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JP Morgan 2016 - Day 3
January 13, 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:
- PTC Therapeutics (PTCT) expects approval of Translarna in Duchenne muscular dystrophy in mid-2016. Just before the start
of the conference, they had announced completion of the rolling NDA submission.
- Enanta (ENTA) announced nomination of FXR agonist EDP-305 as their developmental candidate for NASH (nonalcoholic
steatohepatitis) and PBC (primary biliary cirrhosis). The Company is currently on track to initiate clinical trials in 2016. In preclinical data
presented, EDP-305 was more potent than obeticholic acid (OCA, the active ingredient of INT-747) on FXR activation, and in the STAM
mouse model, there were suggestions it may have an advantage on hepatocyte ballooning and the NAFLD activity score at a similar
dose.
- Esperion (ESPR) reiterated the FDA has never told them they will need a CV outcomes trial completed before approval of
ETC-1002—just that it must be well underway—but said they will only be able to disclose Phase III plans in Q2 2016, after discussions
with the agency. Their focus is on statin intolerant patients, for which no drugs have previously been formally approved.
- Clovis (CLVS) gave reassurance that their next-generation EGFR inhibitor, rociletinib, would both gain approval this year
and be able to compete with Tagrisso (AZN), which beat it to market late last year. Officials did suggest that an ODAC is a distinct
possibility, perhaps in April, but were not sure what questions the FDA would have given the rather straight-forward nature of the single-
arm study. They also suggested that both Tagrisso and rociletinib would be viewed relatively comparable on efficacy in the relevant US
population, and competition with thus likely come down to the different safety profiles (namely rash vs hyperglycemia).
- Earlier this week, Juno (JUNO) announced the acquisition of AbVitro and its single-cell sequencing technology which it is
planning to use to refine its development of T-cell therapies. The company had few other major updates but did seem well-focused on a
singular goal of developing CAR-T therapies for hematologic cancers. Indeed, officials highlighted the difficulty in addressing solid
tumors with CAR-Ts. They similarly suggested an allogeneic therapy would be extremely difficult. Lastly, the company noted that it had
developed an in-house mouse model to study neurotoxicity issues.
- Array (ARRY) suggested that binimetinib NEMO data would probably be presented at ASCO, and OS data would be included
if mature. Filing for binimetinib should also come in the first half of 2016. Officials also highlighted the potential of selumetinib in
neurofibromas.
- Infinity (INFI) and AbbVie (ABBV) reiterated that key top-line data from the duvelisib program in lymphoma are expected later this year. Results from the Phase II DYNAMO study in indolent NHL will be reported in early Q3, followed by an interim analysis from the Phase III DUO study in CLL during the second half of 2016. Both companies are also collaborating on a combination therapy of duvelisib and ABBV’s venetoclax which is slated to advance into a clinical study this year.
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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