The Breast Cancer Startup Challenge was advertised on the DBBS website and the concept of the challenge was very intriguing to me. I immediately decided to participate in the competition, as I am interested in translating scientific discoveries to the bedside and also have won a business plan competition in the past. To accomplish this, I set out to build a capable team having scientific, medical, business and law expertise. I have the background in biotechnology, cancer research and have worked as a consultant with SCIMALS
entific and M
nalysis for L
ciences). I also gained a first hand account of the challenges faced in treating breast cancer patients while shadowing doctors at Siteman Cancer Center as part of my Special Emphasis Pathway in Cancer Biology
fellowship. I reached out to Anurag Agarwal
, a fellow DBBS graduate student and also the co-founder of SCIMALS. Anurag is renowned locally and nationally in the startup biotechnology community and is well connected to early stage life science investors and venture capitalists. He has extensive experience in scientific due diligence of seed stage life science companies and writing business plans which would be crucial to the team’s success.Whitney Grither
, a MSTP student at WashU who has a keen interest in drug development also joined the team bringing in medical and clinical knowledge. Tapping into SCIMAL’s extensive network, we recruited Gurudatta Begur Nadiger, an executive MBA student at Kellogg Business School, who is a business and technology leader and has work experience in the life science industry for 6+ years. To strengthen the team in biotechnology / patent law and licensing aspects, Erik Nyre joined the team. Erik is enrolled in the joint MS/JD dual degree program at University in Minnesota and has experience in cancer research. He also works with the Office for Technology Commercialization at University of Minnesota where his experience in evaluating licenses and technologies would be instrumental for the team’s success.
Immediately after forming the team, we performed extensive due diligence on the 10 technologies that were available for the competition. Based on current market and investment trends, strength of the technology’s patent and our team’s collective experience, we decided to pursue technology #2 which is an autologous whole cell killed tumor vaccine for the competition. The technology was developed in the lab of Dr. Dennis Klinman at the NCI and the preclinical data is very compelling. The vaccine uses the patients own killed tumor cells which is obtained from surgical resection as a source of antigens and chemically conjugates unmethylated CpG oligodioxynucleotides (CpG-ODN) to it, which serves as the adjuvant. When administered to the patient, the CpG-ODN mimics prokaryotic DNA and tricks the immune system, which has evolved to strongly detect CpG sequences, to fight the tumor. Using the patient’s own tumor as an antigen source, elicits a multivalent immune response against the cancer bypassing the need for a druggable molecular marker to be expressed on the tumor.
After finalizing the technology, we approached several distinguished scientists, clinicians and business leaders to mentor our team in the competition. Dr. William Gillanders
, Dr. David Linehan and Dr. Robert Schreiber agreed to be our science mentors. Their input and expertise in tumor immunology, developing cancer vaccines and corresponding clinical trials were crucial for the team to develop an R&D strategy to develop the technology further. Dr. Gillanders especially shed light on the regulatory issues that might concern the FDA and guided us in creating a risk mitigation strategy for the same. He helped us to design the clinical trials and choose the appropriate patient population.
Anurag and SCIMAL’s connections were instrumental in connecting the team with entrepreneurs and investors who served as our business mentors. They include Dr. Rajesh Devraj, Dr. Corey McCann, Dr. Erik Gulve and Mr. Vijay Chauhan and are renowned in the biotechnology community. Collectively, they are experienced in founding multiple life science startup enterprises, leading and directing research in the industry, raising dilutive and non-dilutive seed funding and venture capital, investing in life science start-ups and also successfully exiting companies. Dr. Devraj and Dr. McCann especially advised us to create a strong R&D strategy and gave us valuable perspective as an investor, which helped us to tailor our business plan accordingly. Interestingly, Dr. McCann is an alumnus
of the MSTP program at WashU.
For the business plan, we decided to develop the vaccine for triple negative breast cancer (TNBC) which has limited therapeutic options. Treating TNBC is an unmet clinical need as TNBC has poor prognosis with high metastasis rates and the cancers lacks expression of drugable tumor antigens like Her2. As our broad-spectrum technology does not require prior knowledge of tumor antigens and as such TNBC patients would benefit the most from our technology. Alongside identifying a focused patient population, we also created a very strong R&D plan involving pre-clinical mouse models also feasibility studies using human cancers. Another unique aspect of our business plan is the generation of early efficacy data by conducing outside U.S First In Man clinical trials and also using Circulating Tumor Cells (CTC) as readout in Phase I clinical trials. These strategies were incorporated to add value to the company thereby de-risking investments. We also created a viable financial model which predicted a strong return on investments. As part of the competition, we created a 1 minute elevator pitch and subsequently pitched the business plan live to the judges. And as they say – the rest is history. Whitney Grither traveled to the NIH to attend the award ceremony and the MSTP program generously sponsored her trip. We received a plaque commemorating the win and prize money of $5000.
Winning the competition advanced the team to the next stage wherein we negotiate a license from the NIH, polish our business plan based on feedback from the investor judges and apply for dilutive and non-dilutive seed funding. Successful negotiation of the license and raising seed funding will lead us to incorporate the technology into our own start-up company. This would be the ultimate reward of the endeavor – taking the first step towards moving a promising technology from bench to bedside.
To learn more about the Breast Cancer Startup Challenge, visit the website HERE