Bristol-Myers Squibb hooks the next big immuno-oncology drug in record $3.6 billion deal with Nektar
Nektar Therapeutics has made a record, multibillion-dollar partnership deal with Bristol-Myers Squibb (BMS) for a minority share of its early-stage immuno-oncology drug NKTR-214.
The deal provides BMS with an exclusive development period to pursue a broad new combo development program covering 20 indications involving nine tumors, matching ‘214 with BMS’s two existing immuno-oncology leaders – PD-1 (Opdivo®) and CTLA-4 (Yervoy®).
Furthermore, the deal gives BMS a period of exclusivity on these indications and tumors that extends to a commercial launch or several years after the effective date of the deal. The first trials are already being ramped up with a shot at registrational data that could start rolling in in approximately 18–24 months, according to the Nektar team.
“For years we’ve known how important that pathway was but no one was able to safely access that. This was a singular achievement, a real tour de force of protein engineering,” explained Stephen Doberstein, head of R&D for Nektar.
“There’s a really special synergy between NKTR-214 and the way it basically changes the immune system and how that synergizes with the mechanism of action of Opdivo,” added Jonathan Zalevsky, Nektar’s chief scientific officer.
“We now have three therapies in immuno-oncology,” explained Saurabh Saha, senior vice president and global head of translational medicine at Bristol-Myers: PD-1, CTLA-4 and now ‘214. “The T cell is the warhead against cancer cells,” he concluded.
NICE approves Lenvima® (lenvatinib) in differentiated thyroid cancer
NICE has issued its Final Appraisal Determination (FAD) to recommend Lenvima (lenvatinib) for indviduals with advanced RAI-refractory differentiated thyroid cancer.
The positive NICE recommendation comes after the EMA approved lenvatinib for use almost 3 years ago and the Scottish Medicines Consortium (SMC) approved it for reimbursement in October 2016. This was followed by the All Wales Medicines Strategy Group’s approval in October 2017.
The European Medicines Agency (EMA) approval and subsequent NICE recommendation was based on the pivotal Phase III SELECT study that demonstrated lenvatinib was associated with significant improvements in PFS in patients with progressive RAI-R DTC. Median PFS with lenvatinib was 18.3 months compared to 3.6 months on placebo (HR 0.21; 99% CI 0.14–0.31, p<0.001). In addition, the objective response rate was 64.8% versus 1.5% with placebo (p<0.001).
DiaCarta to expand diagnostic platform following latest funding round
DiaCarta (CA, USA) has announced the completion of its series B funding round, raising $45 million for the expansion of its cancer detection and monitoring technologies.
The funds from the investment are intended to drive growth in the following areas: establishing global clinical study programs, the launch of ColoScape™, an in vitro tool for the detection of colorectal cancer, expansion of Next Generation Sequencing, among other objectives.
Aiguo Zhang, Founder and CEO of DiaCarta, stated; “The Series B financing will support the Company’s core XNA technology platform for early cancer detection, expanding our diagnostic products for non-invasive early detection and monitoring of cancers.”
DiaCarta’s novel QClamp® Xeno-Nucleic Acid (XNA™) is intended as a mutation detection assay, identifying wild-type DNA and silencing mutant DNA. The technology has demonstrated efficacy in sensitive and specific detection, particularly in liquid biopsies.
Cancer Research UK pledges to invest £45 million in clinical trials
Cancer Research UK has announced that £45million will be invested into its network of clinical trials units across the UK, one of the charity’s largest investments in clinical research to date.
The huge sum will be divided over 5 years across eight clinical trials units in Cardiff, Birmingham, Glasgow, Southampton, Leeds and London (at The Institute of Cancer Research, University College London and Queen Mary University of London).
Each year, around 25,000 people take part in a clinical trial that’s supported by Cancer Research UK.
Cancer Research UK’s chief clinician, Charles Swanton commented: “Our clinical research enables us to translate discoveries from the lab in order to improve cancer diagnostics and treatments, giving more patients the best chance of beating their disease.”
Find out about Cancer Research UK’s Grand Challenge projects