I-Corps: Photodynamic Cancer Therapy Innovation

三阴性乳腺癌（TNBC）是最具侵袭性、致死性的乳腺癌之一，由于这种癌症缺乏雌激素、孕激素和人表皮生长因子（HER-2）受体，许多现有的药物治疗对患者生存的影响有限。提出的创新旨在解决缺乏有效治疗TNBC的靶向治疗方法的问题，因为缺乏有效的靶向治疗方法是TNBC患者诊断的重大障碍。由于三阴癌对化疗的反应很差，因此经常进行乳房切除术以提高总生存率。这项提议的创新可能会消除乳房切除术的需要。潜在客户包括医生、卫生保健管理人员和患者。除了给我们开药方的肿瘤学家之外，客户还包括那些对我们的治疗方案有影响的人。这些客户包括医疗服务提供者。通过质子的光释放诱导细胞内酸中毒直到现在还没有作为一种对细胞造成损害的技术来研究。释放显著浓度的氢离子对生物系统造成可变的破坏，并可用于引起病灶区域（如肿瘤内）的凋亡细胞死亡。这种对细胞内pH值的基本改变几乎不可能产生耐药性，已被证明在体外和体内引起显著的癌细胞死亡方面非常有效，具有强烈的聚焦效应，为使用最近开发的pH诱导光动力纳米颗粒靶向特定细胞提供了无限的潜力，并且是一种丰富且相对便宜的化合物。这种知识产权的商业可行性具有巨大的潜力，因为在体外和体内导致三阴癌细胞显著死亡的作用机制不是癌症特异性的。如果开发并进入市场，提出的细胞内酸中毒抗癌技术有可能竞争或超过目前的化疗，放疗或手术治疗癌症的方法。这个I-Corps小组打算确定TNBC治疗领域所有负责人目前未满足的需求，特别是肿瘤学家、医院管理者、制药公司、患者和FDA监管机构。该小组还将确定药代动力学和药效学研究的需求。在项目结束时，该团队将起草一份商业计划，其中包括使命宣言、目标、成功的关键、产品和服务、管理计划、包括客户、定价、竞争和交付在内的市场分析，以及可衡量的进展里程碑。

Triple Negative Breast Cancer (TNBC) represents one of the most aggressive, deadly forms of breast cancer, and because this cancer lacks estrogen, progesterone, and Human Epidermal Growth Factor (HER-2) receptors, many existing pharmacological treatments have a limited effect on patient survival. The proposed innovation aims to address the lack of targeted therapies for effective treatment of TNBC, as the lack of an efficient targeted approach represents a significant barrier for patients diagnosed with TNBC. Because TNBC responds so poorly to chemotherapy, a mastectomy is often performed to increase overall survival. The proposed innovation may eliminate the need for mastectomy. Potential customers include physicians, health care administrators, and patients. In addition to oncologists that would prescribe our treatment, customers would also include people who influence the decision to use the proposed treatment. These customers would include health care providers.Induction of intracellular acidosis via photo uncaging of protons has until not been pursued as a technique for inflicting damage to cells. Releasing significant concentrations of hydrogen ions causes variable disruption to biological systems, and can be used to cause apoptotic cell death in a focal region such as within a tumor. This fundamental alteration to cells intracellular pH is almost impossible to garner a resistance toward, has been shown to be highly effective in causing significant cancer cell death in vitro and in vivo, has an acutely focal effect providing limitless potential for specific cell targeting using a recently developed pH-inducing photodynamic nanoparticle, and is an abundant and relatively inexpensive chemical compound. The commercial viability of this intellectual property has tremendous potential, as the mechanisms of action employed in causing significant death of TNBC cells in vitro and in vivo is not cancer specific. If developed and entered into the market, the proposed intracellular acidosis anti-cancer technique has the potential to rival or surpass current chemotherapeutic, radiation, or surgical methods of cancer treatment. This I-Corps team intends to establish the current unmet needs of all principals in the TNBC treatment space, specifically oncologists, hospital administrators, pharmaceutical companies, patients, and FDA regulators. The team will also identify needs for pharmacokinetic and pharmacodynamics studies. At the end of the project this team will draft a business plan which will include a mission statement, objectives, keys to success, products and services, management plan, market analysis to include customers, pricing, competition, and delivery, and measurable milestones of progress.