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MedNess: bite-size biopharma and medtech news

12th January, 2022
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MedNess This Week
HIGHLIGHTS
 
Regulatory News

Agreement with U.S. FDA on Ph 3 Registrational Study Design for Zilovertamab in the Treatment of MCL Announced
“The completion of End-of-Phase 2 meetings and consensus on clinical trial design and other program elements mark a meaningful and encouraging milestone for Oncternal Therapeutics,” said James Breitmeyer, MD, PhD, Oncternal’s President and CEO. “The agreement underscores our productive dialogue with the FDA on key elements of our program and the Phase 3 clinical trial design as we align on the potential path to commercialization for zilovertamab, which offers potential advantages to patients suffering from aggressive lymphomas such as MCL. The positive data from our ongoing Phase 1/2 CIRLL study recently presented at ASH 2021 underscore those advantages and are supportive of our registration strategy.”
BLA Submitted to U.S. FDA Seeking Approval of Teclistamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
“Despite all the gains that have been made in treating multiple myeloma, the unmet need still remains very high. Our relentless pursuit of treatments for this disease continues with the same sense of urgency that we have always had,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “We look forward to working with the FDA in their review of our teclistamab submission.”
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Trial Results
Positive topline results from the Ph 1 dose-escalating study of NanoZolid®-formulated docetaxel announced
“We are pleased to see that the study meets its primary endpoint of being safe and tolerable and that the reported adverse events are generally mild and local. The latter is most likely due to the observation of a very low systemic exposure of docetaxel which is in line with our intended local treatment regimen. In addition to meeting the primary endpoint, we also see signs of immune activation by an upregulation of key immune regulating molecules. This is indeed encouraging indicating that the NanoZolid®-formulated docetaxel could have the potential to change the immune microenvironment. We are working hard to finalize our plan forward and will very soon communicate how we intend to take the project further in clinical development.” said Nina Herne, CEO of LIDDS.
Ph 1b KEYNOTE B84 Combination Study of Keytruda® + Pepinemab in Patients with Advanced, Recurrent or Metastatic HNSCC Passed Planned Interim Safety Analysis
“We are very pleased that the interim KEYNOTE B84 safety data indicated that the combination of pepinemab and Keytruda appears to be well tolerated,” stated Maurice Zauderer, Ph.D., President and Chief Executive Officer. “Vaccinex hopes that the combination of pepinemab and an anti-PD-1 therapy for the treatment of advanced R/M HSNCC may result in improved patient benefits. There is strong rationale for development in HNSCC because these tumors express very high levels of SEMA4D and we believe that preclinical data indicated that this contributes to disease pathology. We look forward to progressing with the recruitment of the Phase 2 segment of the trial.”
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Trial/Program Status
First Patient Enrolled in NANORAY-312 Global Ph 3 Registrational Study of NBTXR3 in Head and Neck Cancer
“The first patient enrolled in our global phase III study is a testament to the tireless commitment of our team, investigators, and strategic collaborators,” said Laurent Levy, co-founder and chairman of the executive board at Nanobiotix. “Together, we strive to bring innovation to patients with cancer and our belief is that NANORAY-312 will represent another critical step in making our vision a reality.”
Enrollment Completed in Ph 3 CONTACT-03 Pivotal Trial of Cabozantinib + Atezolizumab in Previously Treated mRCC
“With multiple new treatment options approved for kidney cancer over the last decade, there is a need to better understand how therapies can be used sequentially to help address critical unmet needs for this patient population,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. “Now that CONTACT-03 has completed enrollment, we look forward to sharing initial results when the data mature, which will offer insight into the potential of cabozantinib in combination with atezolizumab for patients who have progressed following treatment with an immune checkpoint inhibitor.”
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MedNess Business
Onco-News
Genprex Expands Gene Therapy Oncology Pipeline to Include SCLC
“Data from human studies indicate that REQORSA could be beneficial in targeting small cell lung cancer,” said Mark S. Berger, MD, Chief Medical Officer at Genprex. “Like non-small cell lung cancer, small cell lung cancer consistently has low TUSC2 protein levels and is documented to often have deletion of one TUSC2 gene allele. Extensive stage small cell lung cancer has a very poor prognosis, with a median progression free survival of 5.2 months. Expanding the therapeutic indications targeted by REQORSA to include small cell lung cancer may provide us with another important clinical opportunity to combine REQORSA with small cell lung cancer therapies, including checkpoint inhibitors.”
AVEO Oncology Announces Clinical Trial Collaboration and Supply Agreement with Merck to Evaluate Ficlatuzumab + ERBITUX®b in Patients with Recurrent or mHNSCC
“This collaboration with Merck KGaA, Darmstadt, Germany will play an important role in the advancement of both the ficlatuzumab and cetuximab programs,” said Michael Bailey, president and chief executive officer of AVEO. “The ficlatuzumab and cetuximab combination has demonstrated the potential to play a meaningful part in the treatment of patients with human papillomavirus (HPV) negative R/M HNSCC, which is associated with particularly poor outcomes. We look forward to continuing our dialogue with regulators to finalize the design of a pivotal study, which we now expect to commence in the first half of 2023.” 
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Collated by: Richa Tewari, PhD 
Editors' Desk
Richa Tewari, PhD
Oncology News
Debarati Banik
HealthIT
Darpan Chakraborty
Social Media Manager
IP & BioPharma News
 
Nisha Peter, PhD
Consulting Editor

 
Rinki Saha
BioPharma News
Managing 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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