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MedNess: bite-size biopharma and medtech news

23rd February, 2022
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MedNess This Week
HIGHLIGHTS
 
Drug Approvals
European Commission Approves TEPMETKO® (tepotinib) for Patients with Advanced NSCLC with METex14 Skipping Alterations
“The approval of TEPMETKO provides a much-needed targeted treatment option for patients with advanced non-small cell lung cancer with METex14 skipping alterations,” said Professor Egbert Smit, a VISION study investigator at the Netherlands Cancer Institute. “TEPMETKO has demonstrated durable and consistent response rates and has the potential to help patients with this challenging cancer.”
Regulatory News
FDA grants Fast Track Designation for Anti-LILRB4 Myeloid Checkpoint Inhibitor IO-202 for the Treatment of R/R AML
“We are pleased that the FDA has granted IO-202 Fast Track designation in recognition of its potential to improve outcomes for people with relapsed or refractory AML,” said Paul Woodard, Ph.D., chief medical officer of Immune-Onc. “We look forward to working closely with the FDA to accelerate the clinical development of IO-202, which is currently being evaluated as a monotherapy and in combination with other agents in a Phase 1 dose escalation and expansion trial in patients with AML with monocytic differentiation and in chronic myelomonocytic leukemia (CMML).”
FDA Accepts for Priority Review sBLA for Breyanzi (lisocabtagene maraleucel) as a Second-Line Therapy for Relapsed or Refractory Large B-cell Lymphoma
“Breyanzi as a differentiated CD19-directed CAR T cell therapy has already proven to be an important treatment option for patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy and now has the potential to be a new standard of care for patients after failure of first-line therapy, offering significantly improved outcomes beyond the current mainstay of care,” said Anne Kerber, senior vice president, Cell Therapy Development, Bristol Myers Squibb. “This acceptance from the FDA brings us one step closer to delivering a practice-changing treatment for primary refractory or relapsed large B-cell lymphoma, making Breyanzi available to more patients in need, and underscores the advancements we’re making in cell therapy research to transform the lives of patients with difficult-to-treat blood cancers, including lymphoma.”
Click here for more Regulatory News
Trial Results
Enhertu significantly improved both PFS and OS in Ph 3 DESTINY-Breast04 trial in patients with HER2-low metastatic breast cancer
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca said: “Today’s historic news from DESTINY-Breast04 could reshape how breast cancer is classified and treated. A HER2-directed therapy has never-before shown a benefit in patients with HER2-low metastatic breast cancer. These results for Enhertu are a huge step forward and could potentially expand our ability to target the full spectrum of HER2 expression, validating the need to change the way we categorise and treat breast cancer.”
Lumakras® (Sotorasib) Shows Encouraging And Clinically Meaningful Anticancer Activity In Patients With KRAS G12C-Mutated Advanced Pancreatic Cancer In Codebreak 100 Trial
"Based on these exciting data, we are expanding CodeBreaK 100 to enroll more patients with pancreatic and other tumor types to better understand the efficacy and safety of LUMAKRAS in tumors outside of non-small cell lung and colorectal cancers," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "CodeBreaK is the largest and broadest global clinical trial program to date with one of the most robust, centrally reviewed datasets. As we learn more from the extensive data that we collect, we'll continue to invest in the program by expanding cohorts and exploring new combinations so that we can help as many patients as possible."
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Trial/Program Status
Enrollment paused in Ph 1 ATA2271 Autologous CAR T Trial
“The safety of every patient participating in studies we are funding or conducting is of the utmost priority for Atara,” said Jakob Dupont, MD, Head of Global Research & Development at Atara. “Clinical evaluation of the case remains ongoing, and we are working closely with investigators at MSK, who are conducting the ATA2271 study under their IND, to establish the underlying causes of the event. We anticipate providing a further update in the coming weeks following further discussion and consultation with MSK.”
Progress Reported in Ongoing Ph 2 Clinical Trial with Vilobelimab in Cutaneous Squamous Cell Carcinoma
“We are pleased to see the progress in our first oncology study with vilobelimab and that there are to date no safety concerns in either arm,” said Dr. Korinna Pilz, Global Head of Clinical Research and Development at InflaRx. “Scientific data suggest C5a involvement in tumor formation and progression, as well as in immunosuppression, and there is pre-clinical evidence of synergies between PD-1 and C5a/C5aR inhibitors in inducing anti-tumor responses. While there are PD-1 checkpoint inhibitors approved for the treatment of advanced cSCC, there currently are no treatment options for patients who are PD-1 checkpoint inhibitor resistant or refractory. We look forward to continuing to advance the development of vilobelimab with the hope of bringing a new therapy to treat the advanced stages of this potentially deadly skin cancer.”
Click here for more Trial/Program Statuses
Conference Coverage: 2022 ASCO GU Cancers Symposium
  1. Arvinas PROTAC® Protein Degrader Bavdegalutamide (ARV-110) Continues to Demonstrate Clinical Benefit in Men with mCRPC
  2. Janssen Presents New Data Demonstrating the Combination of Niraparib and Abiraterone Acetate Plus Prednisone Significantly Improved Radiographic PFS as a 1L Therapy in Patients with HRR Gene-Mutated mCRPC
  3. Long-Term Follow-Up Data Reinforce Continued OS Benefit of BAVENCIO® (avelumab) 1L Maintenance Treatment in Patients with Advanced Urothelial Carcinoma
  4. LYNPARZA® (olaparib) Plus Abiraterone Reduced Risk of Disease Progression or Death by 34% Versus Abiraterone in 1L mCRPC, Regardless of Biomarker Status
  5. New ERLEADA® (apalutamide) Analysis Demonstrates Rapid, Deep Prostate-Specific Antigen (PSA) Response in Patients with mCSPC
  6. Opdivo® (nivolumab) + CABOMETYX® (cabozantinib) Combination Demonstrates Continued Survival Benefits with Over Two Years of Follow-Up in the CheckMate -9ER Trial in 1L Advanced RCC
  7. Poseida Therapeutics to Present Interim Results from Ph 1 Trial of P-PSMA-101
  8. Positive Results from Ph III ARASENS Trial Shows NUBEQA® (darolutamide) Plus Androgen Deprivation Therapy (ADT) and Docetaxel Significantly Increases OS in Patients with mHSPC
  9. Results from Ongoing Ph 1/2 CYPIDES Trial of ODM-208 Presented
  10. Seagen and Astellas Announce Initial Results of PADCEV® (enfortumab vedotin-ejfv) in Patients With MIBC Not Eligible for Cisplatin Chemotherapy
  11. Veru to present Updated Data from the Ph 1b/2 Sabizabulin Study in Men with Metastatic Castration Resistant Prostate Cancer
MedNess Business
Onco-News
Avalon GloboCare Expands its Cellular Immuno-Oncology Platform with the Addition of Novel Chimeric Antigen Receptor-Natural Killer (CAR-NK) Cell Therapies
“CAR-NK represents a powerful and innovative tool in the fight against cancer, and we believe our mRNA-based FLASH-CAR™ platform will enable us to develop best-in-class therapies,” said David Jin, M.D., Ph.D., President and Chief Executive Officer of Avalon GloboCare. “We are especially pleased to welcome Dr. Dongfang Liu to our Scientific and Clinical Advisory Board.  Dr. Liu will become an invaluable part of the team in expanding and supporting Avalon’s pipeline. We also appreciate the support of our world-class clinical partners, including the researchers and clinicians at the prestigious Lu Daopei Hospital, as we develop our cellular immuno-oncology programs for hematologic malignancies as well as other unmet medical needs,” added Dr. Jin.
 
Collated by: Richa Tewari, PhD 
Editors' Desk
Richa Tewari, PhD
Oncology News
Debarati Banik
HealthIT
Sohini Dutta
BioPharma News
MedNess Plus
Manoj Mishra
Neuroimmunology and immunotherapies
Darpan Chakraborty
Social Media Manager
IP & BioPharma News
 
Nisha Peter, PhD
Consulting Editor

 
Shalini Roy Choudhury
Genes and Therapy
Managing Editor
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Content Editors: Richa Tewari , Esha Sehanobish , Rinki Saha ,  Shilpa Rawal, PhD ,  Debarati Banik  , Divyaanka Iyer , Arundithi Ananthanarayanan and Abhinav Dey 
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