New CEO Takes Over Rapamycin, Leads Funding Round With Plans for IND

Published: Aug 08, 2017

New CEO Takes Over Rapamycin, Leads Funding Round With Plans for IND August 7, 2017
By Alex Keown, BioSpace.com Breaking News Staff

SAN ANTONIO – Since taking over Rapamycin Holdings in July, Chief Executive Officer Dan Hargrove is moving the company forward rapidly. The company is in the process of raising $3.5 million in Series B funding and is looking to file an investigational new drug application later this year.

Hargrove took over the Rapamycin after a stint as co-founder and chief development officer of Cancer Insight, Xconomy reported. With Hargrove at the helm, the company plans to initiate its first human trials for its eRapa platform, a treatments that is designed to inhibit the progression and recurrence of cancer cells. Company data has shown Rapamycin rejuvenates the immune system exhausted by age and cancer exposure and helps attack early stage bladder and prostate cancer cells, according to information on the company website. Through its mTor mechanism of action, eRapa is designed to inhibit multiplication of cancer cells within the body.

In 2016, there were approximately 181,000 new prostate cancer patients diagnosed in the United States. About 60 percent of these patients are considered low risk, which is the eRapa population target. Men with low risk cancers (Gleason <7) under active surveillance have no effective therapies to slow or prevent cancer progression, the company said on its website. If eRapa is approved, the company said it estimates the drug could generate more than $1 billion in annual global revenue.

Before Rapamycin seeks approval from the U.S. Food and Drug Administration for the IND, Xconomy noted the company is waiting for additional data on “how well the drug lasts on the shelf.” If Rapamycin is granted the IND, the company plans to initiate a Phase I study with 40 patients diagnosed with prostate cancer. The early study will test four doses of eRapa. Additionally, the company could initiate a Phase IIa trial later this year.

While initially targeting prostate cancer, Rapamycin’s eRapa is believed by the company to have multiple indications for cancer, such as bladder cancer, because of the way it is designed to regenerate the immune system. In addition to cancer, the drug could also be beneficial in fighting age-related diseases, particularly cognitive-related ones.

Mouse model data has shown that eRapa restores a normal life span in familial adenomatous polyposis (FAP), which confers an extremely high risk for colon cancer. The National Institute of Aging Intervention Testing Program showed that enterically targeted rapamycin (eRapa) extended life span for wild type genetically heterogeneous mice in part by inhibiting age-associated cancer.

“Like a lot of biotech companies, they have one product and it’s one shot on goal. Here, because of the unique aspect of this fascinating compound, eRapa, we think it can be used for multiple unmet medical needs,” Hargrove told the San Antonio Express News in July after taking over the company.

If the company raises the $3.5 million, Hargrove told Xconomy the funds should be sufficient to finance the trial, which could take up to 21 months.

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