The FDA has approved Bio-Path’s IND for its second drug candidate, but the news sent the company’s shares down over 30 percent.

Bio-Path Holdings (NASDAQ:BPTH) announced Thursday (November 21) the US Food and Drug Administration (FDA) had approved its Investigational New Drug (IND) application for its second drug candidate, surprisingly sending its shares into the red.

The company will now be able to move the drug, called BP1002, into a Phase 1 clinical trial to evaluate its capabilities in treating patients with refractory/relapsed lymphoma and chronic lymphocytic leukemia (CLL).

Despite the approval by the regulatory agency on Thursday, shares of Bio-Path Holdings dropped over 30 percent throughout the course of the trading session to close at US$7.62.

“With this IND submission now accepted by the FDA, the path is now cleared for us to advance our important first-in-human clinical work for BP1002 in cancers with unmet medical need,” Jorge Cortes, director of the Georgia Cancer and chairman of Bio-Path’s scientific advisory board, said in the release.

The goal of BP1002 is to target the B-cell lymphoma 2 protein (Bcl-2). According to the National Cancer Institute, Bcl-2 is a pivotal component in deciding whether a cell lives or dies by blocking or allowing apoptosis, which is a type of cell death.

The company said in the release that BP1002 has demonstrated in preclinical studies to be a “potent inhibitor” in addressing Bcl-2.

Now that BP1002 has been granted the IND, the company anticipates it will begin the Phase 1 trial at cancer centers such as The University of Texas MD Anderson Cancer Center and the Georgia Cancer Center.

“This IND clearance for BP1002 marks an important regulatory milestone for Bio-Path, as we progress our second drug candidate into the clinic,” Peter Nielsen, president and CEO of Bio-Path Holdings, said in the release. “Given the encouraging pre-clinical data and safety profile we have seen to-date, we are eager to begin this first-in-human study.

To start with, six patients will be enrolled in the trial and will each be initially dosed with 20 mg/m2 of BP1002. Patients will receive two doses per week over the four-week trial period.

According to, CLL is the most common form of leukemia in adult patients, amounting to 37 percent of all diagnoses. In 2019, it is estimated that over 20,000 patients in the US will be diagnosed with the condition in 2019, which is more common in people aged over 50. Out of those 20,000, roughly 3,900 will succumb to the disease.

Signs of CLL include the discovery of white blood cells during a blood test; swollen lymph nodes or glands in the neck, under the arms or groin; fever, chills, night sweats or weight loss; and recurring infections.

Thursday’s announcement comes just days after the company issued its Q3 2019 financial results for the quarter ended September 30.

In the results, the company reported a net loss of US$2.2 million for the quarter compared to US$3.1 million for the same quarter last year. Bio-Path also reported that it had US$15.4 million cash at the end of the quarter, which is a significant increase from the US$1 million at the end of 2018.

The company noted its Phase 2 clinical study of prexigebersen is in its final stages in patients with acute-myeloid leukemia and high-risk myelodysplastic syndrome.

“Upon completion of this key milestone, we expect to begin the study of prexigebersen with decitabine plus venetoclax,” Nielsen said. “In addition, an IND for prexigebersen in the treatment of solid tumors starting with ovarian and endometrial cancer is being finalized for filing.”

Moving ahead into 2020, Nielsen said his company will be working towards filing an IND and initiating a Phase 1 study of BP1003 to treat solid tumors such as pancreatic cancer.

Despite the price drop on Thursday, Bio-Path Holdings is currently ranked a “moderate buy” on TipRanks based off one analyst rating. Its shares have an average price target of US$28, which is a 267 percent increase from its current price of US$7.62.

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Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article.


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