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Peloton Therapeutics Announces Completion of Enrollment in Phase 2 Trial of PT2977 for Treatment of Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma

April 9, 2019

DALLAS--(BUSINESS WIRE)--Apr 9, 2019--Peloton Therapeutics, Inc., a clinical-stage biopharmaceutical company advancing first-in-class oral medicines for cancer and other serious conditions, announced the completion of patient enrollment in a Phase 2 clinical trial evaluating the efficacy and safety of its lead drug candidate, PT2977, to treat von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC). The clinical trial, which has enrolled 61 patients at clinical trial centers in the United States and Europe, is ongoing and the company anticipates topline results in the first half of 2020.

This open-label Phase 2 trial will evaluate the efficacy and safety of PT2977 in patients with VHL disease-associated RCC. Key inclusion criteria are the diagnosis of VHL disease based on a germline VHL alteration, the presence of at least one measurable solid RCC tumor, and no evidence of metastatic disease. PT2977 will be administered orally at a once-daily, 120 mg dose. The primary objective of the trial is to evaluate safety and efficacy as measured by overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). Secondary objectives include other measures of efficacy, such as duration of response and progression free survival. The potential impact of PT2977 on VHL disease-associated non-RCC tumors, as well as the tolerability and pharmacokinetics of PT2977, will also be evaluated in this trial.

Further information on the clinical trial of PT2977 can be found on clinicaltrials.gov (Study identifier: NCT03401788).

About PT2977

Peloton’s lead drug candidate, PT2977, is a once-daily, oral inhibitor of hypoxia-inducible factor-2α (HIF-2α). PT2977 has demonstrated anti-tumor activity with a favorable safety profile in an early-stage clinical study in patients with solid tumors. The company is initially focused on developing PT2977 for the treatment of kidney cancer, specifically metastatic clear cell RCC and VHL disease-associated RCC.

About Von Hippel-Lindau Disease (“VHL Disease”)

VHL disease is a familial cancer syndrome that commonly gives rise to renal cell tumors. VHL disease affects about one in 36,000 live births, and it is estimated that there are approximately 20,000 VHL disease patients in the United States and the European Union. The main manifestations of VHL disease include RCC as well as retinal, cerebellar and spinal hemangioblastomas. There are no approved systemic therapies for VHL disease.

About Peloton Therapeutics

Peloton Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on translating novel scientific insights into first-in-class medicines for patients with cancer and other debilitating or life-threatening conditions. The company’s lead development program is evaluating a small-molecule inhibitor of hypoxia-inducible factor-2α (HIF-2α), a transcription factor implicated in the development and progression of clear cell renal cell carcinoma and a variety of other disorders. HIF-2α was previously thought to be intractable using small molecules.

To learn about Peloton Therapeutics, visit http://www.pelotontherapeutics.com.

View source version on businesswire.com:https://www.businesswire.com/news/home/20190409005275/en/

CONTACT: Alan Musso

Chief Financial Officer

Phone: (972) 629-4070

alan.musso@pelotontx.comMike Beyer

Sam Brown Inc.

Phone: (312) 961-2502

mikebeyer@sambrown.com

KEYWORD: UNITED STATES NORTH AMERICA TEXAS

INDUSTRY KEYWORD: HEALTH CLINICAL TRIALS PHARMACEUTICAL

SOURCE: Peloton Therapeutics, Inc.

Copyright Business Wire 2019.

PUB: 04/09/2019 08:00 AM/DISC: 04/09/2019 08:01 AM

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