TGTX up 15% imho investors digesting CS report from other day.
Strategic rationale for PCYC / TGTX combination
PCYC currently has a single product (Imbruvica) for the treatment of lymphoma and
leukemia. Although it has become the standard of care in its approved indications, the
long-term success of PCYC is likely dependent on it acquiring, in-licensing, or developing
drugs well suited for combination use with Imbruvica. This is important because its
competitors including Roche and Gilead are pursuing multi-drug strategies that combine
multiple proprietary drugs.
TGTX has two drugs in development that are likely to be complementary to PCYC's
Imbruvica.
¦ TG-1101 (ublituximab) is a glyco-engineered anti-CD20 antibody. Currently
Roche's CD20 antibody (Rituxan) is the backbone of treatment for all of the indications
that Imbruvica is targeting. Recently, Roche introduced a next-generation CD20
antibody Gazyva that is more potent than Rituxan. Ublituximab is more similar to
Gazyva, and will likely have its first approval in relapsed CLL in combination with
Imbruvica. TGTX previously reported positive interim Phase I data for the combination
of TG-1101 and Imbruvica at EHA (Exhibit 1). The next clinical data for TG-1101 plus
Imbruvca is expected at ASH in December 2014, where TGTX expects to report
efficacy and safety on 30 CLL patients (previously reported on 7 CLL patients). Prior
data demonstrated a 86% response rate (6/7) in combination with Imbruvica.
¦ TGR-1202 is a PI3K delta inhibitor in Phase I development. TGR-1202 is similar to
GILD's Idelalisib and INFI's duvelisib. TGTX believes it is a best-in-class PI3K delta
inhibitor, though this needs to be demonstrated. Like Idelalisib, TGR-1202 is highly
selective for delta (duvelisib also hits gamma). TGTX reports similar preclinical
efficacy with once-daily dosing, no liver toxicity and no GI toxicity. The safety claims
need to be verified in larger clinical trials.
