3
Nov
2017
Tag: business development
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...
21
Aug
2017
Bionest
New Developments on the Alzheimer’s Disease Diagnostic Front — Part I
In July, we attended the Alzheimer’s Association International Conference in London. The big news at the meeting was on the diagnostics front. In the aftermath of the recent string of trial failures, diagnostic tools have become a critical area of focus, in the hopes that patient diagnosis and selection can be improved. Accurately diagnosing...
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
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...
26
Jun
2017
Bionest
Liquid Biopsy – Looking Beyond EGFR
In April, two important reports were published — one in the New England Journal of Medicine, one in Nature — that added evidence in support of liquid biopsy as a means of monitoring for the recurrence of cancer and to predict a patient’s response to adjuvant therapy. Both studies were based on data from the...
20
Jun
2017