BioAroundWorld June 2022 Event: Cross-Border Healthcare Innovation & Partnership

BioInvent & Casi Pharma Case Study

On June 21st, 2022, MSQ Ventures successfully co-hosted BioAroundWorld 2022 June Event: Cross-Border Healthcare Innovation & Partnership together with BioAroundWorld. The event was held online and centered on biopharma cross-border collaboration discussion and biopharma knowledge sharing presented by biopharma company executives. This event brought a panel discussion/ case study and 3 knowledge-sharing presentations.

At the first part of this event, we were very honored to have our guests, Dr. Andres McAllister and Dr. Alexander Zukiwski join our June Interview: “BioInvent & CASI Case Study”. BioInvent licensed out its anti-FcγRllB antibody BI-1206 to CASI Pharmaceuticals for the Greater China region in 4Q2020. CASI's pipeline expanded to include first-in-class monoclonal antibodies developed to unlock anti-cancer immunity in liquid and solid tumors. BioInvent was eligible to receive up to $95 million including upfront and milestone payments, plus tiered royalties. BioInvent completed its first licensing agreement in Greater China, advised by MSQ Ventures.

Here is video for this panel Discussion

 
 

Panel Discussion: BIOINVENT&CASI Successful Case Study

Interview highlights include:

  • Background of BioInvent & CASI case study

  • Rationale of the collaboration

  • Progress of the partnership and upcoming milestones

  • Hurdles during transaction

  • Regulatory requirements in different territories

Dr. Andres McAllister received his doctor in Medicine and Surgery from the Universidad del Rosario (Bogotá) and holds a PhD from the Institut Pasteur/Université Paris 7. Employed since 2017. He has performed academic work at the Pasteur Institut and the University of California, San Francisco on cancer immunotherapy. Andres joins BioInvent from a position as Chief Scientific Officer at Debiopharm, and has previously held senior roles at IDM and BioMérieux/Pierre Fabre.

Dr. Zukiwski joined CASI Pharmaceuticals in April 2017 as Chief Medical Officer. Prior to joining CASI Pharmaceuticals he was Chief Executive Officer and Chief Medical Officer of Arno Therapeutics and has been a Director of Arno Therapeutics since 2014. At Arno, his responsibilities included leading the clinical development and regulatory affairs teams to support the company’s pipeline. Prior to Arno in 2007, he served as Chief Medical Officer and Executive Vice President of Clinical Research at MedImmune. Prior to MedImmune, he held several roles of increasing responsibility at Johnson & Johnson’s (J&J,) medical affairs and clinical development functions at Johnson & Johnson Pharmaceutical Research & Development LLC (J&JPRD); Centocor R&D, and Ortho Biotech. Before joining J&J, he served in clinical oncology positions at pharmaceutical companies such as Hoffmann-LaRoche, Glaxo Wellcome and Rhone- Poulenc Rorer. He has more than 21 years of experience in global drug development and supported the clinical evaluation and registration of many successful oncology therapeutic agents, including Taxotere®, Xeloda®, Procrit®/prex®, Velcade®, Yondelis®, and Doxil®. He previously served as a Member of the Medical Advisory Board at Gem Pharmaceuticals, LLC and served as a Director of Ambit Biosciences Corporation. He holds a bachelor’s degree in pharmacy from the University of Alberta and a Doctor of Medicine degree from the University of Calgary. He conducted his post-graduate training at St. Thomas Hospital Medical Center in Akron, Ohio, and the University of Texas MD Anderson Cancer Center.

Jerry Isaacson: Hello, thank you everybody for joining us for this Bio Around World events. I'm joined by Dr. McAllister and Dr. Zukiwski for the discussion of partnerships in and out of China. My name is Jerry Isaacson and I’m a managing director at MSQ Ventures. Please allow me a moment to introduce our panelists today. Dr. Zukiwski joined CASI pharmaceuticals in April 2017 as their Chief Medical Officer. Prior to joining CASI, he was the CEO and CMO of Arno Therapeutics and has been a director at Arno since 2014. His responsibilities there included leading the clinical development and regulatory affairs teams to support the company's pipeline. He also previously worked at MedImmune, Johnson & Johnson’s (J&J), Hoffmann-La Roche, Glaxo Wellcome, and Rhône-Poulenc Rorer. He has more than 21 years of experience in global drug development and supported the clinical evaluation and registration of many successful oncology therapeutic agents. He also holds a bachelor's degree in pharmacy from the University of Alberta and a Doctor of Medicine degree from the University of Calgary. We're also very happy to be joined today by Dr. Andres McAllister. Dr. McAllister has been the Chief Medical Officer of BioInvent since 2017. He received his Doctor in Medicine and Surgery from the Universidad del Rosario (Bogotá) and holds a PhD from the Institut Pasteur/Université Paris 7 and has performed academic work at the Pasteur Institut and the University of California, San Francisco on cancer immunotherapy. Dr. Andres McAllister previously worked as a Chief Scientific Officer at Debiopharm and held senior roles at IDM and BioMérieux/Pierre Fabre. Thank you, gentlemen, for joining me today, I really appreciate it. So in order to get started, the main topic for today's conversation is going to be the ins and outs of collaboration between international companies and Chinese companies. And of course, the two companies you work for CASI pharmaceuticals and BioInvent are collaborating on BI-1206 in oncology. And to get started, I was hoping maybe Dr. McAllister yon give us a little bit of background on the asset, and what's going on in terms of indications.

Dr. Andres McAllister: Sure, so BI-1206, is a very interesting monoclonal antibody that targets a receptor called FcγRIIB which basically is part of the family of FcγR. FcγR basically bind antibodies by the tail of the antibody. So be a virus, a bacterium, or a cancer cell, of course our interests in cancer. So, it is actually interestingly the only inhibitory receptor, so it resembles what happens with T cells and the breaks of that aspect of the immune system. This is the break of the innate aspect of the immune system. So if FcγRIIB is the only inhibitory receptor in humans and it's interesting because if you block it, you can expect to enhance the activity of other antibodies that you combine with BI-1206. In addition to that in the context of these cell malignancies, there is an additional potential, which is FcγRIIB. So, this individual receptor is born by the tumor cells. If you target that receptor, you basically inhibit a formation of a trimmer that internalizes CD20. If you lose CD20 from the surface, you lose the activity of anti-CD20 antibodies such as rituximab. So, in the first setting that we started developing this drug was in combination with rituximab for the purpose of treating B cell malignancy. I hope that was not too complex, but it is complex biology, but very interesting.

Jerry Isaacson:  No, absolutely very interesting. You also have a development program in combination Keytruda. Can you talk a little bit about the rationale of that program?

Dr. Andres McAllister: Yes. So, after we had started the development of BI-1206 in the non-Hodgkin lymphoma (NHL), there were several groups around the world that published the notion that FcγR and FcγRIIB, in particular, was also important. In modulating the activity of anti-PD1 agents, anti-PDL1 agents, etc. So that was important because as everyone more or less knows oncology today, these are great agents that are really revolutionized the way cancer is treated in a number of malignancies. But unfortunately, a lot of the patients, so is this a large percentage of patient response are the majority of the patients do not respond and those patients that do respond eventually have progressive disease to stop responding to these otherwise excellent treatments. So those groups around the world led by Jeffrey Ravetch at the Rockefeller institute, and Michelle at Harvard university, showed that by blocking these receptors and in particular FcγRIIB you could enhance the activity and help improving the response rates to those agents. BioInvent did his homework and we showed that when you combine the BI-1206 with agents such as pembrolizumab, you enhance the activity of pembrolizumab. So that is the basis of that study in solid tumors.

Jerry Isaacson: Great. Thank you. I really appreciate that. And I just have one more thought about the asset. Are there any thoughts about developing this as a single agent?

Dr. Andres McAllister: So, you could imagine developing BI-1206 as a single agent. In the context of the cell malignancies and in particular, in some settings where you would have very high expression of FcγRIIB, they said is not ideal and you would lose the main mechanism of action which is innovation of that trimer formation that gets rid of CD20 from the surface of the piece of malignance. So, while there may be some single agent activity, the best of the mechanism is one that enhances the activity of anti-CD20 target in agents such as we talked about.

Jerry Isaacson: Thank you for that background. I really appreciate it. So of course, you out licensed for part of the collaboration of the development of this drug to CASI in China. So, Dr. Zukiwski I was wondering if you can maybe give us a little bit of an update on the progress of the partnership and upcoming milestones for the development program.

Dr. Alexander Zukiwski: Jerry, let me take a step back and tell you how we got here. CASI is a US based NASDAQ listed company and we have a major focus in China. Our goal is to bring innovative investigative products to China and to also bring in those commercialized products outside of China that will fit and fulfill an unmet medical need. So, our BD team was extremely active and the initial engagement with BioInvent, we looked at this asset and you know the first response was, well, this could be applied to multiple potential therapeutic antibodies that are currently in clinical use and we could substantially amplify their utility for patients with various malignancies. So, in our due diligence process, my BD colleagues and myself, we undertook an extensive due diligence. And I had the opportunity to meet my colleague, Andres. And you know being the inquisitive nature that we are, we requested to take a deep dive into the individual patient level dataset. At that point of time,  Andres is like the emperor who opened the robe and said, “what do you want to see?” And he took us through every single data point and put up with our numerous questions and queries over hours and hours to confirm what we felt was going to be a just an absolutely a  fantastic potential program that needed to be put through its paces, you know, outside of China. And we started to postulate, okay, what could we do with this asset? How would we build a global development program? Piggybacking with our colleagues at BioInvent. So, it was readily apparent that the entire BioInvent team was open. Andres and his team and the project development team extremely forthcoming, dealt with all our questions. And that was a great way to kick off the collaboration. Once the deal was struck, and the various teams were put together, you could just see how things were going to start to jail. And I think a tremendous amount of the success that we have had to date is based on the collaboration that we have between the two companies. Do we agree on everything? Oh, absolutely not. You know, it's like my wife and we never agree on everything. Just she's the boss. She tells me what to do. But the collaboration at the project team level at the Joint Steering Committee level has been absolutely fantastic, such that when we are making requests sometimes it doesn't always seem to follow the European regulatory authority or the FDA logic. You know our colleagues at BioInvent were extremely accommodating, bending over backward to make sure that we got what we needed in a timely fashion. The clinical trial application was submitted in what I would like to describe as a rapid time frame, with all the translations and everything else that was required. The CTA was approved. Andres, last year in December of 2021, if I remember correctly, we subsequently got the IRB approval in the first quarter of 2022. So, the project in China is moving forward. What we are intending to do is to emulate the BioInvent rituximab BI-1206 combination. Fortunately, we do not necessarily have to go to the lowest dose levels because of the ex-China experience, we have drug products in customs now. And we hope to announce the first patient in the ensuing few weeks. We are very optimistic that this program will allow us to achieve a recommended phase II dose of the combination of BI-1206  plus rituximab, which will emulate the dose that is being tested outside of China. At that point in time, our stated goal had been to piggyback with our colleagues at BioInvent into the global registration program. We feel that under their leadership, and you know when they have all of the feedback from the FDA, from the European health authority, and we get feedback from China, we will be able to move the program forward, very swiftly taking advantage of the large patient population that exists in China. So, it is truly a collaboration. We're always looking at what's next? Fortunately, I get to have a window on the world for BI-1206 every one or two weeks, depending upon when the meetings occur. And there's no surprise on either side of the company.

Jerry Isaacson: Yeah, thank you. I really appreciate that. Building on that, I wonder maybe if I can go back to you Dr. McAllister and ask you what was the view of the build forging this partnership from your point of view? And what were some of the hurdles that you had overcome to successfully get the transaction done?

Dr. Andres McAllister: So, it was very interesting experience and one that shows you how important your feelings are when getting to the point where you want to sign a deal with another company that of course in the geography that we didn't know, etc. So, we did go through several discussions with several different companies, etc. And of course, we feel there was a great deal of synergy. And we were basically on the same page with our colleagues at CASI that was that was a feeling from the start. And as we went through this diligent process, the diligence process is that Alex was commenting on? We also felt with this team, we feel that we can go far away. They have the same goals, having a lot of experience in creating partnerships in my previous life. I know how important that is you may have two great companies, but they if they don't understand what they're doing together, there is no way it'll work even if you have a great drug in your hands, a basis to be able to do that is to be on the same page, to be working on the same direction with the company to really have synergistic possibilities with the company that you're working with. And that's precisely how we feel. I totally can echo what Alex is. We're saying with respect to buyer and then we absolutely feel in exactly the same way when we work together with the CASI team, is a pleasure, the key words are flexibility, transparency, collaboration, exchanges, etc. That's what happens on our on our daily lives. And it is agreed experience to be working with them and in that situation which is really a pleasure.

Dr. Alexander Zukiwski: And I must thank my colleagues at BioInvent for the patients you know keep in mind when you're dealing with the development program and development team in China. Many times, their first language is not English. And so periodically, there is a learning curve. We have to summarize, we have to be patient, we have to make sure that everybody understands you know in and out of midpoint during conversation where the team is going, etc. And after a couple of months things get just dramatically easier. I mean very much. Everyone knows how people are thinking, what their time frame is in terms of the response. So, we're bouncing that to the US east coast to China. And we run around the globe on a constant basis.

Jerry Isaacson: Yeah, it's interesting you're thinking of Dr. McAllister for his patients while he's thinking of you for bringing in patients to the trout. well, you know we from the outside perspective, we often read about these deals getting down in the news every day. And you know that's the big news item that everybody talks about, but fewer people talk about you know kind of the execution of the agreement once it's done. And I would kind of maybe build on Dr. McAllister’s analogy, it's kind of like the partnership and agreement. After that it's like a marriage. And I know Dr. McAllister already touched on this a little bit. But I wonder if you could talk a little bit more about the difference between a kind of engagement and marriage.

Dr. Andres McAllister: You know this has been a happy marriage. So it is very difficult to criticize. Everything runs very smoothly when there is trouble. Everyone runs in the direction in order to solve the issues, etc. You know there's always issues with these things. In particular, when you're sending drug from one company to another one. And something that we must not forget, this was done in the context of COVID. So, the difficulties were multiplied. We've been working with Alex together for the past 3 years or so. We have not been able to have one dinner together. It sounds difficulty has been and we promised each other that we would meeting in shanghai or in Beijing or in New York or one of these places we were just about to be able to meet at ASCO. Unfortunately, we were not able to do it. So, it's been extremely the context has been exchanged with people, but they said we've been able to manage we've been able to overcome all those questions. We're super happy that the Chinese team is going to begin enrolling patients in weeks that will generate data. That will be super useful for the program be it in for the western world or for the Chinese region. And I think we're super happy that this is happening and the way it's happening, etc.

Jerry Isaacson: Yeah, I think you bring up a really good point about the challenges that we've all faced in terms of not having face to face meetings. And I think it's definitely a test of the trusting that you have for each other in the strength of the partnership that you've been able to do to complete this without ever having a handshake. That's a problem that will be overcome. I'm going to leave this open to whoever wants a dancer and I know it's you know the details of this question might be limited at this point, but I wonder if you could give us an idea about kind of the just like the overall picture that you see for a phase III trial in terms of endpoints, patients, and timelines, it’s just how it might look from right now. Obviously, we don't know how exactly how it's going to play out, but what’s your kind of thinking right now.

Dr. Andres McAllister: So, something that we that we would like to mention is that the team has been extremely busy working on a subcutaneous formulation because are you might know that we encountered some in fusion reaction with this asset. And even though we were able to dose it without any serious consequences, those events we can manage that. And this we can do it by using a subcutaneous formulation, we've been working very hard. We have produced GMP batch which is basically ready. We are characterizing it etc. We should be in patients by the end of quarter three of this year perhaps quarter four. But we will be in patients very soon with that formulation. I think that's going to be a game changer for the project. Why do I say that? Because if the data is what we expected to be, and we have of course all the animal data to support it. We will very likely be moving to subcutaneous formulation and from the pivotal study which would be obviously the next study that we would undertake. So, in that sense, it's difficult to say when we will begin the pivotal study because it will depend as on the way the emerging data with the subcutaneous formulation. But they said we did have an end of Phase 1 meeting with the FDA of course we also need to consider the Chinese authorities and the European authorities something that is difficult in this specific setting is that this is of course an orphan drug and an orphan indication, or these are orphan indications in that context. We have a great deal of hopes. Alex and his team will begin dosing patients in some of the most important hematology centers in China that will bring about a lot of potential in terms of being able to recruit more readily. I think that's important. What would Phase 3 studied look like? We must understand the role of BI-1206. We need to do at least some randomization so that we understand, we can isolate that aspect of BI-1206. And we will have to investigate the indications that are independently, so we need to look at Mantle Cell Lymphoma which is one where we think this drug has a great deal of potential and for the follicular lymphoma. So those are the drivers. When you think about that, of course we would like to go for conditional approval in the US that is totally possible. And you know that if we are able to meet those expectations of the FDA and the other jurisdictions, we should be able to get that approval with the next study.

Dr. Alexander Zukiwski: So, CASI is extremely supportive of the BioInvent plans. We will launch our program with the IV formulation. But when we look forward with both companies in mind and see how we can manage the safety profile. Most effectively of BI-1206, the subcutaneous formulation may give us a tremendous opportunity to have a safe and effective drug combination for patients with relapse, refractory, non-Hodgkin lymphoma. So, we are eagerly looking forward to working with BioInvent on all aspects of the development program. We would like to jump in as soon as possible.

Dr. Andres McAllister: Maybe I should add something that we're also working very hard on, which is trying to understand how the level of expression of FcγRllB may drive a clinical response. So that is something that we're working very hard are of course if we can establish a cut of expression and some correlation with clinical response, that would allow us to put in place a test that could let us better speak to the patients that we will treat. You could go into other areas of course such as more difficult to treat non-Hodgkin lymphoma you know large piece of lymphoma things like that. And perhaps other areas really improve the response rates by better choosing the patients and we're working very hard on that as well.

Dr. Alexander Zukiwski: Predictive biomarker which would subsequently translate to a companion diagnostic to treat the most appropriate patient population. And not to treat those patients that are not going to benefit would be welcomed.

Jerry Isaacson: Absolutely. I mean I think that's definitely a strategy that a lot of people are looking at right now. Precision oncology. Absolutely. Thank you both for that perspective and for that information, I appreciate it. So, you know Pivoting a little bit. I wonder Dr. Zukiwski if you could talk to me a little bit from a western perspective about what has been like the most effective strategies, and you know key areas of knowledge that you've relied on in order to integrate a China clinical program into the broader global clinical ecosystem.

Dr. Alexander Zukiwski: So, Jerry that this is actually simpler and easier and more straightforward than one would think. In China the standard of care is very reflective to ex China. The vast majority of therapeutic classes are available. Periodically they take longer to get approved. But when they get into the marketplace, many of them are already investigated in the major institutions in China. You'll find the thing that new therapeutics get adopted very quickly. Keep in mind that many of our very senior clinical investigators have been trained educated outside of China. So, they're very used to you know the adoption of western technologies, etc. So, I look at it as the standard of care in China just like it is anywhere else is evolving. And It's evolving at a pace that is directly proportional to the number of new therapeutic targets that are being introduced and how they find their way perhaps from the initial indication in the third line setting, how they find their way up into a first line setting. So, with our colleagues we are constantly watching, is there going to be a shift in care? How will we integrate, you know, BI-1206 into that standard of care? What is the pivotal trial that's going to be needed to get into the marketplace to get the first approval? How are we going to manage the life cycle of this extremely interesting compound at the end of the day? There's not a week, not a month that goes by that we don't do a constant reassessment of what is coming in. What's going to be on going out? Is there going to be a shift in standard of care? Is there an opportunity for BI-1206 in the treatment portfolio in the treatment milieu in the regime? And it's a constant relative processor.

Jerry Isaacson: Yeah, great. Thank you. I really appreciate that. So going back to you, Dr. McAllister, sir. I wonder if you could talk just a little bit more broadly about your partnering strategy and the value you see of partnering. I mean obviously bio invent is also partnered with MSD and Transgene. And I wonder if you could just mention you know kind of what your overall strategy is when you think about whether or not to partner and how to partner your assets.

Dr. Andres McAllister: So, for us partnering is very important. We have aa platform that is highly productive, and this is due to the history of BioInvent we have a very well characterized monoclonal antibody library based on page display technology. And this combined with looking at immunological targets that are identified by a platform called first actually produces are very interesting anti bodies produce new target setter. So, we've been able to in the past 4 years, we now have five programs in clinical development and actually next year there will be 6. So, there's the productivity of the platform has been you know really, really productive, and very efficient with that actually means is that we would welcome partnerships such as the one with CASI. We have been you know for going in looking into that possibility. It's a rapidly evolving area is that especially this area of in you know ecology. So, you know we can't do everything that we would like to do. And so, partnering is super important for us and for the company and for our investors.

Jerry Isaacson: So, I’d like to take that. Thank you, Dr. McAllister and I’d like to take the same question and kind of flip it around in reverse for you Dr. Zukiwski of course your strategy is more of in-licensing whereas BioInvent is focused more on out-licensing. Owner, if you could just talk about them, your ideas of that type of business model.

Dr. Alexander Zukiwski: Our success is going to be directly proportional to the number of new compounds we bring in. Our first product, EVOMELA®, has been launched and is doing extremely well. That was a deal struck with the spectrum several years back. If you go to our website, you'll see who we have partner with for other pipeline assets? We are constantly looking for you know a novel asset, an asset that will fulfill an unmet medical need in China and our territories, and we intend to build and continue to build. But we have to be smart about it. We are a small company. We do not have the resources of multinational pharma firms. And it has to fit in our portfolio. We are focused on oncology and malignant homology and such that you know we if we could find another asset that we could do a quick Bolton on the commercial side, I can guarantee to you that my boss would be extremely interested in you know another product in the bag of our very efficient and productive salesforce in China would be really nice to have. So, it sounds like you're open to partnerships on kind of the whole spectrum of the wind really clinical to late clinical to commercial that we would not turn down an opportunity we've done many due diligence assessments over the past 12 to 24 months. Our BD leader James E. Goldschmidt is very experienced, very wise and knows how to get things done. At the end of the day.

Jerry Isaacson: Excellent. Yeah, I know. Thank you. I appreciate both of your perspectives on that. So, I want to turn to another slightly different topic. Dr. Zukiwski, I think this is a question directed for you. As we know, there's been several regulatory changes in terms of the NMPA reforms over the last 5 years as well as changes to the reimbursement and insurance policies for China. And I was wondering if you could talk about how these you know regulatory developments have encouraged you to know your efforts, and what that means for Chinese collaborations.

Dr. Alexander Zukiwski: So, I'm going to put it in a slightly different way. But the regulatory bodies around the globe are constantly changing and having increased or slightly different requirements, whether it be in the US, Europe, or China, and as global drugs develop, as we have to adapt, we have to see you know where is the FDA’s position? Do they want us to take two doses of our investigational drug into the phase 2 setting and to look for not just a maximum tolerated dose, but an optimal dose based not only on safety but on PK on pharmacodynamic markers, etc. The same thing if we're going to enter into a global study with a partner. We have to consider what are the changing regulatory opinions, not only in China, but in the United States, but in Europe and the other major uh competent health authorities that are photo give us guidance on what we're going to need. So, I look at it as okay. What's happening this week? What do we need to do? What do I need to tell our partners in Sweden about what is emulating coming out of China. And it is truly data-driven you know we need to develop safe and effective drugs and in today's environment around the globe, nobody is willing to pay for a drug that is going to be minimally effective anymore. We have to be in a very creative precision, the right drug for the right patient and around the globe, the healthy for the remember on until agencies will pay for innovation that brings value. We always have to keep that in mind and like any place else in the world, there's always constant pressure from the reimbursement agencies to keep the costs at their job. Our job is to innovate. Their job is to you know provide care for their uh their population. So there's got to be a balance there.

Jerry Isaacson: Yeah, of course. And that's a challenge that's only going to continue I wonder you know kind of building on what you were just talking about. Have you found obviously all the different regulatory agencies around the world have the same goal of bringing the most innovative and effective drugs to their populations? Do you find that for the most part, the demands of the different regulatory agencies are overlapping or are there different hurdles that you have to jump through? Because the agencies might see certain questions in a different light.

Dr. Alexander Zukiwski: I can tell you that you have to deal with you know I have projects that are being run in Europe on the CASI side. You have to deal with you know the MHRA, the French or the British health authority and I deal with the Chinese health authority on the other side. So you just have to be aware of what their different requirements are going to be. The way that a medical reviewer may view the safety reports and the safety profile of a project running in the United States versus how that you know medical officer will review those reports in China may be slightly different and sometimes they need additional background, additional you know translation and a summary, etc. So, one needs to be able to adapt and don't be surprised at any point in time that there is you know what we might describe is this is an unusual request. Okay. It may seem unusual to me. But we just have to get down, do the work and get them what they need. It's our job to facilitate their understanding.

Jerry Isaacson: That makes sense. And so, Dr. McAllister you know of course working from Europe, you have a number of different regulatory agencies within Europe and of course you always have an eye on the FDA and now of course NMPA as well. Can I get your thoughts on the same question?

Dr. Andres McAllister: yeah. So, I can definitely echo what Alex said and i would probably add that you know the dialogue with the regulators of the essence. So, if you're discussing with FDA it's important that they see exactly with your plans or what you're trying to do and engage that conversation with them. And same thing with European or Chinese authorities and understanding there where they're coming from, they are different. They expect different things. But in that context, the conversation and in the early an ongoing conversation with the regulate occurs, I think is really of the essence. You can identify where their susceptibilities are what they you know they have a visibility over a number of things that you don't so whatever message they convey. I think it's a good thing to integrate it into your uh development plans.

Jerry Isaacson: Absolutely. Makes sense and I think that Dr. Zukiwski, you see you make a good point of ultimately you know the regulatory agencies are going to ask for what they're going to ask for. And it's up to the companies to just be prepared for that. and they're not going to bend over backward to help you. You have to be prepared to give them what they want.

Dr. Alexander Zukiwski: Exactly, jerry you know. At the end of the day. CASI and BioInvent uh when the pivotal trial is completed for the registration of BI-1206, we're going to move forward with a global filing. And that means there's going to be questions from all of the health authorities going to come through. Some will be the same, some will be very similar and others you go, okay. This is going to take the programmers and the statisticians a couple of hours to get this data set for them. It is the way we work and how we work. It just has to be done.

Jerry Isaacson: Yeah so, I think we have just a couple minutes left here, but I wonder if I can just get some closing thoughts from each of, you just on really anything that we've talked about or anything that any thought you have that maybe I didn't ask about, Dr. McAllister?

Dr. Andres McAllister: No, just reiterate how this has been a great collaboration you know when you think back, you really feel you made the right decision in moving forward. And with our partners and we're truly happy about that. I think it's a good case study. It doesn't always work so well. And we're extremely happy to be able to do this with CASI. So, it has that huge perspective for us and their high value there, their input, their working together, et cetera.

Jerry Isaacson: Thank you so much and Dr. Zukiwski - any final thoughts?

Dr. Alexander Zukiwski: You know I can only reiterate what Andres has stated. It's important to have that relationship. It comes right from the very beginning. Open, transparent. And we're not afraid to disagree with each other. We're not afraid to ask questions about well and you know why do we want to do that? And if you don't have that dialogue and that trust, there's no malice ever meant by asking a question. You don't get anywhere.

Jerry Isaacson: So I think that if one thing is abundantly clear to me, it's just like it. Any relationship open and honest communication really seems to be the key to both getting the deal down and then making sure that it works. As time goes done, I think that everything that you've shared with us here today has been very informative for me. And hopefully for our listeners in terms of you know think people that companies were thinking about partnering around the world. And so let me just take one more opportunity to. Thank you both very much for your time. I really appreciate your insights. We'll look forward to having you know make have you guys having dinner together and having a good handshake when the global environment allows it very soon.

Knowledge Sharing

We are honored to have Crist Frangakis, CEO & President, Achelios Therapeutics, Pamela Contag, CEO & Founder, BioEclipse Therapeutics, Inc and Rashida Karmali, CEO and President, Tactical Therapeutics, Inc to be our guest speakers at Knowledge Sharing section.

Topic 1#: Chronic Pain Therapy In Conditions Of High Unmet Medical Need; Alternative To Opioids
Speaker: Crist Frangakis, CEO & President, Achelios Therapeutics

Topic 2#: A Phase 1 Cancer Immune-Therapy With First Four Doses Safe And Well-Tolerated
Speaker: Pamela Contag, CEO & Founder, BioEclipse Therapeutics, Inc

Topic 3#: CTO: First-in-class Inhibitor of Calcium Signaling to Treat Resistant Cancers & Malignant Gliomas
Speaker: Rashida Karmali, CEO and President, Tactical Therapeutics, Inc

Please find the detail sharing below:

 
 

MSQ Ventures are thankful to all the participants and attendants for joining this evnt with us. We hope to see you again at our next event!

Any inquiries, please contact us at event@msqventures.com