21
Nov
2017
Tag: immunotherapy
13
Nov
2017
Bionest
Kite Gains First Adult CAR-T Approval
Less than two weeks following the closing of Gilead’s acquisition of the company, Kite Pharma’s CAR-T immunotherapeutic, axicabtagene ciloleucel, has gained approval from the U.S. Food and Drug Administration as the first CAR-T therapy for an adult indication. The approval, which came more than a month ahead of the expected FDA decision date, is for...
17
Oct
2017
Bionest
ESMO 2017 — Part 2: Building on Biomarkers
The news from ESMO in September once again has highlighted the utility and need for biomarkers to help determine not only who will likely benefit from a particular immuno-oncology (IO) treatment, but also who may require a combination of such therapies right from the start. While higher levels of PD-L1 have generally correlated with...
27
Sep
2017
Bionest
New Big Data Initiatives in Oncology
As cancer therapy moves towards the concept of “real-time” oncology — the ability to constantly monitor changes in a patient’s disease and adjust treatment accordingly — we see big data and high powered analytical approaches increasingly playing a key role. The aim of such efforts will be to find novel biomarkers and a new understanding...
20
Sep
2017
Bionest
Advances and Set Backs for CAR-T Therapy
Late August and early September was a period of big news — both positive and negative — on the CAR-T front. On the positive side, Novartis’ received the first FDA approval of a CAR-T therapy for Kymriah (tisagenlecleucel), for the treatment of children and young adults with B-cell precursor acute lymphoblastic leukemia that is refractory...
16
Aug
2017
Bionest
Recent Developments in IO – Our Take on a Couple of Key Events
On July 27, AstraZeneca (AZ) disappointed their investors and many immuno-oncology watchers with the results of their MYSTIC trial combining two immunotherapies targeting PD-L1 (durvalumab/Imfinzi) and CTLA-4 (tremelimumab) in newly diagnosed Stage-IV lung cancer patients. The AZ combination therapy failed to show a benefit compared to chemotherapy in a primary endpoint of “Progression-free Survival (PFS).”...
26
Jul
2017
Bionest
CAR-T Nears the Marketplace, with Unanimous Approval Recommendation – but Challenges Remain
On July 12, Novartis’ CAR-T therapy, CTL019 (tisagenlecleucel), received a unanimous recommendation for approval from the reviewing U.S. Food and Drug Administration’s advisory panel for use in the treatment of children and young adults with advanced acute lymphoblastic leukemia (ALL). The FDA is now expected to make its final decision by October 3. CTL019...
12
Jul
2017
Bionest
CRISPR Reaches the Clinic
Sometime mid-month, the first clinical trial employing CRISPR gene editing technology within the human body will initiate in China, at Sun-Yat Sen University. Scientists there will seek to use CRISPR and TALEN, another gene editing method, to treat persistent HPV infection and disable the tumor growth mechanism in infected cells. In a non-invasive approach, scientists...
5
Jul
2017
Bionest
FDA: Thinking “Outside the Box”
On May 17, the U.S. Food and Drug Administration granted an expanded approval to Vertex’s Kalydeco (ivacaflor), tripling the number of mutations in the cystic fibrosis (CF)-associated gene CFTR that the drug can treat, from 10 to 33. The agency’s action was unusual in that, for the first time ever, they based their decision on...
26
Jun
2017