April 26, 2017 2:08 PM ET

Pharmaceuticals

Company Overview of Agensys, Inc.

Company Overview

Agensys, Inc. engages in generating, developing, and manufacturing therapeutic fully human monoclonal antibodies (MAbs) to treat cancer. The company develops a pipeline of naked and antibody-drug conjugated (ADC) therapeutic antibodies to treat cancer indications, including prostate, kidney, pancreas, ovary, bladder, lung, colon, breast, and skin. The company develops AGS-1C4D4 for the treatment of pancreatic cancer; and various ADCs, such as AGS-16M8F, ASG-5ME, and ASG-22ME for treatment of various solid tumors. Agensys, Inc. was formerly known as UroGenesys, Inc. and changed its name to Agensys, Inc. in June 2001. The company was founded in 1996 and is based in Santa Monica, California. As...

1800 Stewart Street

Santa Monica, CA 90404

United States

Founded in 1996

Phone:

424-280-5000

Key Executives for Agensys, Inc.

Chief Medical Officer and Senior Vice President
Age: 54
Executive Vice President, Chief Financial Officer and Vice President of Operations
Age: 70
Corporate Secretary and Corporate Counsel
Age: 66
Vice President of Clinical Research and Development
Vice President of Finance
Compensation as of Fiscal Year 2016.

Agensys, Inc. Key Developments

Seattle Genetics and Agensys Highlight Promising Enfortumab Vedotin (ASG-22ME) and ASG-15ME Phase 1 Data in Metastatic Urothelial Cancer at 2016 ESMO Congress

Seattle Genetics, Inc. and Agensys presented updated clinical data for enfortumab vedotin (ASG-22ME) and ASG-15ME at the European Society for Medical Oncology (ESMO) Congress being held October 7-11, 2016 in Copenhagen, Denmark. Enfortumab vedotin and ASG-15ME are investigational antibody-drug conjugates (ADCs) that target the cell surface proteins Nectin-4 and SLITRK6, respectively. The clinical data for both agents continue to demonstrate overall response rates in patients with previously treated metastatic urothelial cancer, including those with prior checkpoint inhibitors. Safety and recommended phase 2 doses were also presented for both programs. While both phase 1 studies will continue to enroll patients, the companies plan to advance enfortumab vedotin and discuss next steps with regulatory agencies. Evaluation of next developmental steps for ASG-15ME is ongoing. Interim data from two phase 1 dose-escalation studies of enfortumab vedotin and ASG-15ME monotherapy in patients with metastatic urothelial cancer will be presented at the ESMO Congress during poster sessions on October 9, 2016. Interim Analysis of a Phase 1 Dose Escalation Trial of ASG-22CE (ASG-22ME; enfortumab vedotin), an Antibody-Drug Conjugate (ADC) in Patients (Pts) with Metastatic Urothelial Cancer (mUC) Abstract #788P. Data were reported from 58 patients with metastatic urothelial cancer having a median age of 67 years. Of these patients, 56 patients (97 %) had undergone treatment with a platinum-based chemotherapy regimen and 20 patients (35%) had progressed on or after treatment with checkpoint inhibitors. Thirty-six patients (62%) had received two or more prior systemic therapies. The primary endpoints of the ongoing clinical trial are to evaluate pharmacokinetics and safety of enfortumab vedotin as a monotherapy at escalating doses of 0.5 to 1.25 milligrams per kilogram (mg/kg) weekly for three of every four week cycles. In addition, the trial is evaluating antitumor activity, objective response rate and disease control rate. Key findings include: Of the 49 patients evaluable for response, 18 patients (37%) had an objective response, including one patient (two%) who achieved a complete response and 17 patients (35%) who achieved a partial response. The preliminary estimate of median progression-free survival is 16.6 weeks. The recommended phase 2 dose is 1.25 mg/kg. In 17 patients treated at the 1.25 mg/kg dose level, 10 patients (59%) had a partial response. Disease control was achieved for 14 patients (82%), defined as achieving complete response, partial response or stable disease. In the 16 patients across dose levels who had previously been treated with checkpoint inhibitors, six patients (38%) achieved a partial response. At the recommended phase 2 dose, four out of seven patients (57%) previously treated with checkpoint inhibitors achieved a partial response. In the 12 patients whose cancer had metastasized to the liver, which typically has a poor prognosis, five patients (42%) achieved an objective response. Of 20 patients previously treated with taxanes, eight (40%) achieved an objective response. The most common treatment related adverse events of any grade occurring in 20% or more of patients were pruritis (31 %), fatigue (30%), diarrhea (29%), nausea (28 %), rash (26%) and alopecia (21%). Eight of 19 patients (42%) experienced a rash at the recommended phase 2 dose and none of these patients required dose modification or discontinued therapy as a result. Enrollment is ongoing at 1.25 mg/kg and the study has been amended to include a checkpoint inhibitor-treated cohort to further understand safety and activity in this population.

Bellicum Pharmaceuticals, Inc. and Agensys, Inc. Announce License Agreement for Cancer Target PSCA in Cell and Gene Therapy

Bellicum Pharmaceuticals, Inc. and Astellas Pharma Inc. announced that Agensys, Inc. have entered into a global license agreement, granting Bellicum rights to develop and commercialize adoptive cell therapies, including CAR-T cells, for tumors expressing Prostate Stem Cell Antigen (PSCA) using PSCA technology, both in-licensed and developed at Agensys. PSCA is a cancer antigen expressed in many malignancies, including prostate, pancreatic, bladder, esophagus, and gastric cancers. Bellicum is developing BPX-601, a GoCAR-T™ product candidate targeting PSCA that has demonstrated robust anti-tumor activity in preclinical studies. GoCAR-T is a proprietary Bellicum technology in which an MC (MyD88/CD40) molecular switch is designed to enable pharmacologic control over the activation, proliferation and persistence of the GoCAR-T cells in a patient. Under the terms and conditions of the license agreement, Agensys will receive an upfront license fee, and is eligible for clinical and sales milestones, as well as single-digit royalties on the sales of any products developed pursuant to the license. Astellas or Agensys retains the option for commercialization of any product targeting PSCA based on Bellicum’s CAR-T cell technology (e.g., BPX-601) in Japan. If the option is exercised, Bellicum would receive an option fee from Astellas or Agensys, and the amount for certain clinical and sales milestones to be paid to Agensys would be reduced. Bellicum would also receive royalties from Astellas or Agensys based upon sales of such product in Japan.

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