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Kura Oncology and Kyowa Kirin Report Positive Pivotal Ziftomenib Monotherapy Data at 2025 ASCO Annual Meeting
- CR/CRh rate of 23% in pivotal Ph 2 cohort of R/R NPM1-m AML patients
- Consistent efficacy with comparable CR/CRh rates and clinically meaningful MRD-negative responses across pre-specified subgroups, regardless of prior HSCT, prior venetoclax, or FLT3/IDH co-mutations
- Favorable safety and tolerability profile in...
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I try and look at life like, you know, this is my journey and for the most part I’m OK, but sometimes the tears just flow. So, when I first went to the dentist and had to write it out, it just truly hit me because it was the first time I had to put it on paper. I knew that I was going to have to tell them that I had cancer, but to actually sit there and fill out the paperwork is two different things. The first impressions that I got was that it wasn’t a big deal. I had gone to a baby shower and all of a sudden, I noticed that I had spots on my hands. The dermatologist, she felt that it could be controlled by using steroids. The creams did seem to tame down the rash. I was still a little concerned, because I didn’t feel like myself. I knew that something was going on in my body. I just didn’t know what it was. So, I continued to go to the doctor. She sent me to a rheumatologist and then he said, well, the good news is you don’t have seizure or or lupus. The bad thing is, is I can’t tell you what you have.
It was especially frustrating because I had seen five doctors by this point with no answers whatsoever. My physical was in November of 2023. Now my white blood cell count is high.After that she finally referred me to the to an oncologist. So, I went to an oncologist. It was December 19th. I was diagnosed with cutaneous T cell lymphoma, Cesare syndrome. Cesare syndrome, a rare form of CTCL, often appears as a red, itchy rash that can resemble sunburn. In some patients, the cancerous T cells can spread to other parts of the body, including lymph nodes and other organs. Because of its rarity, unique presentation, and nature, Cesare syndrome patients can benefit from a multidisciplinary care team, including specialist oncologists. I finally saw my new oncologist and it was like a breath of fresh air. She made me feel at home, made me feel comfortable. I actually called a friend who had been through cancer and she said, Linda, you got to live life.
And so that’s what I decided to do, get out and live life through this journey. I would not have been able to make it without my husband. I would share with him everything that was going on. He sat with me looking at the notes, looking at the trends. He’s my rock. When you’re going through something, to be with people who understand what you’re going through is super important because this is uncharted territories.
We don’t know what we’re going through, just as it was uncharted when I first started on this journey. I’m 69, I’ve lived a lot of years, but I still want to see my granddaughter get married. I still want to spend time with my family. And that’s the one thing we have to remember in life is that there are wonderful people out there. There are good doctors out there, someone who’s going to fight for you, someone who’s going to answer the questions that you have. And don’t be afraid to ask questions. You have to be your own advocate. You have to stand up for yourself.
If you know that there’s something wrong, ask the questions because this is your life and only you can live your life and only you can advocate for yourself and only you can make sure that you get the answers that you need to be comfortable with what you’re going through. There are certain things that stand out in my mind. We don’t grow on the mountaintops, we grow in the valleys. When we go through those valleys is when we learn and we grow. And I have to remember that life is short and that we have so much to be thankful for in those hard times.

What we do here has a profound impact on patients’ lives, and the values that we have are exemplified in how we work every day. Our core cultural commitments, our commitment to life, integrity, innovation, and teamwork/Wa, we have a really long history of innovation and we also have a commitment to each other where the group is greater than the self.
And I think the beauty of the Japanese culture, it brings that harmony together while at the same time allowing us to innovate on behalf of patients.
I think the other thing that’s really nice about Kyowa Kirin is that most of the products that we have right now are relatively young in their life cycle.
And so we have a tremendous opportunity to not only innovate and bring new things to market, but also grow the things that we have.
I’ve had the opportunity since I’ve been here to meet with a number of patients in different therapeutic areas and, and what always strikes me is how long it took them to get the right diagnosis, how long it took them to get the right therapy.
I would like them to know, one, that we’re incredibly committed to them and making their life better through our therapies to the degree to which we can.
I’d also like them to know that we fully support the patient communities which they’re a part of.
The third thing would be letting them know that we are absolutely committed to helping patients like them get through their diagnostic journey into treatment faster.
I think there’s unlimited potential within North America. We have a tremendous baseline portfolio that is young in its life cycle and it’s growing incredibly rapidly.
We are the fastest growing region within Kyowa Kirin.
We have just announced a business development deal again with a company that has an ability to absolutely change lives if not fundamentally alter the course of very serious disease.
So as I think about what the future of Kyowa Kirin North America is, I think for those that are here, it’s our story to write.
And I think that’s a very unique opportunity when you’re part of a pharmaceutical company.

So I think 1st, it’s very important to establish trust between the doctor and the patient. But then also, I do teach my patients that I can’t achieve all the goals in in just one visit, especially initial visit, right? So sometimes patients come in with very long complicated history and they expect that or they hope that I can just fix everything, the ration, the itching and everything else just from the first visit. But I say that I also need time to learn them, to collect adequate history, to learn what worked and what didn’t work before. I, I always recommend for my patients to keep a diary, a lifelong diary of their symptoms, the treatments and the response.
So I think this partnership in in trusting the physician in in the care instructions and following them can be very important and, and communication. So, she touched on some things that are absolutely essential, like following the doctor’s directions. I know some people that have appointments, they cancel all the time and they’re inconsistent with treatments and everything like that. So yeah, it’s important for us to do our parts so that we can get the best out of our relationship with our doctor. If you’re, you know, the doctor sees something that they can’t address, if they refer you to someone, then chances are maybe they have rapport with that that person.
Being able to show your experience so that others don’t feel so alone is is huge. Traditionally, when the medical textbooks, when we hear about these diseases, we hear the manifestation erythema, right, which is redness. Well, in darker skin colors, we do not see redness. We see skin darkening. And a lot of times it is thought to be due to inflammation or scarring or some irritation, while indeed it could be something else like continuous lymphoma. And then we have to learn how treated CTCL is going to look because in patients with lower skin pigmentation, the lesions may result completely. While in patients of color, you may have residual hyperpigmentation darkening that may stay for a very little time and maybe even forever.
And I think that, again, having that in the textbooks and then having that in patient’s handout would be extremely helpful. That’s a really great point. I think we have to look more deeply and broadly at everything across the board from the medical textbooks to the patient materials. Again, to your point, how it may manifest differently, how even if the disease is well managed, there may be residual what does it look like on darker color skin showing photographs. Because I think when we when we show even just your basic photographs with of patients or with the disease is always shown on white skin and that, you know, isn’t always the case. Absolutely. And you know, I think that it’s important for the educational establishments to make sure that the young physicians that nurse practitioner trainees, physicians assistant nursing staff, dual rotations have rotations in the areas where there is high representations of people of color where they can get experience.
And I think that maybe the best language really is sometimes listening. So I think that learning from these patients, actively listening, following them, paying attention and trusting their symptom expression and the expression of symptom severity is very important.

When Nayla was maybe 6 months old or so, I noticed typical little dry patches that will pop up on her skin. I could see her scratching. I took her in to go see her pediatrician and then we got the diagnosis for allergies, asthma, and also for atopic dermatitis. I would be so, so itchy that my mom would have to put socks on my hands so that I didn’t dig into my skin.
With everything that was going on, Nayla and I really felt the need to connect. We got to hear from other parents, hear from other people who dealt with similar things to what we’ve been dealing with, and I feel comfortable in my own skin.

I think it’s important for Kyowa Kirin to have ERGs because diversity drives our core values, especially innovation and teamwork.
We have 3 Employee Resource Groups. We have EmBrace, we have WIN, which is Women’s Initiative Network, and then we have PRIDE.
We organize, we strategize over how to educate the people around us so that they become more understanding, standing and familiar with the issues that LGBTQ plus members of that community face on a daily basis.
I started my journey in diversity, equity and inclusion and employee resource groups when I was with my former company. At that time, I was not comfortable in my own skin, and so I wanted to take on a bold step and get involved in the Pride group.
It allowed me to, you know, walk into a room and speak without reservation, to have more confidence in myself and really speak my mind to advance my opinions. And so, you know, it it, it helped a lot.
We’re trying to show some of the employees who may be considered vulnerable or may not be used to being their authentic self that you can and that this is a company where you can do that.
I many times face gender based differences, challenges and barriers, but I’m happy to tell you that I could find ways to navigate those.
And in Women Initiative Network, we exactly do the same.
We are a group of employees who are very motivated to support this breaking such challenges or barriers which comes on our way based on gender.
As an Employee Resource Group lead, I wish that all employees here in Kyowa Kirin feel confident and a sense of belongingness at workplace.
Once you better understand the shoes that your colleague walks in, it helps in open one’s awareness.
It helps bring more understanding and embracing of inclusivity, which is what we’re trying to achieve as a part of the Embrace ERG.
It’s important that we all work together and support one another, celebrate the differences, help and strive toward inclusivity and belonging within Kyowa Kirin, I will say from personal experience, since being here, I’ve never felt anything less than accepted for who I am.
All those experiences really helped shape me into the person that I am today.

The future Kyowa Kirin North American pharmaceutical manufacturing site planned for Sanford, North Carolina.

Hi, my name is Arvin Tam. I’m a senior scientist and I’m the head of the molecular biology group here at the research department, Kyowa Kirin.
Ever since I was young, I think I wanted to be a scientist.
I love science, I have a have a passion for science. I also have a passion for helping people.
Being in the Pharmaceutical industry, I’m able to do both, apply kind of my passion in science and use the latest technologies to help bring cures to patients.
The reason why I was drawn to Kyowa Kirin was because of the people. I saw the teamwork that that was present in the research team here.
The people who are here have been here for a while, which is very rare for a pharmaceutical company.
And you can feel the teamwork and the way people help each other.
A lot of scientists here do great science with very different backgrounds.
And so being able to come together as a team and put everyone’s knowledge to work to, to find a cure is great.
And it’s also nice to have everyone be very patient focused.
Having everyone kind of put patients first when trying to design cures or trying to design a therapy, it’s very exciting.
The reason why I do science is, is to be able to help people. And you can feel that everyone here has the same kind of passion.
One opportunity that’s here at Kyowa Kirin in research, we are open to all kind of modalities.
We’ve worked with antibodies before, small molecule cell and gene therapy, and so being able to think about and work on different types of modalities are very, very exciting for scientists.
Using the latest technologies, we’re able to almost do anything that we want to try and develop a cure.

I joined Kyowa Kirin back in 2001 as an entry level scientist straight from my postdoctoral fellowship.
And over the last 20, almost 23 years, I’ve been able to develop my career and expand my responsibilities.
I started as a project leader on an early drug discovery project for autoimmune disease indication, and as time went by, I would increase my responsibilities, leading a small team, aim for pipeline projects and then eventually overseeing the research, being responsible for our pipeline and our full portfolio.
I was one of those kids who was interested in science. From very early on, probably elementary school or early junior high, I had a high interest in science.
Within two years of each other, my grandmother was diagnosed with uterine cancer and my mother with myelofibrosis.
And so that just pushed me even more to understand what was happening with them and what treatments were available.
And back then there was almost nothing. That desire to help patients and understand, find treatments or cures or causes of disease drove me into this profession.
Ideas can come from anywhere. So whether it’s an entry level research associate, to a scientist with 20 years experience, I want to hear their ideas and, and we try to create an environment where everyone can speak up and provide ideas from the science to the project to how to make this a better place to work.
But what has been consistent, especially with our side in La Jolla is the teamwork and collaborative spirit and the recognition that we’re stronger when we work together.
And so we haven’t been siloed and we are always open to new ideas and working with individuals and, and we take that out and bring that culture to our collaborations and interactions with the teams in New Jersey as well as with our colleagues in Japan.
As we’re looking towards where the next products are, the next early-stage projects are, we are focusing more on the rare diseases. There are a lot of unmet needs for those patients because they’re rare, they’re not studied as much. We don’t understand the biology. And so they, they represent a need for patients in an area that we can focus on.
I learned something new everyday. I’m challenged everyday and that helps our, our process and our, our work here.
And then it, it goes back to the culture and the people and the collaboration. And so being able to walk down the hall and ask someone a question and have a quick chat about the latest research, the latest results from an experiment and what it means for our projects and how to advance that.

My name is Josh Oakes. I am a research scientist, and I am part of our newly formed cell therapy group.
I actually started my career as a dietitian. Part of being a dietitian, you have to do an internship where you basically work in the hospital and you follow a registered dietitian. Part of this involves working in the intensive care units. It became clear to me that a lot of our available treatments were not adequate.
I decided that I would like to improve the drugs that we can give to patients and that’s why I joined a PhD program to work in the pharmaceutical sciences.
was actually interviewing a few companies when I was recruited here, and my interview here was remarkably pleasant. All of the people were, they asked good questions. They were tough questions.
Since joining here, it’s definitely met my expectations as far as people not just willing to work together, but they’d like to work together. They want to help you succeed, which I think is terrific.
After graduating from my PhD, I did two postdocs academic, and then I actually worked at two startups before.
When compared to a startup, we look at different diseases. We have a choice of modalities. In the startup environment, it’s usually very focused, so you’re targeting just one disease. You usually have one or two drugs.
Here we have the opportunity to look at different diseases wherever the patients need the therapeutic.
A lot of other companies it’s, you know, it’s just one thing and if it doesn’t pan out, then it’s just no go.
One of the big highlights while working at Kyowa Kirin is actually part of my antibody discovery project. We needed an antibody that had a specific property.
We weren’t sure if it was even possible and it turns out not only is it possible, but it works great. I was really happy about that.

My name is Quy Nguyen and I’m a Senior Research Associate 2 at the research site here in La Jolla, CA. I am working in the cellular immunology group.
I got my bachelor’s in cell in molecular biology at UC San Diego, just around next door here.
I was kind of looking into what kind of job, what am I going to do after I graduate?
So I landed at the Sanford Brown Premise Research Institute and I was in a lab working on, you know, viruses like HIV, flu, Zika, so in a disease space.
And so that was something I was really interested in because you know, when you’re young, you want to have an impact on the world. You want to change the world, right?
I actually continued working at that same Research Institute and that same laboratory. You know, there’s kind of a difference in academic research versus pharmaceutical research.
In academic research, it’s knowledge to gain knowledge. Their main goal is to, you know, publish papers and high tier journals and just add to the broader knowledge of, you know, science, cell biology, you know, etcetera, etcetera.
Because I wanted to get into pharmaceutical research, because I wanted to, well, for one, I wanted to have a direct impact on patients’ lives, right?
I wanted to work on a drug that it would eventually make it to commercialization. And so in order to do that, it had to go to pharma.
This is actually my first pharma job, so I have been here for the last eight years or so.
I think it’s important to note that with this new cell gene therapy initiative, cell gene apparently is a really hot new area and a lot of different, other, different companies are, are getting into this space.
It’s important for us to be there by getting into the cell gene therapy space, we are on the the cutting edge of technology, right? We are keeping up with our competitors.
I would say this culture here, this company is so unique. It #1 is a very welcoming and inclusive environment. And I would say highly collaborative as well.
We’re, you know, we’re always collaborating.
We’re always ready to help each other out and we’re always ready to uplift each other.
It’s just a really great environment to work in.
This is a great place to work because not only are we like highly collaborative, the executive committee is very invested in employee development.
And, so you know there is just so many opportunities to like move up to develop yourself as you know just as an individual.
Their contributions to our collaboration have been invaluable.











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