13/11/2022
Kushtia man builds a $4b pharma in US with promises of cheap Covid treatment
HEALTH
Mubin S Khan & Masum Billah
11 November, 2022, 11:00 pm
Last modified: 12 November, 2022, 01:06 pm
It is 9pm, 27 October. The marketing team members were the last one to leave the Tevogen Bio headquarters in Warren, New Jersey, and right now, Dr Ryan Saadi, the founder chair and CEO of the biotech company is the only one working at the sprawling, empty office. Even though he lives just five kilometres away, Dr Saadi is unlikely to leave before 3am.
On Sunday, the company will release an important statement to the press concerning Tevogen 489, their flagship product for elderly and high risk Covid-19 patients. Tevogen 489 is unlike any other Covid-19 treatment out there. It uses genetically unmodified T cells to target the Covid-19 virus genome, specifically the least likely to mutate parts of the virus, ensuring that the therapy works on every possible variant of the virus.
"I fear this will be a rough winter and we will do everything possible to bring Tevogen 489 to patients this winter," says Dr Saadi. The clinical trial has already established it is safe and Tevogen Bio is exploring all options for speedy development and manufacturing of the product.
Raised in Kushtia of Bangladesh, Dr Saadi is a US doctor and entrepreneur. He studied medicine at Dhaka Medical College before moving to the US in 1992 for higher studies at Yale University. Until a few weeks back he was little known to Bangladeshis, before his friend – the education minister Dr Dipu Moni – shared on Facebook the exciting news that Dr Saadi and Tevogen Bio had been nominated for a Nobel Peace Prize for its work in alleviating health inequality.
Tevogen Bio was founded as recently as June 2020 by Dr Saadi, after he spent two decades working for big pharma companies, and he is its majority share owner. None of Tevogen Bio's products are actually commercially available as yet, and still the company is valued at a whopping $4.25 billion, despite resisting the temptation to go public till now.
So how does a company which is just a little more than two years old get nominated for a Nobel Prize?
Part of the answer lies in Tevogen Bio's ability to create safe T cells. T cells are a natural part of our body's immune system and the only one that can fight the viruses even after it has infected our cells. Although T cell therapy is already used to treat different disease conditions, it is both expensive and of limited use, since the therapy itself can become quite toxic.
The treatment breakthrough, however, is only part of the story. The real impact Tevogen Bio promises to have is to dramatically bring down the cost of treatment, increase access to it, and at the same time provide the company with a handsome profit margin.
It took around 18 months for Tevogen 489 to complete proof of concept clinical trials, when typically, pharmaceutical products take anywhere between 7-10 years. Moreover, developing a pharmaceutical product typically costs around $2.6 billion, and in Dr Saadi's words – Tevogen 489 costs a fraction of that. In fact, one of the three patents (with eight other patents pending) that Dr Saadi holds – which he assigned to Tevogen Bio – is on "bringing down the manufacturing cost."
Tevogen 489 is also off-the-shelf, meaning a patient will no longer require a specialised hospital to receive therapy and any doctor can prescribe it.
"I cannot actually develop something which costs patients half a million dollars. But if I don't price it right, then I go out of business. It is a Catch22," says Dr Saadi.
"I had to find a way to apply science to bring down the costs of the medicine, that was one thing. Also, I could not take 10 to 15 years, I had to be quick. By having done that, our products are going to get a price point that any individual will be able to afford," he says.
From Kushtia to Big Pharma
Both Tevogen Bio and its founder Dr Saadi are right now one of the most exciting and talked-about developments in the US biotech industry. The company promises to not just make products that are affordable, targeted and yet profitable, but also address "health inequality" in the US and around the world in the long run.
Addressing health inequality however is not what big pharma is usually known for. In fact, often, they are criticised for being "exploitative". So what motivated Dr Saadi – a big pharma executive for two decades – to take on this task?
For Dr Saadi, part of the motivation stems from where he comes from. In 1971, Saadi was only eight years old when the Bangladesh Independence War broke out, and he experienced first-hand the ravages of the war.
"I lost 11 of my uncles in the war – almost my entire maternal grandfather's family. And I was right in the middle of it. They actually shot at me twice," he says.
Dr Saadi spent his early childhood in Kushtia, in the midst of poverty and destruction left behind by the war. The early years of Bangladesh – when the country was considered the poorest in the world and moniker's such as "bottomless basket" regularly accompanied its description in the international media – left a lasting impression on Dr Saadi.
"I don't know about others, but I was really taken by the words of Bangabandhu Sheikh Mujibur Rahman. My life experience would not be a reality if Sheikh Mujib did not inspire a nation to realise its strength. Most call current Bangladesh a miracle but I see foresightedness of a leader who instilled optimism in every single one of us," he said.
Over the last two and a half decades, Dr Saadi has worked at big pharma companies such as Sanofi, Genzyme, Johnson & Johnson, CSL Behring, while also serving as a Special US Government Employee for Health and Human Services. While still working for big pharma, Dr Saadi studied at the Harvard Business School, an important phase of his life which would go a long way to not just setting up Tevogen Bio, but also to design manufacturing processes that dramatically bring down costs.
"It's not like I am being humble but when I think of it, this is not supposed to be happening to me. The same man who spent his childhood in the then poorest country in the world ended up going to Yale and Harvard; ended up working in 51 countries and living in nine. The universe has been very kind to me," he says.
Dr Ryan Saadi. TBS Sketch
Dr Ryan Saadi. TBS Sketch
Like the garment industry in Bangladesh
In just two years, Tevogen Bio has grown out of Dr Saadi's study room to four different locations in the US, including an R&D Centre in Philadelphia, headed by Dr Neal Flomenberg, one of the leading experts on T Cells in the world.
Both Dr Saadi and Dr Flomenberg come from a background in oncology, the branch of medicine that deals with cancers, as do many others in the top brass, and the company was originally conceived to bring about "better, faster and cost efficient" treatments of cancer and other disease conditions that have "high unmet need", meaning there is nothing meaningful readily available for its treatment, such as multiple sclerosis.
"I was never really satisfied with existing cancer treatments. Most keep patients alive for a few months at a very high cost. So, we wanted to develop better therapies," says Dr Saadi. Tevogen Bio very quickly developed an oncology and neurology pipeline, and then Covid came along.
"We realised our approach should work on Covid-19", he says.
So what is this approach?
CD8+ T-Lymphocytes, also known as Cytotoxic or Killer T Cells, represent one of nature's most powerful weapons against disease. As Dr Flomenberg, also Chief Scientific Officer of Tevogen Bio, describes it: whenever we are infected with a virus, the way our bodies get rid of it is by expanding a group of cytotoxic T cells.
"Cytotoxic literally means capable of killing…Mother Nature basically says I have to kill these cells off. It's like it goes about blowing up virus production factories," says Dr Flomenberg, during a zoom meeting later in the day. All other treatments out there for the most part buy time by slowing the virus down, to try and tip the race between the virus and our immune system.
To date, these cells have not been harnessed to their full potential for clinical application beyond limited CAR-T options, which typically costs half a million dollars per patient and $1.5 million if you include total cost, and only a few medical institutions in the US (140 out of 6,000 hospitals) have the capacity to offer CAR-T.
Furthermore, the therapy itself can become quite toxic. The challenge for the Tevogen Bio team was to create safe T cells, and they invented a way to do it by not genetically modifying the T cells.
"Tevogen 489 is an allogeneic product, meaning it is passed on from one person to another, as opposed to autologous products, where the product is developed from the person's own cell," says Dr Flomenberg.
"We can basically make products for multiple people – from three to upwards – from a single donor. This
