News briefing: Merck preps FDA pitch after adding more data on V114; Bristol Myers, Exelixis get quick review for cancer combo
Merck has new data out from two Phase III trials on its pneumococcal conjugate vaccine candidate covering 15 different serotypes.
The program, dubbed V114, was tested in the first study in healthy adults aged 50 or older, with patients receiving either the experimental vaccine or the approved Prevnar 13, followed by Merck’s Pneumovax 23 vaccine one year later. After that period, immune responses were comparable in both vaccination groups for the 15 serotypes in V114.
In the second trial, which studied the V114 vaccine in adults between 18 and 49 years old with underlying medical conditions associated with higher risks of pneumococcal disease, Merck’s candidate saw comparable immune responses to Prevnar 13 in the 13 overlapping serotypes. V114 also showed higher immune responses in the two serotypes not included in the Prevnar vaccine — 22F and 33F — 30 days after vaccination.
Those two additional serotypes are among the most common causes of invasive pneumococcal disease in adults older than 65 out of more than 90 total serotypes. Merck said its plans to file with the FDA for approval before the end of the year remains on track. — Max Gelman
Armed with stellar PhIII, Bristol Myers, Exelixis are flagged into the FDA’s fast lane
The FDA is offering swift action on the application to combine Opdivo and Cabometyx for advanced renal cell carcinoma. The partners picked up a priority review for their pitch, with a PDUFA date of Feb. 20.
Given their track records, though, regulators may not require all that time to make a decision.
The developers submitted data from the Phase 3 CheckMate -9ER trial to back their application. The collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI) at ESMO, marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis. — John Carroll
Reverse merger adds radiation defense to immunomodulation player’s menu
Immunomodulation-focused biotech Cytocom is merging with Cleveland BioLabs to grab a spot on Nasdaq — and expand its already-broad portfolio even further.
While the new company will be named Cytocom, Cleveland BioLabs’ lead candidate, entolimod, will remain in the pipeline for further development in cancer and radiation defense. Meanwhile, Cytocom will continue to develop its four late-stage programs for Crohn’s disease, fibromyalgia, multiple sclerosis and pancreatic cancer.
That makes Cytocom, which was founded on a platform dubbed Advanced Immunomodulating Multi-receptor System, officially a player in acute radiation injury, oncology, infectious disease, inflammation and autoimmune-mediated conditions.
“We plan to utilize the combined platform to further drive value with additional clinical and commercial products and continue to seek strategic partnerships and acquisitions,” CEO Michael Handley said in a statement.
Just a few months ago he engineered an all-stock deal to buy out a subsidiary of the contract research organization ImQuest, bagging new tools for internal drug discovery and development. — Amber Tong
Science 37 and Signant partner on virtual clinical trials
Science 37 and Signant Health are teaming up to pave the way for virtual central nervous system-focused clinical trials.
The partnership will combine Science 37’s technology and network of patients, telemedicine staff, central raters and mobile nurses with Signant’s electronic clinical outcomes assessment software and randomized and trial supply management (RTSM) technology. As a result, patients will have more options for participating in clinical trials, including virtual and hybrid models.
The goal, according to Science 37 CEO David Coman, is to “bring clinical trials to patients.”
“Out of necessity, our industry has accelerated the pathway to digitally enabled clinical trials,” Signant CEO Roger Smith said in a statement. “That’s why we are proud to partner with Science 37 and help all clinical trial stakeholders continue the progress we have collectively made in clinical trial conduct.” — Nicole DeFeudis