This report provides a comprehensive list of events and catalysts that were added or updated at the 33rd Annual J.P. Morgan Healthcare Conference in San Francisco. A free copy can be downloaded via the form on the right. Key Events Included in this Report:

• Rociletinib for NSCLC; Rucaparib for Ovarian Cancer (CLVS). Clovis provided updated FDA filing timelines and development plans for rociletinib in non-small cell lung cancer and rucaparib in ovarian cancer. The company reiterated plans to file for FDA and EMA approval for rociletinib in T790M mutation-positive NSCLC patients in mid-2015, based on data from the TIGER-2 and TIGER-X (Phase II expansion) trials. Qiagen (QGEN) is working with Clovis to develop a companion diagnostic to test for T790M mutations. Furthermore, the company is now developing rociletinib in the larger population of T790M-negative patients, cohorts of whom are being added to the TIGER-2 and TIGER-3 trials. Patients without biopsied T790M mutations may benefit from rociletinib treatment due to tumor heterogeneity or due to the agent’s inhibition of IGF-1R, since the IGF pathway may play a pro-proliferative role in patients with acquired resistance to EGFR TKIs.
  
  In addition, the company now plans to file for FDA approval of rucaparib in ovarian cancer with a “BRCAness” signature in 2016, based on results from the expanded Phase II ARIEL2 trial. Clovis is working with Foundation Medical (FMI) to develop a companion diagnostic to test for BRCA and other DNA repair mutations.
  
  
• BMN 190 for Neuronal Ceroid Lipofuscinosis (BMRN). BMN 190 demonstrated stability versus matched natural history controls in a small Phase I/II study of CLN2, a late infantile form of Batten Disease. The company hopes to file on the data. While their chances depend on how comparable agencies believe the natural history data is, graphs showing consistency against a number of different matched controls were intriguing.
• VX-661 for Cystic Fibrosis (VRTX). Vertex released additional details about the VX-661 + ivacaftor Phase III program and announced it is to start in February. The program will include only one F508del homozygous study, but also additional heterozygous trials in patients with a gating mutation, residual function mutations, and minimal CFTR function. Phase IIb data from the double combination in F508del homozygous patients is expected to be released early this year, and officials additionally said a much anticipated trial with a next- generation corrector added to the double combination will also start this year.
• Keytruda for Non-Small Cell Lung Cancer (MRK). Merck added more pressure to the hotly-contested race to develop PD-1 immunotherapies by announcing plans to accelerate their timeline for Keytruda (lambrolizumab) in NSCLC. A BLA filing is now planned for mid-2015 which would put a potential approval much closer the anticipated approval for Opdivo near year end 2015.
• Imbruvica for Solid Tumors (PCYC). Imbruvica has been very successful in NHL, already gaining approval in both MCL and CLL. However, at the JPM session, the company suggested plans to evaluate the drug for solid tumors which would open up much larger markets for the pioneering BTK inhibitor.
• BART for Alzheimer’s Disease (BIIB). At the Deutsche Bank BioFEST conference last month, promising data were disclosed that the drug had shown a significant effect in cognition in a large Phase Ib study. However, the measures used to determine cognitive improvement were not detailed. At JPM, it was mentioned that the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) and the Mini-mental state Examination (MMSE) were the specific endpoints.
  
  Biogen also announced that it is acquiring Convergence Pharmaceuticals with the acquisition centered on the development of CNV1014802 being developed for neuropathic pain. Positive data from a Phase II study in patients with trigeminal neuralgia (TGN) were presented in mid-2014, and a pivotal study is anticipated in early 2015.
  
  
• AG-120 for Hematologic Cancer (AGIO, CELG). Agios and Celgene announced that Celgene has exercised its option to license the isocitrate dehydrogenase (IDH) inhibitor AG-120 outside the U.S. The companies have been involved in a global strategic collaboration agreement, and Celgene exercised its licensing option for AG-221 (also an IDH inhibitor) last year. Both of these IDH inhibitors may alter cell metabolism to induce differentiation in cancer cells, thus reducing levels of aberrant proliferation.

For the full report, please download the PDF version at the top of this page.

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