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Peloton Therapeutics Announces Clinical Data Update for PT2977 at European International Kidney Cancer Symposium

April 1, 2019

DALLAS--(BUSINESS WIRE)--Apr 1, 2019--Peloton Therapeutics, Inc., a clinical-stage biopharmaceutical company advancing first-in-class oral medicines for cancer and other serious conditions, announced today the presentation of data from the Phase 2 portion of the company’s Phase 1/2 clinical trial of its lead drug candidate, PT2977, at the Fourteenth European International Kidney Cancer Symposium in Dubrovnik, Croatia. In the Phase 2 portion of the trial, highlighted in an oral presentation and poster session at the symposium, PT2977 showed encouraging anti-tumor activity with a favorable safety profile in patients with previously-treated advanced renal cell carcinoma (RCC).

The presentation titled, “A First-in-Human Phase 1/2 Trial of the Oral HIF-2α Inhibitor PT2977 in Patients with Advanced RCC,” was delivered by lead author Toni K. Choueiri, M.D., Director of the Lank Center for Genitourinary (GU) Oncology at Dana-Farber Cancer Institute and the Jerome and Nancy Kohlberg Chair and Professor of Medicine at Harvard Medical School.

PT2977 is an oral, small molecule inhibitor of hypoxia-inducible factor (HIF)-2α, a transcription factor that is the key oncogenic driver in RCC. Inhibiting HIF-2α can impact multiple pathways that contribute to RCC progression.

The Phase 1/2 study evaluated the safety and efficacy of PT2977. The Phase 1 portion included a once daily administration schedule dose escalation cohort of 37 patients with advanced solid tumors. Based on the results of this cohort, 120 mg once daily was selected as the recommended Phase 2 dose (RP2D). In the Phase 2 portion, 52 patients with advanced clear-cell RCC who had received at least one prior therapy received PT2977 at the RP2D. The data presented included all 52 patients from the Phase 2 portion and three RCC patients from the Phase 1 portion treated at the RP2D, for a total of 55 patients. The data cut-off date for the presentation was January 1, 2019.

Among the 55 patients who were treated at the RP2D, 12 patients (22%) had a confirmed partial response. Median progression free survival (PFS) was not yet reached in the study with a median follow-up of 9 months, and 36% of patients remained on study at the time of the data cut-off.

PT2977 was well tolerated. The most common adverse event was anemia, which was anticipated given regulation of erythropoietin (EPO) by HIF-2α. Two patients discontinued treatment for drug-related adverse events and three other patients required dose reductions for drug-related adverse events.

“The data from this trial indicate that HIF-2α inhibition has the potential to become a promising new treatment option for patients with renal cancer,” said Dr. Choueiri. “The data show that PT2977 can provide clinically meaningful responses in heavily pre-treated patients with a favorable safety and tolerability profile.”

“We are delighted with these results,” said John A. Josey, Ph.D., Peloton’s Chief Executive Officer. “The data presented today pave the way for a planned monotherapy Phase 3 trial that will further explore this exciting new mechanism of action in patients with advanced kidney cancer.”

Further information on the clinical trial of PT2977 can be found on clinicaltrials.gov (Study identifier: NCT02974738). The poster and presentation slides are available online at: https://www.pelotontherapeutics.com/publications.

About PT2977

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. Peloton is also currently evaluating PT2977 in an international Phase 2 trial in von Hippel-Lindau (VHL) disease-associated RCC.

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 more about Peloton Therapeutics, visit www.pelotontherapeutics.com.

View source version on businesswire.com:https://www.businesswire.com/news/home/20190401005214/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 EUROPE NORTH AMERICA CROATIA TEXAS

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS ONCOLOGY PHARMACEUTICAL RESEARCH SCIENCE

SOURCE: Peloton Therapeutics

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

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