Episode #2 The Current State of HIV Treatment and Research

In this episode of Learning & Living STEMM in Connecticut, Drs. Umesh Hanumegowda and Max Lataillade join CASE to discuss the current status of HIV research and treatment, why HIV is a sneaky virus, and how years of HIV research led to a faster response during the COVID-19 pandemic.

Guest & Host Biographies

Dr. Umesh Hanumegowda
Vice President, Head of Drug Discovery
ViiV Healthcare

HIV research and treatmentUmesh Hanumegowda is the Head of Drug Discovery at ViiV Healthcare, a global specialist company dedicated to HIV research. At ViiV, Umesh oversees the discovery efforts in identifying novel targets and assets and selecting drug candidates to treat, prevent, and potentially achieve long-term remission of HIV. He leads a group of highly skilled scientists encompassing the areas of chemistry, biology, and lead optimization, focused on discovering next-generation drug candidates and contributing to the overall scientific strategy for the company.

Prior to ViiV Healthcare, Umesh was a Principal Scientist supporting and leading various discovery programs at Bristol-Myers Squibb.  During the last 20 years in the pharmaceutical industry, working in the areas of infectious diseases, neuroscience, and oncology, Umesh has contributed to advancing several quality drug candidates including beclabuvir for HCV and several HIV maturation inhibitors through various stages of development. With a deep expertise in investigative and mechanistic safety, Umesh has helped reduce late-stage attrition and thus improved overall efficiency in drug discovery and development process.

Umesh obtained his Veterinary Sciences degree and a master’s degree in pharmacology from the University of Agricultural Sciences, Bangalore, India, PhD in pathobiology from the University of Missouri, and did his postdoctoral training at Michigan State University. Umesh is currently a Diplomate of the American Board of Toxicology.

Max Lataillade
VP, Head of Early Development and Global Research Strategy
ViiV Healthcare

HIV research and treatmentDr. Max Lataillade is Head of Early Development and Global Research Strategy at ViiV Healthcare, where he is responsible for global research and development strategy for the HIV pipeline. He oversees end-to-end R&D activities for all novel HIV pipeline programs designed to address key unmet medical needs for people living with HIV (PLHIV). Max ultimately is accountable for several dedicated and diverse teams and leads several programs with a focused approach to developing new antiretroviral agents that are safe and well tolerated with novel mechanisms of action for the treatment, prevention, and ultimately cure of HIV. Max in his current role is leading and driving value creation for both PLHIV and ViiV Healthcare.

Max’s career has spanned both industry and as a practicing physician in academia and the community. He has held several positions of increasing leadership and responsibility within several research and development organizations. He also brings his experience from the clinic and a patient-centered approach to his work.

Max joined ViiV Healthcare in February of 2016, where he currently serves as vice president and head of early development and global research strategy and is accountable for the strategy, and development of early and late development assets such as the HIV-1 Attachment Inhibitor and the ViiV Healthcare early development pipeline. Max is credited for rapidly introducing and implementing an early development structure, along with early development teams within ViiV to efficiently develop novel antiretroviral agents from discovery to the clinic.

Prior to joining ViiV Healthcare, Max was Vice President and Head of Global Development for HIV at Bristol-Myers Squibb where He joined the global clinical research group in 2007 as an infectious disease and HIV specialist from Yale University School of Medicine. During his time at BMS, he played a central role in several virology programs in both HIV and HCV, helping to launch several medicines (including Reyataz and Sustiva for HIV adults and pediatrics, Daklinza and Sunvepra for HCV). His expertise in HIV and HIV/HCV co-infection, his vision and drive, along with his leadership qualities have been recognized throughout the virology field, academia, and the pharmaceutical industry. In 2014, He received the prestigious James Palmer Award for excellence in drug development (BMS R&D award), especially for his leadership and his team’s accelerated development of HIV-1 Maturation Inhibitors, and the attachment inhibitor Fostemsavir. Max and his colleagues recently received on behalf of ViiV Healthcare the 2022 BioNJ Innovation Award for their work on Rukobia. and the long-acting injectable Cabenuva.

Max obtained his medical degree from the University of Medicine and Dentistry of New Jersey-School of Osteopathic Medicine (UMDNJ-SOM-2001), completed his medical residency training at Temple University and Crozer-Chester Medical Center in Philadelphia in 2004, and finished his fellowship in Infectious Diseases and HIV at Yale University School of Medicine in 2007. Max’s sub-specialty training at Yale was in HIV resistance and focused on sequencing of antiretroviral agents for HIV-positive patients that had developed HIV resistance and were in dire need of new antiretroviral agents. His passion for developing new and innovative options for HIV patients is well-known within and outside of ViiV. Max is still a physician with a very diversified practice. He is an assistant professor and teacher attending Yale, and he still volunteers at the West Haven VA HIV clinic in CT.

Outside of work,  Max continues to focus on HIV issues affecting minorities, especially African American Women by being a member and consultant for the AIDS Minority Council. Max also focuses on helping with several health issues in Haiti since the 2011 earthquake. Max is an avid sports fan and is very involved in his children’s sporting activities. He continues to play soccer every week as a member of the Guilford soccer club in CT. He is a devoted family man and enjoys going out, traveling, and exploring the world with his wife and family every year.

Tanimu Deleon, host

Tanimu Deleon has a BS, and MS in Computer Engineering, and a PhD in Biomedical Engineering.  Dr. Deleon has well over a decade of experience in research and development, information technology, submarine design and manufacturing, sustainable investments, and human factors. Dr. Deleon is a Principal Engineer and Technical Lead for Human Factors Engineering and Warfighter Performance at General Dynamics Electric Boat. In this capacity, Deleon works across various disciplines to ensure the human element is factored into the boat’s design.

 

Episode Transcript

Max Lataillade
Somebody said to me recently that science doesn’t work without the right policies. Right. And I think that was a wake-up call for me honestly. When I was told that because as scientists, myself and Umesh, we work to discover new drugs and develop new drugs that are safer and better tolerated for patients, better options, but I think we need to work with setting new better policies to make it as valuable to most.

Tan Deleon
On behalf of the members of the Connecticut Academy of Science and Engineering, welcome to this inaugural edition of Learning and Living STEMM in Connecticut, the podcast of the Connecticut Academy of Science and Engineering. My name is Tan Deleon. I’m an elected member of the Academy, and in 2020, was elected to the Acadamy’s Governing Council. And I’m pleased to serve as host for this podcast. The Academy is a nonprofit created by a special act of the Connecticut General Assembly in 1976, with key areas of work, including advising and informing the people and the State of Connecticut, on science, technology, engineering, mathematics, and medicine, collectively known as STEMM. This podcast is key to sharing with the residents of our state, interesting stem developments and increasing visibility for the state’s innovators and entrepreneurs, businesses and industries, academics, our talented workforce, and those doing STEMM-related work in public service. I am pleased to have as our guests from Viiv Healthcare, Umesh Hanumegowda, Vice President of Discovery Research, and Max Lataillade, Vice President and head of Early Development and Research Strategy for Clinical and Practicing Clinicians at Yale. We’ll be talking about the current status of HIV treatment and research. Umesh first, and then Max. Can you tell us just a bit about yourselves?

Umesh Hanumegowda
Yes, thank you so much. Glad to be here. My name is Umesh Hanumegowda. I am the head of discovery at Viiv Healthcare. We are located in Branford, Connecticut, and Viiv Healthcare is a company focused on HIV research.

Max Lataillade
Good morning to you and your listeners. My name is Max Lataillade and I am the head of global research strategy, early development, and I oversee the treatment pipeline at Viiv Healthcare. I’m also a practicing physician at Yale New Haven health system, especially volunteering at the HIV clinic and infectious disease service at the West Haven VA in Connecticut.

Tan Deleon
Fantastic, glad to have you both on and very much appreciate the insights that you’re both going to deliver. So let’s get right into it. Max, there’s a common perception that HIV is a medical problem that has been solved. Why is this truly a misconception? And why is your company 100% focused on helping patients living with HIV?

Max Lataillade
That’s a great question. I think that because we have better medications now, they’re better tolerated, and having HIV is not a death sentence anymore, people are thinking that HIV is not a major problem. In fact, a young person diagnosed with HIV today can live a normal life and have a similar life expectancy as somebody without HIV as long as they take their medications. But let me tell you why this is a misconception. If you take the problem globally, in 2021, the last time we had the survey for global HIV cases, there were 38 million people living with HIV worldwide. 1.7 million of those people are children and adolescents. 650,000 people died of HIV in 2021. So you can see that broadly, and globally, this is a major pandemic still. Now we have made some efforts. And we’ve made some great strides because of our 28 million people that are on the treatment and are getting access but it doesn’t mean that 100% of these 28 million people are suppressed, and therefore that’s a problem globally because they can transmit the disease to other people. If we bring it closer to home, in the US, 1.2 million people are living with HIV in the US. One in eight people do not know they have the disease, which is a problem right there. And we still getting which is very upsetting 30 to 35,000 infections every year in the US. And so I don’t think that this is acceptable in the US, that we’re still getting this number in terms of 30 to 35,000 per year. So you can see where this is a misconception there. I think the second part of your question is also very important. I think the world and frankly, the US needs to be companies like Viiv, that are 100% dedicated to people living with HIV. In fact, this is a part of our mission to live no person living with HIV behind. And our global vision is to be there until HIV or AIDS is not and therefore curing the disease. So I do think that besides being a company that’s been labeled as innovators and disruptors, a company that has shown great innovation over the last 10 years, we also are very in tune with the unmet needs of people living with HIV. And certainly, we can talk about that as far as your next questions.

Tan Deleon
Thank you, Max. I’m gonna I’m actually going to jump over to Umesh really quickly, if I may, because of something you said about a cure. So Umesh, why is there no cure for HIV? And when will there be one?

Umesh Hanumegowda
So to answer your question of why there is no cure for HIV, we need to know a little bit about the virus, what it does at a molecular level. First of all, the virus once it enters the cell, that’s the host cell, in this case, the human lymphocytes, which are a type of blood cell, it can integrate into the host genome. By that I mean, it can insert its genetic material into the human genetic material, and that makes it very difficult to remove the virus. And secondly, it can mutate. It is prone to mutation, which means it can change. It’s a small change, but significant enough that it cannot be tackled by a therapeutic vaccine. And lastly, but most importantly, is that this virus can hide. So it can stay dormant in a tiny number of infected cells in many tissues, and that’s what we refer to as the reservoir. And that that’s how it escapes immune surveillance and the normal antiretroviral medications cannot target them. So because of these things, you know, it’s a sneaky virus it knows to integrate, it can mutate, and it can hide really well. And that makes it very difficult to cure HIV. Now, regarding the question, you said, like when there will be one, when there will be a cure for HIV? Now, it’s a tough question. Because of the reasons I mentioned, it’s going to be really challenging to find something like a sterilizing cure. By sterilizing, I mean, removing every HIV particle from every infected solid body, it’s going to be really challenging. However, I’m optimistic that there could be – or there will be – a functional cure. By that, I mean, one can expect longer durations of treatment-free remission, and that’s possible.

Tan Deleon
Wow, that’s, I mean, thank you for putting it in such a clear perspective. I mean, people lose a lot of sight of how difficult it is to tackle the HIV virus. And it’s been with us for so long that people just get complacent, I think. So. Thank you. Thank you very much for that. So I’m gonna switch beats and just go back over to Max really quickly, if I may. So, so speaking about, you know, the unmet needs, what are your thoughts on the unmet needs of people living with HIV in the US, and also worldwide today? Because it seems like it’s more endemic worldwide than in the US.

Max Lataillade
We just spoke about one of the great unmet needs, right? I think that we’re getting way too many infections, still. I think we need to do a better job at stopping the HIV epidemic by preventing infections. The second unmet need that is getting to the part of the success of treating HIV is that we are getting an older and older population. And I think when you have an older HIV population, they’re taking many other medications for things like hypertension, diabetes, high cholesterol that are interfering, right with our HIV medications, for drug interaction, I think is an unmet need. The third thing that I would say is that we are still getting people that are dying of AIDS, people that are running out of medications, and those that have had HIV for a long time, and another virus may be resistant to their medications. I think that that’s a separate part right there. And an unmet need is still in pediatric patients that are still getting 1.7 million infections per year globally. And then the next thing that I would switch to instead of unmet needs is our ability to address stigma, which is still a great issue in the US and globally, and health disparities. And I think that’s very sad to see health disparities in HIV mirroring some of the disparities in the US and globally. For example, if you think about the number of people – that are men having sex with men getting HIV – even though they represent a very small percentage of the US population, they get just about 66% of HIV infections. When you think about the African American population, which is only 13% of the US population, almost 50% of the new HIV cases are African American. And then last but not least, if you think about African American women, in terms of new infections in a week, they represent something like 57% of those cases. So those health disparities, I think need to be addressed aggressively for us to be able to solve the problem of HIV and HIV transmission. The last case that I’ll share with you is that if you think about the people in the hotspots in the United States that need prevention the most, they’re getting less and less, for example, out of the 1.1 million people that were eligible for prevention, which means that we have about 1.1 million people in the US that are obtaining HIV, only 9% of these people were people of color accessing prevention. So you could see where there’s a disparity, right, the hotspots, you know, in the gender and the race, where you have most infections, they’re getting prevention less and less. And I think that those are huge unmet needs, that we need to be able to address. And to get back to why we are 100% HIV-invested is that Viiv is one of the key companies that are part of ending the HIV epidemic, and working with the federal government to get it done. And we can talk about that in your next questions if you want to go there.

Tan Deleon
Yeah, let’s just jump into that. Because, I mean, what’s the – so the standard of care seems to be the major issue, as you said, with the way these health discrepancies are based on certain populations, so how is the standard of care evolving? And with new advances or recently approved medicines, how is that helping to benefit those minorities or those minority populations that you described?

Max Lataillade
What a great question. Somebody said to me recently that science doesn’t work without the right policies. Right. And I think that was a wake-up call for me honestly. When I was told that because as scientists, myself and Umesh, we work to discover new drugs and develop new drugs that are safer and better tolerated for patients, better options, but I think we need to work with setting new better policies to make it as valuable to most. Now the standard of care is not the problem, because I think over the years, the standard of care has evolved to offer one pill once a day, genuinely safe, and well tolerated. And if you think about Viiv over the last 10 years, we’ve been the most innovative company and we’ve turned the standard of care upside down a few times. Because if you think about that, we introduced the first two-drug regimen. Because when I trained at Yale, or in infectious disease and HIV, we were trained to only give – to always give three drugs. But our drugs are so potent, that we were actually able to change the standard of care and treatment paradigm to say, hey, you don’t need three drugs because drugs are so potent you can take two. And I think Dovato and Juluca which are two once-a-day pills for treatment and switch or maintenance of HIV patients are the results of such innovation. And you know, on top of that, we went further to say, if you don’t want to take a pill every day, we have an option for you that you can take every two months. So for example, instead of taking a pill 365 days per year, you could have a clinic six times a year, and take two injections every two months. So if you think about the standard of care, I think that there’s a lot of innovation that is happening – a lot of firsts – that should help us take better care of HIV-positive people, and then prevent new infections. And the last example that I give to you is that they are excellent prep jobs. And what I mean by prep is a prophylactic drug that you can take. Apretude, which is a long-acting Cabenuva, a long-acting cabotegravir, which is an integrase inhibitor, you can think that every two months for the prevention of HIV. In addition to the old drugs we have, I think that we need to do a better job at preventing HIV. And if you think about what Umesh was talking about from a queue perspective, and you try to put it in perspective in the population we are living in, it’s over, the times we are living in, the ending the HIV epidemic is we’re looking at suppressing 90% of people, making sure that 90% of people have access, and preventing 90% of infections. So that’s one of the ways to end the HIV epidemic. For example, in Connecticut, which I think has done well, compared to the rest of the states, I think last year, we had something like less than 200 infections in Connecticut. The issue to me is going to be national, we need to get serious about preventing HIV. Number one, big testing campaign, let’s find out who has HIV. Number two, let’s treat those who have HIV, making them undetectable. Because we know that once you’re undetectable, you cannot transmit the virus. It’s called a U equals U – undetectable equals untransmissible. So now once we get that under control, we prevent people from getting HIV with long-acting individuals. By going to key hotspots in the United States. The South is getting 50% of HIV infections in the US, and some key spots there in gender and race, make sure they don’t get HIV. And then after we did that crushing HIV transmission, then Umesh and the discovery colleagues and us, we can focus on curing the people who have HIV at the same time. So I think if we stick to ending the HIV epidemic – 90-90-90 – I think by 2030, our goal is to go from 30,000 infections in the US to three dots. And I think we actually crush HIV transmission in the US and globally if we apply the same concepts.

Tan Deleon
Wow, that’s a very ambitious goal for 2030. And, yeah, to some of the points that you highlighted, you know, it seems like being able to take an injection every few months, would potentially help with compliance. And, and the stigma, as you mentioned, is, you know, the social, the psychosocial issues that occur in society do have a major effect. Also, it appears, understanding and training and having people educated on some of these issues, seem very relevant and important. So thank you very much, Max. So I’m going to switch over to Umesh because I want to get a bit more insight into some of the things that can be done here. So so Umesh what medical and other advances may be seen in the near future, the next five to 10 years, so to speak?

Umesh Hanumegowda
That’s a great question. There is a lot of research going on in the field. And scientists have taken every possible approach to tackle this virus and Max, as he eloquently mentioned, we have come a long way from multiple pills a day to one pill a day, and now one injection every two months. So in the near future, we can expect medications that could be dosed much more infrequently, something like once every six months, or possibly once every year. And there could be also agents that could target the reservoir -the reservoir that’s where the virus hides. That’s to take out the latently infected cells using modalities like broadly neutralizing antibodies, and latency reversal agents. And there could also be agents that could address comorbidities, or aging, which are common issues for people living with HIV. And there are also attempts to excise or cut out the viral genome from the host genome using gene editing technologies. And there are approaches taken to use engineered cells like CAR-T Cells to tackle the infection. And in the long run, perhaps there will be a therapeutic vaccine to treat and hopefully, a prophylactic vaccine to prevent infection in the first place.

Tan Deleon
Interesting, interesting. You said you mentioned something you said latency regenerative. Can you just expound upon that just a little bit? For our listeners?

Umesh Hanumegowda
Yeah, it’s called a latency reversal agent.

Tan Deleon
Oh, I’m sorry. Okay.

Umesh Hanumegowda
So, so when this virus hides, it makes it really difficult to cure. So these latency reversal agents are the agents that can wake up those latently hiding infected cells, and that’s one approach. Once we remove them from hiding, we can kill them. And that’s how we reduce the reservoir and go towards perhaps a functional cure or towards a sterilizing cure.

Tan Deleon
I see. Okay. Thank thank you for that clarification. So, so just sticking to this, this train of thought, what other medical or scientific advantage – advances – excuse me, have been gained as a result of HIV research for treatments? Umesh?

Umesh Hanumegowda
Yeah, there is a tremendous amount of knowledge gained from HIV research, which has been applied in other areas, infectious agents, infectious disease areas, and most notably, COVID-19.

Tan Deleon
Yes, okay.

Umesh Hanumegowda
The infrastructure built during the last four decades of HIV research has helped tremendously and will address the COVID-19 pandemic. By infrastructure, I mean, the resource infrastructure, the clinical trial network infrastructure, and the global network of institutions and agencies, which are established to provide access – HIV medication access – to patients have all helped tremendously in addressing this pandemic. Just from a research perspective, it has helped develop diagnostics, antibody therapeutics, and eventually vaccines. And the clinical trial network facilitated the efficient and effective conduct of the vaccine clinical trials. And from a global perspective, the network of institutions, agencies, and pharmaceutical companies, they all help to get the vaccine access at a global level.

Tan Deleon
Thank you, Umesh. Yeah, that’s a very, very great point. I don’t think many people realize that you know, because of all the research that’s been done so far, that has helped facilitate us getting out of this COVID-19 pandemic and providing therapeutics for those that were adversely affected. So yeah, it’s, it’s, it’s not something that most people realize, and definitely not something that I actually thought about, but very, very well noted. So I definitely appreciate that. So, I wanted to try to switch the conversation a bit just to try to have people understand, you know, how you both got into the fields that you’re in because we have a lot of young listeners on the line. And, you know, you guys are folks that they can look up to and you know, they may aspire one day to actually be in your position, hopefully so, so I’ll start with the Umesh first, can you give any advice to some young folks that would like to potentially do what you do one day and then we’ll switch over to Max?

Umesh Hanumegowda
Sure. I would say in two different ways. One is from a knowledge perspective, you know, take the right course, be strong in your core subjects. Like for example, if anybody wants to be in the field that I’m in, I would say have a strong foundation in biology, biochemistry, and molecular biology, that’s important. And the other aspect is kind of philosophical. You know, if you ask me, be persistent. If you believe in something, and you have got a scientific basis for your belief, be persistent. Never give up. And eventually, you will succeed.

Tan Deleon
Switch over to Max. Max, can you give any insights or advice to some young folks, please?

Max Lataillade
I think having worked with Umesh for so long, I do agree, and he knows my sort of way of looking at life is to never give up. Right, and having a winning sort of personality, sort of winning leadership ideas. And so my perspective, you know, I had humble ideas, as far as what I wanted to be, I only wanted to be a professional soccer player when I was growing up, right? And so I remember then, getting into college and thinking about my first year who I wanted to be, and going into the field of allied health, and going into clinical laboratory sciences. But eventually, what changed the course for me is to understand what I wanted to bring to the world, what I wanted to bring to society, and what kind of change I wanted to make. And I think that veered me toward the Master of Public Health, understanding, sort of how disease affects society. And then later on to understand vaccines and getting into medical school. Because I went to medical school, I went there to be an infectious disease physician and then did my fellowship and training at Yale to be an HIV doctor. But all of that is, I think, the bigger idea of what do I want to be in the world. And how do I want to change the world? One thing that I’m always very humble about is that one of the medications we developed at Viiv, called the WTW, is being given to 24 million people around the world. And I know the people that develop the drug, and we work together and to me, I find that to be extremely humbling and powerful at the same time. So what I would tell young people is really to focus on careers that are going to give you 20, to 30, to 40 years of the ability to innovate. Careers such as engineering, and I really, like Umesh, have to be strong in science. We’re gonna need people to discover new things, biomedical engineering, mechanical, robotics, you know, terms of the next wave of engineering. And in allied health, nursing, medicine, and pharmacology, we talking about physician assistants. Talking about the field of Allied Health, because I do feel that we need to get serious about things like neuroscience, and Alzheimer’s disease, and keep finding ways to cure cancer, and help with aging. Because I think we have a very big issue with the aging population in the US and globally. So, young people, I would say that it’s okay to have big dreams, but get prepared, and be solid with your education. And remember that, especially with kids of color, education, I think, is a major pathway forward to success. And the more education you can get, the more you should actually try to take in and bring in more education into your portfolio as far as how are you going to grow in this society.

Tan Deleon
Thank you both for those two insights. And, and I think that the common thread there was perseverance, right? And it doesn’t matter who you are, where you’re from, you need you’re gonna need perseverance in order to accomplish anything in this life. So, so thank you for that. And it’s not too bad to want to be a professional soccer player either. So, so at this juncture, I’d like to thank our guests, Dr. Umesh Hanumegowda, and Dr. Max Lataillade. For those living in Connecticut, and others tuning in from outside of our state, we enjoyed learning about your research. So again, thank you so much for all those insights.

Max Lataillade
Well, thank you for having us.

Umesh Hanumegowda
Thank you.

Tan Deleon
I encourage you to subscribe to this podcast on Apple podcasts, Google podcasts, or Spotify, and visit the Academy’s website at www.ct.case.org. That’s www.CT-C-A-S-E dot O-R-G. To learn more about the guests, read the episode transcript and access additional resources, as well as to sign up for the CASE Bulletin. Once again, I’d like to thank our guests. I’d like to thank Viiv Healthcare for allowing them to be on our podcast, and I’d like to thank the Academy