Anti-angiogenesis Peptide(Beijing Cancer Hospital)

Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage biopharmaceutical company developing proprietary antibody-based therapeutics to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared its IND application for CTX-009, enabling the company to initiate a global Phase 2 clinical trial for CTX-009 in patients who have advanced Biliary Tract Cancers (BTC) in the United States and South Korea. Compass plans to include the existing Phase 2 in South Korea in this global study, allowing it to expand the ongoing study of CTX-009 under this IND. CTX-009 is a bispecific antibody that simultaneously targets Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF-A). “We are extremely pleased to announce today the FDA has accepted our IND application for CTX-009. We thank the reviewers at the FDA for their review and comments on the Phase 2 study design,” said Thomas J. Schuetz, MD, PhD, CEO and Scientific Founder of Compass. “The ongoing Phase 2 study in South Korea will now be expanded to a global study with the opening of US clinical sites in Q2. We believe that CTX-009 has the potential to be an important new therapy for patients with biliary tract cancers, including cholangiocarcinomas,” added Dr. Schuetz. About CTX-009 CTX-009 is a bispecific antibody that simultaneously targets Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF-A). This next generation angiogenesis inhibitor has completed a Phase 1 dose escalation and expansion study, and a Phase 1b study in combination with chemotherapy. As a monotherapy, CTX-009 demonstrated clinical benefit in heavily pre-treated patients who had progressed after prior therapy with chemotherapy regimens containing VEGF blockers such as bevacizumab and ramucirumab. Several clinical responses were observed in patients with advanced colorectal cancer and in patients with gastric cancer. Additional durable responses were also observed in the combination study with chemotherapy in patients with cholangiocarcinoma. About the Phase 2 Clinical Trial A Phase 2 study was initiated in Q1 2021 in South Korea evaluating CTX-009 in combination with paclitaxel in patients with advanced Biliary Tract Cancers (cholangiocarcinoma) in whom multiple prior regimens had failed. The study is a Simon Two-Stage adaptive Phase 2 Study. Enrollment in Stage 1 of the study has been completed and the criteria to advance to Stage 2 of the study have been met. Notably, five partial responses (PRs) have already been observed among the first 17 patients evaluated leading to a preliminary overall response rate (ORR) of 29%, and all patients evaluated have had stable disease or better with a decline in tumor burden observed in 16 of the 17 patients leading to a Clinical Benefit Rate (CBR) of 100%. The study is being conducted by Handok Pharmaceuticals and the clinicaltrials.gov identifier for the study is NCT04492033. Compass plans to add sites in the United States to this study and plans to initiate Stage 2 of the Phase 2 study with Handok in Q2 of this year. About Compass Therapeutics Compass Therapeutics, Inc. is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass’ scientific focus is on the relationship between angiogenesis, the immune system and tumor growth. The company pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. Compass plans to advance its product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. The company was founded in 2014 and is headquartered in Boston, Massachusetts.

SOUTH SAN FRANCISCO, Calif., March 10, 2021 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, today announced several upcoming preclinical poster presentations at the American Association for Cancer Research annual meeting demonstrating promise and potential of its pipeline of anti-cancer agents. “Our posters at AACR reflect our continued exploration into the role of the immune system in cancer and the potential of immunology-based therapies to address certain challenges in oncology,” said Dirk Brockstedt, Ph.D., Chief Scientific Officer of RAPT. “Specifically, the role and importance of CCR4 inhibition will be highlighted and continue to support the early clinical data we have observed with FLX475, our CCR4 inhibitor being evaluated in a Phase 1/2 trial in multiple tumors. In addition, we will also present preclinical data on two exciting next-generation immune-oncology targets, HPK1 and GCN2, which show that orally available inhibitors elicit potent antitumor immune responses in a variety of cancer models.” Summaries of the studies to be presented: Poster: 1585Title: T-regulatory cells impair CAR T-cell-mediated antitumor activity in a murine solid tumor model Session Title: Combination Immunotherapies Chimeric antigen receptor (CAR) T cell immunotherapy has had only modest success in solid malignancies due in part to tumor antigen heterogeneity and the immunosuppressive tumor microenvironment, which is believed to be at least in part due to immunosuppressive regulatory T cells (Treg). Treg express CCR4 and migrate toward CCL17 and CCL22 which are frequently upregulated in a subset of tumors or increased following immunotherapy. In a murine mesothelioma model, a combination of CAR- T-cells plus CCR4 antagonist significantly slowed tumor growth and significantly improved survival compared to untreated control. Furthermore, enhanced antitumor activity was observed with the combination of CAR T cells and CCR4 antagonist compared to either monotherapy, with 4/9 mice treated with the combination becoming tumor free and experienced significantly increased survival. Poster: 1646Title: Development of small-molecule HPK1 inhibitors to unleash tumor-specific T cell responsesSession Title: Immune Checkpoints Hematopoietic progenitor kinase 1 (HPK1) is an intracellular protein kinase that is associated with inhibition of critical immune T cell signaling and proliferation important for mounting an effective immune response against tumor cells.  RAPT’s small-molecule compounds demonstrated potent inhibition of HPK1 in biochemical assays, reduction of levels of phosphorylated SLP76 and concomitant increase in IL-2 production.  In addition, the Company’s HPK1 inhibitors enhanced cytokine production of human and mouse primary T cells above that observed with T-cell receptor activation alone. Notably, treatment of mice with an orally available HPK1 inhibitor resulted in increased activation of antigen-specific CD8 T-cells and decreased tumor growth as monotherapies and in combination with clinically relevant checkpoint inhibitor antibodies. Poster: 3153Title: Targeting the stress response kinase GCN2 to restore immunity in the tumor microenvironment Session Title: Tumor Microenvironment Recent advances in cancer metabolism suggest that targeting amino acid metabolism represents a promising strategy for the development of novel therapeutic agents. Tumor, stromal and myeloid-derived suppressor cells (MDSC) within the tumor microenvironment (TME) create a nutrient-poor environment that inhibits immune function and support tumor growth. GCN2 (general control nonderepressible 2), a stress response kinase, plays a key role in maintaining cellular homeostasis under a wide range of stressors, leading to T cell anergy, apoptosis, enhanced MDSC-dependent immune suppression and tumor cell survival. The treatment of nutrient-deprived T cells in vitro with a GCN2 inhibitor enhanced CD4 and CD8 T-cell proliferation and effector functions. The GCN2 inhibitor also reversed T cell suppression mediated by MDSCs derived from healthy donors or cancer patients. In syngeneic mouse tumor models, oral administration of a GCN2 inhibitor showed impressive drug-target engagement and potently inhibited GCN2 kinase in the tumor microenvironment. Furthermore, the GCN2 inhibitor as a single agent and in combination with checkpoint inhibitors and angiogenesis inhibitor (anti-VEGFR) delayed tumor growth in renal cell carcinoma and lung cancer syngeneic tumor models. About RAPT Therapeutics, Inc.RAPT Therapeutics is a clinical stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases. Utilizing its proprietary discovery and development engine, the Company is developing highly selective small molecules designed to modulate the critical immune drivers underlying these diseases. RAPT has discovered and advanced two unique drug candidates, FLX475 and RPT193, each targeting C-C motif chemokine receptor 4 (CCR4), for the treatment of cancer and inflammation, respectively. The Company is also pursuing a range of targets that are in the discovery stage of development. Forward-Looking StatementsThis press release contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future performances or achievements expressed or implied by the forward-looking statements. Each of these statements is based only on current information, assumptions and expectations that are inherently subject to change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements about the significance of early results from the Phase 1/2 clinical trials of FLX475 and preclinical studies of HPK1 and GCN2, and statements about the potential of CCR4, HPK1 and GCN2 to enhance antitumor activity. Detailed information regarding risk factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in RAPT’s most recent Form 10-Q filed with the Securities and Exchange Commission and subsequent filings made by RAPT with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. RAPT disclaims any obligation to update these forward-looking statements. Investor Contact:Sylvia Wheelerswheeler@wheelhouselsa.com Media Contact:Aljanae Reynoldsareynolds@wheelhouselsa.com