7
Jan
2019
Tag: cell therapy
15
Oct
2018
Bionest
Gene Therapy Update Part 2
Last week we wrote about recent news in the field of CRISPR/Cas9 research. But CRISPR is not the only approach to gene editing under development, nor the most advanced. First Human Gene Editing Data — But Not from CRISPR Sangamo Therapeutics, Inc. has been developing an approach to gene editing based on zinc...
7
May
2018
Bionest
New Contender in Race to Develop Allogeneic CAR-T Treatments
Just months after negotiating the sale of autologous CAR-T pioneer Kite Pharma to Gilead for $11.9 billion, two of the executives who led Kite to success are back with a new company, a clinical-stage asset, and a portfolio of 16 preclinical therapeutic candidates, as well as substantial financing. This time, the focus is the development...
9
Nov
2017
Bionest
Gene Therapy for Inherited Retinal Disease Achieves a Historic Milestone
This has been an amazing year in the world of drug development, with three new therapeutic classes marking historic gains. We first saw Novartis’ FDA approval for the first CAR-T immunotherapy. Then Alnylam’s RNAi treatment achieved Phase 3 success, the first such for that class of therapeutics. Most recently, Spark Therapeutics received a unanimous recommendation...
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...
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...
17
Jul
2017
Bionest
Gene Therapy: Coming of Age Perhaps, but Who Will Pay?
New technologies tend to go through cycles of interest and attention. Initial excitement about the potential of a technological advance too often builds to over-blown hype, followed by a quick reversal of interest in the aftermath of a big disappointment. But if continued research later produces truly encouraging results, interest can build again as time...
12
Jul
2017