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MedNess: bite-size biopharma and medtech news

20th April, 2022
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MedNess This Week
HIGHLIGHTS
 
Drug Approvals
China NMPA Approves Tislelizumab for Patients with Second-Line Esophageal Squamous Cell Carcinoma
“As a second-line treatment for patients with ESCC, this differentiated checkpoint inhibitor demonstrated significant improvements in overall survival and was generally well-tolerated in our Phase 3 trial of tislelizumab,” commented Mark Lanasa, M.D., Ph.D., Senior Vice President, Chief Medical Officer, Solid Tumors, at BeiGene. “Tislelizumab regulatory submissions in this indication submitted by Novartis are under review by the U.S. FDA and the European Medicines Agency, highlighting our commitment to advancing its progress on behalf of the many patients around the world with ESCC and other forms of cancer.”
Regulatory News
FDA granted Fast Track status to Bria-IMT for the treatment of metastatic breast cancer
“We are grateful for the opportunity to accelerate the development of our novel immunotherapy in advanced breast cancer. We continue to move forward with the clinical evaluation of Bria-IMT™ towards a potential registration study to bring hope to patients living with this deadly disease,” said Dr. Del Priore, BriaCell’s Chief Medical Officer.
 
FDA Partial Clinical Hold for TakeAim Lymphoma Study of Emavusertib (CA-4948)
"We reiterate our previous comments: we are committed to ensuring the safety of patients in our studies and to working collaboratively with the FDA to develop therapies that meaningfully improve and extend patients' lives," said James Dentzer, Chief Executive Officer of Curis. "Given the clinical profile of emavusertib observed to date, we are hopeful that the study can be resumed soon, after appropriate review. We continue to be confident in the potential of emavusertib to address the high unmet need of patients with B-cell cancers, AML, or MDS."
Click here for more Regulatory News
Trial Results
IRC Determines BRUKINSA® (Zanubrutinib) Demonstrates Superior ORR Versus Ibrutinib in Final Response Analysis of ALPINE Trial in CLL
“We are pleased to announce updated topline data from the Phase 3 ALPINE trial for BRUKINSA, which demonstrated a superior overall response rate versus ibrutinib in CLL patients who have seen their disease return or spread after prior therapy,” said Dr. Lai Wang, Global Head of Research & Development at BeiGene. “We understand that for people living with CLL and their families, relapse and treatment resistance are especially devastating. That's why we are encouraged by this final response analysis, which adds to the growing body of clinical evidence for BRUKINSA as a potential treatment for CLL.”
Topline Results for Epcoritamab (DuoBody®-CD3xCD20) from Ph 1/2 Trial in Patients with Relapsed/Refractory Large B-cell Lymphoma (LBCL) Announced
"Together with our partner, AbbVie, we will work with regulatory authorities to determine next steps and continue to evaluate epcoritamab in a variety of clinical trials as a potential treatment option for patients with various hematological malignancies," said Jan van de Winkel, Ph.D., chief executive officer, Genmab. "We look forward to sharing the findings at a future medical meeting."
Trial/Program Status
Development of ONCT-216 Deprioritized to Focus Resources on Ph 3 Trial for Zilovertamab in the Treatment of Mantle Cell Lymphoma
“This asset prioritization allows us to further sharpen our focus on hematological malignancies and prostate cancer, while deploying our capital towards meaningful catalysts as we navigate this historically challenging pandemic, geopolitical and capital markets macroenvironment,” said James Breitmeyer, MD, PhD, Oncternal’s President and CEO. “We believe this focused approach, along with prudent cash management, will enable us to fund our operations well into the third quarter of 2023, as we continue to explore all potential sources of capital to enable us to reach our milestones.”
Ph 2 Trial of IO102-IO103 in Combination With KEYTRUDA® (pembrolizumab) as First-Line Treatment in a Multi-Arm Basket Trial initiated
“Initiating this study with IO102-IO103 further progresses our late-stage development program,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. “We believe IO102-IO103 has the potential to show utility for multiple cancer indications. We look forward to expanding our dataset in these additional indications.”
Click here for more Trial Statuses
Conference Coverage: AACR 2022
  1. Apexigen Announces New Data from a Ph 2 Trial Evaluating Sotigalimab in Combination with Pembrolizumab in Patients with Metastatic Melanoma
  2. BeiGene to Present Clinical Results and Biomarker Data on Tislelizumab in Solid Tumors
  3. BioNTech Presents Positive Preliminary Phase 1/2 Data for First-in-Class CAR-T Program BNT211
  4. CG Oncology Presents Interim Ph 2 Data with CG0070 in Combination with KEYTRUDA® (pembrolizumab) in NMIBC Unresponsive to Bacillus Calmette-Guerin
  5. Coherus and Junshi Biosciences Present Results of Ph 3 Study of Toripalimab in First Line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma
  6. IO Biotech Announces Presentation of New Data from MM1636 Ph 1/2 Clinical Trial
  7. Lumakras® (Sotorasib) Codebreak 100 Study Shows Two-Year Overall Survival Of 32.5% In Patients With KRAS G12C-Mutated Advanced NSCLC
  8. Neoadjuvant Opdivo (nivolumab) with Chemotherapy Significantly Improves EFS in Patients with Resectable NSCLC in Ph 3 CheckMate -816 Trial
  9. Novartis announces early clinical data for unique KRASG12C inhibitor
  10. Sumitomo Pharma Oncology Presents New Data from Investigational Pipeline of Novel Cancer Therapeutics
  11. Three Year Follow-Up Data from Ph 3 CROWN Trial of LORBRENA® (lorlatinib) Confirm Prolonged PFS in First-Line ALK-Positive Advanced Lung Cancer
MedNess Business
Onco-News
Nektar and BMS to end the global Clinical Development Program for Bempegaldesleukin (BEMPEG) in Combination with Opdivo (nivolumab)
“As a leader in developing innovative therapies for patients with cancer, we are committed to continuing to explore novel combinations and pathways and advancing research that may help cancer patients achieve better outcomes,” said Jonathan Cheng, senior vice president and head of oncology development, Bristol Myers Squibb. “We are immensely grateful to the patients and investigators who participated in these studies.”
GSK reaches agreement to acquire late-stage biopharmaceutical company Sierra Oncology for $1.9bn
Luke Miels, Chief Commercial Officer, GSK said: “Sierra Oncology complements our commercial and medical expertise in haematology. Momelotinib offers a differentiated treatment option that could address the significant unmet medical needs of myelofibrosis patients with anaemia, the major reason patients discontinue treatment. With this proposed acquisition, we have the opportunity to potentially bring meaningful new benefits to patients and further strengthen our portfolio of specialty medicines.”
Collated by: Richa Tewari, PhD 
Editors' Desk
Richa Tewari, PhD
Oncology News
Debarati Banik
HealthIT
Sohini Dutta
BioPharma News
MedNess Plus
Shalini Roy Choudhury
Genes and Therapy
Managing Editor
Nisha Peter, PhD
Consulting Editor
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The editors take care to share authentic information.  In case of any discrepancies please write to medness.newsletter@gmail.com
The sponsors do not have any influence on the nature or kind of the news/analysis reported in MedNess. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of Medness. Examples of analysis performed within this article are only examples. They should not be utilized in real-world analytic products as they are based only on very limited and dated open source information. Assumptions made within the analysis are not reflective of the position of anyone volunteering or working for Medness. This blog is strictly for news and information. It does not provide medical advice, diagnosis or treatment nor investment suggestions. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
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Content Editors: Richa Tewari , Esha Sehanobish , Rinki Saha ,  Shilpa Rawal, PhD ,  Debarati Banik  , Divyaanka Iyer , Arundithi Ananthanarayanan and Abhinav Dey 
Concept and Design: Ananda Ghosh and Nisha Peter
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