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AstraZeneca's Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses:

Results of the NIAGARA trial in bladder cancer

The significance of the five-year overall survival data from the HIMALAYA trial, specifically the long-term efficacy of the STRIDE regimen for unresectable liver cancer

Podcasts

In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer. 

Key Findings of the NIAGARA and HIMALAYA Trials

Fran Gregory, Vice President of Emerging Therapies at Cardinal Health, gives insight into:

Recent trends in the cell and gene therapy space

How CAR-T therapies have been gaining momentum and what kind of progress we can expect in the next 10 years

Personalized medicine and gene editing advances

The biggest hurdles within cell and gene therapy space and how do we begin to jump over them

The biggest foci for cell and gene therapy for the next 5 years

Fran Gregory, PharmD, MBA, is Vice President of Emerging Therapies at Cardinal Health, where she is responsible for Cell & Gene Therapies and Biosimilars. Fran’s background includes extensive clinical, HEOR, trade and commercial experience in the payer/PBM, specialty pharmacy, and biotech manufacturer spaces. Her career reflects a consistent focus on complex, innovative, high-value pharmaceuticals, and a passion for breaking down barriers to access and care. Throughout her career she has paved the way in innovation by starting two of the first and largest specialty pharmacies in the US, launching two of the first cell and gene therapies in the world, and bringing several first-to-market biosimilars to patients. As a pharmacist, she has an acute focus on patient outcomes, and is an expert in value-based care models, reimbursement and payment strategies, as well as navigating successful teams in healthcare to deliver solutions to bring advanced therapies and treatments to patients.

The editors of Pharmaceutical Executive bring you the latest commercial insights to master the science of success. Podcast episodes examine current trends, key conferences, and critical topics in the bio/pharmaceutical industry.

Fran Gregory, VP of Emerging Therapies, Cardinal Health discusses her career, how both CAR-T therapies and personalization have been gaining momentum and what kind of progress we expect to see from them, some of the biggest hurdles facing their section of the industry, the importance of patient advocacy and so much more. 

Cell and Gene Therapy Check-in 2024

Etira’s CEO discusses recent developments in R&D and with the company’s leadership.

Developing Therapies for Treatment Resistant Cancers: Q&A with Russell Hayward

As the first major treatment to be approved for schizophrenia in over 30 years, Cobenfy is poised to set the stage for new approaches in treating mental health disorders. 

A New Schizophrenia Treatment: What the Approval of Cobenfy Could Mean for Handling Mental Health Disorders 

Framework proposes three strategies designed to address the unique challenges of personalized and genetic therapies for rare diseases—and increase the probability of economic success for a new wave of potential curative treatments for these conditions. 

ROI and Rare Disease: Retooling the ‘Gene’ Value Machine 

Results from the Phase III SURMOUNT-1 study show that tirzepatide, a dual GIP and GLP-1 receptor agonist, achieved substantial average weight loss of 22.9% in patients with pre-diabetes and obesity. 

Tirzepatide Demonstrates Significant Benefits for Patients with Pre-Diabetes, Obesity Over 176 Weeks

Why tapping the value generated for the next set of therapies is critical. 

Powering Pipelines Forward: Approach Science Differently

AstraZeneca Oncology Agents

PE: Are there any other promising oncology agents in AstraZeneca’s pipeline that you wish to highlight?

So, we are dedicating today into two different types of drugs to attack cancer: the ones that attack cancer directly, by targeting a mutation like EGFR mutations, like directing with ADCs or radioligands to a specific marker in the cell -- so attacking the tumor cell itself. We have a lot of success stories there, like TAGRISSO, LYNPARZA, CALQUENCE, and we have ENHERTU and Dato-DXd coming to the market soon, directing to the cancer cell itself.

Then, the other part of our strategy, which is the part that will be growing more and more in the next few years, is how can we enhance the immune system in controlling the growth of the cancer. Now we were not the first there, this all started with PD-L1 and PD-1 inhibitors. We were not the first ones to enter that but I’m very proud to say today that we now probably have the biggest portfolio in that regard. That includes not only PD-1 and PD-L1 inhibitors, but bispecifics. We also have T-cell engagers in both in solids and in heme, and we also have a big portfolio of cellular therapies coming both in hematological cancers, solid tumors, and even in immunology that we’re starting trials across the world. Well, [we’ve already started trials] in hematology right now; in solid tumors we already started, and in immunology [trials are starting] very very soon So, there's tons of things that will come your way and plenty of opportunities for us to meet again and talk about the ten years or the first year or the five years anniversaries of all the molecules. All in all, what we are expecting in the next 24 months, is something like 20 to 26 read outs if everything goes right.

Videos

In an interview with Pharm Exec Associate Editor Don Tracy, Carlos Doti, VP, Head of Medical Affairs, US Oncology Business Unit, AstraZeneca, discusses a number of oncology targets in the works at AstraZeneca. 

Video Series

A Look into Promising AstraZeneca Oncology Agents

PARP Cancer

PE: Overall, can you discuss the impact that PARP inhibitors have had on the cancer treatment landscape?

 I think PARP inhibitors change several ways of how we think cancer. First of all, it’s not just treating directly to a mutation that impacts the growth of a cancer or just blindly impacting the cancer growth like chemotherapy, but actually synergizing on mechanism of repairs by sensitizing the cell with chemotherapy and then using the PARP inhibitor to have long standing responses. That’s why you can use it as a maintenance of an already accomplished response or in combination with another drug in first line ovarian cancer.

Second thing I also mentioned is that mutation that affects the family members beyond the case that is in discussion, that is not unique to 

, and now we see a lot more of this kind of thinking into oncology, both in solid tumors and in hematological tumors as well. So, I think that it's definitely a tipping point for us in oncology as a whole, by bringing this different kind of thinking when we decide the treatment of a patient and how we impact the whole family members around that. Which it was done before, but not to the extent that we’ve seen it’s been done today. 

PE: Can you briefly speak about the history of LYNPARZA® (olaparib)? Specifically, what caused it to lay dormant for so long and what influenced AstraZeneca to keep working on the drug’s development?

When you're marking drug development, you know this is a journey for years. We have a very conscious decision as a company that we don't develop drugs in isolation. It’s not because we found another mechanism of action or we acquire a company, we just go in that place, and then we move to the next. So, if you see our history in the last 10 years, we decided to go into specific areas of unmet needs such as lung cancer, breast cancer, gynecological cancers, genitourinary gastrointestinal cancers and hematology. And in each of these therapeutic areas that we go, we go all in, right? For us, LYNPARZA was the first of the second generation of drugs that we developed. It helped us and taught us so many things into how to do clinical development here. That’s where we started with second line ovarian. We moved to first line combinations in ovarian. We went also in advanced setting in breast cancer and we also went in the adjuvant setting, which is the other thing that we've learned from LYNPARZA and others to do more. Everything that we do in AstraZeneca we start with the biggest unmet need, which is usually in second line following metastatic, but we want to make sure that we bring our drugs to every single patient that may benefit from it. So, if you see our portfolio, everything that we do, we try to go as early as possible and that is the proof for LYNPARZA both in ovarian and in breast and also in prostate.

Now, if I may, move this a little bit for more personal, LYNPARZA was one of the reasons that I joined AZ eight years ago, and this month is my eight-year anniversary so I’m still celebrating until the 31st of July because when I saw what we can do with this science, we saw that AstraZeneca was thinking oncology in a different way. Although we were not acknowledged as the big players that we are known as today back in 2014, I always thought this is the kind of approach that we need to have. It’s not just solving one indication for a drug, it’s how to solve the patient journey as a whole and LYNPARZA has a lot to do within science today in AstraZeneca.

In an interview with Pharm Exec Associate Editor Don Tracy, Carlos Doti, VP, Head of Medical Affairs, US Oncology Business Unit, AstraZeneca, talks PARP inhibitors in cancer treatment and the history of Lynparza. 

AstraZeneca VP, Head of Medical Affairs, US Oncology, Discusses the Impact of PARP Inhibitors on Cancer Treatment 

The Impact of Lynparza

PE: Can you update current research efforts into new indications for LYNPARZA® (olaparib)?

LYNPARZA, as you know, is a PARP inhibitor, right? Now, like every other drug, not only in oncology, in everything, it has a desired effect and adverse events. Most of these adverse events sometimes in oncology come from, they’re called the “off target innovation”. So, you’re planning to block one target in one specific cell, but you also block that target in another cell that’s not intended, or you block more than one target. So, the next generation of PARP inhibition is selective PARP inhibition, and we’re already developing a next generation of PARP inhibitors. One of the first molecules that will come to market is saruparib, which is a PARP1 select. So, selecting just PARP1, into this inhibition by bringing the benefits that we get from LYNPARZA, but with less adverse events in the indications that we are currently operating, but potentially to become a safer drug to be used in combinations in other places where PARP inhibitions may play a role. Not only in solid tumors but in other areas as well. So, I think that LYNPARZA set up the tone on how researching this area should be delivered, and then saruparib will actually expand into PARP inhibitions into other areas as well. And potentially also combinations because. one of the problems when you have specific adverse events is it makes some of these drugs hard to combine. By being more selective, you can expand the number of combinations that you can bring to market.

PE: Out of all of its approved indications, for which cancer type do you think LYNPARZA has had the greatest impact?

This is like asking somebody which kid they love the most. So, it’s hard to say. I think that there's two ways of measuring this. If you measure by number of patients impacted, it's easy to say probably breast cancer or ovarian cancer, because this is where you have the broad indications. But you have a patient with pancreatic cancer that has no other resource, and you are identified by this 

 mutation. For that single individual, what LYNPARZA can bring is unique. So, it’s hard to say the impact from a society perspective. You may have one answer and from a patient perspective, you may have another. I think the most relevant part of this is, whenever there's a potential that by using a PARP inhibitor, we can make a difference. We will definitely want to go there. It all started with ovarian cancer, and we have a long line of usage there, but we've seen also in breast cancer that early adoption. And I’ll give you an example, not only the early adoption for the drug itself, but I think what LYNPARZA changed completely is the early adoption of testing for 

. So, 10 years ago, only a handful of patients were tested for that. Now today, a lot of patients, most of them when they reach in their journey in breast cancer or ovarian cancer, they are being tested by 

, and if you find that patient who has that 

 mutation, that unlocks testing in the family types. So, in breast and in lung, we’re saving lives, not only by using the LYNPARZA in that case that was identified, but by preventing ovarian and breast cancer in the family members that have that mutation and they don’t know. And wouldn’t know if it wasn’t by that individual in the family that has ovarian or breast cancer.

In an interview with Pharm Exec Associate Editor Don Tracy, Carlos Doti, VP, head of medical affairs, US oncology business unit, AstraZeneca, provides an update on current research efforts for Lynparza and discusses its impact on cancer patients over the past decade. 

The Impact of Lynparza as a Cancer Treatment 

Femasys Femaseed Femblock

PE: Recently, during the Femaseed pivotal trial, it demonstrated that 24% of women became pregnant after Femaseed with severe male factor. Moving forward, what does this mean for the future of treating infertility, and do you expect this to improve as time goes on?

There was actually a landmark study that was published in 2022 that shows very concerning trends related to male sperm count. In fact, what the publication showed was that we have a decline of over 50% in male sperm count in all age categories in every country. It’s a worldwide issue and there is no therapeutic option available to improve sperm count. No one has been able to determine the exact cause. There are a number of suspected reasons. But with that being said, when you have less sperm, just by the nature of the numbers alone, it's really critical that there be technologies that help address that, which is exactly what we did with Femaseed, bringing sperm to where it needed to go.

In our clinical trial, we showed that 24% of women have a partner with a significant male sperm count issue. The results were that those 24% of women were able to achieve pregnancy. This is very significant, because the only other option for them is truly IVF, which, for many reasons, women or couples will never make it to that particular choice. IUI has already been determined not to be effective in low sperm count, so Femaseed is going to fill a very significant void that's a growing concern and a trend that we're seeing around the world.

PE: Can you briefly discuss the history of Fembloc and what it means for the safety of birth control?

I’m actually the inventor of Fembloc. I developed this product very purposely for something I would agree to undergo, or something I would recommend for my daughters to undergo. From a permanent birth control standpoint, there is only one option available to women around the world, and that's surgical tubal ligation. When we come to that point in our lives, whether we're had enough children in our 20s or in our 40s, or don't want to have any more children, the options are so limited. Fembloc was designed to be non-surgical. This means that there’s no anesthesia or incisions. We also developed this product so we would not leave anything behind, so there would be no implants or hormones.

The products works by delivering a proprietary biopolymer that we've created that stays in the patient for a short period of time, and ultimately, we leave her with her own tissue and growth. From a safety standpoint, it's her own tissue. We are not introducing anything long-term that's a foreign body, and that's really critical when we look at women's health. We created this product to ultimately be the safest choice that women can make when they don't want to have a risk of pregnancy any longer.

PE: With the upcoming presidential election, how do you see the potential outcome effecting women’s healthcare, particularly in areas such as reproductive rights?

I've never seen this much discussion and spotlighting of women's health issues and concerns for wherever anyone stands on the issue. I think most would agree that women deserve more options, and they need to be better. I don't think on either side there will be discordance around the fact that we need more options for women, and we need to support companies that are willing to undergo that task. It is a very difficult specialty to get funding. It's very difficult from a regulatory standpoint to advance technologies. The fact that it’s such a topic of conversation for a presidential election warms my heart from a feminist standpoint, because we've been for two decades trying to advance our technologies forward. I'm encouraged by looking at kind of what positive could come about, and hopefully the discussions will continue as women's voices are now being heard.

In an interview with Pharm Exec Associate Editor Don Tracy, Kathy Lee-Sepsick, Founder, CEO, Femasys, discusses results of the Femaseed pivotal trial, Fembloc birth control, and how the outcome of the 2024 United States presidential election could impact women's health. 

Femasys CEO Talks Results of the Femaseed Pivotal Trial and the History of Fembloc Birth Control

Citius Pharmaceuticals Leonard Mazur Mino-Lok

PE: Citius recently announced positive topline results from the pivotal Phase III clinical of Mino-Lok, which is designed to salvage catheters in patients with central line-associated infections or catheter-related bloodstream infections. Can you briefly explain what the data found?

Basically, there’s two arms. One was the Mino-Lok arm, which was a treatment arm. And the other arm was something we call a home-brew, which is something that the hospital mixes up on their own at times when a patient’s catheter is infected and they no longer have access points to remove and replace, they have to try and salvage that catheter. So, they’ll mix up something and attempt to dollars a catheter that way. This trial was designed to cap an endpoint of time to catheter failure. It's a negative event in reality. The p-value success that we had was probably record breaking in terms of statistical significance between the two arms. Actually, everybody was surprised. That was our primary endpoint.

PE: What enables Mino-Lok to salvage catheters in these two scenarios?

Mino-Lok is a very unique formulation, and I think the minocycline in it. The inventor of it had worked for years to try and find the ideal combination to be able to salvage a catheter within a time frame that would not compromise the integrity of the IV treatment. That’s a key part. With Mino-Lok, you’re able to do this in a way that’s administered two hours at a time, two hours a day. That means that the solution gets injected into the catheter. It’s hemodynamically locked, so the solution does not go into the human body. After two hours, the nurse comes back in and aspirates out the content, and the patient has 22 hours of uninterrupted IV flow. That’s not really part of the trial per se, but in the real world, that means an awful lot, because those IV lines are critical.

We have this formulation consisting of minocycline, disodium EDTA, and alfarol, and that combination is what allows it to work. It’s due to minocycline being brought back into the market.

I was the co-founder of a dermatological company that made acquisition called tryouts, and we would acquire dermatological products. So, we acquired minocycline from Wyeth, and it's mainly an antibiotic for acne. Around a year and a half after acquiring it, we got a call one day from the Department of Defense, and they wanted to see if we could put the IV form back on the market. They were treated soldiers that were wounded in Iraq and Afghanistan in a German hospital for an infection that they found minocycline gave them the best result. The only difficulty was that they couldn’t continue treatment in the United States. The reason they gave was because Wyeth discontinued the IV form when they launched another hospital-based antibiotic, and they didn't want to have two of them out there. I said “Listen, we’re a derm company, we’re not a hospital company, we’re not anything remotely resembling that.” He begged me to bring it back.

So, I sat down with my late partner at the time, and I happen to be a Marine veteran. I said “We’re going to lose money on this proposition all the way, but I think it's the patriotic thing to do. Let's bring this thing back.” It took us a year, but we got it, we sourced it, we did everything, and all we could afford were to put two salespeople on the road. A couple of months go by, and I notice we’re getting all this buying from MD Anderson Hospital in Houston. I go down there meet with the chief of infectious disease, and I found out he wasn’t buying this drug to treat, but for experimental purposes. When it became available, he all of the sudden had something new to experiment with, and that’s how this drug came to be.

Everybody tried all different combinations and most of the time, they would have to keep the solution inside the catheter and a line for hours on end. His name is Issam Raad, and he’s the inventor of it. He did a great job in terms of getting everything formulated.

In an interview with Pharm Exec Associated Editor Don Tracy, Leonard Mazur, Co-Founder, CEO, Citius Pharmaceuticals, discusses recent topline results from the pivotal Phase III Clinical Trial of Mino-Lok, which works to salvage catheters infections. 

Citius Pharmaceuticals Co-Founder and CEO Talks Promising Results from a Phase III Clinical Trial for Mino-Lok, a Treatment Designed to Salvage Catheters in Patients with Central-Line Associated Infections

Pedro Valencia AbbVie Bispecific Biologic Therapies Solid Tumors Blood Cancers

PE: Can you discuss how AbbVie is advancing the development of bispecific biologic therapies for solid tumors and blood cancers?

We’ve been working with bispecifics for a while. We have one bispecific called CD3xCD20. The CD3 tackles a T-cell and the CD20 tackles the malignant cell. It’s already approved for non-Hodgkin’s lymphoma.

We’re also working on a bispecific in multiple myeloma. It’s BCMA-CD3 against the cancer cell, and that’s in late development. Last week, we announced a Phase III in multiple myeloma. Now in solid tumors, those bispecifics are definitely less common. We have c-Met and a target of choice. We also have a bispecific that tackles an NK cell and c-Met, and we call it TriNKET. It’s currently in the clinic and in dose escalation against multiple tumor types. We are very excited about bispecifics.

PE: Can you please discuss other potential treatments in AbbVie’s solid tumor pipeline that you wish to highlight?

I’d like to highlight two specifically. One is ELAHERE and that’s the one we recently acquired from Immunogen last year. It’s a first-in-class polar receptor Alpha ADC that has a DM4 payload and has been the first one ever to show survival benefit in a patient segment that is really tough to treat. It’s called platinum-resistant ovarian cancer. We’re rapidly expanding it to go to other patient segments within ovarian cancer, such as early lines of therapies or platinum-sensitive ovarian cancer. That one is moving forward at full speed, and we are looking forward to sharing more as we go. Last week, we shared a press release of a single arm monotherapy study that showed promising results in the platinum-sensitive patient segment.

The other one I'd like to mention is in our second area of focus in immuno-oncology. We have a novel mechanism called livmoniplimab. We tackle the TGF beta GARP complex. This gets formed in the tumor microenvironment and prevents the T-cells from tackling the tumor. By blocking this, we can actually make the T-cells tackle the tumor, and PD1 therapies work better. We have that specific therapy being evaluated in combination with our own PD1 in cancer types such as bladder cancer, liver cancer, lung cancer, and colorectal cancer. It's still quite novel, and I look forward to sharing more results in the next year or so.

In an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses how AbbVie is advancing the development of bispecific biologic therapies in both solid tumors and blood cancers. 

Advancing Bispecific Biologic Therapies for Solid Tumors and Blood Cancers

Regeneron Velocisuite

PE: Do you believe that this treatment could eventually become a frontline treatment for MM?

We are very encouraged by the data that we are observing in relapsed/refractory multiple myeloma, and the intentions are to transition into early lines of therapy. Currently, we have a Phase III trial. We are also evaluating in other conditions, so yes, the intentions are to transition into earlier lines of therapy.

PE: Can you discuss Regeneron’s VelociSuite Technologies and how that has bolstered ongoing research in hematologic malignancies?

We have different kinds of platforms, including the VelociSuite technology, and I will focus more on that. So, VelocImmune is a technology that is helping us to produce optimized fully human monoclonal antibodies, which use a proprietary mouse platform engineered with a genetically humanized immune system to create a multitude of different antibody candidates that are efficiently and directly from immunized mice. This is helping us to produce a type of human monoclonal antibody that is not going to present all the challenges that some humanized antibodies have.

The other technology that we are using is Veloci-Bi. It’s a technology that allows us to generate a full-length bispecific antibody, similar to the native antibodies. Therefore, these are likely to have more favorable pharmacokinetic properties. We are applying the knowledge of three decades worth of biology expertise to develop medicines that help patients with different conditions including hematologic malignancies.

PE: Are there any other candidates in Regeneron’s oncology pipeline that you would like to highlight?

We are very encouraged by all of this year’s findings. First of all, I would like to focus on linvoseltamab. Our regulatory filing was accepted and its currently under review. A final decision is expected on August 22, 2024. We are also in the process of review with the EMA.

We have multiple studies and as I mentioned before, we have Phase III trials, and we have a Phase II study that is being evaluated in high risk smoldering multiple myeloma and also monoclonal gammopathy of undetermined significance. Apart from these in the case of hematology, we are also developing odronextamab, which is our CD20xCD3 bispecifc in relapsed/refractory follicular lymphoma and in diffuse large B-cell lymphoma that is currently under review by the EMA. In the case of the FDA, we have discussions that are ongoing. Beyond that, some additional data is going to be presented at ASCO. 

In an interview with Pharm Exec Associate Editor Don Tracy, Karen Rodriguez-Lorenc, Global Program Head of Linvoseltamab, Regeneron talks about the possibility of linvoseltamab becoming a frontline treatment for multiple myeloma (MM) as well as the company's VelociSuite technology. 

Regeneron Global Program Head of Linvoseltamab Discusses the Potential for Linvoseltamab to Become a Frontline Treatment for Multiple Myeloma

Regeneron MM

PE: What are some of the key findings from the ongoing phase I/II trial of linvoseltamab in multiple myeloma that led to the BLA submission and priority review designation?

The lymphoma was evaluated in the LINKER-MM1 study. This is a study that is being run in relapsed/refractory multiple myeloma. We think that the study represents the patient population in multiple myeloma quite well, because the inclusion of a large patient population that is older than 75 years. Also, there’s a representation of African American patients. This study was presented with a follow up of 11 months median duration. It was a 71% overall response rate, with 46% of the patients retaining complete response. 62% of those patients retain VGPR, which is a very good partial response. This was also evaluated by the independent review committee. We have a median response time of one month, a median time of VGPR of three months, and a median time of complete response of eight months. The median duration of response progression free survival and overall survival have not yet been reached. We have a landmark analysis that was done at 12 months, with an estimated probability of maintaining the response at 78%, of being progression fee at one year of 69%, and of overall survival at one year of 75%. We also observed that it was information of MRD negativity. In patients that were evaluable, the rate of the MRD negativity to the 10 to the minus five was 93%. The safety was consistent with the preliminary observations, and we did not have any new safety signals.

PE: Can you discuss the ongoing clinical trial program for this treatment and what you have found regarding the drug’s efficacy treating multiple myeloma?

In Phase I, we evaluated nine different doses. We evaluated from three milligrams to 800 milligrams. When we transitioned to Phase II, doses of 50 and 200 milligrams were evaluated. which are consistent with the concordant. 200 milligrams was selected as the dose to pursue further development. As I mentioned before, results of efficacy were in 71% of responses, and the important thing is that we did a pre-pacified subgroup analysis for efficacy. The observations were very consistent, even in patients that are more difficult to treat. In the case of African American and Black patients, 85% had a response. In older patients, there was a response rate of 71%. Extramedullary plasmacytoma, which usually consists of patients that are difficult to treat, had a response rate of 53%.

The other thing we try to evaluate is if a different regiment with less intense doses could help so help us to maintain the efficacy and mitigate the safety. In the Phase II part of the 200 milligram patients, the evaluation was to reduce the intensity after reaching six months of treatment for those patients that achieve very good clinical response. 29 of those patients reached a good clinical response. Despite reducing the intensity of the treatment, approximately 50% of those patients achieved a complete response or better.

In an interview with Pharm Exec Associate Editor Don Tracy, Karen Rodriguez-Lorenc, Global Program Head of Linvoseltamab, Regeneron talks key findings from the ongoing phase I/II trial of linvoseltamab in multiple myeloma that led to the submission of an FDA Biologics License Application (BLA). 

Regeneron Global Program Head of Linvoseltamab Discusses Key Findings of a Phase I/II Trial in Multiple Myeloma

How LP-284 uniquely addresses unmet needs compared to existing or emerging treatments for relapsed/refractory lymphomas and solid tumors

Addressing Unmet Needs with LP-284 for Relapsed/Refractory Lymphomas and Solid Tumors

The oncology landscape is crowded with novel therapies. How do you see LP-284 uniquely addressing unmet needs compared to existing or emerging treatments for relapsed/refractory lymphomas and solid tumors?

The thing about 284 is, you know, that is novel, it is mechanistically in a class, it's fairly well accepted and known, it's, you know, it's opposed to alkyl later. Now, it's a selective alkyl later, because it seems to really target cancer cells, or B cells and cancer cells. And not all cells, like most calculators, it also has, you know, several times more potency than most calculators. So, I think the fact that there's a known mechanism, it seems to prefer cancer cells, I think that makes it unique. And it's relatively more goal to scale and produce most of the other biologics out there. They're going after NHL today.

Can you speak on the anticipated timeline for a next stage and any key milestones to watch for as LP-284's development progresses?

The key things that we're going to be looking at this year is obviously in the phase one, to get to our maximum tolerated dose, that's going to be very important so that we can open up, you know, combination trials, we also expect to have some data toward the end of this year about LP 284 In other autoimmune conditions. So, we've actually started a campaign to look at LP 284 and LP284's mechanism in categories that we historically have not been in but are pretty significant. So that also excites us. And we'll have some data about that. And I think also we're beginning a lot of discussions with pharma partners that are historically have larger footprints in non Hodgkins lymphomas, because as I mentioned before, this drug shows remarkable synergy with some of the mainstays in non Hodgkins lymphomas like rituximab and cyclophosphamide, and some of those has great synergy potential. 

So, when you think about patients that roll off of that or stop responding to that, effectively, we think that this drug can reenergize and actually be a great option for recurrent events for those patients, which today there aren't very many of them. That you know, as the data from the trial will tell us everything and will inform us where it's working best but will also guide us as to what sub indications are genetically defined populations and non Hodgkins lymphomas are even better responders. Right now, we go in with a thesis that mantle cell lymphoma and high grade B cell lymphoma, especially double hit and triple hit are going to be the ones that are most responsive based on all of our preclinical work and based on the in silico analysis that we've done. And if we can get a sense of that in the trial. And also, the trial, as you noted, probably is also open to a number of sarcomas.

So certainly, no sarcomas are genetically very, very, hugely heterogeneous. You know, some look more like solid tumors, some look with more like blood cancers, some look like a mishmash of things. And so, there are definitely some sarcomas that we're beginning to see some good data on in the early phase of this trial. And so, if we see some servos that are uniquely responsive, and as you know, some patients don't have a lot of options. And so that also could be something that opens up. We haven't applied for orphan indication in the sarcomas yet, but that's something that we'll probably do. And so, you'll one of the other events we'll see for 284 is expanding the number of orphan indications we have two already, and we think we'll probably gather a few others as we develop the drug.

In this Pharmaceutical Executive video interview, Panna Sharma, CEO, Lantern Pharma, discusses how LP-284 uniquely addresses unmet needs compared to existing or emerging treatments for relapsed/refractory lymphomas and solid tumors.

Panna Sharma, CEO, Lantern Pharma, talks about ensuring global access to LP-284, particularly in regions with limited resources

Ensuring Global Access to LP-284

With an estimated 40,000-80,000 potential annual beneficiaries worldwide, how will you go about ensuring global access to LP-284, particularly in regions with limited resources?

One thing I think that's really unique about this drug in particular non Hodgkins lymphoma (NHL) is we're in an era now, where NHLs with recurrent, especially recurrent, are being treated with fairly expensive regimens, Carty therapy by specific antibodies, things that are very hard to pronounce, they don't have three or four syllables anymore, they have six to nine syllables. And so every syllable, you're adding another $100,000, I feel like in the pharma world, but you know, those are not affordable drugs. This is a small molecule, we can make this at small molecule level prices. And again, it's a brand new drug, the drug never been even, you know, had a concept of it, you know, four or five years ago. We think that it can be widely available, easily produced and distributed using the same molecule, small molecule machinery that all the big farmers have. So we think there's going to be a lot of interest, especially places where it's difficult to do Carty, where it's difficult to whether it's an autologous or allogeneic. And by specifics are really expensive to produce and distribute, and there's a lot of cold chain issues, etc. So we think this is a drug that has shown pretty equivalent, if not superior, preclinical data to some of the cutting edge therapies being used. Again, that's preclinical, but showing preclinical to preclinical if you've got pretty equivalent data monotherapy, and actually better data in combination. I think that's a great starting place.

And our cost of making this drug is a decimal place different than most biologics. I mean, the farmers are addicted to burning cash. And so there's no there's no incentive to try to do things cheaper, unless you're a small company that has no money, every shot that we take has to count. And so, when we designed to eight, four, we looked at the manufacturing process and said, How can we piggyback on the pharmacophores of 184 for its sister molecule? By doing that, it allowed us to really skip through a whole series of some synthesis, and steps and, and do some kind of separation later on down. And we actually, you know, we think we can actually make that more efficient, actually, the next go round.

It's very exciting because one, we want to make drugs cheaper, that's kind of our core mission is to make them more precise, and to make them more efficiently. And I think this is a great case study for that. And that's why we're particularly excited. And we're also going to extend to a for the next round in in combination therapy. So, we've published on this and one of the Mainstays and non Hodgkins lymphoma as you probably know in your readers or viewers, is rituximab, and we've published on 284. Plus, rituximab in combination shows remarkable efficacy, even much better than monotherapy of either drug alone, and we can cut the dose even in half and have even a better window for the for the combination regimen. So, we're pretty excited by that. And we're going to do you know, probably that in a phase one beast slash to probably Phase II combination, we'll probably do a combination of the rituximab and 284 as a safety role and then go to a full combination trial versus 184 alone and see how that does. So again, the avenues because it's so well molecularly characterized, we've got a number of publications. We think it opens us up to actually other diseases outside of cancer. So like I mentioned before, this is a really potent B cell depleted and so B cells play a role in a number of autoimmune conditions as well. And we wouldn't be the first company looking to partner this asset with some of the big autoimmune players to looking at some of those kinds of diseases.

In this Pharmaceutical Executive video interview, Panna Sharma, CEO, Lantern Pharma, talks about ensuring global access to LP-284, particularly in regions with limited resources

R&D/Clinical Trials

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