The clamor for more transparency from the leading pandemic vaccine contenders has been getting louder, especially after AstraZeneca’s trial was briefly stopped in the U.K. (and is still on hold in the U.S.).
These growing calls for transparency have led Moderna (PDF), swiftly followed by Pfizer/BioNTech (and a pledge from AstraZeneca), to release their protocols this week, all of which are in the later stages of testing and likely to see data, and maybe emergency approvals, in the coming months.
The way Pfizer is running its phase 3, in conjunction with BioNTech, is focused on speed; it did not share a timetable for competition, though CEO Albert Bourla has repeatedly said they should have data by the end of October.
The normally secret protocol said the Big Pharma will have an interim analysis after just 32 people test positive, i.e., if six are positive in the vaccine group and 26 are positive in the placebo. For the final analysis, of 164 cases, it will need to hit 50% efficacy to be deemed a success by the FDA.
Moderna said data should be reported by year-end or early next year, and AstraZeneca has previously given a similar timetable.
Moderna’s protocol also gave more color, saying its first analysis of early trial data might not be conducted until late December, although company officials now say they expect the initial analysis in November.
In terms of how it’s measuring efficacy, a total of 151 COVID-19 cases “will provide 90% power to detect a 60% reduction in hazard rate (60% vaccine efficacy [VE]), rejecting the null hypothesis,” it said in its protocol.
“This is a case-driven study,” Moderna’s protocol said. “If the prespecified criteria for early efficacy are met at the time of either interim analysis or overall efficacy at the primary analysis, a final study report describing the efficacy and safety of mRNA-1273 will be prepared based on the data available at that time.
“In the event that success criteria are met either at the time of the interim analyses or when the total number of cases toward the primary endpoint have accrued, participants will continue to be followed in a blinded fashion until month 25, to enable assessment of long-term safety and durability of VE . If the study concludes early, all participants will be requested to provide a final blood sample at the time of study conclusion.”
Its first interim analysis (IA) will occur when around 35% of the total cases have been observed and the second at 70%, with the primary analysis to be “performed when approximately 151 cases have been observed in the study.”
“There is no intention to stop the study early if the efficacy has been demonstrated at any of the IAs,” Moderna added. “If efficacy is demonstrated at an IA, the subsequent IA or primary analysis will be considered supportive in nature.”
So far, 25,000 patients have been enrolled into Moderna’s trial, with 10,000 having had their second shot.
U.S. President Donald Trump is banking a lot of political capital on these vaccines coming in before the election, or soon after, with pressure mounting for drugmakers—many of which are getting government cash—to get a vaccine out ASAP.
Earlier this month, AstraZeneca, which has also promised to release its vaccine protocol (but at time of writing has not), and its partner the University of Oxford had to halt their phase 3 after a serious safety concern cropped up in one patient.
The trial was briefly halted in the U.K. before resuming (although it’s still on hold in the U.S.), with officials expressing concern about the event and many on bio-Twitter wondering why AstraZeneca is being coy about the exact details of what happened.
Reports from the media, including CNN, suggested a rare nerve disease had hit one patient, but AstraZeneca has come out to flatly deny this. The diagnosis was “based on preliminary findings” and is inaccurate, it said in response to the articles. If it does publish its protocol, this information will not be a part of it.
The release of the protocols has prompted kudos from some in the scientific community. “I want to acknowledge a good deed done,” said Peter Doshi, who is on the faculty at the University of Maryland School of Pharmacy in Baltimore and an editor with The BMJ, talking to The New York Times.
“They have opened up, for the first time, the ability for researchers not involved in the trial to form their own independent judgment about the design of this study.”
Tyler Jacks, founding director of MIT’s Koch Institute, to step down
The Koch Institute for Integrative Cancer Research at MIT, a National Cancer Institute (NCI)-designated cancer center, has announced that Tyler Jacks will step down from his role as director, pending selection of his successor.
“An exceptionally creative scientist and a leader of great vision, Tyler also has a rare gift for launching and managing large, complex organizations, attracting exceptional talent and inspiring philanthropic support,” says MIT President L. Rafael Reif. “We are profoundly grateful for all the ways he has served MIT, including most recently his leadership on the Research Ramp Up Lightning Committee, which made it possible for MIT’s research enterprise to resume in safe ways after the initial Covid shutdown. I offer warmest admiration and best wishes as Tyler steps down from leading the Koch and returns full time to the excitement of the lab.”
Jacks, the David H. Koch Professor of Biology, has served as director for more than 19 years, first for the MIT Center for Cancer Research (CCR) and then for its successor, the Koch Institute. The CCR was founded by Nobel laureate Salvador Luria in 1974, shortly after the federal government declared “war on cancer,” with the mission of unravelling the molecular core of cancer. Jacks became the center’s fourth director in 2001, following Luria, Nobel laureate and Institute Professor Phillip Sharp, and Daniel K. Ludwig Professor for Cancer Research Richard Hynes.
Aided by the championship of then-MIT President Susan Hockfield and a gift of $100 million from MIT alumnus David H. Koch ’62, SM ’63, Jacks oversaw the evolution of the Center for Cancer Research into the Koch Institute in 2007 as well as the construction of a new home in Building 76, completed in 2010. The Koch Institute expands the mission of its predecessor by bringing life scientists and engineers together to advance understanding of the basic biology of cancer, and to develop new tools to better diagnose, monitor, and treat the disease.
Under the direction of Jacks, the institute has become an engine of collaborative cancer research at MIT. “Tyler’s vision and execution of a convergent cancer research program has propelled the Koch Institute to the forefront of discovery,” notes Maria Zuber, MIT’s vice president for research.
Bolstered by the Koch Institute’s associate directors Jacqueline Lees, Matthew Vander Heiden, Darrell Irvine, and Dane Wittrup, Jacks oversaw four successful renewals of the coveted NCI-designated cancer center stature, with the last two renewals garnering perfect scores. In 2015, Jacks was the recipient of the James R. Killian Jr. Faculty Achievement Award, the highest honor the MIT faculty can bestow upon one of its members, for his leadership in cancer research and for his role in establishing the Koch Institute.
“Tyler Jacks turned the compelling idea to accelerate progress against cancer by bringing together fundamental biology, engineering know-how, and clinical expertise, into the intensively collaborative environment that is now the Koch Institute for Integrative Cancer Research,” says Hockfield. “His extraordinary leadership has amplified the original idea into a paradigm-changing approach to cancer, which now serves as a model for research centers around the world.”
To support cross-disciplinary research in high-impact areas and expedite translation from the bench to the clinic, Jacks and his colleagues shepherded the creation of numerous centers and programs, among them the Ludwig Center for Molecular Oncology, the Marble Center for Cancer Nanomedicine, the MIT Center for Precision Cancer Medicine, the Swanson Biotechnology Center, the Lustgarten Lab for Pancreatic Cancer Research, and the MIT Stem Cell Initiative. In addition, Jacks has co-led the Bridge Project, a collaboration between the Koch Institute and Dana-Farber/Harvard Cancer Center that brings bioengineers, cancer scientists, and clinical oncologists together to solve some of the most challenging problems in cancer research. Jacks has raised nearly $375 million in support of these efforts, as well as the building of the Koch Institute facility, the Koch Institute Frontier Research Program, and other activities.
Jacks first became interested in cancer as a Harvard University undergraduate while attending a lecture by Robert Weinberg, the Daniel K. Ludwig Professor of Cancer Research and member of the Whitehead Institute, who is himself a pioneer in cancer genetics. After earning his PhD at the University of California at San Francisco under the direction of Nobel laureate Harold Varmus, Jacks joined Weinberg’s lab as a postdoctoral fellow. He joined the MIT faculty in 1992 with appointments in the Center for Cancer Research and the Department of Biology.
Jacks is widely considered a leader in the development of engineered mouse models of human cancers, and has pioneered the use of gene-targeting technology to construct mouse models and to study cancer-associated genes in mice. Strains of mice developed in his lab are used by researchers around the world, as well as by neighboring labs within the Koch Institute. Because these models closely resemble human forms of the disease, they have allowed researchers to track how tumors progress and to test new ways to detect and treat cancer. In more recent research, Jacks has been using mouse models to investigate how immune and tumor cells interact during cancer development and how tumors successfully evade immune recognition. This research is expected to lead to new immune-based therapies for human cancer.
Outside his research and MIT leadership, Jacks co-chaired the Blue Ribbon Panel for the National Cancer Moonshot Initiative, chaired the National Cancer Advisory Board of the National Cancer Institute, and is a past president of the American Association for Cancer Research. He is an elected member of the National Academy of Science, the National Academy of Medicine and the American Academy of Arts and Sciences. Jacks serves on the Board of Directors of Amgen and Thermo Fisher Scientific. He is also a co-founder of T2 Biosystems and Dragonfly Therapeutics, serves as an advisor to several other companies, and is a member of the Harvard Board of Overseers.
Sharp will lead the search for the next director of the Koch Institute, with guidance from noted leaders in MIT’s cancer research community, including Hockfield and Hynes, as well as Angela M. Belcher, head of the Department of Biological Engineering and Jason Mason Crafts Professor; Paula T. Hammond, head of the Department of Chemical Engineering and David H. Koch Professor of Engineering; Amy Keating, professor of biology; Robert S. Langer, David H. Koch Institute Professor; and David M. Sabatini, Professor of Biology and member, Whitehead Institute for Biomedical Research.
“Jacks is a renowned scientist whose personal research has changed the prevention and treatment of cancer,” says Sharp. “His contributions to the creation of the Koch Institute for Integrative Cancer Research and his leadership as its inaugural director have also transformed cancer research at MIT and nationally. By integrating engineers and cancer biologists into a community that shares knowledge and skills, and collaborates with clinical scientists and the private sector, this convergent institute represents the future of biological research in the MIT style.”
After Jacks steps down, he will continue his research in the areas of cancer genetics and immune-oncology and his teaching, while also stewarding the Bridge Project into its second decade.
“It has been a privilege for me to serve as director of the MIT Center for Cancer Research and the Koch Institute for the past two decades and to work alongside many of the brightest minds in cancer research,” says Jacks. “The Koch Institute is a powerhouse of research and innovation, and I look forward to the next generation of leadership in this very special place.”
Silencing gene expression to cure complex diseases
Many people think of new medicines as bullets, and in the pharmaceutical industry, frequently used terms like “targets” and “hits” reinforce that idea. Immuneering co-founder and CEO Ben Zeskind ’03, PhD ’06 prefers a different analogy.
His company, which specializes in bioinformatics and computational biology, sees many effective drugs more like noise-canceling headphones.
Rather than focusing on the DNA and proteins involved in a disease, Immuneering focuses on disease-associated gene signaling and expression data. The company is trying to cancel out those signals like a pair of headphones blocks out unwanted background noise.
The approach is guided by Immuneering’s decade-plus of experience helping large pharmaceutical companies understand the biological mechanisms behind some of their most successful medicines.
“We started noticing some common patterns in terms of how these very successful drugs were working, and eventually we realized we could use these insights to create a platform that would let us identify new medicine,” Zeskind says. “[The idea is] to not just make existing medicines work better but also to create entirely new medicines that work better than anything that has come before.”
In keeping with that idea, Immuneering is currently developing a bold pipeline of drugs aimed at some of the most deadly forms of cancer, in addition to other complex diseases that have proven difficult to treat, like Alzheimer’s. The company’s lead drug candidate, which targets a protein signaling pathway associated with many human cancers, will begin clinical trials within the year.
It’s the first of what Immuneering hopes will be a number of clinical trials enabled by what the company calls its “disease-canceling technology,” which analyzes the gene expression data of diseases and uses computational models to identify small-molecule compounds likely to bind to disease pathways and silence them.
“Our most advanced candidates go after the RAS-RAF-MEK [protein] pathway,” Zeskind explains. “This is a pathway that’s activated in about half of all human cancers. This pathway is incredibly important in a number of the most serious cancers: pancreatic, colorectal, melanoma, lung cancer — a lot of the cancers that have proven tougher to go after. We believe this is one of the largest unsolved problems in human cancer.”
A good foundation
As an undergraduate, Zeskind participated in the MIT $100K Entrepreneurship Competition (the $50K back then) and helped organize some of the MIT Enterprise Forum’s events around entrepreneurship.
“MIT has a unique culture around entrepreneurship,” Zeskind says. “There aren’t many organizations that encourage it and celebrate it the way MIT does. Also, the philosophy of the biological engineering department, of taking problems in biology and analyzing them quantitatively and systematically using principles of engineering, that philosophy really drives our company today.”
Although his PhD didn’t focus on bioinformatics, Zeskind’s coursework did involve some computational analysis and offered a primer on oncology. One course in particular, taught by Doug Lauffenburger, the Ford Professor of Biological Engineering, Chemical Engineering, and Biology, resonated with him. The class tasked students with uncovering some of the mechanisms of the interleukin-2 (IL-2) protein, a molecule found in the immune system that’s known to severely limit tumor growth in a small percentage of people with certain cancers.
After Zeskind earned his MBA at Harvard Business School in 2008, he returned to MIT’s campus to talk to Lauffenburger about his idea for a company that would decipher the reasons for IL-2’s success in certain patients. Lauffenburger would go on to join Immuneering’s advisory board.
Of course, due to the financial crisis of 2007-08, that proved to be difficult timing for launching a startup. Without easy access to capital, Zeskind approached pharmaceutical companies to show them some of the insights his team had gained on IL-2. The companies weren’t interested in IL-2, but they were intrigued by Immuneering’s process for uncovering the way it worked.
“At first we thought, ‘We just spent a year figuring out IL-2 and now we have to start from scratch,’” Zeskind recalls. “But then we realized it would be easier the second time around, and that was a real turning point because we realized the company wasn’t about that specific medicine, it was about using data to figure out mechanism.”
In one of the company’s first projects, Immuneering uncovered some of the mechanisms behind an early cancer immunotherapy developed by Bristol-Myers Squibb. In another, they studied the workings of Teva Pharmaceuticals’ drug for multiple sclerosis.
As Immuneering continued working on successful drugs, they began to notice some counterintuitive patterns.
“A lot of the conventional wisdom is to focus on DNA,” Zeskind says. “But what we saw over and over across many different projects was that transcriptomics, or which genes are turned on when — something you measure through RNA levels — was the thing that was most frequently informative about how a drug was working. That ran counter to conventional wisdom.”
In 2018, as Immuneering continued helping companies appreciate that idea in drugs that were already working, it decided to start developing medicines designed from the start to go after disease signals.
Today the company has drug pipelines focused around oncology, immune-oncology, and neuroscience. Zeskind says its disease-canceling technology allows Immuneering to launch new drug programs about twice as fast and with about half the capital as other drug development programs.
“As long as we have a good gene-expression signature from human patient data for a particular disease, we’ll find targets and biological insights that let us go after them in new ways,” he says. “It’s a systematic, quantitative, efficient way to get those biological insights compared to a more traditional process, which involves a lot of trial and error.”
An inspired path
Even as Immuneering advances its drug pipelines, its bioinformatics services business continues to grow. Zeskind attributes that success to the company’s employees, about half of which are MIT alumni — the continuation of trend that began in the early days of the company, when Immuneering was mostly made up of recent MIT PhD graduates and postdocs.
“We were sort of the Navy Seals of bioinformatics, if you will,” Zeskind says. “We’d come in with a small but incredibly well-trained team that knew how to make the most of the data they had available.”
In fact, it’s not lost on Zeskind that his analogy of drugs as noise-canceling headphones has a distinctively MIT spin: He was inspired by longtime MIT professor and Bose Corporation founder Amar Bose.
And Zeskind’s attraction to MIT came long before he ever stepped foot on campus. Growing up, his father, Dale Zeskind ’76, SM ’76, encouraged Ben and his sister Julie ’01, SM ’02 to attend MIT.
Unfortunately, Dale passed away recently after a battle with cancer. But his influence, which included helping to spark a passion for entrepreneurship in his son, is still being felt. Other members of Immuneering’s small team have also lost parents to cancer, adding a personal touch to the work they do every day.
“Especially in the early days, people were taking more risk [joining us over] a large pharma company, but they were having a bigger impact,” Zeskind says. “It’s all about the work: looking at these successful drugs and figuring out why they’re better and seeing if we can improve them.”
Indeed, even as Immuneering’s business model has evolved over the last 12 years, the company has never wavered in its larger mission.
“There’s been a ton of great progress in medicine, but when someone gets a cancer diagnosis, it’s still, more likely than not, very bad news,” Zeskind says. “It’s a real unsolved problem. So by taking a counterintuitive approach and using data, we’re really focused on bringing forward medicines that can have the kind of durable responses that inspired us all those years ago with IL-2. We’re really excited about the impact the medicines we’re developing are going to have.”
Universities should lead the way on climate action, MIT panelists say
Under its Plan for Action on Climate Change, MIT has a goal of reducing its greenhouse gas emissions by at least 32 percent below its 2014 emission levels, by 2030. Those reductions are now at 24 percent, and the Institute is track to meet or exceed the goal, said Joe Higgins, vice president for campus services and stewardship, thanks to Institute-wide efforts that benefit from connecting research and operations.
In the fifth of six symposia in the Climate Action series, held Oct. 20, an online panel of MIT experts including Higgins discussed the role of research universities in tackling climate change. Research universities like MIT provide critical technology and policy innovations, the speakers said, but can also act as role models for other institutions.
“Higher education has a responsibility, an opportunity to set their sights on being an exemplar organization and community in how to face, respond to, and address the climate change issue,” said Professor Paula Hammond, head of the Department of Chemical Engineering and a co-chair of the symposium.
The 170 acres of the MIT campus and its affiliate programs are a kind of living laboratory and testbed for climate solutions, “to demonstrate the technology and the choices that we as people make to move the campus forward,” said Krystyn Van Vliet, associate provost and professor of materials science and engineering and of biological engineering.
In one effort to connect research and operations, Higgins and his colleagues asked participants at the 2018 MIT Energy Hack to find ways of using machine learning to reduce emissions in large buildings. The MIT Sustainability DataPool, a portal of campus sustainability data open to the MIT community, is another way the Institute encourages its researchers “to use the campus as a testbed to generate game-changing solutions” to climate challenges, said Julie Newman, director of sustainability and lecturer in the Department of Urban Studies and Planning.
Having this model in place was a tremendous help when the Covid-19 pandemic created a new influx of personal protective equipment (PPE) and single-use plastic items to manage within the campus’ consumption and waste sustainability plan, said Newman, also a symposium co-chair. “When all of a sudden the challenge of Covid comes and we notice that we’re going to have to grapple with supply chain and use and disposal of PPE, it didn’t take but a couple of weeks to reach out and pull together a research team, an operations team, a finance team, and say let’s study this in MIT style.”
Research universities must be a source of innovations to address global climate change, said Associate Provost Richard Lester, “because our existing government-led innovation system is falling short, even relative to the inadequate benchmarks set by governments themselves.”
Among the efforts to encourage these innovations is MIT Climate Grand Challenges, a program launched in July 2020 that encourages all MIT researchers to develop and implement climate mitigation and adaptation solutions. The program already has received more than 100 letters of interest from more 300 faculty and senior researchers, Lester said.
Technological breakthroughs are still needed urgently to stop the buildup of greenhouse gases in the atmosphere, despite the talk among some experts that the technological solutions are already available, said Maria Zuber, MIT vice president for research and the E.A. Griswold Professor of Geophysics.
“I wish these individuals who think we have the technology were right. But they’re not. We do not currently have the technology we need to rapidly and adequately make the needed energy transition,” Zuber said. “This is why our work at MIT matters so much.”
Climate solutions must include more than just advanced science and technology capabilities, said Melissa Nobles, the Kenan Sahin Dean of the School of Humanities, Arts, and Social Sciences, and professor of political science. At MIT, she notes, classes on the ethics of climate change, the J-PAL King Climate Action Initiative, and Charlotte Brathwaite’s “Bee Boy” theater project are some examples of how the social sciences and arts can be brought to bear on climate issues.
“As I see it, the more that research institutions can invent practical ways for these various forms of knowledge to intersect, blend, and become mutually informing, the more quickly we can generate effective climate solutions,” Nobles said.
At the same time, universities should remember that climate change policy is only one of several issues, including global health, poverty, and racism, “which deserve and command our attention,” said Institute Professor Emeritus John Deutch. He also sounded a note of caution about how universities should engage in policy discussions. “They cannot speak out with one voice, or should do so very rarely,” he said, because members of the university community often hold diverse opinions and points of view.
The final symposium in the series, “What is the World Waiting For? Policies to Fight Climate Change” will take place online Nov. 16.
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