Tuesday, October 12, 2021

Exclusive: Will the Microbiome Save us All?

Innovative San Diego biotech company is showing that microbes, which can now be identified in a blood test, can detect cancer at early stages 

Micronoma co-founders: Greg Poore, Sandrine Miller-Montgomery and Rob Knight

One of the newest and most promising developments in cancer research is the use of state-of-the-art blood tests to detect cancer.


It may sound counter-intuitive, but blood tests have never been especially helpful in detecting cancer. Ironically, not even blood cancers.


I speak from experience. 


As a three-time survivor of stage IV non-Hodgkin’s lymphoma, my initial blood tests were virtually normal. More invasive tests, including surgical biopsies, revealed widespread cancer.


But that scenario is beginning to change.

Companies such as StageZero Life Sciences, Cleveland Diagnostics, Exact Sciences, GRAIL and others are showing in multiple trials and in the clinic that cancer can be detected in its early stages via biomarkers found in the blood.

This is potentially game-changing for patients, for multiple reasons. It will likely mean earlier and far less invasive detection, as well as far less invasive treatment. Or perhaps no treatment at all besides potentially a localized surgery.

This could have an especially profound impact on adolescents and young adults who are most often diagnosed with later stages of cancer than any other age group.

Among the most interesting and promising of these companies is Micronoma. Originating at the University of California San Diego, Micronoma is the only company that is leveraging the body’s microbiome to detect early-stage cancer.

Most companies in the so-called liquid biopsy space seek a molecular signature coming from within the cancer or some fragment of its DNA in the blood.

But Micronoma is focused on the microbiome, the vast collection of microbes -- bacteria, fungi, protozoa, and viruses – mostly beneficial, that live inside your body and mine.

While initially known to be found primarily in our gut and on our skin, these microbes can also be found in our mouths, tissues, stools and, yes, the blood -- even when we’re healthy. And in each of these locations, even within one individual the composition of these communities will differ.

Sandrine Miller-Montgomery, Micronoma’s CEO, told The Reno Dispatch that microbes in the blood can be used to detect cancer thanks to microbial biomarkers, which are characteristics of the tumor that you can utilize to identify the progress of a condition or disease.

When analyzed properly, she said, these microbial biomarkers can reveal cancer, even at stage I of the disease.

I’m not a scientist, but this feels to me like a no-brainer. Why wouldn't there be clues about cancer in the microbiome? After all, the gut has been called the “center of the human body’s immune system.”

Two years ago, Newsweek reported that the gut contains “60 to 70 percent” of the body's immune cells.

There’s been a growing interest in the link between circulating microbiome signatures and early cancer detection since Micronoma’s publication last year in Nature.

“Our team came together at a time when computer science, microbiome knowledge and sequencing were all reaching a peak, while costs were going down,” said Miller-Montgomery.

“There was a clear clinical need and we had a validated hypothesis, so the time was right for us to harness the tumor-associated circulating microbiome to make a difference in the lives of many.”

Margaret McFall-Ngai, director of the pacific biosciences research center at the University of Hawaii at Manda, noted at the 1st Microbiome Center Consortium in June 2019 that microbes were on the planet millions of years before us.

“The same way that knowledge of the universe moved from geocentric to heliocentric, it may be time for the scientific community to realize that microbiome is not something that should be put on the back burner to better understand our health and diseases,” she said.

Micronoma recently announced a collaboration with University of New South Wales, Sydney (UNSW) on a $4 million grant from the Australian Government to fund research into hepatocellular carcinoma, the most common type of primary liver cancer.

The collaboration, led by associate professor Amany Zekry and professor Emad El-Omar from UNSW medicine & health, will enable the development of microbial-based biomarkers powered by artificial intelligence for early detection of liver cancer.

Micronoma's chief scientific officer, Eddie Adams, joins the UNSW project as a co-principal investigator on the grant.

This research will use machine learning to examine thousands of microbiome plasma features to discover, validate, and translate microbial-derived biomarkers for the early detection of HCC.

“Micronoma is currently the only cancer diagnostic company in the world that uses microbial DNA signatures in the blood (mb-DNA) to detect early-stage cancer," Zekry said in a press statement.

"Their minimally invasive microbiome-driven liquid biopsy approach is focused on detecting early-stage lung cancer and will provide valuable expertise in establishing an HCC-related microbiome platform.”

The diagnostic implications of microbiome markers in liquid and tissue biopsies are extensive.

“It has the great potential to prevent unnecessary suffering caused by later-stage cancer diagnosis, as well as potentially enabling personalized and less invasive treatments at the earliest stages of cancer,” said Miller-Montgomery.

“Cancer is a disease that is affecting all of us either directly or indirectly through a family member. The team is working relentlessly to ensure that we can help reduce the burden of this disease on all of our loved ones.”

Wednesday, September 22, 2021

EXCLUSIVE: Trial Results Show Moderna Vaccine Continued to Be Safe and Efficacious More Than Five Months After Second Dose

Good news regarding Covid-19 has been rather scarce of late. But results from a Phase 3 clinical trial published today in the New England Journal of Medicine show that more than five months post-second injection, the Moderna (mRNA-1273) vaccine’s efficacy did not wane. These findings dramatically demonstrate the high level of protection COVID-19 vaccines are continuing to give us.

On a personal note, as a cancer patient, two-time Moderna vaccine recipient and advocate for Covid-19 patients and cancer patients, I am pleased to learn the results of this study.  

“Overall, our results continue to demonstrate that vaccines work and work extremely well at preventing COVID-19,” Dr. Lindsay Baden, the trial's co-corresponding author, said in a press statement.

Baden, who works in the Division of Infectious Diseases at Brigham and Women’s Hospital, said that researchers are continuing to explore questions about duration of immunity following vaccination and the impact of variants. Snd the news is largely good. Even as we examine the possibility of waning immunity, Baden said, "We see evidence that the vaccine is still very protective."

The peer-reviewed NEJM paper details the findings.  Starting 14 days after the second dose of the Moderna vaccine, the vaccine efficacy was 93.2 percent for the prevention of COVID-19 compared to placebo.  Prevention of COVID-19 remained consistent across the follow-up period, with greater than 90 percent vaccine efficacy against disease observed four or more months after the second injection.

 

"Safety data were assessed continuously throughout the trial, including severe adverse events. The team solicited data on local and systemic adverse events seven days after each injection and collected data on unsolicited adverse events 28 days after each injection," the study noted. 

 

The frequency of other adverse events — including severe adverse events — were generally similar between the vaccine and placebo group, regardless of age. Vaccine efficacy was consistently high in subgroups, including participants who were 65 and older, 75 and older, those with comorbidities, different racial and ethnic groups, and different categories of occupational risk exposures. 

 

In secondary analyses, researchers also found substantial protection against asymptomatic infection.

“Overall, our results continue to demonstrate that vaccines work and work extremely well at preventing COVID-19,” said Baden. “We are continuing to explore questions about duration of immunity following vaccination and the impact of variants. But even as we examine the possibility of waning immunity, we see evidence that the vaccine is still very protective.”

The trial enrolled 30,415 participants; 15,209 were assigned to receive the mRNA- 1273 vaccine, and 15,206 to receive placebo. Vaccine efficacy in preventing Covid-19 illness was 93.2%. The efficacy in preventing severe disease was 98.2%. 

And vaccine efficacy was consistent across ethnic and racial groups, age groups, and participants with coexisting conditions. No safety concerns were identified.