“Bringing hope from the bench to the bedside”

For MimiVax, Inc., the business is amodel to provide hopeto patients. Their objective is to bring new therapeutics to market to treat cancer, particularly glioblastoma, one of the most aggressive adult cancers. MimiVax is committed to developing their lead agent, SurVaxM, an anti-cancer vaccine being studied to treat glioblastoma and adding it to cancer patients' therapeutic options The key to MimiVax iscarefully collecting data and following where it leads, according to Michael Ciesielski, PhD the CEO of the company.

Dr. Ciesielski holds a PhD in molecular immunology from the University at Buffalo and has gained experience in experimental therapeutics from first-hand laboratory work on the academic side of neuro-oncology and immunotherapyat Roswell Park Comprehensive Cancer Center for over 20 years. He has extensive academic expertise in these fields and has gained significant experience in drug development over the past decade. There has been very little advancement in new treatments for glioblastoma in the last 20 years, which motivates himto develop new therapies. Herealized the need for new therapies early on and worked to translate them from thebench to the bedside.

Dr. Ciesielskico-founded MimiVax with a clinical neurosurgeon/scientist at Roswell Park Comprehensive Cancer Center (Robert Fenstermaker, MD) with the goal of taking their own anti-cancer vaccine from the lab into clinical trials to address the unmet medical needs of brain tumor patients. They have conducted seven trials in five different disease indications in the journey to obtain FDA approval for the SurVaxM vaccine which, they are hopeful to be nearing that approval stage.

Michael has a skill for assembling teams and finding individuals with complementary expertise, focusing on people who are driven to make a difference and have the creativity and skillset to do so. He is hands-on in his business but open-minded to seek advice from prominent business advisorsalong the way. There are many ups and downs in the development of new drugs, the most difficult being traversing what is known as “the valley of death”or the gap between lab science and clinical application. The reality is the valley is made of many small bridges to cross, some in good shape and others of broken boards and twine. The goal is to navigate through productmanufacturing and raw material resources, manage clinical trials and hospital negotiationsas well as working with regulatory agencies, and the never-ending hunt forgrants, donations,and investment to keep the whole enterprise moving forward.

The over-arching focus is always on helping patients and developing SurVaxM, for them, and hopefully to make it more accessible for those who could potentially benefit from it. We want to give patients hope for a better future and deliver on that message.

Dr. Ciesielski’s style comes from an academic scientific background where many exciting things are being developed in the lab but also a frustration as to why basic science ideas are rarely ever moved or even tried in the clinic. Early on advice he received wasto stay on course and let your data speak for your accomplishments. He believes that MimiVax’s success is still based on the at simple idea of just following the data. Sometimes it is difficult for some to accept this concept as science is by nature very difficult, but it is also systematically leading you somewhere and you must be open to where it is taking you. There are many failures in our industry often when expectations prematurely guide a project. The data from clinical studies while complex is usually providing guidance on what to do next or how to improve, but you need to take the time to decipher it and be ready to pivot if it’s not what you thought it would say.

As a business, MimiVax has always focused on what was absolutely needed to complete the task, not building unnecessary infrastructure, or doing something because everyone else does it. As a result, they have run an extremely lean but very effective program. They have aspired to try and control clinical costs along the way, and hopefully they have even given some resistance into spiraling healthcare costs.

Michael has maintained stability in his company by limitingfund-raising to only what is necessary to bridge to the next stage. He believes it is important to maintain strong relationships withtheir earliest investors who initially supported them and took that leap of faith. This also keeps a lifeline open for valuable advice and many additionalopportunities along the way. As a result of that approach a sense of hometown pride has developed with MimiVax, and showing gratitude to the local Buffalo, NY investors and Roswell Park donors that have helped propel MimiVax forward.

He shared that one of his volunteer roles has been asa youth footballcoach.Which has provided more analogies and strategies to business development than he ever would have expected. Hard work and perseverance do translate well.Currently, one of his favorite non-work activities is seeing his three boys play high school and college footballand travelling with his wife to watch them playaround the country.

Based on his experience, Michael suggests that things that are important and evidence-based tend to sell themselves. He believes his job is to remove the obstacles to drug development, because if patients are responding to a drug and doing well, we are responsible to pave a pathway to get it toapproved and out patients as best possible. It’s not an easy course, but with enough perseverance, it is a manageable one, he adds.