BioNTech's Hesitance and Matinas BioPharma's Persistence: A Study in Risk Tolerance

Thomas Edison is known to have failed a thousand times before he finally invented the electric light bulb. Every failure was a lesson that pushed him closer to his ultimate success. There's something powerful in the ability to fail, learn, and continue striving despite setbacks. And yet, it appears that this mindset is not always prevalent in the world of biotechnology.

One very recent example of this came from BioNTech's relationship with Matinas BioPharma. BioNTech, a company that has always struck me as being non-aggressively academic with a low tolerance for risk, recently abandoned its work with Matinas after a single in-vivo study did not demonstrate preclinical activity.

This move reminds me of when Yahoo had the opportunity to buy Google and Blockbuster could have purchased Netflix. As we all know, both these companies passed up on these opportunities, decisions that, in hindsight, were monumental mistakes. So, what happens when a company like BioNTech decides to abandon a project after a single unsuccessful study? Let's look at Matinas BioPharma as a case in point.

Following the end of their exclusivity period with BioNTech, Matinas moved forward, signing an agreement with National Resilience to study the applications of Lipid Nanocrystal (LNC) technology to deliver mRNA. The company, undeterred by BioNTech's withdrawal, is also developing an internal program for the delivery of siRNA therapies using its LNC platform.

Furthermore, Matinas has also filed numerous patents related to their systemic delivery of mRNA using a novel system called Phosphatidylserine Nanoparticles (PS-NP). This move is particularly interesting, considering BioNTech is currently facing a lawsuit for the alleged theft of lipid nanoparticle technology. One cannot help but wonder if they also had plans to make use of LNC or PS-NP technology.

Matinas has not given up. They've shown the same persistence that saw Edison to his lightbulb and Indiana Jones to his Holy Grail. They've carried on in the face of BioNTech's risk-averse approach, and their determination seems to be paying off.

The FDA appears to be favoring Matinas' MAT2203, an oral, broad-spectrum amphotericin B product designed to treat invasive fungal infections (IFIs), with a phase 3 study focusing on aspergillosis. This comes as no surprise since aspergillosis affects a significant number of Americans each year and is listed in the Critical Priority Group of the World Health Organization's fungal priority pathogen list.

Furthermore, Matinas has been successful in presenting MAT2203 compassionate use cases at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). The company's Compassionate Use Program has already treated seven patients with various IFIs, demonstrating the safety and effectiveness of MAT2203.

As if this wasn't enough, Matinas is also actively seeking non-dilutive funding from the Biomedical Advanced Research and Development Authority (BARDA) and the Advanced Research Project Agency for Health (ARPA-H) to further the development of MAT2203.

So, while BioNTech decided to abandon ship after one failed in-vivo study, Matinas has continued to sail forward, navigating through the choppy seas of clinical trials and regulatory processes.

Think about it like this.

Imagine if you were trying to start a hamburger business aimed at displacing McDonald's. You create a new burger, similar to the Big Mac, and give it to a few people. They don't like it. Does your partner throw up his hands and walk away? Of course not. You would try another combination, maybe even thousands of them. The chance of success lies in the number of attempts, not in the immediate acceptance of the first trial. This principle, it seems, is something BioNTech has failed to grasp. The rewards of defeating McDonald's in the hamburger arena would be monumental, just as the rewards of overcoming initial failures in drug development can lead to groundbreaking therapies that change the face of medicine.

BioNTech, in my opinion, are dinosaurs that give up too easily. They've invested heavily in their BioNTainers, planning to manufacture lipid nanoparticles on a massive scale in hard-to-reach areas like Kigali, Rwanda. It appears they're stuck in the past, reluctant to invent a better wheel, especially if it's going to cost them a lot to modify their platforms.

The comparison here is evident: while BioNTech may be content with their approach, preferring to stick to their tried-and-true methods, Matinas is boldly exploring new horizons. Like the proprietary sauce in our hamburger metaphor, Matinas' LNC technology has already proven successful with amphotericin B (our burrito), and now they're looking to expand its application, potentially revolutionizing the field of mRNA delivery.

The future of the biopharmaceutical industry, particularly the development and delivery of oral mRNA therapies, could represent a trillion-dollar market by 2050, given the vast array of oncology treatments and additional therapeutic programs currently in development. Companies that are willing to take risks, to fail and learn from those failures, will be the ones leading the charge. Matinas, with its persistence and commitment to innovation, has shown that it is ready for the challenge.

This isn't to say that BioNTech is destined to fail – far from it. The company has an impressive pipeline based on using LNP to deliver mRNA. However, their reluctance to engage in risk and their premature withdrawal from the collaboration with Matinas paints them as a company potentially more concerned with maintaining the status quo than pushing the boundaries of what's possible.

The Promising Results of Matinas BioPharma's Compassionate Use Program for MAT2203

Compassionate use programs are a critical part of the healthcare landscape, particularly in the world of biopharmaceuticals. They allow patients with life-threatening conditions to access promising investigational drugs when no other options are available. One such program is the compassionate use program for MAT2203 (Matinas BioPharma’s oral version of amphotericin B.) In this program, seven patients with various invasive fungal infections (IFIs) were treated and the results are striking.

To grasp the significance of these results, we must first understand the context. Fungal infections are notoriously difficult to treat, and the conditions of these seven patients were no exception. Many were suffering from infections resistant to standard antifungal treatments, and most were already in a compromised health state due to other conditions, such as systemic lupus erythematosus, chronic immunosuppression, acute myeloid leukemia (AML), Crohn's disease, and more.

Despite these challenges, MAT2203 demonstrated impressive effectiveness and safety across the board. For example, the first patient, a 37-year-old female with systemic lupus erythematosus, was at risk of losing her foot due to a non-healing ulcer and osteomyelitis caused by Rhodotorula mucilanginosa. After six months of treatment with MAT2203, she saw complete clinical resolution and regained full use of her foot, which had previously been at risk for amputation. Her renal function, which had deteriorated due to other treatments, also improved and remained at baseline throughout treatment with MAT2203.

A similar story unfolded for the second patient, a 71-year-old male with multiple painful skin lesions caused by Prototheca wickerhamii. After several months of ineffective treatment with voriconazole and posaconazole, the patient reported significant improvements in his skin lesions after using MAT2203.

A 15-year-old female patient suffering from AML and steroid-induced diabetes experienced a significant improvement in her condition after four months of treatment with MAT2203. She had a severe case of pansinusitis caused by Mucor nidicola and probable pulmonary aspergillosis caused by Aspergillus calidoustus. Despite extensive surgical debridement, her condition only improved after treatment with MAT2203. Her renal function, which had been compromised due to other treatments, returned to normal.

While the compassionate use program's success was not universal (a 39-year-old male patient with Crohn's disease discontinued MAT2203 treatment after only two days due to increased ileostomy output), the overall trend was overwhelmingly positive.

For instance, a 61-year-old male with recurrent hemorrhagic cystitis due to chronic Candida krusei infection had complete clinical resolution after just 14 days of treatment with MAT2203. His renal function, which had worsened after treatment with IV amphotericin B, returned to normal.

Similar success was seen in a 40-year-old female patient with C5-C6 quadriplegia and 34% Total Body Surface Area burns. After just 15 days of treatment with MAT2203, her renal function returned to normal, her skin graft was 90% healed, and she was able to transfer to a facility closer to her home.

The final patient, a 27-year-old male who had recently undergone a bone marrow transplant due to relapsed Hodgkin's disease, was suffering from proven invasive fungal meningitis and possible coccidioidomycosis. After failing voriconazole treatment and not tolerating IV Ambisome, the patient began treatment with MAT2203. His treatment is expected to continue for six months.

The success of MAT2203 in these cases is a testament to its potential in treating invasive fungal infections. The fact that patients who had previously experienced adverse reactions or resistance to other antifungal medications showed significant improvements with MAT2203 indicates that this drug might be a game-changer in the field.

Moreover, the success of this compassionate use program will likely lead to additional requests for MAT2203 treatment under similar programs. In the world of biopharmaceuticals, success breeds interest, and the impressive results seen in these seven patients will undoubtedly garner attention from both the medical community and potential patients alike.

This is significant not only for those suffering from IFIs but also for the continued development and eventual approval of MAT2203. Each successful treatment adds to the growing body of evidence supporting this drug. The data obtained from these compassionate use cases can provide invaluable insights into MAT2203's effectiveness, safety, and tolerability, supplementing data obtained from formal clinical trials.

Moreover, the wide range of patients treated — varying in age, underlying health conditions, and specific IFIs — highlights MAT2203's broad potential applicability. This diversity of successful use cases suggests that MAT2203 could be a versatile tool in the fight against IFIs.

There is also a broader implication here: the success of MAT2203's compassionate use program underscores the importance of such programs in the development of new drugs. Compassionate use programs provide real-world testing environments that can offer insights beyond those gained from controlled clinical trials. They allow for the treatment of patients who are often sicker and have more complicated medical histories than typical trial participants. Thus, they can reveal a drug's effectiveness in situations that more closely resemble the complex realities of medical practice.

The success of Matinas BioPharma's compassionate use program for MAT2203 is a promising sign of the drug's potential. By demonstrating its effectiveness and safety in a diverse range of patients, MAT2203 has not only provided a lifeline for individuals suffering from challenging IFIs but also bolstered its case for broader application. As we anticipate additional compassionate use requests and continued data collection, the future of MAT2203 looks bright — a beacon of hope in the ongoing battle against invasive fungal infections.

Moving on

The split between BioNTech and Matinas is a perfect illustration of the broader dynamics at play in the biopharmaceutical industry. The difference between a company that stays within its comfort zone, and one that dares to fail in pursuit of innovation, can be the difference between a company that merely survives, and one that truly thrives.

Matinas' story is a testament to the truth that failure is not the end, but rather a steppingstone towards success. While BioNTech's hesitation may have led to their withdrawal, Matinas has shown us all that, sometimes, the best way forward is to keep going, regardless of the obstacles in our way.

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