granted Breakthrough Therapy Designation by the FDA for Adjuvant Treatment of Patients With High-Risk Melanoma Following Complete Resection
“The FDA’s Breakthrough Designation for mRNA-4157/V940 in combination with KEYTRUDA reflects the excitement that we have for the potential promise of individualized cancer treatments,” said Stephen Hoge, M.D., Moderna’s President. “mRNA-4157/V940 in combination with KEYTRUDA provided the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial and potentially represents […]
Imfinzi plus Imjudo approved in the EU for patients with 1L HCC and mNSCLC based on significant survival benefits in HIMALAYA and POSEIDON Ph 3 trials
Bruno Sangro, MD, PhD, Director of the Liver Unit and Professor of Internal Medicine at Clínica Universidad de Navarra, and a lead investigator in the HIMALAYA Phase III trial, said: “This approval in Europe is welcome news for eligible patients with advanced liver cancer, who face a poor prognosis and are in need of well-tolerated […]
NMPA grants Tislelizumab + chemo approval for 1L use in advanced gastric or gastroesophageal junction adenocarcinoma with high PD-L1 expression
“Advanced gastric cancer remains a significant cause of cancer-related mortality in China and we are pleased that tislelizumab plus chemotherapy demonstrated a meaningful survival benefit for patients whose tumors express PD-L1 in the RATIONALE 305 study,” said Lai Wang, Ph.D., Global Head of R&D at BeiGene. “We are grateful to the patients, investigators, and experts […]
Calquence tablet formulation approved in the EU for CLL patients
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “The Calquence tablet formulation underscores our commitment to understanding the needs of the chronic lymphocytic leukaemia community and providing patient-oriented treatment solutions. Today’s approval offers physicians and patients in the EU more flexibility to determine the right treatment plan and enables more patients to potentially […]
Enhertu approved in China for patients with HER2-positive metastatic breast cancer treated with one or more prior anti-HER2-based regimens
Binghe Xu, MD, Professor and Director of the Department of Medical Oncology, Cancer Hospital and Institute Cancer Hospital, Chinese Academy of Medical Sciences, said: “This approval marks an important day for the breast cancer community in China as patients with HER2-positive metastatic breast cancer continue to need additional treatment options. Despite initial treatment, patients with […]
Fusion Pharmaceuticals To Acquire Ph 2 Program For 225Ac-PSMA I&T, A Radiopharmaceutical Targeting mCRPC
“We are pleased to announce this acquisition, which adds an ongoing Phase 2 program for a validated cancer target to our pipeline of innovative TATs,” commented Fusion Chief Executive Officer John Valliant, Ph.D. “From our inception, Fusion has recognized the potential opportunity for actinium-based therapies to address unmet needs in cancer given the power and […]
Cullinan Oncology enters into an exclusive license with Harbour BioMed for the development and commercial rights of HBM7008 (CLN-418) in the U.S.
“We are pleased to bring CLN-418, a potential first-in-class, clinical-stage bispecific immune activator, into our diversified portfolio. We believe the best approach to conditional activation of 4-1BB is by targeting B7H4, a tumor associated antigen that is highly expressed across multiple cancers and minimally overlaps with PD-L1 expression. CLN-418 is a strong strategic fit for […]
Gaia Biomedicine & TreeFrog Therapeutics announce collaboration for the expansion of allogeneic NK-like cells against solid tumors
“With 3 ongoing clinical trials, GAIA is one of the world’s most advanced cell therapy companies in the field of solid tumors. They have a very compelling allogeneic immune cell therapy strategy, which relies on GAIA-102 NK-like cells – a specific population of immune cells isolated from healthy donor blood samples that exhibit strong anti-tumor […]
Vir Biotechnology Announces Amended Collaboration Agreement with GSK
George Scangos, Ph.D., Chief Executive Officer of Vir Biotechnology, said: “Our rapid response to the COVID-19 pandemic and ability to provide an important new treatment option to millions of patients around the world was made possible through our collaboration with GSK. Together, we remain committed to sotrovimab and to continuing to build on our successful […]
Gritstone bio and the National Cancer Institute (NCI) Establish a Clinical Trial Agreement to Evaluate a Neoantigen Cell Therapy-Vaccine Combination
“We are privileged to establish this collaboration with NCI and Dr. Rosenberg, a pioneer of cancer immunotherapy and an expert in cell therapy,” said Andrew Allen, M.D., Ph.D, Co-founder, President & Chief Executive Officer of Gritstone bio. “To date, cell therapy’s success in treating blood cancers has not translated to the more common solid tumors. […]
Nexcella Enters into U.S. GMP Manufacturing Agreement to Expand Ongoing NXC-201 Ph 1b/2 Clinical Trial to the U.S.
“We are excited about our progress toward bringing NXC-201 to United States clinical sites. Securing clinical supply is a critical step in advancing NXC-201 toward a potential U.S. regulatory submission. We believe NXC-201 could become a best-in-class therapy for patients suffering from AL amyloidosis and multiple myeloma,” said Gabriel Morris, President of Nexcella.
Akamis Bio, Parker Institute for Cancer Immunotherapy and Cancer Research Institute Announce Expanded Partnership to Advance Novel Treatments for Pancreatic Cancer
“Pancreatic cancer is one of the most complex and difficult to treat cancers. The wide variety of cell types, molecular pathways, and immune resistance mechanisms involved in the development and progression of the disease make it nearly impossible to treat with a single agent,” said Robert Vonderheide, M.D., D.Phil., Director of the Abramson Cancer Center […]
MD Anderson and KKR-backed Replay form new product company Syena to pioneer first-in-class TCR NK cell therapy
“NK cells play a pivotal role in anticancer immunity and, following the successes of CAR T cell therapy and the potential for CAR NK therapies, TCR NK cells are positioned to be a next-generation agent for cancer therapy,” Rezvani said. “We believe that the TCR NK cell approach will allow targeting of a broad range […]
Wellmarker Bio Announces Clinical Trial Collaboration with MSD to evaluate WM-A1-3389 in combination with KEYTRUDA
“Under the agreement, WMBIO will sponsor the Phase 1 (or Phase 1b) clinical trial for WM-A1-3389, a novel therapeutic antibody for Non-Small Cell Lung Cancer (NSCLC) patients with low or no PD-L1 expression, in combination with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy. Some NSCLC patients with low or no PD-L1 expression have shown limited response to […]
Nectin Therapeutics and Merck to test Anti-PVR Antibody NTX1088 + KEYTRUDA® in Patients with Locally Advanced and Metastatic Solid Tumors
“We are very pleased to partner with Merck to explore the therapeutic potential of NTX1088 in combination with KEYTRUDA®. This collaboration represents an important milestone for Nectin, and a promising new therapy for cancer patients,” said Dr. Keren Paz, Chief Development Officer of Nectin Therapeutics. “Our preclinical studies have shown that PVR blockade by NTX1088, […]
Actinium Signs Cooperative Research and Development Agreement with NCI to Further Enhance Clinical & Non-clinical Development of Actimab-A for the Treatment of AML and Other Hematologic Malignancies
Sandesh Seth, Actinium’s Chairman and CEO, said, “We are incredibly honored to be collaborating with NCI and excited that they share our vision for Actimab-A’s potential for the treatment of AML and other blood cancers. The CRADA will allow Actimab-A’s broad applicability to be fully studied and developed by leading oncology network groups as well […]
Ankyra Therapeutics Announces Collaboration to Evaluate ANK-101 in Early Clinical Trials Focused on Lung Cancer
“We are delighted to enter this collaboration in our mission to bring forward new, impactful treatments for cancer,” said Howard Kaufman, M.D., president and chief executive officer. “We have designed our ANK-101 immunotherapy candidate to increase the therapeutic window of IL-12, a potent cytokine, while also aiming to ensure patient tolerability. Patients with lung cancer […]
Nodus Oncology Secures £2.4m ($2.9m) Investment
Ian Waddell, CEO of Nodus Oncology said: “Nodus is focused on developing the next wave of cancer therapeutics in the DDR space, bringing new and effective treatment options to patients. This funding will allow us to continue to accelerate our development programmes, including our PARG program, and allow us to expand our innovative portfolio. I […]
