- Rebastinib is a Potent and Selective Inhibitor of the TIE2 kinase, the Receptor for Angiopoietins, an Important Family of Vascular Growth Factors in the Tumor Microenvironment -
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, announced today that it has initiated an open-label, multicenter, Phase 1b/2 study of rebastinib in combination with paclitaxel to assess safety, tolerability, pharmacokinetics and efficacy in patients with advanced or metastatic solid tumors.
“We are excited to initiate this Phase 1b/2 clinical trial of rebastinib, our small molecule switch control inhibitor of TIE2,” said Michael D. Taylor, Ph.D., Deciphera’s President and Chief Executive Officer. “In preclinical testing rebastinib has shown activity as a single agent and when combined with paclitaxel, we observed synergistic reductions in circulating tumor cells and ablating distant metastases. As a result, we believe rebastinib has the potential to be an important new therapy for cancer patients when combined with chemotherapy. In addition to the Phase 1b/2 clinical trial with paclitaxel, we intend to initiate a second Phase 1b/2 clinical trial of rebastinib in combination with carboplatin in the coming months.”
In this two-part Phase 1b/2 clinical trial, rebastinib will be evaluated for the treatment of patients with advanced or metastatic solid tumors in combination with paclitaxel. Part 1 is designed to evaluate the safety, tolerability and pharmacokinetics of 50 mg and 100 mg rebastinib twice daily (BID) when administered in combination with paclitaxel, and to determine the recommended phase 2 dose (RP2D) of rebastinib in combination with paclitaxel, in patients with advanced or metastatic solid tumors that are refractory to standard therapies. In part 2, the safety, tolerability and efficacy of the RP2D of rebastinib in combination with weekly paclitaxel will be assessed across multiple cohorts, including: breast cancer, ovarian cancer, and endometrial cancer. This trial will enroll up to 36 evaluable patients in part 1 and up to 132 evaluable patients in part 2. For more information about the clinical trial design please visit www.clinicaltrials.gov (NCT03601897).
“There is an increasing understanding of the mechanisms by which tumors co-opt the surrounding microenvironment to grow, survive and become more invasive. TIE2 kinase is involved in multiple mechanisms favoring a pro-tumoral microenvironment, including the regulation of a population of immunosuppressive macrophages, promotion of tumor angiogenesis, and participation in perivascular pumps that lead to tumor cell intravasation and distal metastasis,” said Oliver Rosen, M.D., Chief Medical Officer at Deciphera. “Certain of these macrophages express TIE2 and we believe selective inhibition of this kinase with rebastinib in combination with paclitaxel is a promising approach to treating these patients.”
About Rebastinib
Rebastinib is an investigational, orally
administered, potent and selective inhibitor of the TIE2 kinase, the
receptor for angiopoietins, an important family of vascular growth
factors in the tumor microenvironment that also activate pro-tumoral
TIE2 expressing macrophages. In a Phase 1 clinical trial, biomarker data
have demonstrated rebastinib-induced increases in the TIE2 ligand
angiopoietin 2, secondary to TIE2 inhibition. Rebastinib is currently
being evaluated in a Phase 1b/2 clinical trial in combination with
paclitaxel (NCT03601897) and an investigator sponsored Phase 1b trial in
patients with metastatic breast cancer in combination with paclitaxel or
eribulin (NCT02824575).
About Deciphera Pharmaceuticals
Deciphera Pharmaceuticals is
a clinical-stage biopharmaceutical company focused on improving the
lives of cancer patients by tackling key mechanisms of drug resistance
that limit the rate and/or durability of response to existing cancer
therapies. Our small molecule drug candidates are directed against an
important family of enzymes called kinases, known to be directly
involved in the growth and spread of many cancers. We use our deep
understanding of kinase biology together with a proprietary chemistry
library to purposefully design compounds that maintain kinases in a
“switched off” or inactivated conformation. These investigational
therapies comprise tumor-targeted agents designed to address therapeutic
resistance causing mutations and immuno-targeted agents designed to
control the activation of immunokinases that suppress critical immune
system regulators, such as macrophages. We have used our platform to
develop a diverse pipeline of tumor-targeted and immuno-targeted drug
candidates designed to improve outcomes for patients with cancer by
improving the quality, rate and/or durability of their responses to
treatment.
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Cautionary Note Regarding Forward-Looking Statements
This
press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995, as amended,
including, without limitation, statements regarding the potential for
rebastinib as a treatment for cancer; and statements regarding plans,
enrollment and timelines for the clinical development of rebastinib,
including, without limitation, our intent to initiate a Phase 1b/2
clinical trial of rebastinib in combination with carboplatin; and
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clinical trials or the development of our drug candidates, including
rebastinib, our ability to successfully demonstrate the efficacy and
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