TRANSFORMING CANCER OUTCOMES

Imvax™ is a clinical-stage biotechnology company focused on the development of novel patient-specific vaccines and immunotherapy strategies for the treatment of malignant gliomas and other cancers with unmet medical needs.

Our product, IGV-001, is an autologous tumor cell vaccine that delivers a multi-pronged response against tumor cells by leveraging the patient’s immune system as a defense mechanism.

CLINICAL TRIALS

Glioblastoma multiforme (GBM) is the most common and lethal malignant brain tumor in adults. Our initial objective is to define the treatment for this devastating disease.

We have demonstrated safety and proof of concept for our autologous cell vaccine in patients with recurrent and newly diagnosed GBM thus far, and our ongoing clinical trial serves to establish the recommended treatment regimen for future clinical trials. As we expand our knowledge through research and development both in the clinic and laboratory, we evaluate other common solid tumor cancers that may also benefit from our technology.

IGV-001 has been granted orphan drug designation for the treatment of malignant gliomas by the US Food and Drug Administration (affects fewer than 200,000 people in the US) and the European Medicines Agency (affects fewer than 5 in 10,000 in the EU).

 

ONGOING PHASE 1B TRIAL FOR NEWLY-DIAGNOSED GBM

This single-center, randomized, Phase 1 study is evaluating IGV-001 in 33 patients with newly diagnosed malignant glioma. Standard of care (ie, radiotherapy and temozolomide) is initiated 4-6 weeks after treatment with IGV-001.

This study was designed to evaluate the safety and tolerability of IGV-001. Additional endpoints include tumor responses, biomarkers, overall survival and progression-free survival following treatment with IGV-001. Patient accrual completed on March 1, 2018.

ClinicalTrials.gov Identifier: NCT02507583

PHASE 1A TRIAL FOR RECURRENT GBM

This single-center, open-label, Phase 1 study evaluated IGV-001 in 12 patients with recurrent glioblastoma who failed standard of care (ie, radiotherapy and temozolomide).

This study was designed to evaluate the safety and tolerability of IGV-001. Additional endpoints included evaluation of tumor responses and biomarkers. IGV-001 was well-tolerated. Median OS from original diagnosis was 21.2 months.

ClinicalTrials.gov Identifier: NCT01550523

PHASE 1: RECURRENT GBM

This single-center, open-label, Phase 1 study evaluated an autologous tumor cell vaccine containing an antisense oligonucleotide in 12 patients with recurrent glioblastoma who failed standard of care (ie, radiotherapy and temozolomide). This study established the safety and tolerability of the autologous GBM vaccine.

OUR HISTORY

During the initial years, our research and clinical evaluation of our novel patient-specific vaccine for the treatment of GBM was funded by $6.7 million in grants from private philanthropists, including the Samuel J. Paparone Foundation and the Albert F. Stevens Foundation, and also from the Kimmel Cancer Center at Thomas Jefferson University.

Following encouraging outcomes in the early clinical trials, Imvax, Inc. was launched as a stand-alone company in December 2015, to accelerate research and development of its vaccine.

In June 2016, Imvax, Inc. obtained an exclusive license agreement with Thomas Jefferson University granting it the right to develop and market the medical technology.

We completed a Series A round of fundraising of $15 million in June 2017 and continue to evaluate the clinical safety and efficacy of IGV-001, while advancing the technology and benefit of our vaccine.

OUR TECHNOLOGY

Based on early clinical research, treatment with IGV-001 autologous tumor cell vaccine has the potential to trigger a multi-pronged therapeutic immune response, including a short-term innate immune response followed by longer-term adaptive immune activities that are directed at the patients’ tumor cells.

Our research and clinical development suggests our technology:
  • Prevents the development of circulating CD163 monocytes expressing programmed death-ligand 1 (PD-L1) that are the precursors to tumor-associated macrophages (TAMs);
  • Results in the pro-tumor microenvironment changing towards one favoring anti-tumor interactions;
  • Promotes the emergence of therapeutic anti-tumor T cells and sustained immunological memory; and
  • Is beneficial in other solid cancer malignancies, including breast, pancreatic, hepatocellular carcinoma and lung cancers.
Overview of therapy for GBM

IGV-001 is an autologous cell vaccine consisting of glioblastoma tumor cells.

Our therapy begins with surgical resection of the patient’s brain tumor, much like standard of care. At the time of surgery, two small incisions are made on the patient’s abdomen, for later vaccine delivery. Immediately following surgery, the patient’s tumor tissue is combined with a small antisense molecule designed to inhibit continued cancer cell growth. The combined product is packaged into small biodiffusion chambers with porous membranes.

These biodiffusion chambers are then implanted into the patient within the previously made incision sites where they remain for 48 hours. During this time, the vaccine works to boost the patient’s immunity to their own residual malignant glioma tumor tissue. At the expiration of the 48-hour period, the biodiffusion chambers are explanted, incisions closed, and the patient’s vaccination with IGV-001 is complete.

Mechanism of action

Our research has indicated that IGV-001 works through several processes including exposing the immune system to brain tumor antigens, re-programming pro-tumor immune cells and boosting anti-tumor immunity.

IGV-001 is hypothesized to induce tumor immunity through a three-step process. The hypothesized process specific to GBM is as follows

  1. Release of tumor antigens by GBM cells and inactivation of anti-inflammatory CD163 positive TAMs in the biodiffusion chamber through the inhibition by an antisense molecule of insulin-like growth factor 1 receptor (IGF-1R) expression in these cells;
  2. Induction of a pro-inflammatory environment at the site of the immune recognition of tumor antigens outside of the implanted biodiffusion chamber through inactivation of local and circulating M2 CD163 positive macrophages by the diffusion of the antisense molecule from the chamber;
  3. Activation of a GBM tumor specific T cell-dependent immune response and immunological memory against tumor antigens released by the biodiffusion chamber as evidenced by increased interferon gamma (IFN-ɣ) production.

Our proprietary technology is protected by US patents and applications directed to our product and method of treating patients in the US and globally.

OUR TEAM

The combined skillset and efforts of our Imvax, Inc. team drives the current and future success of our company.

Imvax, Inc. has a team of driven and skilled company employees, contractors, and consultants including scientists, clinical researchers, and product development contributors. We partner with experienced vendors who provide quality and reliable product manufacturing and testing as well as clinical trial management services.

As individuals, our knowledge base extends across scientific and clinical research in cancer immunotherapy, execution and oversight of early and late phase clinical trials, product development and manufacturing from concept to commercialization, and business and operational management.

As a team, our wealth of knowledge in clinical development is helping advance our goal of developing novel patient-specific vaccines and immunotherapy strategies for the treatment of cancers.


Leadership

David W. Andrews, MD
Imvax Co-Founder, Interim Chief Executive Officer, Chief Medical Officer

 

 

Craig Hooper, PhD
Imvax Co-Founder, Chief Scientific Officer

 

 

Arthur W. Howe, IV, MBA
Imvax Co-Founder, Chief Financial Officer

 

 

Catherine Kessler, MS
Chief Regulatory Officer

 

 

Kara Pigott, MS, CCRP
Director of Clinical and Regulatory Operations

 

 

Samantha Garcia, PhD
Director of Scientific Regulatory Operations

 

 

Jennifer Bagin, CPA
Controller

 


Board of Directors

Peter B. Corr, PhD
Imvax Co-Founder and Executive Board Chairman

 

 

David W. Andrews, MD
Imvax Co-Founder, Interim Chief Executive Officer, Chief Medical Officer

Arthur W. Howe, IV, MBA
Imvax Co-Founder, Chief Financial Officer

Steven M. Altschuler, MD
Managing Director/Healthcare Ventures at Ziff Capital Partners and Chair, Board of Directors of Spark Therapeutics

Ira Brind, JD
President, Brind Investments, Inc., Board of Trustees, Thomas Jefferson University Hospital, Trustee and former Chairman of the Board of Wistar Institute.

Thomas Pfisterer
Head of Direct Investments, Wild Group Management AG

David G. Bunning
Founder, Chief Executive Officer, and Chief Investment Officer of The TLP Group LLC

Craig Hooper, PhD
Chief Scientific Officer

Ted Koutouzis, MD
Fixed Income Head of Healthcare Research, Fiscus Ventures and Reimagined Ventures (affiliates of Magnetar Capital)


Medical Advisory Board

Stuart Grossman, MD
Professor of Oncology, Medicine, Neurosurgery, Johns Hopkins University School of Medicine
US Chairman Adult Brain Tumor Consortium

Walter J. Curran, MD
Executive Director, Winship Cancer Institute of Emory University
Associate Vice President, Cancer, Woodruff Health Sciences Center
Lawrence W. Davis Chair of Radiation Oncology, Emory University School of Medicine

John R. Adler, MD
Professor Emeritus, Stanford University Department of Neurosurgery
Chairman, ZAP Surgical

Ulrich Mueller, MD
Chief Business Officer, SEngine Precision Medicine

For Our Patients

Our patients are the heart of our company, and they, along with their families, friends and caregivers, are just as much members of the Imvax, Inc. team as our leaders and employees. Patient care is our priority, and it is our joint effort and mission to change the course of cancer treatment and transform cancer outcomes.

At Imvax, Inc., we’re focused on the development of patient-specific vaccines and immunomodulatory strategies (therapies that utilize the body’s immune system) for the treatment of malignant gliomas (a specific type of brain tumor) and other cancers with unmet medical needs. As a company, we are obligated to ensure the safe and proper use of our therapies and to provide access at the appropriate time, in the right manner and under the guidance of regulatory authorities, specifically the US Food and Drug Administration (FDA).

We are working with the FDA to expeditiously advance our investigational therapy, IGV-001, into the next phase of clinical development in GBM. This includes finalizing clinical sites and preparing those sites to accommodate patients and confirming proper manufacturing of our investigational therapy. At this time, Imvax, Inc. has no actively recruiting clinical trials.

Our next planned clinical trial to evaluate the safety and effectiveness of IGV-001 in GBM will be done in partnership with multiple major academic institutions. In the near future, we will post details on this website regarding the status of our next clinical trial.

If you or your physician have general questions regarding Imvax, Inc. or our autologous tumor cell vaccine, or would like to connect with one of our patient advocates, please contact us at contact@imvax.com.

Meanwhile, we encourage you to consult with your physician and reach out to the National Brain Tumor Society or one of the many of the other caring organizations listed below.

CONTACT US