Nov. 10 Quick Takes: Tezepelumab meets in asthma Phase III; plus a call for speedy trial results, updates on COVID vaccines from Sinovac, CureVac and more
AZ, Amgen rise on asthma data
Tezepelumab from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Amgen Inc. (NASDAQ:AMGN) met the primary endpoint of a statistically significant reduction in annualized asthma exacerbation rate in the Phase III NAVIGATOR trial to treat patients with severe, uncontrolled asthma. Shares of both companies gained 3% adding billions in market cap on the readout for the anti-TSLP mAb.
NIH asks clinical researchers to share COVID-19 results promptly
NIH Director Francis Collins encouraged the clinical research community to share COVID-19 clinical trial results as quickly as possible on ClinicalTrials.gov — ahead of regulatory deadlines. NIH is prioritizing the processing of COVID-19 submissions to the website and providing on-on-one support to researchers during the process of submitting results.
Brazil halts study of Sinovac COVID-19 vaccine
Brazil’s National Health Surveillance Agency has paused a Phase III trial of a COVID-19 vaccine from Sinovac Biotech Ltd. (NASDAQ:SVA) after a serious adverse event on Oct. 29. Sinovac, which is in discussions with the agency about next steps, said Brazilian partner Butantan Institute believes the SAE is not related to CoronaVac.
CureVac picks pivotal dose for COVID vaccine
CureVac N.V. (NASDAQ:CVAC) plans to test 12 µg CVnCoV in a 36,500-participant Phase IIb/III trial based on interim Phase I data published in medRxiv evaluating 2-20 µg doses. Two weeks after prime-boost administration of the mRNA COVID-19 vaccine at 12 µg, study participants had mean neutralizing titers of 113 as did a panel of convalescent sera from outpatients who had multiple symptoms. Convalescent sera from hospitalized COVID-19 patients had a mean neutralizing titer of 640. The trial will start in the coming weeks.
Praxis tumbles on FDA hold
Neurology play Praxis Precision Medicines Inc. (NASDAQ:PRAX) fell 22% to $27.98 Tuesday after FDA placed a full clinical hold on its IND for lead program PRAX-114 ahead of the start of a Phase II/III trial to treat major depressive disorder. The company said FDA did not provide a reason for the clinical hold on the allosteric modulator of GABA A receptor. Praxis raised $190 million in an IPO on Oct. 16 that saw its shares jump $8.80 (46%) to a first-day close of $27.80.
OncoSec’s IL-2 shows safety, efficacy at SITC
OncoSec Medical Inc. (NASDAQ:ONCS) said Tavo tavokinogene telseplasmid plus Keytruda led to an ORR of 30% in 54 checkpoint inhibitor-resistant metastatic melanoma patients. In the interim analysis of the Phase IIb KEYNOTE-695 study, the DNA plasmid encoding IL-2 led to three (6%) complete responses and no serious adverse events, an improvement over first-generation IL-2 therapies with serious toxicities. Data were shared in an abstract released ahead of the Society for Immunotherapy of Cancer (SITC) meeting.
Lenvima combinations hit in first-line renal cell carcinoma
Merck & Co. Inc. (NYSE:MRK) said the combination of Keytruda pembrolizumab and tyrosine kinase inhibitor Lenvima lenvatinib from Eisai Co. Ltd. (Tokyo:4523) met the primary endpoint of improving PFS over Sutent sunitinib and key secondary endpoints of improving OS and ORR as first-line treatment for advanced renal cell carcinoma (RCC) in the Phase III KEYNOTE-581/CLEAR study. Lenvima plus everolimus also improved PFS and ORR over Sutent. Merck is discontinuing a separate Phase III study evaluating Keytruda plus anti-CTLA-4 mAb Yervoy ipilimumab, KEYNOTE-598, due to futility in patients with PD-L1-high non-small cell lung cancer (NSCLC) lacking genomic alterations in EGFR or ALK.
Early clinical data for Repertoire’s immune therapy
Repertoire Immune Medicines Inc. has revealed that following administration of PRIME IL-15 — a T cell therapy with a cytokine nanogel payload — 10 of 17 metastatic solid tumors patients achieved stable disease and four were stable for more than six months. No toxicities were observed. Further dose escalation is planned for the Phase I/II study.
ALK – Anaplastic lymphoma kinase
CTLA-4 (CTLA4; CD152) – Cytotoxic T-lymphocyte associated protein 4
EGFR – Epidermal growth factor receptor
IL-2 – Interleukin-1
PD-L1 (B7-H1; CD274) – Programmed cell death 1 ligand 1