Entrepreneurship

Mission Statement

Here will be the mission statement

Unmet Need in Lung Cancer Treatment

Lung cancer remains one of the most challenging and deadly forms of cancer, with many patients still lacking effective, long-term treatment options. In this section, we outline the urgent unmet need by highlighting three key aspects: the global burden and rising incidence of the disease, the critical limitations of current treatment modalities, and the firsthand experiences of both clinicians and patients confronting these gaps in care.

Disease Burden

Lung cancer remains one of the leading causes of cancer-related mortality worldwide. According to the American Cancer Society 2025 report, lung cancer is responsible for approximately 1 in 5 cancer deaths, with an estimated 226,650 new cases and 124,730 deaths (Lung & bronchus cancer) expected in the United States alone this year [1]. Globally, according to GLOBOCAN 2022, lung cancer was the most commonly diagnosed cancer, accounting for nearly 2.5 million new cases (12.4% of all cancers), and the leading cause of cancer death, responsible for 18.7% of global cancer-related mortality. The burden is particularly high among men, though incidence among women is rising, with substantial geographic variation observed across continents [2].

The World Health Organization (WHO) attributes the rising burden of lung cancer, particularly in regions such as Asia, to increasing tobacco consumption [3].

Figure 1 - Age-standardized incidence of lung cancer worldwide in 2022 [2]

Despite advances in targeted therapies and immunotherapies, the five-year survival rate for lung cancer remains below 30%, largely due to late-stage diagnosis and limited treatment options for patients with rare or less-studied mutations [5].

Figure 2 - Five-year relative survival rates for selected cancers by race and stage at diagnosis, United States, 2014 to 2020 [5]

According to GLOBOCAN 2022, the number of new cancer cases worldwide is expected to reach over 35 million by 2050, marking a 77% increase compared to approximately 20 million cases reported in 2022. This projected rise is largely attributed to population growth and ageing, occurring alongside a global demographic shift toward lower birth and death rates. In parallel, the International Agency for Research on Cancer (IARC) anticipates a significant rise in lung cancer, with incidence projected to grow by 58.8% and mortality by 64% between 2020 and 2040 [2].

The development of lung cancer is strongly associated with environmental and behavioral risk factors. Smoking remains the predominant cause, contributing to approximately 85–90% of all cases. However, other exposures, such as second-hand smoke, family history, and contact with carcinogenic substances are also significant contributors. Additionally, underlying medical conditions like pulmonary fibrosis, HIV infection, and lifestyle factors such as alcohol use further increase the likelihood of developing the disease [3].

Despite advances in surgery, radiation, chemotherapy, and immunotherapy, non-small cell lung cancer (NSCLC) remains a major clinical challenge, particularly due to the high rates of recurrence and metastasis after treatment. NSCLC accounts for approximately 85% of all lung cancer cases, with three main types - adenocarcinoma (40%), squamous cell carcinoma (25–30%), and large cell carcinoma (5–10%). However, many patients who undergo curative-intent surgery still experience distant metastases or local recurrence, highlighting the limitations of current therapeutic strategies and the urgent need for novel approaches [3].

NSCLC is often diagnosed at an advanced stage, limiting treatment options. The most common symptom is cough (50–75% of cases), but its nonspecific nature contributes to delayed detection. Despite the use of PET-CT and liquid biopsy, accurate diagnosis still requires tissue sampling [3].

Metastatic non-small cell lung cancer (mNSCLC) imposes a substantial economic burden on the U.S. healthcare system, particularly during the period between diagnosis and the initiation of first-line treatment. A 2023 ISPOR study revealed that for patients with commercial insurance, average per-patient-per-month (PPPM) costs during this early phase reached $64,253, driven primarily by medical services ($61,824) and pharmacy-related expenses ($2,429). Even for patients with public insurance (Medicaid), PPPM costs exceeded $34,000. These costs decline in subsequent phases, but remain significant. Notably, patients with mNSCLC without actionable EGFR or ALK mutations, who make up the majority, face limited treatment options despite repeated healthcare utilization and high failure rates of existing first-line therapies. This gap highlights both a clinical and financial need for a new biologic therapy that accelerates therapeutic efficacy or delays progression. Such an intervention could reduce resource-intensive care periods and hospitalization rates, lowering payer expenditures while improving patient outcomes [4].

Our project focuses on developing an antisense oligonucleotide (ASO) based therapy tailored to a genetically defined subpopulation of lung cancer patients. To ensure both clinical relevance and scalability, we aim to target a mutation (or set of mutations) present in at least 5% of lung cancer patients. This precision approach will allow us to address a biologically significant subset of patients who may not respond well to current treatments.

By identifying such a subgroup and designing molecular therapy, we aim to fill a critical gap in personalized oncology. Our approach is particularly relevant for non-small cell lung cancer (NSCLC), which accounts for about 85% of all lung cancer cases, and where genetic heterogeneity poses a challenge for effective, long-term treatment.

Current Treatment Limitations

Despite major advances in therapy over the past two decades, significant limitations persist across existing treatment modalities.

Traditional chemotherapy kills rapidly dividing cells indiscriminately, leading to severe side effects and often incomplete tumor eradication [6], the last two decades have seen the rise and consolidation of all major cancer treatment modalities. These include targeted therapies (e.g., EGFR, ALK inhibitors) and biological drugs (e.g., monoclonal antibodies like Nivolumab or Bevacizumab), which act more selectively on cancer-driving molecules [7],[8]. At the same time, traditional treatments such as chemotherapy and radiotherapy remain widely used in clinical practice, although the primary focus of research and innovation has shifted toward more precise and personalized approaches.

These newer therapies offer improved safety and efficacy - but only for a subset of patients with specific genetic mutations or protein biomarkers, and even these advanced therapies have limitations:

1. Restricted to Membrane: Most targeted therapies act on cell-surface proteins. This restricts their utility because intracellular targets, such as mutated proteins, mRNA, or non-coding RNAs, remain largely inaccessible. Antibody development is limited to extracellular targets and is expensive, time-consuming, and often hampered by tumor heterogeneity and antigen loss [9],[10].
2. Mutation-Driven Resistance: Cancer cells are highly dynamic. During treatment, secondary mutations, alternative splicing, or gene amplifications can emerge, rendering once-effective drugs obsolete. This is especially common with EGFR and ALK inhibitors, where resistance often develops within months. As resistance accumulates and toxicities limit further treatment, some patients exhaust all available drug options, leaving their physicians with no additional therapies to offer - a devastating outcome that underscores the need for more versatile and durable treatment strategies [11],[12].
3. Patient Eligibility Is Narrow: Precision oncology often depends on identifying specific mutations or biomarkers in each patient. Even within a single gene, such as EGFR or KRAS, dozens of distinct mutations can exist - each potentially requiring a different therapeutic approach. As a result, most drugs are only effective for a small subset of patients with the "right" mutation, leaving many without an applicable targeted treatment [13].
4. Missed Opportunities: Targeted therapies have largely focused on oncogenic drivers - genes that gain function and can be inhibited. In contrast, tumor suppressor genes such as TP53, RB1, and APC, which are inactivated in many lung cancers, present a major therapeutic gap. Their loss-of-function nature, combined with the diversity of mutations involved, makes it nearly impossible to "repair" them with a single drug. As a result, these critical genes are often ignored in current treatment paradigms.

To better understand the existing landscape, we compiled a comprehensive table of all FDA-approved non-chemotherapy treatments for lung cancer - including targeted therapies, immune checkpoint inhibitors, and angiogenesis inhibitors.

See Table: “Lung Cancer non-chemotherapy Current Approved Therapies”

While modern therapies have improved outcomes for select patient populations, the limitations outlined above reveal substantial gaps in lung cancer treatment - particularly for patients lacking druggable oncogenic drivers or harboring tumor suppressor gene mutations. These challenges highlight the urgent need for novel, versatile approaches that can overcome resistance, broaden patient eligibility, and effectively target the currently “undruggable” vulnerabilities in cancer.

Patient /Clinician Insight

While lung cancer remains the leading cause of cancer-related death worldwide, the personal experiences of patients and clinicians reveal a deeper, more human dimension of this crisis. One defined not only by biology, but by pain, limitations, and unmet therapeutic needs.

During our meeting with Prof. Amir Onn, Chair of the Institute of Pulmonary Oncology at Sheba Medical Center, he shared the story of a young mother he has been treating since 2016. After nine years of battling lung cancer, none of the available treatments are effective anymore. “I have nothing left to give her”, he said. “No drug works anymore”.

This sense of helplessness, echoed by clinicians facing treatment resistance, is deeply connected to the lived experiences of patients. As therapies lose efficacy over time, patients are left struggling not only with physical decline but with the emotional weight of limited options and uncertain futures.

A 25 year old nurse shared her story after being diagnosed with stage IV non-small cell lung cancer despite having no risk factors. She recalled the emotional toll of chemotherapy [14]:

“I started chemotherapy and fell into a deep depression. One day, in between chemo sessions, I remember sitting in my bed and thinking: "It would be so much easier if I just ended it now and saved everybody the trouble.”

Following initial chemotherapy, she began drug therapy that brought temporary improvement, but she remained aware of its limitations:

“Drug therapy isn't a cure; it’s a treatment. I had to come to terms with that. Eventually, the drugs will become less effective as my body adapts and the cancer finds ways around it.”

Still, she expressed cautious hope for the future:

“The hope is to one day treat this type of lung cancer, or all cancers, like we treat diabetes—as a chronic condition that can be managed.”

These personal accounts are echoed by the study 'Symptoms and experiences of frailty in lung cancer patients with chemotherapy' [15] which explored the experiences of 302 lung cancer patients undergoing chemotherapy. Many reported severe fatigue, appetite loss, anxiety, and social withdrawal.

Further supporting this picture, the study 'Living with advanced or metastatic lung cancer - A qualitative study on the experiences of patients' [16], interviewed 19 patients with advanced or metastatic NSCLC. Participants described how symptoms like shortness of breath, persistent cough, and fatigue interfered with walking, sleeping, and daily life. They also reported confusion about whether their symptoms came from the disease or the treatment - adding emotional distress to physical discomfort.

Together, these insights highlight the urgent need for treatments that reduce systemic toxicity, preserve patients’ quality of life, and adapt to the evolving biology of lung cancer. ASO-based therapeutics represent a promising direction toward fulfilling this unmet need.

Solution and Tech

Market Size and Opportunity

Our comprehensive market analysis reveals a significant opportunity in the target sector. The market is experiencing rapid growth due to increasing demand for sustainable solutions and regulatory support for innovative biotechnology applications.

Competitive Landscape

We have conducted thorough competitive analysis, identifying key players and their strengths and weaknesses. Our solution addresses gaps in the current market offerings, providing unique value that differentiates us from competitors.

Customer Segments

Through extensive customer discovery interviews, we have identified primary and secondary customer segments. Our target customers have validated the problem we're solving and expressed strong interest in our proposed solution.

Market Analysis

Minimum Viable Product (MVP)

Our MVP demonstrates the core functionality of our solution while minimizing development costs and time to market. We have successfully prototyped and tested our MVP with potential customers, receiving valuable feedback for iterative improvements.

Technical Feasibility

We have thoroughly assessed the technical feasibility of our solution, conducting proof-of-concept studies and scalability analyses. Our technical approach is grounded in solid scientific principles and validated through rigorous experimentation.

SWOT analysis

Revenue Model

Our revenue model is based on thorough market analysis and validated pricing strategies. We have developed multiple revenue streams to ensure sustainable growth and minimize risk.

Cost Structure

We have carefully analyzed our cost structure, including research and development, manufacturing, marketing, and operational expenses. Our projections account for economies of scale and operational efficiency improvements over time.

Funding Requirements

Based on our financial projections, we have identified specific funding requirements for different growth phases. We have developed a comprehensive funding strategy that includes grants, angel investment, and venture capital opportunities.

Competitive Landscape & Differentiation

Go-to-Market Strategy

Our go-to-market strategy is designed to maximize market penetration while building strong customer relationships. We have identified key distribution channels and partnership opportunities that align with our target customer segments.

Regulatory Pathway

We have thoroughly researched the regulatory requirements for our solution and developed a clear pathway to compliance. Our regulatory strategy includes engagement with relevant authorities and alignment with industry standards.

Risk Management

We have identified potential risks and developed comprehensive mitigation strategies. Our risk management approach includes technical, market, financial, and regulatory considerations.

Business Model & Value Proposition

Core Team

Our team combines strong technical expertise with business acumen and entrepreneurial experience. We have assembled a diverse group of individuals with complementary skills essential for successful commercialization.

Advisory Board

We have established an advisory board comprising industry experts, successful entrepreneurs, and technical specialists. Our advisors provide strategic guidance and valuable connections within the industry.

Key Partnerships

We have formed strategic partnerships with leading organizations in our target market. These partnerships provide access to resources, expertise, and distribution channels critical for our success.

Inspirations

We drew inspiration from successful iGEM teams who have demonstrated excellence in entrepreneurship. Their approaches and achievements provided valuable insights for our own entrepreneurship journey.