TILT Biotherapeutics Announces Final Close of €22 Million Financing Round to Advance to Phase II Oncology Immunotherapy Trials
Timo Ahopelto, Founding Partner of Lifeline Ventures, said, “We invest in future category-leading companies with strong founders, and support them through their growth. We saw the potential in TILT’s cancer immunotherapies early on and continue to build on that potential in Europe as well as the U.S market with this funding round.”
Dragonfly Therapeutics Announces All Rights Revert to Dragonfly for DF6002, its Proprietary IL12 Investigational Immunotherapy Program
“We are very excited to have the Dragonfly developed IL12 asset back,” said Joseph Eid, MD, Dragonfly’s President of Research and Development, who previously led the pioneering clinical development of KEYTRUDA®. “Given the encouraging profile we have seen both in preclinical models and in the clinic to date, we are accelerating DF6002’s development across a […]
Nykode Therapeutics Announces Collaboration with The GOG Foundation, Inc. to Conduct the VB-C-04 Trial in Advanced Cervical Cancer
“Based on the positive interim data and in line with our potential registrational trial strategy, we look forward to starting the VB-C-04 trial in the U.S. The trial is aimed at providing a fast path to making VB10.16 available to patients,” said Klaus Edvardsen, Chief Development Officer of Nykode Therapeutics.
Trilaciclib Ph 3 PRESERVE 1 trial in CRC patients to discontinue after absence of efficacy signals in early data
“PRESERVE 1 is the first clinical evaluation of trilaciclib in a 5-FU-based chemotherapeutic backbone,” said Raj Malik, M.D., G1 Therapeutics’ Chief Medical Officer. “This study reaffirms that trilaciclib is a highly effective drug for myeloprotection that all but eliminated neutropenia as a concern for patients with CRC in the trial, which helps inform our ongoing […]
Ph 3 Study of Uproleselan in R/R AML to continue to Originally Planned Final Analysis Following Interim Analysis by Independent Data Monitoring Committee
“We thank the independent DMC for its recommendation and are strongly encouraged as the blinded pooled survival data continues to show patients living longer than historical benchmarks. Going forward, survival duration for new events in the study will be greater than 14 months since the last patient was randomized, giving us confidence in the potential […]
Positive Initial Results From The MVP-S Ph 2B VITALIZE Trial Presented
“VITALIZE is our most advanced and rigorous trial to date, and we are encouraged by the way the data for MVP-S are trending. This is the most refractory population of patients we have treated so far, and to show complete, confirmed clinical responses is notable. These positive initial results, combined with the accelerating recruitment of […]
Last Patient Enrolled in Pivotal PANOVA-3 Study of Tumor Treating Fields in Pancreatic Cancer
“There is a severe unmet need for patients with pancreatic cancer,” said Asaf Danziger, Novocure’s Chief Executive Officer. “Each year in the U.S. alone, approximately 43,000 people are diagnosed with unresectable pancreatic cancer; however, the five-year survival rate remains stagnant at just 10%. The completion of the PANOVA-3 study marks a critical milestone for our […]
First Patient Dosed in ASPEN-07 Ph 1 Study of Evorpacept for the Treatment of Patients with Urothelial Cancer
“Outcomes for patients diagnosed with locally advanced or metastatic UC remain poor, and treatment options after initial chemotherapy and immunotherapy are limited,” said Sophia Randolph, M.D., Ph.D., ALX Oncology’s Chief Medical Officer. “We are excited to initiate ASPEN-07 to investigate this novel combination therapy that has the potential to change the treatment course of advanced […]
First Patients Dosed in Ph 2 Registrational Trial of Ziftomenib in NPM1-Mutant AML
“Dosing the first patients in our registration-directed trial of ziftomenib marks a significant milestone for our menin inhibitor program,” said Troy Wilson, Ph.D., J.D., President & Chief Executive Officer of Kura Oncology. “Building on the strength of our Phase 1 data, we remain committed to our mission to realize the full potential of ziftomenib as […]
Ph 2 Randomized Trial for ATR Inhibitor ART0380 plus Gemcitabine in Patients with Platinum Resistant Ovarian Cancer initiated
Dr. Niall Martin, Chief Executive Officer at Artios, said: “This is the first of three proof of concept Phase 2 studies planned to evaluate our potentially best-in-class ATR inhibitor, ART0380, that has demonstrated a favorable safety and tolerability profile and clinical activity in the Phase 1 dose escalation. We are delighted to be collaborating with […]
Ph 1/2 VELA Trial of BLU-222 on Partial Clinical Hold
“Patient safety is our first priority, and we are working closely with the FDA to investigate the reported visual adverse events as well as amend the VELA trial protocol to provide specific guidance to investigators on how to monitor for and manage these events should they occur,” said Becker Hewes, M.D., Chief Medical Officer at […]
Positive Final OS Results of Ph 3 JUPITER-02 Trial of Toripalimab as Treatment for Recurrent or mNPC announced
“In the pivotal JUPITER-02 trial, toripalimab has demonstrated a statistically significant and clinically meaningful overall survival benefit for patients with advanced NPC, an aggressive head and neck tumor with no current FDA-approved treatment options,” said Rosh Dias, M.D., Coherus’ Chief Medical Officer. “These mature overall survival data continue to demonstrate the benefit of toripalimab in […]
Trodelvy® Demonstrates Positive Efficacy Treating Both Platinum-Ineligible And Rapidly Progressing, Post-Platinum Metastatic Urothelial Cancer
“The TROPHY-U-01 data show consistent benefit of Trodelvy across multiple types of metastatic urothelial cancer, including the most difficult-to-treat and, often times, frail patients where treatment options are still scarce,” said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. “Trodelvy has the potential to become a cornerstone treatment in metastatic urothelial […]
THIO + Atezolizumab or Pembrolizumab demonstrated Significantly Greater Tumor Inhibition
“The THIO-102 trial is operationally on track to begin enrolling patients later this year,” said Mihail Obrocea, MD, MAIA’s Chief Medical Officer. “Based on the data generated on these indications, we are targeting accelerated approvals in these tumor types; in addition, we have now added a fourth arm which includes solid tumors of all types, […]
Final Topline Data from Successful European Ph 1 monotherapy Trial of Annamycin in R/R AML patients announced
“We are very pleased with these topline results, both in terms of safety and the initial data suggesting efficacy,” said Moleculin Chairman and CEO Walter Klemp, “especially since these patients were relapsed or refractory.” Mr. Klemp continued, “Given the recently published research showing that Annamycin in combination with Cytarabine substantially outperformed Annamycin as a single […]
Ph 1 Dose Escalation Results from Ongoing Ph 1/2 Study of BT8009 Announced
“We are encouraged by the Phase I dose escalation results as they continue to demonstrate the potential for BT8009 to be best-in-class for the treatment of urothelial cancer based on the observed anti-tumor activity and tolerability profile as well as the potential to treat other tumor types with significant unmet need,” said Kevin Lee, Ph.D., […]
New Analyses Reinforce Survival Benefit of BAVENCIO First-Line Maintenance Treatment in Patients With Advanced Urothelial Carcinoma
“Based on the significant improvement in overall survival demonstrated in the Phase III JAVELIN Bladder 100 study, platinum-based chemotherapy followed by avelumab maintenance treatment in patients without evidence of disease progression, has become a standard of care for advanced urothelial carcinoma. The findings presented today reinforce that all patients eligible for platinum-based chemotherapy, either cisplatin […]
Opdivo® + CABOMETYX® shows Durable Survival with Over Three Years of Follow-Up in the CheckMate -9ER Trial in 1L Advanced RCC
“Despite the progress made through science and medicine, there remains a need for treatment options that can durably extend survival for patients with metastatic renal cell carcinoma, especially for those classified as higher risk,” said Mauricio Burotto, M.D., medical director, Bradford Hill Clinical Research Center, Santiago, Chile. “With these updated results from CheckMate -9ER, we’ve […]
Early Ph 1 Results for BPX-601 in Prostate Cancer Presented
“We believe these encouraging initial clinical results in mCRPC support the potential of BPX-601 and the GoCAR-T® platform,” stated Rick Fair, President and Chief Executive Officer, Bellicum Pharmaceuticals. “We designed the GoCAR-T platform to enhance immune cell proliferation and persistence, resist exhaustion, and override key inhibitory factors in the solid tumor microenvironment. We are excited […]
Updated Data Demonstrating Improved Outcomes from Niraparib + Abiraterone + Prednisone as a 1L Therapy in Patients with BRCA-Positive mCRPC announced
“Patients with HRR-positive mCRPC, especially those with BRCA mutations, are more likely to experience poor outcomes. Although additional follow-up for overall survival continues, it is encouraging to see a trend toward improvement in overall survival among patients with BRCA-positive mCRPC who received niraparib and AAP as compared to placebo and AAP,” said Kim Chi*, M.D., […]
Positive TALZENNA® and XTANDI® Combination Data from Ph 3 TALAPRO-2 Study Announced
“Novel hormone therapies dramatically changed outcomes for patients with mCRPC in the last decade, and the results from the TALAPRO-2 study show that the addition of talazoparib to the existing standard of care adds significant clinical benefit,” said Neeraj Agarwal, M.D., FASCO, Professor of Oncology and Presidential Endowed Chair of Cancer Research at Huntsman Cancer […]
Adjuvant Opdivo Continues to Provide Significant, Durable Clinical Benefits for Patients with Radically Resected, High-Risk MIBC After 3 Yrs in CheckMate -274 Trial
“Patients with muscle-invasive urothelial carcinoma face a high chance of recurrence due to micrometastatic disease, especially within the first three years after surgical removal of the bladder or kidney. The three-year results from CheckMate -274 show a stable decrease in the risk of disease with adjuvant nivolumab with longer follow-up,” said Matthew D. Galsky,* M.D., […]
Final Results of Key Secondary OS Endpoint From Phase 3 PROpel Trial presented, OS endpoint not met
Susan Galbraith, executive vice president, oncology R&D, AstraZeneca, said, “Both PARP, the target of LYNPARZA, and the androgen receptor are important for providing DNA repair in prostate cancer. The results in the overall trial population from PROpel illustrate how the combination of LYNPARZA and abiraterone can exploit the dependency of the androgen receptor’s role in […]
KEYTRUDA + Chemo Significantly Improved OS vs chemo Alone in With HER2-Neg Gastric or GEJ Adenocarcinoma Patients Regardless of PD-L1 Expression
“Most gastric cancers go undetected until an advanced stage, at which point the five-year survival rate is just 6%, one of the lowest across cancer types,” said Dr. Sun Young Rha, director and professor of medical oncology in the Department of Internal Medicine, Songdang Institute for Cancer Research, Yonsei University College of Medicine, Yonsei University […]
Clinical Responses from the Ph 2 OATH Clinical Trial Evaluating ONA-XR for the Treatment of Endometrial Cancer highlighted
“Data from the ongoing Phase 2 OATH clinical trial supports the potential for ONA-XR plus ANA combination therapy to serve as an effective therapeutic option in metastatic EC. We are encouraged by these findings and look forward to continued enrollment in the trial,” said Martin Lehr, CEO of Context Therapeutics.
Abecma (idecabtagene vicleucel) Reduced the Risk of Disease Progression or Death by 51% vs SoC in Earlier Lines of Therapy for R/R Multiple Myeloma Based on Results from Ph 3 KarMMa-3 Study
“In earlier lines of treatment for multiple myeloma, regimens consisting of immunomodulatory agents, proteasome inhibitors, and anti-CD38 monoclonal antibodies are often used to help manage the disease. This shift in the treatment paradigm leaves many patients who are triple-class exposed with relapsed and refractory disease and in need of new treatment options sooner,” said Paula […]
42-Patient Interim Data, with 90% ORR in R/R Multiple Myeloma at NXC-201 Therapeutic Dose from Ph 1 Expansion Trial presented
“I am pleased to present promising NXC-201 efficacy data from our interim Phase 1 dataset, which brings us one step closer to meeting an urgent need for greater access to CAR-T therapies that can considerably shorten treatment waiting time for patients with relapsed or refractory multiple myeloma,” said Polina Stepensky, M.D., Director of the Hadassah […]
Tecartus® CAR T-Cell Therapy Demonstrates OS Benefit In 3-Year Follow-Up Of Pivotal ZUMA-3 Trial In R/R B-Cell Acute Lymphoblastic Leukemia
“For adult patients living with ALL, there is a need for therapeutic options that provide long-term responses,” said Bijal Shah, MD, ZUMA-3 investigator and medical oncologist, Moffitt Cancer Center, Tampa, Florida. “The continued durable response and significant improvement in survival indicated by these new data can potentially establish a new standard of care for adult […]
2023 EBMT-EHA: Encouraging initial safety and efficacy data for point-of-care manufactured GLPG5201 CAR-T in rrCLL presented
“We were very pleased to present strong initial data from the ongoing Phase 1/2 study of our fresh CD19 CAR-T candidate manufactured at point-of-care. This marks an important milestone in our journey to transform the lives of patients with severe blood cancers, including patients with RT, through the acceleration of innovation and breakthrough science”, said […]
FDA grants Fast Track designation for KIN-3248 for the treatment of patients with metastatic cholangiocarcinoma
“U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Kinnate’s investigational pan-FGFR inhibitor, KIN-3248, for the treatment of patients with unresectable, locally advanced or metastatic cholangiocarcinoma (CCA) harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other alterations, who have received at least one prior systemic therapy.”
