Date: 2016-07-11
Type of information: Licensing agreement
Compound: Generx® [Ad5FGF-4] angiogenic gene therapy product candidat
Company: Angionetics (USA - CA) Huapont Life Sciences Affiliate (China)
Therapeutic area: Cardiovascular diseases
Type agreement: licensing commercialisation
Action mechanism: gene therapy. Generx® (Ad5FGF-4) is a first in class, disease altering, one-time administered, late-stage clinical product candidate initially for the treatment of patients with myocardial ischemia and refractory angina due to coronary artery disease. Generx® has been biologically engineered to enhance blood flow (perfusion) in ischemic regions of the heart by leveraging cardiac plasticity to promote the natural formation and growth of microvascular coronary structures (collateral vessels). This is achieved by stimulating and augmenting the heart's innate natural capacity to modulate the enlargement of pre-existing collateral arterioles (arteriogenesis), and to form new capillary vessels (angiogenesis) in select ischemic regions downstream from large coronary arteries.
The angiogenic biological process driven by the Generx® product candidate is referred to as "medical revascularization," in contrast to the classic "mechanical revascularization" procedures that include coronary artery bypass surgery (CABG), and percutaneous coronary intervention (PCI) involving angioplasty and stents.
Disease: refractory angina due to ischemic heart disease
Details: * On July 11, 2016, Angionetics , a wholly-owned subsidiary of Taxus Cardium Pharmaceuticals, announced that it has entered into an exclusive territorial distribution and license agreement with an entity affiliated with Huapont Life Sciences (through sublicense to a technology agreement with Bayer Pharma AG), for Huapont to clinically develop, to market and sell the Generx® [Ad5FGF-4] angiogenic gene therapy product candidate in Mainland China. The initial medical indication will be for the treatment of patients with refractory angina due to ischemic heart disease.
Under the exclusive distribution and license agreement, Angionetics will be responsible for a planned U.S.-based Phase 3 clinical program, and working in cooperation with researchers at Angionetics, Huapont Life Sciences' affiliated entity will focus on the clinical development, registration, marketing and sales of the Generx product candidate in China.
Angionetics has submitted the planned Generx [Ad5FGF-4] Phase 3 AFFIRM clinical study protocol to the FDA as well as updates to all key elements of the Generx IND. The recent submission included an updated Investigator's Brochure and a summary of clinical efficacy and safety data from the four FDA cleared, U.S. and international clinical studies. The clinical data, including patient subset analyses, were used as the basis for the AFFIRM study design and target patient population. The updated long-term safety data totaled over 2,500 patient years, and represented the completed safety dataset for the prior clinical studies. A detailed review of product manufacturing procedures, testing strategies and up-to-date stability data were also provided to the FDA.
The new U.S.-focused AFFIRM clinical study protocol, as submitted to the FDA, incorporates important research innovations that include: (1) enhanced cardiac delivery procedures utilizing standard balloon catheters, supported by research showing that transient ischemia may enhance gene transfer to heart cells; and (2) a more comprehensively characterized target patient population based on Ad5FGF-4 responder data from the four FDA cleared clinical studies. The study patient population includes patients with refractory angina (no longer responsive to anti-anginal medications and not a candidate CABG or PCI), and documented clinical evidence of myocardial ischemia within the past 12 months. Patients must have clinically significant limitation of physical activity due to angina (CCS Class 3 or 4) and angina-limited baseline exercise treadmill test (ETT) duration of 3-7 min. The proposed primary efficacy endpoint will be improvement in ETT duration in Generx®-treated patients compared to a placebo control group. Secondary efficacy endpoints include change in CCS angina class, change in weekly angina frequency and nitroglycerin usage, and change in quality of life, assessed using the Seattle Angina Questionnaire (SAQ).
Financial terms: Huapont's affiliated entity will assume the costs associated with the commercial development of Generx® in China, and Angionetics will be entitled to royalties on net sales, and potentially share economic consideration as a result of a monetization event. This transaction stands in place of a previously announced Generx® license transaction with Shanxi Taxus Pharmaceuticals Co. Ltd. which was not consummated as planned. On July 11, 2016, it was also reported that an affiliated entity of Huapont had entered into a $3,000,000 private equity financing, and acquired a 15% preferred stock equity interest in Angionetics to support the advancement of Angionetics as a cardiovascular gene therapy company independent of Taxus Cardium. The equity will be purchased in two tranches, an initial investment of $1,000,000 has been paid, and the remaining $2,000,000 is payable upon the successful clearance by the FDA of a Phase 3 clinical trial for Generx®.
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