General FAQs

The following Frequently Asked Questions and answers provide patients with information about Genitope’s lead product candidate, MyVax® personalized active immunotherapy. Click on an area of interest, or click on a specific question to read its answer.

About MyVax® Personalized Active Immunotherapy

Making MyVax® Personalized Active Immunotherapy

What to Expect When Receiving MyVax® Personalized Active Immunotherapy

Talking to Your Healthcare Team About MyVax® Personalized Active Immunotherapy

About MyVax® Personalized Active Immunotherapy

What is MyVax® personalized active immunotherapy?

MyVax® personalized active immunotherapy (“MyVax®”) is the proposed brand name for an exciting potential treatment currently being studied in clinical trials for patients with B-cell malignancies, including non-Hodgkin’s lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). It is a type of treatment that uses a person’s immune system (thus, the term immunotherapy) in an attempt to combat disease. MyVax® is called personalized active immunotherapy because it is developed from a protein called an idiotype, or Id, which is identified from the patient’s cancer cells and is unique to that patient’s tumor. In fact, the Id can be thought of as a tumor “fingerprint.”  MyVax® is different from currently available therapies in that it is made individually and specifically for each patient. Because it has been custom-designed to work with each patient’s specific immune system and to target each patient’s particular tumor, healthy cells within the patient’s body should not be affected.

Are there other names for personalized active immunotherapy?

Yes, you may also hear personalized active immunotherapy referred to as active idiotype immunotherapy, idiotype (Id) vaccines, or therapeutic idiotype vaccines. These are simply different names for the same therapeutic approach.

What is MyVax® personalized active immunotherapy made of?

MyVax® personalized active immunotherapy is composed of (1) the patient- and tumor-specific idiotype (Id) protein, and (2) a second protein called keyhole limpet hemocyanin (KLH). KLH comes from a giant sea mollusk that lives off the coast of California. It is highly immunogenic, meaning that when it is injected into the body, the immune system responds strongly to it—and to anything attached to it.

Although technically not part of the personalized active immunotherapy, an adjuvant, or substance that enhances the immune response, is administered with MyVax®. This adjuvant is called granulocyte macrophage colony-stimulating factor (GM-CSF).

How does MyVax® personalized active immunotherapy work?

The immune system is the body’s natural defense mechanism. It is designed to prevent and combat disease. It works by distinguishing between the body’s own cells and those of foreign invaders, such as viruses or bacteria. While the immune system is good at defending the body against infectious disease, it is generally ineffective in defending the body against cancer, because cancer develops from the body’s own cells. Because of this, the immune system thinks the cancerous cells are part of the body, and thus, they are not attacked.

MyVax® personalized active immunotherapy works by helping the patient’s immune system to recognize his or her tumor as foreign (i.e., something that should be attacked). When the patient's tumor-specific idiotype (Id) is joined to KLH and the Id-KLH immunotherapy is then injected into the body, a strong immune response is typically generated against KLH and—because the Id protein is attached—theoretically against the Id protein. This immune response not only targets the Id proteins attached to KLH, but also the Id proteins on the cancer cells from which the sample used to make MyVax® was originally taken. The treatment is tumor-specific, so that the patient’s immune system should target only the cancer cells for destruction, while leaving normal cells unharmed.

What is the difference between MyVax® personalized active immunotherapy and vaccines given to prevent diseases such as measles, mumps, or polio?

Therapeutic idiotype (Id) vaccines such as MyVax® personalized active immunotherapy are used to treat diseases (i.e., cancer) that are already present in the body, in an effort to prevent them from coming back or to keep them from getting worse. Vaccines for measles, mumps, polio, and other diseases, on the other hand, are prophylactic, or preventative vaccines used to prevent disease from occurring in the first place. Another difference between the two vaccines is that MyVax® personalized active immunotherapy is made individually for each patient, while preventative vaccines are mass-produced.

Since it is made from the patient’s tumor, can MyVax® personalized active immunotherapy cause the patient’s lymphoma to come back?

MyVax® personalized active immunotherapy contains a recombinant, or genetically engineered, form of the idiotype (Id) protein, not live cancer cells. Therefore, it cannot cause a recurrence of cancer. Disease recurrence is thought to be due to residual circulating cancer cells (ie, cells not destroyed by previous therapies) and/or genetic mutations related to the disease.

For what diseases is Genitope Corporation testing MyVax® personalized active immunotherapy?

MyVax® personalized active immunotherapy is currently being tested in patients with B-cell NHL and chronic lymphocytic leukemia (CLL). Specifically, a phase 3 study in patients with follicular lymphoma (fNHL) in first remission following chemotherapy is ongoing. A study in CLL is also ongoing. Other studies may be conducted in patients with other B-cell or T-cell malignancies.

Making MyVax® Personalized Active Immunotherapy

What is needed from the patient to make MyVax® personalized active immunotherapy?

Since MyVax® personalized active immunotherapy is made specifically for each individual patient, a sample containing cancer cells is needed. In lymphoma, this often involves a lymph node biopsy. Excisional lymph node biopsies are best, but it is possible to work with cancer cells obtained from a core needle biopsy, fine needle aspiration, or bone marrow sample or peripheral blood sample. In CLL, peripheral blood samples are often used because the blood contains a high number of circulating cancer cells. Only a small amount of tissue or blood containing cancer cells is required to manufacture the therapy, but additional samples may be needed for lab work or other studies. The cells do not need to be alive, so tissue samples can be frozen. Cells that are preserved, or "fixed”, cannot be used.

In lymphoma, tissue obtained during the diagnostic biopsy can often be frozen and used to make a personalized active immunotherapy. In some instances, a second biopsy may be needed to obtain enough cancer cells.

How is MyVax® personalized active immunotherapy made?

Once Genitope Corporation has a patient’s sample containing cancer cells, the next step is to identify and isolate the genetic material associated with the specific idiotype (Id) the patient’s specific tumor is expressing, or producing. This genetic material is then used to produce a recombinant, or genetically engineered, version of the Id protein, which is then purified and combined with KLH. (See “What is MyVax® personalized active immunotherapy made of ?” Question 3)

How does Genitope Corporation make sure patients get their own specific personalized active immunotherapy?

At multiple points during the production process, the idiotype (Id) contained in the patient’s immunotherapy is compared to the Id from the original specimen. This ensures that they match and that the patient is getting a personalized active immunotherapy that specifically targets his/her cancer.

Can MyVax® personalized active immunotherapy be made for every patient?

Currently, MyVax® personalized active immunotherapy is an investigational therapy and, as such, MyVax® can be made only for patients involved in clinical trials. In a small number of cases, it may not be possible to produce a personalized active immunotherapy for a specific patient due to the biology of his/her disease (i.e., the cancer cells may not express an idiotype [Id] protein or may not produce enough of the Id protein).

What to Expect When Receiving MyVax® Personalized Active Immunotherapy

Why do some patients have chemotherapy before receiving MyVax® personalized active immunotherapy?

Experts believe that lowering the amount of tumor in the body through chemotherapy before giving MyVax® personalized active immunotherapy may optimize the effects of the personalized active immunotherapy, giving it the best possible chance to work. However, in clinical trials, patients treated with MyVax® alone have been able to mount an immune response to the immunotherapy.

How is MyVax® personalized active immunotherapy given?

Each MyVax® personalized active immunotherapy injection is given just under the skin, or subcutaneously, via a small needle. Each MyVax® injection is followed by a GM-CSF injection. In some series, an additional three days of GM-CSF injections may be given.

What reactions do patients experience with MyVax® personalized active immunotherapy?

Reactions that patients should expect to experience with MyVax® personalized active immunotherapy include injection-site reactions, such as redness, swelling, bruising, itching, soreness, and/or pain at the site of the injection. Some patients also experience flu-like symptoms, including fever, chills, nausea, and muscle soreness. These reactions may be related to the Id-KLH immunotherapy and generally last for a few days after the injection, although they can last longer.

Side effects seen with the adjuvant, GM-CSF, include fever, bone or joint pain, flu-like symptoms (nausea, headache, tiredness), and mild skin reactions at the injection site. More information about GM-CSF side effects can be found at www.leukine.com.

As with any medication, there is a possibility of allergic reactions with MyVax®. Allergic reactions have been seen only in a small number of patients, and patients are monitored closely after each injection for signs of such a reaction. There are very effective medications available should they be required to counteract allergic reactions. MyVax® should not be used in patients with known allergy to the product.

What can be done to manage these side effects?

Patients should discuss any injection-site reactions or side effects they are experiencing with their doctor, who will be able to recommend treatment options. Ice or heat may be applied to the injection site to minimize discomfort. Over-the-counter medications such as acetaminophen, aspirin, antihistamines, and ibuprofen can be useful in helping to combat flu-like symptoms and injection-site reactions. Use of these medications is permitted in most clinical trials. Use of oral, inhaled, and/or topical corticosteroids or other medications that suppress the immune system are not permitted in MyVax® personalized active immunotherapy clinical trials, as they may interfere with the immune response. If you are a patient in one of Genitope Corporation’s clinical trials and you are unsure about a medication, consult with your healthcare team.

For suggestions on how to manage side effects associated with GM-CSF, visit www.leukine.com.

Talking to Your Healthcare Team About MyVax® Personalized Active Immunotherapy

I want to talk to my doctor about the possibility of receiving MyVax® personalized active immunotherapy. What should I say?

Currently, the only way for patients to receive MyVax® personalized active immunotherapy is to be enrolled in a clinical trial. Ask your doctor if any of the trials now enrolling patients are right for you. To learn more about MyVax® clinical trials, call 1-866-436-4687, send an email to clinicalinfo@genitope.com or visit www.genitope.com.