Yahoo Finance Bio-Path (BPTH) Rises on Upbeat Updates From Blood Cancer Study
Bio-Path Holdings, Inc. BPTH announced that it has completed the second dose cohort in the dose-escalation portion of an early-stage study evaluating its investigational candidate, BP1002, for the treatment of refractory/relapsed (R/R) acute myeloid leukemia (AML) patients, including venetoclax-resistant patients.
The novel AML therapy, BP1002, is being developed by leveraging Bio-Path’s proprietary DNAbilize antisense RNAi nanoparticle technology. Per the company, BP1002 targets the Bcl-2 protein, which is responsible for driving cell survival in up to 60% of all cancers.
Venetoclax, an oral Bcl-2 inhibitor, in combination with a hypomethylating agent or with low-dose cytarabine, is currently the standard-of-care (SOC) therapy for patients with AML who are not eligible for intensive chemotherapy.
The dose escalation portion of phase I/Ib enrolled six R/R AML patients who have progressed after SOC treatment to receive BP1002 monotherapy over two dose levels with a starting dose of 20 mg/m2 and a second dose of 40 mg/m2.
Per the announcement, Bio-Path has completed the testing of both the 20 and 40 mg/m2 dose levels of BP1002 and the study will pause for a brief data review by the FDA. Contingent upon successful feedback, the company expects to initiate testing the next planned higher dose of BP1002 (60 mg/m2) as a monotherapy in the dose-escalation portion of the phase I/Ib AML study.
BPTH further reported that the company will initiate the phase Ib portion of the early-stage program after the completion of testing in all the BP1002 monotherapy cohorts. The phase Ib portion will evaluate the safety and efficacy of BP1002, in combination with Dacogen (decitabine), for patients with R/R AML.
The stock soared 30% in the last trading session on Apr 18 driven by the encouraging developmental update for BP1002 from the AML program. Year to date, shares of Bio-Path have plunged 54.6% compared with the industry’s 11.2% decline.
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In treating R/R AML, the company has stated that there is a significant downside to SOC therapy, as many patients become resistant to venetoclax treatment.
Bio-Path also referred to a case study that showed that AML patients who had relapsed from frontline venetoclax-based treatment were refractory to salvage therapy and had a median survival of less than three months.
However, management expects the novel approach of the company’s BP1002 therapy to overcome and prevent some of the mechanisms of resistance that affect venetoclax treatment. Bio-Path also reiterated results from pre-clinical studies of BP1002, which has shown its potential to be an inhibitor against the Bcl-2 target, while exhibiting a favorable safety profile.
Besides BP1002, BPTH’s innovative clinical pipeline comprises its lead product candidate, BP1001 (targeting the Grb2 protein), which is currently being evaluated in a phase II study for blood cancers.
The company is also gearing up to file an investigational new drug application for its novel preclinical candidate, BP1003, which is being developed as a specific inhibitor of STAT3.
In a separate press release, Bio-Path announced that it has entered into a definitive agreement with certain institutional investors to issue and sell 375,000 shares of its common stock at a purchase price per share of $3.225 in a registered direct offering.
Additionally, the company has also agreed to issue unregistered warrants to purchase up to 375,000 shares of common stock at an exercise price of $3.10 per share to these investors in a concurrently private placement.
Bio-Path Holdings, Inc. Price and Consensus
Bio-Path Holdings, Inc. price-consensus-chart | Bio-Path Holdings, Inc. Quote
Zacks Rank & Stocks to Consider
Bio-Path currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are ADMA Biologics ADMA, FibroGen FGEN and Annovis Bio ANVS. While ADMA sports a Zacks Rank #1 (Strong Buy), FGEN and ANVS carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has remained constant at 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has remained constant at 50 cents. Year to date, shares of ADMA have soared 37.2%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has remained constant at $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share has remained constant at 6 cents. Year to date, shares of FGEN have jumped 32%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.49 to $3.35. The estimate for Annovis’ 2025 loss per share is currently pegged at $2.82. Year to date, shares of ANVS have plunged 47.3%.
ANVS beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 15.70%.
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