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JP Morgan 2016 - Day 4
January 14, 2016
The 34th annual JP Morgan Healthcare Conference is being held in San Francisco, CA from January 11-14, 2016. A list of events and
catalysts that were announced or updated at the conference today is included in this report.
Below are some key points from today’s company presentations:
For our disclosures, please read the BioMed Tracker Research Standards.
Below are some key points from today’s company presentations:
- Kite (KITE) presented new data from its NCI study of KTE-C19 showing consistency of PR/CRs in the total population,
aggressive NHLs, and with its new cell manufacturing process. Notably, the durability of response has remained impressive for this
refractory population. Officials also discussed in depth the neurotoxicity associated with CAR-T therapies, and overall, they appear of
only modest concern since they typically self-resolve in a few days. Next for Kite are interim data from the pivotal ZUMA study and the
initiation of clinical development for its T-cell receptor therapies in 2016.
- Dynavax (DVAX) reviewed efficacy and safety data from the recent HBV-23 trial for Heplisav-B, their hepatitis B vaccine.
New details were released showing more Bell’s palsy cases in the Heplisav-B arm of HBV-23. When the data from all safety trials were
analyzed, the imbalance was smaller and statistically insignificant with incidences of 0.07% and 0.05% in the Heplisav-B and Engerix-B
arms, respectively.
- The company reiterated that they will resubmit the BLA for Heplisav-B by the end of the quarter. They expect their first product launch by the end of the year. As of September 30, 2015 the company had $220.7 million in cash and equivalents which they expect will carry them until they see revenue from Heplisav-B.
- The company also presented new details on SD-101, a Toll-Like Receptor 9 (TLR9) agonist. A Phase Ib dose escalation study (MEL- 01) for SD-101 combined with the Merck PD1 inhibitor pembrolizumab in patients with metastatic melanoma has started enrollment. Complete enrollment is expected by Q3. Expansion studies are expected to initiate enrollment in Q316. There are two additional SD- 101 studies that are planned for Q416: SD-101 with pembrolizumab in an additional tumor type and SD101 with an undisclosed checkpoint inhibitor.
- Officials from beleaguered Aegerion (AEGR) acknowledged that the launch of the less expensive PCSK9 inhibitors has reduced the number of patients on Juxtapid and it was still difficult to tell what the ultimate impact would be (they estimated PCSK9 inhibitors accounted for half of a roughly 20% drop over 2015). They are trying to understand the cycle time for patients who may not be able to meet goals on PCSK9 inhibitors and resume Juxtapid. They also plan to start a Juxtapid-PCSK9 inhibitor combination study in Q2 and review the size of their customer facing organization.
For our disclosures, please read the BioMed Tracker Research Standards.
| Disease Group Covered: |
Autoimmune/immunology
Cardiovascular Dermatology Endocrine Gastroenterology (Non Inflammatory Bowel Disease) Hematology Infectious Disease Metabolic Neurology Oncology Ophthalmology Psychiatry Renal Respiratory Rheumatology (Non Autoimmune) |
| Indications Covered: | Dysmenorrhea |
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