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Personalized, whole tumor-derived immunotherapies

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Harnessing decades of research and multiple validated technologies, Imvax’s unique platform captures a tumor’s full antigen signature – and weaponizes it.

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From clinical developments to novel research and our engagement with local communities — keep up with everything Imvax here.

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Our team has a passion for patient care, a focus on innovation, and a commitment to working with integrity as part of our deeply collaborative environment. Sound like a fit for you?

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One platform: Multiple programs targeting intractable solid tumors

Imvax is leveraging its unique immunotherapy platform to develop a pipeline of personalized, whole tumor-derived treatments targeting intractable solid tumors, which represent a majority of adult cancers.

Pipeline Graph:

Target validation
IND-enabling
Phase 1
Phase 2
Phase 3
IHV-001
Hepatocellular carcinoma
IND-enabling
IOV-001
Ovarian cancer
IND-enabling
IPV-001
Pancreatic cancer
IND-enabling

IGV-001 Glioblastoma

Glioblastoma multiforme (glioblastoma, or GBM) is a brain cancer that is nearly always fatal. It is the most common malignant tumor that affects the central nervous system (CNS) and overall the third most common tumor of the brain and CNS.

A person newly diagnosed with GBM has a median overall survival (OS) or life expectancy of 12 to 15 months, and less than 6% of GBM patients survive to five years after diagnosis. The current standard of care treatment is based on surgery to remove as much of the tumor as possible. Surgery is typically followed by radiotherapy and chemotherapy.

IGV-001 is Imvax’s most advanced product candidate, in development to treat GBM. It has completed a Phase 1a in recurrent glioblastoma and a Phase 1b in newly diagnosed glioblastoma which in total dosed 46 patients. In the Phase 1b study, IGV-001 was well tolerated and multiple efficacy signals were observed. These included significant improvements in progression-free survival, radiographic evidence of tumor response, and multiple biomarkers changes that supported the presence of an immune response.

A randomized, placebo-controlled Phase 2b trial of IGV-001 in patients with newly diagnosed glioblastoma will be initiated in the fourth quarter of 2021. With positive data, Imvax plans to initiate a Phase 3 trial in the first quarter of 2023.

Renal cell carcinoma (RCC)

Glioblastoma multiforme (glioblastoma, or GBM) is a brain cancer that is nearly always fatal. It is the most common malignant tumor that affects the central nervous system (CNS) and overall the third most common tumor of the brain and CNS.

A person newly diagnosed with GBM has a median overall survival (OS) or life expectancy of 12 to 15 months, and less than 6% of GBM patients survive to five years after diagnosis. The current standard of care treatment is based on surgery to remove as much of the tumor as possible. Surgery is typically followed by radiotherapy and chemotherapy.

IGV-001 is Imvax’s most advanced product candidate, in development to treat GBM. It has completed a Phase 1a study in recurrent glioblastoma and a Phase 1b study in newly diagnosed glioblastoma which in total dosed 46 patients. In the Phase 1b study, IGV-001 was well tolerated and multiple efficacy signals were observed. These included significant improvements in progression-free survival , radiographic evidence of tumor response, and multiple biomarkers changes that supported the presence of an immune response.

A randomized, placebo-controlled Phase 2b trial of IGV-001 in patients with newly diagnosed glioblastoma will be initiated in the fourth quarter of 2021. With positive data, Imvax plans to initiate a Phase 3 trial in the first quarter of 2023.

Colorectal carcinoma (CRC)

Glioblastoma multiforme (glioblastoma, or GBM) is a brain cancer that is nearly always fatal. It is the most common malignant tumor that affects the central nervous system (CNS) and overall the third most common tumor of the brain and CNS.

A person newly diagnosed with GBM has a median overall survival (OS) or life expectancy of 12 to 15 months, and less than 6% of GBM patients survive to five years after diagnosis. The current standard of care treatment is based on surgery to remove as much of the tumor as possible. Surgery is typically followed by radiotherapy and chemotherapy.

IGV-001 is Imvax’s most advanced product candidate, in development to treat GBM. It has completed a Phase 1a study in recurrent glioblastoma and a Phase 1b study in newly diagnosed glioblastoma which in total dosed 46 patients. In the Phase 1b study, IGV-001 was well tolerated and multiple efficacy signals were observed. These included significant improvements in progression-free survival , radiographic evidence of tumor response, and multiple biomarkers changes that supported the presence of an immune response.

A randomized, placebo-controlled Phase 2b trial of IGV-001 in patients with newly diagnosed glioblastoma will be initiated in the fourth quarter of 2021. With positive data, Imvax plans to initiate a Phase 3 trial in the first quarter of 2023.

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Imvax’s story began with a physician’s dedicated pursuit of new hope for patients with a deadly cancer. Today, our team is driven by that same mission to deliver transformational outcomes for people living with cancer through a new approach to personalized immunotherapy.

Patients’ care has always been at the center of our work. We are committed to the highest standards of professional excellence as we strive to rapidly advance a portfolio of investigational therapies, in collaboration with our network of clinical professionals.

As a company, we are obligated to ensure the safe and proper use of our investigational therapies and to provide access at the appropriate time, in the right manner and under the guidance of regulatory authorities, specifically the U.S. Food and Drug Administration (FDA).

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

Imvax’s clinical studies can always be viewed at the database provided by clinicaltrials.gov.

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Harnessing the full antigen signature of solid tumors

Informed by decades of research, Imvax’s platform elegantly turns the complexity of a solid tumor against itself by capturing its complete antigenic signature and converting it into a highly immunostimulatory ‘training program’. This is designed to deliver both innate and adaptive immune stimulation to overcome the challenges of solid tumors’ variability and ability to suppress the immune system.

Our Immunotherapy Platform

Imvax’s platform is a multi-step process designed to deliver personalized, whole tumor-derived immunotherapies. It relies on multiple validated technologies and can be incorporated into the standard of care for cancer. Click into the major two steps unique to Imvax’s platform to find out more.

Day 1

Patient admitted to hospital

Day 2

Antigen signature preparation

Day 3

Immune system training

Day 4

Patient leaves hospital

Day 5

Standard of care proceeds

Unique Advantages Highlights

Full antigenic signature capture

Imvax’s platform bypasses the defenses of solid tumors and fully exposes their antigenic signature to an enhanced immune system, providing an opportunity for a broader anti-tumor effect without the selection pressure created by single antigen-targeting therapies.

Broad spectrum immune activation

Imvax’s platform delivers immunotherapy that is autologous – personalized to a patient’s entire unique tumor – and incorporates multiple mechanisms that stimulate both the innate and adaptive immune system. This broad spectrum effect could potentially also enhance the effects of other immunotherapies used in combination.

No ‘off-target’ effects

Imvax’s platform trains the immune system to comprehensively address a tumor’s entire antigenic signature. Because the immune system ignores ‘self’ antigens, Imvax’s platform inherently does not encourage off-tumor immune attack.

Rapid tissue processing

Imvax’s platform uses overnight tumor tissue processing to prepare its proprietary chambers for implantation. By contrast, many emerging therapies targeting one or a small number of antigens are based on expensive, difficult-to-manufacture cell therapy techniques.

Integrated into the ‘standard-of-care’

Imvax’s platform begins with tumor samples from resection, commonly part of the standard of care for solid tumors. Rapid transition to the implantation step also facilitates integration into the standard of care.

Life at Imvax Quotes

Hear from our team about their motivations, experiences and aspirations at Imvax.

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Imvax is committed to creating an inclusive community where every individual is treated with dignity and respect. Fostering a culture in which we celebrate and embrace every team member’s authentic self is vital to our mission. By welcoming varied perspectives and voices, we create a better environment and encourage the curiosity and creativity that are essential ingredients for medical innovation.

Career Opportunities

Imvax offers a comprehensive and highly competitive benefits package and is an equal opportunity employer that celebrates and embrace every team member’s authentic self as vital to our mission.

Imvax Team Members

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John P. Furey

Chief Executive Officer

david andrews

David W. Andrews, MD

Co-Founder, Chief Medical Officer

arthur howe

Arthur W. Howe, IV, MBA

Co-Founder

mark exley

Mark Exley, PhD

Chief Scientific Officer

sean hemingway

Sean Hemingway, MS

Chief Operating Officer

catherine kessler

Catherine Kessler, MS

Chief Regulatory Officer

john limongelli

John M. Limongelli

Chief Legal Officer

josh muntner

Josh Muntner, MBA

Chief Financial Officer

peter corr

Peter B. Corr, PhD

Co-Founder, Chairman of the Board

steven altschuler

Steven M. Altschuler, MD

Ziff Capital Partners

arthur howe

Arthur W. Howe, IV, MBA

Co-Founder

david bunning

David G. Bunning

TLP Investment Partners LLC

iran brind

Ira Brind, JD

President, Brind Investments, Inc.

wendy dicicco

Wendy DiCicco

Board Advantage, LLC

team-placeholder

John P. Furey

Chief Executive Officer

thomas pfisterer

Thomas Pfisterer

Wild Group Management AG

team-placeholder

Ted Koutouzis, MD

Fiscus Ventures & Reimagined Ventures

shefali agarwal

Shefali Agarwal

Epizyme

tyler curiel

Tyler Curiel

UT Health San Antonio

Our Passion for Patient Care

What does a Phase 2 trial investigate?

Generally, Phase 2 trials utilize the same dose and schedule of a drug determined to be safe and effective in Phase 1, but in a larger group of patients. The goals of a Phase 2 trial are to further determine the safety of a new drug and to evaluate the effectiveness of a new drug or drugs.

What is the design of the Phase 2 study?

Based on the encouraging results in the Phase 1 trials, Imvax has initiated a Phase 2b trial with IGV-001 in 93 patients with ndGBM. The trial will be run at several cancer centers, generally in the Eastern half of the United States. All patients will have biodiffusion chambers placed in the abdomen after surgery for the brain tumor. One-third (1/3) of the patients will have a placebo (inactive drug) in the biodiffusion chambers, and two-thirds (2/3) will have active IGV-001 in the biodiffusion chambers. The study is blinded, meaning you, your doctors, and your treatment team will not know if you are receiving IGV-001 or the placebo. In rare cases, your treatment can be revealed (unblinded) if your doctors feel that information is important to know for additional medical care or an emergency.
All patients will receive standard chemotherapy (temozolomide) with radiation followed by chemotherapy (temozolomide) following recovery from brain tumor surgery, just as was done in the Phase 1 study.

What are the requirements to enroll in the Phase 2 study?

The primary requirement for eligibility in the Phase 2 study is that you must have glioblastoma that is newly diagnosed, without starting chemotherapy or radiation yet. Other important requirements for your eligibility in the study, such as your general health and other medications will be reviewed and discussed with you by your doctor and research team. Not all patients with ndGBM will be eligible for this study.

What happens if I’m interested in enrolling?

Once the study, including risks, benefits, and other treatment options, have been discussed with you and if you are willing to proceed in the study, you will be asked to sign an informed consent form, acknowledging that you are willing to proceed with the study treatment. You can withdraw your consent to participate in the study at any time and for any reason you decide. Procedures that you may be financially responsible for will also be discussed, although in most cases these procedures can be billed to your insurance company.

How is my eligibility determined?

Once you sign the consent form, your research team will begin scheduling and performing various tests required to determine your eligibility for the study. These will include items such as scans, blood tests, and tests on your heart, for example. When all of these tests are performed, and the results are satisfactory, you will be scheduled for surgery on your brain tumor. Your treatment team will provide a schedule for all of these. If you are determined to not be eligible for the study, your treatment team will discuss other treatment options with you.

Where is the study taking place?

You can find the study listing (NCT04485949) in www.clinicaltrials.gov.These are currently the sites participating in the study:

Additional study sites will be added soon. Please check back regularly for additional information or
get in touch with our clinical affairs team with any other key questions.

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Patients and Community Resources

Clinical trials are highly regulated by federal regulatory agencies. You can find additional information at the website of The U.S. Food and Drug Administration.

Additional information can be found in the following websites:
• American Cancer Society (ACS)
• National Cancer Institute (NCI)
• National Comprehensive Cancer Network (NCCN)
• ClinicalTrials.gov

Patient Advocacy Groups (PAGs) are organizations that provide vital support for the GBM community. We have provided the links below for your convenience.