Bio-path Holdings Inc.
Bio-Path is engaged in the business of financing and commercializing novel cancer therapeutics acquired from MD Anderson Cancer Center. Their first Antisense drug BP-1001 has completed a combination (with LDAC) safety phase 8 cohort for treatment of AML. No toxicity was seen. 5 out of 6 patients acheived at least partial remission. 50% had total remission! The company has completed the review by the FDA for this drug to begin phase II. The patient dosing has begun at trials which will occur at up to 8 sites or more, including MD Anderson, Baylor and University of Kansas. Bio-Path Holdings is focused on antisense drugs which work at a cellular level to interrupt protein production by the diseased cell. The lead drug is BP1001 targeting the Grb-2 protein. Several years ago Gilead attempted to produce viable antisense drugs unsuccessfully because of high toxicity caused by their cationic (positively charged) liposome delivery system. Bio Path Holdings' delivery system is a small molecule neutral liposome system. Through the 8 cohort of phase 1 (treating different types of leukemia) there has been absolutely no toxicity. Testing performed by Bio Path demonstrates an uptake of the drug at a cellular level. The pErk results demonstrate not only a 50+% knockdown of the target protein but shows the pathway was shut down validating our delivery system. With the completion of the combination safety trials with LDAC and FDA approval, phase 2 has begun and is accepting patients. This trial will occur at several sites. The purpose of phase 2 will be to test the effectiveness of the drug. The company may explore FDA accelerated status after testing is complete on 19 additional patients which is expected to occur in mid 2017. A CML combination drug safety study for BP1001 is also expected to be completed by mid 2017.
Bio-Path Holdings will also begin phase 1 testing of their antisense drug BP1001 on certain types of breast cancer which the date have been resistant to treatment. Additionally, BPTH is initiating development of a second drug BP1002 targeting Bcl-2 for Follicular Lymphoma. An IND for BP1002 is projected for early 2017. The company has entered into a sponsored research agreement with the University of Texas Southwestern Medical Center to evaluate BPTH's pipeline for efficacy in down-regulating the immune response using systemic lupus erythematosus (SLE) as a model. Bio-Path has entered into a sponsored research agreement with Thomas Jefferson University to investigate DNAbilize™ antisense DNA technology for the development of a brain cancer immunotherapy that works by activating the patient’s own immune system to fight their cancer. Also, BPTH has entered into a sponsored research agreement with MD Anderson to evaluate the ability of its pipeline to modulate pancreatic cancer.
While antisense drugs fell out of favor following Gilead's failed efforts there is now renewed interest. Ionis established partnerships with Biogen Idec and GlaxoSmithKline for their antisense technology. If Bio-Path holdings proves the validity of their delivery system, I would expect similar partnerships.
This link to the company website describes their novel delivery technology: http://biopathholdings.com/technology/
The company was founded on the technology from M.D. Anderson Cancer Center at the University of Texas in Houston. M.D. Anderson was the largest shareholder. After raising an additional 10 million dollars the company has $11+ million in cash. These funds should allow the company to start phase II testing of their antisense drug BP1001 on leukemia and begin phase I testing for breast cancer. The company has an "at the market" credit facility in place with Cantor Fitzgerald to raise another $25 million.
Bio-Path Holdings do not manufacture their drug but uses contractors. Once the efficacy of BP1001 is established, I would anticipate a manufacturing partnership will occur. The CEO says the company has now ramped up their structure as they are a phase 2 developmental company.