FDA clears IND for LYL845, a TIL Product Candidate Enhanced with its Novel Epigenetic Reprogramming Technology for Solid Tumors
“Advancing LYL845 into the clinic represents steady progression of our mission to develop T-cell therapies that can outlast and eradicate solid tumors,” said Liz Homans, chief executive officer of Lyell. “Our goal is to develop LYL845 as an effective TIL therapy for patients with solid tumor cancers such as melanoma, as well as for indications […]
BLAs for for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of R/R LBCL and DLBCL submitted
“Even with existing therapies to treat these lymphomas, there is a significant medical need for alternative and accessible treatment options for patients who are unable to tolerate current treatments or whose treatments have failed,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “Together with our partner AbbVie, we believe epcoritamab has the […]
U.S. FDA Approves TECVAYLI (teclistamab-cqyv) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
“Today’s achievement, which marks an important addition to our diverse and growing oncology portfolio, strengthens our resolve to discover and develop much-needed cancer treatments for patients and physicians,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “The approval of TECVAYLI, which demonstrated an overall response rate of more […]
Imjudo (tremelimumab) in combination with Imfinzi approved in the US for patients with unresectable liver cancer based on Ph 3 HIMALAYA trial
Ghassan Abou-Alfa, MD, MBA, Attending Physician at Memorial Sloan Kettering Cancer Center (MSK), and principal investigator in the HIMALAYA Phase III trial, said: “Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival. In addition to this regimen demonstrating a favourable three-year survival rate in the HIMALAYA trial, […]
XPOVIO® Approved in Taiwan for the Treatment of RRMM and DLBCL
“Antengene is very pleased to receive regulatory approval for XPOVIO® in Taiwan for R/R MM and R/R DLBCL. There remains an unmet need to extend survival for patients with these life-threatening diseases and XPOVIO® presents Taiwan physicians and patients with a new novel addition to existing therapies. We continue to build our Antengene presence across […]
HOOKIPA Announces Strategic Collaboration And License Agreement With Roche To Develop Novel Arenaviral Immunotherapy For KRAS-Mutated Cancers
“Roche is an ideal partner, both in terms of development and reaching patients with novel cancer therapeutics. We look forward to working with them to benefit people with KRAS-mutated cancers,” said Joern Aldag, Chief Executive Officer at HOOKIPA. “This collaboration validates the potential of our arenavirus platform and accelerates the development pathway to bring new […]
Erasca Announces Clinical Trial Collaboration and Supply Agreement with Pfizer to Evaluate ERAS-007 and Palbociclib Combination
“We are excited to expand our existing relationship with Pfizer to explore ERAS-007 in combination with palbociclib in RAS-mutated GI malignancies as part of our HERKULES-3 program,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “Preclinical evidence supports synergistic anti-tumor effects when downstream RAS/MAPK pathway inhibition is combined with cell cycle inhibition in […]
Kite And Refuge Biotechnologies Announce Exclusive License Agreement For Investigational Gene Expression Platform For Blood Cancers
“First-generation autologous CAR T-cell therapies have dramatically changed outcomes for people with certain blood cancers yet more work needs to be done to reach additional patients. As the global CAR T-cell therapy leader, Kite is working on the next generation of cell therapies with the goal to improve upon the great results we have today […]
Jazz Pharmaceuticals and Zymeworks Announce Exclusive License Agreement to Develop and Commercialize Zanidatamab
“Zanidatamab is a novel HER2-targeted bispecific antibody with biparatopic binding and the potential to transform the current standard of care in multiple HER2 expressing cancers,” said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. “This agreement reflects Jazz’s strategic focus on opportunities where we can not only […]
Advaxis and Ayala Pharmaceuticals Enter into Merger Agreement
Kenneth A. Berlin, President and Chief Executive Officer of Advaxis, said, “Advaxis took a thorough approach in our quest to find the right partner with the right products. This merger is expected to enhance Advaxis’s portfolio of clinical assets, with Ayala’s proprietary gamma secretase inhibitors that are being developed as targeted therapies for rare and […]
LG Chem to Acquire AVEO Oncology for $15.00 Per Share in Cash
“With its track record of clinical success, deep pipeline of innovative therapies and continued growth trajectory following the successful commercialization of FOTIVDA®, AVEO is the perfect partner for LG Chem Life Sciences,” said Shin Hak-Cheol, Chief Executive Officer of LG Chem. “This transaction represents the next step in our portfolio transformation towards higher growth markets […]
Gilead And MacroGenics Announce Oncology Collaboration To Develop Bispecific Antibodies
“MacroGenics’ bispecific expertise naturally complements Gilead’s portfolio strengths in immuno-oncology and our growing hematology franchise,” said Bill Grossman, MD, PhD, Senior Vice President, Oncology Clinical Development, Gilead Sciences. “We believe MGD024, with its potential to reduce CRS and permit intermittent dosing through a longer half-life, could translate to more patient-friendly dosing and enhanced clinical outcomes […]
First Patient Enrolled in DeFianCe Study of DKN-01 for the Treatment of Colorectal Cancer Patients
“We believe that DKN-01 has broad clinical potential. Based on the role of DKK1 in suppressing the immune system in the tumor microenvironment and enabling resistance to chemotherapy in CRC, we are excited to explore this new indication, one of the most frequent and dangerous types of GI cancers where patients continue to look for […]
Ph I part of the clinical trial of Bria-IMT™, in combination with retifanlimab, in advanced breast cancer completed
“We are very impressed by the clinical data showing a favorable safety profile for our treatment in advanced breast cancer patients who have failed other therapies,” commented Dr. Del Priore, BriaCell’s Chief Medical Officer. “We look forward to further advancing this program and sharing the data in the coming months.”
New Patient Enrollment in Ph 1/2 Trial of Seclidemstat in Ewing Sarcoma and FET-Rearranged Sarcomas paused after patient death
“Patient safety is our primary concern, and this is reflected in the design of our clinical trial protocol, which automatically paused enrollment based upon this SUSAR,” said David Arthur, chief executive officer of Salarius. “Unfortunately, pauses to enrollment occur in early-stage drug development, but these pauses allow time to understand new data and adjust clinical […]
Data from CheckMate -76K Shows that Opdivo Reduced the Risk of Recurrence or Death by 58% vs. Placebo in Patients with Completely Resected Stage IIB/C Melanoma
“Within five years after surgery, one third of stage IIB and one half of IIC patients see their cancer return. Helping reduce that risk remains a need to be addressed when it comes to treating melanoma,” said Professor Georgina Long, AO, MD, PhD, Co-Medical Director of Melanoma Institute Australia (MIA) and chair of melanoma medical […]
LuMIERE Ph 1 Data Of FAP-2286 announced
“The LuMIERE trial is the first prospective trial of a FAP peptide targeted radionuclide therapy and is currently in the dose escalation phase. To date we have not seen evidence of significant associated toxicities that would limit therapy, and have seen some evidence of early efficacy,” said Thomas A. Hope, M.D., Director of Molecular Therapy […]
FDA Grants Fast Track Designation to TTI-101 for Hepatocellular Carcinoma
“We are pleased to receive Fast Track designation for TTI-101 in HCC from the FDA,” said Imran Alibhai, PhD, CEO of Tvardi. “This designation provides validation of the compelling safety and efficacy we have seen in last-line HCC patients in our Phase 1 trial. This comes at a perfect time as we look forward to […]
NDA of BCMA CAR T Zevor-cel (CT053) accepted by China NMPA
Prof. Wenming Chen, the principal investigator of the CT053-MM-01 study, Director of Hematology Department, Beijing Chao-Yang Hospital, Capital Medical University, said: “Results from the LUMMICAR-1 study show that the fully human autologous BCMA CAR T-cell product, zevor-cel, demonstrated strong and durable efficacy in patients with relapsed/refractory multiple myeloma, and was generally well tolerated. We are […]
Yescarta Receives European Marketing Authorization For Use In 2L DLBCL And High-Grade B-Cell Lymphoma
“We are very proud to announce Kite’s fifth approved indication in Europe in our continued commitment to the research and delivery of cell therapies with curative potential to patients who might benefit around the world,” said Christi Shaw, CEO, Kite. “Today’s approval marks an important step by providing patients in Europe this option of CAR […]
Mirati Therapeutics & Aadi Bioscience Partner to Evaluate Adagrasib + Nab-sirolimus in Advanced NSCLC and Other Solid Tumors patients with a KRAS[G12C] Mutation
“We are pleased to collaborate with Aadi on this clinical study of adagrasib and nab-sirolimus. Our collaborative preclinical work has demonstrated that combinatorial mTOR and KRAS inhibition addresses key bypass and feedback pathways associated with either drug target and also results in enhanced efficacy in tumor models harboring KRASG12C mutations. We believe the data from […]
VBI Vaccines and Agenus Announce Collaboration to Evaluate VBI-1901 in Combination with Balstilimab in a Ph 2 Study in Primary Glioblastoma Patients
David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, commented, “GBMs are notoriously one of the most immunosuppressive solid tumors, which is why there are few effective treatment options. Based upon the encouraging data we have observed to date, we believe VBI-1901 has the potential to activate and boost specific T cell immunity capable of trafficking […]
Tavros Therapeutics and Vividion Therapeutics Announce Strategic Collaboration to Discover and Enhance Targeted Oncology Programs
“The future of cancer treatment lies in the precision targeting of therapies in the optimal clinical settings. This partnership allows Tavros to expand the actionability of our platform into a new target space by pairing our precision oncology platform with Vividion’s unmatched ability to drug the traditionally undruggable,” said Tavros CEO and co-founder Eoin McDonnell, […]
Inceptor Bio and Avectas Announce Collaboration to Improve Manufacturing of CAR-T Cell Therapies for the Treatment of Solid Tumors
“Inceptor Bio is committed to building and advancing a pipeline of programs based on diversified cell therapies, including CAR-M, CAR-T, and CAR-NK. This collaboration with Avectas is part of our strategy of advancing Inceptor Bio’s next-generation cell therapy platform focused on multiple novel mechanisms to address solid tumors,” said Shailesh Maingi, Founder and CEO of […]
Allogene Therapeutics Launches CAR T Together™, a First-of-its-Kind Initiative with Leading Oncologists Nationwide, Focused on Accelerating Development and Clinical Trial Recruitment for “Off-The-Shelf” Allogeneic Cell Therapy Investigational Products
“Many of the physicians who are part of CAR T Together here and behind the scenes were critical in advancing autologous CAR T therapies. These first-generation CAR Ts transformed how we treat certain difficult-to-treat cancers, but the arduous, individualized manufacturing process and complex supply chain have made it hard for drugmakers to keep up with […]
Development of CYAD-101, Allogeneic TIM-based, NKG2D CAR T Candidate for Metastatic Colorectal Cancer (mCRC), to be discontinued
Based on a strategic, financial and medical review, taking into account the costs associated with the pursuit of the program and the delays to reach key medical milestones following the resolution of the previous Clinical Hold, the Company has decided to discontinue the development of CYAD-101 There were no new safety concerns leading to this […]
Enrollment Completed in Global Multi-Center Ph 3 Clinical Trial of Trilaciclib in Patients with mTNBC
“TNBC tumors are aggressive and difficult to treat; and while chemotherapy with or without targeted therapy remains first line TNBC standard of care, there is a great need to improve survival beyond that expected from it – particularly without increasing toxicity,” said Raj Malik, M.D., G1’s Chief Medical Officer. “PRESERVE 2 is exciting as it […]
First Patient Enrolled into the French National Cancer Institute (INCA) Sponsored Ph 1/2/3 Clinical Study for Natrunix™ Therapy for Colorectal Cancer
Investigators are combining XBiotech’s Natrunix with trifluridine/tipiracil as a new candidate therapy for metastatic colorectal cancer. Subjects receiving the experimental therapy have failed earlier treatment with oxaliplatin, irinotecan, and fluoropyrimidine. Subjects are randomized to receive Natrunix plus trifluridine/tipiracil chemotherapy or placebo plus the chemotherapy. The study is designed to seamlessly proceed through Phase III development […]
First Patient Enrolled in Part C of Ph 2 DisTinGuish Study of DKN-01 in Combination with Tislelizumab for the Treatment of Gastric or Gastroesophageal Junction Cancer
“We are excited to announce another important milestone for our DKN-01 clinical program in combination with our partner BeiGene’s tislelizumab, advancing this unique combination therapy into Part C of the DisTinGuish study,” said Cynthia Sirard M.D., Chief Medical Officer of Leap Therapeutics. “The data to date from the DisTinGuish study show the DKN-01 plus tislelizumab […]
First US Patient Dosed in TILT-123 Immunotherapy Ph 1 Clinical Trial in Ovarian Cancer
TILT Biotherapeutics’ CEO, Akseli Hemminki, a cancer clinician who has personally treated hundreds of cancer patients with earlier versions of oncolytic viruses, said, “Ovarian cancer is a killer disease with a pressing need for better therapies. There are no oncolytic viruses or check point inhibitors approved for use in that indication. The first US patient […]
