Monday, December 16, 2019

Can Global Biopharmaceutical Alliances Bring the World Closer Together?

While covering the American Society of Hematology (ASH) conference this past week, I was moved by the international flavor of the event. For a few days, the world seemed refreshingly small. And united. Science can do that. Sometimes. It’s not like the 30,000-some cancer researchers joined hands and sang a verse of “Kumbaya.” But it was darn close.

ASH is the largest blood cancer and blood disease conference in the world. I cover it each year. And it never fails to educate me and frankly light my fire. ASH reminds me just how much groundbreaking research is going on out there. Here's what matters: much of what you see at ASH will eventually make its way to your local cancer clinic and prolong, improve and save lives.

I always learn from this event, but there was something about this year’s ASH that stopped me in my tracks. I guess I never fully considered just how global and significant this thing really is, and what it can mean not only for cancer research but for the planet. ASH’s international impact was on glorious display as companies and scientists from 25 countries announced their latest data. And most of these scientists don’t just take their research home to their respective countries. They share their research, and clinical trials, with clinicians, and patients, around the world.

Drug companies now are literally global. Many of them anyway. And many of these companies from Europe, Asia and other corners of the globe now have a presence in North America, and vice versa, and are actually partnering with American pharma and American cancer hospitals.

Can pharmaceutical companies bring this world a little closer together via science? Well, one might argue that they’re already doing just that. Pharma has gotten some bad press in recent years. But let us please remember that drug companies are seeking and finding new treatments and cures every day.

And they are working together in a way they have never done before. Providing combination treatments and joint clinical trials in multiple countries is an undeniably good thing for patients and for the future of this wobbly blue sphere. It's harder for countries to fight when they are working together every day to find cures for cancer.

Here are some examples:

Daiichi Sankyo
Daiichj Sankyo, the pharmaceutical concern based in Tokyo, has an increasing presence in the US, and globally. Daiichi provides innovative products in oncology and much more to 20 countries around the world.
Daiichi is studying a new treatment for adult T-cell lymphoma (ATL), one of the most aggressive forms of non-Hodgkin’s lymphoma.
At ASH, Daiichi announced encouraging early results for valemetostat, the company’s oral, potential first-in-class EZH1/2 dual inhibitor, in patients with relapsed/refractory ATL. Although rare, ATL occurs with greater frequency in certain regions including Japan. An often fast-growing form of T-cell lymphoma, ATL is associated with human T-cell lymphotropic virus type 1 (HTLV-1).

Treatments for ATL, which is a complex and heterogeneous disease, have to date been largely limited to systemic chemotherapy combinations, and patients who relapse often face a difficult prognosis.

Arnaud Lesegretain, vice president, oncology R&D at Daiichi Sankyo, explained to me during the ASH conference that research has shown that EZH1 and EZH2 are highly expressed or mutated in many blood cancers and are involved in suppression of genes that control tumor cell growth and proliferation.

Valemetostat has displayed preliminary activity in various blood cancers in preclinical models. Early clinical data is very encouraging, said Lesegretain, who noted that the response rate among ATL patients is 55 percent in 9 patients. “We have four patients that have remained on the treatment for more than 300 days,” he said. “But it is early.”

As Lesegretain explained, this is the only dual inhibitor in development, and it is an oral treatment. “This is not chemotherapy. Patients benefit and can stay on it. The safety profile appears to be manageable and acceptable,” he said.

In addition to the pivotal phase 2 trial in relapsed/refractory ATL, valemetostat is in phase 1 clinical development for several types of non-Hodgkin’s lymphomas, including ATL, peripheral T-cell lymphoma (PTCL) and B-cell lymphomas.

 

Trials are now enrolling patients in the U.S. and Japan. A phase 1 study is also underway with valemetostat in other blood cancers including acute myeloid leukemia (AML) and acute lymphocytic leukemia.


“Valemetostat is a novel targeted therapy that has demonstrated preliminary potential in several types of NHL including ATL, which represents one of the greatest areas of need among lymphoma patients, particularly in Japan,” Kaszushi Araki, DVM, PhD, valemetostat global team leader, Oncology Clinical Development Department, Oncology Function, Daiichi Sankyo, said last week at ASH.
Added Lesegretain, “We want to fulfill our commitment to science and technology and deliver first in-class treatments that can change the standard of care. It is early, there is still lot of work to be able to fulfill our vision, but we are on a very interesting journey to defeat cancer.” 

BeiGene
I have been writing about China for more than a decade. I have many friends and colleagues in China, I covered the Beijing Olympics for Newsweek, and I have covered China’s booming biopharmaceutical industry for the last several years.

I'm currently directing a technology and friendship initiative, The China Lymphoma Project, which will provide support and information to my friends in China who have been diagnosed with lymphoma and their families.

Among the most significant pharmaceutical companies in the lymphoma space in China is BeiGene, a company that began with a handful of scientists in Beijing and is now a global entity with a large presence in the United States. 

BeiGene’s slogan? We have no borders.

BeiGene just announced last month that the American Food and Drug Administration (FDA) has granted accelerated approval to BeiGene’s lead cancer drug, Brukinsa (zanabrutinib), for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

BeiGene also showed its presence at ASH with new data on its successful drug Brukinsa for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.

In two oral presentations, the treatment demonstrated consistent safety and a high overall response rate. Brukinsa combined with BeiGene’s investigational anti-PD-1 antibody tislelizumab in patients with previously treated B-cell malignancies showed preliminary efficacy and was generally well tolerated.

Jane Huang, M.D., chief medical officer, hematology at BeiGene, said the trial results demonstrated “robust clinical activity and a safety profile consistent with what we’ve observed to date in our clinical trials, including safety data that supported the recent U.S. FDA accelerated approval in patients with previously treated mantle cell lymphoma.”

That's the world. Coming together. 

Friday, November 15, 2019

Two Worlds, One Dream: American Writer and Russian Rocker Share Lifelong Passion for the Music of Chicago


From Russia With Love: Leonid & Friends - The World's #1 Chicago Tribute Band
Growing up in the American Midwest in the early 1970’s, I developed an almost preternatural passion for Chicago, the rock band with horns whose dynamic, melodic songs resonated with me and made me want to become a musician and songwriter. Meanwhile, at the very same time, on the other side of the globe, Leonid Vorobyev was making the same musical discovery.

But in his hometown of Chita, a city in Eastern Russia affectionately known as the “Gateway to Siberia,” the options for musicians were limited. There was very little access to the outside world. There were no record stores. No guitar stores. No rock and roll on TV or on the radio. In fact, there wasn't a single electric guitar for sale in the vicinity. 

"In the Soviet Union in the 1970’s, American popular music was hard to come by," Leonid says. "You had to search for it."

But fate dealt Leonid a hand when a rock band from Moscow arrived in Chita one day to perform a rare local concert. Leonid attended, of course, and afterward introduced himself to the musicians.

“The drummer was a nice guy and asked me if I wanted to hear some cool records,” Leonid says. “He told me to come over to the hotel where the band was staying the next morning at 8 a.m., and he said 'bring your tape recorder' so that I could record the music and enjoy it.”

Leonid did not have to be asked twice. The next morning, he arrived at the hotel and proceeded to spend the day listening to and recording a bunch of rock songs of that era, including the first three albums from Chicago. At that time Chicago was one of the most popular bands in the world, but virtually unknown in Russia.

“Chicago was the drummer’s favorite band,” Leonid recalls, “We listened to each of those albums from start to finish. By the end of the day I was overwhelmed with all this music. It was this small window of opportunity for me to hear and record these songs.”

That day cemented Leonid’s resolve to pursue a career in music and learn how to play electric guitar. With no guitars in sight, he decided to build his own electric guitar from scratch.

“I found a copy of Popular Science magazine that explained how to make an electric guitar, complete with sketches,” Leonid explains. “In Russia in those days, if you were a musician you had to work really hard to get what you wanted. You really had to love it.”

Leonid found success in the music business. He spent 25 years as a music producer, arranger and session musician for a Moscow music studio. He also paid his dues playing in several casual rock bands in Russia.

His pet project, Leonid & Friends, a Chicago tribute band, gigged in and around Moscow. But it was no easy task to create a Chicago tribute band in a country that had very little awareness of the band.

Even in Moscow, finding horn players who could tackle rock, jazz and rhythm and blues was difficult. He managed to assemble a group of stellar musicians. But they were only performing sporadically, and while the word of mouth was good, they were not breaking any box-office records in Russia. No one in the band had any idea what was about to happen.

About five years ago, as Leonid approached his 60th birthday, Leonid decided to bring the band together in the studio to record just one Chicago song. His choice was “Brand New Love Affair (Part I and II),” which starts as a slow jam then builds into a rocker. It happens to be my favorite song from the Chicago VIII album in 1975.

“It was just a gift I gave to myself,” says Leonid, who worked long hours on the song so that it sounded just like the original recording. Leonid’s painstaking attention to every musical detail was both inspiring for his band mates and exhausting.

During the recording session, Leonid decided to film an in-studio video of the band recording and performing the song. 

“I didn’t think anyone would ever see it, I wasn’t sure that anyone in America wanted to see a bunch of guys from Russia playing Chicago songs,” says Leonid, who also plays bass and piano, sings lead and backing vocals, transcribes all the musical sources, and produces, mixes, and masters all audio and video productions.

Much to the band’s surprise, the “Brand New Love Affair” video got a very warm reception. Just two weeks after it debuted online, the video was on Chicago’s website, which no one on the band expected.

People can criticize the Internet all they want, but in this situation it made the world a little smaller and more attainable for Leonid, who naturally decided to do a second video.

“I said ‘Okay, let’s record ‘Make Me Smile’,” says Leonid of the brassy powerhouse classic that is arguably Chicago’s signature song. And the rest is history. Both videos went viral.

Leonid’s unwavering love for music had finally paid off in an enormous way. His band is now in high demand and touring America. On Monday, Nov. 18, they stop for their second performance at The Belly Up in Solana Beach, Calif., one of my favorite San Diego area music venues. I will be among the happy fans in attendance.

Leonid’s little Chicago project is now the world’s most popular Chicago tribute band. There are a bunch of videos now on Youtube, including Leonid's take on "Beginnings," which is my favorite song ever written. 

But ironically, to this day no one in the band has actually seen Chicago in concert because the band has never played in Russia.

The 11-piece outfit of musicians from Russia and Ukraine now has more than 140,000 followers on Facebook. On the band’s YouTube channel more than 2.5  million people have viewed the band’s take on “25 or 6 to 4,” and more than 1.6 million for its recording of my very favorite Chicago song, “Beginnings.”

The band has more than 35 million views overall for its videos. And the group’s two albums of Chicago songs, “Chicagovich” and “Chicagovich II,” enjoy very positive reviews from fans on Amazon, CD Baby and Google Play. The songs are spot-on like the originals, but there still is a pure joy in the performances. The band is simply staggering. The musicianship is impeccable.

Developing an enormous fan base in America, Leonid’s ultimate dream of performing in America came true earlier this year the band played its first American gig in New York City, then performed several shows at The Village studios, the famous Los Angeles recording studio where artists such as Fleetwood Mac, Elton John and Steely Dan have recorded.  

I interviewed Leonid and his son, Roman Vorobyev, the hard-working manager of the band and congenial host at each of the band’s gigs, while the two of them were driving to their next gig.

I was immediately struck by Leonid’s willingness to listen as well as talk. I think it has helped him get where he is now. His entire journey in America has been a learning experience, he says, and a happy one.

The message the band conveys at every gig is that music brings people together and breaks down social, political and ethnic barriers in ways that virtually nothing else can. These are guys who love rock and roll, soul and jazz, all the elements Chicago had and has, and the bonding that takes place between the audience and Leonid’s band is something to behold. It is unique and special.

Perhaps what has been the most satisfying thing about this journey for Leonid is that several current and former members of Chicago are big fans of the band. They admire what Leonid and his mates are doing.

Robert Lamm, Chicago’s founding keyboardist, co-lead singer and chief songwriter, met with the band recently and attended a show.

Tris Imboden, the outstanding drummer who was with Chicago for nearly 30 years, sat in with Leonid & Friends at the Belly Up a few months ago.

They are world-class musicians with an eye for detail that is almost frightful,” Tris says. “When I closed my eyes while I was playing with them at the Belly Up recently, it felt almost like it did when I would close my eyes and play along with those early Chicago records I used to listen to.”

Tris, who’s also played with such artists as Honk, Kenny Loggins, Michael McDonald, Michael Jackson, Crosby, Stills and Nash and Al Jarreau, adds that the members of Leonid & Friends “are some of the nicest people I’ve ever met.”

The band has also received support and friendship from Jon Huntsman, the former United States Ambassador to Russia and Utah governor, who also happens to be a keyboard player who had his own dreams of rock stardom when he was a high schooler  in Utah.

“Jon is a musician and he loves Chicago. He came to one of our shows,” Leonid says. “He has since played on stage twice with us, one time in a club in Moscow and one time on July 4th at the U.S. Embassy in Moscow.”

Roman tells me that the reception the band is getting at every stop during the current U.S. has been overwhelmingly positive for the band. "None of this was expected, and we are all just enjoying it very much," Roman says.

In 2019, there are lamentably a lot of people who don’t know or don’t remember just how powerful and gifted a band Chicago was when those original seven musicians headed from the Windy City to Hollywood, where they recorded the group’s groundbreaking and now-legendary debut album Chicago Transit Authority.

That record, and the following records in the 1970’s, represented popular music it its very best. Chicago had it all:

A powerful and nuanced horn section in Lee Loughnane, Walter Parazaider and James Pankow; a brilliant drummer in Danny Seraphine; a stellar lineup of three lead vocalists; two superb songwriters in Robert Lamm and James Pankow; one of the world’s most underrated rock bass players and rock tenors in Peter Cetera;  and one of the greatest rock guitarists of all time, Terry Kath, a monster musician who Jimi Hendrix once said was better than him.

Chicago, who were finally inducted into the Rock and Roll Hall of Fame a few years ago simply blew audiences away. The first time I saw them was in the summer of 1974 at the Iowa State Fair. At that moment in time, Chicago was the most popular band in the world. It wasn’t even close. The band was charismatic and really connected with audiences and brought an energized blend of rock, jazz, soul and pop to the world.

And that feeling still lingers when you see Chicago today. They are still a great live act. But the pure, raw energy of vintage Chicago and the power of those songs really shine through at a Leonid & Friends show.

When performing, Leonid & Friends somehow manage to recapture much of that original Chicago magic in ways that one might not think is possible. It is the freshest, most astounding cover band I have ever seen.

And now they throw in a couple of non-Chicago (but compatible) songs in the setlist, including the Earth, Wind & Fire’s “September” and Blood, Sweat & Tears’ “Spinning Wheel.”

For a lifelong Chicago fan like me, Leonid & Friends is a blessing. As someone who has loved Chicago all my life and who had the honor of recording one of my songs with Chicago co-founder Robert Lamm, seeing a group of mostly very young musicians from Russia and Ukraine enthusiastically playing Chicago’s songs warms my heart and fires me up.

Leonid & Friends are doing what any real tribute bands should do: They are effectively reminding the world what a kick-ass band Chicago was, and is. It is a testament to the music, and to Leonid’s resolute desire to pay homage to a band that gave him so much joy. Here’s hoping that for Leonid, this is only the beginning.

Leonid and his band perform on Monday night at The Belly Up in Solana Beach, Calif. Tickets are still on sale but I'm told they are going fast.