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JP Morgan 2015 - Day 2
January 13, 2015
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:
- 4-Antigen Vaccine for Prevention of Staphylococcal Infections (PFE). Pfizer announced that the company plans to initiate a Phase IIb clinical trial for this vaccine candidate in patients receiving elective orthopedic surgery. This trial is potentially registrational (accelerated approval) and will initiate in mid-2015. In a Phase I/II study, healthy adults exhibited strong antibody responses following administration of a single, high-dose vaccine.
- PF-06463922 for NSCLC (PFE). Pfizer provided a fairly informative overview including the guidance that a pivotal NSCLC trial for their promising ALK-inhibitor, PF-06463922, is expected to start in 2015. Little information has been publicly released for this drug, but a fairly large Phase I/II study initiated nearly a year ago. The presentation also revealed broad plans to evaluate PFE’s immuno-oncology agents in combination with Merck KGaA’s PD-1 inhibitor, avelumab, after progress evaluating avelumab as a monotherapy has been made.
- REGN2810 for Cancer (REGN). Regeneron is joining the checkpoint inhibitor race with a the disclosure of an IND filing for its PD-1 inhibitor, REGN2810.
- Keytruda for Solid Tumors (MRK). Following its JPM presentation yesterday disclosing a more aggressive timeline for Keytruda (pembrolizumab) development in NSCLC, Merck and Eli Lilly announced a collaboration to conduct several trials evaluating Keytruda in combination with LLY’s compounds including pemetrexed, ramucirumab, and necitumumab.
- ZS-9 for Hyperkalemia (ZSPH). ZS Pharma continues to focus on its lead asset, ZS-9, which binds potassium to treat hyperkalemia. Positive pivotal trial data have already been presented, and regulatory filings are anticipated in the first half of 2015. The JPM presentation suggested pricing for ZS-9 could be in-line with other drugs used to treat electrolyte imbalances including Renvela ($750-800/mo.) and Sensipar. A tablet formulation, rather than the powder being used at launch, should be available approximately 1 year after initial approval.
- IMGN853 for Gynecologic Cancer (IMGN). Immunogen provided updates on the development timeline for IMGN853, an antibody-drug conjugate targeting folate receptor alpha (FR-alpha), at J.P. Morgan and in a press release immediately preceding the start of the conference. The sponsor expects to start Phase II trials in endometrial and/or ovarian cancer in 2015. Depending on the interim data and reception from regulatory agencies, these trials could be registrational (toward accelerated approval) given the unmet need in these gynecological cancers. Immunogen is partnering with Ventana/Roche to develop a companion diagnostic to quantitate FR-alpha expression on tumor biopsy samples.
Disease Group Covered: |
Autoimmune/immunology
Dermatology Endocrine Infectious Disease Neurology Oncology Ophthalmology Psychiatry |
Indications Covered: |
Dysmenorrhea
Ischemic Stroke Sleep Apnea |