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MedNess: bite-size biopharma and medtech news

1st June, 2022
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Onco-this-Week
HIGHLIGHTS
 
Drug Approvals
EC Approves KEYTRUDA + Chemo as Neoadjuvant, Then as Adjuvant Monotherapy After Surgery for Locally Advanced or Early-Stage TNBC at High Risk of Recurrence
“Triple-negative breast cancer has a high risk of recurrence within the first five years, so it’s meaningful for patients to have access to new therapies that can reduce the risk of disease progression,” said Dr. Peter Schmid, lead, Centre for Experimental Cancer Medicine, Barts Cancer Institute in London, England. “The approval of this KEYTRUDA regimen marks a turning point for patients with high-risk early-stage TNBC, as they now have an immunotherapy option in early stages of the disease that has demonstrated significant improvements in pathological complete response and event-free survival compared to neoadjuvant chemotherapy.”
FDA approves Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma
"We are proud of today's FDA approval of a third indication for Kymriah. We hope this treatment option that has the potential for long-lasting results may help break the unrelenting cycle of treatment for patients with follicular lymphoma,” said Victor Bulto, President, Novartis Innovative Medicines US. “We are on a mission to build on our pioneering work in cell therapy and continue to innovate for patient impact.”
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Regulatory News
FDA Fast Track Designation Granted to Seribantumab for the Tumor-Agnostic Treatment of Solid Tumors Harboring NRG1 Gene Fusions
"There are currently no approved therapies that specifically target NRG1 fusions, and therefore, receipt of Fast Track designation in a tumor-agnostic setting is a significant step in addressing this unmet need," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "NRG1 fusions are a type of genomic alteration that causes unregulated cell growth and proliferation in a variety of solid tumors, and we look forward to working closely with the FDA as we continue exploring the potential of seribantumab to improve outcomes for patients whose tumor harbors this unique oncogenic driver."
EMA Grants Orphan Drug Designation to CPI-613® (Devimistat) for Treatment of Patients with Advanced Unresectable Biliary Tract Cancer
“We are on a mission to develop cancer treatments for patients who have significant unmet clinical needs. Biliary tract cancer is considered rare and aggressive, with a large gap in effective treatment options,” said Sanjeev Luther, President and CEO of Cornerstone Pharmaceuticals. “Our goal is that this milestone will provide hope for patients and families in a setting where the current prognosis is devastating.”
Trial Results
Positive NX-2127 Dose Finding Data announced in CLL; Advanced to Next Phase of Clinical Development
“Our decision to advance NX-2127 in patients with CLL is based on the promising efficacy, safety, pharmacokinetic, and pharmacodynamic data from the ongoing Phase 1a dose escalation trial. There is a significant unmet need for a therapeutic approach with the potential to address the growing problem of relapse due to the development of BTK inhibitor resistance. We aim to meet that need and are encouraged by the emerging data demonstrating the potential of BTK degradation to treat acquired resistance mutations for both standard of care and newly developed BTK inhibitors,” said Robert J. Brown, M.D., executive vice president of clinical development at Nurix. "We look forward to highlighting the biomarker data and preliminary safety and efficacy data that guided our decision to expand the trial for CLL patients at Nurix’s R&D Day, scheduled for May 26th in New York City, and will provide a full clinical update at a future medical conference in the second half of 2022.”
Preliminary Data Shows Clinical Benefit from Ph 1/2 Trial of Galinpepimut-S (GPS) in Combination with Keytruda® in Patients with WT1+ Advanced Ovarian Cancer
“These early data are an example of a new direction in development of immunotherapy for platinum-refractory ovarian cancer,” commented Jeffrey S. Weber, M.D., Ph.D.; Deputy Director of the Perlmutter Cancer Center at New York University (NYU)-Langone Health; Co-Director of its Melanoma Research Program Center; and Chair of SELLAS’ Scientific Advisory Board. “In patients who failed as many as five lines of previous therapy, with small numbers of patients, the disease control rate and progression free survival that were observed merit further study. The GPS combination with checkpoint blockade, such as pembrolizumab, should be further explored, both in active disease as well as potentially in the setting of maintenance therapy after patients reach minimal residual disease post salvage therapies,” added Dr. Weber.
Trial/Program Status
FDA Removes Partial Clinical Hold on NEON-2 Clinical Trial of Davoceticept (ALPN-202) in Combination with Pembrolizumab
FDA removed the partial clinical hold placed on its NEON-2 trial evaluating davoceticept (ALPN-202), a first-in-class conditional CD28 costimulator and dual checkpoint inhibitor, in combination with pembrolizumab in adults with advanced malignancies.
The FDA removed the hold after review of the Company’s Complete Response, which included a comprehensive review of the davoceticept safety database, as well as a revised investigator brochure and study protocol. As previously disclosed, under the terms of the hold, previously enrolled participants continued to receive study drug, but no new participants could be enrolled until the partial clinical hold was removed. The ongoing NEON-1 study was not subject to the hold.
MedNess Business
Onco-News
Oxford BioTherapeutics Announces Collaboration with Agenus to Support the Clinical Development of OBT076 in combination with Balstilimab
““I am very excited about our new partnership with Agenus, which will allow us to progress the clinical development of OBT076 in combination with balstilimab,” said Christian Rohlff, PhD, Chief Executive Officer (CEO) of Oxford BioTherapeutics. “Our preliminary data suggest that depletion of CD205+ immuno-suppressive cells and subsequent T-cell activation after OBT076 treatment followed by a single cycle of a CPI coincides with the rapid resolution of the primary tumor, as well as metastases, and we believe that balstilimab is the ideal combination agent for these studies.”
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
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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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