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ImmunoRestoration Inc.

An immunotherapeutic technology company

 

 

Presenter: Peter Malamis, COO

 

Monday, June 11, 2018

Embassy Suites, Chesterbrook, Pennsylvania (directions)

 

About

 

ImmunoRestoration, Inc. was formed in 2016 to commercialize groundbreaking immunotherapeutic cancer vaccine research begun in 2004 at the University of Pennsylvania. The decision to pursue this opportunity was made after carefully evaluating data associated with pre-clinical research and studies involving more than 100 patients. Late in 2017, the company acquired the global exclusive rights to bring this technology to market and is now poised to help usher in a new era of precision, patient-centric cancer treatment.

 

Our novel platform is just one of a handful of immuno-oncology technologies in the later stages of development and brings a profound set of advantages to patients, physicians and payers. ImmunoRestoration’s planned Phase IIB trial is at the forefront of the first breakthrough approach to cancer treatment in decades.

 

Market

By 2020 worldwide cancer medicine spending is expected to exceed $150 billion. Spending on cancer vaccines is expected to increase rapidly from a currently negligible amount to $3.5B cancer vaccine by 2021.

 

Breast cancer is the most common type of cancer in women. The American Cancer Society estimates that in 2016, there were 246,660 new cases of breast cancer with 40,450 breast cancer–related deaths. Breast cancer incidents alone account for close to 15% of the total cancer cases in the U.S. In 2013, there were more than 3 million women living with breast cancer in the U.S. alone. The average per patient treatment cost is $103,000 but ranges from $71,000 in DCIS, the least invasive type, to more than $180,000 in the Stage 4 patients. We estimate that the addressable market for our initial indication is approximately $500M.

 

Unmet Needs

There has not been a clinically significant breakthrough cancer treatment in years. After decades of steady, meaningful improvement, the survival rate in our initial target indication, breast cancer, effectively stalled. Despite billions spent on new treatments and additional screening, the overall improvement in the survival rate in the most recent ten-year reporting period is just one-quarter that for the previous ten-year period. This stagnation, the lack of innovation, inability to link reduced recurrence rates to treatment, undesirable treatment effects, skyrocketing costs, and an increasingly restrictive payment environment combine to create immense opportunity. 

 

The Promise of Immuno-Oncology

After years of potential, immuno-oncology has leapt to the forefront. There are now only 26 approved immuno-oncology agents. However, as of September 2017, 940 IO agents are in clinical development, with another 1,064 in the preclinical phase. There are 3,042 interventional active clinical trials. Of the 940 agents, just 7% are in Phase 3. And while 36% of the total are vaccines, just 3% are in Phase 3. 

 

Research progress has fueled skyrocketing investment in the area. More than 300 immuno-oncology deals were signed between 2012 and 2016, growing at a compound annual growth rate of 48%. Aggregate deal value over this period was $48B. There were 14 $100M+ “megarounds” to immuno-oncology startups since 2012, nine of which occurred after January 2015.

 

Our Technology

More importantly, ImmunoRestoration’s core technology is a novel, integrated dendritic cell-based immunization system that overcomes some of the known obstacles facing anti-cancer vaccines. Our research focuses on using dendritic cells (DC) as they are the liaison cells between the T cells and the other cells of the immune system. The platform is the result of on-going research led by Drs. Brian Czerniecki and Gary Koski. The company continues to work closely with both investigators. 

 

In more than 100 patients immunized since 2004, ImmunoRestoration has found:

  • No treatment-limiting side effects
  • No long-term health issues
  • Disease disappeared in about 30% of subjects in one cohort
  • No patient required additional radiation or chemotherapy
  • No recurrence in the patients achieving total disappearance of DCIS
  • Some patients able to select breast conserving surgery over complete mastectomy

2018 Objectives

The company is aggressively pursuing three objectives:

  • assembling an experience full-time clinical and commercial management team;
  • preparing for an anticipated FDA guidance meeting this summer; and
  • raising capital.

At this juncture, the company is well capitalized having raised enough funds to enable pre-trial activities needed for the next phase of research. However, projected trial-driven costs require substantial additional capital. A short-term convertible debt round is underway with a Series A round to be initiated later this year.

 

 

 

3 Major Issues

 

  1. We are start-up with a single therapeutic platform and investigator initiated research in one indication that should enable us to begin a Phase 2B trial later this year. What are the key factors that should be considered when determining the optimal time to pursue a strategic development partnership.
  2. We have a novel platform in a relatively small patient population, specifically what special regulatory designations – breakthrough, fast-track, orphan, etc. should we pursue, if any?
  3. How should the clinical development plan balance the myriad of potential platform applications? What should guide that decision-making?

 

 

Program:

 

6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)

8:00 - Peter Malamis, COO of ImmunoRestauration, will deliver "Elevator" Pitch to the Group

8:20 - A Panel will address three major issues crucial to helping the Company reach the next level.

9:00 - Open discussion: members and guests

 

 

 

Available Media

Please note: All information obtained here is the property of those presenting and should not be copied or duplicated without written consent.

 

Slides

None available at this time

Audio

None available at this time

Video

None available at this time

Webcast

None available at this time

Contact Info:

 

 

Our Sponsors

EisnerAmperGlaxoSmithKlineKEH Insurance Agency
New Jersey Institute of Technology
Science CenterWhite and Williams

 

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Questions or Coments?

Contact: Peter van der Kam,

peter@rxpcci.com | (610) 296-8086

 

 

 

Good Company! Good Drink! Good Food! Good Program! Good Fun!

 

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Meetings Held at Embassy Suites - Valley Forge

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