A recent cancer study showed that the incidence rates of early-onset cancer "increased substantially" from 2010 to 2019. Breast cancer had the highest number of incident cases, and gastrointestinal cancers had the fastest-growing incidence rates among all early-onset cancers. The National Cancer Institute reports that colorectal cancer has become the leading cause of cancer-related deaths for Americans aged 20 to 59 years old. Doctors are expecting that in 2024, there will be more than 2 million new cases of cancer; this would be the first year the U.S. would cross that threshold, marking almost 5,500 cancer diagnoses a day. The increasing cancer incidence, especially among young people, is a big cause for concern in the medical community. Specifically, there is an increase in pancreatic cancer, which is expected to become the second-highest cause of cancer-associated deaths in 2030 in the U.S.

Fortunately, fatality rates from cancer have steadily been on the decline for the past 30 years. This is largely due to better detection systems and advancements in treatment. Theriva Biologics (AMEX:TOVX) is one of the biotech companies that is helping push the envelope in cancer treatment. The company specializes in developing oncolytic viruses that are unique and highly differentiated. These viruses have been optimized for systemic administration and are designed to treat various types of cancer and make other cancer therapies more effective. They are optimized to be administered in combination with chemotherapy and immunotherapies, increasing access to the tumor and exposing the tumor to the immune system. 

The company's lead drug candidate is VCN-01, which is a uniquely engineered human adenovirus 5. VCN-01 also expresses a protein named hyaluronidase that degrades the dense matrix surrounding human tumors, and this helps the action of chemotherapy and immunotherapies. The phase 1 clinical trials of VCN-01 have shown promising results for the treatment of several additional indications such as pancreatic cancer, retinoblastoma, head and neck squamous cell carcinoma (HNSCC) and colorectal cancer (CRC) in combination with chemotherapy and immunotherapies. The company’s innovative Albumin Shield™ platform and oncolytic virus discovery engine have enabled the development of a distinct product pipeline that holds promise in the fight against cancer.

Currently, the company is conducting a phase 2b clinical trial of its VCN-01 in combination with standard-of-care chemotherapy for first-line metastatic pancreatic cancer. Theriva Biologics is on track to complete enrollment into the VIRAGE Study by the first half of 2024. In the first quarter of 2024, a Drug Monitoring Committee (DMC) conducted a thorough safety review of VCN-01, ensuring that the drug meets the necessary criteria for continued development. By the second half of 2024, Theriva Biologics aims to perform an interim analysis of the data obtained from the VIRAGE Study.

The pancreatic cancer market's size was estimated at $2.2 billion in 2022, and it’s expected to grow at a CAGR of 13.6% between 2023 and 2032, reaching approximately $7.91 billion by 2032. Theriva Biologics seems well-positioned to excel in this space with its innovative VCN-01 drug candidate, with the potential to also serve other multi-billion dollar markets – such as head and neck cancer drugs, set to surpass $2.99 billion by 2030. 

Theriva Biologics reported $31.6 million in cash and short-term investment for Q3 2023. The company also increased research expenses to $4 million from $2.6 million a year ago while decreasing general and administrative expenses by 91% y-o-y. The company narrowed its net loss for the quarter from $4.49 million in Q3 2022 to $3.3 million in Q3 2023, and the basic loss per share for the quarter was $0.19 compared to $0.3 a year ago. Theriva Biologics currently has a market capitalization of about $8 million.