Cornerstone Pharmaceuticals, Inc. (“Cornerstone” or the “Company”), a company focused on rare cancer therapeutics and formerly known as Rafael Pharmaceuticals, today announced that data on its lead compound CPI-613® (devimistat) in combination with gemcitabine and nab-paclitaxel in patients with locally advanced or metastatic pancreatic cancer will be presented at the European Society of Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer 2022, taking place June 29 through July 2, 2022 in Barcelona, Spain. 

“We are excited to share updates from our open-label phase 1 study for devimistat in pancreatic cancer at ESMO,” said Sanjeev Luther, President & CEO of Cornerstone Pharmaceuticals. “From their frontline experience treating cancer and evaluating devimistat, Dr. Alistar and her team at Atlantic Health are able to share perspectives on new treatment options, including these results, which strengthen the hope that safer and more effective treatment options are within reach.”

Poster Details:Poster Title: GA CPI 613: A Single Arm, Open-Label Phase I Study of CPI-613 in Combination with Gemcitabine and Nab-paclitaxel For Patients With Locally Advanced or Metastatic Pancreatic Cancer

Authors: Angela Alistar, Bonny Morris, Sanjeev Luther, Timothy Pardee, Neil Morganstein, Nicole Burak, Justin Alpert

Devimistat’s mechanism of action aims to stunt the growth of cancer cells, creating an opportunity to increase survival rates for cancers like pancreatic, which have historically produced grim outlooks for patients. Pancreatic cancer is the third leading cause of cancer death in the United States, with current standard of care treatments including moderate toxicity, and median overall survival of less than 12 months.

“I’m pleased to share the results of this study on devimistat for pancreatic cancer,” said Angela Alistar, M.D., Medical Director of Gastrointestinal Medical Oncology at Atlantic Health System in New Jersey and principal investigator of the study. “The results demonstrate that treatment with devimistat is feasible, well tolerated and potentially clinically synergistic with chemotherapy for patients with pancreatic adenocarcinoma. With each milestone, we’re one step closer to delivering potential new treatment options.”

Held at Atlantic Health System, the study was comprised of a two-stage dose-escalation schema to evaluate the maximum tolerated dose (MTD) of devimistat. 22 patients were evaluated for at least six months of treatment. The treatment was well-tolerated overall. The results prove that the treatment is feasible. Further expansion of the combination in a multisite setting is being evaluated.

About Cornerstone Pharmaceuticals, Inc.Cornerstone Pharmaceuticals (“Cornerstone”) is committed to the development of therapies for rare cancers that have few to no treatment options available. Cornerstone’s lead compound, CPI-613® (devimistat), is designed to target the mitochondria of cancer cells in order to disrupt their energy production, cutting off the fuel for disease growth. Devimistat is undergoing multiple clinical trials and has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the following indications: Burkitt’s lymphoma, biliary tract cancer, soft tissue sarcoma, myelodysplastic syndrome (MDS) and peripheral T-cell lymphoma. In addition, the European Medicines Agency (EMA) has granted orphan drug designation to devimistat for Burkitt’s lymphoma.

With science stemming from the world’s most renowned institutions and compassion that runs deep, Cornerstone strives to improve the lives of people with rare cancers, inaugurating a new era of hope. For more information, please visit www.cornerstonepharma.com.

Safe Harbor StatementThis press release contains forward-looking statements. These statements relate to future events or the company’s future financial performance. In some cases, you can identify forward-looking statements by terminology such as "may", "will", "should", "expect", "plan", "anticipate", "believe", "estimate", "predict", "potential" or "continue", the negative of such terms, or other comparable terminology. These statements are only predictions. Actual events or results may differ materially from those in the forward-looking statements as a result of various important factors. Although we believe that the expectations reflected in the forward-looking statements are reasonable, such statements should not be regarded as a representation by the company, or any other person, that such forward-looking statements will be achieved. The business and operations of the company are subject to substantial risks which increase the uncertainty inherent in forward-looking statements. We undertake no duty to update any of the forward-looking statements, whether as a result of new information, future events or otherwise. In light of the foregoing, readers are cautioned not to place undue reliance on such forward-looking statements.

Morrena Villanueva
cornerstone@antennagroup.com
(201) 465-8015
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