LIPAC Oncology spun out of TesoRx to advance Oncology Franchise

LIPAC Oncology was spun out as a separate company to focus on developing novel cancer therapies with an initial treatment for non-muscle invasive bladder cancer. Read press release or visit LIPAC's website

The first pipeline product is THG-1001, for which LIPAC anticipates beginning human clinical trials soon after the successful review of its filed IND. The company is also pursuing the development of treatments for additional oncology indications and has recently filed patents for a novel treatment for upper track urothelial carcinoma (UTUC). It has other treatment candidates in early stages of pre-clinical development.


The first chemotherapy to be approved for intravesical use in Non-Muscle Invasive Bladder Cancer (NMIBC)

THG-1001 is a novel chemotherapy that enables the local instillation of a highly active chemotherapy agent with the following benefits:

  • Proliposomal formulation greatly enhancessolubility and availability
  • Demonstrated solubility and activity against bladder cancer cells in acidic bladder-like environment
  • Reduced risk of systemic exposure and toxicity
  • Allows use of Paclitaxel in the bladder, providing greatly needed additional treatment option

Current NMIBC Treatments

There have been no new products approved for the treatment of NMIBC in the last 18 years.

Physicians have been using infusions of BCG and Mitomycin C as the standard of care even though they pose the following challenges:

  • Maintaining solubility is difficult in acidic bladder
  • Penetration into urothelium is limited with current agents
  • Available/marketed chemotherapies are not formulated / approved for intravesical administration
  • Requires patient optimization (alkalization, dehydration) that is often not done properly.
  • Drug preparation requires a fume hood and exposure risk to medical staff
  • Manufacturing disruptions for BCG and Mitomycin C

Market

NMIBC is a common disease with a high rate of recurrence, limited treatment options and substantial market opportunity:

  • Prevalence:  ~600,000 cases in the US; 900,000 in the EU

  • Incidence:  74,000 cases per year, 70% of which are NMIBC

  • Recurrence:  31-78% five year recurrence rate

  • Expensive:  $65,000 lifetime cost

  • Underserved:  0 new products approved since 1998


Development

Preclinical

Proof of concept has been established in pre-clinical studies. Formulating Paclitaxel with TesoRx's delivery platform has shown ~10-100X more effectiveness in vitro vs. the approved formulation of Paclitaxel. Studies have also shown how the new formulation attaches to the urothelium in the bladder for maximum exposure.

Rats were instilled with liposomes containing trace amounts of fluorescent lipid. Eight hours after instillation bladder sections were taken of the whole bladder. A fluorescent signal detected by a microscope in bladder sections was localized in the top layers of the urothelium in the bladder

Rats were instilled with liposomes containing trace amounts of fluorescent lipid. Eight hours after instillation bladder sections were taken of the whole bladder. A fluorescent signal detected by a microscope in bladder sections was localized in the top layers of the urothelium in the bladder

Clinical

LIPAC filed its IND in December 2016 and plan on starting clinical trials in early 2017. The company plans to conduct a phase 1/2 study to establish the highest non-toxic dose, as well as to get human proof-of-concept on efficacy. Other highlights include:

  • FDA has acknowledged the critical need for new products in this space
  • PLIP would be the first intravesical chemotherapy agent approved for this indication
  • De-risked 505(b)(2) pathway to approval given established profile of paclitaxel
  • Manufacturing and preparations for clinical studies underway
  • Clinical proof of concept expected by the second half of 2018