NEW YORK—Targeted toward treating blood-based diseases, biopharmaceutical company TG Therapeutics Inc. has forged a global agreement with Checkpoint Therapeutics Inc., a newly formed subsidiary of Coronado Biosciences Inc., to develop and commercialize Checkpoint’s fully human anti-PD-L1 and anti-GITR antibody research programs in treating chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL) and Hodgkin’s lymphoma.
Focused on the acquisition of novel treatments for B-cell malignancies and autoimmune diseases, TG Therapeutics is developing two therapies targeting hematological malignancies. One is TG-1101 (ublituximab), a glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes; the other is TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes, TG stated in a March 4 news release.
Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies. The company also has a preclinical program to develop IRAK4 inhibitors, also for B-cell malignancies and autoimmune diseases.
Per the terms of the agreement, Checkpoint will develop and commercialize these antibodies in solid tumors. The antibodies were generated in the laboratory of Dr. Wayne Marasco, a professor in the department of cancer immunology and AIDS at Dana-Farber Cancer Institute.
“We are very excited to add Dr. Marasco’s anti-PD-L1 and anti-GITR programs to our growing portfolio of agents targeting hematological malignancies,” Michael S. Weiss, executive chairman, interim CEO and president of TG Therapeutics, stated in a news release.
“At this time, we cannot speculate in terms of dollars what the collaboration may be worth to the company,” Weiss tells DDNews of the deal with Checkpoint. “However, we are extremely excited to learn more about each program and see how they may be able to complement our current portfolio.”
Weiss explains that TG Therapeutics has “in-licensed both the anti-PDL1 and the anti-GIRT research programs. Both are preclinical. We at TG believe that incorporation of immuno-therapy will prove to be a second paradigm shift in the treatment of these diseases, and it is our goal to be at the forefront, leading this charge.”
“We believe that the first paradigm shift was from chemo/radiation to targeted agents such as our glycoengineered anti-CD20 monoclonal antibody, TG-1101, and our P13K-Delta inhibitor, TGR-1202, or combinations of targeted agents,” Weiss adds. “Now the second shift will be towards the incorporation of immuno-therapy.”
Immuno-oncology targeted agents “have already demonstrated the ability to transform the way we treat cancer by unlocking the immune system, offering the promise of deep and durable remissions,” Weiss says. “As we’ve said previously, we will continue to build our portfolio to optimize our combination approach to provide the best possible outcomes to patients with B-cell malignancies without the need to use harsh chemotherapy—ideally pushing toward a cure.”
Weiss believes that the two Checkpoint antibodies can work synergistically together and that “adding them to the already marked activity we are seeing with our proprietary combination of TG-1101 and TGR-1202 across CLL and NHL could greatly enhance the therapeutic benefit to patients with hematological malignancies. Our goal is to advance both of these antibodies into the clinic in the second half of next year.”
On March 11, Weiss announced TG Therapeutics’ financial results for the fourth quarter and year ended Dec. 31, 2014, saying at one point, “We ended the year on a high note, presenting a significant amount of data at the American Society of Hematology meeting. In addition to very encouraging data on the combination of TG-1101 and TGR-1202, we also presented data demonstrating high response rates for the combination of TG-1101 and ibrutinib, data that we believe support our now-ongoing Phase 3 trial of that combination being conducted under a Special Protocol Assessment. For 2015, we plan to focus on recruitment into our GENUINE Phase 3 study, as well as our planned first Phase 3 clinical trial of the combination of TG-1101 and TGR-1202, with a longer-term vision toward additional combination trials, with the goal of continuing to push toward better patient outcomes.”