Friday, April 21, 2023

The Magnificent Obsession of Mike Milken

If I asked you to pick one person who is most responsible for the remarkable progress we've seen in the cancer drug development arena in the last 25 years, who would you choose? 

Here are ten of my top candidates for that honor:

Jim Allison, the father of modern immunotherapy;  Carl H. June, one of the pioneers of CAR T-cell research;  Dennis Lo, who detected fetal cfDNA in the blood and introduced the first commercially available liquid biopsy assay;  and Steve Rosenberg, whose hard work led to the world’s first gene therapy that deployed the body’s immune system to fight cancer.

There are also Gwen Nichols, a renowned physician, researcher and chief medical officer at the Leukemia and Lymphoma who plays a critical role in advancing cures;  Michala Short, for her compassion toward patients as well as her work establishing Australia’s first proton therapy center;  and Mark Kaminski, the hematologist and researcher who co-developed Bexxar, a radio-immunotherapy that saved my life.  There are also Dr. Jian Zhou, the inventor of the cervical cancer vaccine;  Bert Vogelstein, the first scientist to explain the molecular basis of a common human cancer;  And Jennifer Doudna, whose work could make ultra-precise edits to DNA in cells and potentially cure cancer and more.

Those are ten of my personal heroes. But as much as I admire each of these men and women, there is one person who outshines even these bright stars. The Most Valuable Player in the cancer arena over the last three-plus decades is unquestionably Mike Milken. 
The more you learn about what he has done nationwide and worldwide, the more I think you will agree. 

Mike’s work in fact extends to all life-threatening diseases, not just cancer. In a recent WSJ op-ed (linked here), he refers to heart disease, polio, AIDS, Covid, infectious diseases, Alzheimer’s, hereditary conditions, and more.

But this story is focused on his work in the cancer world. And it is extraordinary. I generally avoid hackneyed descriptions like “larger than life” when describing someone in print. But Mike (he prefers Mike) really is. He's dramatically changed the cancer drug landscape. 

Mike is not a doctor. He is a financier, medical research innovator, cancer survivor, writer and devoted family man. And he has has somehow managed to bring the once-fractured cancer sector together. 

That includes pharma and biotech, academia, regulators, politicians, advocates, patients, all coming together in ways that we have never seen before. They are breaking bread and breaking the mold. Yes, it's still competitive. But the landscape has changed dramatically for the better thanks to Mike. 

The New Book Takes You Inside His World

Mike Milken
In his brilliant new book, Faster Cures: Accelerating the Future of Health, which you can purchase here, Mike takes us behind the curtain to show us just how he took on this enormous challenge. 
 
The book details the work he has done to get all the players in the cancer sector on the same page so that they can move cancer research forward. 
 
“It seemed crazy,” Mike writes. “These doctors held patients’ lives in their hands, yet they had an incomplete picture of the disease without the benefit of expertise from other institutions."

He goes on to say that the physicians and scientists at various elite centers viewed one another as competitors, not collaborators. “They were all drawing from the same small pool of grant money, and they were all trying to attract revenue-producing patients,” he writes.

“It reminded me of when I coached my kids’ soccer games. The biggest challenge was getting the youngsters to stay in position and cooperate as a team rather than everyone running to where the ball is. Too many medical researchers were running after the same scientific ball and not communicating with each other.”

Mike infiltrated the entrenched, isolated cancer "camps" and brought them together to expedite the development of lifesaving cancer modalities and get them to the public. His work has changed the world.

In the book, he shares personal stories about his childhood and what motivated him to become a global cancer warrior. The book works both as a ruminative autobiography (with co-writer Geoffrey Evans Moore) and a primer of how one man really can change an industry.

While many people are aware that Mike runs and hosts the Milken Institute, the nonprofit, nonpartisan think tank that helps people build meaningful lives, I'd guess that only a small handful of people know just how much he has done for the cancer community.

The Impossible Dream

Mike’s Quixotic dream of speeding up the process of drug development has been his mantra for 50 years. He's succeeded to the point where Fortune describes him as "the man who changed medicine." 

A pragmatic dreamer, he is a gentle but relentless advocate. He's very smart, and keenly aware that the only way to pursue this is to be non-partisan. But he has little patience for the way some research institutions act like sports teams carefully guarding their playbooks so their “opponents” won't know what they are  doing. Collaboration is the only way to move forward, he says.

It's hard to accurately quantify just how much he has given because there has been such an overwhelming ripple effect throughout the entire oncology world from his work. But thanks to Mike, even staunch and sometimes hostile competitors have come together. 

Cancer drug development is an arduous and expensive endeavor from the time a scientist has a notion in the lab to the clinical trial stages to FDA approval to manufacturing to marketing the product. But it's gotten much easer and more streamlined thanks to Mike. 

CaP CURE

His mission actually started in the 1970’s with a few programs to advance drug development. But he knew there was so much more to do. As he writes in the book, he decided in the early 1990's that the cancer universe needed a complete overhaul. It was time to roll up the sleeves and get to work.

His resolve would lead to the formation of the Prostate Cancer Foundation, Melanoma Research Alliance, and ultimately FasterCures. By March 1993, Mike had come up with a new name for his organization: CaP CURE. 

The “Ca” stood for all cancers, he explains. The the “P” stood for prostate. And “CURE” was for all diseases. And he was inspired to fund young scientists. 
 
For nearly 50 years, Mike has advanced the careers of more than 600 early career researchers. “We call them young investigators, or YI’s,” Mike writes. “They work in two dozen countries."

Mike has connected with thousands of medical and scientific experts worldwide. 
He came up with this list of principles:

• Focus on the career paths of these young physicians.
• Focus on collaboration in place of competition.
• Build cross-sector ties.
• Identify the most promising research not funded by the National Institutes of Health (NIH).
• Eliminate needless bureaucracy.
• Relinquish intellectual property rights in exchange for speed and administrative costs.
• Supplement traditional therapies with proven alternative concepts. Generate public awareness.
• Educate members of Congress.
• Assure other disease groups that we were a resource, not a threat.
• Act with urgency.

These are just some of the organizations Mike has created. Each one is doing stellar work and is worthy of your support:

Milken Center for Advancing the American Dream (MCAAD)
The Milken Center for Advancing the American Dream believes anyone with a dream, and the drive to achieve it, should have the opportunity to make it come true— through expanding access to education, health, and economic freedom, and by unleashing the power of entrepreneurship and innovation.

Milken Institute
A non-profit, non-partisan economic think tank whose scholars lead an international dialogue on solutions in the areas of economics, health, aging, human capital, philanthropy and capital markets.

FasterCures
This Washington, D.C.-based think tank is removing barriers to progress against all life-threatening diseases.

Milken Family Foundation

Established in 1982, the Foundation is one of America's leading charitable organizations supporting education and a broad range of medical research.

Bioscience/Public Health
Major recent initiatives include the Milken Institute’s COVID-19 Treatment and Vaccine Tracker, and the biggest health initiative -- The Milken Institute School of Public Health.

Milken Scholars Program
The Milken Scholars Program provides outstanding high school students with a commitment of four years of college financial assistance, counseling, volunteer opportunities and preparation for graduate studies and beyond.

Melanoma Research Alliance

The MRA has awarded approximately $123 million to medical investigators in 18 countries focused on accelerating new therapeutic approaches for melanoma, improving existing treatments, developing new biomarkers and advancing understanding of risk factors. Since 2007, the FDA has approved 13 new melanoma treatments.

Prostate Cancer Foundation
The world's largest philanthropic source of funds for prostate cancer research, the Prostate Cancer Foundation is helping reduce the death rate from one of the most common cancers.

Other Non-Profit Activities
Mike's five decades of philanthropy include many other programs in medical research, public health and education.
 
Immunotherapy Has Come of Age
 
Meanwhile, it’s fitting and poetic that just as Mike’s book was released, Moderna and Merck announced the results of a Phase 2 clinical trial that combines Moderna’s personalized mRNA cancer vaccine and Merck’s blockbuster immunotherapy drug Keytruda for people with melanoma.

In the trial, which I wrote about this week for Healthline, the drug-vaccine combination reduced the risk of death or recurrence of melanoma, the most deadly type of skin cancer, by 44% compared with Merck’s immunotherapy Keytruda alone.

Several immunotherapies have made their way from the lab to the clinic, largely because of Mike’s support. Keytruda, for example, the checkpoint inhibitor, is now approved for more than a dozen types of cancer. I've written about Keytruda extensively.

And now the world is getting the first look at what can happen when you combine an immunotherapy with a personalized cancer vaccine. This is the future of cancer medicine, right here, right now. 

The next step of course is a Phase 3 trial, which could lead to a new option for people with melanoma. This is just the beginning of the cancer vaccine combination.
Moderna is of course the company that saved countless lives during the pandemic. 
Personalized medicine is just beginning to blossom. 

Throughout this magnificent obsession of Mike's, he has been consistent and unwavering. And to his credit, he has always been especially enamored of immunology. He is fascinated with the science of getting your own body to fight the cancer. 

Mike was convinced that this could be a game-changing medicine decades before the world began to open their eyes and minds to the idea that we have an immune system. I, too, was an early believer in immunology. 

From a young age, I instinctively believed that we all have an immune system. In late 1996, I was diagnosed with stage IV non-Hodgkin’s follicular lymphoma. My oncologist told me I would be lucky to live three years. But I had other plans. 

I was originally treated with a type of chemotherapy called CHOP. It was rough. It gave me a remission. But two and a half years later I was back in the trenches. 

This time, I took charge of my situation. First thing I did was get a new oncologist, who was much kinder and far more open-minded about my desire to enroll in a clinical trial. 
I looked far and wide for any and all potential treatments, including trials. I chose to enroll in a Phase 3 trial of a drug called Bexxar, a so-called radio-immunotherapy.
 
Bexxar was a monoclonal antibody linked with radioactive iodine I-131. Monoclonal antibodies are built to target and destroy only certain cells in the body. At the time, the drug, which was used to treat certain forms of non-Hodgkin's lymphoma, was usually given after other medications had been tried without successful treatment.

Bexxar not only put me back into remission and saved my life, it cured me. I have many friends who were also cured by that drug. But it was sadly shelved by Glaxo Smith Kline (GSK) for all the wrong reasons.

The drug company didn’t effectively market the drug and they clearly didn’t think it was going to be financially advantageous to continue offering this remarkable medicine. I was heartbroken with the drug was scrapped. Because it works.

GSK scientists have certainly done some very good things. But this decision was wrong on all kinds of levels. I have written extensively about Bexxar in Newsweek, where I proudly spent 23 years as a national correspondent, and International Business Times, and The Reno Dispatch news blog you are reading, and many other publications.

I still believe we should resurrect Bexxar and its sister medication, Zevalin, which is also a radio-immunotherapy that showed very good results with minimal side effects. These are both safe and effective medicines that were poorly marketed and underutilized. Perhaps they arrived too soon.
 
Thanks again, Mike

As a fellow cancer survivor, I thank you again for all you have done for the national and global cancer communities. If you ever need me for anything, please do not hesitate to ask.


Friday, April 7, 2023

EXCLUSIVE: Why Are Teen And Young Adult Cancer Patients Still Not Getting The Research And Support They Deserve?



When Allison Rosen (above) was diagnosed with colorectal cancer at age 32, it came as a complete shock. She had no idea someone her age could be diagnosed with this type of cancer, which most Americans still associate with people who are much older.

It was a daunting challenge for Rosen, physically and emotionally. But she bravely pushed on, endured treatment, and is now in remission.


Rosen, a trained scientist who worked for years in a lab, now works in cancer prevention and is a passionate advocate for her fellow adolescent and young adult cancer patients (AYA’s). 


“I believe there needs to be more research and more attention given to teens and young adults with cancer,” says Rosen.


“The physical as well as psychological aspects of being diagnosed with cancer just as your life is beginning can be devastating.” 


Rosen is intensely focused on increasing awareness of the unique challenges faced by adolescent cancer patients ages 15 to 39. And she’s not alone.


The idea is unambiguous: Teens and young adults too often get the short end of the stick when it comes to cancer care, and it has to change, for the sake of us all.


Why does this age group need and deserve more attention? There are multiple compelling reasons.


First of all, teens and young adults are diagnosed with cancer at later stages than any other sector of the population.


Teens and young adults are also the sector of cancer patients who are most often misdiagnosed. 


Teens and young adults also get by far the fewest research dollars thrown their way, the least amount of clinical trials, and the least amount of space in cancer hospitals.


The young adults age group is also the least likely to have health insurance. While kids and teens are typically covered under their parents’ insurance, young adults are often not covered. And many of them are just not even thinking about cancer or any other serious illness.


Teens and young adults also generally do not get tested for cancer. It’s simply not on their radar, or their doctor’s, if they have a doctor.


But the sad and chilling fact is that cancers in young people are alarmingly on the rise in America.


In a recent study of cancer trends among adolescents and young adults in the US, researchers reported a shocking 30 percent increase in cancer diagnoses among individuals fifteen to thirty-nine years old between 1973 and 2015. 


Despite the fact that cancer in AYA’s is alarmingly increasing, data on the epidemiology of cancer in AYAs are still inexcusably limited.


AYA’s Need Their Space


And lest we forget, there are the psycho-social aspects of being diagnosed in this age group, as well, and just where this age group is typically being treated. It’s insulting for someone who is 16 years old to be relegated to the pediatric cancer ward next to a very young child.


It is also unfair for for a 23-year-old cancer patient to be placed in the same treatment room as a person who is two or even three times his or her age.


Neither is optimal. Teens and young adults want and need their own space. A treatment environment that is age-appropriate is something every cancer patient wants and deserves.


Teen Cancer America (TCA) is addressing these needs. The non-profit organization works tirelessly every day to support adolescents and young adults with cancer, including establishing spaces in hospitals that are exclusively designed for this age group. 


Simon Davies, CEO of TCA, says that people of all ages need so support this sub-group of cancer patients.


“We need real change to improve the treatment experience, services, and research for this largely forgotten group of teenagers and young adults with cancer."


Roger Daltrey, legendary lead singer of the Who, is co-founder with his Who bandmate Pete Townshend of both Teen Cancer America and Teenage Cancer Trust in the UK. 


"AYA cancer awareness is the most important week of the US calendar,” Roger says. “We need everyone to understand the unique needs of young people with cancer and support these advocating charities in their vital work to save young lives."


Stupid Cancer Steps Up


Another leader in the AYA cancer coalition is Stupid Cancer, whose CEO, Alison Silberman, is proud that so many disparate organizations have come together for this age group.


Silberman says there is nothing but sincere collaboration going on here. “We all support each other. We all want the same thing,” she says.


The 411 on Teen and Young Adult Cancer


According to the American Cancer Society, approximately 90,000 people ages 15-39 are diagnosed with cancer each year.


Every hour in America, a young person between the ages of 13 and 25 is diagnosed with cancer.


Teens and young adults with cancer are usually treated in children's units (pediatrics) if they are teens or treatment with older people (medical oncology) if they are older young adults.


The average age for pediatrics is 6 and average age in adults is 60.


Entering high school or college, critical exams, career pathways, more significant relationships. These are just a few of the challenges of this age group. Cancer can disrupt and adversely affect all of these, sometimes causing irreparable damage. 


Peer groups are of course key at this age. Losing contact with friends and being treated where there are no other people of the same age is depressing and isolating. 


In some cancers affecting young people, such as bone cancer, there has been little progress or improvement in survival in 30 years.


Compare that to leukemia where survival has improved from 20% to 80%.


There has been a paucity of research and clinical trials in the AYA field. Their outcomes and survival have made inferior progress compared to older and younger populations.


This must change. 


Teens and young adults are old enough to know what is happening to them but often they are understandably not mature enough to cope with all of the unexpected and unwelcome changes and challenges.


It is not uncommon for a young person to protect his or her family from how distressed and frightened he or she may be.


Issues such as body image and loss of fertility are also complex and difficult things to navigate during cancer treatment.


Losing hair, fatigue, weight loss due to cancer or weight gain due to some treatments, surgery and scarring are all hugely important issues for a teenager who is just discovering his or her own identity.


A young person being told they may not be able to have children can have distressing long-term effects. The simple act of deciding when or how to tell a boyfriend or girlfriend that this is a possibility can be a harrowing experience.



Davies of Teen Cancer America says his organization plans to be an antidote to much of the above by developing specialized facilities, services and teams that will improve the treatment experience of young people, their outcomes and their survival. 

Teenagers and young people should be treated with people of their own age, Davies notes. Just as they are in schools, universities and youth groups. Even the criminal justice system treats teenagers differently.


The facilities that Teen Cancer America creates are vibrant, teen-friendly environments geared specifically to meet their needs. They are based on the successful model developed by Teenage Cancer Trust in the UK over the past 25 years and which are now a main stream part of cancer services over there.


These spaces can include social areas, kitchen/dining areas, computers, gaming systems, music systems and digital lighting. They may have pool tables and jukeboxes installed to create a strong youth centered environment. 


Having both facilities and expert teams in place at cancer hospitals will inevitably enable researchers to focus on this age group and study both the effect of the cancers on them and the effects of the treatments.


Teen Cancer America developed the first US specialized facility at UCLA. 


Some of the hospitals with whom Teen Cancer America is currently working are UCLA (CA), MSK (NYC), Yale (CT), Children’s Hospital of Philadelphia, Dana Faber (MA), Stanford (CA), Moffitt (FL), Baylor Scott and White, Fort Worth (TX), University of Chicago (IL), UH Hospitals/Seidman Cancer Center (OH), Duke (NC), UNC (NC), Children’s Hospital of Minnesota (MN) Lurie (IL) North Western (IL), UC Davis (CA), James (OH), and Nationwide (OH).


Allison Rosen Is Living Her Life

 

Allison Rosen during treatment
Meanwhile, the good news is that Allison Rosen is getting on with her life and continuing to inspire and inform her fellow cancer patients and survivors.


“I work in cancer research, and now in cancer prevention,” she says . “I was living my life, having a great time and not thinking I was on the clock to get married or have kids. When I was first diagnosed it was overwhelming. But there is help, and hope.”


Rosen asked her oncologist if there was another patient or group of patients around the same age that she could talk to for support at her hospital, MD Anderson. “I went to one support group, but it was older adults, and they just do not have the same needs,” she says. 


Rosen played an early role in the development of the AYA support group at MD Anderson.


“They did not have a young adult support group, so I brought that up in a meeting,” she said. “They took it from there and created a young adult support group. I am in remission, but still attend to this day.”


The simple message, Rosen says, is that you will need emotional support for rest of your life, people you can connect with.


“That support group saved my life,” she says. “I felt alone, I didn’t understand, and these perfect strangers have turned into some of my best friends.”

Tuesday, April 4, 2023

Concert Review: Legendary Band The Who Defies Time

 

There are many time travel-themed films such as "Back to the Future," "Interstellar" and "The Terminator." There are also a bunch of acclaimed time travel-themed books such as "Slaughterhouse Five," "Kindred" and "A Wrinkle in Time." 

Traveling through time is clearly a universally popular notion. But I always thought it was a purely fictional enterprise. However, after seeing The Who on Saturday night, I'm not so sure.

The legendary rock band's lead singer, Roger Daltrey, 78, and lead guitarist and songwriter, Pete Townshend, 77, were in impossibly good form when they performed with a full orchestra at the Honda Center in Anaheim, Calif. I was flabbergasted by how youthful they looked and sounded. It literally felt as if they were visiting us from another time.
 
Roger is singing as powerfully and with as much nuance as he did 40 years ago. Maybe even more so. Pete is singing and playing with the energy and passion of a teenager, and still does those trademark windmills. And that alone is inconceivable. Both of these living legends have tremendous energy on stage. It borders on the supernatural.  
 
The most memorable scream in rock and roll history is of course Roger's joyously blood-curdling wail near the end of "Won't Get Fooled Again." I did not expect him to reach the same emotional, eardrum-shattering level as he did back in the day. But he did. It was bloody brilliant!

It was the same raw, gut-punching, emotional roar that I heard the first time I listened to the song from "Who's Next," which could very well be the greatest rock album of them all. I was ten years old when I first heard that record. It is now written into my DNA.

There are basically three untouchables in the history of rock and roll. Three bands who tower above the rest in terms of, well, greatness. There is no real need to name them, but of course they are The Beatles, The Rolling Stones and The Who. And The Who is the only one of the three that is currently active. 

Yes, original drummer Keith Moon and original bass player John Entwistle are both sadly no longer with us. But Roger and Pete keep the fire burning. 

Townshend's energy belies time and physics. I'd have been happy just to hear these guys sing and play. But what I did not expect was how powerfully and superbly they sang and played, and how much visible, palpable joy they felt as they performed.

With a superb orchestra behind them, the band opened with several songs from "Tommy," the iconic rock opera which of course was made into a wild and wildly acclaimed film of the same name directed by Ken Russell. 

Then the orchestra departed, and the band continued to rock with such favorites as "You Better You Bet," "The Seeker," "Won't Get Fooled Again" (as mentioned above) and "Behind Blue Eyes." 

When the orchestra returned, the band played a few songs from "Quadrophenia," the group's other rock opera and concept album that has been called the "anti-musical," but whose songs are genius. 

They ended the show with two of their epic best: "Love, Reign O'er Me" and "Baba O'Riley," which many refer to as "Teenage Wasteland." 

I guess we all get more sentimental as we grow older. We all begin to sense our own mortality, though I try not to dwell on that. I'm not ashamed to say that I had tears of joy in my eyes for a good portion of the show. 

Music has been a huge part of my life since I can remember. I have an absurdly clear memory of myself at age 5 flipping over plastic buckets and kitchen pans to use as a drum set as I played along with the "I Saw Her Standing There" by The Beatles. And of course I remember vividly when I bought my first guitar at age 14. 

Besides the love of my family and friends, there has been no greater joy in my life than music. And getting an opportunity to see these masters play at such a high level this late in their careers is touching, reassuring and amazing. 

Thank you Roger and Pete for all the music you have given given the world. And thanks, too, for the amazing work you have been doing for teen and young adult cancer patients for the last 30 years with the Teenage Cancer Trust in the UK and for the last 10 years in America with Teen Cancer America

The band gave $2 per ticket to Teen Cancer America on the recent tour. That’s worth over $400,000 to the charity and makes every fan feel like they are helping young people with cancer.  

The Who rocks, and cares! 


Wednesday, February 8, 2023

Outer Space & Inner Space: A Potentially Game-Changing New Cancer Test Has Just Arrived

When NASA's New Horizons spacecraft sent back the first high-resolution outer space views of Pluto in 2015, they were the most remarkably vivid close-ups of the "dwarf planet" that humans had ever seen. NASA scientists and then the rest of the world were stunned by the breathtaking, high-resolution photos.

Meanwhile, in inner space (the human body), cancer scientists, too, are seeing things they have never seen before and working in an equally vast and mysterious universe that they are just beginning to comprehend. 

On that note, I participated in an enlightening interview this week with Dr. Rick Baehner, Chief Medical Officer, Precision Oncology at Exact Sciences. It's a dynamic cancer screening and diagnostic testing (liquid biopsy) company that I've been following for several years. 

He put it all in the proper perspective with an insightful and appropriately cosmic take. 

"Working with liquid biopsy technology is like looking at the horizon and seeing Pluto and its moon imagery," said Baehner, who was eager to talk about the company's breakthrough test and what it means for people with cancer. 

This week, the company turned its relevance in the cancer arena up yet another notch. My conversation with Baehner was a bit like speaking with astronomer/scientist/author Carl Sagan and physician/biologist/author Siddhartha Mukherjee at the same time. 

The conversation made me consider both outer space and the human body, which can feel just as ominously vast and unfamiliar.

But thanks to companies like Exact Sciences and scientists like Baehner, that is changing. And people with cancer are the beneficiaries of this change.

Cancer cells in the body

Exact Sciences has just launched a personalized cancer test that provides doctors with vitally important information needed to make important decisions about therapy based on the specific patient's cancer. 

"As diagnostic medicine continues to move forward," said Baehner, "the importance of having genetic information about a specific tumor becomes even more essential and will ultimately benefit the person who is taking the test."

The OncoExTra therapy selection test was announced this week in the United States. 

OncoExTra is a next-generation sequencing (NGS), comprehensive DNA and RNA based genomic test that provides physicians and their patients with a complete molecular picture of the patient's cancer. 

The test provides reliable and actionable results personalized to each patient. Remember that word: Personalization. It is the future of cancer medicine, and ideally all medicine. 

"The OncoExTra test substantially enhances our ability to characterize and understand solid cancer tumors, giving out patients the best chance at treating their cancer successfully," said Stephen Gruber, MD, PhD, MPH, vice president  of the City of Hope National Medical Center and Director, Center for Precision Medicine at City of Hope in a press statement this week.

"With this test, I have a much better picture of my patient's cancer, allowing me to prescribe the most effective treatment for their specific tumor," Gruber said. 

Personalized Cancer Treatment

As you read this, the majority of eligible cancer patients do not receive comprehensive genomic profiling (CGP) to help understand their disease and guide treatment. 

Personalized medicine, powered by CGP, helps oncologists understand the unique biology of each patient's tumor and prescribe treatments  that offer the best outcomes. 

In a press statement this week, Kevin Conroy, chairman and CEO of Exact Sciences, said the company continues to build its leadership in cancer diagnostics by offering innovative tests addressing clinical needs at every step of a patient's cancer care.

"We are glad to add OncoExTra to our growing portfolio of cancer solutions across the cancer-care-care continuum, and deliver new levels of tumor-specific information and insights to doctors and patients that guide vital treatment decisions to achieve the best outcomes," Conroy said.

The OncoExTra test uses NGS to assess the tumor's RNA and DNA, providing actionable information to inform treatment decisions and uncover variants possibly missed by only evaluating DNA.

NGS is a method used to determine a portion of the nucleotide sequence of an individual's genome. 

 This technique utilizes DNA sequencing technologies that are capable of processing multiple DNA sequences in parallel. 

The test works by profiling the entire exome and the transcriptome across 20,000 genes. 

The “exome” consists of all the genome's exons, which are the coding portions of genes. The "transcriptome" is simply the sum total of all the messenger RNA molecules expressed from the genes of an organism.

The American Society of Clinical Oncology (ASCO) has updated its guidelines to recommend FNA-based fusion testing for patients with no actionable information provided by a standard  DNA, multigene panel test.

Medicare covers the OncoExTra test. And doctors can order the test for all advanced solid tumors.

Bottom line

Cancer scientists are now discovering remarkable, game-changing things related to cancer in the human body that they have never seen or identified before simply because they did not have the tools to look. 

This is truly the golden age of cancer screening and treatment. Only 2o years ago, we knew very little about how cancer really works in the body. 

But scientists have learned more about cancer in the last ten years than they did in the previous century.  

For more information, visit precisiononcology.exactsciencves.com




 




Thursday, January 5, 2023

Caris Life Sciences - Equal Amounts Innovation And Compassion


Dr. David Spetzler, President, Caris
It's important when covering new cancer innovations to steer clear of hyperbole. The bar for the Next Big Thing in cancer must remain high. I'm not interested in providing false hope. But some things are hard to overstate.

As we begin 2023, arguably the most promising breakthrough in cancer is the liquid biopsy. These are the blood assays you may have heard about that identify biomarkers in body fluids and give scientists valuable information about cancer. 

These tests are far less invasive than traditional screening, but are often more informative than most current screening tests. 

Liquid biopsies look for cancer cells from a tumor or small pieces of DNA, RNA, or other molecules released by tumor cells into a person’s body fluids.  

These assays can identify cancer in the body at very early stages, help physicians decide which treatment will work best, identify new targets in the blood that can conceivably lead to new treatments, and more.

Liquid biopsies allow multiple samples to be taken over time, which can help doctors understand what kind of genetic or molecular changes are taking place in a tumor. 

It's fair to expect that in medicine, 2023 will be The Year of the Liquid Biopsy. These technologies have come of age. Yes, more work needs to be done in the lab to hone and advance this technology. But the potential is vast. 

Liquid biopsies bring the promise of a new paradigm for cancer detection, treatment, recurrence and even cure. At my last count, there were more than 150 viable liquid biopsy and early cancer detection companies now doing business. 

What Makes Caris Life Sciences Unique?

Among the new leaders in the liquid biopsy space is Caris Life Sciences, a patient-focused company that has remained somewhat under the radar as it builds its impressive foundation of liquid biopsy as well as tissue-based work. 

Caris, whose ascension has been deliberate and effective, is revolutionizing precision medicine by providing physicians and patients with the highest quality information about their health. 

The goal is to develop new targets for a variety of cancers and partner with pharmaceutical companies to move these drugs into the market.

What makes Caris unique? The company provides cancer patients and oncologists with reliable, high-quality, comprehensive molecular information. 

Because of all the other advances that we have seen in recent years, knowing what cancer looks like at the molecular level can now lead to better treatment options for people with cancer. 

Cancer treatments have advanced dramatically over just the last decade, and it's increasingly important to understand the molecular features of a cancer when the diagnosis is made so oncologists can create a personalized treatment plan. 

Regardless of where a tumor is located, its molecular composition tells docs a lot about how the cancer may behave and what treatments may be most effective.

Caris was the first to provide Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS) for every person with cancer. All molecular profiling orders include next-generation sequencing of all 22,000 genes.  

This gives Caris an edge in terms of collecting targets that can actually lead to new treatments. 

Big Announcement Today

And on that note, Caris today announced a new multi-year strategic option and license agreement with Xencor, Inc., a clinical-stage biopharmaceutical company, to apply Caris Discovery to identify novel targets for bispecific antibody drug candidates. 

Bispecific antibodies are simply a type of antibody that can bind to two different antigens at the same time. 

Antigens are basically any substance that causes the body to initiate an immune response against that substance. 

Antigens include toxins, chemicals, bacteria, viruses, or other substances that come from outside the body. Body tissues and cells, including cancer cells, also have antigens on them that can cause an immune response.

Bispecific antibodies, which are made in the lab, are being studied in the imaging and treatment of a variety of cancers, including blood cancers. 

I've been covering bispecific antibodies for the last several years as a journalist, author and cancer patient advocate. They took center stage at the annual American Society of Hematology (ASH) meeting last month. 

The partnership will put these two companies on the front lines of precision cancer drug development. 

It's easy to feel optimistic about this. It shows that liquid biopsies will indeed be an integral part of the cancer treatment landscape moving forward. 

Strong Leadership, Bright Future

I recently had the pleasure of meeting with the leadership at Caris. It was a fascinating conversation. They explained to me that what the company is focusing on is people with cancer who have either bad treatment options or none. 

The company's novel approach leverages the aggregate strength of its platform to unlock previously inaccessible drug targets in oncology. 

"Despite numerous breakthroughs in the cancer research sector, discovering new cancer medicines remains intensely challenging and one of the biggest stumbling blocks is the scarcity of viable targets," said David Spetzler, M.S., Ph.D, MBA, president and chief scientific officer of Caris. 

"Building on our strength in molecular profiling, an unparalleled repository of real-world samples and industry-leading clinico-genomic database, the company has spent years investing in the formation of Caris Discovery, a platform to identify and validate targets for cancer development," Spetzler said.

Milan Radovich, Ph.D, senior vice president and chief precision medicine officer at Caris, said that historically the vast majority of potential drug targets were considered undruggable, which simply means a protein that is not pharmacologically capable of being targeted.

"But with the proliferation of new therapeutic modalities, the universe of targets for cancer medicines has vastly expanded," said Radovich, who added that these targets will lead to novel medicines that transform patient care. 

Through tireless efforts, breakthrough molecular science and a passionate commitment to quality, Caris is clearly on an impressive track. They are moving forward.