Nona Biosciences Enters into a Global License Agreement with Pfizer for HBM9033, an MSLN-Targeted Antibody-Drug Conjugate (ADC)
“We are delighted to collaborate with Pfizer, a company that is committed to developing high-impact medicines for people living with cancer,” said Jingsong Wang, M.D., Ph.D., Chairman of Nona Biosciences. “This agreement represents a significant milestone in the advancement of our proprietary Harbour Mice® platform and the ADC ecosystem, affirming Nona’s robust capabilities and expertise […]
Orion and Glykos announce research collaboration and licensing agreement to develop next-generation ADCs
Juhani Saarinen, CEO of Glykos, said: “The acknowledgment of our ADC technology by an esteemed pharmaceutical company like Orion is a strong statement to the transformative potential of these technologies in enhancing the therapeutic index of ADCs. We look forward to partnering with Orion and believe that with their expertise on cancer therapies and robust […]
Menarini Group and Insilico Medicine Enter Global Exclusive License Agreement for Novel KAT6 Inhibitor for Potential Breast Cancer Treatment and Other Oncology Indications
“We are delighted to enter a collaboration with Insilico that harnesses the power of generative AI as a leader in the field, to explore a promising new treatment approach and potentially unlock transformative new cancer therapies,” said Elcin Barker Ergun, CEO of the Menarini Group. “Having brought the first innovation in endocrine therapy after almost […]
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 […]
Global Phase 3 studies started for bomedemstat (LSD1 inhibitor), nemtabrutinib (BTK inhibitor), MK-2870 (anti-TROP2 ADC) and MK-5684 (CYP11A1 inhibitor)
“These Phase 3 trial initiations for four of our investigational candidates represent a critical step forward in our efforts to advance potential treatment options for people with solid tumors and hematologic neoplasms and malignancies,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “We have a proud […]
Patients enrolled into the Third Dosing Cohort of Phase 1/2 Study of ONCT-534 for the Treatment of R/R Metastatic Castration-Resistant Prostate Cancer
“The ONCT-534-101 investigators are enthusiastic about this study, and we are excited about the enrollment and progress through the initial dosing levels. Reaching the third cohort represents an important milestone for the program, as we believe we are nearing potentially therapeutic doses that may benefit prostate cancer patients who have progressed after treatment with approved […]
First Patient Dosed in Phase 1 Clinical Trial of ST-001 in T cell NHL
“There have been relatively few new cancer breakthroughs for T-cell lymphoma in several years, so we are excited to announce this milestone for patients suffering from this rare disease.” said Earle Holsapple, SciTech’s President, and CEO. “Our scientific team has worked extremely hard to bring this new drug to the people that need it most. […]
23ME-00610 Phase 1/2a clinical trial in advanced neuroendocrine and ovarian cancer patient cohorts expanded
“23ME-00610 has been well-tolerated with a very manageable side effect profile and we’ve also seen some encouraging signs of activity, particularly in neuroendocrine cancers that we’ve previously presented,” said Drew W. Rasco, MD, Associate Director of Clinical Research at the START Center for Cancer Care, and a principal investigator for the 23ME-00610 study. “CD200R1 is […]
First Patient Dosed in Phase 2 Neoadjuvant/Adjuvant Solid Tumor Basket Trial
“We continue to see promising data and a favorable safety profile supporting use of our lead investigational therapeutic cancer vaccine candidate, IO102-IO103, combined with PD-1 inhibitors to treat various types of cancer, including melanoma, lung cancer and head and neck cancer,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. “In patients with advanced […]
Status of Phase 1/2 Study of ONCT-808 in Patients with Relapsed or Refractory Aggressive B-cell Lymphoma announced
Salim Yazji M.D., Chief Medical Officer at Oncternal Therapeutics, commented, “The safety of every patient who participates in our studies is of the utmost priority for us. We believe these early disease response data indicate that ONCT-808 is a particularly potent autologous CAR T product with the potential to address significant unmet needs for patients […]
Two Phase 3 Trials of Datopotamab Deruxtecan Plus Durvalumab Initiated in Patients Across Two Breast Cancer Subtypes
“While the addition of immune checkpoint inhibitors to chemotherapy has led to survival improvements for patients with triple negative breast cancer, the overall prognosis for these patients remains poor,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo. “These two phase 3 trials will evaluate whether combining datopotamab deruxtecan, a TROP2 directed antibody […]
Dose Selection announced in THIO-101 Phase 2 Clinical Trial for NSCLC
“All THIO dose levels tested exceeded the disease control rate (DCR) thresholds in Stage 1 of the THIO-101 Phase 2 trial. We observed disease control in the first 8 to 9 patients with a post baseline scan in each arm, beating our goal of disease control in 8 out of 19 patients per arm. Among […]
Investigator-initiated Phase 1/2 Clinical Trial of Seclidemstat in Combination with Azacitidine to Treat Hematologic Cancers Resumes Patient Enrollment
“We are pleased that the FDA has removed the partial clinical hold on the MD Anderson trial with seclidemstat in blood cancers, and we are excited about the prospect of MD Anderson enrolling additional patients and building a broader database of patient data,” said David Arthur, president and chief executive officer of Salarius Pharmaceuticals. “MDACC […]
Enrollment Completed in Phase 3 Bridging Study of Uproleselan in Chinese Patients with Relapsed/Refractory Acute Myeloid Leukemia
“Uproleselan, as a potent E-selectin antagonist, is the first in this novel mechanism class to be tested in Phase 3 AML studies, and has the potential to transform the care and positively impact the outcomes of relapsed and refractory AML patients,” said Dr. Jianxiang Wang, Chinese Academy of Medical Sciences and Peking Union Medical College, […]
Phase 1b portion of phase 1b/2 lanraplenib study in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia completed
“Kronos Bio was founded with a clear vision: to tackle the challenge of deregulated transcription, a hallmark of cancer,” said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. “To best meet this challenge, we pursued a multi-pronged strategy using our proprietary product engine to map TRNs, find their key modulators, and identify […]
First Patient Dosed in Trial Evaluating Efti and BAVENCIO in Metastatic Urothelial Cancer
Immutep CSO, Frédéric Triebel, M.D., Ph.D., “Immunotherapy has made great strides in improving clinical outcomes for patients with bladder cancer, including avelumab that has set a new standard of care for many metastatic urothelial carcinoma patients, and we are pleased to commence patient enrollment in the INSIGHT-005 study that we hope will build upon this […]
First Patient Dosed In Phase 1/2 Trial Of TNG348 In Patients With BRCA1/2-Mutant and Other HRD+ Cancers
“Dosing the first patient in the TNG348 phase 1/2 trial is an important milestone for us and for patients with advanced ovarian, breast and certain other cancers. TNG348 has the potential to become a meaningful treatment for cancers caused by DNA damage repair pathways defects,” said Barbara Weber, M.D., President and Chief Executive Officer of […]
Positive Topline Data Achieving Primary Endpoint in Pivotal Clinical Study of Iopofosine I 131 in Waldenstrom’s Macroglobulinemia Announced
“There is a critical need for new therapies with novel mechanisms of action to treat WM. There are no approved treatments for patients post BTKi therapy, where currently the expected response rate to salvage treatments is approximately 10%, and the expected duration of response in those patients is less than six months,” said Sikander Ailawadhi, […]
Scemblix Shows Superior MMR Rates Vs. SoC TKIs In Phase III Trial For Newly Diagnosed Patients With CML
“We are very encouraged by these results given that a significant proportion of patients with newly diagnosed chronic myeloid leukemia, or CML, do not achieve their treatment goals,” said Prof. Tim Hughes, MD, South Australian Health & Medical Research Institute (SAHMRI). “There remains a significant need in first-line therapy of CML for tolerable treatment options, […]
Clinical Efficacy of Enitociclib in Combination with Venetoclax and Prednisone in Lymphoma announced
“Enitociclib continues to differentiate itself in the CDK9 inhibitor field,” said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx. “Enitociclib is well tolerated, making it ‘the partner of choice’ for novel combinations. We are pleased to see the high response rate and tolerability of enitociclib in combination with venetoclax and prednisone in patients with hard-to-treat […]
FDA Issued New Postmarketing Requirement on sNDA seeking full approval of LUMAKRAS® (sotorasib)
“FDA has completed its review of the company’s supplemental New Drug Application seeking full approval of LUMAKRAS® (sotorasib). This review, which resulted in a Complete Response Letter, was based on the CodeBreaK 200 trial results for the treatment of adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC). The […]
FDA Clearance of Investigational New Drug Application for SC262 for Patients with Relapsed or Refractory B-cell Malignancies
“Patients who have failed a CD19-directed CAR T therapy represent a significant unmet need, and this population is growing as more patients receive these therapies,” said Doug Williams, PhD, Sana’s President of Research and Development. “SC262 represents an important potential option for these patients and is the next step in building Sana’s hypoimmune CAR T […]
U.S. FDA clears IND Enabling Phase 1 Initiation for PI3Ka inhibitor, OKI-219
“OnKure plans to initiate a first-in-human clinical trial, OKI-219-101 (PIKture-01), in the first quarter of 2024 that will include a dose escalation in patients with advanced solid tumors harboring the PI3Ka H1047R mutation. Subsequent evaluation of OKI-219 in combination with the SERD fulvestrant in ER+/ PI3Ka H1047R advanced breast cancer, and with the HER2-monoclonal antibody […]
Rinatabart Sesutecan FDA Fast Track Designation for Patients with Advanced Ovarian Cancer
“Our receipt of Fast Track designation from the FDA underscores our belief in the tremendous promise of Rina-S as a potential best-in-class FRα ADC to address the significant need for improved treatment options for advanced ovarian cancer,” said Naomi Hunder, Chief Medical Officer of ProfoundBio. “FRα is a highly prevalent antigen in ovarian cancer and […]
U.S. FDA Lifts Partial Clinical Hold on Lacutamab Clinical Program
“We have worked closely with the FDA to diligently resolve the partial clinical hold on the lacutamab IND, which included an in-depth analysis of the fatal case which was due to progression of an aggressive form of the disease.” said Dr Quaratino, Chief Medical Officer of Innate Pharma. “The lacutamab program continues to plan following […]
Jemperli (dostarlimab) + Zejula (niraparib) combination significantly improved PFS in primary advanced or recurrent endometrial cancer in RUBY Part 2 Phase III trial
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “Patients with MMRp/MSS primary advanced or recurrent endometrial cancer have few approved treatment options. Today’s positive topline results reinforce our approach of building combination therapies with dostarlimab as the backbone in an effort to improve patient outcomes and options.”
FAILED TRIAL: CARMEN-LC03 trial did not meet dual primary endpoint of improving progression-free survival; tusamitamab ravtansine clinical development program will be discontinued
Dietmar Berger, Chief Medical Officer and Head of Development, said, “Our team is grateful to the patients, families and healthcare professionals involved in the tusamitamab ravtansine development program. Although the results are not what we hoped for, our research and work to advance potentially transformative therapies in areas of high unmet need for people living […]
Positive Follow-Up Immune Response and Survival Data reported in Completed Phase 1 Study of Galinpepimut-S Combined with Opdivo® in Advanced Malignant Pleural Mesothelioma
Angelos Stergiou, M.D., Sc.D. h.c., President and CEO, SELLAS commented: “We are excited that in a bulky, measurable disease setting, such as in this relapsed/refractory advanced mesothelioma study, we have observed yet again strong GPS-specific immune responses which appear to be correlated with significant survival benefit in patients when combined with checkpoint inhibitors, a more […]
Unprecedented Preliminary Survival and Clinical Benefit reported in Antibody-Drug Conjugate (ADC) Refractory Patient Subset treated with Bria-IMT™ regimen
“We are excited with our findings of unprecedented survival and clinical benefit in very difficult-to-treat patients who failed ADCs and view our findings as a significant clinical breakthrough in the field of cancer therapy. This is highly encouraging given our ongoing pivotal study is investigating the effects of Bria-IMT™ regimen in advanced breast cancer with […]
71% Central Nervous System Response Rate in Advanced Breast Cancer Patients reported
“We have accumulated positive clinical responses in five patients with intracranial metastases, which generally are extremely difficult to treat, and have a very poor prognosis. This antitumor activity furthers our excitement in our ongoing Phase 3 pivotal trial studying the Bria-IMT™ regimen in advanced breast cancer,” stated Dr. William V. Williams, BriaCell’s President and CEO.
