Company Update (NASDAQ:TGTX): TG Therapeutics Inc Announces Double and Triple Combination Therapy Data Presentations at the 58th American Society of Hematology Annual Meeting


TGTXTG Therapeutics Inc (NASDAQ:TGTX) announced the presentation yesterday of data from three combination studies involving the Company’s lead compounds, TGR-1202, the Company’s once-daily PI3K delta inhibitor, and TG-1101 (ublituximab), the Company’s novel glycoengineered anti-CD20 monoclonal antibody at the 58th American Society of Hematology (ASH) Annual Meeting, in San Diego, California.

Michael S. Weiss, the Company’s Executive Chairman and Interim CEO stated, “We are very pleased to continue to see a highly differentiated safety profile for TGR-1202 across multiple double and triple combination studies with a high level of activity.  Each of the four clinical studies presented at the ASH meeting, enhanced our overall understanding of the breadth of activity of TGR-1202.  In addition to DLBCL, FL and CLL, where we have already shown data previously, it was nice to see the flexibility of TGR-1202 and its ability to be combined with brentuximab vedotin in relapsed or refractory Hodgkin’s and with ruxolitinib in Myelofibrosis.” Mr. Weiss continued, “We are also encouraged by the triple combination data of TG-1101, TGR-1202, and bendamustine in relapsed or refractory, difficult to treat, DLBCL and FL patients which showed no discontinuations for a treatment related adverse event, as well as an 80% overall response rate across both DLBCL and FL patients and a high level of CR’s.  We, and our investigators, believe this triplet combination is a promising regimen and plan to study it in this patient population in a registration-directed trial.”

Highlights from yesterday’s presentations include the following:

Poster Presentation: Combination of Ublituximab, TGR-1202, and Bendamustine Demonstrates Significant Activity in Patients with Advanced DLBCL and Follicular Lymphoma (Abstract Number 4197)

This poster presentation includes data from patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) treated with the triple combination of TG-1101 (ublituximab), TGR-1202 and bendamustine.  Nineteen patients were evaluable for safety of which 15 were evaluable for efficacy (3 patients were too early to evaluate and 1 patient had a non-related adverse event (AE) prior to efficacy assessment). The triple combination appears well tolerated with no discontinuations for a treatment related AE. Neutropenia and anemia were the only Grade 3/4 AE’s occurring in more than 1 patient.  Importantly, no Grade 3/4 transaminitis was reported, no events of pneumonia or pneumonitis, and only 1 transient event of Grade 3 diarrhea, with a duration of 1 day, was observed.  Eleven patients (58%) were refractory to prior treatment.  Median time on study at the data cut off was approximately 6 months with the majority of patients continuing on study and follow-up ongoing.

Efficacy highlights from this poster include:

  • 71% (5 of 7) Overall Response Rate (ORR), including a 43% Complete Response (CR) rate observed in patients with relapsed or refractory DLBCL
  • 88% (7 of 8) ORR, including a 37% CR rate observed in patients with relapsed or refractory FL 4/6 CR’s that were achieved between the DLBCL and FL groups occurred at the first 8 week efficacy assessment
  • First response assessment occurred at Month 3 following initiation of therapy, with durable responses observed notably amongst DLBCL patients.

Poster Presentation: A Phase I Trial of TGR-1202, a Next Generation Once-Daily PI3Kδ Inhibitor, in Combination with Brentuximab Vedotin, in Patients with Relapsed/Refractory Hodgkins Lymphoma (Abstract Number 4146)

This poster presentation includes data from patients with relapsed and refractory Hodgkin’s Lymphoma (HL) treated with TGR-1202 at either 400mg or 600mg dosed orally once daily in combination with brentuximab vedotin in continuous 21 day cycles.  14 patients were evaluable for safety, of which 11 were evaluable for efficacy (3 discontinued prior to disease evaluation (2 AE’s and 1 withdrew consent)).  43% (6 of 14) of patients had prior exposure to brentuximab vedotin and all were refractory to prior brentuximab vedotin therapy.  The combination demonstrated tolerability with nausea, diarrhea, and neutropenia being the most prevalent adverse events.  Notably all but one case of diarrhea was Grade 1 or 2 in severity.

Efficacy highlights from this poster include:

  • 60% (3 of 5) ORR, including a 40% CR rate observed across brentuximab vedotin refractory patients
  • 64% (7 of 11) ORR, including a 45% CR rate observed across all patients treated

Oral Presentation: Preliminary Results from a Phase I Dose Escalation Trial of Ruxolitinib and the PI3Kδ Inhibitor TGR-1202 in Myelofibrosis (Abstract Number 1125)
This oral presentation includes data from patients with myelofibrosis treated with the combination of ruxolitinib, the JAK1/2 inhibitor and TGR-1202.  The combination was well tolerated and efficacious in the twelve patients treated.  The most prevalent adverse events deemed at least possibly related to TGR-1202 included anemia, thrombocytopenia, neutropenia, AST/ALT elevation and amylase/lipase elevation and diarrhea, all of which were notably Grade 1/2 with the exception of Grade 3 amylase/lipase elevation seen in 2 patients (16.7%), and Grade 3 diarrhea seen in 1 patient (8.3%). Presentation highlights included:

  • The patient population enrolled was advanced, with the majority having 2 or more prior mutations at baseline;
  • Per protocol, all enrolled patients were on a stable dose of ruxolitinib monotherapy with best response to ruxolitinib monotherapy achieved prior to enrollment;
  • Following the addition of TGR-1202, 11/12 patients experienced improvement in hemoglobin, many with a concomitant reduction in platelet counts indicating clinical benefit beyond ruxolitinib monotherapy; and
  • 83% of study participants experienced clinical benefit (hematologic improvement, reduced spleen size and/or improvement in symptoms) including one patient who achieved a CR and continues on study, now out 72 weeks (Original Source)

Shares of TG Therapeutics are currently trading at $5.55, down $0.15.  TGTX has a 1-year high of $13.67 and a 1-year low of $4.90. The stock’s 50-day moving average is $6.05 and its 200-day moving average is $6.79.

On the ratings front, TG Therapeutics has been the subject of a number of recent research reports. In a report issued on November 7, FBR analyst Edward White reiterated a Buy rating on TGTX, with a price target of $24, which represents a potential upside of 321% from where the stock is currently trading. Separately, on the same day, Roth Capital’s Joseph Pantginis reiterated a Buy rating on the stock and has a price target of $33.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Edward White and Joseph Pantginis have a yearly average loss of 8.3% and 14.2% respectively. White has a success rate of 27% and is ranked #4092 out of 4256 analysts, while Pantginis has a success rate of 32% and is ranked #4167.

Sentiment on the street is mostly bullish on TGTX stock. Out of 4 analysts who cover the stock, 4 suggest a Buy rating . The 12-month average price target assigned to the stock is $23.00, which represents a potential upside of 304% from where the stock is currently trading.

TG Therapeutics, Inc. is a biopharmaceutical company. It is focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. The company develops two therapies targeting hematological malignancies: TG-1101 and TGR-1202.