Groundbreaking Lung Cancer Vaccine Research Set to Start in Santa Barbara
by Ethan Stewart

No type of cancer kills more men and women each year than lung cancer, but, if all goes well with a clinical trial set to commence at the Cancer Center of Santa Barbara later this month, doctors around the world may soon have a potent new weapon in the war against the deadly disease. After more than 20 years of development, a lung cancer vaccine called Lucanix is slated to begin its Phase III clinical trials-the final step before seeking FDA approval-at some 60 research centers around the world. Even better, after achieving glowing results with virtually no negative side effects in earlier trials, hopes are running high for the groundbreaking treatment. As Dr. Fred Kass, director of research and wellness at the Cancer Center, put it this week, “Cancer vaccines have been on the horizon for a long, long time. That we are now at this point with one and doing it here in Santa Barbara is : well, it is pretty amazing.”

According to Kass, also a practicing physician with the Santa Barbara Hematology Oncology Medical Group, Lucanix is an injectable vaccine that, in short, works to use your own immune system to fight off the formation of non-small cell lung cancer. (The vast majority of all lung cancer cases are diagnosed as non-small cell cancer, as opposed to small cell cancer). Much like a traditional flu vaccine, the treatment is essentially an injection of dead cells, initially derived from four different strains of living lung cancer cells, that are artificially aged so they express their complete properties. In other words, the cells are designed to trick your body into putting up a fight, and thus, when the real thing begins to form, better prepare you to hold off an advancement of the disease. Though not meant for every lung cancer patient-the trial is geared solely for people with advanced, inoperable, non-small cell lung cancer that has already been temporarily stabilized by either chemotherapy, radiation, or a combination of the two-the vaccine will theoretically provide two things that are invaluable for otherwise terminal patients: time and quality of life. In fact, according to data from Phase II clinical testing, patients on Lucanix lived on average nearly 16 months longer than those without the vaccine. “We are not at the stage where this vaccine will cure lung cancer,” said Kass, “but what this trial means to me, even if it doesn’t work as well as people hope it does, is that we finally got a vaccine that works for cancer.”

The trial, which already has one person enrolled here in Santa Barbara, is open to all people over age 18 and under age 75 who meet the advanced stage disease presentation and treatment status requirements (i.e., chemo and radiation have concluded for the time being); it has a total limit of 506 participants. Once signed up, people will get a monthly shot of either Lucanix-which needs to be kept at a chilly minus-80 degrees Fahrenheit until the inoculation is prepared less than an hour before injection-or a placebo in concert with close monitoring by physicians who painstakingly document every step of the treatment via blood tests, x-rays, etc. Here in Santa Barbara, that job will belong to Kass and the full-time research support staff at the Cancer Center, the latter providing the data-crunching personnel who make the whole process possible. Things will continue in this manner for at least 18 months or until the patient’s cancer begins to grow again, whichever comes first.

The hope is that a concrete degree of effectiveness can be determined by observing a trend between how long it takes placebo recipients to get sick again versus the people getting the actual Lucanix dose. Acknowledging the less-than-ideal reality for trial participants who are stuck with a placebo at an ¼ber-critical time in their life (for this trial, patients on Lucanix will outnumber those on a fake cocktail by a 2 to 1 margin), Kass explained that a “monitoring committee” will be keeping close tabs on patient status updates in order to ensure that all trial participants will have access to the drug if it becomes apparent that it is effective. “In clinical research, [Phase III trials] are really where the rubber meets the road : Using a placebo versus vaccine comparison is the only way we will know if the vaccine works,” summed up Kass.

Cheryl takes an in-depth look at how big the problem of Lung Cancer is, affecting anyone at any age. Featuring the Bonnie J. Addario Lung Cancer Foundation, the Addario Lung Cancer Medical Institute (ALCMI), with special guests Bonnie and Tony Addario, Drs. David Jablons, Thierry Jahan, David Larson and Stage IV survivor and world-renowned opera singer Zheng Cao. Click here to view. Please email us with your comments and feedback. Sit back and enjoy the show!

APRIL 24, 2010 GAINESVILLE, FLORIDA–CLICK HERE TO SIGN-UP/REGISTER

June 19, 2010 CLEVELAND, OHIO–CLICK HERE TO SIGN-UP/REGISTER

2010 WALK.RUN. Schedule (Check back for registration. Scroll down to see video, photos from past walk/runs)

APRIL 24, 2010 OMAHA, NEBRASKA

JULY 24, 2010 CHICAGO, ILLINOIS

AUGUST 21, 2010 EDMONDS, WASHINGTON

AUGUST 28, 2010 SANTA MONICA, CALIFORNIA

SEPTEMBER, 2010 NEW YORK, NEW YORK

SEPTEMBER, 2010 SAN FRANCISCO, CALIFORNIA

SEPTEMBER, 2010 WASHINGTON, DC

OCTOBER 3, 2010 ATLANTA, GEORGIA

OCTOBER 31, 2010 BEIJING, CHINA

NOVEMBER, 2010 HOUSTON, TEXAS

DECEMBER, 2010 SHANGHAI, CHINA

PAST RUNS

FEBRUARY 7, 2010, BERKELEY, CA —JOG FOR JILL

JOG FOR JILL, BERKELEY, CALIFORNIA

CLICK HERE TO READ ARTICLE AND WATCH A VIDEO Sunday, February 7, 2010 was a beautiful sunny day for nearly 1000 participants who came in support of Jill Costello and raised over $40,000. The Bonnie J. Addario Lung Cancer Foundation and the women of Kappa Kappa Gamma’s first annual “JOG FOR JILL: A BREATH AWAY FROM THE CURE 5K” was an overwhelming success and possibly the largest gathering for Lung Cancer in history. A celebration and Superbowl party followed at Bear’s Lair. VIEW SLIDESHOW/PHOTOS

MORE VIDEO Many thanks to all—especially Darby Anderson—for helping Jill make her dream come true to begin the END OF LUNG CANCER.

CLICK HERE AND DONATE MORE TODAY FOR JOG FOR JILL!!!

Important Note: The JOG FOR JILL page remain active until May 7, 2010, to continue to make Jill Costello’s dream to END Lung Cancer come true, and raise much needed funding for Lung Cancer Research. New events will follow…Darby and Jill are already brainstorming a concert in Golden Gate Park this summer and maybe a walk around Wrigley Field in July with the CUBS… so stay tuned!

The Bonnie J. Addario Lung Cancer Foundation Third Annual ‘Addario Lectureship Award” Announced

Award to Recognize Luminaries in the Quest to Eradicate Lung Cancer

San Francisco, Jan 4, 2010/PRNewswire-USNewswire/–The Bonnie J. Addario Lung Cancer Foundation (BJALCF) today announced the winner of the 2010 Addario Lectureship Award, which each year recognizes luminaries in the quest to eradicate Lung Cancer. The recipient will be honored at the 11^th International Lung Cancer Congress in Southern California held on July 8-11, 2010.

2010 Addario Lectureship Award —The recipient of the 2010 Addario Lectureship award is Dr. David R. Gandara. Dr. Gandara is considered to be one of the world’s main thought leaders in Lung Cancer today.  He has been a productive and innovative Lung Cancer researcher in Lung Cancer therapeutics and is a champion of personalizing cancer therapy through predictive biomarkers.

Dr. Gandara earned his M.D. with honors at the University of Texas and completed his fellowship in Hematology and Oncology at the Letterman Army Medical Center in San Francisco.  Since 1994, he has been Professor of Medicine, Director of Clinical Research and the Director of the Thoracic Oncology Program at the UC Davis Cancer Center. Dr. Gandara is Chair of the Lung Cancer Committee of the nationally recognized and prestigious NCI-sponsored Southwest Oncology Group (SWOG) since 1997, is currently President of the International Association for the Study of Lung Cancer (IASLC), and Editor-in-Chief for “Clinical Lung Cancer.”  He is chair of the NCI Lung Correlative Sciences Committee and a founding co-chair of the NCI Investigational Drug Steering Committee (IDSC). Dr. Gandara was the co-chair of the 13^th World Conference on Lung Cancer in San Francisco. He has been critically important to achieving BJALCF’s goals and also serves as a member of the Scientific Leadership Board of the Addario Lung Cancer Medical Institute (ALCMI).  Dr. Gandara has been an essential force driving the definition and successful launch of ALCMI over the last year.

Dr. Gandara was also the recipient of the Bonnie J. Addario Lung Cancer Foundation’s Dr. Fred Marcus SIMPLY THE BEST AWARD in 2008. The Simply the Best Award recognizes individuals who make extraordinary contributions to the battle against, and progress towards, making lung cancer a manageable disease. It is the highest recognition by BJALCF for achievement and service to humanity in three categories:  outstanding and compassionate clinical care for patients with Lung Cancer, cutting edge and innovative research, and exemplary educational contributions.

As further recognition of his many contributions to the field, the Third Annual Addario Lectureship Award belongs to Dr. Gandara not only for his tireless efforts and brilliant strategies to advance both Foundations’ missions forward at rapid speed, but also for his incredible ability to provide the best possible care and treatment options, “up-to-the-minute treatment options” for patients, and to extend the lives of patients, despite the statistics and against all odds.

Dr. Gandara provides breakthrough vision, strategy and HOPE for Lung Cancer patients on an hourly basis and is most deserving of this award.

2008 Recipient: Paul A. Bunn, Jr. MD, Principal Investigator and Director, University of Colorado Cancer Center

2009 Recipient: Harvey Pass, MD, BA, Director of the Division of Thoracic Surgery and Chief of Thoracic Surgery, New York University Medical Center

About the Bonnie J. Addario Lung Cancer Foundation (BJALCF)

BJALCF is one of the nation’s largest philanthropies and recognized force devoted exclusively to eradicating Lung Cancer through research, early detection, education, prevention, and treatment. The Foundation works with a diverse group of physicians, organizations, individuals, and survivors to identify solutions and make timely and meaningful change. BJALCF was established in 2006 as a 501(c)(3) non-profit organization and has raised over four million dollars for Lung Cancer. BJALCF was the first Foundation allowed to participate in the International Lung Cancer Congress in 2008 and 2009. Contact: Sheila Von Driska, Executive Director, sheila@lungcancerfoundation.org/415.357.1278/www.lungcancerfoundation.org

About the Addario Lung Cancer Medical Institute (ALCMI)

Lung Cancer survivor Bonnie J. Addario and her supporters established the Addario Lung Cancer Medical Institute (ALCMI) in 2008 as a 501(c)(3) non-profit organization in order to accelerate the discovery, development, and delivery of new treatment options for Lung Cancer patients in need.

The mission of ALCMI is to significantly improve Lung Cancer patient outcomes and survival. This will be accomplished by directly helping to foster greater understanding of the molecular bases of the disease through collaborative research programs, shared infrastructure such as biospecimen repositories and data systems, and helping to accelerate the development and study of targeted therapies leading to individualized, more effective therapies for Lung Cancer patients.

Contact: Steven Young, President, syoung@alcmi.net/ www.alcmi.net

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Research yields new agent for some drug-resistant non-small cell lung cancers

Pasi Antero Jänne, MD, PhD is a member of the Scientific Leadership Board of the Addario Lung Cancer Medical Insititute (ALCMI) and the Bonnie J. Addario Lung Cancer Foundation Medical Advisory Board

December 23, 2009 BOSTON-The ability to make, test, and map the atomic structure of new
anti-cancer agents has enabled a team of Dana-Farber Cancer Institute scientists to discover a compound capable of halting a common type of drug-resistant lung cancer.

In a study to be published in the December 24/31 issue of the journal Nature, the researchers report that non-small cell lung cancers that had become invulnerable to the drugs Iressa(R) and Tarceva(R) were stymied by a compound designed and formulated in a Dana-Farber lab.  The compound, whose basic chemical framework is different from that of other cancer drugs, acts against a protein – known as an epidermal growth factor receptor (EGFR) kinase – that
carries a specific structural defect.

“This type of drug discovery, in which an agent is developed for a specific gene or protein target, and then screened against cancer cells as well as in laboratory models, is rare in academic medicine,” says the study’s senior author Pasi A. Jänne, MD,PhD, of Dana-Farber and Brigham and Women’s Hospital (BWH).

“This requires contributions from researchers in multiple disciplines and a coordinated approach to planning experiments and sharing results. That we accomplished this is evidence of the contribution academic medical centers can make to the quest for new cancer treatments.”

The study also illustrates how rapidly lung cancer research and treatment are advancing.  It was less than five years ago that investigators at Dana-Farber and elsewhere traced some non-small cell lung cancers (NSCLCs) to mutations in the EGFR gene and discovered that Iressa and Tarceva slowed such tumors’ growth by targeting the abnormal EGFR protein.  While the discovery has extended the lives of thousands of NSCLC patients around the world, EGFR blockers are only temporarily effective: after about eight months of treatment, the tumors begin to grow back.  And because the drugs target normal EGFR protein as well as abnormal, many patients have severe side effects such as skin rashes and diarrhea.

All current EGFR inhibitors have a structural “backbone” known as a quinazoline core.  They lodge in a notch on EGFR normally reserved for a molecule known as ATP, which delivers chemical energy to the cell.  By blocking ATP from binding to EGFR, the inhibitors prevent EGFR from sending signals that are essential to keep the tumor cells growing.

Over time, however, the tumor cells develop additional abnormalities in EGFR, enabling them to recommence their growth, even in the presence of Iressa or Tarceva.  The most common of these abnormalities – present in about 50 percent of patients with drug-resistant tumors – is known as EGFR T790M.

Dana-Farber investigators hypothesized that current agents lose their potency because they don’t bind as tightly or fully to the EGFR T790M protein as they ideally should.  To improve the fit, researchers led by chemical biologist Nathanael Gray, PhD, prepared a group of inhibitors with a different structural scaffold, known as a pyrimidine core, which, it was thought, would mesh more
thoroughly.  They lab-tested the agents in NSCLC cells with EGFR T90M and found several that were up to 100 times more potent than quinazolines in restricting cell growth.  As an unexpected bonus, these compounds were nearly 100 times less powerful at slowing the growth of cells with normal EGFR, suggesting they would be less likely to produce side effects than current drugs.  The agent which performed the best is the pyrimidine WZ4002.

“This work provides a possible therapeutic chapter to a longstanding record of validating EGFR as a drug target,” says Gray.  “This has involved the identification of activating mutations in EGFR as a predictor of drug response, the discovery of multiple drug resistance mechanisms, and the elucidation of how these mutations work at an atomic level.”

In follow-up experiments, Dana-Farber and BWH’s Kwok-Kin Wong, MD, PhD, screened
the pyrimidine agents in mice with Iressa- and Tarceva-resistant NSCLC tumors driven by EGFR T790M, and found them to be highly effective at impeding tumor growth.  Dana-Farber’s Michael Eck, MD, PhD, conducted crystallography studies to determine the molecular structure of the pyrimidines, providing a better picture of why they are so potent and how they target EGFR T790M cells so precisely.

“Not only did we determine that the compound WZ4002 could slow tumor growth, we
also demonstrated that it is possible to selectively target the drug-resistant mutant EGFR in tumors, with relatively less effect on the normal EGFR in healthy tissues,” says Wong.

Much work remains to determine if WZ4002 and its chemical cousins will be effective therapies, the authors caution, but the discovery demonstrates the power of screening specially designed compounds against cancers with certain genetic quirks.

“Obviously these are very early days with respect to the possible use of these compounds in patients – we still have much to learn about their possible liabilities,” Eck remarks.  “But I am optimistic that our approach is correct and that it will lead to an effective treatment for the thousands of non-small cell lung cancer patients worldwide who development resistance to Iressa and Tarceva every year.”

Other contributors to the study include lead author Wenjun Zhou, PhD, and co-first authors Dalia Ercan, Liang Chen, PhD, Cai-Hong Yun, PhD, as well as Danan Li, PhD, Marzia Capelletti, PhD, Alexis Cortot, MD, all of Dana-Farber; Lucian Chirieac, MD, and Robert Padera, MD, of Brigham and Women’s Hospital; and Roxana Iacob, PhD, and John Engen, PhD, of Northeastern University.

The study was supported by grants from the National Institutes of Health, the Cecily and Robert Harris Foundation, Uniting Against Lung Cancer, the Flight Attendant Medical Research Institute, the Hazel and Samuel Bellin research fund, and the Damon Runyon Foundation.

Dana-Farber Cancer Institute (www.dana-farber.org) is a principal teaching affiliate of the Harvard Medical School and is among the leading cancer research and care centers in the United States. It is a founding member of the Dana-Farber/Harvard Cancer Center (DF/HCC), designated a comprehensive cancer center by the National Cancer Institute.

Contact: Bill Schaller/Rob Levy (617) 632-4090

We sincerely HOPE to see you all there,  because although we cannot direct the wind, we can adjust the sails and we can remember that even in moments of darkness, each day brings its own gifts… we just have to untie the ribbons…

ONCE YOU CHOOSE HOPE–ANYTHING IS POSSIBLE

XOXO

What our attendees are saying:

I wanted to let everyone know that I really enjoyed our meeting last night.  It was my first support group meeting ever and I didn’t know what to expect.  I left excited, so happy, and really appreciative that I found all of you.  Thank you so much for the honesty, sharing your personal stories, all the advice and anecdotal suggestions.  What a wealth of knowledge our combined group possesses!  I am really looking forward to our next meeting!   – Love, Diem

For more information, please call Danielle Hicks at 650.670.4065 or email danielle@lungcancerfoundation.org • 1100 Industrial Road, San Carlos, CA 94070

PLEASE VIEW THE ALCMI VIDEO.

The Fairmont Grand Ballroom was filled with guests from all over the world including BJALCF’s new Nebraska affiliate and mastermind creator of the viral WTF-WHERE’S THE FUNDING? for Lung Cancer campaign, Jennifer Stauss Windrum and her LC survivor mom, Leslie Lehrman. We are so happy to have this dynamic duo and their movement join our movement and find the funding. It’s coming. Please visit Jennifer’s campaign, buy WTF merchandise, and spread the word and watch the latest on Fox 42KPTM.com.      VIEW GALA PHOTOS HERE

Thanks to Margaret Duckhorn and Perry and Carolyn Juslyn, the fabulous dinner was pared with ONLY the best wine. Top Chef Hosea Rosenberg, winner of Bravo’s Top Chef Season 5, created a menu TO LIVE FOR and taught everyone that Buffalo is the new Filet Mignon. Special thanks to Chef James of the Fairmont for making over 500 of the plates perfect. To read more about Hosea and his mom and dad, CLICK HERE. And as Ed Rosenberg reminds us, “Be sure to do what makes you smile.”

The Dr. David Jablons “Asclepios Award” honoring pioneers in research went to Dr. David Carbone. “I chose David Carbone for his endless dedication to his patients,” said Jablons. “And his relentless pursuit of better therapies and improving outcomes based on incorporating novel therapeutics and treatment options as they emerge. He has built a great team of scientists and clinicians at Vanderbilt and is widely recognized as one of the leading researchers worldwide in Lung Cancer today. He is a smart guy and, amazingly, as nice a guy as there is in the business. He is richly deserving of this award and it is my great honor to present it to him tonight…” Dr. Carbone is currently chair of the Scientific Leadership Board of the Addario Lung Cancer Medical Institute (ALCMI).

The Dr. Theirry Jahan “A Breath Away from the Cure” Award was accepted by Dr. Giorgio Scagliotti who flew in for a quick 24-hour trip—all the way from the University of Turino, Italy. “Each year, this award is given to honor individuals for their excellence in oncology,” said Jahan. “It is my great honor to choose Giorgio for his coordinated treatment, care and compassion, for those with Lung Cancer. Through all of his efforts, he has redefined the way we treat Lung Cancer and through his work he has inspired me as well as the entire Lung Cancer Community for the past two decades.”

The Dr. Fred Marcus “Simply the Best” Award honoring outstanding performance in the fight to end Lung Cancer went out to Kathy Danenberg, President and CEO of Response Genetics. “It is with the greatest appreciation for Kathy’s dedication to the advancement of Lung Cancer biology and biologic testing,” said Marcus. “And the application of scientific discovery to help people with Lung Cancer NOW and for her insights and humanistic philosophy of how her important discoveries and methods should be available to all people with Lung Cancer, and her alliance with ALCMI, that I bestow this highest honor from BJALCF.”

All but one of the thirteen-member cast of the “ALCMI: Making it Personal One Patient at Time” video were in attendance. Narrator Bonnie Addario, in a John Catchings Production, opens the biggest Lung Cancer movie of the past four decades (or ever, really) with the question, “What do a world-renowned opera singer, a two-time Emmy Award winner and two young college students have in common?” As Dr. Marcus explained during the premiere, we no longer have to imagine a world where you are an experiment and you CAN receive therapies for Lung Cancer that are tailor made to provide the most efficacy, eliminating therapies that might provide toxic side effects. The personalized information coming out of ALCMI now gives an oncologist the most specific and advanced information possible to make the best possible decision for treatment the FIRST time…your individual genetic identity is the key factor to survival. ALCMI is dispelling the barrier myths about Lung Cancer and is accelerating tomorrow because TODAY, for many, is the only day. ALCMI is NOW working on a project with seven major University Medical Centers in the United States and Europe that will take the Lung Cancer tissue from the biopsy and a single blood sample directly to real-time laboratory technology that will select the right drug the first time. “If we can analyze the genes in your cancer cell and see the mutations that make this particular cancer more susceptible to dying in response to a certain treatment then that’s the treatment you need.” explains Ite Laird-Offringa, researcher at USC and ALCMI member. This is personalized medicine and as Bonnie states, “This should be the protocol. The cavalry is coming.” CAST members (SURVIVORS): Bonnie J. Addario, Zheng Cao, 23-year old Taylor Bell, 21-year old Jillian Costello, Kathryn Joosten, Grace White • (DOCTORS AND RESEARCHERS): David Carbone, MD, PhD, David Gandara, MD, David Jablons, MD, Ite-Laird-Offringa, Fred Marcus, MD, Giorgio Scagliotti, MD, PhD,  and ALCMI PRESIDENT, Steven Young.

Next, the Bonnie J. Addario “Unsung Hero” Award was presented to over 40 Lung Cancer survivors in the room including our youngest survivor Gabby Wilson who said she had the ” best time of her life” while world-renowned mezzo-soprano Zheng Cao sang “Somewhere Over the Rainbow” with Josy Hicks-Jablons, a rising star. There was not a dry eye in the house.

Auctioneer David Silverman steered the crowd back into party mode commandeering about $150,000 with the Fund the Need and a wild live auction. Dominick and Gloria Chirichillo of Domenico Wines donated the most lively item…a collectible and authentic Felipe Rose Village People Indian Costume which Jablons donned while “macho man” played, and EVERYONE else ended up wearing the costume throughout the evening. What began with a $100 opening bid, soared to $3500 and survivor Ed Lynch is now the proud owner.

The dancing began at 9:15pm sharp with Bill Hopkin’s Rock ‘N Orchestra, and we welcome any additional stories coming from you. EMAIL US.

Simply the Best Dinner Gala V will be held at the San Francisco Fairmont on Saturday, November 13, 2010. Save the Date and please join us.

Notes: Marc Galbraith of San Francisco won the Smart Car and Crete Wood of Colorado won the Jewelry. Pictures and video to come. Stay tuned…

PLEASE CLICK HERE TO DONATE TODAY

Read more about Jennifer and her mom Leslie in the gothenbergtimes