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MedNess: bite-size biopharma and medtech news

11th August, 2021
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MedNess This Week
HIGHLIGHTS
Regulatory News

FDA Accepts for Priority Review the sNDA for CABOMETYX® for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer
“The FDA’s acceptance of our sNDA with Priority Review is an important step toward our goal of bringing CABOMETYX to patients with previously treated radioactive iodine-refractory differentiated thyroid cancer,” said Michael M. Morrissey, Ph.D., Exelixis’ President and Chief Executive Officer. “Considering the lack of a standard of care in the treatment of this cancer following anti-VEGFR therapy, the progression-free survival benefit demonstrated in the phase 3 COSMIC-311 pivotal trial means CABOMETYX, if approved, could become an important new treatment for these patients.”
US FDA grants Priority Review to Tecentriq as adjuvant treatment for patients with early PD-L1+ve NSCLC
“New treatment options are urgently needed in early-stage non-small cell lung cancer to help the nearly 50% of people who currently experience a recurrence following surgery,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Tecentriq is the first cancer immunotherapy to show a clinically meaningful benefit in the adjuvant lung cancer setting, and we’re working closely with the FDA to bring this significant advancement to patients as quickly as possible.”
Trial Results
Phase 3 Trial of Libtayo® (cemiplimab-rwlc) Combined with Chemotherapy Stopped Early Due to Significant OS Improvement in 1L NSCLC Patients
"Libtayo in combination with chemotherapy increased median overall survival to 22 months in patients with advanced non-small cell lung cancer, compared to 13 months with chemotherapy alone," said Miranda Gogishvili, M.D., an oncologist at the High Technology Medical Center, University Clinic, in Tbilisi, Georgia and a trial investigator. "Notably, the Phase 3 trial enrolled patients with a variety of challenging-to-treat disease characteristics, as well as those with locally advanced disease. These data add to the growing body of evidence supporting Libtayo in advanced non-small cell lung cancer, which also includes the pivotal results for Libtayo monotherapy in cases of high PD-L1 expression."
Adjuvant KEYTRUDA® Significantly Prolonged RFS vs placebo for Patients With Stage II Resected High-Risk Melanoma in Ph 3 KEYNOTE-716 Trial
 “KEYNOTE-716 is the first Phase 3 study to evaluate adjuvant therapy solely for stage IIB and IIC melanoma – an area with high unmet need,” said Dr. Jason Luke, director, Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center. “By moving immunotherapy with KEYTRUDA to earlier stages of melanoma, we have the opportunity to reduce the risk of recurrence for high-risk stage II patients compared to observation alone following complete resection.”
     Click here for more Trial Results
Trial/Program Status
FAILED TRIAL: Istodax PTCL indication withdrawn After Ph 3 Trial Failed to Show Progression-Free Survival Improvement
“While the outcome of the confirmatory study in peripheral T-cell lymphoma is disappointing, Bristol Myers Squibb will continue to provide Istodax for patients with cutaneous T-cell lymphoma, where it remains an approved and important treatment option,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Hematology Development, Bristol Myers Squibb. “As always, our efforts across blood cancer research and development remain centered on delivering better outcomes for patients in need.”
First Patient dosed For Triple Combination (efti + anti-PD-1 + chemo) in INSIGHT-003 trial
CSO and CMO Dr.  Frédéric  Triebel said:  “INSIGHT-003  is the first time a  triple combination therapy consisting of efti plus anti-PD-1 plus chemo is administered. We are evaluating how efti might boost an approved chemotherapy and anti-PD-1 combination therapy, looking at safety and initial activity. Dosing the first patient in this trial is a significant milestone and it sets the wheels in motion for reporting first data which are currently anticipated in 2022.”
     Click here for more Trial/Program Statuses
MedNess Reviews
University of Pittsburgh’s inhalable anti-COVID nanobodies shows promising activity against delta variant 
Back in May, researchers at the University of Pittsburgh School of Medicine published promising preclinical research on a novel inhalable therapy for the treatment of the COVID-19 virus based on nanobodies. However, with the emergence of newer variants of the virus such as the delta strain, the researchers conducted further separate studies to determine if the therapy might be effective against the variants. 
In their recent findings reported in Nature Communications, the researchers now show evidence that that the drug and other treatments like it can disarm the virus using one of three possible strategies, making them effective against COVID-19 variants.
In their study the researchers initially demonstrated that nanobodies- tiny fragments of antibodies – raised against the were able to clear the virus from the lungs of hamsters within 10 days when administered by inhalation. For the new study to test the efficacy of the nanobodies against the new strains of the virus, the Pitt researchers worked with a team at Case Western Reserve University to study how eight of the most potent nanobodies they isolated interact with SARS-CoV-2, and how variants affect those interactions. They used a high-resolution imaging technology called cryoelectron microscopy to record the interactions.
They observed that the nanobodies used three pathways to neutralize the COVID variants. One group prevented the spike protein from attaching to the cell by interacting with a binding site on healthy cells and thus preventing the virus from entering. A second group of nanobodies bound to part of the spike protein that seems to stay constant across SARS-CoV-2 and all its variants, as well as other coronaviruses, giving the drugs the ability to broadly neutralize many iterations of virus. And the third group targeted a region of spike that’s inaccessible to larger antibodies, preventing entry to healthy cells.
Nanobodies could offer several advantages over larger antibodies being used or studied to gith COVID-19 and other diseases. In the May study in hamsters, the Pitt researchers showed that smaller doses of one of the nanobodies they isolated could be given as an inhalation in the nose. 
Nanobodies against SARS-COV-2 developed by Twist Bioscience are also showing positive results in in-vivo hamster studies.
MedNess Business
Onco-News
F-star Therapeutics and MSD to Evaluate FS120 in Combination with KEYTRUDA
Louis Kayitalire, Chief Medical Officer of F-star, said “This partnership with MSD represents a significant milestone for our FS120 Phase 1 trial as F-star looks to transform the care of those patients with cancer who have limited treatment options. FS120 offers an opportunity to improve upon current treatment paradigms, either as a monotherapy or in combination. In preclinical studies, FS120 has demonstrated strong additive effects in combination with PD-1 monoclonal antibodies. We look forward to working with MSD to evaluate the potential combined effect of FS120 with KEYTRUDA as we strive to improve the quality of life and duration of response for patients with difficult to treat cancers.”
BioInvent and Merck to Evaluate BI-1808 + KEYTRUDA in Patients with Advanced Solid Tumors
“We are very pleased we have reached a second collaboration with MSD that supports the expansion of the clinical trial program with our anti-TNFR2 antibody BI-1808. The Phase 1 component is already enrolling patients who receive BI-1808 as a single agent. We are excited about the potential synergistic activity of BI-1808 in combination with pembrolizumab and this agreement supports the strong interest elicited by our broadening pipeline of anti-cancer antibodies,” said Martin Welschof, CEO of BioInvent.
Click here for more on mergers, acquisition and business news
Collated by: Richa Tewari, PhD
Editors' Desk
Richa Tewari, PhD
Oncology News
Shilpa Rawal, PhD
Onco I-Analyse
Arundithi Ananthanarayanan
MedNess Reviews
Divyaanka Iyer
BioPharma News
Debarati Banik
HealthIT
Darpan Chakraborty
Social Media Manager
Nisha Peter, PhD
Consulting Editor
Abhi Dey
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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