CellxLife

A Cellular Therapy with curative outcome in Pediatric Cancer



Company overview

CellxLife has developed a dendritic cell-based therapy to treat children with recurring metastatic Ewing sarcoma and osteosarcoma. Osteosarcoma, also known as bone cancer, is an aggressive disease where malignant tumors form inside the bones. Teens are the most commonly affected age group when it comes to bone cancer.

The data indicates that in the Phase I trial (human data), 75% of the children with metastatic osteosarcoma, who responded well to surgery, overcame their cancer and are still alive today. Out of all the participants of the trial, 62.5% of children with metastatic osteosarcoma that were treated with the dendritic cell-based therapy lived for over 15 years. For children with recurring metastatic Ewing or osteosarcoma, the 5-year survival rate is usually less than 20% (Dana Farber Cancer institute).

This immunotherapy does not contain chemotherapy, and the side effects of the cell-derived therapy were generally considered to be milder than other treatment options. The research has demonstrated that this particular cell-based therapy could also be used to treat other solid tumors in the case of breast, ovarian, cervical, lung, prostate, stomach and brain cancer.

Problem

For children suffering from osteosarcoma, treatment options are limited. The most common treatment is surgery in combination with radiation and chemotherapy, which is an excruciating experience for both patients and their family members. Especially since 80% of the children succumb to their disease within five years. Often, despite the removal of tumors, the cancer is likely to return. The same also applies to other cancers that produce solid tumors: the primary tumor can be surgically removed but cancer cells remain in the body, leading to recurrence.

cellxlife problem
Solution

Through CellxLife’s proprietary therapy, cancer cells are taken from the body and altered using a cell- based methodology to fight the disease, then re-administered back into the body. The scientific data has indicated that the altered cells will shape the immunological memory and the response to remaining cancer cells in the body, greatly reducing the chances of the cancer returning.

cellxlife solution


Technology

The original trial for the dendritic cell-derived therapy was conducted in Austria in the early 2000s. The cell-based therapy, which travels directly to the lymph nodes and the immunological memory and response to cancer cells, was evaluated in eight children, five of whom lived for 15 years or longer and three who are still alive today. The data demonstrates that the children who responded well to the surgical removal of the tumor had the best results (75%). All of the children in the trial had recurring metastatic cancer, which has the worst outcomes.

The technology has been further developed over the last twenty years including the refinement of the manufacturing processes. The research has indicated that the proprietary technology can also be used to treat other solid tumors. The foundation laid out by these scientists will allow the research to enter a Phase II trial. Since it is an orphan designation indication, it will most likely be fast-tracked through the FDA. This will cut the time it takes to get through the final regulatory hurdles from 6-8 years to 3-5 years.


CellxLife Executive Summary

Clinical-Stage Oncology Program Focused on High Unmet Need Indications
> Pediatric focus on children with terminal relapsed, metastatic Ewing Sarcoma and Osteosarcoma
> Exceptional activity in Phase 1 (63% >10-year survival rate; 50% > 15-year survival; 38% still alive)
> Disease with limited treatment options, poor survival, and no new approaches since 2000
> Fastest growing orphan drug space with clear path to reimbursement (Global Sarcoma Market worth >$2B)

Differentiated and Derisked Clinical Asset
> Autologous cell-derived immunotherapy with distinct mechanism of action
> A powerful way to engage the interplay between the innate and adaptive immune systems
> Established and proprietary manufacturing processes

Accelerated Path to Market and Early Exit Potential
> Orphan Designation and potential for Rare Pediatric Priority Review Voucher (PRV)
> Partnerships with university and leading clinical centre that enable rapid trial recruitment


Limited Options for Pediatric Bone Cancer Patients

  • Poor prognosis for refractory/recurrent metastatic disease
  • Post-relapse survival rates are << 20%


  • Recurrence is common (80%)
  • No new treatments since 2000
  • No Immunotherapy
Limited Options for Pediatric Bone Cancer Patients

Autologous cancer vaccine modalities yield modest efficacy to date


Immunotherapy is a type of cancer treatment that helps the patient’s immune system fight cancer
Patient’s immune cells are made to recognize the cancer and attack it, just as they would a foreign agent causing infectious disease
Unlike chemotherapy & radiation therapy, which can have many adverse side-effects, cancer
immunotherapy can have significantly less toxicity
However, autologous cancer vaccines have not delivered on their potential

Autologous cancer vaccine modalities yield modest efficacy to date

CellxLife Unique Protocol Leverages Immunological Memory

> A unique process modifying the mechanism of action to greatly boost autologous cell immunotherapy
> Unlike cytotoxic or radiation therapies and transplants, is well-tolerated
> Potential to dramatically increase survival in pediatric bone cancers and achieve curative outcomes

CellxLife Unique Protocol Leverages Immunological Memory

CellxLife Unique Protocol Modification to Improve Efficacy, Survival

>> Special processing in the original TUVAC1 trial resulted in a unique, modified cancer vaccine product that correlates with long-term patient survival

  • CellxLife final product comprises matured and specially-processed DCs able to induce a potent, long-lasting anti- tumor immune stimulation
  • CellxLife induces immunological memory needed to avoid tumor recurrence for a long time after vaccination
  • CellxLife increases inflammatory and cytotoxic responses in in vitro experiments compared to standard DC vaccine and results in better localization to lymphoid tissues in vivo
CellxLife Unique Protocol Modification to Improve Efficacy, Survival
Experienced Team with a Track Record of Delivering Innovative Therapies
Management
Eric von Hofe, PhD

CEO

Eric has over 30 years of experience in managing and overseeing biotechnology projects, with a focus on cancer immunotherapy and technology development. Most recently he led development efforts at the startup company AffyImmune Therapeutics raising over $20M and advanced a novel CAR T cell therapeutic into the clinic against refractory thyroid cancer, an orphan indication. Previously he was at Antigen Express where he led the development of an immunotherapeutic vaccine for breast and prostate cancer, resulting in a collaboration with Merck and a valuation in excess of $300M. Prior to that he held positions at Millennium
Pharmaceuticals where he oversaw the advancement of ~$30M in internal technology development projects and personalized medicine. Previously, he was an Assistant Professor of Pharmacology at the University of Massachusetts Medical School and completed postdoctoral fellowships at the University of Zurich and Harvard.

Ruvin Orbach

Founder

Ruvin founded the healthcare advisory firm Bridle Path investments. Bridle Path assists healthcare companies with their financing and partnering strategy. Bridle Path has worked with biotech, diagnostics, biologics, regenerative medicine, devices and digital health companies. The company has worked directly with the venture capitalists Lumira Ventures and Epic Capital on their funds. The firm specialized in private sources of capital from Family Offices, UHNWIs and impact investors. The firm represented clients internationally: Germany, Britain, Australia, Canada and Switzerland. Prior to Bridle Path Investments, Ruvin worked in the tech, media and entertainment industry. He represented companies in the AI and loyalty space. He helped fund media companies and a film fund. He was previously a CEO of a content company that was involved in publishing and had an online presence. He has helped finance film projects independently.

Andrea Bartzen

Marketing/Comm. Strategy

Andrea is a strategic commercial/communication consultant that partners with New York City investment teams looking to fund innovative biotech, life science and health tech companies. As a multidisciplinary strategic commercial pre- launch and launch expert, she has had successful results with the strategic planning, implementation and team leadership for some of the largest and influential pharmaceutical brand launches in the last 10 years. Through promo med ed, HCP promotion, market access and PR channels, she has directed full life-cycle development, from early commercial, medical need/disease-shaping at phase 2 (Ilaris), brand development (Keytruda), franchise positioning (BMS PD1) and post-LOE strategy (Lipitor). Bartzen has also helped develop breakthrough medical communication platforms in each category: Keytruda (Immuno-oncology/PD1 inhibitor); Pradaxa (stroke); Lipitor (cardiovascular) Atripla(HIV); Botox, Vimpat (CNS), as well as successfully developed education and communication strategies that shift KOL and specialists' mindsets, leading to the transformation of medical paradigms and treatment norms.

Michael Friedman

Michael has 25 years of M&A and capital markets experience at firms such as Bank of America, Meriill Lynch, Jefferies and Ladenburg. Most of that has been working with healthcare companies. He has extensive relationships with funds, wall street firms, lawyers and large pharma. He completed $30 billion in transaction value. He has completed multiple venture rounds, PIPEs, licensing deals, sell side and buy side M&A, venture capital, IPOs, term debt, high yield, venture debt, asset sales, asset purchases, reverse mergers, spinoffs and divestitures. In addition to investment banking, he also spent several years working in a private equity fund. At the fund, he held interim management and board positions for portfolio companies. Over the last several months, he has been working with Emerald Biosciences which is an Incubator and venture capital firm run by TIm Opler. Michael has been fundraising and advising various portfolio companies on strategy, capital structure, M&A and operational aspects. Additionally, he is currently on the board of directors of Peak Bio (ticker PKBO). He sits on the compensation and audit committees. He will oversee another public board shortly. Michael has an MBA from the University of Chicago and a BBA from the University of Wisconsin.

Scientific Advisory Board
Anton Neschadim, PhD MBA

Anton Neschadim is a biomedical industry executive, scientist, innovator, entrepreneur and venture capitalist with more than 20 years of combined industry and academic experience in research, drug development and venture capital. Anton's industry experience spans C- level and Director-level roles in biotech and medtech. Anton led transactions totalling billions in potential deal value. Anton's venture capital investment experience spans various deals across Seed and Series A financings and multiple exits . Anton is known for developing novel biological therapeutics and gene therapy treatment modalities, and published scientific works and patents across all major areas of biomedical research, including immunology, oncology, regenerative medicine, gene therapy and biological chemistry. Anton got his PhD, MBA, MSc, Hon. BSc and postdoctoral training at the University of Toronto, and executive education at the Harvard Business School, Yale School of Management, Stanford University, and MIT Sloan School of Management.

William Johnson

William has over 25 years experience working in the biotechnology and pharmaceutical fields. He previously held positions as research scientist at EMD Millipore, and as a consultant at Bullet Biotechnology in Menlo Park, CA. Prior to this, William held key research leadership and supervisory positions at Novartis, Wyeth, the Broad Institute of MIT and Harvard University, Dana-Farber Cancer Institute, Mayo Clinic, The Scripps Research Institute, and others. William holds a Master of Science in Molecular Neuroscience from the Mayo Clinic Graduate School and a Bachelor of Science in Biology from the University of Oregon.

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