FDA Accepts the PMA Application for TTFields Therapy in NSCLC
“We are thrilled to announce the FDA has accepted our PMA application for review of the LUNAR data in NSCLC,” said Asaf Danziger, Novocure’s Chief Executive Officer. “This significant milestone brings us one step closer to treating patients seeking treatment for NSCLC, post-platinum, for which very few effective non-toxic options exist today. I would like […]
European Commission approves Tecentriq SC, the EU’s first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types
“We are pleased to introduce the first subcutaneous PD-L1 cancer immunotherapy in Europe,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Giving Tecentriq subcutaneously provides more flexibility to patients, while also helping to free up resources in constrained healthcare systems.”
Boehringer Ingelheim and 3T Biosciences signed a second T-cell focused collaboration
“At Boehringer Ingelheim, we are committed to transforming patients’ lives. The initial success of our work with 3T gives us confidence that together we can and will expand and accelerate our pipeline of first-in-class T-cell based anti-cancer therapies,” said Lamine Mbow, Ph.D., Global Head of Cancer Immunology and Immune Modulation, Boehringer Ingelheim.
AbbVie and Umoja Biopharma Announce Strategic Collaboration to Develop Novel In-Situ CAR-T Cell Therapies
“As we continue to strengthen our oncology portfolio, we believe that in-situ CAR-T cell therapy represents a paradigm shift utilizing genetic medicine concepts,” said Jonathon Sedgwick, Ph.D., vice president and global head of discovery research at AbbVie. “We look forward to working with Umoja’s team to advance next-generation in-situ CAR-T therapies, and potentially expand the […]
BioInvent regains rights to immuno-oncology targets from Exelixis
“We have appreciated the excellent partnership with Exelixis which has identified very interesting new pathways,” said Dr. Martin Welschof, CEO of BioInvent. “These novel targets, generated from our proprietary F.I.R.S.T™ platform, formed the basis for generation of unique antibodies for immuno-oncology therapy. BioInvent has a long track record of successful collaborations and the positive progress […]
Merck to Acquire Harpoon Therapeutics
“At Merck, we continue to enhance our oncology pipeline through strategic acquisitions that complement our current portfolio and advance breakthrough science to help address the needs of people with cancer worldwide,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “This agreement reflects the creativity and commitment of scientists and clinical development teams at Harpoon. […]
Last Patient Enrolled in Phase 3 TRIDENT Trial in Newly Diagnosed Glioblastoma
“TTFields therapy has played a critical role in the treatment of newly diagnosed glioblastoma for nearly a decade, and the TRIDENT trial represents the potential evolution of this treatment paradigm by introducing TTFields earlier, at the same time as radiation therapy and temozolomide,” said Asaf Danziger, Novocure’s Chief Executive Officer. “Preclinical research has shown that […]
Enrollment opens for Phase 1b/2 Study Evaluating Ampligen® (rintatolimod) in Combination with Imfinzi® (durvalumab) for the Treatment of Pancreatic Cancer
Prof. Casper H.J. van Eijck, MD, PhD, the DURIPANC Study’s Coordinating Investigator and a pancreato-biliary surgeon at Erasmus MC, stated, “While immune checkpoint inhibitors targeting PD1/PDL1 have shown promise in other solid tumors, they have shown limited efficacy thus far in ductal cancer of the pancreas. Findings from our previous study collectively provide compelling evidence […]
First Dose Cohort in Phase 1 Clinical Trial Evaluating BP1002 to Treat R/R Lymphoma and Refractory/Relapsed CLL Patients completed
“We are delighted to safely complete this first dose cohort and to advance BP1002 into the next cohort as it brings us one step closer to providing access to this very promising treatment for the most vulnerable patients who have limited therapeutic options,” said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. “We […]
First Patients Treated with IDP-023 Allogeneic Natural Killer (NK) Cell Therapy for Cancer
“We are excited to transition to a clinical stage company,” said Dr. Mark Frohlich, CEO of Indapta. “Based on the encouraging clinical activity of NK cells demonstrated by others and the superior activity of IDP-023 compared to conventional NK cells in preclinical models, we are looking forward to evaluating the safety and clinical activity of […]
Clinical Response Update on AFM24-102 Trial in EGFR-wildtype Non-Small Cell Lung Cancer Provided
“We are encouraged by the responses in these patients who had all progressed on PD1 targeting therapy and made the strategic decision to expand this patient cohort,” said Dr. Andreas Harstrick, CMO and interim Chief Executive Officer of Affimed. “There is a significant unmet need for these patients who have exhausted all previous lines of […]
TIVDAK® sBLA Accepted for Priority Review by FDA for Patients with Recurrent or Metastatic Cervical Cancer
“The Phase 3 innovaTV 301 trial demonstrated a favorable benefit/risk profile, including improvement in overall survival, and adds to the overall data supporting TIVDAK as a treatment option for people with recurrent and metastatic cervical cancer who have limited treatment options,” said Roger Dansey, M.D., Chief Development Officer, Oncology at Pfizer. “The FDA acceptance of […]
Update on Zolbetuximab Biologics License Application in U.S.: FDA rejects the application
Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Senior Vice President and Head of Immuno-Oncology Development, Astellas said, “We remain confident in zolbetuximab’s clinical profile and potential to fill a significant therapeutic gap for those diagnosed with advanced gastric or GEJ cancer whose tumors are CLDN18.2 positive. Astellas is committed to working with the FDA and the third-party manufacturer […]
FDA Fast Track Designation for SLS009 for Treatment of Relapsed/Refractory Acute Myeloid Leukemia
“Receiving Fast Track Designation for SLS009 for r/r AML, following the recent Orphan Drug Designation for the same indication, underscores the potential for SLS009 and highlights the critical unmet need for patients with AML who face a poor prognosis due to the progressive nature of the disease,” said Angelos Stergiou, MD, ScD h.c., President and […]
ANDA for Generic LUTATHERA® (Lutetium Lu 177 Dotatate) announced
“Based on the most recent update to the FDA’s online paragraph IV database listings,1 Lantheus believes it is the first applicant to have filed a substantially complete ANDA for Lutetium Lu 177 Dotatate containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Should its ANDA be approved by the FDA, Lantheus believes […]
RC88 Obtained FDA Fast Track Designation
Reflecting on this process, Dr. Jianmin Fang, CEO of RemeGen, said, “The FDA’s FTD accelerates the development and review process of RC88, which affirms our commitment to pioneering treatments that address the urgent needs of those facing challenging disease. Moving forward, RemeGen will continue to accelerate the development of its ADC products, with the aim […]
European Commission Approves KRAZATI (adagrasib) for Patients with Advanced NSCLC with a KRASG12C Mutation
“KRAZATI offers an efficacious and tolerable therapeutic option for patients living with advanced KRASG12C -mutated NSCLC and this approval expands the potential treatment options available,” Martin Reck, MD, PhD, Lung Clinic Grosshansdorf, Germany. “With it’s differentiated profile, KRAZATI offers an impactful treatment option for patients living with lung cancer. This approval will assist physicians in […]
FDA Approves KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer
“Today’s approval of KEYTRUDA plus chemoradiotherapy is welcome news and gives patients with newly diagnosed FIGO 2014 Stage III-IVA cervical cancer, for the first time ever, the option of an anti-PD-1-based regimen to treat their cancer,” said Dr. Bradley Monk, oncologist and professor of obstetrics and gynecology at University of Arizona’s College of Medicine and […]
Boehringer Ingelheim And 3T Biosciences Enter Into A Second Partnership To Develop Next-Generation Cancer Immunotherapies
“At Boehringer Ingelheim, we are committed to transforming patients’ lives. The initial success of our work with 3T gives us confidence that together we can and will expand and accelerate our pipeline of first-in-class T-cell based anti-cancer therapies,” said Lamine Mbow, Ph.D., Global Head of Cancer Immunology and Immune Modulation, Boehringer Ingelheim.
Orion and MSD Announce Initiation of Two Phase 3 Trials Evaluating ODM-208/MK5684 in Certain Patients with Metastatic Castration-Resistant Prostate Cancer
“The start of our co-development Phase 3 program with MSD provides exciting opportunities to evaluate the potential of ODM-208/MK5684 as a novel treatment of mCRPC, both in front-line and late-line patients, including those with and without androgen receptor ligand binding domain (AR LBD) mutations,” said Professor Outi Vaarala, Senior Vice President, Innovative Medicines and Research […]
Nuvectis Pharma, Inc. Announces a Collaboration with Mayo Clinic to Evaluate NXP800 in an Investigator-Sponsored Clinical Trial in Cholangiocarcinoma
“We are honored to announce this collaboration with Mayo Clinic,” said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. “Similar to platinum resistant, ARID1a-mutated ovarian cancer, this clinical development program in cholangiocarcinoma represents another opportunity for NXP800 in a serious condition of unmet medical need and we are very hopeful that the robust activity […]
Innate Pharma Announces Licensing Of A Fourth Natural Killer Cell Engager In Oncology To Sanofi
Eric Vivier, Ph.D., DVM, PhD, Senior Vice President, Chief Scientific Officer of Innate Pharma, said: “We have been collaborating with Sanofi since 2016 and together we have made significant progress in advancing multi-specific NK Cell Engagers for the treatment of various cancers with two programs now in the clinic. Building on our partnership with Sanofi, […]
GSK enters exclusive license agreement with Hansoh for HS-20093
Hesham Abdullah, SVP, Global Head Oncology, R&D, GSK, said: “B7-H3 is highly expressed in a broad range of solid tumours where there remains a significant need for novel treatment options. We look forward to progressing this potential new treatment across several indications and in future potential combination approaches with our established portfolio.”
Verastem Oncology Selects Oral KRAS G12D Inhibitor GFH375/VS-7375 as Lead Program in Discovery and Development Collaboration with GenFleet Therapeutics
“We are pleased to announce this oral KRAS G12D inhibitor with a potential best-in-class profile as the lead program from our collaboration with GenFleet supporting our mission to bring needed therapies to patients with RAS pathway-driven cancers,” said Dan Paterson, President and Chief Executive Officer of Verastem Oncology. “Although there has been significant progress in […]
Bristol Myers Squibb Adds Premier Radiopharmaceutical Platform with Acquisition of RayzeBio
“This transaction enhances our increasingly diversified oncology portfolio by bringing a differentiated platform and pipeline, and further strengthens our growth opportunities in the back half of the decade and beyond,” said Christopher Boerner, Ph.D., Chief Executive Officer of Bristol Myers Squibb. “Radiopharmaceutical therapeutics are already transforming cancer care, and RayzeBio is at the forefront of […]
AstraZeneca to acquire Gracell, furthering cell therapy ambition across oncology and autoimmune diseases
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “The proposed acquisition of Gracell will complement AstraZeneca’s existing capabilities and previous investments in cell therapy, where we have established our presence in CAR-T and T-cell receptor therapies (TCR-Ts) in solid tumours. GC012F will accelerate our cell therapy strategy in haematology, with the opportunity to bring […]
Ambrx Announces Sale to Johnson & Johnson
“We are excited to reach this agreement with Johnson & Johnson for advancing scientific research to treat cancers with high unmet needs,” said Daniel J. O’Connor, Chief Executive Officer of Ambrx. “With our deep and unique knowledge of precision engineering of protein therapeutics enabled by our proprietary technology incorporating synthetic amino acids in living cells, […]
Merck to Acquire Harpoon Therapeutics, including HPN328 in certain patients with small cell lung cancer and neuroendocrine tumors
“At Merck, we continue to enhance our oncology pipeline through strategic acquisitions that complement our current portfolio and advance breakthrough science to help address the needs of people with cancer worldwide,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “This agreement reflects the creativity and commitment of scientists and clinical development teams at Harpoon. […]
Avenzo Therapeutics Announces Global License Of AVZO-021 (ARTS-021), A Clinical Stage CDK2 Inhibitor From Allorion Therapeutics
“With this agreement, we have laid the foundation for our potentially best-in-class oncology pipeline,” said Athena Countouriotis, M.D., co-founder, president and CEO of Avenzo. “Patients with HR+/HER2- metastatic breast cancer continue to have limited therapeutic options, and we believe AVZO-021 may provide patients with a new treatment option both as a single agent and in […]
ImmunityBio Announces $320 Million Investment by Oberland Capital, with $210 Million Funded at Closing, Bringing Total Financing in 2023 to $850 Million
“This transaction raises significant capital for the Company to support important growth plans, yet with limited equity dilution and with a cap on total payments tied to the initial investment,” said Richard Adcock, Chief Executive Officer and President of ImmunityBio. “Besides providing a capital source at a key inflection point for ImmunityBio, this investment demonstrates […]
