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TG Therapeutics (TGTX) is a major holding of my Marketocracy Portfolio and it is also one of my best stock ideas.
TGTX saw a huge 300% appreciation in
2014 and I think it will continue it sharp price move in the coming 12
months. If it isn't acquired by AbbVie before then.
TGTX’s success comes on the back of pre-clinical and clinical positive results of its two promising immunotherapy drugs TG-1101, TGR-1202, and combination therapies for treating various blood cancers. Treatment efficiency and safety profile data presented so far has impressed investors and offers blood cancer patients improved treatments with less harsh side-affects.
Their
drug TG-1101 is a third generation anti-CD20 monoclonal antibody
(attacks cancer cells from the outside) while their drug TGR-1202 is a
next generation PI3K delta inhibitor (attacks cancer cells from the
inside). The drugs can be used on their own as mono-therapies or
together in combination therapy.
In combination therapy the two drugs are a nice complement, they use a double-pronged mechanism of action to attack the same cancer cells. One drug attacking the outside of cancer cells while the other drug attacks the inside of cancer cells. These two drugs have so far show excellent safety profiles so they would also be suited for combination use with other companies antibodies and checkpoint inhibitors.
Most FDA approved antibodies and checkpoint inhibitors come with Adverse Events (AE) Label Warnings. High toxicity levels are present in same-class drugs like Roche's Rituxan and Gilead's Idelalisib. TGTX's drugs are showing much lower toxicity levels which at this stage would not require them to carry a label warning. Their drugs' safety profiles look to be best in class right now which offers TGTX a significant competitive advantage. Efficiency for these drugs looks impressive from Phase 2 trial results.
In combination therapy the two drugs are a nice complement, they use a double-pronged mechanism of action to attack the same cancer cells. One drug attacking the outside of cancer cells while the other drug attacks the inside of cancer cells. These two drugs have so far show excellent safety profiles so they would also be suited for combination use with other companies antibodies and checkpoint inhibitors.
Most FDA approved antibodies and checkpoint inhibitors come with Adverse Events (AE) Label Warnings. High toxicity levels are present in same-class drugs like Roche's Rituxan and Gilead's Idelalisib. TGTX's drugs are showing much lower toxicity levels which at this stage would not require them to carry a label warning. Their drugs' safety profiles look to be best in class right now which offers TGTX a significant competitive advantage. Efficiency for these drugs looks impressive from Phase 2 trial results.
TGTX
is a small company with a MC of less than 800M. It has so far flown
under-the-radar on Wall Street. I think the next 12 months are set-up
for investors to really take notice of this company's potential.
This will be a busy year for TGTX, they will be rolling-out at least another two Phase 3 clinical trials and together with their ongoing clinical trails and several new combo trials to be initiated they will be generating much more investor interest. Coupled with more positive trial result announcements TGTX can expect to maintain its current share-price momentum.
This will be a busy year for TGTX, they will be rolling-out at least another two Phase 3 clinical trials and together with their ongoing clinical trails and several new combo trials to be initiated they will be generating much more investor interest. Coupled with more positive trial result announcements TGTX can expect to maintain its current share-price momentum.
Lead Program
Enrollments have begun in TGTX's lead
program. This is a Phase3 combination trial with their drug TG-1101 plus
Pharmacyclics*** (PCYC) inhibitor drug Imbruvica for treating relapsed high-risk CLL. This combo study will be run against Imbruvica as a mono-therapy. Enrollment completion will be around Q3 2016.
According to the Nation Cancer Institute we have around 100,000 CLL patients in the US and around 15,000 new CLL cases are diagnosed every year.
The market size for CLL is expected to grow to $3.3B by 2018 across six major markets, http://healthcare.globaldata.com/media-center/press-releases/pharmaceuticals/new-entrants-to-boost-c...
GlobalData forecasts that drugs Imbruvica and Idelalisib will have a total combined sales of $2B in 2018, a 60% share of total CLL market.
This Phase3 study has a high likelihood of success based on results seen from their Phase2 clinical trial. TGTX's combination demonstrated a superior patient treatment efficiency.
Impruvica as a mono-therapy has an Overall Response Rate (ORR) near 60% while TGTX's combo showed a higher ORR of 87% . In high risk CLL patients an even higher 95% ORR (19 of 20 patients) was achieved. The Phase3 study is designed for this high risk CLL patient population.
http://finance.yahoo.com/news/data-phase-2-clinical-trial-184134490.html
Should this Phase3 trial achieve similar highly efficient results as seen in Phase2 TGTX will also likely win Breakthrough Therapy Designation which will be another share price catalyst.
According to the Nation Cancer Institute we have around 100,000 CLL patients in the US and around 15,000 new CLL cases are diagnosed every year.
The market size for CLL is expected to grow to $3.3B by 2018 across six major markets, http://healthcare.globaldata.com/media-center/press-releases/pharmaceuticals/new-entrants-to-boost-c...
GlobalData forecasts that drugs Imbruvica and Idelalisib will have a total combined sales of $2B in 2018, a 60% share of total CLL market.
This Phase3 study has a high likelihood of success based on results seen from their Phase2 clinical trial. TGTX's combination demonstrated a superior patient treatment efficiency.
Impruvica as a mono-therapy has an Overall Response Rate (ORR) near 60% while TGTX's combo showed a higher ORR of 87% . In high risk CLL patients an even higher 95% ORR (19 of 20 patients) was achieved. The Phase3 study is designed for this high risk CLL patient population.
http://finance.yahoo.com/news/data-phase-2-clinical-trial-184134490.html
Should this Phase3 trial achieve similar highly efficient results as seen in Phase2 TGTX will also likely win Breakthrough Therapy Designation which will be another share price catalyst.
***Two weeks ago AbbVie made a $21B acquisition of
Pharmacyclics and their drug Imbruvica. This is an unexpected positive
catalyst for TGTX because much of their planned treatments are in
combinations with Imbruvica. TGTX, with a relatively small $800M MC may
also be on AbbVie's Acquisition list.
http://abbvie.mediaroom.com/2015-03-04-AbbVie-to-Acquire-Pharmacyclics-including-its-blockbuster-product-Imbruvica-Creating-an-Industry-Leading-Hematological-Oncology-Franchise
There are several immunotherapy drugs already approved for treating CLL; like Roche's Rituxan and Gazyva, GlaxoSmithKline's Arzerra and now AbbVie's Imbruvica.
Rituxan was the dominant treatment in this space. In 2013, it generated around 7.0B in sales, which inludes CLL and other cancer indications. Roche has produced a next generation Rituxan drug, it's called Gazyva. Gazyva is proven to have a superior efficiency to Rituxan. Patients taking Gazyva plus chemo live a median 26.7 months without cancer progression (PFS) compared with 15.2 months for Rituxan plus chemo.
Analysts are forecasting Gazyva peak sales of between $1.5 and $2.5B. http://www.fiercebiotech.com/special-reports/gazyva-rituxan-follow-joins-next-generation-roche-cance...
TGTX's CLL combo treatment so far appears superior to Roche's Gazyva in both efficiency and safety profile. Gazyva has a 76% ORR vs TGTX's 87% ORR. Gazyva carries an AE warning label while TG-1101 is unlikely to carry one.
http://www.gene.com/media/press-releases/14559/2013-11-01/fda-approves-gazyva-obinutuzumab-for-peo
Should TGTX reproduce similar efficiency and safety profile data in their Phase3 trial their superior treatment should be able to capture a size-able slice of this CLL immunotherapy market.
In Sept 2014, the FDA granted SPA (Special Protocol Assessment) for TGTX's combo TG-1101 plus Imbruvica.
I have confidence TGTX's management can continue to execute their detailed plans as they demonstrated in 2014. And should their upcoming clinical results be nearly as good as those in 2014 this stock will be at least a double in a years time. That is if it's not acquired before then.
http://abbvie.mediaroom.com/2015-03-04-AbbVie-to-Acquire-Pharmacyclics-including-its-blockbuster-product-Imbruvica-Creating-an-Industry-Leading-Hematological-Oncology-Franchise
There are several immunotherapy drugs already approved for treating CLL; like Roche's Rituxan and Gazyva, GlaxoSmithKline's Arzerra and now AbbVie's Imbruvica.
Rituxan was the dominant treatment in this space. In 2013, it generated around 7.0B in sales, which inludes CLL and other cancer indications. Roche has produced a next generation Rituxan drug, it's called Gazyva. Gazyva is proven to have a superior efficiency to Rituxan. Patients taking Gazyva plus chemo live a median 26.7 months without cancer progression (PFS) compared with 15.2 months for Rituxan plus chemo.
Analysts are forecasting Gazyva peak sales of between $1.5 and $2.5B. http://www.fiercebiotech.com/special-reports/gazyva-rituxan-follow-joins-next-generation-roche-cance...
TGTX's CLL combo treatment so far appears superior to Roche's Gazyva in both efficiency and safety profile. Gazyva has a 76% ORR vs TGTX's 87% ORR. Gazyva carries an AE warning label while TG-1101 is unlikely to carry one.
http://www.gene.com/media/press-releases/14559/2013-11-01/fda-approves-gazyva-obinutuzumab-for-peo
Should TGTX reproduce similar efficiency and safety profile data in their Phase3 trial their superior treatment should be able to capture a size-able slice of this CLL immunotherapy market.
Encouraging Recent
developments
TGTX reported updated data at ASH (Dec
2014) from 3
clinical trials in various Lymphomas such as Chronic Lymphocytic
Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL), Mantle Cell Lymphoma (MCL)
and Small Lymphocytic Lymphoma (SLL).
The trial results presented demonstrated impressive treatment efficiencies alongside excellent safety profiles. The data was encouraging enough to push TGTX’s share price up over 30% intra-day.
Trials reported on -
The trial results presented demonstrated impressive treatment efficiencies alongside excellent safety profiles. The data was encouraging enough to push TGTX’s share price up over 30% intra-day.
Trials reported on -
* TGTX
announced positive clinical results from its Phase2 study of TG-1101 plus Imbruvica combo.
* TGTX presented preliminary data
from its ongoing Phase1/2 dose escalation study of its combo TG-1101 plus TGR-1202.
*Presented data of its triple arm combo dose escalation study of Imbruvica, TG-1101 and TGR-1202.
*TGTX updated data of its Phase 1
single-agent dose escalation study for TGR-1202.
In Sept 2014, the FDA granted SPA (Special Protocol Assessment) for TGTX's combo TG-1101 plus Imbruvica.
I have confidence TGTX's management can continue to execute their detailed plans as they demonstrated in 2014. And should their upcoming clinical results be nearly as good as those in 2014 this stock will be at least a double in a years time. That is if it's not acquired before then.
Disclosure - TGTX is a core holding of my Marketocracy Fund. This Fund is available for investment at http://www.marketocracy.com/managers.php?manager=781
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I do not short stocks.
