Immune Design Corporation IMDZ announced that the FDA has granted Orphan Drug Designation to LV305 and G305 for the treatment of soft tissue sarcoma.
Both LV305 and G305 are complementary agents that constitute the company’s cancer immunotherapy product candidate, CMB305. We note that CMB305 is being developed using a “prime-boost” approach, in which LV305, from Immune Design’s ZVex platform, is dosed sequentially with G305, an agent from its GLAAS platform.
Orphan drug designation is given to drugs being developed for rare diseases/disorders that affect less than 200,000 people in the U.S. Incentives that come with orphan drug status include close guidance from the FDA that may accelerate the time to marketing approval, orphan drug grants, tax credits and a period of market exclusivity upon marketing approval.
Immune Design is currently evaluating CMB305 in a phase Ib trial in patients with locally advanced, relapsed or metastatic solid cancers whose tumors express NY-ESO-1. The candidate is also being evaluated in a phase II trial in combination with Roche’s RHHBY Genentech’s investigational cancer immunotherapy candidate, atezolizumab (MPDL3280A; anti-PD-L1), in patients with soft tissue sarcoma.
Another candidate in Immune Design’s pipeline is G100. Both the candidates (CBM305 and G100) are products of the company’s two synergistic discovery platforms, ZVex and GLAAS.
Immune Design is collaborating with Merck MRK to evaluate G100 and LV305 in phase I studies in combination with Merck’s Keytruda in patients with non-Hodgkin’s lymphoma and melanoma, respectively.
Immune Design currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Corcept Therapeutics Inc. CORT, sporting a Zacks Rank #1 (Strong Buy).
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