Sunday, September 9, 2012

Peregrine Pharmaceuticals - Bavituximab shows breakthrough data in NSCLC

Key Takeaways
1) Clinical Implications - The drug is a breakthrough in NSCLC treatment - Provides a median OS of 12 months, almost twice the existing standard of care.

2) Investment Implications -
  • The potential peak sales of bavituximab can exceed $1billion. The stock price may go up another 100% from current levels. Peregrine is clearly a potential acquisition target.
  • Roche's Tarceva is the current standard of care in 2nd line NSCLC. The data poses potential threat to Tarceva (Erlotinib) sales, which currently generates around $1billion in sales.
  • A study in first line NSCLC is also ongoing, and if the data is positive the data should impact LLY's Alimta (Pemetrexed), which is the standard of care in first line.
Clinical Data 
Interim results on Peregrine Pharmaceuticals's biologic drug - Bavituximab demonstrated breakthrough survival benefit.  The placebo controlled double blind randomized Phase 2b trial  enrolled 121 refractory non-small cell lung cancer (NSCLC) patients, who had progressed after 1 chemotherapy regimen. The blinded study evaluated two dose levels of bavituximab (bavituximab-containing arms) given with docetaxel versus docetaxel plus placebo (control arm).  The higher dose (3mg / kg) of bavituximab demonstrated an OS of 13.1 mo, while the lower dose demonstrated an OS of 11.1 months. The placebo (docetaxel) arm was associated with an OS of 5.6 months.  Tarceva which is the current standard of care in second line is associated with an overall survival of 6.7 months. In the EGFR+ve patients as well, bavituximab  seems to exceed Tarceva's benefit, as Tarceva is associated with an OS of 9.7 in patients with EGFR +VE NSCLC. The new drug poses Potential threat to Roche's Tarceva in 2nd line and LLY's Alimta in first line

The Phase 3 trial would be intiated by mid-2013.

About Bavituximab

Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that represents a new approach to treating cancer. Bavituximab is the lead drug candidate from the company's PS technology platform and is currently being tested in eight clinical trials including three randomized Phase II trials in front-line and second-line non-small cell lung cancer, front-line pancreatic cancer and five investigator-sponsored trials (ISTs) in additional oncology indications.
PS is a highly immunosuppressive molecule usually located inside the membrane of healthy cells, but "flips" and becomes exposed on the outside of cells that line tumor blood vessels, creating a specific target for anti-cancer treatments. PS-targeting antibodies target and bind to PS and block this immunosuppressive signal, thereby enabling the immune system to recognize and fight the tumor.

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