A STATEMENT FROM GRADALIS

At Gradalis, we are committed to bringing new and innovative therapies to patients for whom new treatment options are most urgently needed. Our investigational Vigil engineered autologous tumor cell (EATC) therapy is in the final stages of clinical trials required to seek U.S. Food and Drug Administration (FDA) review and approval of the treatment for advanced Ewing’s sarcoma.  Recently, there has been a social media campaign on behalf of a young patient asking us to supply Vigil EATC therapy after the patient had been randomized and treated on the chemotherapy control arm of this important study.

The trial in question randomly assigns patients with Ewing’s sarcoma to receive either the investigational cancer immunotherapy, Vigil EATC, or a currently available treatment combination where published clinical results have shown activity in patients with recurrent Ewing’s sarcoma. We closely follow each patient’s case in partnership with the team of treating physicians and evaluate outcomes to ensure the best care throughout the clinical trial.

Our clinical trials are carefully designed in consultation with the FDA, to ensure we achieve the data quality required for validation and approval of Vigil EATC. Any deviation from trial design, such as switching therapeutic arms, impacts the integrity of the data and can void the entire trial – significantly delaying availability of any new treatment.

While we are encouraged by early results with Vigil EATC in certain patients with Ewing’s sarcoma, we need the results from this trial to provide more definitive proof of clinical benefit.  All of Gradalis is working hard to see this study completed as quickly as possible so that ultimately, through the FDA review and approval process, we might provide access to Vigil EATC to a broader group of Ewing’s patients.

To that end, we appeal to the Ewing’s sarcoma community to help us raise the awareness of this trial so that we may finish accrual as soon as possible.  A list of the sites where the trial is open is published on our clinical trials website www.vigilclinicaltrials.com.  

We cannot express the depth of our gratitude to the patients and families who agree to be part of our clinical trial program.  Your contributions are nothing short of heroic, and together we will advance the care of Ewing's sarcoma.  

 

 

Guest Post by Bert Thomas, CEO Sarcoma Foundation of America

The post below has been reprinted with permission from Bert Thomas, CEO Sarcoma Foundation Alliance

Medical Innovation Provides Hope for Pediatric Sarcoma Patients - Bert E. Thomas IV, PhD, MBA,

As I write this blog, we find ourselves in the midst of Childhood Cancer Awareness Month, a time to educate the public about the realities of childhood cancer and to draw attention to the need for more pediatric cancer research.  For the Sarcoma Foundation of America, Childhood Cancer Awareness Month is also a time to remind everyone that sarcomas are not just a cancer of adults, but also of children and young adults.  Sarcomas account for 15 – 20% of all childhood cancers, a number that is far too large.  Unfortunately, there has been very little hope for many children with sarcoma who rely on therapies approved more than 30 years ago to treat their disease.

But I believe that there is now cause for HOPE!  And that hope comes in the form of innovative sarcoma research – the type that the Sarcoma Foundation of America funds every year.  The timeline from new discoveries to new therapeutics is long as it can take 10, 20, even 30 years for these discoveries to turn into new therapeutics that save lives.  But if we don’t fund innovative sarcoma research every year, with as much passion and effort as the sarcoma community can muster, who else is going to do it for us?

There is a payoff, even if the timelines are long.  We are in a time where there are more innovative therapeutics being explored in the clinic for pediatric sarcomas than in any other period in the past.  Let me tell you about a few.

There is HOPE in the form of immunotherapy.

The first experimental therapeutic I would like to tell you about is based on an immunotherapy platform called Vigil®.  Vigil® utilizes the patient’s own cancer cells to create a fully personalized cancer immunotherapy.  The goal of the platform is to activate the patient’s T-cells against their own unique tumor cells.   This immunotherapy approach is currently being tested in Ewing’s Sarcoma patients in a Phase 2 clinical trial.

The second experimental therapeutic I would like to tell you about is also based on an immunotherapy approach.  ADXS-HER2 is based on the Lm Technology which uses live, attenuated bioengineered Listeria monocytogenes (Lm) bacteria to stimulate the immune system to view tumor cells as potentially bacterial-infected cells and target them for elimination.  ADXS-HER2 was developed to target human epidermal growth factor receptor 2 (HER2)-expressing cancers which is expressed in certain solid-tumor cancers, including osteosarcoma. A Phase 2 clinical trial is currently being planned in collaboration with the Children’s Oncology Group.

The last experimental immunotherapy I will share is being developed for Synovial Sarcoma, which occurs about 1/3 of the time in childhood patients.   The therapeutic is called NY-ESO TCR and it targets the NY-ESO peptide which is present across multiple cancer types. NY-ESO-1 is one of the best-characterized and most immunogenic cancer testis antigens, and is frequently expressed by tumors of different origins and in advanced tumors, including synovial sarcoma.  NY-ESO TCR is currently being evaluated in a Phase 1/2 open-label clinical trial of NY-ESO therapeutic candidates in patients with synovial sarcoma.

There is HOPE in the form of new targeted agents.

There are a few experimental targeted agents that may have a role in treating pediatric sarcoma patients.  The first experimental targeted agent that I would like to share is specifically for Ewing’s Sarcoma.  TK216 is a small molecule that inhibits the biological activity of ets-family transcription factor oncoproteins in a variety of tumor types including Ewing’s Sarcoma, stopping cancer cell growth and tumor formation.  TK216 is currently being studied in a Phase 2 clinical trial in Ewing’s Sarcoma patients.

Other experimental targeted therapeutics are designed to inhibit the tropomyosin receptor kinases (TRK) family.  Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body.   These gene fusions can cause sarcomas in pediatric and adult patients.  While there are differences between LOXO-101 and Entrectinib that are beyond the scope of this blog, they are two more examples of how innovative targeted therapies are being developed for pediatric sarcoma patients.  Both are being evaluated in early stage clinical trials.

There is HOPE! 

While all of these experimental therapies may not make it through clinical trials to our pediatric sarcoma patients, they all represent the efforts of many scientists over the years to better understand sarcoma, the associated molecular pathways and the immune system, and translate those understandings into innovative experimental therapeutics that have the potential to save lives. The more research we fund, the more potential we have to find even more innovative therapeutics that can save the lives of our pediatric sarcoma patients.

Gradalis Team Meets Local Leaders of National Ovarian Cancer Coalition

As part of Ovarian Cancer Awareness Month, the Culture Club at Gradalis invited the local Chair person of National Ovarian Cancer Coalition, Ms. Sarah Harris, to share her thoughts about patient advocacy in Ovarian Cancer.   Ms. Harris graciously agreed to attend the event and brought along an Ovarian cancer survivor, Ms. Danielle Dennis.  Over an hour of presentation and questions/answers session, both of them shared their individual stories candidly and answered our questions.  

We were tremendously impressed by the commitment of the two presenters to the cause of eradicating Ovarian cancer.  All of us were touched by their emotional stories and were able to gain a better perspective on the dire need for new drugs in Ovarian cancer.  

Many among us have been working on the Vigil technology for several years,  some for over seven or eight years,  and this event gave us a perspective into why our daily grind matters. The stories of Sarah and Danielle helped us understand that Ovarian cancer impacts lives of woman in their prime - women whose entire lives are ahead of them.  These women are anxiously waiting for us to complete the trials so that we may see if Vigil can provide them the much needed relief.  

Many in the audience, me included, left the room committing myself to redouble the effort for timely completion of the Vigil ovarian cancer clinical trial.

Raising Ovarian Cancer Awareness: DFW NOCC Run/Walk

September 5 was National Ovarian Cancer Awareness Day. Last Friday (and because of the Labor Day holiday), we wore teal to mark the occasion and to show our support. However, our commitment to supporting Ovarian Cancer survival did not end when we went home for the holiday weekend. While many of us enjoyed time with our families, some of us returned to work to check on samples or schedule appointments to keep the business of the company running smoothly.

These were arguably smaller, less visible, and less glamorous commitments than remembering to wear a colored shirt, but they show that we are dedicated to helping patients fight against ovarian cancer. Our largest clinical trial is designed to do just that. We will join the fight again today, as we do every day, with the hope that we are helping as many people, as many women, as possible.

We are extremely excited to announce that we will show our support for ovarian cancer survivors and patients in another, more visible, way. We’re thrilled to be a part of the National Ovarian Cancer Coalition’s campaign to Break the Silence, which supports ovarian cancer research, early awareness, and survivor and caregiver quality of life.

The 9th Annual National Ovarian Cancer Coalition (NOCC)’s Run/Walk to Break the Silence on Ovarian Cancer®, coordinated by the DFW NOCC chapter, will be held at Lone Star Park in Grand Prairie on Sunday, September 25, 2016.   Each of us is preparing to participate in our own way: by running or walking, preparing to support the runners and walkers, or encouraging our families and friends to participate in or donate to the cause. If you’re in the Dallas/Fort Worth area, join us on September 25 at the race.

If you can’t make the race that day, consider donating to our team or participating in your own chapter’s Run/Walk to Break the Silence. We hope to hear from you soon, and we will continue to raise awareness of ovarian cancer and show solidarity with our community. Keep fighting!

September is Ovarian Cancer Awareness Month

September is Ovarian Cancer Awareness Month and the Gradalis team is using this opportunity to learn more about Ovarian cancer and help raise the awareness of others in our community. Our involvement is especially meaningful since we are trying to change the trajectory of this deadly disease with Vigil EATC-Ovarian Cancer clinical trial.

The company culture club has developed a series of activities for Ovarian Cancer Awareness Month, starting with “Wear Teal To Work” Day, which we celebrated  on Friday, Sept 2nd, by wearing teal color.  

Gradalis Employees Celebrating Ovarian Cancer Wear Teal to Work Day

Several other informational events are planned including:

  • Presentation by Dr. Martin Birkhofer, MD on Ovarian cancer clinical trials
  • Presentation by Dr. Minal Barve, MD, on a clinician's perspective of Ovarian cancer
  • Visit by Ms. Sarah Harris, from National Ovarian Cancer Coalition to provide us the patient perspective.  

In addition, many company employees will participate in a Walkathon on September 25, being organized by National Ovarian Cancer Coalition in Lone Star Park, Grand Prairie, TX.  Gradalis employees will be wearing Gradalis T-shirt, so come and say hello if you are participating in the Walkathon.

At the end of September, we hope to be much better informed about Ovarian cancer ourselves, and help raise awareness among out friends and family.

Gradalis Inc Launches A Patient Friendly Vigil Clinical Trials Website

Dear Visitor,

Today, July 7, 2016, we are launching this website to improve our communication with cancer patients who might be looking for information on Vigil® clinical trials.  While Vigil clinical trials are listed on clinicaltrials.gov, the information is in medical/technical language which often makes it difficult for a person without science background to understand it easily.  On this website, we hope to provide the same information in a more easy-to-understand format.  For a person interested in more details, links are provided to the clinicaltrials.gov webpage for your convenience.

If you still find the information difficult to understand, please don’t hesitate to write to us.     

As you can see from this website, Gradalis, Inc., has multiple clinical trials underway evaluating the clinical benefit of Vigil Engineered Autologous Tumor Cells (EATCs).  These trials are either evaluating Vigil EATCs alone, or Vigil EATCs in combination with a new class of drugs called PD1/PD-L1 inhibitors.  The Vigil EATCs are being studied alone in Ewing’s Sarcoma, and Ovarian Cancer, while the combination studies are going on in Melanoma, Lung Cancer (NSCLC) and Triple Negative Breast Cancer.

We have multiple centers open for these clinical trials, but you may find that at this time we have listed only a few of them on this website.  This is because each center has to individually provide us permission to list their site’s information.  As we receive these permissions, we will continually update the information.  Meanwhile, if you wish to find out whether the Vigil clinical trial is open at a center close to you, please use the toll free number (1-888-582-2282) or email us at clinicaltrials@gradalisinc.com.  Alternatively, you can also use the “contact us” page, to write to us.

Cancer is a terrible disease, but unlike 10 or 15 years ago, there are many options available to cancer patients.  Clinical trials of new cancer drugs like Vigil EATCs are a legitimate option for cancer patients as recommended by National Comprehensive Cancer Network (also known as NCCN).  However clinical trials carry some risks and it is important for the patient to discuss their options with their health care provider.  We hope that by making the Vigil clinical trials information available to you in an easy-to-understand language, we are making it possible for you or your loved one to have a thoughtful discussion with your doctor. 

Please let us know if you find this resource helpful.

-          Team Gradalis