FDA sends CRL for LYMPHIR™ (Denileukin Diftitox) for the Treatment of Patients with R/R Cutaneous T-Cell Lymphoma
“We appreciate the FDA’s expeditious review of our application. We intend to provide additional data and remain fully engaged with the FDA as we continue to work toward approval. We remain confident in the potential of LYMPHIR to become an important addition to the treatment landscape for patients with relapsed or refractory CTCL and make […]
FDA Orphan Drug Designation granted to Elraglusib for Treatment of Pancreatic Cancer
“We are pleased with the FDA’s decision to grant Orphan Drug Designation to elraglusib for the treatment of pancreatic cancer. Pancreatic cancer remains an area of high unmet medical need, with less than 10% survival in the US at 5 years. The Orphan Drug Designation furthers our ability to advance development and regulatory interactions with […]
European Commission Approves LONSURF® (Trifluridine/tipiracil) in Combination With Bevacizumab in 3rd Line Refractory mCRC
“The approval by the European Commission is supported by data from the phase 3 SUNLIGHT trial for patients suffering from an advanced colorectal cancer who have already failed two prior chemotherapy regimens. The Marketing Authorization covers the 27 countries of the European Union as well as Iceland, Northern Ireland, Liechtenstein and Norway.”
Jemperli (dostarlimab) + chemo approved in the US as 1L treatment for dMMR/MSI-H primary advanced or recurrent endometrial cancer
Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK, said: “Today’s expanded approval of Jemperli redefines the treatment landscape for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer. Until now, chemotherapy alone has been the standard of care with many patients experiencing disease progression. In the RUBY trial, Jemperli plus chemotherapy demonstrated […]
Immatics Announces $35 Million Equity Investment from Bristol Myers Squibb
“This investment is further testimony to the strength of the relationship and of our differentiated platform technologies that are the foundation of our TCR-based cell therapies and bispecifics,” commented Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. “We remain steadfast in our commitment to advancing innovative treatment options for patients in their fight against cancer, […]
ImmunoGen Announces Multi-Target License and Option Agreement with ImmunoBiochem to Develop Next-Generation ADCs
“We are excited to partner with ImmunoBiochem, which brings a novel approach to tumor targeting for ADCs,” said Eric Westin, ImmunoGen’s Vice President of Clinical Development and Translational Sciences. “This agreement reflects our commitment to leverage our rich IP portfolio through strategic partnering in order to further reinvigorate our research and development in support of […]
Infinity Pharmaceuticals Terminates Merger Agreement with MEI Pharma
“At a special meeting of MEI stockholders on July 23, 2023, MEI did not obtain MEI stockholder approval for the merger with Infinity, nor could MEI obtain approval for an adjournment of the special meeting. In the process of attempting to obtain approval for the merger, which the MEI board supported based on the value […]
Crescendo Biologics secures $32M and announces expansion of CB307 Phase 1b trial in PSMA+ solid tumours
“We are delighted to have secured this additional financing which will enable us to accelerate the clinical development of CB307,” commented Theodora Harold, CEO at Crescendo Biologics. “Preclinical data generated by Crescendo, such as those recently presented at AACR in Orlando, as well as clinical data presented by others earlier this year, illustrate the profound […]
AbbVie and Calibr Expand Strategic Collaboration to Advance Several Preclinical and Early-stage Clinical Assets
“AbbVie has been a trusted partner to Scripps Research for many years, as proven by our successful ongoing R&D collaborations spanning numerous disease areas that have yielded four clinical stage programs,” says Peter Schultz, PhD, President and Chief Executive Officer of Scripps Research and Calibr. “This expansion represents an important step forward in our mission […]
Phase 3 Study of V940 (mRNA-4157) + KEYTRUDA initiated for Adjuvant Treatment of Patients with Resected High-Risk (Stage IIB-IV) Melanoma
“As we continue our efforts to advance novel treatment options for patients with high-risk Stage IIB-IV melanoma, the initiation of the V940-001 Phase 3 trial represents an important step forward in these efforts and our study of individualized neoantigen therapy,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, […]
Phase 3 ENHANCE Study of Magrolimab Plus Azacitidine in Higher-Risk MDS To Discontinue
“The health and well-being of patients are our top priorities and while this is disappointing news it confirms the challenges of treating HR-MDS, where no new class of treatments have been approved in nearly 20 years,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Gilead is deeply grateful to the patients, families, investigators, […]
First Patient Dosed in TNG260 Phase 1/2 Trial in Patients With STK11-Mutant Cancers
“The TNG260 phase 1/2 clinical trial is the first trial to use genetic patient selection in combination with checkpoint inhibitor therapy to reverse the cancer-specific immune evasion caused by STK11 loss of function mutations. Resistance to immunotherapy is a major challenge faced by patients with STK11-mutant cancers, which TNG260 is specifically designed to overcome,” said […]
Phase 2 LOTIS-9 Clinical Trial of ZYNLONTA® (loncastuximab tesirine-lpyl) and Rituximab in Unfit or Frail Previously Untreated DLBCL Patients to be discontinued
ADC Therapeutics today announced that it plans to discontinue the Phase 2 LOTIS-9 clinical trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) and rituximab (Lonca-R) in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Given the challenges of defining the addressable segment of the difficult-to-treat unfit or frail DLBCL patient population, including many patients […]
Topline Data from UPLIFT Clinical Trial in Patients with Platinum-Resistant Ovarian Cancer and Strategic Reprioritization Announced
“We are deeply disappointed that UPLIFT’s efficacy failed to replicate previous data from approximately 100 patients in the dose expansion portion of our Phase 1b clinical trial,” said Dr. Arvin Yang, Senior Vice President and Chief Medical Officer of Mersana Therapeutics. “While the duration of response was longer than that from the dose expansion portion […]
UGN-102 Met Primary Endpoints in Both Phase 3 ATLAS and ENVISION Clinical Trials in NMIBC patients
“UGN-102 has demonstrated a robust and consistent therapeutic profile across multiple clinical trials, providing a compelling picture of its potential to be a transformational product and advance the standard of care away from repetitive surgery to a minimally invasive, non-surgical option for LG-IR-NMIBC,” says Liz Barrett, President and Chief Executive Officer of UroGen. “If approved, […]
In CARES 310 trial, camrelizumab + rivoceranib statistically prolonged OS and PFS and improved ORR versus sorafenib in uHCC
“As evidenced in the CARES 310 study, camrelizumab plus rivoceranib demonstrate significant promise as a potentially improved therapy for advanced hepatocellular carcinoma,” said Saeho Chong, Elevar chief executive officer. “Elevar is pleased The Lancet, a prestigious peer-reviewed journal, recognized the significance of these results as we continue to work toward commercial development of this combined […]
BMF-219 Induces Complete Responses in Target Acute Myeloid Leukemia (AML) Patient Population
“We are very excited to share these early findings confirming that our targeted, covalently binding menin inhibitor, BMF-219, can elicit profound and rapid responses in patients with menin inhibitor-sensitive acute leukemia even at this dose level, which we believe we can further build on,” said Steve Morris, MD, Biomea’s Chief Medical Officer. “Notably these complete […]
Cosibelimab Longer-Term Results Demonstrating Substantial Increases in Complete Response Rates in Advanced Cutaneous Squamous Cell Carcinoma
Mr. Oliviero continued, “Unlike PD-1 inhibitors, cosibelimab does not interrupt the body’s PD-1/PD-L2 pathway, which we believe results in cosibelimab’s low rates of autoimmunity. We believe cosibelimab’s favorable safety profile should position the product as the preferred immunotherapy of oncologists for the large number of high-risk cSCC patients, such as those with solid organ transplants […]
Enhertu demonstrated clinically meaningful PFS and OS across multiple HER2-expressing advanced solid tumours in DESTINY-PanTumor02 Phase II trial
Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca, said: “The progression-free survival and overall survival results for Enhertu alongside the continued robust and durable tumour responses seen with further follow up underscore the potential value of this important medicine for patients with HER2-expressing cancers who currently have no targeted treatment options. With […]
Ph 3 KEYNOTE-756 Trial Met Primary Endpoint of pCR Rate in Patients With High-Risk, Early-Stage ER+/HER2- Breast Cancer
“This is the first positive Phase 3 study evaluating an immunotherapy-based regimen for patients with high-risk, early-stage ER-positive, HER2-negative breast cancer, and an important milestone in our efforts to advance research in early-stage breast cancer,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “We look forward to sharing the detailed results […]
FDA Grants Fast Track designation to IVS-3001 for the Treatment of Renal Cell Carcinoma
“We are thrilled to receive the FDA’s Fast Track designation for IVS-3001, said Dr. Jake Kushner, CEO of Invectys. “This recognition further validates the potential of our CAR-T cell therapy in revolutionizing cancer treatment for patients with solid tumors. The dedicated team at Invectys, as well as our partners, are committed to bringing this innovative […]
EMA Approves Clinical Trial Application (CTA) for AVC-201 for the Treatment of R/R AML and other CD123 Hematological Malignancies
“We are excited to build on the early success and promising activity and safety of our ongoing switchable autologous clinical program in AML (AVC-101) by now including what we believe is the most scientifically-compelling allogeneic technology in the industry,” said Andrew Schiermeier, AvenCell’s President & CEO. “With the application of both platform technologies, we are […]
Complete Response Letter from the US FDA for LYMPHIR™ (Denileukin Diftitox) for the Treatment of Patients with R/R Cutaneous T-Cell Lymphoma
“We appreciate the FDA’s expeditious review of our application. We intend to provide additional data and remain fully engaged with the FDA as we continue to work toward approval. We remain confident in the potential of LYMPHIR to become an important addition to the treatment landscape for patients with relapsed or refractory CTCL and make […]
CHMP Positive Opinion for JZP458 for the Treatment of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
“Today’s positive CHMP opinion is welcome news for those in the ALL and LBL community who are unable to be treated with E. coli-derived asparaginase due to hypersensitivity reactions,” says Robert Iannone, MD., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. “We look forward to receiving the final decision that […]
FDA clears IND application for first-in-class T-Cell Receptor Natural Killer (TCR-NK) cell therapy for multiple myeloma
“This IND clearance of Syena’s engineered TCR-NK cell technology in hematological malignancies swiftly follows the FDA’s clearance of our solid tumor study in sarcoma, signalling the rapid advancement of our TCR-NK program into the clinic and the breadth of our engineered TCR-NK cell therapy’s potential,” said Adrian Woolfson, Executive Chairman, President, and Co-Founder of Replay.
European Commission Approves Trodelvy For Pre-Treated HR+/HER2- Metastatic Breast Cancer
“The European approval of sacituzumab govitecan is an important milestone for the European breast cancer community,” said Dr. Javier Cortes, Head of the International Breast Cancer Center, in Madrid and Barcelona, Spain. “We now have a new treatment option that has delivered a proven and clinically meaningful survival benefit for women in Europe with pre-treated […]
LEQEMBI approved by FDA for early Alzheimer’s disease treatment
The U.S. Food and Drug Administration (FDA) has now approved LEQEMBI under the traditional pathway making it the first approved treatment for early AD with a significant reduction in disease progression rate and slowing cognitive and functional decline. It marks Eisai’s success in research collaboration with Biogen and BioArctic for joint development and commercialization of […]
LianBio Partner NANOBIOTIX Enters into License Agreement with Janssen for NBTXR3, with LianBio Retaining Development and Commercialization Rights in Greater China, South Korea, Singapore and Thailand
“Data generated to date suggest NBTXR3 has potential to address the treatment limitations of standard of care radiotherapy across multiple solid tumor indications,” said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. “We believe Nanobiotix’s collaboration with Janssen will provide additional expertise and financial resources to broadly develop NBTXR3 in areas of high unmet medical […]
First Patient Dosed with ELU001 in Expansion Cohort of Phase 1/2 Clinical Trial
“This is a notable milestone for the company, as we continue to progress our lead CDC candidate, ELU001, in this important Phase 1/2 trial. The safety data to date has been differentiating for ELU001 when compared to ADCs, including those targeting the same folate receptor alpha target, and we look forward to presenting ELU001 clinical […]
Ph 3 ENHANCE Study Of Magrolimab Plus Azacitidine In Higher-Risk MDS To Discontinue
“The health and well-being of patients are our top priorities and while this is disappointing news it confirms the challenges of treating HR-MDS, where no new class of treatments have been approved in nearly 20 years,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Gilead is deeply grateful to the patients, families, investigators, […]
