Life sciences are a sweet spot for VisionTech Angels so when I met Jim Hussey, CEO of Seneca Therapeutics , at the ACA Life Sciences Syndicate meeting and learned about their virus that combats “cold” cancer tumors, I thought our group would be interested. Cancer therapeutics tend to be a long haul for investors, but Seneca is starting its Phase 2 trials of their lead asset, SVV-001, an oncolytic virus that shows significant clinical benefit in neuroendocrine tumors. Specifically, SVV-001 works to turn cold solid tumors hot and therefore treatable with immunotherapies. The VisionTech Screening Committee and I invited Jim to pitch during our June Pitch Week. Here’s a sneak preview. I hope you’ll join us to hear Jim and join in the discussion on this investment opportunity.
BP: Seneca Therapeutics has a strong leadership and scientific team. Tell me about your founder, Paul Hallenback, and yourself.
JH: We are really proud of the team we’ve assembled. Paul Hallenbeck is our founder, president and chief scientific officer. He’s spent the last 27 years in the biotechnology industry with tremendous expertise in all phases of cancer immuno-therapeutics R&D. Paul is also a serial entrepreneur and was the sole founder of Neotropix, where he raised $30 million in venture capital. Now with Seneca, Paul has led our lead asset, SVV-001, through IND approval and completed several Phase I/II clinical trials, establishing its safety and early evidence of efficacy.
I’ve spent my entire career in the pharmaceutical and biotech industries, the last 27 years in C-suite positions. I left Morphosys—where I was president of the U.S. business—and joined Seneca because of the enormous upside of SVV-001. My focus is positioning Seneca for our Series B and ultimately an exit or partnership with big pharma with a highly favorable, near-term return for our investors.
BP: I’m not an oncologist so please explain the issue here.
JH: Certainly! Immunotherapy drugs are very effective on some types of cancers because they enable the body’s own T-cells to find and kill cancer cells. However, for these drugs to work, the tumor must be functional, hot and inflamed. The issue is many solid cancer tumors are cold and not inflamed so the immune system does not recognize them as foreign and does not attack the tumor. As a result, cold solid tumors do not respond to promising immunotherapies.
There is a significant gap in the percentage of cancer patients who respond to immunotherapy. About 12.5% of tumors do respond and about 44% do not respond to the newer immunotherapies primarily because of cold tumors. So how do we enable the body’s immune system to get to work? Oncolytic viruses like SVV-001 are unique in the ability to turn cold tumors hot and respond to immunotherapies like checkpoint inhibitors.
Checkpoint inhibitors like Keytruda and Opdivo you’ve probably seen advertised are immunology drugs that work by blocking checkpoint proteins from binding with their partner proteins and sending an “all clear” message to the body. Using SVV-001, an oncolytic virus, the previously cold tumor is recognized as hot and the T cells do their job, which is attacking the cancer cells and allowing the checkpoint inhibitor to work.
BP: What is novel about your lead asset, SVV-001?
JH: SVV-001 is small in size enabling rapid, potent, and efficient distribution and infection within tumors. This infection turns the tumor hot and leads to tumor cell death. SVV-001 is a “best in class” oncolytic virus drug because of its “TEM8” advantage which makes it the most cancer-specific oncolytic virus. What TEM8 does is provide the opportunity to define the population where SVV-001 mediated therapy can make a major impact in terms of treatment response and outcomes. Due to the presence of TEM8 on more than 60% of solid tumors, we predict that more than 60% of patients may benefit. This would dramatically increase the number of patients with solid cancer tumors that respond to immunotherapy drugs.
BP: What types of cancer is this best utilized for?
JH: Ultimately, SVV-001 could be utilized in any type of solid tumors expressing TEM8 such as breast cancer, lung cancer and pancreatic cancer. Seneca is currently focused on neuroendocrine tumors and neuroendocrine carcinoma.
BP: What kind of IP do you have?
JH: When the mechanism of action (binding to TEM8) for SVV-001 was discovered in 2017, it allowed new IP to be filed and issued through 2040. There is other IP as well covering the gene delivery technology for SVV-001.
BP: Where are you in the commercialization process?
JH: We hope to file our BLA (biologics license application) with the FDA in the fourth quarter of 2023 and have this therapy on the market by second quarter 2024.
BP: What does the market look like for an oncolytic virus like SVV-001?
JH: The market for oncolytic virus platforms is robust with a tremendous amount of activity in the last three years and a lot of potential for additional exits. Some highlights include a $1 billion plus exit of BeneVir to Johnson & Johnson and a $900 million exit of Turnstone to Takeda. Both were pre-clinical, which says a lot about the level of interest. Here’s another—Replimune completed an IPO in July 2018 and now has a valuation of $1.6 billion and they’re currently in Phase II clinical trials. You also have Merck and Boehringer Ingelheim that have made acquisitions.
BP: What will this round be used for?
JH: We completed our Series A February 1 and are now raising a convertible bridge round leading into our Series B this fall. The bridge gives us additional time and flexibility as we plan the next round of Phase II and III clinical trials. The time and flexibility is for completing the animal data before we begin the clinical trial this fall and for negotiations with potential strategic pharma partners or VCs. Our goal is to raise $5 million in our Series B and we have around $3 million left to raise.
BP: Why should VisionTech investors back you?
JH: The risk reward is very favorable. This is a later stage asset, with substantial human and animal data. We also have a ton of positive data from 76 humans who have received SVV-001 and that data supports the premise that SVV-001 solves the cold tumor issue. Turning cold tumors hot and therefore receptive to immunotherapies is a significant development for patients whose tumors were previously not responding to immunotherapies.
To learn more about Seneca Therapeutics, visit their website. VisionTech Angels’ June Pitch Events will be virtual on Tuesday, June 22 and Thursday, June 294at 6 p.m. Pitch events are open to our members and accredited investors interested in joining our group. To register, check your email for an invitation, go to our Events page or email Ben Pidgeon at email@example.com.